Zamadol SR Capsules 50mg, 100mg, 150mg, 200mg

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 prolonged-release hard capsules is and what it is used for
2. Before you take Zamadol SR prolonged-release hard capsules
3. How to take Zamadol SR prolonged-release hard capsules
4. Possible side effects
5. How to store Zamadol SR prolonged-release hard capsules
6. Further information

Do not take Zamadol SR prolonged-release hard capsules:

• 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 prolonged-release hard capsules

• If taken for long periods there is the rare possibility that addiction may develop.
• There is the rare possibility that Zamadol SR prolonged-release hard capsules may cause con vulsions (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 prolonged-release hard capsules 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 prolonged-release hard capsules you must tell your doctor:

• if you are pregnant or breast feeding.
• if you have been taking Zamadol SR prolonged-release hard capsules 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 prolonged-release hard capsules 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 prolonged-release hard capsules 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 prolonged-release hard capsules, and what dose.

• In isolated cases the side effects of selective serotonin re-uptake inhibitors (SSRI’s) (certain anti depressants) can be intensified when taken with tramadol. Zamadol SR prolonged-release hard capsules 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 prolonged-release hard capsules 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 prolonged-release hard capsules.
• Anticoagulants to thin your blood such as warfarin. The effectiveness of the medicines may be altered if you are also taking Zamadol SR prolonged-release hard capsules.

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

Taking Zamadol SR prolonged-release hard capsules with food and drink

You can take Zamadol SR prolonged-release hard capsules with or without a meal. Avoid drinking alcohol while taking this medicine.

Pregnancy and breast-feeding

Zamadol SR prolonged-release hard capsules 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 prolonged-release hard capsules 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 prolonged-release hard capsules affects you.

Important information about some of the ingredients of Zamadol SR prolonged-release hard capsules

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.

Dosage for adults:

Always take Zamadol SR prolonged-release hard capsules 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 prolonged-release hard capsules 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 prolonged-release hard capsules 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 prolonged-release hard capsules. 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 prolonged-release hard capsules 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 prolonged-release hard capsules

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

If you stop taking Zamadol SR prolonged-release hard capsules

Do not stop taking Zamadol SR prolonged-release hard capsules, or lower the dose, without first checking with your doctor. Generally there will be no after-effects when treatment with Zamadol SR prolongedrelease hard capsules is stopped. However, on rare occasions, people who have been taking Zamadol SR prolonged-release hard capsules 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 prolonged-release hard capsules please consult your doctor.

What Zamadol SR prolonged-release hard capsules contains:

The active substance is tramadol hydrochloride.

Zamadol SR 50 mg, 100 mg, 150 mg and 200 mg prolonged-release hard capsules contains 50 mg, 100 mg, 150 mg and 200 mg tramadol hydrochloride.

The other ingredients of the capsule contents are:

sugar spheres (sucrose and maize starch)

colloidal anhydrous silica

ethylcellulose

shellac

talc.

The capsule contains:

gelatin

titanium dioxide (E171)

iron oxide yellow (E172) (50 mg, 150 mg and 200 mg)

indigotine (E132) (50 mg and 150 mg)

The printing ink contains:

shellac

iron oxide black (E172)

propylene glycol

ammonium hydroxide.

What Zamadol prolonged-release hard capsules look like and the contents of the pack:

Prolonged-release hard capsules

Zamadol 50 mg prolonged-release hard capsules are dark green and marked with T50SR.

Zamadol 100 mg prolonged-release hard capsules are white and marked with T100SR.

Zamadol 150 mg prolonged-release hard capsules are dark green and marked with T150SR.

Zamadol 200 mg prolonged-release hard capsules are yellow marked with T200SR.

This medicinal product is in the form of a prolonged release hard capsule. The capsules release the active ingredient over a period of time.

All the capsules are packaged in PVC/PVDC-aluminium blisters of 10 capsules. Each pack contains 1, 2, 3, 5, 6 or 10 blister blisters, i.e each pack contains 10, 20, 30, 50, 60 or 100 capsules per pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria
Adamon SR 50/100/150/200 mg-Kapseln

Belgium
Tradonal Retard 50/100/150/200 mg, gélules à libération prolongée

Tradonal Retard 50/100/150/200 mg, capsules met verlengde afgifte, hard

Tradonal Retard 50/100/150/200 mg, Hartkapseln, retardiert

Denmark
Gemadol Retard

France
Zamudol LP 50/100/150/200 mg, gélule à libération prolongée

Germany
Travex retard 50/100/150/200 mg Hartkapseln, retardiert

Italy
Tradonal SR 50/100/150/200 mg 30/60 capsule rigide rilascio prolungato

Luxembourg
Tradonal Retard 50/100/150/200 mg, gélules à liberation prolongée

Tradonal Retard 50/100/150/200 mg, capsules met verlengde afgifte, hard

Tradonal Retard 50/100/150/200 mg, Hartkapseln, retardiert

The Netherlands
Tramadol Retard 50/100/150/200 mg

Portugal
Travex Cápsula dura de libertação prolongada

Spain
Tradonal retard x mg cápsulas duras de liberación prolongada

Sweden
Gemadol 50/100/150/200 mg depotkapsel hård

United Kingdom
Zamadol SR 50/100/150/200 mg prolonged-release hard capsules