TRAMADOL 50MG CAPSULES

Tramadol 50mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What are Tramadol 50mg Capsules and what are they used for 2. Before you take Tramadol 50mg Capsules 3. How to take Tramadol 50mg Capsules 4. Possible side effects 5. Storing Tramadol 50mg Capsules 6. Further information If you feel light-headed, faint, cold or clammy, or look pale. If you su er from asthma, or other lung disease or have difficulty in breathing If you su er from kidney or liver disease.

1.

WHAT ARE TRAMADOL 50mg CAPSULES AND WHAT ARE THEY USED FOR?

In such cases please consult your doctor before taking the medicine. Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg). Please note that Tramadol 50mg Capsules may lead to physical and psychological addiction. When Tramadol 50mg Capsules is taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development). In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with Tramadol Capsules should only be carried out for short periods and under strict medical supervision. Please also inform your doctor if one of these problems occurs during Tramadol Capsules treatment or if they applied to you in the past. Taking other medicines Tramadol Capsules should not be taken together with MAO inhibitors (certain medicines for the treatment of depression). The pain-relieving effect of tramadol Capsules may be reduced and the length of time it acts may be shortened, if you take medicines which contain carbamazepine (for epileptic fits); pentazocine, nalbuphine or buprenorphine (pain killers); ondansetron (prevents nausea). Please tell your doctor or pharmacist: If you are taking other medicines including tranquilizers, sleeping pills, antidepressants and other pain relievers such as morphine and codeine. You may feel drowsier or feel that you might faint. If you are going to be given a general anaesthetic tell your doctor or dentist that you are taking Tramadol 50mg Capsules. If you are taking carbamazepine, a treatment for epilepsy, this may reduce the pain relieving effect of Tramadol 50mg Capsules. Your doctor will tell whether Tramadol 50mg Capsules is suitable for you. If you are taking antidepressants these may cause convulsions (fits). The chance of having a fit is rare, but if you are also taking Tramadol 50mg Capsules, the risk of having a fit may increase. Your doctor will tell you whether having Tramadol 50mg Capsules is suitable for you. If you are taking selective serotonin reuptake inhibitors (often referred to as SSRI's) or triptans or MAOI's because it has been shown that Tramadol may interfere with these medicines and you may experience symptoms such as confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, or diarrhoea. If you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol Capsules. The effect of these medicines on blood clotting may be affected and bleeding may occur. If you are taking lithium, make sure your doctor or dentist knows. Tramadol 50mg Capsules could alter the effect of lithium. If you are taking coumarin anticoagulants (blood thinning medicines) e.g. warfarin. Tramadol 50mg Capsules could alter their effects if taken at the same time. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription and herbal remedies. Taking Tramadol 50mg Capsules with food and drink You should avoid alcohol during treatment with Tramadol 50mg Capsules. If you use alcohol with Tramadol 50mg Capsules you may feel drowsier than when you are taking alcohol alone.

Tramadol 50mg Capsules are 'analgesics' which act on the central nervous system (the brain and the spinal cord). Analgesics are often called 'pain killers' or 'pain relievers'. Tramadol 50mg Capsules relieve pain and can also be taken to prevent pain. Pain is a symptom not an illness. There are many types of pain with many different causes, for example back-ache, toothache, pain after an operation or pain from broken bones. Tramadol 50mg Capsules help your body's system for relieving pain. It does this in two ways: - Acts directly on parts of your brain and spinal cord to reduce the amount of pain you feel - Reduces the size of the pain message passed from one nerve to another. Tramadol 50mg Capsules should only be taken by adults or children over 12. BEFORE YOU 2. CAPSULES TAKE TRAMADOL 50mg Do not take Tramadol 50mg Capsules If you have had an allergic reaction, skin rash, swelling of the face, wheezing or difficulty breathing after taking tramadol or any of the other ingredients in Tramadol 50mg Capsules. If you are hypersensitive (allergic) to tramadol hydrochloride or any of the other ingredients in Tramadol 50mg Capsules If you are pregnant or if you are breast-feeding If you are taking a monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks. You should know if you are taking MAOI because your doctor or chemist will have told you, and you may also have a treatment card. If you su er from epilepsy not controlled by treatment If you have drunk enough alcohol to make you feel whoozy or drunk. If you feel 'high' or excited because you have taken medicines that slow the nervous system. These medicines include tranquillisers, sleeping pills, psycho-tropic medicines (medicines that affect your mood or emotions) or other pain relievers such as morphine and codeine. If you have severe kidney disease. As a substitute in drug withdrawal. Take special care with Tramadol 50mg Capsules If you think that you are addicted to other pain relievers (opioids); If you su er from consciousness disorders (if you feel that you are going to faint); If you have had a head injury or have brain disease. If you have a very bad headache or vomit without feeling sick first, this could be a sign of this. If you su er from epilepsy, convulsions or seizures (fits) or have had them in the past.

Pregnancy and breast feeding Ask your doctor or pharmacist for advice before taking any medicine. There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use Tramadol Capsules if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns. Generally, the use of tramadol is not recommended during breast-feeding. Small amounts of tramadol are excreted into breast milk. On a single dose it is usually not necessary to interrupt breast-feeding. Please ask your doctor for advice. Driving and using machines Tramadol can cause drowsiness. Do not drive or operate any tools or machines if you feel tired or sleepy after treatment with Tramadol 50mg Capsules. These effects are made worse if alcohol and/or CNS depressants are taken at the same time.

Very common (> 1/10) Some people may feel dizzy or nauseous Common (<1/100, 1> 1/10) Some people may vomit or sweat, have a dry mouth and have diarrhoea or constipation, or suffer headaches or drowsiness. tiredness, weariness, weakness, low energy Uncommon (<1/1000, 1> 1/100) Some people may su er from palpitations (awareness of your heartbeat), or tachycardia (rapid heart beat), irregular heartbeat, retching, gastro-intestinal irritation, skin irritation and develop a rash. Some people may suffer postural hypotension (dizziness or light headedness when standing up too quickly). Rare (<1/10,000, 1> 1/1000) Some people may develop high blood pressure, bradycardia (slow heartbeat) or changes in appetite. Parasthesia (pins and needles), convulsions, hallucinations, sleep pattern disturbances and nightmares can also occur. Some people may get blurred vision or have difficulty in passing urine. Very few people may experience unusual effects on the nervous system such as confusion, changes of mood, delusions, feelings of loss of identity or unusual perceptions such as itching, tingling or numbness. Rarely, people have also suffered allergic or anaphylactic reactions. These may include a rash, itching, swelling of the face or breathing problems (shortness of breath and wheezing). In a few isolated cases, blood disorders have also been reported. Very rare (<1/10000): Increase in liver enzyme values If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Contact your doctor immediately if: You have di culty breathing Your asthma gets worse You get an allergic reaction, skin rash, swelling of the face, or wheezing You have a fit You constantly have a sore throat or high temperature

3. HOW TO TAKE TRAMADOL 50mg CAPSULES
Follow your doctor's instructions on how many Tramadol 50mg Capsules to take and when to take them. You will also find this information on the label. You should usually swallow one or two capsules at a time. Do not take them more often than every four hours and do not take more than eight capsules in any 24 hours unless your doctor tells you to. Swallow the capsules whole, not divided or chewed, with sufficient liquid. Tramadol capsules do not need to be taken with food. If you are not sure, ask your doctor or pharmacist. Do not take a different amount of Tramadol 50mg Capsules or take it more often than your doctor has told you to. These Tramadol 50mg Capsules are for you. You must not give them to other people. If you have chronic pain (pain that lasts for long periods of time) it is best to take Tramadol 50mg Capsules over short periods and only when you need it. If you take more Tramadol 50mg Capsules than you should:If you take two single doses of Tramadol 50mg capsules at once by mistake, this will generally not be harmful. If pain returns, continue taking Tramadol 50mg Capsules as usual. If high doses are taken accidentally (e.g. a dose of more than two Tramadol 50mg Capsules at once), a number of symptoms may occur. These might include:pin-point pupils, vomiting, a fall in blood pressure, a fast heartbeat, collapse, disturbed consciousness including coma (deep unconsciousness), epileptic fits and difficulties in breathing. If you suspect that you or someone else has taken an overdose of Tramadol 50mg Capsules, contact your doctor or go to your local hospital immediately. Always take the carton and this leaflet with you if possible. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you forget to take Tramadol 50mg Capsules If you forget to take the capsules, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking the capsules as before. If you stop taking Tramadol 50mg Capsules Tramadol 50mg Capsules may cause dependence (addiction / reliance on a medicine). Although this is rare, when you stop taking Tramadol 50mg Capsules, you may feel agitated, anxious, nervous or shaky. You may become hyperactive and have difficulty sleeping. Very few people may experience unusual effects on the nervous system such as confusion, delusions or unusual perceptions such as itching, tingling or numbness or noise in the ear (tinnitus) or stomach and bowel disorders. These effects usually disappear after a few days. Tell your doctor if you experience any of these symptoms after stopping Tramadol 50mg Capsules.

5. HOW TO STORE TRAMADOL 50mg CAPSULES
Keep out of the reach and sight of children. Do not use Tramadol 50mg Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 30 C. Medicines should not be disposed of via waste water 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 Tramadol 50mg Capsules contain The active substance is called tramadol hydrochloride. Each Capsule contains 50mg of tramadol hydrochloride. The other ingredients are Calcium hydrogen phosphate (dihydrate), Magnesium Stearate and Silica (Colloidal anhydrous). The capsule is made of gelatine and contains the colour Titanium dioxide (E171). The printing ink contains the ingredients shellac, Black Iron oxide, Soya Lecithin and Antifoam DC 1510. What Tramadol 50mg Capsules look like and the contents of the pack Tramadol 50mg Capsules are all white and have 'TR50' printed on the outside. They are packed in blister strips and supplied in boxes of 30 or 100 capsules. Marketing Authorisation Holder and Manufacturer Relonchem Ltd, 27 Old Gloucester Street, London, WC1 3XX. UK Distributor Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, UK This leaflet was last amended in: May 2012
CP.TDL.50C.RC.V1P1

4. POSSIBLE SIDE EFFECTS
Like all medicines. Tramadol 50mg Capsules can cause side effects, although not everybody gets them. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.