p 1 / 2

neso

> laetus 43

PATIENT INFORMATION LEAFLET: INFORMATION FOR USER

Zamadol® Capsules 50 mg

active substance: tramadol 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 your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others as 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 is and what it is used for

2.    Before you take Zamadol

3.    How to take Zamadol

4.    Possible side effects

5.    How to store Zamadol

6.    Further information

1.    What Zamadol is and what it is used for

The name of your medicine is Zamadol® Capsules 50 mg (referred to as a Zamadol throughout this leaflet).

Zamadol belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. The active substance, tramadol hydrocloride, 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 does not stop the pain from happening, but you will not be able to feel the pain as much.

Zamadol is used to relieve moderate to severe, a sudden or a long-standing pain (for example pain after an operation, or after an injury)

2.    Before you take Zamadol Do not take Zamadol 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)

•    you are taking, or you have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs), these are medicines to treat depression

•    you are suffering from uncontrolled epilepsy

•    you have drunk enough alcohol to make you feel woozy or drunk

•    you have taken more than prescribed dose of your sleeping tablets, antipsychotics, antidepressants (antipsychotics and antidepressants are medicines that affect mood and emotions) or other pain killers, which can slow down your breathing and reactions. (See section ‘Taking other medicines’ for details)

Take special care with Zamadol

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

•    There is rare possibility that Zamadol may cause convulsions (fits). The risk is increased if doses above the daily maximum are taken and if you are also taking anti-depressants or antipsychotics.

•    If you have tendency to drug addiction or abuse you should take Zamadol 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 caused by opiates (morphine- like medicines).

•    If you have a head injury, breathing difficulties or severe liver or kidney problems.

Taking other medicines

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

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

•    The pain relief effect of Zamadol may be weakened and/or shortened if you also take medicines containing:

-    Carbamazepine (used to treat epilepsy)

-    Buprenorphine, nalbuphine, or pentazocine (pain killers)

•    The risk of side effects increases if you are taking certain antidepressants. Zamadol may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 °C.

The risk of side effects increases if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Zamadol at the same time. Your doctor will tell you whether Zamadol is suitable for you.

•    Medicines used to treat epilepsy may very rarely cause convulsions (fits), but if you are also taking Zamadol 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.

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

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

Taking Zamadol with food and drink

You can take Zamadol with or without a meal. It is better not to drink alcohol with this medicine. Pregnancy and breast-feeding

Zamadol should not be taken during pregnancy or while breast feeding.

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

Driving and using machines

Zamadol 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 affects you.

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 or dental problem and

-    You have taken it according to the instructions given by the prescriber or 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.

3.    How to take Zamadol

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

The usual dose is 1 or 2 capsules every 4 to 6 hours.

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

The maximum dose is usually 400 mg daily (8 capsules).

> laetus 43

Dosage for children and adolescents:

Over 12 years - as for adults (see above). Under 12 years - Zamadol should not be taken by children under 12.

Dosage for elderly patients:

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or kidney disease (insufficiency)/dialysis patients:

Patients with severe liver and/or kidney insufficiency should not take Zamadol.

If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration:

Ask your doctor or pharmacist if:

•    you are not sure how many tablets to take or when to take them

•    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, your doctor may advise you to open the capsules. The capsules should be opened very carefully by pulling and twisting each end. The capsule should be opened over a spoon so that all the pellets stay in the spoon. The pellets should then be swallowed, take a sip of water afterwards to make sure that you have swallowed all the pellets. Remember that the pellets should not be chewed.

If you take more Zamadol than you should

If you accidentally take more tablets 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 capsules with you.

If you forget to take Zamadol

Do not take more than one dose to make up for the forgotten dose.

If you stop taking Zamadol

Do not stop taking Zamadol, or lower the dose, without first checking with your doctor. Your doctor may want you to gradually reduce the amount of Zamadol you are taking before stopping completely to ensure that you do not suffer from withdrawal symptoms.

Withdrawal symptoms include: agitation, anxiety, nervousness, difficulty sleeping, restlessness, trembling and gastro-intestinal problems.

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 can cause side effects, although not everybody gets them. Please stop taking this medicine and contact your doctor as soon as possible if you experience any of the following rare reactions:

•    allergic reaction such as difficulty in breathing, wheezing, swelling of the face or throat.

•    anaphylactic reaction (an extreme allergic reaction)

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)

•    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

•    flushing

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

•    vertigo (feeling of dizziness or “spinning”)

•    asthma and breathing difficulties

•    elevated liver enzymes

•    dependency

Frequency not known (cannot be estimated from available data)

•    low blood sugar level 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 Zamadol

•    Keep out of sight and reach of children.

•    Do not use Zamadol after the expiry date which is stated on the carton.

The expiry date refers to the last day of that month.

•    Keep your capsules in the original package.

•    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 Capsules 50 mg contains:

The active substance in Zamadol Capsules 50 mg is tramadol hydrochloride.

In addition the other ingredients include dibasic calcium phosphate anhydrous, magnesium stearate, highly dispersed silicon dioxide. The capsule coating and printing ink contains gelatine, shellac and the approved colouring agents, titanium dioxide (E 171) and/or iron oxide black (E 172), propylene glycol and ammonium hydroxide.

What Zamadol Capsules 50 mg look like and contents of the pack The 50 mg Capsules are white in colour with black T 50 printing.

All the capsules are packaged in blister strips of 10 capsules, with 1,2, 3, 5, 6 or 10 blister strips in each carton. These presentations are not available in all countries.

The marketing authorisation holder is:

MEDA Pharmaceuticals Ltd

Skyway House, Parsonage Road,

Takeley, Bishop’s Stortford,

CM22 6PU, UK o

The manufacturer of this product is:

Temmler Pharma GmbH Temmlerstrasse 2,

35039 Marburg, Germany    70037125-38 13/45

This leaflet was last revised in 03/2014