Cepatresic Film-Coated Tablets

CEPATRESIC 37,5 / 325 is used to treat moderate to moderately-severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed.

Do not take CEPATRESIC 37,5 / 325 :

• if you are hypersensitive (allergic) to tramadol hydrochloride, any other opioids such as codeine, paracetamol or any of the other ingredients (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
• to treat withdrawal symptoms caused by the stopping of narcotic medication such as morphine, codeine.
• if you struggle to breathe
• if you had a severe head injury or suffer from any brain disease
• if you have a liver disorder.
• if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with CEPATRESIC 37,5 / 325. MAOIs are used in the treatment of depression or Parkinson’s disease.
• if you have epilepsy or suffer from seizures.
• Do not give CEPATRESIC 37,5 / 325 to children younger than 12 years old.
• Do not give CEPATRESIC 37,5 / 325 to children younger than 18 years old that have just had surgery to remove their tonsils or adenoids.

Warnings and precautions

Take special care with CEPATRESIC 37,5 / 325: Talk to your doctor before taking CEPATRESIC 37,5 / 325

• if you take other prescription or over the counter medicines containing paracetamol or tramadol
• if you have kidney problems
• if you have liver problems. If you notice your eyes and skin turning yellow, this may suggest jaundice. Tell your doctor immediately.
• if you are dependent on alcohol or have previously suffered from alcohol abuse
• if you have severe difficulties in breathing, for example asthma or severe lung problems
• if you are dependent on any medicine (for example morphine)
• if you have epilepsy or have already experienced fits or seizures
• if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine
• if you have previously had an allergic reaction to codeine or other opioid medicines
• if you are going to have an anaesthetic (tell your doctor or dentist that you are taking CEPATRESIC 37,5 / 325)
• if you experience symptoms of low sodium levels such as nausea, vomiting, headache, muscle cramps or weakness while taking CEPATRESIC 37,5 / 325
• CEPATRESIC 37,5 / 325 can cause low levels of oxygen in the blood and a problem called sleep apnoea (stopping breathing from time to time whilst sleeping). Tell your doctor if you have a history of sleep apnoea or if someone notices that you stop breathing while sleeping or you find yourself gasping for breath during sleep.

Do not share medicines prescribed for you with any other person. Always take CEPATRESIC 37,5 / 325 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines. In general the lowest pain-relieving dose should be taken. Take CEPATRESIC 37,5 / 325 for as short a time as possible and no longer than your doctor has told you. Do not take more than the dose prescribed by your doctor.

Adults and adolescents over 12 years

The usual dose is 1 to 2 tablets every 4 to 6 hours as required for pain relief. The shortest time between doses must be at least 4 hours. Do not take more than 8 tablets per day.

Not for use in children under 16 years of age

Severe kidney disease (insufficiency)/dialysis patients

Patients with severe kidney insufficiency should not take CEPATRESIC 37,5 / 325. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval. Do not exceed 2 tablets every 12 hours.

Method of administration

The tablets are for oral use. Swallow the tablets whole with sufficient liquid. Do not break or chew the tablets. The tablets may be taken with or without food.

CEPATRESIC 37,5 / 325 can have side effects. Not all side effects reported for CEPATRESIC 37,5 / 325 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CEPATRESIC 37,5 / 325, please consult your healthcare provider for advice.

If any of the following happens, stop taking CEPATRESIC 37,5 / 325 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• convulsions and fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to CEPATRESIC 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:

• Diarrhoea, vomiting, muscle spasms, high body temperature, sweating, shivering, clumsiness, tremors, confusion and other mental changes
• difficulty breathing
• flu-like symptoms appear first and a painful rash that spreads and blisters follows (Stevens-Johnson syndrome)

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

Tell your doctor if you notice any of the following:

Frequent side effects

• nausea
• vomiting, constipation, flatulence, diarrhoea, stomach pain, dry mouth, indigestion
• dizziness, headache, tiredness, shaking
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of intense excitement), loss of appetite
• excessive sweating
• physical weakness, lack of energy, hot flushes.

Less frequent side effects

• weakness and fatigue due to anaemia (a decrease in number of red blood cells (RBCs) or less than the normal quantity of haemoglobin in the blood)
• increase in pulse or blood pressure, heart rate or heart rhythm disorders, decrease in blood pressure
• vision blurred, constriction of the pupil (miosis)
• excessive dilation of the pupils (mydriasis)
• abnormal vision
• ringing in the ears, feeling of spinning
• difficulty swallowing, blood in the stools, swollen tongue
• chills, chest pain
• changes in appetite
• muscle weakness
• changes that show up in blood tests of the liver

Store all medicine out of reach of children. Store at or below 25 °C. Do not use the tablets after the expiry date shown on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).