PACKAGE LEAFLET: INFORMATION FOR THE USER. MEPHENON 10mg/1ml, solution for injection MEPHENON 5mg, tablets. Methadone hydrochloride

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER MEPHENON 10mg/1ml, solution for injection MEPHENON 5mg, tablets Methadone hydrochloride Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What MEPHENON is and what it is used for 2. What you need to know before you use MEPHENON 3. How to use MEPHENON 4. Possible side effects 5. How to store MEPHENON 6. Contents of the pack and other information 1. WHAT MEPHENON IS AND WHAT IT IS USED FOR Methadone hydrochloride is a morphinic derivative being one of the main pain relief medications. MEPHENON can be used - for the treatment of the symptoms but not the cause of intense pain and/or pain that has not responded to less potent analgesics cough that has not responded to other medicines against cough - within the framework of a detoxification program to alleviate the symptoms of opioid withdrawal. Treatment must be dispensed by a specialist centre and the patient continuously monitored by qualified staff. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEPHENON Do not use MEPHENON MEPHENON must absolutely not be used in following cases : - if you are allergic to the active substance and to opioids derivatives or to any of the other ingredients of this medicine (listed in section 6); - respiratory depression; - head injury causing raised intracranial pressure; - use of certain medicines for depression (MAO inhibitor e.g.); - use in children under the age of two; - severe abdominal pain of unknown origin; Page 1 de 6

2 - acute alcoholism. Warnings and precautions Talk to your doctor or pharmacist before using MEPHENON. Caution is required in the following cases: - impaired renal and hepatic function; - over-active thyroid; - increased prostate volume; - central nervous system depression; - the elderly; - subjects with a history of addiction to medicines with central nervous system effects (morphinic derivatives); - decreased cortico-adrenal function; - if you are receiving methadone injections, an antidote must be available. MEPHENON use is unadvised in following cases : - bronchial asthma; - chronic obstructive bronchopulmonary disease; - bowel obstruction; - gastrointestinal surgery; - cardiac disorders; - decreased thyroid function; - shock. Cases of QT interval prolongation and torsades de pointe have been reported in patients during treatment with methadone, particularly at high doses (>100 mg/day). Methadone should be administered with caution to patients at risk of developing QT interval prolongation, e.g. in the event of: - history of QT interval prolongation; - advanced heart disease; - ischemic cardiopathies and hepatic affections; - concomitant treatment with one or more medicines liable to cause QT interval prolongation. Other medicines and MEPHENON Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. If your urine becomes more acidic, renal elimination (clearance) of MEPHENON may increase. * Recommended Interactions: only with medical advice - laxatives: to alleviate the constipation caused by MEPHENON; - antispasmodics: to reduce stomach cramps and liver pain. * Avoid taking MEPHENON at the same time as: - alcohol and medicines causing a central nervous system depressive effect, i.e. which moderate the nervous system, since these effects could be exacerbated and the dose of one or both of these medicines will have to be reduced: This is the case for: antihistamines (medicines used to treat allergies and chills); sleeping tablets, tranquillisers, drug used for the treatment of anxiety and depression; other potent analgesics; Page 2 de 6

3 medicines used for anaesthesia (for instance, for dental procedures); certain muscle relaxants. - medicines which are metabolised by the same liver enzymes since they may trigger withdrawal syndrome. This is the case for: some antiviral medications : efavirenz, névirapine, ritonavir. anti-epileptic drugs : phenytoïne, carbamazepine. an antituberculosis drug : rifampicine. - some medicines which may increase plasma levels (for instance, fluvoxamine, certain antidepressants, medicines which inhibit the enzymes that break down methadone in the body, particularly macrolide antibiotics, cimetidine and the azole antifungal agents). - abacavir (an antiviral drug) as it can increase elimination of MEPHENON. - anticholinergic agents as they may increase the risk of constipation and/or decrease urinary volume. - naloxone levallorphan (opioids antagonists) since they may trigger withdrawal symptoms. - medicines affecting cardiac conduction and medicines potentially inducing electrolyte anomalies, since they may cause risks of cardiac effects. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. * Interferences with results of diagnostic tests: - Pregnancy test - Physiological tests Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy MEPHENON crosses the placental barrier and may be harmful for the foetus or neonate. The doctor will assess the risk/benefit ratio. Breast-feeding MEPHENON is excreted in breast milk and may cause dependency in infants. MEPHENON cannot be used during this period. Driving and using machines As MEPHENON may cause drowsiness, patients should be strongly advised not to drive or operate machinery if affected. A latency time of 4 to 6 hours must be respected after taking MEPHENON. MEPHENON contains Tablets: This medicine contains lactose. Therefore do not take this medicine if you have hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome. 3. HOW TO USE MEPHENON Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adults Page 3 de 6

4 1. For pain: Treatment duration should be as short as possible. - Tablets: 5 to 10 mg (or 1 to 2 tablets) every 6 to 8 hours if necessary. (The tablets can be dissolved in water or fruit juice immediately before administration). - Ampoules (by intramuscular or intravenous route): 5 to 10 mg every 6 to 8 hours. 2. For cough: In case of refractory cough : 2,5 to 10 mg every 5 to 6 hours. MEPHENON dose must never exceed 120 mg a day. 2. Treatment for all opioid withdrawal symptoms: For tablets: There is no single optimal dose for all patients. Positive outcomes have been described with low doses (10 to 20 mg a day), whilst other patients require higher doses to achieve the desired effect. Always take the dose your doctor has prescribed for you. Children Use of this medicine as an analgesic is not recommended in children. If you use more MEPHENON than you should If you used too much MEPHENON, immediately contact your doctor, your pharmacist or the Poison Center (070/ ). Symptoms - more or less deep coma; - slower breathing; - blue skin colour; - low blood pressure; - constricted pupils; - decrease urinary volume; - decreased body temperature (blanched, cold and clammy skin); - muscle flaccidity, slack jaw, the tongue may be swallowed and block the airways; - fluid on the lungs. Treatment If a patient has taken too much MEPHENON, call a doctor as soon as possible to find out whether emergency treatment in a hospital is required. In the meantime, monitor the patient's breathing and set up artificial respiration, if necessary. Antagonist of first choice: Naloxone by intravenous route (0,4 to 0,8 mg, then monitor the patient with the assistance of specialised staff). If you forget to use MEPHENON Do not take a double dose to make up for a forgotten dose. If you stop using MEPHENON SPECIAL WARNING MEPHENON is a narcotic to which patients may become addicted, i.e. physically and psychologically dependent on the drug and increasingly resistant to its effects after repeated administration. Stopping a long-term treatment abruptly causes side effects as the body reacts to the sudden lack of the drug (withdrawal syndrome). Page 4 de 6

5 This withdrawal syndrome starts a few hours after long-term treatment is stopped. The effects most commonly observed are : yawning, watery eyes, sneezing, migraine headaches, sweating, anxiety, insomnia, nausea, vomiting, diarrhoea, dehydration and abdominal and muscle cramps. The risk of dependency increases with the dose administered and duration of treatment. The duration of treatment must be as short as possible and methadone should not be withdrawn suddenly but the dose gradually tapered (decrease in the number of intakes until it is completely stopped), to prevent withdrawal syndrome. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, MEPHENON can cause side effects, although not everybody gets them. Warning: Methadone causes psychological and physical dependency and therefore induces substance abuse. The duration of treatment must be as short as possible and the treatment should not be withdrawn suddenly but the dose gradually tapered (decrease in the number of intakes until it is completely stopped). Psychiatric disorders and central nervous system effects: Uncommon: unusual nervousness, headaches, sleep disorders; Rare: mental confusion, hallucinations (only with high doses); unusual fatigue. Eye disorders: Constricted pupils (myosis); Visual disorders (overdosage). Cardiovascular system disorders: Blood pressure drop (only at high doses); risk of increase in the volume of the skull contents (intracranial hypertension), abnormally slow pulse (bradycardia) and palpitations, rare cases of cardiac rhythm disorders (QT interval prolongation and torsades de pointes). Respiratory disorders: Short, irregular, panting or slowed breathing. Gastrointestinal disorders: Very common: constipation by slowed bowel motility; Common: nausea, vomiting; Uncommon: dry mouth, appetite loss, stomach cramps, liver pain, constipation. Skin and subcutaneous tissue disorders: Common: facial redness, excessive sweating; Rare: skin rash, redness, itching, pain at the injection site. Genitourinary effects: Uncommon: decreased urinary volume but increased need to urinate; Decreased libido and impotence. Page 5 de 6

6 If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 5. HOW TO STORE MEPHENON Keep out of the sight and reach of children. Solution for injection : Store at room temperature. Tablets : Do not store above 30 C. Do not use MEPHENON after the expiry date which is stated on the carton and the ampoule after the mention "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What MEPHENON contains - The active substance is : Solution for injection : each 1ml ampoule contains 10mg methadone hydrochloride. Tablets : each tablet contains 5mg methadone hydrochloride. - The other ingredients are : Solution for injection : Sodium chloride, water for injection. Tablets : pregelatinised starch, lactose, talc, magnesium stearate. What MEPHENON looks like and contents of the pack Solution for injection for intramuscular or intravenous use. Box of 6 ampoules of 1ml. Tablets for oral use, packed into blisters. Box of 30 tablets. Marketing Authorisation Holder and Manufacturer Laboratoires STEROP SA - Avenue de Scheut Brussels - Belgium. Prescription : On medical prescription Numbers of Authorisation on the market : Solution for injection : BE Tablets : BE This leaflet was last revised in 06/2013 Page 6 de 6