PACKAGE LEAFLET 1 Package leaflet: Information for the user <[Levomethadone hydrochloride dne]> 5 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 10 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 15 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 20 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 25 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 30 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 35 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 40 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 45 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 50 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 55 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 60 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 65 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 70 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 75 mg oral solution in single-dose container levomethadone hydrochloride Read all of this leaflet carefully before you start taking 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 if 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. See section 4. What is in this leaflet 1. What <[Levomethadone hydrochloride dne]> is and what it is used for 2. What you need to know before you take <[Levomethadone hydrochloride dne]> 3. How to take <[Levomethadone hydrochloride dne]> 4. Possible side effects 5. How to store <[Levomethadone hydrochloride dne]> 6. Contents of the pack and other information 1. What <[Levomethadone hydrochloride dne]> is and what it is used for <[Levomethadone hydrochloride dne]> contains the active substance levomethadone hydrochloride. It belongs to a group of medicines which act on your nervous system. <[Levomethadone hydrochloride dne]> is used to treat adults who are addicted to drugs called ‘opioids’ or ‘narcotic analgesics’ - such as heroin and morphine. It acts as a substitute for the addictive drugs. Treatment should be given concomitantly with medical, psychological and social follow-up. 2 2. What you need to know before you take <[Levomethadone hydrochloride dne]> When using <[Levomethadone hydrochloride dne]>, it is important to always follow your doctor’s advice. Levomethadone (<[Levomethadone hydrochloride dne]>) is stronger than methadone. It is crucial that you use <[Levomethadone hydrochloride dne]> according to your doctor’s prescription to avoid overdose (see also section 3 “How to take <[Levomethadone hydrochloride dne]>”). <[Levomethadone hydrochloride dne]> is for oral use only. You must under no circumstances inject this medicine, as injecting may cause serious and permanent damage to your body with possible fatal consequences. Do not take <[Levomethadone hydrochloride dne]>: - if you are allergic to levomethadone or any of the other ingredients of this medicine (listed in section 6). - if you are taking medicines for depression or Parkinson’s disease called ‘MAOIs’ (monoamine oxidase inhibitors) or have taken them in the last 2 weeks (see ‘Other medicines and <[Levomethadone hydrochloride dne]>‘) - if you have severe breathing or lung problems - if you are addicted to drugs other than the opioid type. During the treatment with <[Levomethadone hydrochloride dne]>, other medicines to treat addiction must not be used, except for the treatment of overdose (see ‘Other medicines and <[Levomethadone hydrochloride dne]>’). Do not take <[Levomethadone hydrochloride dne]> if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking <[Levomethadone hydrochloride dne]>. Warnings and precautions Talk to your doctor or pharmacist before using <[Levomethadone hydrochloride dne]> if: - you have acute asthma attacks - you have reduced lung capacity due to a lung disease or suffer from breathing difficulties. Your doctor will have to evaluate your treatment carefully - you have low levels of potassium in your body (hypokalaemia) - you have kidney problems (including kidney stones and gallstones) - you have liver problems - you have an under-active thyroid gland (so called hypothyroidism) - you have enlargement of the prostate gland or narrowed urether (may cause difficulty in passing urine) - you have suffered a head injury and the pressure inside your brain is higher than it should be (check this with your doctor). You might be getting bad headaches. - you have abdominal pain, diarrhoea or constipation - you have certain types of changes in your heart rhythm or other severe heart disease. <[Levomethadone hydrochloride dne]> may affect the electrical signals which control your heart contractions, particularly at high doses. Therefore, tell your doctor if you have a history of heart problems. - you are taking strong painkillers (opioids) (see ‘Other medicines and <[Levomethadone hydrochloride dne]>’) - you are taking medicines that make you relax and help you to sleep (barbiturates and benzodiazepines) (see ‘Other medicines and <[Levomethadone hydrochloride dne]>’) If any of the conditions above apply to you, please consult your doctor. 3 Store out of reach and sight of children Children are more sensitive to levomethadone than adults, that is why poisoning may occur at very low doses. To avoid unintentional intake of levomethadone by children when it is taken at home, keep it in a safe place where children cannot reach it. Children and adolescents Children and adolescents below 18 years of age must not take this medicine. Other medicines and <[Levomethadone hydrochloride dne]> Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. The following medicines must not be taken during treatment with <[Levomethadone hydrochloride dne]>: medicines used to treat depression or Parkinson’s disease known as monoamine oxidase inhibitors (MAOIs), particularly if you have taken them within the last two weeks (see also section “Do not take <[Levomethadone hydrochloride dne]>”). other medicines to treat addiction e.g. methadone, naltrexone, buprenorphine and naloxone (except for the treatment of overdose) Tell your doctor if you are taking any of the following: any medicine that have an effect on your mental state e.g. risperidone, thioridazine, perphenazine, phenotiazines, haloperidol and sertindole – these are used for treating e.g. psychoses, and atomoxetine used for treating ADHD strong painkillers (opiods)- such as morphine and pentazocine medicines used to treat heart diseases e.g. verapamil, quinidine, propafenone, flecainide, metoprolol, sotalol, amiodarone medicines used to treat depression e.g. clomipramine, nortriptyline, desipramine, nefazodone, fluoxetine, fluvoxamine, paroxetine and sertraline tamoxifen, a medicine to treat cancer medicines used to inhibit inflammations and medicines used to lower the body’s immune reactions e.g. dexamethasone and cyclosporine antiviral drugs including some medicines used to treat HIV e.g. amprenavir, nevirapine, zidovudine, efavirenz, nelfinavir, ritonavir, lopinavir, saquinavir, abacavir, delavirdine, didanosine and stavudine antibiotics of macrolide type (medicines used to treat bacterial infections) e.g. clarithromycin, telithromycin and erythromycin medicines used to treat fungal infections e.g. ketoconazole, itraconazole and fluconazole rifampicin a medicine used to treat tuberculosis or ‘TB’ drugs used to treat epilepsy e.g. phenytoin, phenobarbital and carbamazepine products that make urine more acidic e.g. ammonium chloride and vitamin C-tablets medicines used to treat diarrhoea e.g. loperamide and diphenoxylate medicines called “anticholinergics” since these medicines can cause constipation or blockage of the gut when taken with <[Levomethadone hydrochloride dne]> diuretic medicines e.g. spironolactone medicines or products containing cannabinoides herbal medicines containing St John´s Wort medicines that make you relax and help you to sleep (barbiturates and benzodiazepines) Concomitant use of <[Levomethadone hydrochloride dne]> and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. 4 However, if your doctor does prescribe <[Levomethadone hydrochloride dne]> together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. <[Levomethadone hydrochloride dne]> with drink and alcohol You must not drink alcohol while taking <[Levomethadone