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Demser® (metirosine, MSD) PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. Keep this leaflet. You may want to read it again. What is in your capsules? Active ingredient The active ingredient in your capsules is metirosine. Demser is available as two-tone blue, opaque capsules containing 250 mg of metirosine USP. Other ingredients Hydroxypropyl cellulose EP colloidal anhydrous silica EP, indigo carmine E132 titanium dioxide E171, gelatin EP. Demser Capsules are available in bottles of 100. How do your capsules work? The active ingredient in your capsules is metirosine. Metirosine inhibits an enzyme called tyrosine hydroxylase which is important in the production of certain hormones including adrenaline and noradrenaline. These hormones are naturally occurring chemicals in your body and are involved in the control of heart rate and blood pressure. In certain diseases, where adrenaline and noradrenaline are produced in abnormally high levels, treatment with metirosine is used to reduce these amounts. Who makes your capsules? Your capsules are made by Merck Manufacturing Division Merck & Co. Inc., West Point, Pennsylvania USA, for Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, UK, who hold the Product Licence in the UK and the Product Authorisation in Ireland. Why do you need to take these capsules? Your doctor has prescribed Demser for you to treat a condition known as phaeochromocytoma, which .,e will probably have explained to you. Phaeochromocytoma is a tumour which usually occurs near the kidney, and secretes the hormones adrenaline and noradrenaline. The increased levels of these hormones, if left untreated, may cause high blood pressure and increase your risk of stroke, heart attack and damage to your kidneys. Are there patients who should not take these capsules? Yes, do not take the capsules if you have had a bad reaction to this or similar medicines, or to any of the ingredients in the past. Demser should not be given to children under 12 years of age. Demser is not suitable for the treatment of ordinary high blood pressure or 'essential hypertension'. If you think any of these apply to you, do not take the capsules, go and talk to your doctor first and follow his advice. What else should you know before taking your capsules? You should check with your doctor before taking the capsules if:
Your doctor will probably have told you that it is important that you drink plenty of liquids while being treated with Demser. Your doctor might examine your urine occasionally during treatment and suggest that you increase the amount of liquid you are drinking. What about alcohol? Alcohol should be avoided during treatment with 'Demser', as the medicine may increase the effects of alcohol. |
What about driving and operating machinery? When you start taking the capsules, or if the dose is increased, Demser may make you feel weak and drowsy and reduce physical coordination. If this occurs, you should avoid hazardous activities like driving, or operating machinery. If you are unsure or confused, talk to your doctor or pharmacist. Can you take Demser with other medicines? There are a few other medicines which may not mix with 'Demser'. Your doctor knows about these and will alter your treatment as needed. It is important that you tell your doctor about all the medicines you are taking, including any drugs obtained without a doctor's prescription. If you are taking any of the following medicines, you should talk to your doctor about them: sleeping pills, sedatives, tranquillisers and anti-anxiety agents. How should you take Demser? You must take your capsules by mouth exactly as advised by your doctor or pharmacist. The number of capsules you take each day will depend on your condition. For many people the initial dose is 1 capsule four times a day, which may be increased by 1 or 2 capsules daily. The dosage range is usually 8-12 capsules a day. When 'Demser' is given before an operation, the optimum dose range should be given for five to seven days before surgery. Your doctor will probably monitor your condition regularly by carrying out laboratory tests on urine and, possibly, blood samples. What if you forget to take a capsule or take too many? If you miss a dose just carry on with the next one as normal. Do not take an extra one to make up. If you take too many capsules by mistake, seek medical attention immediately. What unwanted effects could your capsules have? Like all medicines, Demser may occasionally cause side effects in some patients. The most common side effect is sedation or fatigue, which usually appears .within the first 24 hours of treatment, peaks after two or three days, and decreases during the next few Jays. Less frequent side effects are diarrhoea, drooling, trembling, jerky movements, and speech difficulty. Anxiety, depression, hallucinations, disorientation and confusion may occur but usually disappear if the dose is reduced. Rarely, slight swelling of the breast, nasal stuffiness, dry mouth, headache, nausea, vomiting, abdominal pain, and impotence or failure of ejaculation, and occasional difficulty or pain in passing urine may occur. Slight swelling of hands or feet, and skin rashes, have occurred rarely. Patients may have altered sleep patterns or increased alertness after stopping treatment. If you notice any of the above effects, or you have any unusual symptoms or feelings, stop taking the capsules and seek medical attention. You should remember to tell the doctor you are taking Demser if you have a blood, urine or other test, as the medicine may affect test results. How should your capsules be kept? Keep your medicine out of the reach of children. Keep the container tightly closed, store below 25ºC, protected from light. Do not transfer the capsules into another container, as they might get mixed up. If you have any capsules left over when your doctor tells you to stop taking them, then return them to the pharmacist. Do not take the capsules past the expiry date which is clearly marked on the pack. REMEMBER, this medicine is for you. Do not share it with anyone else. It may not suit them. Date of issue: March 1996.How can you obtain more information about Demser? This leaflet gives you some of the most important patient information about Demser. If you have any |
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questions after you have read it, ask your doctor or pharmacist, who will give you further information. ® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. |
© Merck Sharp & Dohme Limited, 1994. All rights reserved. |