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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol hydrochloride and Paracetamol 37.5 mg/325 mg film-coated tablets

(Tramadol hydrochloride/Pa­racetamol)

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• 1. What Tramadol hydrochloride and Paracetamol tablet is and what it is used for

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

• 3. How to take Tramadol hydrochloride and Paracetamol tablets

• 4. Possible side effects

• 5. How to store Tramadol hydrochloride and Paracetamol tablets

• 6. Contents of the pack and other information

1. what tramadol hydrochloride and paracetamol tablet is and what it is used for

Tramadol hydrochloride and Paracetamol tablet 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 tramadol hydrochloride and paracetamol tablets

Do not take Tramadol hydrochloride and Paracetamol tablets

• if you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients in Tramadol hydrochloride and Paracetamol tablets (see 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 also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Tramadol hydrochloride and Paracetamol tablets. MAOIs are used in the treatment of depression or Parkinson’s di­sease.

• if you have a severe liver disorder

• if you have epilepsy that is not adequately controlled by your current medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol hydrochloride and Paracetamol tablets if you:

• take other medicines containing tramadol or paracetamol

• have liver problems or disease where 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 such as chronic obstructive pulmonary disorder (COPD)

• have epilepsy or have already experienced fits or seizures

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

• are dependent on any medicine (for example morphine, heroin etc.)

• take other 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 Tramadol hydrochloride and Paracetamol tablets).

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.

Other medicines and Tramadol hydrochloride and Paracetamol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with Tramadol hydrochloride and Paracetamol tablets.

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

Do not take Tramadol hydrochloride and Paracetamol tablets with MAOIs (see section ‘Do not take Tramadol hydrochloride and Paracetamol tablet’).

Tramadol hydrochloride and Paracetamol tablet 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 relievers).

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

• tranquilizers, sleeping pills, other pain relievers such as morphine and codeine (also as a 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 Tramadol hydrochloride and Paracetamol tablets is suitable for you.

• warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4).

• - metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/bein­g sick)

• - cholestyramine (medicine used to reduce cholesterol in the blood) - ketoconazole or erythromycin (medicines used against infections).

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.

Tramadol hydrochloride and Paracetamol tablets with food and drink Do not drink alcohol while you are taking Tramadol hydrochloride and Paracetamol tablets, as you may feel drowsy.

Pregnancy and breast-feeding

Do not take Tramadol hydrochloride and Paracetamol tablets while you are pregnant.

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.

Breast-feeding

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

Driving and using machines

If you feel drowsy while taking Tramadol hydrochloride and

Paracetamol tablets, do not drive, use tools or use --------------

machinery. bar code

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:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

o 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 hydrochloride and paracetamol tablets always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with sufficient liquid. Do not break or chew the tablets.

Take Tramadol hydrochloride and Paracetamol tablets for as short a time as possible and no longer than your doctor has told you.

Adults and adolescents over 15 years

The recommended dosage is to start with 2 tablets, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor.

Children12 –15 years: One to two tablets every 6 hours when necessary.

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

Your doctor may increase the time between doses if:

• you are older than 75 years

• you have kidney problems

• you have liver problems.

• NOT RECOMMENDED

If you think that the effect of Tramadol hydrochloride and Paracetamol tablet 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 Tramadol hydrochloride and Paracetamol tablets 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 Tramadol hydrochloride and Paracetamol tablets If you forget to take the tablets, pain is likely to return.

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

If you stop taking Tramadol hydrochloride and Paracetamol tablets 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 and Paracetamol tablets 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 Tramadol hydrochloride and Paracetamol tablets for some time and want to stop, contact your doctor because your body may have become used to Tramadol hydrochloride and Paracetamol tablets.

People may:

• feel agitated, anxious, nervous or shaky

• be over active

• have difficulty sleeping

• have stomach or bowel disorders.

• panic attacks

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

• ringing in the ears.

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 Tramadol hydrochloride and Paracetamol tablets with medicines used to thin the blood (e.g. warfarin, phenprocoumon).

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

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

• nausea (feeling sick)

• dizziness, drowsiness.

Common side effects (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 side effects (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 side effects (affecting less than 1 in 1,000 but more than 1 in 10,000 people treated)

• fits, uncoordinated movements

• addiction

• blurred vision

• transient loss of consciousness.

Unknown frequency:

• decrease in blood sugar level

• Very rare cases of serious skin reaction

• 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 at: reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store tramadol hydrochloride and paracetamol tablets 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 blister after EXP. The expiry date refers to the last day of that month. 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.

6. contents of the pack and other information

What Tramadol hydrochloride and Paracetamol tablets contain

• 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:

What Tramadol hydrochloride and Paracetamol tablets look like and contents of the pack

Tramadol hydrochloride and Paracetamol tablets are yellow coloured, elongated, film-coated tablets with “325” debossed on one side and ‘‘37.5’’ debossed on the other side. They are packed in blisters of 60 or 100 tablets in a carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, UK

Manufacturer

Drugsrus Limited, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD, UK

This leaflet was last revised in June 2018.