Package leaflet: Information for the patient

Tramadol/Paracetamol 75mg / 650mg Tablets

Tramadol Hydrochloride/ Paracetamol

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

•    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 have any side effects including any side effects not listed in the leaflet, talk to your doctor, pharmacist or nurse. See section 4.

In this leaflet:

1.    What this medicine is and what it is used for

2.    What you need to know before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

1.    What this medicine is and what it is used for

This medicine is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.

2.    What you need to know before you take this medicine

Do not take this medicine

•    If you are allergic (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6).

•    In cases of acute alcohol poisoning

•    If you are taking sleeping pills, pain relievers or medicines that affect mood and emotions

•    If you are taking medicines called monoamine oxidase inhibitors (MAOIs) or if you have taken MAOIs in the last 14 days before treatment. MAOIs are used in the treatment of depression or Parkinson's disease.

•    If you suffer from a severe liver disorder.

•    If you suffer from epilepsy that is not adequately controlled by your current medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine if you:

•    are taking other medicines containing paracetamol or tramadol;

•    have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice;

•    have kidney problems;

•    have severe difficulties in breathing for example asthma or severe lung problems;

•    have epilepsy or have already experienced fits or seizures;

•    have recently suffered from a head injury, shock or severe headache associated with vomiting (being sick);

•    became dependent on any medicine (for example, morphine);

•    are taking medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine;

•    are going to have an anaesthetic (tell your doctor or dentist that you are taking this medicine).

Other medicines and Tramadol/Paracetamol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with this medicine.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.

Do not take this medicine with MAOIs (see section ‘Do not take this medicine').

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 this medicine at the same time. Your doctor will tell you whether this medicine is suitable for you.

•    If you are taking certain antidepressants. This medicine 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.

This medicine is not recommended with the following medicines, as it may affect how well they work:

•    Carbamazepine (a medicine used to treat epilepsy or some types of pain)

•    Buprenorphine, nalbuphine or pentazocine (opioid-type pain killers)

This medicine may increase the risk of side effects if you also take the following medicines:

•    Triptans (used for migraine) or selective serotonin reuptake inhibitors (SSRIs, used for depression). Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable jerking of muscles or diarrhoea.

•    Tranquilizers, 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. Check with your doctor if you feel drowsy or feel faint.

•    Antidepressants, anaesthetics, medicines that affect the state of mind or bupropion (used to help stop smoking).

The risk of having a fit may increase. Your doctor will tell you whether this medicine is suitable for you.

•    Warfarin or phenprocoumon (for blood thinning).

The effectiveness of such medicines can be altered and bleeding may occur.

The effectiveness of this medicine may be altered if you also take the following medicines:

•    Metoclopramide, domperidone and ondansetron (medicines used to treat nausea and vomiting/being sick).

•    Cholestyramine (medicine used to reduce cholesterol in blood).

•    Ketoconazole and erythromycin (medicine used against infections).

This medicine with food, drink and alcohol

Do not drink alcohol while you are taking this medicine, as you may feel drowsy.

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. Do not take this medicine while you are pregnant. If you become pregnant while taking this medicine, talk to your doctor before taking the next tablet. Tramadol is excreted into breast milk. For this reason, you should not take Tramadol/Paracetamol more than once during breast-feeding, or alternatively, if you take Tramadol/Paracetamol more than once, you should stop breast-feeding.

Driving and using machines

If you feel drowsy while taking this medicine, do not drive, use tools or use machinery.

This 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 this medicine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. As you prefer the tablets can be swallowed whole or you can halve them and have with a glass of liquid, preferably water.

Tramadol/ Paracetamol 75mg/ 650mg can be halved to form two equal doses of 37.5mg/325mg.

Take this medicine for as short a time as possible and no longer than your doctor has told you.

Adults and adolescents over 12 years:

Unless your doctor says otherwise, the normal starting dose for adults and children over 12 years old is 1 tablet. If required, further doses may be taken, as instructed by your doctor.

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.

The shortest time between doses must be at least 6 hours.

Do not take more than 4 tablets per day.

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 this medicine. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Children under 12 years of age:

Not recommended.

If you think the effect of this medicine is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.

If you take more of this medicine than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you forget to take this medicine

If you forget to take the tablets, pain is likely to return.

Do not take a double dose to make up for forgotten individual doses; simply continue taking the tablets as before.

If you stop taking this medicine

Generally, there will be no after-effects when treatment with this medicine is stopped.

Rarely, people who have been using a medicine containing tramadol may become dependent on it, making it hard to stop taking it. If you have been taking this medicine for some time and want to stop, contact your doctor because your body may have become used to this medicine.

People may:

•    Feel agitated, anxious, nervous or shaky

•    Be over active

_•    Have difficulty sleeping

•    Have stomach or bowel disorders.

Very few people may also get:

•    Panic attacks

•    Hallucinations, unusual perceptions such as itching, tingling and numbness

•    Ringing in the ears.

If you experience any of these complaints after stopping this medicine, please contact your doctor. Other side effect information is listed in section 4.

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

4. Possible side effects

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

Some side effects could be serious. Contact your doctor immediately if any of the following occur:

•    Rarely cases of skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment. Do not take the medicine again.

•    Prolonged or unexpected bleeding, from the use of this medicine with medicines used to thin the blood (e.g. warfarin, phenprocoumon).

Additionally, if any of the following side effects become serious, contact your doctor or pharmacist:

Very common: may affect more than 1 in 10 people;

•    nausea.

•    dizziness, drowsiness.

Common: may affect up to 1 in 10 people;

•    vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth.

•    itching, sweating.

•    headache, shaking.

•    confusion, sleep disorders, mood changes (anxiety, nervousness, 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.

•    skin reactions (for example rashes, hives).

•    tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, 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.

Rare: may affect up to 1 in 1000 people;

•    fits, uncoordinated movements

_•    addiction

_•    blurred vision

•    transient loss of consciousness (syncope).

Not known (frequency cannot be estimated from the available data)

•    Decrease in the blood sugar level

In addition the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol:

•    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

•    nose bleeds or bleeding gums, which may result from a low blood platelet count.

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 (website: 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 this medicine

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton (after EXP). The expiry date refers to the last day of that month. 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. Contents of the pack and other information

What this medicine contains

The active substances are tramadol hydrochloride and paracetamol.

A tablet contains 75mg of tramadol hydrochloride and 650mg of paracetamol.

The other ingredients (excipients) are: Povidone (E1201), magnesium stearate (E152), colloidal anhydrous silicon, sodium starch glycolate (Type A) of potato and pregelatinized corn starch.

What this medicine looks like and contents of the pack

These tablets are oval and white for oral administration packed in cartons containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets. Not all pack sizes may be marketed. The tablets are scored and can be broken into two equal half doses.

Marketing Authorisation Holder:

Aspire Pharma Ltd., Bellamy House, Winton Road, Petersfield, Hampshire, GU32 3hA, United Kingdom.

Manufacturer:

Ferrer Internacional, S.A., Joan Buscalla, 1-9,

Sant Cugat del Valles (Barcelona), Spain.

This leaflet was last revised in 07/2016

1010296/P2.2

Artwork for:	Aspire Pharma Limited
Product name:	Tramadol/Paracetamol 75mg/650mg Tablets
Size:
PL/PA no:
Type:	Leaflet
Artwork dimensions:	280mm x 175mm
Profile supplied:	Yes
Date of first artwork:	9 February 2015
Reason for request:	Text edits
Version no:	2.2
Date of revision:	13 July 2016
Colours:	As swatch(es)
Font(s):	Strada Condensed 9pt line feed
Artwork software:	InDesign CS6
BAC ref:	T022 (formerly S842)