Indometacine Sandoz may be available in the countries listed below.
Indometacin is reported as an ingredient of Indometacine Sandoz in the following countries:
International Drug Name Search
Generic Name: griseofulvin (Oral route)
gris-ee-oh-FUL-vin
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antifungal
Griseofulvin belongs to the group of medicines called antifungals. It is used to treat fungus infections of the body, feet, groin and thighs, scalp, skin, fingernails, and toenails. This medicine may be taken alone or used along with medicines that are applied to the skin for fungus infections.
Use of griseofulvin for prevention of fungus infection have not been established.
This medicine 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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of griseofulvin in children. However, safety and efficacy have not been established in children up to 2 years of age.
No information is available on the relationship of age to the effects of griseofulvin in geriatric patients.
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 this medicine, 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 this medicine 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain griseofulvin. It may not be specific to Gris-PEG. Please read with care.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Keep yourself clean to help control infection and prevent reinfection.
Griseofulvin is absorbed best when it is taken with a high fat meal, such as a cheeseburger, whole milk, or ice cream. Tell your doctor if you are on a low-fat diet.
Griseofulvin is best taken with or after meals, especially fatty ones (e.g., whole milk or ice cream). This lessens possible stomach upset and helps to clear up the infection by helping your body absorb the medicine better. However, if you are on a low-fat diet, check with your doctor.
For patients taking the oral liquid:
You may swallow the tablets whole or sprinkle the crushed tablets in one tablespoonful of applesauce. Swallow it immediately without chewing.
The dose of this medicine 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 this medicine. 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 this medicine, 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 should check the progress of you or your child at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several weeks or months before your infection gets better.
Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
Griseofulvin has been shown to cause liver and thyroid tumors in some animals. You and your doctor should discuss the good this medicine will do, as well as the risks of taking it.
Birth control pills containing estrogen may not work properly if you take them while you are taking griseofulvin. Unplanned pregnancies may occur. To keep from getting pregnant, use another form of birth control for up to 1 month after your last treatment. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
Griseofulvin may increase the effects of alcohol. If taken with alcohol it may also cause fast heartbeat, flushing, increased sweating, or redness of the face. If you have these symptoms, do not drink alcoholic beverages while you are taking this medicine, unless you have checked first with your doctor.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.
Griseofulvin may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
If you have a severe reaction from the sun, 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: Gris-PEG side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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.
Boots Sleepeaze 25 mg Tablets
(Diphenhydramine Hydrochloride)
This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.
This medicine contains Diphenhydramine Hydrochloride which belongs to a group of medicines called sedating antihistamines, which help you to sleep.
It can be used to relieve short term sleeplessness.
This medicine can be taken by adults and children aged 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
Driving and using machines: This medicine causes drowsiness. You should not drive or operate machinery for at least 8 hours after taking the tablets.
Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.
If you take this medicine continuously for a long time (e.g. more than 2 weeks), you may become dependent on it.
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
Check the foil is not broken before use. If it is, do not take that tablet.
Adults and children of 16 years and over: Take two tablets 20 minutes before going to bed. Don’t take a third tablet in the same night.
Swallow the tablets with water.
Do not give to children under 16 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you take too many tablets: Talk to a doctor straight away. Take your medicine and this leaflet with you.
Most people will not have problems, but some may get some. If you are elderly you may be more likely to get some of these side effects.
If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.
Do not store above 25°C.
Store in the original package. Keep the foil in the outer carton.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton.
Each tablet for oral administration contains Diphenhydramine Hydrochloride 25 mg, which is the active ingredient.
As well as the active ingredient, the tablets also contain lactose, maize starch, magnesium stearate.
The pack contains 20 tablets.
by
Leaflet prepared June 2007
If you would like any further information about this medicine, please contact
In addition to Boots Sleepeaze 25 mg Tablets, the following guidelines may enhance your sleep pattern and help you enjoy the benefits of a good night’s sleep.
3029aXPil
Mysoline 50mg Tablets
Each tablet contains 50mg primidone.
For full list of excipients see section 6.1
Tablet
White or virtually white, round, biconvex, uncoated tablets intagliated with a single M on one side and plain on the reverse.
Mysoline is indicated in the management of grand mal and psychomotor (temporal lobe) epilepsy. It is also of value in the management of focal or Jacksonian seizures, myoclonic jerks and akinetic attacks.
Management of essential tremor.
Epilepsy: Treatment must always be planned on an individual basis. In many patients it will be possible to use Mysoline alone, but in some, Mysoline will need to be combined with other anticonvulsants or with supporting therapy.
Mysoline is usually given twice daily and may be administered using either the 50 mg or 250 mg strength tablets.
Begin with 125 mg once daily late in the evening. Every 3 days increase the daily dosage by 125 mg until the patient is receiving 500 mg daily. Thereafter, every 3 days increase the daily dosage by 250 mg in adults or 125 mg in children under 9 years - until control is obtained or the maximum tolerated dosage is being given. This may be as much as 1.5 g a day in adults; 1 g a day in children.
Average daily maintenance doses:
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The total daily dose is usually best divided and given in two equal amounts, one in the morning and the other in the evening. In certain patients, it may be considered advisable to give a larger dose when the seizures are more frequent. For instance: 1) if the attacks are nocturnal then all or most of the day's dose may be given in the evening; 2) if the attacks are associated with some particular event such as menstruation, a slight increase in the appropriate dose is often beneficial.
Elderly patients: It is advisable to monitor elderly patients with reduced renal function who are receiving primidone.
Patients on other anticonvulsants: Where a patient's attacks are not sufficiently well controlled with other anticonvulsants, or disturbing side effects have arisen, Mysoline may be used to augment or replace existing treatment. First add Mysoline to the current anticonvulsant treatment by the method of gradual introduction described previously. When a worthwhile effect has been achieved and the amount of Mysoline being given has been built up to at least half the estimated requirement, withdrawal of the previous treatment can then be attempted. This should be done gradually over a period of 2 weeks, during which time it may be necessary to increase the Mysoline dosage to maintain control.
Withdrawal of previous treatment should not be too rapid or status epilepticus may occur. Where phenobarbitone formed the major part of the previous treatment, however, both its withdrawal and Mysoline substitution should be made earlier, so as to prevent excessive drowsiness from interfering with accurate assessment of the optimum dosage of Mysoline.
Essential tremor: Initially a dose of 50 mg daily should be introduced. The daily dose should be increased gradually over a 2 to 3 week period until remission of symptoms or the highest dose tolerated up to a maximum of 750 mg daily.
Patients with essential tremor who have not previously been exposed to anticonvulsants, or other drugs known to induce increased hepatic enzyme activity, may experience acute symptoms of tolerance to Mysoline, frequently characterised by vertigo, unsteadiness and nausea. It is, therefore, essential to start such patients at a low dosage (initially 50 mg daily) increasing very slowly up to the maximum tolerated dose or that which produces remission of tremor (up to 750mg daily).
Patients who exhibit hypersensitivity or an allergic reaction to primidone, to a constituent of the formulation or to phenobarbitone, should not receive the drug. Primidone should not be administered to patients with acute intermittent porphyria.
Mysoline should be given with caution and may be required in reduced dosage in children, the elderly, debilitated patients or those with impaired renal, hepatic or respiratory function.
Primidone is a potent CNS depressant and is partially metabolised to phenobarbitone. After prolonged administration there is a potential for tolerance, dependence and a withdrawal reaction on abrupt cessation of treatment.
Exceptionally, as with phenytoin and phenobarbitone, megaloblastic anaemia may develop requiring discontinuation of primidone. This condition may respond to treatment with folic acid and/or vitamin B12. There have been isolated reports of other blood dyscrasias.
Primidone has the potential to harm the foetus, see section 4.6 before considering use during pregnancy.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for primidone.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Both primidone and its major metabolite phenobarbitone are metabolized by, and also induce, liver enzyme activity, principally the CYP 450 3A4 enzyme system..
Agents which inhibit the CYP 450 3A4 enzyme system, such as chloramphenicol, felbamate, nelfinavir*, metronidazole and sodium valproate may result in increased plasma levels of concomitantly administered primidone and its metabolite phenobarbitone.
In addition, St. John's Wort* induces the CYP450 enzyme system and may result in a reduction of plasma levels of concomitantly administered primidone and of its major metabolite phenobarbitone.
Theophylline protein binding may affect phenobarbitone binding, affecting free phenobarbitone levels.
Primidone therapy may also lead to altered pharmacokinetics in concomitantly administered drugs, whose metabolism may be increased and lead to lowered plasma levels and/or a shorter half-life. These drugs include androgens*, beta-antagonists, carbamazepine, cyclosporin, cloazepine, chloramphenicol, corticosteroids/glucocorticosteroids, cyclophosphamide, dicoumarins, digitoxin*, doxycycline, ethosuxamide, etoposide, felbamate, granisetron, lamotrigine, losartan, methadone*, metronidazole, mainserin, montelukast*, nelfinavir*, nimodipine, oral-contraceptives, oxcarbazepine, phenytoin, quinidine, rocuronium, sodium valproate, tiagabine, theophyllines, topiramate, tricyclic antidepressants, vecuronium, warfarin and zonisamide.
Primidone inhibits the glucoronidation of paracetamol* and may increase the hepatotoxicity of paracetamol.
The CNS depressant effect of primidone is additive to those of other CNS depressants such as alcohol, opiates and barbiturates.
The above interactions are potentially clinically significant.
* No formal interaction studies have been performed. The inclusion of the drug is based on reports of their influence or dependence upon enzyme systems influenced by, or of relevance to the metabolic pathways of primidone or its major metabolite, phenobarbitone.
Pregnancy: Primidone is suspected to have caused serious birth defects when administered during pregnancy. In infants born of epileptic mothers treated with primidone, there have been reports of congenital abnormalities including congenital heart disease, cleft palate and conditions associated with maternal folate deficiency, including spina bifida, microencephaly and anencephaly. Primidone should not be used during pregnancy unless clearly necessary to manage epilepsy in the mother where withdrawal of therapy may cause risks or where alternative anti-epileptic managements are unsuitable.
Withdrawal symptoms may occur in the newly born whose mothers have received primidone during late pregnancy.
Long-term anticonvulsant therapy can be associated with decreased serum folate levels. As folic acid requirements are also increased during pregnancy, regular screening of patients at risk is advised, and treatment with folic acid and Vitamin B12, although controversial, should be considered.
Anticonvulsant therapy in pregnancy has occasionally been associated with coagulation disorders in the neonates. For this reason pregnant patients should be given Vitamin K1 through the last month of pregnancy up to the time of delivery. In the absence of such pretreatment, 10 mg Vitamin K1 may be given to the mother at the time of delivery and 1 mg should be given immediately to the neonate at risk.
Lactation: During breast feeding the baby should be monitored for sedation.
As with most other anticonvulsants, patients who drive vehicles or operate machinery should be made aware of the possibility of impaired reaction time.
If adverse effects do appear, the most common side effects are drowsiness and listlessness but these generally occur only in the beginning of treatment.
Visual disturbances, nausea, headache, dizziness, vomiting, nystagmus and ataxia have been reported but are usually transient even when pronounced. On occasions an idiosyncratic reaction may occur which involves these symptoms in an acute and severe form necessitating withdrawal of treatment.
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Vitamin D supplementation may be needed during long-term primidone therapy, since vitamin D catabolism may be increased.
Exceptionally, as with phenytoin and phenobarbitone, megaloblastic anaemia may develop requiring discontinuation of primidone. This condition may respond to treatment with folic acid and/or Vitamin B12.
Primidone is metabolised extensively to phenobarbitone and overdosage leads to varying degrees of CNS depression which, depending on the dose ingested, may include ataxia, loss of consciousness, respiratory depression and coma.
Crystalluria may occur in overdosage and could be used as a helpful diagnostic aid where primidone overdosage is suspected.
Depending on the severity of intoxication, therapy should include aspiration of stomach contents, administration of activated charcoal, administration of intravenous fluids, forced alkaline diuresis (striving for a urine pH of 8.0), and general supportive measures. In more life threatening circumstances, haemoperfusion (if the patient is hypotensive) or haemodialysis are effective.
There is no specific antidote.
Pharmacotherapeutic group: Antiepileptics (barbiturates and derivatives).
Therapeutic classification: N03AA03
The activity of Mysoline is due to the anticonvulsant properties of three active moieties, namely primidone itself and its two major metabolites phenobarbitone and phenylethylmalonamide. The relative contribution of these three moieties to the clinical anticonvulsant effect has not been firmly established. Although the precise mode of action of primidone is unknown, in common with other anticonvulsants, effects on the neuronal membrane particularly with respect to alteration of ionic fluxes are likely to play a fundamental role.
Primidone, as with other anticonvulsants, can induce liver enzymes.
Primidone is absorbed rapidly from the gastrointestinal tract, peak plasma levels being attained approximately 3 hours after ingestion. Primidone is well distributed in all organs and tissues: it crosses the blood-brain and placental barriers and is excreted in breast milk. The pharmacokinetics of primidone are complex because of biotransformation into two metabolites, phenobarbitone and phenylethylmalonamide, that have anticonvulsant activity and complex pharmacokinetic properties. Primidone has a plasma half-life of approximately 10 hours which is considerably shorter than those of its principal metabolites.
Primidone and phenylethylmalonamide are bound to plasma proteins to only a small extent, whereas approximately half of phenobarbitone is bound. Approximately 40% of the drug is excreted unchanged in urine.
Primidone is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
Carmellose calcium
Gelatin
Magnesium stearate
Povidone K30
Purified water
Stearic acid
Not applicable.
5 years.
Store below 25°C.
HDPE bottle containing 100 tablets, with a white HDPE, tamper-evident, child resistant push-on cap with a white LDPE liner.
No special requirements.
Acorus Therapeutics Limited
Office Village
Chester Business Park
Chester
Cheshire
CH4 9QZ.
UK
PL 20132/0006
02/06/2010
02/06/2010
Treating Parkinson disease. It may also be used for other conditions as determined by your doctor.
Kemadrin is an anticholinergic agent. It works by relaxing smooth muscle, which stops muscle spasms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Kemadrin. 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 Kemadrin. 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 Kemadrin 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 Kemadrin 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 Kemadrin.
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:
Blurred vision; constipation; dilated pupils; dry mouth; giddiness; lightheadedness; loss of appetite; nausea; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; difficult or painful urination; difficulty swallowing; eye pain; fast or pounding heartbeat; mental or mood changes; uncontrolled movements.
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: Kemadrin 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 dilated pupils; fast breathing; fast heartbeat; hot, dry, or flushed skin.
Store Kemadrin 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 Kemadrin out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Kemadrin. 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.
Clonazepamum may be available in the countries listed below.
Clonazepam is reported as an ingredient of Clonazepamum in the following countries:
International Drug Name Search
Tracetin may be available in the countries listed below.
Bacitracin is reported as an ingredient of Tracetin in the following countries:
Neomycin is reported as an ingredient of Tracetin in the following countries:
International Drug Name Search
