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

Tramadol and paracetamol are the active substances in ULTRACET. They are painkillers that act on the brain and spinal cord to control pain. ULTRACET is used for the management of moderate to moderately severe pain in adults.

Do not take ULTRACET if:

• if you are hypersensitive (allergic) to tramadol or paracetamol or to any other opioid or any of the other ingredients of ULTRACET (listed in section 6);
• if you take other medicines containing paracetamol or tramadol;
• if you have a moderate to severe liver disease;
• if you are taking alcohol;
• if you are taking sleeping pills;
• if you are taking other psychotropic medicines (medicines that affect mood and emotions);
• if you are taking MAO inhibitors (certain medicines used for depression) or have taken them in the last 14 days before treatment with ULTRACET;
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• if you have difficulty in breathing;
• If you have epilepsy or suffer from seizures;
• Do not give ULTRACET to a child under 12 years of age;
• Do not give ULTRACET to a child under 18 years of age that has just had an operation to remove their tonsils or adenoids.

Warnings and precautions

Take special care with ULTRACET:

• Do not take more than your recommended dose;
• Tell your doctor if you have ever had an allergic reaction (characterised by significant skin rash, itching, hives, difficulty breathing, and/or swollen face) while taking codeine or other opioids;
• Tell your doctor if you are taking other medicines which contain tramadol or paracetamol;
• Tell your doctor if you have fits (seizures);
• Tell your doctor if you are taking any other medicine, because taking some medicines together with ULTRACET may increase your risk of fits (seizures);
• Tell your doctor if you use sedatives, tranquilisers, sleeping pills, medicines for pain relief, anaesthetics or if you drink alcohol;
• Tell your doctor if you have recently suffered from a head injury or severe headaches associated with vomiting;
• If you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• Tell your doctor if you are dependent on any opioid painkillers;
• Tell your doctor if you are dependent on alcohol or have a history of alcohol abuse;
• Tell your doctor if you want to stop taking ULTRACET. You may become dependent on ULTRACET and may need to reduce the dose of ULTRACET slowly to avoid withdrawal symptoms;
• Tell your doctor if you know you have a kidney disorder. The dose of ULTRACET may need to be adjusted;
• Tell your doctor if you know you have a liver problem. ULTRACET may not be recommended for you;
• Stop taking ULTRACET and tell your doctor immediately if you experience skin rash, especially:
• A red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever (acute generalised exanthematous pustulosis);
• A life-threatening rash with blisters and peeling skin over much of the body (toxic epidermal necrolysis);
• A severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
• Tramadol works by being converted (metabolised) into its active component. Some patients convert (metabolise) tramadol to this active component more rapidly and completely than other patients. These patients are more likely to have serious side effects, such as breathing difficulties, with slow or shallow breathing. If you experience these types of side effects, stop taking ULTRACET and consult with your doctor immediately.
• Some patients taking ULTRACET may experience low levels of sodium in the blood (hyponatraemia). Symptoms of low blood sodium may include nausea and vomiting, headaches, feeling confused, feeling very tired, feeling restless, feeling irritable, muscle weakness, spasms or cramps and seizures. Elderly patients and patients taking other medicines that lower sodium in the blood are most at risk for this side effect. If you get any of these symptoms while taking ULTRACET, consult with your doctor immediately.
• ULTRACET 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 anyone notices you stop breathing from time to time whilst sleeping. This product contains paracetamol and is 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.

Other medicines and ULTRACET:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take ULTRACET exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

ULTRACET comes in the form of a tablet to be taken by mouth. Do not take more than the recommended dose of ULTRACET. The lowest effective dose should be used for the shortest period of time. The usual dose is:

• Adults (including elderly) and children over 16 years of age: Take 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. ULTRACET should not be given to children under 16 years of age.

Patients with kidney or liver impairment: Do not take ULTRACET if you have 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. DO NOT TAKE MORE THAN THE RECOMMENDED DOSE. Your doctor will tell you for how long your treatment with ULTRACET will last. If you have the impression that the effect of ULTRACET is too strong or too weak, tell your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

Frequent side effects of ULTRACET:

• Nausea;
• Dizziness;
• Headache;
• Muscle tremor;
• Stomach pain;
• Constipation;
• Diarrhoea;
• Indigestion;
• Passing wind;
• Dry mouth;
• Vomiting;
• Loss of appetite;
• Feeling anxious;
• Feeling confused;
• Feeling extremely happy (euphoria);
• Feeling sleepy;
• Feeling nervous;
• Feeling weak;
• Feeling very tired;
• Hot flushes;
• Itching;
• Rash;
• Increased sweating;
• High blood pressure;
• High blood pressure that is worse than before;
• Low blood pressure;
• Abnormal heart rhythm;
• Heart beat feels fast;
• Fast heart beat;
• Changes that show up in blood tests of the liver;
• Loss of coordination;

Less Frequent side effects of ULTRACET:

• Confusional state;
• Excessive contraction of the pupil of the eye;
• Prolonged dilatation of the pupil of the eye;
• Speech disorder;
• Movement disorder;
• Low blood sugar. (Most cases were in patients who had existing risk factors such as diabetes, kidney disease or in elderly patients);
• Low levels of sodium in the blood and/or inappropriate antidiuretic hormone secretion (SIADH);
• Seeing, feelings, hearing or smelling things that are not there (hallucinations);

Side effects of tramadol hydrochloride:

• Feeling dizzy upon sitting up or standing up;
• Allergic reactions including:
• a severe allergic reaction that may include:
• a swollen face, lips, mouth, tongue or throat;
• difficulty swallowing or breathing;
• itchy rash (hives);
• hives;
• severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
• life-threatening rash with blisters and peeling skin over much of the body (toxic epidermal necrolysis);
• Difficulty thinking, remembering information, or solving problems;
• Thoughts of harming or killing yourself;
• Inflamed liver;
• Increased level of creatinine in the blood;
• Life-threatening increases of 'serotonin' in the brain (serotonin syndrome), which may lead to:
• feeling confused or restless;
• sweating, shivering, muscle jerks, fast heart beat, particularly if you take other medicines used to treat depression such as Monoamine Oxidase Inhibitors (MAO inhibitors) or Selective Serotonin Reuptake inhibitors (SSRI’s) at the same time as ULTRACET;
• Severe confusion;
• Constricted pupils;
• Dilated pupils;
• Speech problems;
• Problem being able to produce or control movement;
• Changes in the effects of blood thinners (such as warfarin) including an increase in prothrombin time, causing an increased risk of bleeding;
• Low level of sugar in the blood;
• Low level of sodium in the blood.

Side effects of paracetamol:

• Allergic reactions (skin rash);
• Allergic reaction to paracetamol;
• Low level of ‘prothrombin’ in the blood, causing an increased risk of bleeding when taken with blood thinners;
• Red and swollen skin that may blister.

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 or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ULTRACET.

Keep ULTRACET in a cool, dry place, at or below 30 °C. Do not remove the blisters from the carton until required. Store all medicines out of reach of children. Protect from light and moisture. Do not use after the expiry date stated on the label. Store this medicine securely, where other people cannot access it. It may harm people who may take this medicine by accident, or intentionally when it has not been prescribed for them. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).