A1817

PATIENT INFORMATION LEAFLET

S5

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM

TAMOLTRA film coated tablets

Please read all of this leaflet carefully before you start taking TAMOLTRA

• Keep this leaflet. You may need to read it again.

• If you have any further questions, please ask your doctor or your pharmacist.

• TAMOLTRA has been prescribed for you personally and you should not share your

medicine with other people. It may harm them, even if their symptoms are the same as

yours.

1. WHAT TAMOLTRA CONTAINS

• The active substances are tramadol hydrochloride 37,5 mg and paracetamol 325 mg.

• The other ingredients are magnesium stearate, microcrystalline cellulose, Opadry yellow

(hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron

oxide), pregelatinised starch, sodium starch glycolate.

Sugar free.

2. WHAT TAMOLTRA IS USED FOR

TAMOLTRA is used for the treatment of moderate to moderately severe pain in adults.

3. BEFORE YOU TAKE TAMOLTRA

Do not take TAMOLTRA

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• If you have any hypersensitivity to tramadol, paracetamol or other opioids such as codeine or

any ingredient of TAMOLTRA (see WHAT TAMOLTRA CONTAINS)

• If you have a severe liver disorder

• If you have been drinking alcohol

• If you have been using any medicines for sleep disorders, anxiety, severe pain or other

medicines that affect your nervous system

• If you are receiving a monoamine oxidase inhibitor (MAOIs) for the treatment of depression

or have been using one within the last 14 days

• If you have a lung disorder

• If you experienced a head injury recently

Take special care with TAMOLTRA

TAMOLTRA contains paracetamol which may be fatal in overdose. In the event of suspected

overdose and notwithstanding the fact that the person may be asymptomatic contact the

nearest doctor, hospital or Poison Centre immediately.

• Dosages in excess of those recommended may cause severe liver damage

• If you are taking any other medications containing tramadol paracetamol, anaesthetic

substances, phenothiazines (used for mental disorders), tranquilizers and sedative hypnotics

• If you are taking any other medications containing tramadol paracetamol, anaesthetic

substances, phenothiazines (used for mental disorders), tranquilizers and sedative hypnotics

• If you have a history of addiction or dependence, especially to medicines of the same class

as tramadol (opioids)

• If you are taking any other medicines for depression

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• If you have seizures and/or convulsions

• If you use alcohol excessively

• In the event of reduced consciousness for unknown reasons, respiratory disorders and

patients suffering from emotional disturbances, TAMOLTRA should be taken with extreme

caution

• If you have kidney or liver problems.

Taking TAMOLTRA with food and drink

Do not take TAMOLTRA with any alcohol containing beverages.

Pregnancy and breastfeeding

Do not take TAMOLTRA while you are breastfeeding, as small amounts of tramadol may pass

into the breast milk. If you are pregnant or breastfeeding your baby, please consult your doctor,

pharmacist or other healthcare professional for advice before taking this medicine.

Driving and using machines

Your ability to drive or operate machinery may be affected by TAMOLTRA. This may be

worsened by other medicines affecting your nervous system or alcohol. Do not drive or operate

machines because TAMOLTRA could interfere with your ability to do so safely.

Taking other medicines with TAMOLTRA

If you are taking other medicines on a regular basis, including complementary or traditional

medicines, the use of TAMOLTRA with these medicines may cause undesirable interactions.

Please consult your doctor, pharmacist or other healthcare professional for advice if you are

taking any of the following medication:

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Combinations containing any of the following medications may interact with TAMOLTRA tablets:

• Carbamazepine (used for the management of epilepsy or seizures)

• Fluoxetine or paroxetine (used to treat depression), quinidine (used to stabilize your heart

rhythm) and amitriptyline (used to treat depression)

• Cimetidine (used to treat stomach ulcers or heartburn)

• Monoamine Oxidase Inhibitors (used to treat depression) or 14 days after stopping treatment

• Digoxin (used to treat heart disorders)

• Warfarin (used to “thin” the blood)

• Diflunisal (a pain killer)

• Lithium, tricyclic antidepressants and SSRIs, medicines used in depression

• Triptans (medicines for migraine)

• Metoclopramide (used for nausea)

• Cholestyramine (used to “lower” cholesterol).

Do not use TAMOLTRA with other medication that contains tramadol and paracetamol.

4. HOW TO TAKE TAMOLTRA

Do not share medicines prescribed for you with any other person.

Always take TAMOLTRA exactly as your doctor or pharmacist has instructed you. You should

check with your doctor or pharmacist if you are unsure on how to use your medicine.

DO NOT EXCEED THE RECOMMENDED DOSE.

The usual dose is:

For use in adults and children over the age of 16 years.

Take 1 to 2 tablets every 4 to 6 hours as instructed.

Do not take more than 8 tablets in 24 hours.

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Your doctor will adjust your dose if you have a kidney disorder.

If you have the impression that the effect of TAMOLTRA is too strong or too weak, talk to your

doctor or pharmacist.

If you take more TAMOLTRA than you should

In the event of overdosage, consult your doctor or pharmacist.

If neither is available, seek help at the nearest hospital or poison control centre. Immediate

treatment is essential.

Please refer to the information on paracetamol overdosage under Take special care with

TAMOLTRA.

If you forget to take a dose of TAMOLTRA

If you miss a dose of TAMOLTRA, take it as soon as you remember.

However, if it is almost time for the next dose, skip the missed dose and go back to the regular

dosing schedule. Do not take a double dose to make up for the forgotten individual dose(s).

Effects when treatment with TAMOLTRA is stopped

If TAMOLTRA is abruptly discontinued, withdrawal symptoms may occur, such as panic attacks,

severe anxiety, hallucinations, paraesthesia (abnormal physical sensation), tinnitus (ringing in the

ears), and unusual central nervous system symptoms. These symptoms may be relieved by

tapering TAMOLTRA instead of abruptly stopping treatment.

5. POSSIBLE SIDE EFFECTS

TAMOLTRA can have side effects.

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Not all side effects reported for TAMOLTRA are included in this leaflet. Should your general

health worsen while taking TAMOLTRA, please consult your doctor, pharmacist or other

healthcare professional for advice.

If any of the following happens, stop taking TAMOLTRA and tell your doctor immediately or

go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in

swallowing or breathing

• rash or itching

• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic

reaction to TAMOLTRA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you

notice any of the following:

• unexpected or prolonged bleeding when using TAMOLTRA with medicines used to thin

the blood (e.g. warfarin)

• increase in pulse or blood pressure, heart rate or heart rhythm disorders

• shivering, hot flushes, pain in the chest

• difficulty breathing

• feeling faint when getting up from a lying or sitting position, slow heart rate, fainting

• worsening of existing asthma.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• nausea

• dizziness, drowsiness

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

dry mouth

• sweating

• headache, shaking

• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits)

• difficulty or pain when urinating

• 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

• fits, uncoordinated movements

• addiction – becoming dependant on TAMOLTRA

• blurred vision

• 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 low platelet count.

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If you notice any side effects not mentioned in this leaflet, please inform your doctor or

pharmacist.

6. STORAGE AND DISPOSAL OF TAMOLTRA

Store at or below 25 °C in a cool, dry place

Store in the original container

Keep the blisters in the carton until required for use

Do not use after the expiry date printed on the carton

Return all unused medicine to your pharmacist

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets)

STORE ALL MEDICINE OUT OF REACH OF CHILDREN.

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