Glicenex may be available in the countries listed below.
Metformin is reported as an ingredient of Glicenex in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Glicenex in the following countries:
International Drug Name Search
Trimidura may be available in the countries listed below.
Trimipramine maleate (a derivative of Trimipramine) is reported as an ingredient of Trimidura in the following countries:
International Drug Name Search
Nicozid may be available in the countries listed below.
Isoniazid is reported as an ingredient of Nicozid in the following countries:
International Drug Name Search
0006805-41-0
C54-H84-O23
1101
Agent for antivaricose therapy
Vasoprotective agent
Saponin isolated from Aesculus hippocastanum
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Dafalgan Codeine may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Dafalgan Codeine in the following countries:
Paracetamol is reported as an ingredient of Dafalgan Codeine in the following countries:
International Drug Name Search
Kiatrium may be available in the countries listed below.
Diazepam is reported as an ingredient of Kiatrium in the following countries:
International Drug Name Search
Dipal may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Povidone-Iodine is reported as an ingredient of Dipal in the following countries:
International Drug Name Search
Pennsaid Solution is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you use Pennsaid Solution for a long time. Do not use Pennsaid Solution right before or after bypass heart surgery.
Pennsaid Solution may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Treating pain in the knee joints caused by osteoarthritis. It may also be used for other conditions as determined by your doctor.
Pennsaid Solution is an NSAID. Exactly how it works is not known. It may work by blocking certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Pennsaid Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Pennsaid Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pennsaid Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Pennsaid Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Pennsaid Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dry skin or mild irritation at the application site; gas; nausea; stomach upset.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; burning, numbness, or tingling of the skin; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent irritation at the application site; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes, stomach pain, diarrhea); unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Pennsaid side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea, vomiting, or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.
Store Pennsaid Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pennsaid Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Pennsaid Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Retimax may be available in the countries listed below.
Pentoxifylline is reported as an ingredient of Retimax in the following countries:
International Drug Name Search
Generic Name: formoterol (for MOE ter all)
Brand Names: Foradil Aerolizer, Perforomist
Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.
Formoterol inhalation is used to prevent bronchospasm in people with reversible obstructive airways disease, including symptoms of night-time asthma. It is also used in people with chronic obstructive pulmonary disease (COPD) such as emphysema and chronic bronchitis.
Formoterol inhalation may also be used for other purposed not listed in this medication guide.
Asthma is often treated with a combination of different drugs. If you use formoterol inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.
If you have any of these other conditions, you may need a dose adjustment or special tests:
a food or drug allergy;
heart disease or high blood pressure;
epilepsy or other seizure disorder;
diabetes; or
a thyroid disorder.
Asthma is often treated with a combination of different drugs. If you use formoterol inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. This device is not to be used with a spacer. Ask your doctor or pharmacist if you have any questions.
If you are using formoterol inhalation to prevent exercise-induced asthma, use the medicine 15 minutes before exercising, or as directed by your doctor. Allow at least 12 hours to pass before you use the medicine again.
Use formoterol inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.
Use the medication as soon as you remember, then wait 12 hours before using the medication again. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include chest pain, nervousness, dry mouth, nausea, sleep problems (insomnia), tremors, chest pain, fast or irregular heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).
chest pain, fast or pounding heartbeats, tremors, shaking, or restless feeling;
wheezing, choking, or other breathing problems after using this medication;
increased thirst or hunger, urinating more than usual; or
worsening asthma symptoms.
Less serious side effects may include:
dizziness, anxiety, headache;
sleep problems (insomnia);
back pain, muscle cramps;
sore throat, dry mouth, cough, stuffy nose;
skin rash, itching; or
changes in your voice.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before using formoterol inhalation tell your doctor if you are taking any of the following medicines:
cisapride (Propulsid);
droperidol (Inapsine);
methadone (Methadose);
pentamidine (NebuPent, Pentam);
a diuretic (water pill);
caffeine, diet pills, cold medicine, or a stimulant medication;
an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);
medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), or thioridazine (Mellaril);
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), or sotalol (Betapace);
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
an antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
This list is not complete and other drugs may interact with formoterol inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Foradil Aerolizer side effects (in more detail)
In the US, Diphen (diphenhydramine systemic) is a member of the following drug classes: anticholinergic antiemetics, anticholinergic antiparkinson agents, antihistamines, miscellaneous anxiolytics, sedatives and hypnotics and is used to treat Allergic Reactions, Cold Symptoms, Cough, Extrapyramidal Reaction, Hay Fever, Insomnia, Motion Sickness, Nausea/Vomiting, Pruritus and Urticaria.
US matches:
Diphenhydramine hydrochloride (a derivative of Diphenhydramine) is reported as an ingredient of Diphen in the following countries:
International Drug Name Search
Depotrust may be available in the countries listed below.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Depotrust in the following countries:
International Drug Name Search
Deptran may be available in the countries listed below.
Doxepin hydrochloride (a derivative of Doxepin) is reported as an ingredient of Deptran in the following countries:
International Drug Name Search
Ibu-hepa may be available in the countries listed below.
Heparin is reported as an ingredient of Ibu-hepa in the following countries:
Ibuprofen is reported as an ingredient of Ibu-hepa in the following countries:
International Drug Name Search
Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Benadryl Allergy and Sinus Liquid is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by promoting sinus and nasal drainage, which relieves congestion and pressure.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Benadryl Allergy and Sinus Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Benadryl Allergy and Sinus Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Benadryl Allergy and Sinus Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Benadryl Allergy and Sinus Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Benadryl Allergy and Sinus Liquid.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, and throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble urinating or inability to urinate; unusual bruising or bleeding.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Benadryl Allergy and Sinus side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.
Store Benadryl Allergy and Sinus Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Benadryl Allergy and Sinus Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Benadryl Allergy and Sinus Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Defencat may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Permethrin is reported as an ingredient of Defencat in the following countries:
International Drug Name Search
Biorgan may be available in the countries listed below.
Trimebutine is reported as an ingredient of Biorgan in the following countries:
International Drug Name Search
Nopain may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Nopain in the following countries:
Metamizole sodium monohydrate (a derivative of Metamizole) is reported as an ingredient of Nopain in the following countries:
Nalbuphine hydrochloride (a derivative of Nalbuphine) is reported as an ingredient of Nopain in the following countries:
Naproxen is reported as an ingredient of Nopain in the following countries:
Naproxen sodium salt (a derivative of Naproxen) is reported as an ingredient of Nopain in the following countries:
International Drug Name Search
Diprosalic Ointment
Betamethasone Dipropionate 0.064% w/w*
(* equivalent to 0.05% Betamethasone)
Salicylic Acid 3.00% w/w
Ointment
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid. It is active topically and produces a rapid and sustained response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and it is also effective in the less responsive conditions, such as psoriasis of the scalp, chronic plaque psoriasis of the hands and feet, but excluding widespread plaque psoriasis.
Topical salicylic acid softens keratin, loosens cornified epithelium and desquamates the epidermis.
Diprosalic presentations are therefore indicated for the treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses where the cornified epithelium may resist penetration of the steroid. The salicylic acid constituent of Diprosalic preparations, as a result of its descaling action, allows access of the dermis more rapidly than by applying steroid alone.
Adults :
Once to twice daily. In most cases a thin film should be applied to cover the affected area twice daily.
For some patients adequate maintenance therapy may be achieved with less frequent application.
It is recommended that Diprosalic preparations are prescribed for two weeks, and that treatment is reviewed at that time. The maximum weekly dose should not exceed 60g.
Children :
Dosage in children should be limited to 5 days.
Rosacea, acne, perioral dermatitis, perianal and genital pruritus. Hypersensitivity to any of the ingredients of the Diprosalic presentations contra-indicates their use as does tuberculous and most viral lesions of the skin, particularly herpes simplex, vacinia, varicella. Diprosalic should not be used in napkin eruptions, fungal or bacterial skin infections without suitable concomitant anti-infective therapy.
Occlusion must not be used, since under these circumstances the keratolytic action of salicylic acid may lead to enhanced absorption of the steroid.
Local and systemic toxicity is common, especially following long continuous use on large areas of damaged skin, in flexures or with polythene occlusion. If used in children or on the face courses should be limited to 5 days. Long term continuous therapy should be avoided in all patients irrespective of age.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons, including rebound relapses following development of tolerance, risk of generalised pustular psoriasis and local systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important.
It is dangerous if Diprosalic presentations come into contact with the eyes. Avoid contact with the eyes and mucous membranes.
The systemic absorption of betamethasone dipropionate and salicylic acid may be increased if extensive body surface areas or skin folds are treated for prolonged periods or with excessive amounts of steroids. Suitable precautions should be taken in these circumstances, particularly with infants and children.
If irritation or sensitization develops with the use of Diprosalic Ointment and Lotion, treatment should be discontinued.
Any side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
If excessive dryness or increased skin irritation develops, discontinue use of this preparation.
Peadiatric Use: Peadiatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
None stated
Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
None stated.
Diprosalic skin preparations are generally well tolerated and side-effects are rare.
Continuous application without interruption may result in local atrophy of the skin, striae and superficial vascular dilation, particularly on the face.
Adverse reactions that have been reported with the use of topical corticosteroids include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis and allergic contact dermatitis.
The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
In addition, prolonged use of salicylic acid preparations may cause dermatitis.
Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal functions resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism, including Cushing's disease.
Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
With topical preparations containing salicylic acid excessive prolonged use may result in symptoms of salicyclism. Treatment is symptomatic. Measures should be taken to rid the body rapidly of salicylate. Adminster oral sodium bicarbonate to alkalinize the urine and force diuresis.
The steroid content of each tube is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
Diprosalic preparations contain the dipropionate ester of betamethasone which is a glucocorticoid exhibiting the general properties of corticosteroids, and salicylic acid which has keratolytic properties.
Salicylic acid is applied topically in the treatment of hyperkeratotic and scaling conditions where its keratolytic action facilitates penetration of the corticosteroid.
In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory and/or immune suppressive effects.
Topical corticosteroids such as betamethasone dipropionate are effective in the treatment of a range of dermatoses because of their anti-inflammatory, anti-pruritic and vasoconstrictive actions. However, while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanisms of their action in each disease are uncertain.
Salicylic acid exerts only local action after topical application.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal barrier and the use of occlusive dressings.
Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolised primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted in the bile.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Liquid Paraffin
White Soft Paraffin
None Stated.
60 months
Do not store above 25°C.
15, 30 or 100gm expoxy-lined aluminium tubes with plastic caps.
Not applicable
Schering-Plough Ltd
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
England
PL 0201/0070
10th June 1986 / 25th July 1997
8 June 2009
Prescription Only Medicine
Diprosalic-O/UK/06-09/5
em-trye-SYE-ta-been, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate, a component of emtricitabine/tenofovir disoproxil fumarate. Not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine/tenofovir; monitor hepatic function upon discontinuation of therapy .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor
Emtricitabine and tenofovir combination is used with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Emtricitabine and tenofovir combination will not cure or prevent HIV infection or the symptoms of AIDS; however, it helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Emtricitabine and tenofovir combination will not keep you from spreading HIV to other people. People who receive emtricitabine and tenofovir may continue to have other problems usually related to AIDS or HIV infection.
emtricitabine and tenofovir is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For emtricitabine and tenofovir, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to emtricitabine and tenofovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of emtricitabine and tenofovir combination in children younger than 12 years of age and weighing less than 35 kilograms. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of emtricitabine and tenofovir combination have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving emtricitabine and tenofovir combination.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking emtricitabine and tenofovir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using emtricitabine and tenofovir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using emtricitabine and tenofovir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of emtricitabine and tenofovir. Make sure you tell your doctor if you have any other medical problems, especially:
Take emtricitabine and tenofovir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
emtricitabine and tenofovir comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.
emtricitabine and tenofovir can be taken with or without food.
Keep using emtricitabine and tenofovir for the full time of treatment, even if you or your child begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.
emtricitabine and tenofovir works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.
Do not change the dose or stop using emtricitabine and tenofovir without checking first with your doctor. When your supply of emtricitabine and tenofovir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of emtricitabine and tenofovir.
The dose of emtricitabine and tenofovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of emtricitabine and tenofovir. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of emtricitabine and tenofovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check the progress of you or your child at regular visits to make sure that emtricitabine and tenofovir is working properly. Blood and urine tests may be needed to check for unwanted effects. You should remain under the care of a doctor while taking emtricitabine and tenofovir.
You should not use emtricitabine and tenofovir if you or your child are also taking adefovir (Hepsera®), Atripla™, Emtriva®, or Viread®. Do not use emtricitabine and tenofovir if you are also using medicines containing lamivudine (e.g., Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Trizivir®). Tell your doctor right away if you or your child are using any of these medicines. Do not start using emtricitabine and tenofovir combination until your doctor tells you to.
Two rare but serious reactions to emtricitabine and tenofovir are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Check with your doctor right away if you or your child have abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; unusual tiredness or weakness; or yellow eyes or skin.
emtricitabine and tenofovir is not for the treatment of hepatitis B virus infection. Patients infected with both HBV and HIV who take emtricitabine and tenofovir combination need close medical follow-up for several months after stopping treatment to make sure their hepatitis B infection does not get worse.
emtricitabine and tenofovir may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you or your child have any concerns.
emtricitabine and tenofovir may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.
Make sure any doctor or dentist who treats you knows that you or your child are using emtricitabine and tenofovir. emtricitabine and tenofovir may affect the results of certain medical tests.
Emtricitabine and tenofovir combination does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: emtricitabine and tenofovir side effects (in more detail)
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The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Digoxin Grindeks may be available in the countries listed below.
Digoxin is reported as an ingredient of Digoxin Grindeks in the following countries:
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Deribadex may be available in the countries listed below.
Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Deribadex in the following countries:
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Dequalinium Chloride Synco may be available in the countries listed below.
Dequalinium Chloride is reported as an ingredient of Dequalinium Chloride Synco in the following countries:
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Colofac Tablets 135 mg
Mebeverine Tablets 135mg
Fomac Tablets 135 mg
Colofac IBS
Boots Pharmacy IBS Relief 135mg Tablets
Mebeverine hydrochloride 135mg.
For excipients, see section 6.1
Coated tablets.
Round white sugar coated tablets, with no superficial markings.
Colofac Tablets/Mebeverine Tablets 135 mg/Fomac Tablets 135mg:
For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Colofac is effectively used to treat the symptoms of these conditions, such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.
Colofac IBS/ Boots Pharmacy IBS Relief 135mg Tablets: For the symptomatic relief of Irritable Bowel Syndrome.
Colofac Tablets/Mebeverine Tablets 135 mg/Fomac Tablets 135mg:
Adults (including the elderly):
One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks, when the desired effect has been obtained, the dosage may be gradually reduced.
Paediatric Population
Mebeverine 135 mg tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
Colofac IBS/Boots Pharmacy IBS Relief 135mg Tablets:
Adults (including the elderly):
One tablet three times a day, preferably 20 minutes before meals.
If symptoms persist for more than 2 weeks, consult your doctor.
Warning: Do not exceed the stated dose.
Paediatric Population
Mebeverine 135 mg tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.
Hypersensitivity to the active substance or to any of the excipients.
Since Mebeverine coated tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Colofac IBS / Boots Pharmacy IBS Relief 135mg Tablets :
If this is the first time you have had these symptoms, consult your doctor before using any treatment.
If any of the following apply, do not use mebeverine. It may not be the right treatment for you. See your doctor as soon as possible.
- you are aged 40 years or over
- you have passed blood form the bowel
- you are feeling sick or vomiting
- you are looking pale and feeling tired
- you are suffering from severe constipation
- you have a fever
- you have recently travelled abroad
- you are or may be pregnant
- you have abnormal vaginal bleeding or discharge
- you have difficulty or pain passing urine
Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.
No interaction studies have been performed. .
No clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing to pregnant women.
There is insufficient information on the excretion of mebeverine in human or animal breast milk. Physico-chemical and available pharmacodynamic data on mebeverine point to excretion in breast milk and a risk to the suckling child cannot be excluded. Mebeverine should not be used during breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed.
Allergic reactions mainly but not exclusively limited to the skin have been observed (A frequency cannot be estimated from the available data)
Immune system disorders:
Hypersensitivity
Skin and subcutaneous tissue disorders:
Urticaria, angioedema, erythematous rash
Theoretically CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible.
No specific antidote is known; gastric lavage and symptomatic treatment is recommended.
Pharmacotherapeutic group: Synthetic anticholinergics, esters with tertiary amino group, ATC-Code: A03AA04
Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.
Mebeverine is rapidly and completely absorbed after oral administration in the form of tablets or suspension. Mebeverine is not excreted as such, but metabolised completely. The first step in the metabolism is hydrolysis, leading to veratric acid and mebeverine alcohol. Both veratric acid and mebeverine alcohol are excreted into the urine, the latter partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.
During its development phase the entity mebeverine was extensively tested in several animal species in acute, (sub) chronic and reproduction investigations.
The oral LD50 ranged from 902 - 1995 mg/kg.
The main symptoms in the animals, after very high oral and parenteral doses, were indicative of central nervous involvement with behavioural excitation.
The dosages used in animal studies exceeded several times the dosages used for humans (40 mg/kg for animal dosing versus 6 mg/kg for humans).
No mutagenic or clastogenic effects were found in in vitro and in vivo studies with mebeverine.
Lactose, starch (potato or maize), povidone, talc, magnesium stearate, sucrose, gelatin, acacia, carnauba wax.
Not applicable.
5 years.
Do not store above 30°C. Store in the original package.
Boxes containing 10, 15, 84 or 100 tablets in blister strips.
HDPE tamper-evident tablet container with snap on cap containing 500 tablets.
None.
Abbott Healthcare Products Limited/Abbott Healthcare Products Limited trading as Boots Pharmacy
Mansbridge Road
West End
Southampton
SO18 3JD
PL 00512/0044
14 March 1978/21 April 2005
31/03/2011
Colofac Tablets/ Mebeverine Tablets 135 mg/Fomac 135 mg: POM
Colofac IBS/ Boots Pharmacy IBS Relief 135mg Tablets: P
