Please read this leaflet carefully before you start to take your medicine.
This leaflet provides a summary of the information known about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Remember, this medicine is for you. Only a doctor can prescribe this medicine and it may harm someone else, even if their symptoms are the same as yours.
About your medicine
What is your medicine?
The name of your medicine is Zamadol SR Capsules (common name tramadol hydrochloride).
SR means that the capsules are sustained (slow) release.
There are four strengths of Zamadol SR Capsules:
Zamadol SR 50 mg Capsules contain 50 mg tramadol hydrochloride,
Zamadol SR 100 mg Capsules contain 100 mg tramadol hydrochloride,
Zamadol SR 150 mg Capsules contain 150 mg tramadol hydrochloride and
Zamadol SR 200 mg Capsules contain 200 mg tramadol hydrochloride.
Zamadol SR Capsules also contain sugar, maize starch, colloidal anhydrous silica, ethylcellulose, shellac and talc. The capsule coating contains gelatin and the approved colouring agents, titanium dioxide (E171) and/or iron oxide yellow (E172) and/or indigotin (E132). The printing ink contains shellac, propylene glycol and black iron oxide (E172).
The 50 mg SR Capsules are green, contain E171, E172 and E132, and are printed T50SR.
The 100 mg SR Capsules are white, contain E171, and are printed T100SR.
The 150 mg SR Capsules are dark green, contain E171, E172 and E132, and are printed T150SR.
The 200 mg SR Capsules are yellow, contain E171 and E172 and are printed T200SR.
All the capsules are packaged in blister strips of 10 capsules, with one, three or six blister strips in a carton.
What your medicine does
Zamadol SR Capsules are analgesics (pain killers or pain relievers). The active ingredient of Zamadol is tramadol; it 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 tramadol does not stop the pain from happening, but you will not be able to feel the pain as much.
Who produces your medicine?
The marketing authorisation for Zamadol SR Capsules is held by
Zamadol SR Capsules are manufactured by
What your medicine is used for
Zamadol SR Capsules are used to relieve sudden or long-standing pain, either when the pain occurs or to prevent pain from occurring. The type of pain may be moderate or severe and it can be any type of pain, for example pain after an operation, or after an injury.
The sustained release capsules release the active ingredient over a period of time. Depending upon how much Zamadol you have taken and how bad your pain is, relief is normally felt within 30 minutes after taking Zamadol SR Capsules and lasts for about 12 hours. If you take Zamadol SR Capsules daily, your pain should be controlled.
Before taking your medicine
WARNING: Do not take Zamadol SR Capsules if:
- you are a child under 12 years old.
- you have ever had an allergic reaction to tramadol hydrochloride or any of the other ingredients in this medicine.
- you are taking, or have you taken in the last two weeks, monoamine oxidase inhibitors (MAOIs) – these are medicines to treat depression.
- you are suffering from uncontrolled epilepsy.
- you have taken enough alcohol to make you feel even slightly drunk or you have taken several sleeping pills, other pain killers or any other medicines which slow down your thinking or breathing rate.
- you are pregnant or breast-feeding.
If the answer to any of the following questions is “yes”, you must tell your doctor – he may decide to alter your treatment:
- Have you been taking Zamadol or any other tramadol containing medicine for a long time?
- Are you addicted to morphine?
- Have you had an allergic reaction to any morphine-like medicines?
- Do you have severe problems with your liver or kidneys?
- Have you recently had a head injury or do you have a very bad headache that makes you sick?
- Have you ever had convulsions (fits) or do you suffer from epilepsy?
- Do you have asthma or trouble breathing?
- Are you taking any tranquillisers or antidepressants or treatment for epilepsy?
What about other medicines that you may be taking?
Some medicines used to treat epilepsy, some antidepressants and tranquillisers may cause convulsions (fits). This is rare, but if you are also taking Zamadol SR Capsules the possibility of having a convulsion (fit) is more likely.You must ask your doctor about this.
If you are taking carbamazepine for epilepsy, anticoagulants such as warfarin or monoamine oxidase inhibitors for depression, you must also tell your doctor.
Zamadol SR Capsules may cause drowsiness and this effect may be increased by antidepressant medication, or other medicines which slow down your nervous system (making you feel faint). These include sleeping pills, tranquillisers, other pain killers (such as buprenorphine, nalbuphine and pentazocine) or a general anaesthetic. Tell your doctor or dentist if you are taking any of these medicines.
What about food and drink?
Zamadol SR Capsules are not known to react badly with food or soft drinks. It is better not to drink alcohol with this medicine.
Special warnings
This medicine contains sucrose.
Driving and using machines
Zamadol SR Capsules may make you feel drowsy. Do not drive or operate heavy machinery unless you know how Zamadol SR Capsules affect you.
Taking your medicine
How to take your medicine
Follow your doctor's instructions on how many Zamadol SR Capsules you should take and when to take them.You should normally take your Zamadol SR Capsules every 12 hours, for example first thing in the morning and then at the same time in the evening. The number of capsules you take will depend upon the dose your doctor prescribes, but you should not take them more frequently than every 12 hours. Normally you should not take more than 400 mg tramadol per day. If you are not sure how many capsules to take or when to take them, ask your doctor or pharmacist.
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.
What to do if you forget to take your medicine
If you forget to take your medicine, take it as soon as you remember then take the next dose 12 hours later, but DO NOT TAKE MORE THAN ONE DOSE AT THE SAME TIME.
What to do if you see a different doctor, or have to go to hospital
If you see another doctor or have to go to hospital for any reason, tell them about all the medicines you are taking including Zamadol.
What to do if you take an overdose
If you ever take too many capsules or if a child accidentally takes Zamadol SR Capsules contact your nearest hospital casualty department or tell your doctor immediately.
After taking your medicine
Zamadol SR Capsules, like all other medicines, may have side-effects.You may not have any of these side-effects or you may have some of them.
These side-effects may include feeling sick or being sick, sweating, a dry mouth, drowsiness, tiredness, dizziness (especially after standing up suddenly from a sitting down position), headache, constipation or shortness of breath.
Zamadol SR Capsules may (rarely) also cause dependence (addiction), blurred vision, tingling sensations, hallucinations, nightmares and sleep disturbances, confusion, changes in mood such as feelings of sadness, nervousness or fidgetiness, fits (convulsions), tremor, rapid or slow heart beat, an increase or fall in blood pressure, flushing or blood changes, difficulty passing urine, minor changes in liver function, irritation of the stomach (feeling of bloatedness) and changes in appetite. In very rare cases withdrawal symptoms may be experienced when your treatment is stopped.
An allergic reaction to tramadol could make your asthma worse if you already have asthma, or it could make you feel as though breathing is difficult. Allergic reactions to tramadol may also include itching or skin rash. In very rare cases a very severe allergic reaction called anaphylaxis may occur. If you experience any of these allergic reactions, please stop taking the capsules and contact your doctor immediately.
If you have any questions about these side-effects, or if you notice any other side-effects or problems, you should tell your doctor or pharmacist.
How to store your medicine
- Keep your capsules in the original package and in a safe place where children cannot see or reach them.Your capsules could harm them.
- Do not use your capsules after the expiry date on the box, even if there are some capsules left. Ask your doctor to replace them with a new prescription and take any unused capsules back to the pharmacist.
- If your doctor tells you to stop taking the capsules, please take them back to the pharmacist.
This leaflet was written in June 1998 and revised in June 2008.
ZAMADOL is a registered trademark of MEDA
© MEDA
70037142-2308/46
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