TRAMACET 37.5 MG / 325 MG EFFERVESCENT TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user

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, 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).

• 1. What TRAMACET is and what it is used for

• 2. What you need to know before you take TRAMACET

• 3. How to take TRAMACET

• 4. Possible side effects

• 5. How to store TRAMACET

• 6. Contents of the pack and other information

1. what tramacet is and what it is used for

TRAMACET 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 tramacet

carbamazepine (a medicine used to treat epilepsy or some types of pain) buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers).

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

• metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/bein­g sick)
• cholestyramine (medicine used to reduce cholesterol in the blood)

Taking TRAMACET with food and alcohol

Do not drink alcohol while you are taking TRAMACET, as you may feel drowsier.

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 TRAMACET while you are pregnant or breast-feeding.

Check with your doctor if you become pregnant during treatment with TRAMACET and before taking any further tablets.

Breast-feeding

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

Based on human experience tramadol is suggested not to influence female or male fertility. No data on the influence of the combination of tramadol and paracetamol on fertility are available.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

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.

TRAMACET contains Sunset yellow (E110) and sodium

• The medicinal product contains the colorant sunset yellow (E110) which may cause allergic reactions.
• This medicinal product contains 7.8 mmol (or 179.4 mg) sodium (main component of cooking/ table salt) in each effervescent tablet. This is equivalent to 9.1% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 2 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

3. how to take tramacet

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

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

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.

Adults and adolescents over 12 years:

The recommended starting dose, unless otherwise prescribed by your doctor is 2 effervescent tablets for adults and adolescents over 12 years.

If required, further doses may be taken, as instructed by your doctor.

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

Do not take more than 8 tablets per day.

Children under 12 years of age:

• not recommended.

Older people:

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

Method of administration:

The effervescent tablets are for oral use.

Take effervescent tablets by dissolving in a glass of drinking water.

If you think that the effect of TRAMACET 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 TRAMACET 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 TRAMACET

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 TRAMACET

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).

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.

4. possible side effects

Like all medicines, this medicine can cause side effects, however 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 TRAMACET with medicines used to thin the blood (e.g. warfarin, phenprocoumon).
• serious skin reactions; very rare cases have been reported with paracetamol.
• respiratory depression (decrease in the ability to breathe in and out); rare cases have been reported with tramadol.
• decrease in blood sugar level.

Additionally, if any of the following side effects get 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 (hyperhidrosis)
• headache, shaking
• confusional state, 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 tingling, numbness or feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle twitching
• depression, nightmares, hallucination (hearing, seeing or sensing things that are not really there), memory lapses
• difficulty breathing
• difficulty swallowing, blood in the stools
• skin reactions (for example rashes, hives)
• increase in liver enzyme values
• presence of albumin in the urine, difficulties or pain on passing urine
• shivering, hot flushes, pain in the chest.

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

• fits, uncoordinated movements, transient loss of consciousness (syncope)
• drug dependence
• delirium
• vision blurred, constriction of the pupil (miosis)
• speech disorders
• excessive dilation of the pupils (mydriasis)

Unknown: frequency unknown

• decrease in blood sugar level (hypoglycaemia)

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
• Frequency not known: hiccups.

Serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you need to know before you take TRAMACET”).

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help ==

provide more information on the safety of this medicine.

5. how to store tramacet

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

Do not use this medicine after the expiry date which is printed on the carton and, blister or bottom of the plastic tube. The expiry date refers to the last day of that month.

Tablets packed in blister strips (aluminium foil):

• Do not store above 25°C.

Tablets packed in plastic tubes:

• Do not store above 30°C.
• After first opening: Keep the container tightly closed in order to protect from moisture.
• Shelf-life after first opening: 1 year, not exceeding the expiry date.

Do not throw away any medicine via waste water 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 TRAMACET contains

The active substances are tramadol hydrochloride and paracetamol.

One (1) tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.

The other ingredients are:

monosodium citrate anhydrous, citric acid anhydrous, polyvinylpyrro­lidone, sodium hydrogen carbonate, macrogol 6000, silica colloidal anhydrous, magnesium stearate, orange flavouring (maltodextrin (maize), modified starch (E1450), natural and artificial flavourings)), acesulfame potassium, saccharin sodium, sunset yellow (E110).

What TRAMACET looks like and contents of the pack

TRAMACET effervescent tablets look off white to slightly rosy coloured with some coloured speckles. The tablets may be available in strips of coated aluminium foil or plastic tubes.

In aluminium strips: packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets.

In plastic tubes: packs of 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grunenthal Pharma Ltd

4045 Kingswood Road

Citywest Business Park

Citywest

Co. Dublin

Ireland

Manufacturers:

Grunenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany.

Other formats of this leaflet

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• Please call free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

• Product name:

TRAMACET 37.5 mg/325 mg effervescent tablets

• Reference number: