Zamadol Melt 50 Mg Tablets.
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PATIENT INFORMATION LEAFLET
Zamadol® Melt 50mg Tablets
(Tramadol Hydrochloride)
Please read this leaflet carefully before you start taking this medicine. You should keep this leaflet as it provides the information you need to know about your medicine. If you have any further questions or are not sure about your medication, please ask your doctor or pharmacist.
Remember, this medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
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1. What Zamadol Melt is and what it is used for
2. Before you take Zamadol Melt
3. How to take Zamadol Melt
4. Possible side effects
5. Storing Zamadol Melt
6. Further information
Zamadol® Melt 50mg Tablets
(Tramadol Hydrochloride)
The active substance in Zamadol Melt is tramadol hydrochloride. Each tablet contains 50mg tramadol hydrochloride. It also contains other ingredients including: ethylcellulose N7, copovidone, silicon dioxide, mannitol (E421), crospovidone, aspartame (E951), mint rootbeer flavouring, magnesium stearate.
The marketing authorisation holder for Zamadol Melt is: MEDA Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishop's Stortford CM22 6PU, UK.
The manufacturer of Zamadol Melt is: Ethypharm Industries, Z.I. de Saint-Arnoult, 28170 Chateauneuf-en-Thymerais, FRANCE.
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1. WHAT ZAMADOL MELT IS AND WHAT IT IS USED FOR
The name of your medicine is Zamadol Melt (common name tramadol hydrochloride). 'Melt' means that these tablets will dissolve on your tongue. The tablets are white in colour and packaged in blister strips of 10 tablets with 1,6 or 10 blister strips in each carton.
Zamadol Melt is an analgesic (pain killer or pain reliever). The active ingredient of Zamadol Melt is tramadol; it interrupts the pain messages being sent to your brain, and it also reacts 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.
Zamadol Melt is 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, or the pain of arthritis. Pain relief is normally felt within 30 minutes and lasts for about 6 hours.
2. BEFORE YOU TAKE ZAMADOL MELT DO NOT take Zamadol Melt if:
- You are a child under 12 years of age.
- You have ever experienced an allergic reaction to tramadol hydrochloride or any of the ingredients in this medicine. Allergic reactions to tramadol could include skin rash, swelling of the face, wheezing or difficulty in breathing.
- You are pregnant or breast feeding.
- You are taking, or 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 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 taking strong pain killers containing nalbuphine, buprenorphine, pentazozine or carbamazepine. Take special care with Zamadol Melt:
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 or have a tendency to drug abuse?
- Have you had an allergic reaction to any morphine-like medicines?
- Do you have severe problems with your liver or kidneys? (If you have kidney or liver problems or are over 75 years, you may need a lower dose of Zamadol Melt or a longer interval between doses).
- 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 antidepressants, antipsychotics (drugs for schizophrenia) or anticonvulsants (drugs for epilepsy), tranquillisers (drugs to treat anxiety) or anti-histamines that that cause drowsiness?
Taking Zamadol Melt with food and drink:
Zamadol Melt is not known to react badly with food or soft drinks. It is better not to drink alcohol with this medicine. You should not take Zamadol Melt even if you are feeling slightly drunk.
Driving and using machines:
Zamadol Melt may cause drowsiness. If this occurs you should not drive or operate tools or machines. Important information about some of the ingredients:
The ingredient aspartame contains a source of phenylalanine which may be harmful to people with phenylketonuria.
Taking other medicines with Zamadol Melt:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Driving and using machines
If you are taking certain types of antidepressant, such as tricyclic antidepressants (TCAs) or selective serotonin re-uptake inhibitors (SSRIs), or you are being treated with antipsychotic or anticonvulsant medicines there is a risk that Zamadol Melt may increase the possibility of a convulsion occurring. You must ask your doctor about this.
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
If you see a different doctor, or have to go to hospital:
If you see any other doctor or have to go to hospital for any reason, you must tell them about the Zamadol Melt and any other medication you are taking.
4. POSSIBLE SIDE EFFECTS
Like many other medicines, Zamadol Melt 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 being sick or feeling sick, sweating, dry mouth, drowsiness, fatigue and tiredness, dizziness (especially after standing up suddenly from a sitting down position), palpitations, headache, constipation or irritation of the stomach (feeling of bloatedness).
Zamadol Melt may (rarely) also cause dependence (addiction), blurred vision, tingling sensations, hallucinations, nightmares and sleep disturbances, confusion, changes in mood such as feelings of sadness or nervousness, fits (convulsions), tremor, an increase or fall in blood pressure, difficulty passing urine and changes in appetite. Rarely withdrawal symptoms may be experienced when your treatment is stopped. If this occurs you may feel agitated, anxious, nervous or shaky, and you may have difficulty in sleeping. These effects will usually disappear within a few days.
Very rarely you may experience vertigo, flushing, worsening of asthma, difficulty in breathing or minor changes in liver function.
Sometimes an allergic reaction may occur. Allergic reactions to Zamadol may include itching or a skin rash. In rare cases, an allergic reaction to Zamadol Melt could make your asthma worse if you already have asthma, it could make you feel as though breathing is difficult, or it may cause angioneurotic oedema (a swelling of your face and lips). If you experience any of these allergic reactions, please stop taking the tablets immediately and contact your doctor.
Frequency not known (cannot be estimated from the 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. STORING ZAMADOL MELT
Keep your medicine out of the sight and reach of children. Your tablets could harm them. Store in the original package.
Do not use your tablets after the expiry date stated on the box, even if there are some left. Ask your doctor to replace them with a new prescription and take any unused tablets back to the pharmacist.
If your doctor tells you to stop taking your tablets, please take them back to the pharmacist.
6. FURTHER INFORMATION
For further information please contact the Marketing Authorisation Holder. This leaflet was last revised in 03/2014 ® ZAMADOL is a registered trademark of MEDA Pharma GmbH & Co. KG © MEDA Pharmaceuticals Ltd
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Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
If you are taking carbamazepine for treatment of epilepsy, coumarin anticoagulants (blood thinning medicines) such as warfarin, or monoamine oxidase inhibitors or lithium for treatment of depression, you must tell your doctor.
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. You must tell your doctor if you are taking any of these medicines.
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.
Zamadol Melt 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, anti-histamines that make you drowsy, antipsychotics, other pain killers or a general anaesthetic. Tell your doctor or dentist if you are taking any of these medicines.
Always take Zamadol Melt exactly as instructed by your doctor. If you are unsure please check with your doctor or pharmacist.
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 usual dose is 1 or 2 tablets every 4 to 6 hours. The number of tablets you take and how often will depend on the type of pain you have and how strong it is. Normally you should not take more than 8 tablets per day (400 mg). Check the label for how many tablets to take and how often to take them. If you are not sure how many tablets to take, ask your doctor or pharmacist.
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.
Dosage for patients with kidney and/or liver problems:
Patients with severe liver and/or kidney insufficiency should not take Zamadol. If in your case the problem is mild or moderate your doctor may recommend prolonging the dosage interval.
Do not swallow Zamadol Melt tablets. These tablets should be sucked, not chewed, as they will dissolve on your tongue. If necessary you may dissolve each tablet in half a glass of water.
If you have chronic pain (long-lasting pain), you should check regularly with your doctor that it is appropriate for you to continue taking tramadol.
If you take more Zamadol Melt than you should:
If you ever take too many tablets or if a child accidentally takes Zamadol Melt, contact your nearest hospital casualty department or tell your doctor immediately.
If you forget to take Zamadol Melt:
If you forget to take your medicine, take it as soon as you remember. Then take the next dose 6 hours later, but DO NOT TAKE MORE THAN ONE DOSE AT THE SAME TIME.
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# 56UK22940005-02_p02.indd 2 24.04.14 10:56