Patram 37,5 mg/325 mg Film-Coated Tablets

PATRAM is indicated for the management of moderate to moderately-severe pain in adults. PATRAM is not recommended for minor pain that may be treated adequately through lesser means.

Do not take PATRAM:

• If you have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) after taking tramadol or paracetamol or any of the other ingredients in PATRAM (listed in section 6).
• If you experience or have previously experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4) stop using PATRAM immediately and contact your doctor.
• if you take other medicines containing paracetamol or tramadol;
• In acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions).
• If you are also taking MAO inhibitors (certain medicines used for treatment of depression or Parkinson’s disease) or have taken them in the last 14 days before treatment with PATRAM.
• If you suffer from a moderate to severe liver disorder.
• If you have epilepsy that is not adequately controlled on your current medicine.
• As part of treatment of withdrawal from drugs.
• If you had serious head injuries or a brain disease causing pressure on your brain.

Warnings and precautions

Take special care with PATRAM: Do not take more than your recommended dose; PATRAM contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately. Dosages in excess of those recommended may cause severe liver damage and other problems (see possible side effects).

Do not share medicines prescribed for you with any other person. Always take PATRAM exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults and children over 16 years of age is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. DO NOT EXCEED THE RECOMMENDED DOSE. Your doctor will tell you for how long your treatment with PATRAM will last. If you have the impression that the effect of PATRAM is too strong or too weak, tell your doctor or pharmacist.

Patients with impaired kidney or liver function:

Do not take PATRAM if you have moderate to severe liver problems. Tell your doctor if you have a kidney disorder (a creatinine clearance < 30 mL/min). Do not take more than 2 tablets every 12 hours. PATRAM is not recommended for children under 16 years of age.

How and when should you take PATRAM

The tablets should be swallowed whole with water and may be taken with or without food. If you take more PATRAM than you should: In the event of overdosage or suspected overdose and even if no symptoms of overdosage are noticeable, you must be taken to the nearest doctor, hospital or Poison Centre immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken. If you forget to take PATRAM: The pain is likely to return. Do not take a double dose to compensate; just wait for the next dose, and take a normal dose as prescribed by your doctor. If you stop taking PATRAM: Withdrawal symptoms may occur if PATRAM is discontinued abruptly. You may experience anxiety, nervous excitement, difficulty sleeping, excessive abnormal movements, tremor and gastrointestinal symptoms.

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

Very serious side effects: If any of the following happens, stop taking PATRAM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• A skin rash (indicating an allergic reaction), sudden swelling of the face and neck, difficulty breathing or drop of blood pressure and fainting. These are very serious side effects. If you have them, you may have had a serious allergic reaction to PATRAM. You may need urgent medical attention or hospitalisation.

Serious side effects: Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Yellow skin and eyes (hepatitis)
• Irregular heartbeat that is much rapid and more pronounced than usual, increased blood pressure, pain in the chest
• Elevated liver enzymes, resulting in abdominal pain, dark urine, pale stools, weakness, fatigue.
• Feeling faint when getting up from lying down or sitting position, trouble performing routine tasks
• Difficulty swallowing, blood in stools
• Addiction
• Blurred vision

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: Confusional state, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits).
• Dizziness, excessive sleepiness, fatigue, feeling weak
• Headache, trembling.
• Nausea, vomiting, constipation, dry mouth, diarrhoea, stomach pain, indigestion, stomach gas.
• Loss of appetite;
• Itching, rash, swelling of the tongue.
• Loss of coordination, fits, abnormal muscle tension.

Less frequent side effects: Itching, increased sweating, shivering, hot flushes. Depression, seeing, hearing, smelling, tasting or imagining things, nightmares. Involuntary muscular contractions, feeling pins and needles (tingling or prickling sensation), loss of memory. Ringing in the ear. Rapid, strong, or irregular heartbeat, very fast heartbeat, dysrhythmia. Weight decrease. Chills. Chest pain. Problems with urination. Difficulty breathing. Increase in blood pressure. 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). Metabolic acidosis (nausea, vomiting, fatigue, confusion, rapid breathing).

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. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Suspected adverse reactions can also be reported directly to the HCR via email: [email protected] or tel: +27(0) 643 2000. By reporting side effects, you can help provide more information on the safety of PATRAM.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Do not remove the blister strips from the cartons until required for use. Do not use the PATRAM Tablets after the expiry date which is printed on the carton and the edge of the blister. The expiry date refers to the last day of that month.