TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG / 325 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg Film-coated Tablets

Package leaflet: Information for the patient

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 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. WhatTramadol hydrochloride/Pa­racetamol is and what it is used for

• 2. What you need to know before you take Tramadol hydrochloride/Pa­racetamol

• 3. How to take Tramadol hydrochloride/Pa­racetamol

• 4. Possible side effects

• 5. How to store Tramadol hydrochloride/Pa­racetamol

• 6. Contents of the pack and other information

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What Tramadol hydrochloride/Paracetamol is and what it is used for

Tramadol hydrochloride/Pa­racetamol is a combination of two ____analgesics, tramadol and paracetamol, which act together to relieve your pain.

Tramadol hydrochloride/Pa­racetamol is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.

Tramadol hydrochloride/Pa­racetamol should only be taken by adults and adolescents 12 years and older.

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What you need to know before you take Tramadol hydrochloride/Paracetamol

Do not take Tramadol hydrochloride/Pa­racetamol

• if you are allergic to tramadol or paracetamol 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
• Parkinson’s di­sease) or have taken them in the last 14 days before treatment with Tramadol hydrochloride/Pa­racetamol;
• if you suffer from a severe liver disease;
• if you have epilepsy that is not adequately controlled on your current medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol/Para­cetamol

• if you take other medicines containing paracetamol or tramadol;
• if you have liver problems or liver disease or if you notice your eyes and skin turning yellow.This may suggest jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe difficulties in breathing for example asthma or severe lung problems;
• if you have epilepsy or have already experienced fits or seizures;
• if you have recently suffered from a head injury, shock or severe headaches associated with vomiting;
• if you are dependent on any medicines including those used to relieve pain, for example morphine;
• if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine;
• if you are going to have an anaesthetic. Tell your doctor or dentist that you are takingTramadol hydrochloride/ Paracetamol.

If any of the above-mentioned points applied to you in the past or applies to you while you are taking Tramadol hydrochloride/ Paracetamol, please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.

Other medicines and Tramadol hydrochloride/Pa­racetamol

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

Important: This medicine contains paracetamol and tramadol. Tell your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily doses.

You must not take Tramadol hydrochloride/Pa­racetamol together with monoamine oxidase inhibitors (“MAOIs”) (see section “Do not takeTramadol hydrochloride/Pa­racetamol”). Tramadol hydrochloride/Pa­racetamol is not recommended to be taken with the following:

• carbamazepine (a medicine commonly used to treat epilepsy or some types of pain such as severe pain attacks in the face called trigeminal neuralgia),
• buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers). The pain-relieving effect may be reduced.

Concomitant use of Tramadol/Para­cetamolTeva and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Tramadol/Para­cetamol Teva together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

The risk of side effects increases 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 takeTramadol hydrochloride/ Paracetamol at the same time. Your doctor will tell you whether Tramadol hydrochloride/Pa­racetamol is suitable for you.
• certain antidepressan­ts.Tramadol hydrochloride/Pa­racetamol 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.
• tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant) medicines used to lower blood pressure, antidepressants or medicines to treat allergies. You may feel drowsy or feel faint. If this happens, tell your doctor.
• antidepressants, anaesthetics, neuroleptics (medicines that affect the state of mind) or bupropion (to help stop smoking). The risk of having a fit may increase. Your doctor will tell you whetherTramadol hydrochloride/Pa­racetamol is suitable for you.
• warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

The effectiveness of Tramadol hydrochloride/Pa­racetamol may be altered if you also take:

• metoclopramide, domperidone or ondansetron (medicines for treatment of nausea and vomiting),
• cholestyramine (medicine to reduce cholesterol in the blood),
• ketoconazole or erythromycin (medicines against infections).

Your doctor will tell you which medicines are safe to take with Tramadol hydrochloride/Pa­racetamol.

Tramadol hydrochloride/Pa­racetamol with food, drink and alcohol

Tramadol hydrochloride/Pa­racetamol may make you feel drowsy or dizzy. Alcohol may make you feel more drowsy, so it is best not to drink alcohol while you are takingTramadol hydrochloride/Pa­racetamol.

Pregnancy, breast-feeding and fertility

Pregnancy

As this medicine contains tramadol, you should not take this medicine during pregnancy. If you become pregnant during treatment with Tramadol hydrochloride/Pa­racetamol, please consult your doctor before taking any further tablets.

Breast-feeding

Tramadol is excreted into breast milk. For this reason, you should not take Tramadol hydrochloride/Pa­racetamol more than once during breast-feeding, or alternatively, if you takeTramadol hydrochloride/Pa­racetamol more than once, you should stop breast-feeding.

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.

Driving and using machines

Tramadol hydrochloride/Pa­racetamol may make you feel drowsy or dizzy and this may affect your ability to drive, or use tools and machines, safely.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‚sodium -free‘.

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.

How to take Tramadol hydrochloride/Paracetamol

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should take Tramadol hydrochloride/Pa­racetamol for as short a time as possible.

Unless otherwise prescribed by your doctor, the usual starting dose for adults and adolescents 12 years and older is 2 tablets. If required, further doses may be taken, as recommended by your doctor. The shortest time between doses must be at least 6 hours.

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 8 Tramadol hydrochloride/Pa­racetamol Film-coated Tablets per day.

Do not take Tramadol hydrochloride/Pa­racetamol more often than your doctor has told you.

Your doctor may increase the time between doses

• if you are older than 75 years,
• if you have kidney problems or
• if you have liver problems.

Use in children

The use in children below the age of 12 years is not recommended.

Method of administration:

The tablets are for oral use.

Swallow the tablets whole with sufficient liquid, they should not be broken or chewed.

If you think that the effect of Tramadol hydrochloride/Pa­racetamol is too strong (i.e. you feel very drowsy or have difficulty breathing) or too weak (i.e. you have inadequate pain relief), contact your doctor.

If you take more Tramadol hydrochloride/Pa­racetamol than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well.This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take Tramadol hydrochloride/Pa­racetamol

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

If you stop taking Tramadol hydrochloride/Pa­racetamol Generally there will be no after-effects when treatment with Tramadol hydrochloride/Pa­racetamol is stopped. However, on rare occasions, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly (see section 4. “Possible Side Effects”). If you have been taking Tramadol hydrochloride/Pa­racetamol for some time, you should talk to your doctor if you want to stop because your body may have become used to it.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following , stop treatment and see a doctor immediately. You must not take the medicine again.

Rare (may affect up to 1 in 1,000 people):

• skin rash, indicating an allergic reaction, with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting.

Other reported side effects include:

Very common (may affect more than 1 in 10 people):

• nausea,
• dizziness, drowsiness.

Common (may affect up to 1 in 10 people):

• vomiting, digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
• itching, sweating,
• headache, shaking,
• confusion, sleep disorders, mood changes (anxiety, nervousness, a feeling of high spirits).

Uncommon (may affect up to 1 in 100 people):

• increase in pulse or blood pressure, heart rate or heart rhythm disorders,
• difficulty or pain on passing water, increase of a certain protein in the urine (albuminuria),
• skin reactions (for example rashes, hives),
• tingling, numbness or feeling of pins and needles in the limbs, ringing in the ear, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), memory lapses,
• difficulty swallowing, blood in the stools,
• shivering, hot flushes, pain in the chest,
• difficulty breathing,
• increase in liver enzymes (hepatic transaminases).

Rare (may affect up to 1 in 1,000 people):

• fits, difficulties in carrying out coordinated movements,
• addiction,
• blurred vision
• transient loss of consciousness (syncope)

Unknown frequency (frequency cannot be estimated from the available data):

• decrease in blood sugar level

The following are recognised side effects which have been reported by people using medicines that contain only tramadol or only paracetamol.

However, if you experience any of these while taking Tramadol hydrochloride/Pa­racetamol, you should tell your doctor:

• feeling faint when getting up from a lying or sitting position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of existing asthma. Very rare cases of serious skin reactions have been reported.

In rare cases, using a medicine of the type of tramadol may make you become dependent on it, making it hard to stop taking it. On rare occasions, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. 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 also get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). If you experience any of these complaints after stopping Tramadol hydrochloride/ Paracetamol, please consult your doctor.

In exceptional cases blood tests may reveal certain abnormalities, for instance, low counts of blood platelets, which may result in nose bleeds or bleeding gums.

Use of Tramadol hydrochloride/Pa­racetamol together with medicines used to thin the blood (e.g. phenprocoumon, warfarin) may increase the bleeding risk. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

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:

By reporting side effects you can help provide more information on the safety of this medicine.

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How to store Tramadol hydrochloride/Paracetamol

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 after EXP.The expiry date refers to the last day of that month.

Discard the bottle 50 days after first opening

This medicinal product does not require any special storage conditions.

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.

Contents of the pack and other information

What Tramadol hydrochloride/Pa­racetamol contains

• – The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.

• – The other ingredients are: tablet core: kollicoat IR coating [Macrogol poly(vinyl alcohol) grafted copolymer], pregelatinised maize starch, cellulose microcrystalline, sodium starch glycolate (type A), Hyprolose, magnesium stearate; film-coating: opadry II beige 85F97409: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

What Tramadol hydrochloride/Paracetamol looks like and contents of the pack

Tramadol hydrochloride/Pa­racetamol Film-coated Tablets are peach coloured, capsule-shaped, engraved withT37.5 on one side and A325 on the other side.

Tramadol hydrochloride/Pa­racetamol comes in cartons with blister packs of 2, 10, 15, 20, 30, 40, 60, 90 and 120 tablets and bottles with 10 tablets and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

Teva UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex, B N22 9AG

United Kingdom

This leaflet was last revised in June 2018 323 × 200

PL 00289/1731 32117-L

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