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Buprenorphine 0.4 mg - 2 mg - 8 mg, sublingual tablet

1.3.1.2 - Package Leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER

BUPRENORPHINE

0.4 mg, 2 mg and 8 mg sublingual tablets Buprenorphine

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 Buprenorphine sublingual tablets are and what they are used for

2.    What you need to know before you take Buprenorphine sublingual tablets

3.    How to take Buprenorphine sublingual tablets

4.    Possible side effects

5.    How to store Buprenorphine sublingual tablets

6.    Contents of the pack and other information

1.    WHAT BUPRENORPHINE SUBLINGUAL TABLETS ARE AND WHAT THEY ARE USED FOR

Medicinal product used in opioid dependence.

Buprenorphine sublingual tablets are used as part of a medical, social and psychological treatment program for patients addicted to opiate (narcotic) drugs. Treatment with Buprenorphine sublingual tablets is intended for use in adults and adolescents over 15 years of age.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPRENORPHINE SUBLINGUAL TABLETS

Do not take Buprenorphine sublingual tablets

-    if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)

-    if you have serious breathing problems

-    if you have serious problems with your liver, or if your doctor detects the development of such a problem during treatment

-    if you are intoxicated due to alcohol or have delirium tremens (the “shakes” and hallucinations)

-    if you are breast-feeding

Buprenorphine sublingual tablets should not be used in children under the age of 15 years. Warnings and precautions

Talk to your doctor, or pharmacist before taking Buprenorphine sublinguakl tablets:

-    if you suffer from asthma or other breathing problems

-    if you have liver or kidney disease

-    if you have recent head injury or brain disease

-    if you suffer from decrease of blood pressure

-    in men: if you have urinary disorders (especially linked to enlarged prostate)

Misuse, especially by injection and at high dose is dangerous and could be fatal.

Some people have died from respiratory failure (inability to breathe) because they misused buprenorphine or took it in combination with other central nervous system depressants such as alcohol, benzodiazepines (medicines used to treat anxiety or sleep disorders) or other opioids.

Cases of severe acute liver injury have occurred in a context of misuse. These injuries could be due to special conditions as viral infections (chronic C hepatitis), alcohol abuse, anorexia or medicines association (for example: antiretroviral nucleoside analogues, aspirin, amiodarone, isoniazid, valproate). If you have symptoms of severe fatigue, no appetite, itching or if your skin or eyes look yellow, tell your doctor immediately, so that you can receive the proper treatment.

This medicine can cause:

-    withdrawal symptoms if you take it less than six hours after you use a narcotic (morphine, heroin or other related products)

-    drowsiness, which may be made worse if you also drink alcohol or take tranquillisers or antianxiety drugs. If you are drowsy, do not drive or operate machinery.

-    sudden drop in blood pressure, causing you to feel dizzy if you get up too quickly from sitting or lying down

-    drug dependency

-    a positive reaction to “anti-doping” tests (athlete’s should be aware)

Other medicines and Buprenorphine sublingual tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Before taking Buprenorphine sublingual tablets, you must tell your doctor if you are taking any of the following:

-    benzodiazepines and other medicines used to treat anxiety or sleep disorders

-    other medicines with sedative properties including sedating antihistamines, certain antidepressants and clonidine (a treatment for high blood pressure, migraine, menopausal flushing)

-    strong pain killers (opioid analgesics), cough medicines containing opioid-related substances and methadone

-    monoamine oxidase inhibitors (a type of antidepressant)

-    antipsychotic drugs

-    gestodene (an oral contraception)

-    medicines to treat HIV / AIDS (protease inhibitors) including indinavir, ritonavir and saquinavir.

-    anti-epileptic (anticonvulsant) medicines including phenobarbital, carbamazepine and phenytoin

-    antibiotic medicines including rifampicin, troleandomycin and ketoconazole (a treatment for fungal infections)

-    phenprocoumon (a blood thinning drug)

Buprenorphine sublingual tablets with food, drink and alcohol

Do not drink alcohol when you are being treated with Buprenorphine. Alcohol increases the sedative effects of buprenorphine, which can make driving and operating machinery hazardous.

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.

Do not take Buprenorphine during pregnancy, unless your doctor tells you to do so.

Do not take Buprenorphine if you are breast-feeding.

Driving and using machines

Buprenorphine may cause drownsiness, particularly when taken together with alcohol or certain antidepressants. If you feel tired, do not drive or operate machinery.

Buprenorphine sublingual tablets contain lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE BUPRENORPHINE SUBLINGUAL TABLETS Method of administration

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

The tablets are administered sublingually. This means that you must place the tablet under your tongue and allow it to dissolve, which will take 5 to 10 minutes. This is the only way the tablets should be taken. Do not chew or swallow them whole, as this will make them ineffective.

Dosage

The usual dose is:

Adults and adolescents over the age of 15 years: the initial dose is from 0.8 to 4 mg, administered once a day.

Patients who have not undergone withdrawal: one dose of Buprenorphine sublingual tablets tablets at least 6 hours after the last use of the opioid (narcotic), or when the first signs of craving appear.

Patients receiving methadone: before beginning treatment, your doctor should reduce your dose of methadone to a maximum of 30 mg a day. Buprenorphine may cause withdrawal symptoms in patients who are dependent on methadone.

During your treatment, your doctor may increase your dose of Buprenorphine to a maximum single daily dose of 24 mg, depending upon your response. After a period of successful treatment, your doctor may gradually reduce your dose. Depending on your condition, your dose may continue to be reduced under careful medical supervision, until it is stopped altogether.

If you take more Buprenorphine sublingual tablets than you should

You must go or be taken immediately to an emergency centre or hospital for treatment. Immediately advise your doctor or your pharmacist.

If you forget to take Buprenorphine sublingual tablets

Do not take a double dose to make up for a forgotten dose. Contact your doctor.

If you stop taking Buprenorphine sublingual tablets

Stopping treatment suddenly may cause withdrawal symptoms.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (affect more than 1 per 10 patients):

-    insomnia

-    a general feeling of weakness

-    withdrawal syndrome

Common side effects (affect less than 1 per 10 but more than 1 per 100 patients):

-    headache

-    fainting

-    dizziness

-    anxiety

-    nervousness

-    constipation

-    nausea

-    vomiting

-    diarrhoea,

-    abdominal pain

- tearing disorder

-    runny nose

-    drowsiness

-    drop in blood pressure on changing position from sitting or lying down to standing,

-    sweating

-    back pain

-    chills

Uncommon side effects (affect less than 1 per 100 but more than 1 per 1000 patients):

-    hallucinations

-    respiratory depression (severe difficulty in breathing)

-    liver problems with or without jaundice

-    necrosis of the liver (death of the cells of the liver)

Very rare side effects (affect less than 1 per 10,000 patients):

-    hypersensitivity (allergic) reactions have been reported. Symptoms may include skin rash, hives, and itching. If you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, swelling of the eyes, lips, throat, tongue or hands) seek medical help

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 reorting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE BUPRENORPHINE SUBLINGUAL TABLETS

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 pack after “Expiry date”. The expiry date refers to the last day of that month.

Buprenorphine sublingual tablets 0.4 mg: Do not store above 25°C.

Buprenorphine sublingual tablets 2 mg and 8 mg: this medicinal product does not require any special temperature storage conditions.

Store in the original package to protect from light and moisture.

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 Buprenorphine sublingual tablets contains

-    The active substance is buprenorphine (as buprenorphine hydrochloride). Each tablet contains 0.4 mg, 2 mg or 8 mg of buprenorphine.

-    The other ingredients are lactose monohydrate, mannitol, maize starch, citric acid, sodium citrate, povidone K30, Sodium stearyl fumarate.

What Buprenorphine sublingual tablets looks like and contents of the pack

Buprenorphine 0.4 mg sublingual tablets are white, round sublingual tablets marked with “^” on one side.

Buprenorphine 2 mg sublingual tablets are white, round sublingual tablets marked with “2” on one side and with “^” on the other side.

Buprenorphine 8 mg sublingual tablets are white, round sublingual tablets marked with “8” on one side and with “^” on the other side.

Your medicine is available in blisters packed in boxes of 7 or 28 or 70 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ethypharm

194, Bureaux de la Colline Batiment D

92213 Saint-Cloud Cedex France

Manufacturer

Ethypharm

Chemin de la Poudriere, 76120 Grand-Quevilly France

and

Ethypharm

Z.I de Saint-Arnoult, 28170 Chateauneuf-en-Thymerais France

and

ALKALOID-INT d.o.o.

Slandrova ulica 4 1231 Ljubljana - Crnuce Slovenia

Member States of the EEA under the following names:

Buprenorphine Alkaloid 0.4 mg/2 mg/8 mg, cydanHrBaaHH TadaeTKH Buprenorphine Alkaloid 0.4 mg/2 mg/8 mg, sublingvalni tablety Buprenal Viogen 0.4 mg/2 mg/8 mg, unoyAmaaia SiaKa Buprenorphine Alkaloid 0.4 mg/2 mg/8 mg, nyelvalatti tabletta Buprenorfina Ethypharm 0.4 mg/2 mg/8 mg, compressa sublinguali Buprenorphine Alkaloid 0.4 mg/2 mg/8 mg, tabletki podj^zykowe Buprenorfin Alkaloid-INT 0.4 mg/2 mg/8 mg podjezicna tableta Buprenorfina Alkaloid 0.4 mg/2 mg/8 mg, comprimate sublinguale Buprenorphine 0.4 mg/2 mg/8 mg, sublingual tablets

This leaflet was last approved in 07/2015

Edition 07/2015 5/5