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Buprenorphine 0.4mg Sublingual Tablets

Document: leaflet MAH GENERIC_PL 00240-0347 change

TEXT FOR BUPRENORPHINE 0.4MG LEAFLET PL 00240/0347

T&R

Buprenorphine 0.4mg Sublingual Tablets Patient Information

Please read this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions please ask your doctor or pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them even if their symptoms are the same as yours.

•    If any of the side effects become serious or you notice any side effects not listed in the leaflet please tell your doctor or pharmacist.

This leaflet informs you about:

1.    What Buprenorphine 0.4mg Sublingual tablets are and what they are used for

2.    Before you take Buprenorphine 0.4mg Sublingual tablets

3.    How to take the tablets

4.    Possible side effects

5.    How to store the tablets

6.    Further information

1. What Buprenorphine 0.4mg Sublingual tablets are and what they are used for

Buprenorphine 0.4mg Sublingual tablets contain bupreorphine hydrochloride equivalent to 0.4mg buprenorphine.

Buprenorphine is one of a group of medicines used in opioid dependence. When it is used for the treatment of patients addicted to opiate (narcotic) drugs, such as morphine and heroin, it acts as a substitute for these drugs and therefore aids the patient in withdrawing from them over a period of time. If treatment is stopped abruptly, withdrawal symptoms can occur.

These tablets are described as ‘sublingual’. This means that the tablet should be placed under the tongue and kept there until fully dissolved which usually occurs within 5 to 10 minutes.

2. Before you take Buprenorphine 0.4mg Sublingual tablets

Buprenorphine 0.4mg Sublingual tablets should not be used:

•    in children under the age of 16 years

•    if you are allergic to buprenorphine or any of the other ingredients in this medicine

•    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

•    if you are pregnant (unless your doctor tells you to take it)

Tell your doctor if you have any of the following illnesses before treatment or develop them during treatment as your doctor may need to reduce your dose of this medicine or you may need extra treatment to control them.

•    asthma or other breathing problems

•    kidney disease

The tablets should be used exactly as prescribed by your doctor. Some people have died from respiratory failure (inability to breathe) whilst using benzodiazepines (medicines used to treat anxiety and sleep disorders) in combination with Buprenorphine and also when Buprenorphine was not used according to doctor’s instructions.

Therefore whilst you are being treated with this medicine do not use benzodiazepines unless they have been prescribed by your doctor.

Some cases of severe liver problems have occurred during treatment although they may not necessarily have been caused by these tablets. If you develop severe fatigue, have no appetite or if your skin or eyes look yellow tell your doctor immediately.

This medicine can cause withdrawal symptoms if you take less than four hours after you use a narcotic (morphine, heroin or other related products).

This medicine can cause drowsiness, which may be made worse if you also drink alcohol or take tranquillisers or anti-anxiety drugs. If you are drowsy do not drive or operate machinery.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

The tablets may cause your blood pressure to drop suddenly causing you to feel dizzy if you get up too quickly from sitting or lying down.

Drug dependence may occur as a result of taking this medicine.

Athletes should be aware that this medicine may cause a positive reaction to anti-doping tests.

Are there any medicines that should not be taken at the same time as Buprenorphine 0.4mg Sublingual tablets?

You should not use benzodiazepines (medicines used to treat anxiety and sleep disorders) whilst you are taking this medicine unless they are prescribed by your doctor.

Strong pain killers and cough medicines containing opioid-related substances, certain antidepressants including monoamine oxidase inhibitors, sedating antihistamines, sedatives, antianxiety drugs, certain drugs for high blood pressure and antipsychotic drugs may increase the effects of buprenorphine.

Ketoconazole a medicine used for the treatment of fungal infections can increase the effects of Buprenorphine if both are taken at the same time. If you are taking ketoconazole or any of the following medicines: gestodene, troleandomycin, the HIV protease inhibitors ritonavir, indinavir and saquinavir you should tell your doctor or pharmacist as they may need to reduce your dose of buprenorphine.

Also tell your doctor or pharmacist if you are taking any of the following medicines: phenobarbital, carbamazapine, phenytoin, rifampicin. You will be closely monitored whilst you are taking these medicines at the same time as buprenorphine.

Be sure to tell your doctor if you are taking a blood thinning agent called phenprocoumon.

If you are taking any other medicines you should tell your doctor or pharmacist before you begin treatment with buprenorphine.

Do not drink alcohol or take medicines that contain alcohol whilst you are being treated with buprenorphine. Alcohol and certain other medicines (as listed above) increases the sedative effects of buprenorphine which can make driving or operating machinery hazardous.

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

3. How to take the tablets

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 effective and safe way the tablets should be taken. Do not chew or swallow them whole as this will make them ineffective.

Your doctor will tell you how many 0.4mg Sublingual tablets to take and you should always follow his advice.

Adults and children over the age of 16 years: the initial dose is from 0.8 to 4mg administered once a day.

For drugs addicts who have not undergone withdrawal: one dose of 0.4mg Sublingual tablets at least six hours after the last use of the opioid (narcotic) or when the first signs of craving appear.

For patients receiving methadone: before beginning treatment your doctor should reduce your dose of methadone to a maximum of 30mg a day.

These tablets may cause withdrawal symptoms in patients who are dependent on methadone.

During your treatment, your doctor may increase your dose to a maximum single daily dose of 32mg 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. Do not suddenly stop taking these tablets as this may cause withdrawal symptoms.

What to do in the case of overdose

You should contact your doctor immediately.

What do to if you forget to take your tablets

You should tell your doctor and follow his or her instructions.

4. Possible side effects

Like all drugs, these tablets may cause side effects. After your first dose you may suffer from some opiate withdrawal symptoms. Other side effects which may occur are constipation, headaches, difficulty in sleeping, lack of energy or weakness, drowsiness, nausea and vomiting, fainting and dizziness, drop in blood pressure on changing position from sitting or lying down to standing; sweating.

Rarely the following have occurred; severe difficulty in breathing, liver problems, hallucinations. If you think you are suffering from these or any other side effects you should tell your doctor.

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 difficult breathing, wheezing, swelling of the eyes, lips, tongue, throat or hands) seek urgent medical help.

Drug dependence can occur as a result of taking this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

5.    How to store the tablets

Keep out of the sight and reach of children.

Do not use after the expiry date which is stamped on the container.

Medicines should not be disposed of via wastewater or household waste. Return any unused tablets to your pharmacist. These measures will help protect the environment.

6.    Further information

Each sublingual tablet contains buprenorphine hydrochloride equivalent to 0.4mg buprenorphine base as the active ingredient along with the following inactive ingredients; Lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate and magnesium stearate. Buprenorphine 0.4mg Sublingual tablets also contain talc and silica colloidal anhydrous.

The sublingual tablets are available in cartons containing 7 tablets in a strip.

Marketing Authorisation Holder: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturer: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.

PL number: 00240/0347

This leaflet was last revised in February 2015