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Natzon 0.4mg Sublingual Tablet

PACKAGE LEAFLET: INFORMATION FORTHE USER

Natzon 0.4mg Sublingual Tablets

(Buprenorphine)


Read all of this leaflet carefully before you

start taking this medicine because it

contains important information foryou.

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

•    If you have any further questions, ask your doctoror 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 Natzon Sublingual Tablets are and what they are used for

2.    What you need to know before you take Natzon Sublingual Tablets

3.    How to take Natzon Sublingual Tablets

4.    Possible side effects

5.    How to store Natzon Sublingual Tablets

6.    Contents of the pack and other information


1. What Natzon Sublingual Tablets are and what they are used for


Natzon belongs to a group of medicines called an opioid (also known as "opiates" or "narcotics"). Opioids, such as morphine or diamorphine (heroin), are often subject to abuse, which can lead to dependence (addiction). If you are addicted to these drugs, you need a regular dose to feel "normal". Otherwise you will develop withdrawal symptoms within a day or so of the last dose. Withdrawal symptoms include sweating, feeling hot and cold, runny eyes and nose, feeling or being sick, diarrhoea, stomach cramps, poor sleep and just feeling awful.

Natzon Sublingual Tablets are used as a substitution (replacement) treatment in patients who are addicted to opioid drugs such as heroin and morphine. The tablets prevent or reduce the unpleasant withdrawal symptoms experienced when addicts stop using opioid drugs.

Treatment with Natzon Sublingual Tablets may form one aspect of a specialist support programme aimed at resolving opioid addiction.

The tablets are not to be used for pain relief purposes.


2. What you need to know before you take Natzon Sublingual Tablets


Do not take Natzon Sublingual Tablets:

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

•    if you have severe breathing problems.

•    if you have severe liverdisease.

•    if you are an alcoholic or regularly drink large amounts of alcohol.

•    if you have delirium tremens ('DTs1, 'the shakes' and hallucinations).

•    if you are breast-feeding (see the section 'Pregnancy and breast-feeding' below for more information).

Natzon Sublingual Tablets must not be used by children or adolescents under 16 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking Natzon Sublingual Tablets:

•    if you have asthma or any other breathing problems.

•    if you have any kidney problems.

•    if you have any liver problems.

Other medicines and Natzon Sublingual Tablets

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

The following medicines have sedative effects (make you feel sleepy/drowsy). These effects are increased if these medicines are taken while you are being treated with buprenorphine:

•    benzodiazepines (used for treatment of


anxiety or sleep disorders) e.g. diazepam and temazepam: you should not take these medicines while you are taking buprenorphine, unless prescribed by your doctor because this combination can be fatal if the correct dose is not carefully determined.

•    barbiturates and other medicines used for the treatment of anxiety orsleep disorders.

•    other medicines containing opioid-related medicines e.g. codeine, dihydrocodeine and morphine (used as strong painkillers and in some cough medicines).

•    medicines used for the treatment of depression, including medicines known as monoamine oxidase inhibitors (MAOIs) e.g. phenelzine.

•    antihistamine medicines (used for treatment of allergy and/or hay fever) e.g. promethazine and chlorphenamine.

•    medicines known as antipsychotics (used for the treatment of schizophrenia) e.g. chlorpromazine and haloperidol.

•    certain medicines for the treatment of high blood pressure (antihypertensives) e.g. clonidine.

If you are taking any of the following medicines, your doctor may need to prescribe a lower dose ofbuprenorphine:

•    the antifungal medicine, ketoconazole.

•    medicines used to treat infections caused by viruses (antiviral agents) e.g. ritonavir, saquinavir and indinavir, which are used in the treatment of HIV infections.

•    oral contraceptive medicines containing gestodene.

•    certain medicines called 'macrolide antibiotics'(used for the treatment of infections).

If you are taking any of the following medicines, your doctor may need to prescribe a higher dose ofbuprenorphine:

•    medicines used for the treatment of epilepsy e.g. phenobarbital, carbamazepine and phenytoin.

•    the antibiotic medicine, rifampicin (used for the treatment of tuberculosis).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Natzon Sublingual Tablets with food and drink

These tablets should not be taken at the same time as food or drink. You should not drink alcohol or take any medicines that contain alcohol while taking Natzon sublingual tablets.

Pregnancy and breast-feeding

Before taking these tablets, tell your doctor if you are pregnant or trying to become pregnant. If you become pregnant during treatment with buprenorphine, tell your doctor straight away.

Since buprenorphine is passed into breast milk, you must not breast feed while taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you feel drowsy while being treated with this medicine, you should not drive or operate machinery.

The 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:

■    The medicine has been prescribed to treat a medical ordental problem and

■    You have taken it according to the instructions given by the prescriberor in the information provided with the medicine and

■    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.

Natzon 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 medicine.


3. Howto take Natzon Sublingual Tablets


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 described as 'sublingual'. This means that the tablet should be placed under the tongue and kept there until fully dissolved. Do not chew or swallow the tablets whole - the medicine will not work this way and you may get withdrawal symptoms. Do not take the tablets at the same time as food or drink.

Adults and adolescents aged 16 years and over:

The usual starting dose is 0.8 mg to 4 mg daily.

•    If you are still taking opioids, the dose of buprenorphine must be taken at least 6 hours afterthe last use of the opioid orwhen the first signs of craving appear.

•    If you have been receiving methadone, your doctor should reduce the dose to no more than 30 mg per day before starting treatment with buprenorphine. This is because buprenorphine can cause withdrawal symptoms in patients who are dependent on methadone, if taken less than 24 hours after using methadone.

During your treatment, your doctor may increase your dose of buprenorphine to a maximum single daily dose of 32 mg, depending upon how you get on. After a period of successful treatment, your doctor may gradually reduce your dose. With careful medical supervision, your dose may continue to be reduced until it is stopped altogether.

Your doctor may wish to perform some tests to assess how well your liver is working before starting treatment with Natzon Sublingual Tablets, and at regular intervals during treatment.

Natzon Sublingual Tablets must not be used by children or adolescents under 16 years old.

If you take more Natzon Sublingual Tablets than you should

Tell your doctor immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take Natzon Sublingual Tablets

You should tell your doctor and follow their instructions. Do not take a double dose to make up for the missed dose, unless your doctor tells you to.

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

If you stop taking Natzon Sublingual Tablets

Do not suddenly stop taking the tablets unless told to do so by your doctor, as this may cause withdrawal symptoms.


The following side effects have also been reported:

The most common side effects are: constipation, headache, difficulty in sleeping, weakness or lack of energy, drowsiness, nausea and vomiting (feeling and being sick), fainting and dizziness (especially when changing position from sitting or lying down to standing) and sweating.

After your first dose, you may suffer from opioid withdrawal symptoms. This is more likely if buprenorphine is taken less than six hours after using an opioid (e.g. heroin).

Rare side effects', severe difficulty in breathing, hallucinations.

•    Athletes should be aware that this medicine may cause a positive reaction to 'antidoping tests'.

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

Other side effects: difficulty in urinating.

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


5. How to store Natzon Sublingual Tablets


Keep this medicine out of the sight and reach of children.

Store your medicine in the original packaging to protect from moisture.

Do not store above 30°C.

Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

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 to protect the environment.


6. Contents of the pack and other information


4. Possible side effects


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

All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking these tablets, you should contact your doctor immediately:

•    Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.

•    Peeling and blistering of the skin, mouth, eyes and genitals.

•    Rash affecting yourwhole body.

If you develop severe fatigue, loss of appetite or if your skin or eyes look yellow, tell your doctor immediately.


What Natzon Sublingual Tablets contain

•    The active substance is buprenorphine (as buprenorphine hydrochloride). Each tablet contains 0.4mg ofbuprenorphine.

•    The other ingredients are lactose monohydrate, mannitol (E421), maize starch, citric acid (anhydrous), sodium citrate, povidone (plasdone K29/32), magnesium stearate, ascorbic acid and edeticacid (EDTA).

What Natzon Sublingual Tablets look like and the contents of the pack

Natzon 0.4mg Sublingual Tablets are off-white to brownish, round, biplane tablets.

Your medicine is available in blisters containing 7,14, or 28 tablets.

Not all pack sizes may be marketed.

MarketingAuthorisation Holder

Morningside Healthcare Limited

115 Narborough Road

Leicester

LE3 OPA

United Kingdom.

Manufacturer

SMBTECHNOLOGYS.A.

39 rue du Parc Industriel 6900 Marche en Famenne Belgium

This leaflet was last revised in December 2014.