Tramadol 50mg Capsules
24 mm
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMADOL 50 mg CAPSULES
(Tramadol Hydrochloride)
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, please 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 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. See section 4.
What is 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
The name of your medicine is Tramadol 50mg Capsules. Tramadol - the active substance of this medicine - is a painkiller 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. Tramadol Capsules are used for the treatment of moderate to severe pain.
2. What you need to know before you take Tramadol Capsules
DO NOT take these capsules if you:
• have ever been told you are allergic to tramadol or any of the other ingredients (these are listed in Section 6). This may have been a skin rash, swelling of the face, wheezing or difficulty in breathing
• are taking a monoamine oxidase inhibitor (MAOI) (certain medicines used for the treatment of depression) or have taken them in the last 14 days such as moclobemide, phenelzine
• are suffering from acute poisoning/intoxication with alcohol, sleeping pills, opioids (pain killer) or other psychotropic medicines (medicines acting on the mind)
• are an epileptic and your fits are not adequately controlled by treatment
• are taking tramadol as a substitute in narcotics withdrawal treatment
Warnings and Precautions
Talk to your doctor before taking Tramadol Capsules
• 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 towards 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 (400 mg).
Please note that Tramadol capsules may lead to physical and psychological addiction. When Tramadol capsules are 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.
Other medicines and Tramadol capsules
Tell your doctor or pharmacist if you are taking, have taken or might take any 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).
Your doctor will tell you whether you should take Tramadol Capsules, and 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 capsules. 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 having a fit may increase if you take Tramadol capsules at the same time. Your doctor will tell you whether Tramadol capsules is suitable for you.
• if you are taking certain antidepressants. Tramadol capsules 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 380C.
• 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.
Tramadol Capsules with food, drink and alcohol
Do not drink alcohol during treatment with Tramadol capsules as its effect may be intensified. Food does not influence the effect of Tramadol capsules.
Pregnancy, breast-feeding and fertility
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 passed 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
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.
If you feel that your reactions are affected, do not operate machinery.
Important information about some of the ingredients of this medicine
These capsules contain methyl parahydroxy benzoate (E218) and propyl parahydroxy benzoate (E216) which may cause allergic reactions (possibly delayed).
3. How to take Tramadol Capsules
• Always take these capsules exactly as advised by your doctor. 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.
Unless otherwise prescribed by your doctor, the usual dose is: Adults and adolescents from the age of 12 years
One or two capsules (equivalent to 50 mg - 100 mg)
Your doctor may prescribe a different, more appropriate dosage of Tramadol capsules if necessary. Do not take more than 8 Tramadol capsules (equivalent to 400 mg tramadol hydrochloride) daily, except if your doctor has instructed you to do so.
Children
Tramadol capsules 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.
Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not take Tramadol capsules. 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 Capsules?
Tramadol Capsules are for oral use.
Always swallow tramadol Capsules whole, not divided or
chewed, with sufficient liquid, preferably in the morning and evening. You may take the capsule on an empty stomach or with meals.
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 (overdose) 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 capsules at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heart beat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.
If you forget to take Tramadol Capsules
If you forget to take the capsule, pain is likely to return. Do not take a double dose to make up for the forgotten dose, simply continue taking the capsule as before.
If 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 hyperactive, have difficulty in 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). 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, Tramadol Capsules may sometimes cause side effects, although not everybody gets them.
STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following:
• allergic reactions e.g. difficulty in breathing, wheezing, swelling of skin (occurs rarely),
• swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties in breathing (occurs rarely).
Other side-effects:
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
• tiredness, weariness, weakness, low energy
• constipation, dry mouth, vomiting (being sick)
• sweating
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 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
• 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).
• 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 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 (mostly high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to errors in judgment).
• Drug dependence may occur. 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”).
• blurred vision
• 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 water difficult or painful, less urine than normal.
Very rare: may affect up to 1 in 10,000 people
• increase in liver enzyme values
Not known: frequency cannot be estimated from the available data
• decrease in blood sugar level
• speech disorders
• dilated pupils
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. 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 (EXP) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw 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. Contents of the pack and other information What Tramadol Capsules contain
• The active substance is tramadol hydrochloride 50mg
• The other ingredients are microcrystalline cellulose, sodium starch glycollate, magnesium stearate and silica colloidal anhydrous.
• The capsule shell contains gelatin, sodium laurylsulphate, methyl parahydroxy benzoate (E218) and propyl parahydroxy benzoate (E216), and colours indigo carmine (E132), yellow ferric oxide (E172) and titanium dioxide (E171).
What Tramadol Capsules look like and contents of the pack
• These are green and yellow coloured hard gelatin capsules.
• They are available in packs of 10, 20, 30 or 100 capsules.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder/Manufacturer:
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom.
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Tramadol 50mg Capsules; PL 17907/0110
This leaflet was last revised in June 2014
To request a copy of this leaflet in braille, large print or audio
format, please contact the licence holder at the address above (or
telephone, fax, email)
V2 27-06-2014 D1
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