PACKAGE LEAFLET: INFORMATION FOR THE USER

Your medicine is called Zamadol SR 100mg Capsules, but will be referred to as Zamadol SR throughout this leaflet. Other strengths 50mg, 150mg & 200mg are available.

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

In this leaflet:

1.    What Zamadol SR is and what it is used for

2.    Before you take Zamadol SR

3.    How to take Zamadol SR

4.    Possible side effects

5.    How to store Zamadol SR

6.    Further information

1.    What Zamadol SR is and what it is used for

Zamadol SR belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. The active substance, tramadol hydrochloride, interrupts the pain messages being sent to your brain, and it also acts in your brain to stop pain messages from being felt. This means that Zamadol SR does not stop the pain from happening, but you will not be able to feel the pain as much.

Zamadol SR is used to relieve moderate to severe pain. (for example pain after an operation, or after an injury).

2.    Before you take Zamadol SR

Do not take Zamadol SR:

■    if you are allergic (hypersensitive) to tramadol hydrochloride or to any of the other ingredients resulting in a skin rash, swelling of face or difficulty in breathing (see section 6, "Further Information")

■    if you are taking, or you have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs) to treat your depression (see section 2, "Taking other medicines")

■    if you have epilepsy which is not controlled by treatment

■    if you have drunk enough alcohol to make you feel woozy or drunk

■    if you have taken more than the prescribed dose of your sleeping tablets, neuroleptics, antidepressant (neuroleptics and antidepressants are medicines that affect mood and emotions) or other pain killers, which can slow down your breathing and reactions.

Take special care with Zamadol SR

■    If taken for long periods there is the rare possibility that addiction may develop.

■    There is the rare possibility that Zamadol SR may cause convulsions (fits). The risk is increased if doses above the daily maximum are taken and if you are also taking antidepressants or neuroleptics.

■    If you have a tendency to drug addiction or abuse you should take Zamadol SR for short periods only. Please tell your doctor about this as he/she may want to monitor your pain control more closely.

■    You should not take this product for the treatment of withdrawal symptoms in drug addicts.

Before taking Zamadol SR you must tell your doctor:

■    if you are pregnant or breast feeding.

■    if you have been taking Zamadol SR or any other tramadol containing medicine for a long time.

■    if you are addicted to morphine.

■    if you have had an allergic reaction to any morphine-like medicines.

■    if you have severe problems with your liver or kidneys.

■    if you have recently had a head injury or have a very bad headache that makes you sick.

■    if you have ever had convulsions (fits) or you suffer from epilepsy.

■    if you have asthma or trouble breathing.

■    if you are taking other medicines.

■    if you are going to have surgery requiring a general anaesthetic.

If any of the above apply to you, you must tell your doctor as he/she may decide to alter your treatment.

Taking other medicines

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

■    Do not take Zamadol SR at the same time, or within 14 days of taking medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson's disease).

■    The pain relieving effect of Zamadol SR may be weakened and/or shortened if you also take medicines containing:

■    Carbamazepine (used to treat epilepsy)

■    Buprenorphine, nalbuphine, or pentazocine (pain killers)

■    Ondansetron (prevents nausea)

Your doctor will tell you whether you should take Zamadol SR, and what dose.

■    In isolated cases the side effects of selective serotonin reuptake inhibitors (SSRI's) (certain antidepressants) can be intensified when taken with tramadol. Zamadol SR may enhance effect of these medicines and could cause a 'serotenergic syndrome' with symptoms such as confusion, restlessness, tremor, fever, sweating and diarrhoea. You must tell your doctor if you are taking any of these medicines.

■    Medicines used to treat epilepsy may very rarely cause convulsions (fits), but if you are also taking Zamadol SR the possibility of having a convulsion is more likely. You must ask your doctor about this.

■    Medicines that act on the nervous system such as hypnotics, tranquillisers, sleeping pills and pain killers may make you feel drowsier or faint when taken with Zamadol SR.

■    Anticoagulants to thin your blood such as warfarin. The effectiveness of the medicines may be altered if you are also taking Zamadol SR.

Tell your doctor or dentist if you are taking any of these medicines.

Taking Zamadol SR with food and drink

You can take Zamadol SR with or without a meal. Avoid drinking alcohol while taking this medicine.

Pregnancy and breast-feeding

Zamadol SR should not be taken during pregnancy or while breastfeeding. This is because it is not yet known how safe it is to take this medicine when you are pregnant.

Ask your doctor or pharmacist for advice before taking any medicine. Please contact your doctor if you become pregnant during your treatment.

Driving and using machines

Zamadol SR may cause drowsiness, particularly if taken with alcohol, anti-histamines and other medicines that may cause drowsiness. Do not drive or operate heavy machinery unless you know how Zamadol SR affects you.

Important information about some of the ingredients of Zamadol SR

This medicine contains sucrose. 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 Zamadol SR

Dosage for adults:

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

The usual initial dose is 50-100 mg twice daily, morning and evening. Your doctor may increase this dose up to 150-200 mg twice daily according to your needs. You should normally take your Zamadol SR every 12 hours, at the same time each morning and evening.

The maximum dose is usually 400 mg daily. Your prescribed daily dose will depend on the severity of your pain.

Dosage for children and adolescents:

Over 12 years - as for adults (see above).

Under 12 years - Zamadol SR should not be taken by children under 12.

Dosage for elderly patients:

In elderly patients the doctor may reduce the frequency that the capsules are taken.

Dosage for patients with kidneys and/or liver problems:

If you have severe liver and/or kidney problems you should not take Zamadol SR. If, in your case the problem is mild or moderate, your doctor may recommend making the time between taking the tablets longer.

Ask your doctor or pharmacist if:

■    you are not sure how many capsules to take or when to take them

Tell your doctor or pharmacist if

■    you think that the effect is too strong or too weak

Swallow the capsules whole with water without chewing.

If you have difficulty in swallowing, you may open the capsules. You must open them very carefully by pulling and twisting each end over a spoon so that all the pellets stay in the spoon. Do not chew. Swallow all the pellets with water.

If you take more Zamadol SR than you should

If you accidentally take more capsules than your prescribed dose, tell your doctor or pharmacist immediately and if necessary contact your nearest hospital casualty department. Remember to take the pack and any remaining medicines with you.

If you forget to take Zamadol SR

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

If you stop taking Zamadol SR

Do not stop taking Zamadol SR, or lower the dose, without first checking with your doctor. Generally there will be no after-effects when treatment with Zamadol SR is stopped. However, on rare occasions, people who have been taking Zamadol SR for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. If you experience any of these complaints after stopping Zamadol SR please consult your doctor.

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

4. Possible side effects

Like all other medicines, Zamadol SR can cause side effects, although not everybody gets them.

The most serious side effects which may occur include allergic reaction (difficulty in breathing, wheezing and swelling of the face or throat), anaphylactic reaction (an extreme allergic reaction resulting in difficulty breathing, changes in heart rate, faintness, collapse or unconsciousness due to a drop in blood pressure) or convulsions (fits). If you have any of these symptoms you must stop taking Zamadol SR immediately and seek medical advice.

Very Common (occurs in more than 1 in 10 patients)

■    Dizziness

■    Vomiting and nausea (being and feeling sick)

Common (occurs in more than 1 in 100 patients and less than 1 in 10 patients)

■    headache

■    drowsiness, sleepiness (fatigue)

■    constipation, dry mouth

■    sweating

Uncommon (occurs in more than 1 in 1,000 patients and less than 1 in 100 patients)

■    rapid heart beat, palpitation, sudden drops in blood pressure. These adverse effects may occur especially on intravenous administration and in patients who are physically stressed

■    itching, skin rash

■    retching, feeling bloated    or    full

Rare (occurs in more than 1 in 10,000 patients and less than 1 in 1000 patients)

■    allergic reaction such as    difficulty in breathing, wheezing,

swelling of the face or throat.

■    anaphylactic reaction (an extreme    allergic reaction)

■    appetite changes

■    psychic effects including: changes in mood, activity, behaviour and perception, hallucinations, confusion, restlessness, sleep disturbances and nightmares

■    convulsions (fits)

■    tingling sensation and    trembling

■    slow heart beat, increase in blood pressure

■    muscle weakness

■    difficulty or inability in    passing    urine

■    blurred vision

Very rare (occurs in less than 1 in 10,000 patients including isolated cases)

■    flushing

■    vertigo (feeling of dizziness or "spinning")

■    asthma and breathing difficulties

■    elevated liver enzymes

Withdrawal symptoms including: agitation, anxiety, nervousness, difficulty sleeping, restlessness, trembling and gastro-intestinal problems (see section 3, "How to take Zamadol SR").

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.

5.    How to store Zamadol SR

■    Keep out of the sight and reach of children.

■    Do not store above 25°C.

■    Store in the original package.

■    Do not use your capsules after the expiry date printed on the carton and blister labels, even if there are some capsules left. The expiry date refers to the last day of that month.

Ask your doctor to replace them with a new prescription and take any unused capsules back to the pharmacist.

■    If your doctor decides to stop the treatment, return any capsules left over to the pharmacist. Only keep them if your doctor tells you to.

■    If your capsules appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.

■    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 Zamadol SR contains

Each prolonged release hard capsule contains 100mg of the active ingredient tramadol hydrochloride. SR means the capsules are sustained (slow) release.

The other (inactive) ingredients are: sugar spheres (sucrose and maize starch), colloidal anhydrous silica, ethylcellulose, shellac and talc.

The capsule coating contains: gelatine and titanium dioxide (E171).

The printing ink contains: shellac, iron oxide black (E172) and propylene glycol.

What Zamadol SR looks like and contents of the pack

Zamadol SR are white, prolonged release hard capsules with 'T100SR' printed in black ink on the shell cap.

They are available in blister packs of 30 and 60 capsules.

Manufacturer

Manufactured by: Temmler Pharma GmbH & Co. KG, Marburg, Germany.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: BR Lewis Pharmaceuticals Ltd.,

Kirk Sandall, Doncaster, DN3 1QR.

PL No: 08929/0395    POM

Leaflet revision & issue date (ref): 24.12.12

Zamadol® is a registered trademark of Meda Pharma GmbH & Co. KG.

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