Tramadol Hydrochloride 50mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMADOL HYDROCHLORIDE 50 mg CAPSULES
The name of your medicine is Tramadol Hydrochloride 50 mg Capsules, which will be referred to as Tramadol Capsules throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them,
- even if their signs of illnessare the same as yours.If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Tramadol Capsules are and what they are used for
2. What you need to know before you take Tramadol Capsules
3. How to take Tramadol Capsules
4. Possible side effects
5. How to store Tramadol Capsules
6. Contents of the pack and other information
1. WHAT TRAMADOL CAPSULES ARE AND WHAT THEY ARE USED FOR
Tramadol Capsules contain the active ingredient tramadol hydrochloride, which is a painkiller. Tramadol Capsules are used to treat and prevent moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL CAPSULES Do not take Tramadol Capsules if you
- are allergic (hypersensitive) to tramadol or any of the other ingredients of Tramadol Capsules (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
- are drunk (intoxicated with alcohol)
- are taking, or have taken in the last two weeks, monamine oxidase inhibitors ( a type of antidepressant)
- are taking sleeping pills
- are taking another similar painkiller (such as codeine, morphine, pethidine, etc)
- are taking drugs that affect the brain, e.g. for mental illness
- are short of breath or you are taking another drug that affects your breathing
- suffer from constipation following surgery or illness (paralytic ileus)
- are an epileptic and your fits are not adequately controlled by treatment
- are taking this medicine as a substitute in drug withdrawal
Take special care with Tramadol Capsules Warnings and precautions
Addiction
This medicine may cause physical and psychological dependence (addiction) with long-term use. In patients who might become addicted to drugs, this medicine should only be used for very short periods and under strict medical supervision. Tell your doctor if you have a history of drug abuse or dependence or you are addicted to other pain relievers (opioids) , as you should only use this medicine for short periods and under strict medical supervision.
Tramadol Capsules can cause withdrawal symptoms (see Section 3 When you stop taking Tramadol
Capsules)
- Talk to your doctor before taking Tramadol if youhave a head injury
- have severe kidney or liver disorder
- suffer from increased intracranial pressure (an increase in normal brain pressure causing symptoms such as headache and vomiting)
- suffer from asthma (do not take tramadol during an attack) or other lung diseases, or have slow or troubled breathing
- suffer from epilepsy, fits or seizures or have had them in the past. 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)
- suffer from consciousness disorders (if you feel that you are going to faint)
- are in a state of shock (cold sweat may be a sign of this)
When Tramadol is taken for a long time, its effect may decrease, so that higher doses have to be taken
(tolerance development)
Tell your doctor that you are taking Tramadol Capsules if you are going to have a general anaesthetic.
Other medicines and Tramadol
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
DO NOT take Tramadol if you are taking:
• monoamine oxidase inhibitor (MAOI, which is a type of medicine that can treat Parkinson's Disease or depression) such as selegiline or moclobemide, or if you have taken any of these medicines within the past two weeks.
The pain-relieving effect of Tramadol 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 (given before chemotherapy or an operation to prevent patient being sick).
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 Tramadol at the same time. Your doctor will tell you whether Tramadol is suitable for you.
- if you are taking certain antidepressants. Tramadol 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.
Talk to your doctor or pharmacist if you are taking, have recently taken or might take any of the following:- other medicines that slow the nervous system, including tranquilisers (e.g. diazepam, alprazolam), sleeping pills, antidepressants and other pain relievers such as morphine and codeine - lithium (a medicine used to treat certain types of mental illness)
- medicines which may cause convulsions (fits), such as certain antidepressants. The risk having a fit may increase if you take Tramadol at the same time
- selective serotonin reuptake inhibitors (often referred to as SSRIs , used to treat depression). Tramadol may interact 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 diarrhea.
- cimetidine (to treat ulcers)
- coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol. The effect of these medicines on blood clotting may be affected and bleeding may occur.
Before you have a general anaesthetics (medicines used for temporary loss of bodily sensation during operation), make sure you tell your doctor or dentist that you are taking Tramadol Capsules.
It may still be all right for you to be given Tramadol Capsules. Your doctor will be able to decide what is suitable for you.
Taking Tramadol Capsules with food and drink
• DO NOT take alcohol whilst taking Tramadol capsules. Food does not influence the effect of Tramadol.
Pregnancy ,breast-feeding and fertility
You should not take Tramadol Capsules if you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Tramadol Capsules may cause sleepiness and this is made worse by alcohol and some other drugs that affect the brain. Tramadol Capsules may also cause dizziness, drowsiness and blurred vision. Use caution when driving or operating heavy machinery until you are aware of how this drug 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.
Important information about some of the ingredients of Tramadol Capsules
Tramadol Capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE TRAMADOL CAPSULES
Tramadol capsules are for oral use. Always swallow Tramadol capsules whole, not divided or chewed, with sufficient liquid.
Always take this medicine exactly as your doctor has told you..Check with your doctor or pharmacist if you are not sure.
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.
Dosage
Adults, the elderly and children aged 12 years and over:
- For short-term pain, a first dose of 2 capsules (100mg) is taken. This can be followed by doses of 1-2 capsules (50 -100 mg) not more often than every 4 hours.
- For long-term pain, a first dose of 1 capsule (50 mg) is taken and then further doses are taken depending on how severe the pain is.
- The maximum daily dose is usually 8 capsules (400mg).
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 Tramadol. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
Children under 12 years old:
Not recommended.
How long should you take Tramadol capsules
You should not take Tramadol capsules for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Tramadol capsules and at what dose. If you have the impression that the effect of Tramadol capsules is too strong or too weak, talk to your doctor or pharmacist.
If you take more Tramadol Capsules than you should
Go to the nearest casualty department or contact your doctor immediately. Take the capsule carton with you. The symptoms of overdose are pinpoint pupils of the eyes, vomiting, fits, shallow breathing, sleepiness and coma.
If you forget to take Tramadol Capsules
If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose.
When you stop taking Tramadol Capsules
If you interrupt or finish treatment with Tramadol capsules too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your doctor. Generally there will be no after-effects when treatment with Tramadol capsules is stopped. However, on rare occasions, people who have been taking Tramadol capsules for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be confused, hyperactive, have difficulty sleeping, spasm or uncontrolled muscular action, tremor and have stomach or bowel disorders. Very few people may get panic attacks, delusions, paranoia, hallucinations or feeling a loss of identity. They may experience unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). If you experience any of these complaints after stopping Tramadol capsules, please consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Serious side effects
If you notice any of these symptoms, stop taking the capsules and consult your doctor straight away.
- Convulsions (fits)
- Breathing difficulties such as shallow breathing, breathlessness, asthma-like symptoms, and worsening of asthma
The following side effects have also been reported:
Usually the frequency of side effects is classified as follows:
• very common (more than 1 out of 10 persons)
• common (more than 1 out of 100 persons)
• uncommon (more than 1 out of 1,000 persons)
• rare (more than 1 out of 10,000 persons)
• very rare (less than 1 out of 10,000 persons)
• not known (can not be estimated from the available data)
Heart and blood circulation disorders
uncommon: effects on the heart and blood circulation (pounding of the heart, fast heart beat, a fall in blood pressure on standing up which causes dizziness, light-headedness, feeling faint or collapse).
These adverse effects may particularly occur in patients in an upright position or under physical strain.
rare: slow heart beat, increase in blood pressure.
Nervous system disorders very common: dizziness. common: headaches, drowsiness.
rare: changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), trembling, slow breathing, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope).
Not known: difficulty in speaking
If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
Epileptic fits have occurred mainly at high doses of Tramadol capsules or when tramadol capsules was taken at the same time as other medicines which may induce fits.
Psychiatric disorders
rare: hallucinations, confusion, sleep disorders, anxiety and nightmares.
Psychological complaints may appear after treatment with Tramadol Capsules. Their intensity and nature may vary (according to the patient’s personality and length of therapy). These may appear as a change in mood, behavior and lifestyle interests (mostly high spirits, occasionally irritated mood), changes in activity (slowing down but sometimes an increase in activity) and being less aware and less able to make decisions, which may lead to errors in judgement. Dependence may occur.
Metabolism and nutrition disorders Not known: decrease in blood sugar level Eye disorders
Rare: blurred vision
Not known; dilation of the pupil
Respiratory disorders
Rare: shortness of breath (dyspnoea).
Worsening of asthma has been reported, however it has not been established whether it was caused by tramadol capsules.
Stomach and bowel disorders Very common: feeling sick.
Common: being sick, constipation, dry mouth.
Uncommon: urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
Skin disorders Common: sweating
Uncommon: skin reactions (e.g. itching, rash).
Muscle disorders Rare: weak muscles.
Liver and biliary disorders
Very rare: increase in liver enzyme values.
Urinary disorders
Rare: passing water difficult or painful, less urine than normal.
General disorders
Common: tiredness, weakness and low energy.
Other side effects:
Excessive sweating, feeling flushed (feeling hot and red skin) have rarely been seen during the treatment. Blood disorders has been reported. Blood disorders may be characterised by fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising.
If Tramadol capsules is taken over a long period of time dependence may occur, although the risk is very low. When treatment is stopped abruptly signs of withdrawal may appear (see ‘If you stop taking Tramadol Capsules’).
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. 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 TRAMADOL CAPSULES Keep this medicine out of the sight and reach of children.
Do not store above 250C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tramadol capsules contain:
The active substance is tramadol hydrochloride 50 mg
The other ingredients are: microcrystalline cellulose, povidone K30, a-lactose monohydrate, magnesium stearate and sodium starch glycollate. The capsule shell contains gelatine and titanium dioxide (E171). The black ink contains shellac, industrial methylated spirit 74 OP, soya lecithin, antifoam DC 1510, n-butyl alcohol and black iron oxide (E172).
What Tramadol capsules looks like and contents of the pack The capsules are white and marked “T50”
Tramadol capsules come in blister packs of 30 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer PLIVA Pharma Ltd Ridings Point,
Whistler Drive,
Castleford,
West Yorkshire,
WF10 5HX
This leaflet was last revised in:
September 2014
PL 10622/0050