Document: Metadon Evolan oral solution ENG PL change

• Metadon Evolan oral solution PL
• Metadon Evolan oral solution ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Metadon Evolan 1mg/ml Oral Solution

Methadone hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

- 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. Do not pass it on to others It may harm them, even if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What metadon Evolan is, and what it is used for

This medicine contains methadone hydrochloride, which belongs to a group of medicines called narcotic analgesics

It is used as part of the treatment of dependence on opium-related substances such as heroin and for the treatment of symptoms of withdrawal from heroin.

Do not use Metadon Evolan:

ingredients in the oral solution, especially benzoates (see section 6 and end of section 2)

• If you have brain damage or raised pressure in the brain

• If you have heart failure

• If you have severe breathing difficulties (e.g. obstructive airway diseases, respiratory

depression)

result of a shortage of oxygen in the blood (cyanosis)

• If you are experiencing withdrawal symptoms from alcohol (i.e. delirium tremens)

• If you are taking monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease, or have taken them in the past 2 weeks

Metadon Evolan must not be usedin children.

Take special care with Metadon Evolan

You must tell your doctor or pharmacist and take special care:

an increased activity of the prostate (prostatic hypertrophy)

• If you have asthma or breathing difficulties

• If you have liver diseases

• If you have kidney stones or gallstones.

• If you have inflammatory bowel disease or a blockage in the bowel

• If you are elderly and/or have cardiovascular disease there is an increased risk of low

blood pressure and fainting

• If you have or have recently had a head injury

• If you have a history of irregular heart beat

• If you have a history of heart disease

• If you have a family history of people suddenly dying without cause

• If you have low potassium, sodium or magnesium levels

You should avoid taking other opiates, benzodiazepines, barbiturates or other medicines with a strong sedative effect at the same time as Metadon Evolan as these can increase the effects and side effects of methadone.

Using other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is because Metadon Evolan can affect the way some other medicines work. Also some medicines can affect the way Metadon Evolan works.

You must nottake Metadon Evolan at the same time or within 2 weeks of taking monoamine oxidase inhibitors (MAOIs).

Tell your doctor or pharmacist if you are taking any of the following, medicinal products, since interactions between these and methadone can be hazardous:

• Medicines used to treat heart problems (e.g. quinidine, verapamil and spironolactone)

• Medicines used to treat bacterial infections (e.g. rifampicin, clarithromycin, erythromycin, and telithromycin)

• Medicines used to treat viral infections, including HIV (e.g. nevirapine, efavirenz, amprenavir, delavirdine, zidovudine, stavudine, didanosine, ritonavir, nelfinavir, saquinavir and lopinavir)

• Medicines used to treat fungal infections (e.g. fluconazole, itraconazole and ketoconazole).

• Medicines to treat depression or anxiety problems (e.g. selective serotonin reuptake inhibitors such as fluoxetine and fluvoxamine, nefazodone, the herbal preparation called St. John’s Wort)

• Anti-psychotics used to treat mental illness.

• Hypnotics (to help you sleep, including anaesthetics).

• Natural compounds such as ascorbic acid (vitamin C) and grapefruit juice

• Opioid antagonists (naloxone, naltrexone, buprenorphine) used to reverse the effects of opioid drugs

• Loperamide and diphenoxylate (medicine used to treat diarrhoea)

• Opioid drugs which are strong painkillers (e.g. nalbuphine)

• Drugs used to treat epilepsy (e.g. phenytoin, phenobarbital and carbamazepine).

• Medicine used to treat inflammation (e.g. dexamethasone)

Using methadone oral solution with food and drink

Do notdrink alcohol while you are taking this product. This medicine and alcohol can react with each other and this can increase their effects. Do not drink grapefruit juice while you are taking Methadone, as it may alter the effect of the medicinal product.

Pregnancy and breast-feeding

Talk to your doctor before taking Metadon Evolan if you are pregnant or likely to become pregnant.

You should not take this medicine whilst you are in labour.

Breast‑feeding is possible if you are taking 20 mg a day or less of Metadon Evolan talk to your doctor before starting breast‑feeding.

Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

• Do not drive, because the use of methadone oral solution can result in you no longer being safe to drive.

• Do not use any tools and do not operate any machines.

Important information about some of the ingredients of this medicine

Your medicine also contains:

3. How is metadon Evolan taken

Always take Metadon Evolan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take Metadon Evolan daily. The dose is adjusted for you personally. Your doctor or pharmacist will tell you the correct amount of methadone oral solution to take each day.

For the treatment of withdrawal symptoms the initial dose is usually set at 20mg (20ml solution). Depending on the effect, your doctor may decide to give you another dose of 20 mg (20 ml solution) after 3-4 hours. Treatment can be continued with a daily dose of 30-50 mg (30-50ml solution). This dose may be reduced slowly over a period of about 3 weeks.

For patients on a maintenance treatment program, the initial dose is set in a similar way as for treatment of withdrawal symptoms (see above). The normal daily dose is 50-100 mg (50-100ml solution), usually about 60mg (60ml solution). When physical, psychological and social conditions have improved a withdrawal regimen may be considered.

Metadon Evolanshould be administered at lower doses to patients who suffer from liver and kidney problems. A longer period of time between doses is required for such patients.

Metadon Evolan should not be used in children.

If you take more Metadon Evolan than you should

Overdose can cause coma and in severe cases death. If you take too much Metadon Evolan, you can experience the following:

• difficulty breathing

• extreme sleepiness, fainting or coma

• pin point pupils

• muscle weakness

• cold and clammy skin

• slow heartbeat, low blood pressure, heart attack or shock

Medical attention is required urgently and you should go to the nearest hospital casualty department and take the medicine pack with you if possible.

If you forget to take Metadon Evolan

If you have forgotten a dose, you must tell your carer.

Never take a double dose of methadone oral solution in order to make up for the forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Metadon Evolan can cause side effects, although not everybody gets them.

Side effects which may occur include:

Very common side effects: These may affect more than 1 in 10 people treated with Methadone	feeling sick or being sick
Common side effects: These may affect up to 1 in 100 people treated with Methadone	weight increase water retention constipation feeling high (euphoria) seeing or hearing things that are not real (hallucinations) feeling of dizziness or spinning blurred vision pin point pupils feeling sleepy skin rash sweating feeling tired
Uncommon side effects: These may affect up to 1 in 1000 people treated with Methadone	loss of appetite breathing difficulty (including with cough) dry mouth inflammation of tongue feeling down (dysphoria) agitation difficulty sleeping confusion reduction of sex drive headache fainting low blood pressure itching hives rash swelling of legs weakness bile duct spasm (abdominal pain) facial flush difficulty in passing urine difficulty achieving or maintaining an erection disturbances in menstruation
Rare side effects: These may affect up to 1 in 10,000 people treated with Methadone	heart problems slower heart beat feeling your heart beat (palpitations)
Unknown side effects: Frequency of these side effects is not known yet.	deficiency of potassium or magnesium in blood lower levels of platelets in blood taste disturbances, dependence, mood changes, feeling cold, drop in blood pressure, cardiac arrest.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Long-term use of Methadone oral solution may cause dependence (addiction) just as with other opiates.

5. How to store metadon Evolan

Keep Metadon Evolan out of the reach and sight of children.

Do not use Metadon Evolan after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What this medicine contains

- The active ingredient is methadone hydrochloride, 1mg in each ml.

- The other ingredients are liquid maltitol (E965), propylene glycol, benzoic acid (E210), sodium hydroxide and purified water.

What this medicine looks like and contents of the pack

Metadon Evolan is a clear colourless solution. It is supplied in bottles of various sizes: 10, 25, 30, 40, 50, 80, 100, 200, 300, 500 ml and 1, 2 and 5 litre. Not all pack sizes may be marketed.

In Sweden: pack sizes over 100 ml should only be handled by health care personnel.

Marketing Authorisation Holder and Manufacturer

To be completed nationally

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

Sweden: Metadon Evolan 1 mg/ml oral lösning

Denmark: Metadon Evolan 1 mg/ml oral opløsning

This leaflet was last approved in 2013-07-02