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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 called ‘’ or ‘narcotic ’ - such as and . 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 . 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 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 ( and ) (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, , and (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, and sertindole – these are used for treating e.g. psychoses, and used for treating ADHD  strong painkillers (opiods)- such as morphine and  medicines used to treat heart diseases e.g. , quinidine, propafenone, flecainide, metoprolol, sotalol, amiodarone  medicines used to treat depression e.g. clomipramine, , , nefazodone, fluoxetine, fluvoxamine, paroxetine and sertraline  , 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, and  products that make urine more acidic e.g. ammonium chloride and vitamin C-tablets  medicines used to treat diarrhoea e.g. and  medicines called “” 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 You must not drink alcohol while taking <[Levomethadone hydrochloride dne]> since this can cause serious side effects. Do not drink grapefruit juice while you are taking <[Levomethadone hydrochloride dne]> as it may alter the effect of the medicinal product.

Pregnancy, breast-feeding and fertility <[Levomethadone hydrochloride dne]> may affect the foetus and the nursing baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy <[Levomethadone hydrochloride dne]> may be used during pregnancy after careful risk-benefit assessment by a doctor, preferably under supervision in a specialized medical centre. Breastfeeding Levomethadone is excreted into breast milk. Your doctor decides whether breastfeeding is allowed during substitution treatment. Fertility Levomethadone has been reported to cause sexual dysfunction in male patients on maintenance treatment. Whether this can reduce fertility in men is not known.

Driving and using machines Do not drive or use any tools or machines while taking <[Levomethadone hydrochloride dne]>. This is because you may feel sleepy and less alert while taking the medicine and for some time after you stop taking it. If and when you can drive or use machines varies from person to person and this will be decided by your doctor.

<[Levomethadone hydrochloride dne]> contains methyl parahydroxybenzoate (E218) This may cause allergic reactions (possibly delayed).

<[Levomethadone hydrochloride dne]> contains glycerol If the levomethadone dose is taken as several units of the lower strengths giving a total volume above 55 ml, the total intake of glycerol per dose would exceed 10 g. This may cause headache, stomach upset and diarrhea.

3. How to take <[Levomethadone hydrochloride dne]>

Always take the dose exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your dose will be decided by your doctor:  it is chosen for you as an individual

5  it is based on how soon your withdrawal symptoms start  levomethadone (<[Levomethadone hydrochloride dne]>) is stronger than methadone and dosing will therefore be different. It is crucial that you use <[Levomethadone hydrochloride dne]> according to your doctor’s prescription to avoid overdose. o do not take more or less of this medicine than you have been told o do not take this medicine more or less often than you have been told.

You will begin the treatment with a starting dose which will be gradually increased over a period of a few weeks. After this initiation period, your dose will be stabilised and your maintenance dose adjusted depending on how the medicine affects you.

The dose is normally administered once daily.

Talk to your doctor if you feel that you get impaired concentration capability, feel drowsy, excited or dizzy when standing. The doctor may need to reduce your dose.

Elderly people and very ill people Your dose may be reduced if you are over 65 years of age or if you have very poor health. In these cases, your doctor may want to monitor you more closely. Kidney and liver problems Your dose may be reduced if you have kidney problems or severe, long term liver problems. In these cases, your doctor may want to monitor you more closely. Method of administration  <[Levomethadone hydrochloride dne]> must only be taken by mouth. You must under no circumstances inject this product, as injecting may cause serious and permanent damage to your body with possible fatal consequences.  This medicine is ready to use and the oral solution comes in a single-dose container.

If you take more <[Levomethadone hydrochloride dne]> than you should If you take more <[Levomethadone hydrochloride dne]> than you should, talk to a doctor or go to hospital straight away. Take the medicine pack with you. The following effects may happen:  breathing problems  feeling very sleepy, nearly passing out (‘unconscious’) or falling into a coma  very small pupils in your eyes  cold and clammy skin  a very slow pulse, low blood pressure, heart attack or shock.  muscle weakness. In severe cases an overdose may be fatal.

If you forget to take <[Levomethadone hydrochloride dne]> During a course of treatment it is important that, should you miss a dose, you take the dose as soon as you remember. However, if it is almost time for you to take your next dose, skip the dose and wait until the next scheduled dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking <[Levomethadone hydrochloride dne]> Do not stop taking <[Levomethadone hydrochloride dne]> without talking to your doctor first. This is because you may get side effects and withdrawal syndrome. If you need to stop taking <[Levomethadone hydrochloride dne]>, your doctor will help you stop it slowly.

6 If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side eff ects which may occur include:

Very common: may affect more than 1 in 10 people  nausea, vomiting

Common: may affect up to 1 in 10 people  water retention in your body  feeling high (euphoria)  seeing or hearing things that are not real (hallucinations)  feeling sleepy  blurred vision  pin point pupils  constipation  skin rash  sweating  feeling tired  weight increase

Uncommon: may affect up to 1 in 100 people  loss of appetite (anorexia)  feeling down (dysphoria)  agitation  difficulty sleeping  disorientation  reduction of sex drive  headache  fainting  facial flush  low blood pressure  water retenion in the lungs  breathing difficulty (including with cough)  dry mouth  inflammation of tongue  bile duct spasm (abdominal pain)  itching  hives  severe water retention in your body (oedema)  difficulty in passing urine  difficulty achieving or maintaining an erection  disturbances in menstruation  swelling of legs  weakness

Rare: may affect up to 1 in 1,000 people

7  slower heart beat  feeling your heart beat (palpitations)  heart problems (especially with high doses)

Not known: frequency cannot be estimated from the available data  deficiency of potassium or in blood  lower levels of platelets in blood

You may notice some side effects become less severe with time. However, constipation and sweating more than usual are not likely to get better. Talk to your doctor or pharmacist about treatment to relieve the symptoms of these side effects. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store <[Levomethadone hydrochloride dne]>

 Keep this medicine out of the sight and reach of children.  Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP.’. The expiry date refers to the last day of that month.  This medicinal product does not require any special storage conditions.  Do not freeze.  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 <[Levomethadone hydrochloride dne]> contains - The active substance is levomethadone hydrochloride. Each dose oral solution contains 5 mg , 10 mg, 15 mg , 20 mg, 25 mg, 30 mg , 35 mg , 40 mg , 45 mg , 50 mg , 55 mg , 60 mg , 65 mg , 70 mg or 75 mg of levomethadone hydrochloride. - The other ingredients are methyl parahydroxybenzoate (E218), betaine hydrochloride, glycerol, purified water.

What <[Levomethadone hydrochloride dne]> looks like and contents of the pack <[Levomethadone hydrochloride dne]> is a clear and colourless oral solution in a single-dose container. It is supplied in 50 mL amber coloured glass bottles closed with a tamper-evident, child-resistant plastic screw cap.

Pack sizes: 1 or 7 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder dne pharma as Karihaugveien 22

8 NO-1086 OSLO NORWAY

Manufacturer Pharma Production AS Karihaugveien 22 NO-1086 OSLO NORWAY

This medicinal product is authorised in the Member States of the EEA under the following names:

Member State Name Norway Levomethadone hydrochloride dne Estonia, Germany, The Netherlands Ellepalmiron

This leaflet was last revised in {MM/YYYY}

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