Oztrak Film-Coated Tablets

OZTRAK 37.5/325 contains tramadol and paracetamol. Tramadol is a painkiller belonging to the class of the opioids that acts on the central nervous system. It is used for the management of moderate to moderately severe pain. Paracetamol, the other active substance, has centrally acting analgesic effects.

Do not take OZTRAK 37.5/325 :

• If you are allergic to tramadol, paracetamol, any of the other ingredients mentioned in section 6.1, or other opioids such as codeine.
• If you are suffering from acute alcohol poisoning.
• If you are taking sleeping pills, pain relievers or medicines that affect mood and emotions.
• If you are also taking medicines such as tranylcypromine and moclobemide or have taken them in the last 14 days before treatment with OZTRAK 37.5/325 which are used to treat depression. These medicines are used to treat depression and belong to a group called monoamine oxidase inhibitors (MAOIs).
• If you have a severe liver disorder.
• OZTRAK 37.5/325 must not be used for narcotic (an addictive substance) withdrawal treatment.
• You should not take OZTRAK 37.5/325 if you suffer from severe breathing problems.
• You should not take OZTRAK 37.5/325 if you are suffering from increased intracranial pressure or central nervous system depression, which are characterised by decreased rate of breathing, decreased heart rate, and loss of consciousness.
• You should not take OZTRAK 37.5/325 if you have fits that are not controlled.

Warnings and precautions

Take special care with OZTRAK 37.5/325:

• If you take other medicines containing paracetamol or tramadol.
• If you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice.
• If you have kidney problems.
• If you have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick).
• If you are dependent on any other medicines (for example morphine).
• If you have epilepsy or have experienced fits or seizures.

Do not share medicines prescribed for you with any other person. Always take OZTRAK 37.5/325 exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with OZTRAK 37.5/325 will last. If you have the impression that the effect of OZTRAK 37.5/325 is too strong or too weak, talk to your doctor or pharmacist.

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

Adults: The recommended dosage is 1 or 2 tablets every 4 to 6 hours, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor. Do not take more than 8 tablets per day.

If you take more OZTRAK 37.5/325 than you should In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center. 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 from too much paracetamol. Your kidneys can also become damaged in the absence of liver damage.

If you forget to take OZTRAK 37.5/325 If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking OZTRAK 37.5/325 Withdrawal symptoms may occur if OZTRAK 37.5/325 is discontinued abruptly. You may experience anxiety, nervous excitement, difficulty sleeping, excessive abnormal movements, tremor and gastrointestinal symptoms. Other symptoms that have very rarely been seen if tramadol hydrochloride is discontinued abruptly include: panic attacks, severe anxiety, hallucinations, tingling or prickling sensation and ringing in the ears.

OZTRAK 37.5/325 can have side effects. Not all side effects reported for OZTRAK 37.5/325 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking OZTRAK 37.5/325, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking OZTRAK 37.5/325 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Rash or itching all over the body
• Allergic reactions along with breathing problems or closing of the throat
• Increased bleeding time

These are all very serious side effects. If you have them, you may have had a serious reaction to OZTRAK 37.5/325. 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:

The following side effects occur frequently:

• A severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• A combination of any of the following symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).

Tell your doctor if you notice any of the following:

Frequent side effects

• confusional state, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits)
• dizziness, excessive sleepiness
• headache, trembling
• nausea, vomiting, constipation, dry mouth, diarrhoea, stomach pain, indigestion, stomach gas

Less frequent side effects

• depression, seeing, hearing, smelling, tasting or imagining things, nightmares
• involuntary muscular contractions, tingling or prickling sensation, loss of memory
• ringing in the ear
• rapid, strong, or irregular heartbeat, very fast heartbeat, dysrhythmia

Difficulty swallowing, blood in faeces

chills

chest pain

problems with urination

difficulty breathing

increase in blood pressure, hot flushes

low blood sugar

drug dependence

mental confusion and emotional disruption

convulsions, fainting, speech disorders

slurred speech, stumbling, convulsions, syncope, speech disorders.

vision blurred, constriction of the pupil (miosis)

excessive dilation of the pupils (mydriasis)

Frequency unknown

An increased risk of stomach pain and inflammation of the pancreas.

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.

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

Reporting of side effects If you get 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 via http:///www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of this medicine.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Protect from light and moisture. Store in the original package/container. Keep the blister in the carton until required for use. Do not store in a bathroom. Do not use OZTRAK 37.5/325 after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).