TRAMADOL HYDROCHLORIDE 50 MG CAPSULES - patient leaflet, side effects, dosage

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50mg Capsules than you should

I f 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 Hydrochloride 50mg 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 heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.

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Tramadol – the active substance in Tramadol Hydrochloride 50mg Capsules – 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 Hydrochloride 50mg Capsules is used for the treatment and prevention of moderate to severe pain.

2 YOU TAKE TRAMADOL

. HYDROCHLORIDE 50MG CAPSULES

Do not take Tramadol Hydrochloride 50mg Capsules:

• – if you are allergic to tramadol or any of the other ingredients of 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 Hydrochloride 50mg Capsules (see “Other medicines and Tramadol Hydrochloride 50mg Capsules”);

• – if you are an epileptic and your fits are not adequately controlled by treatment;

• – if you are pregnant, or are planning to become pregnant

• – as a substitute in drug withdrawal.

Warnings and precautions

Talk to your doctor before taking Tramadol Hydrochloride 50mg 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 have experienced dizziness while taking this medicine as it may increase the risk of falling

• – 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 Hydrochloride 50mg Capsules may lead to physical and psychological addiction. When Tramadol Hydrochloride 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 Hydrochloride 50mg Capsules should only be carried out for short periods and under strict medical supervision.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Please also inform your doctor if one of these problems occurs during Tramadol Hydrochloride Capsules treatment or if they applied to you in the past.

Children and adolescents

Use in children with breathing problems: Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.

Other medicines and Tramadol Hydrochloride 50mg Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tramadol Hydrochloride 50mg Capsules should not be taken together with MAO inhibitors (certain medicines for the treatment of depression) now or within the last two weeks, or any other medicines used for depression (e.g. amitriptyline, fluoxetine and lithium).

The pain-relieving effect of Tramadol Hydrochloride 50mg 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)

• – warfarin (drug used to thin the blood).

– selective serotonin reuptake inhibitors (SSRIs) taken with tramadol hydrochloride may cause confusion, agitation, fever, sweating, unsteadiness, muscle rigidity or spasms and diarrhoea. These symptoms may be an indication of a serious disorder called serotonin syndrome. If you experience any of these symptoms contact your doctor immediately.

Concomitant administration of Tramadol with other centrally depressant medicinal products including alcohol may potentiate the CNS effects.

The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related products increases the risk of respiratory depression, sedation, coma and death because of additive CNS depressant effect. The dose of Tramadol and the duration of the concomitant use should be limited.

Other active substances known to inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of Tramadol.

Your doctor will tell you whether you should take Tramadol Hydrochloride 50mg 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 Hydrochloride 50mg 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

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antidepressants or antipsychotics. The risk of having a fit may increase if you take Tramadol Hydrochloride 50mg Capsules at the same time. Your doctor will tell you whether Tramadol Hydrochloride 50mg Capsules is suitable for you.

– if you are taking certain antidepressants, Tramadol Hydrochloride 50mg 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 38"C.

– if you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol Hydrochloride 50mg Capsules.

The effect of these medicines on blood clotting may be affected and bleeding may occur.

– if you are breast feeding

Tramadol Hydrochloride 50mg Capsules with food and alcohol

Do not drink alcohol during treatment with Tramadol Hydrochloride 50mg Capsules as its effect may be intensified.

Food does not influence the effect of Tramadol Hydrochloride 50mg Capsules.

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 Hydrochloride 50mg Capsules if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in new-borns. Tramadol is excreted into breast milk. For this reason, you should not take tramadol capsules more than once during breast-feeding, or alternatively, if you take tramadol capsules more than once, you should stop breast-feeding. Based on human experience tramadol is suggested not to influence female or male fertility. Please ask your doctor for advice.

Driving and using machines

This medicine may make you sleepy, confused, forgetful, unsteady, or affect your concentration or co-ordination. This may affect your performance at skilled tasks, e.g. driving or operating machinery.

DO NOT drive or operate machinery if you are affected.

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 your medicine

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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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.

Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents from the age of 12 years

One or two Tramadol Hydrochloride 50mg Capsules (equivalent to 50 mg – 100 mg tramadol hydrochloride).

Your doctor may prescribe a different, more appropriate dosage of Tramadol Hydrochloride 50mg Capsules if necessary.

Do not take more than 8 Tramadol Hydrochloride 50mg Capsules (equivalent to 400 mg tramadol hydrochloride) daily, except if your doctor has instructed you to do so.

Children

Tramadol Hydrochloride 50mg 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 Hydrochloride 50mg 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 Hydrochloride 50mg Capsules:

Tramadol Hydrochloride 50mg Capsules are for oral use.

Always swallow Tramadol Hydrochloride 50mg 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 Hydrochloride 50mg Capsules?

You should not take Tramadol Hydrochloride 50mg 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 Hydrochloride 50mg Capsules.

Tramadol Hydrochloride 50mg Capsules and at what dose.

If you have the impression that the effect of Tramadol Hydrochloride 50mg Capsules is too strong or too weak, talk to your doctor or pharmacist.

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If you forget to take Tramadol Hydrochloride 50mg Capsules

If you forget to take the capsule, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking the capsule as before.

If you stop taking Tramadol Hydrochloride 50mg Capsules

If you interrupt or finish treatment with Tramadol Hydrochloride 50mg Capsules too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your doctor.

You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).

Generally there will be no after-effects when treatment with Tramadol Hydrochloride 50mg Capsules is stopped. However, on rare occasions, people who have been taking Tramadol Hydrochloride 50mg 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 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 Hydrochloride 50mg Capsules, please consult your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4.

Like 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 Hydrochloride 50mg Capsules are nausea and dizziness, which occur in more than 1 in 10 people.

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, strong desire for sleep, or sleeping for unusually long periods
• 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 be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach bloating), diarrhoea
• skin reactions (e.g. itching, rash)
• sudden fall in blood pressure
• flushing

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).
• changes in appetite
• hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
• blurred vision, dilated or contracted pupils 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.
• swelling of the skin
• dependence/wit­hdrawal symptoms may occur allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin)
• 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.

Psychological complaints may appear after treatment with Tramadol Hydrochloride 50mg 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).

When treatment is stopped abruptly, signs of withdrawal may appear (see “If you stop taking Tramadol Hydrochloride 50mg Capsules”).

• Very rare: may affect up to 1 in 10,000 people increase in liver enzyme values ringing of the ears

Not known: frequency cannot be estimated from the available data

• decrease in blood sugar level

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KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 25°C in a dry place. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away

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Your medicine comes in pack sizes of 30, 50, 100, 250 and 500 capsules. Not all pack sizes may be marketed.

What Tramadol Hydrochloride 50mg Capsules contains

Each capsule contains 50mg of tramadol

hydrochloride, the active ingredient. The capsules also contain the inactive

microcrystalline cellulose, povidone, lactose monohydrate, sodium starch glycolate and magnesium stearate. The capsule shell contains gelatin and the colours titanium dioxide (E171), indigotine (E132), yellow iron oxide (E172) and erythrosin (E127). The ink on the capsule shell contains shellac, propylene glycol and the colour black iron oxide (E172).

MARKETING AUTHORISATION HOLDER AND MANUFACTURER

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Manufacturer responsible for batch release

Kent Pharmaceuticals Limited, Crowbridge Road

Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0037

This leaflet was last revised October 2020.

CP.TDL.50C.OM.V5P1

Pharmacde