Tramadol Hydrochloride 50mg Capsules
Ver12 update in line with reference product, Zydol (PL 21727/0001)
PATIENT INFORMATION LEAFLET TRAMADOL HYDROCHLORIDE 50MG CAPSULES
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. Y ou may need to read it again.
• If you have any further questions, ask your doctor or your 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 illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (section 4).
In this leaflet:
1. What tramadol is and what it is used for
2. What you need to know before you take tramadol
3. How to take tramadol
4. Possible side effects
5. How to store tramadol
6. Content of the pack and other information
WHAT TRAMADOL IS AND WHAT IT IS USED FOR
The name of your medicine is Tramadol Hydrochloride 50mg Capsules (called tramadol throughout this leaflet). Tramadol contains a medicine called tramadol hydrochloride. It is a painkiller (analgesic) belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
It is used to treat moderate to severe pain.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL
Do not take tramadol:
• if you are allergic to tramadol or any of the other ingredients in this medicine (listed in section 6);
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);
• if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with tramadol (see “Other medicines and Tramadol”)
• If you are an epileptic and your fits are not adequately controlled by treatment;
• as a substitute in drug withdrawal
Do not take tramadol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking tramadol.
Warnings and precautions
Talk to your doctor before taking tramadol
• if you think that you are addicted to other pain relievers (opioids);
• if you suffer from consciousness disorders (if you feel that you are going to faint);
• if you are in a state of shock (cold sweat may be a sign of this);
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• if you have difficulty in breathing;
• if you have a tendency toward epilepsy or fits because the risk of a fit may increase;
• if you suffer from a liver or kidney disease;
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 (400mg).
Please note that tramadol may lead to physical and psychological addiction. When tramadol 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 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 treatment or if they applied to you in the past.
Other medicines and tramadol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Tramadol should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
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);
- Ondansetron (prevents nausea).
Your doctor will tell you whether you should take tramadol, and at what dose.
The risk of side effects increases
- if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking tramadol. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
- 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 .
- if you take 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.
Tramadol with food and alcohol
Do not drink alcohol while you are taking these capsules. This is because alcohol can change the way tramadol affects you. Food does not influence the effect of tramadol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use tramadol 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. After a single dose it is usually not necessary to interrupt breastfeeding.
Based on human experience tramadol is suggested not to influence female or male fertility.
Driving and using machines
Tramadol may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected, do not drive a car or other vehicle, do not use electric tools or operate machines.
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.
3. HOW TO TAKE TRAMADOL
Always take tramadol exactly as your doctor has told you. You should 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. Do not take more than 400mg tramadol hydrochloride daily, except if your doctor has instructed you to do so.
How much to take
Adults and adolescents from the age of 12 years
• The usual starting dose of tramadol is 1 or 2 capsules.
• Depending on the pain the effect lasts for about 4-8 hours.
• Wait at least 4 hours before taking another dose of 1 or 2 capsules. Do not take more than 8 capsules in any 24-hour period.
Children
Tramadol is not suitable for children below the age of 12 years.
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 or may lower your dose.
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.
How and when should you take tramadol?
Tramadol is for oral use.
Always swallow the capsules whole, not divided or chewed with a drink of water, preferably in the morning and evening. You may take the capsule on an empty stomach or with meals.
How long should you take tramadol?
You should not take tramadol 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 and at what dose.
If you have the impression that the effect of tramadol is too strong or too weak, talk to your doctor or pharmacist.
If you take more tramadol than you should
If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed.
If you (or someone else) swallow a lot of tramadol at the same time tell your doctor or go to your nearest hospital casualty department or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.
If you forget to take tramadol
If you forget to take the capsule, pain is likely to return. Do not take a double dose to make up for the forgotten individual doses, simply continue taking the capsule as before.
If you stop taking tramadol
If you interrupt or finish treatment with tramadol 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 is stopped.
However, on rare occasions, people who have been taking tramadol 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. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, changes in perception of their own personality (depersonalisation), change in perceptions of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely.
If you experience any of these complaints after stopping tramadol and consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
As with all medicines, this medicine can cause side effects, although not everybody gets them.
You should see a doctor immediately if you experience symptoms of an allergic reaction such as swollen face, tongue and/or throat, and/or difficulty swallowing or hives together with difficulties in breathing.
The most common side effects during treatment with tramadol are nausea and dizziness, which occur in more than in 1 out of 10 patients.
Very common (may affect more than 1 in 10 people):
• dizziness
• nausea (feeling sick)
Common (may affect up to 1 in 10 people):
• headaches, drowsiness
• fatigue
• constipation, dry mouth, vomiting (being sick)
• sweating (hyperhidrosis)
Uncommon (may affect up to 1 in 100 people):
• effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.
• urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
• skin reactions (e.g. itching, rash)
Rare (may affect up to 1 in 1,000 people):
• allergic reactions (e.g. difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulation failure) have occurred in very rare cases
• slow heartbeat
• increase in blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders
• epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits
• changes in appetite
• hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
• psychological complaints may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient’s personality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally increase) and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to errors in judgement)
• drug dependence may occur. If tramadol 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”)
• blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupil (miosis)
• slow breathing, shortness of breath (dyspnoea)
• worsening of asthma has been reported, however it has not been established whether it was caused by tramadol. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down
• weak muscles
• passing urine with difficulty or pain, passing less urine than normal (dysuria)
Very rare (may affect up to 1 in 10,000):
• increase in liver enzyme values
Not known (frequency cannot be established from the available data):
• decrease in blood sugar level
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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack.
Store your medicine in the original packaging in order to protect from moisture.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENT S OF THE PACK AND OTHER INFORMATION
What Tramadol Hydrochloride 50mg Capsules contain
Each capsule contains 50mg of tramadol hydrochloride (the active ingredient).
The other ingredients are: calcium hydrogen phosphate dihydrate, magnesium stearate, silica, gelatin, quinoline yellow (E104), red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and patent blue V. The ink used to print on the capsules contains shellac, N-butyl alcohol, isopropyl alcohol, propylene glycol, black iron oxide and ammonium hydroxide (for pH adjustment).
What Tramadol Hydrochloride 50mg Capsules look like and contents of pack
Tramadol Hydrochloride 50mg Capsules are green and yellow capsules with S12 printed on one end.
They come in boxes of 30 and 100 capsules.
Marketing Authorisation Holder and Manufacturer is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.
This leaflet was last updated in May 2015 Zentiva is a registered trademark.