Tenston Sa 150 mg/10 mg/200 mg/30 mg Capsules

TENSTON SA CAPSULES contain the active ingredients Paracetamol 200 mg, Codeine phosphate 10 mg, Caffeine 30 mg and Meprobamate 150 mg. TENSTON SA CAPSULES are used for the symptomatic relief of mild to moderate pain and fever.

Do not take TENSTON SA CAPSULES:

• if you have ever had an allergic reaction to paracetamol, codeine phosphate, opioid analgesics caffeine, meprobamate or any of the other ingredients in the capsules (these are listed in section 6),
• if you need to remain alert,
• if you have porphyria (a rare inherited blood disorder),
• if you have severe kidney or liver problems,
• if you are experiencing an asthma attack or heart failure (secondary to a chronic lung disease),
• if you suffer from a head injury or any conditions in which intracranial pressure is raised (a rise in the pressure around your brain),
• if you had an operation on the biliary tract (liver, gall bladder and bile ducts),
• if you have any lung/airway (respiratory) problems, especially in the presence of cyanosis (condition where your skin or lips turn blue due to an insufficient level of oxygen in the blood) and excessive mucus and fluid secretion in the airways,
• if you suffer from acute alcoholism (alcohol poisoning due to rapid and excessive alcohol intake),
• if you have a history of fits (epilepsy),
• if you are taking an antidepressant in the class called monoamine oxidase inhibitors or within fourteen days of stopping such treatment,
• if you are under 12 years old,
• if you are breastfeeding,
• if you are pregnant, do not take codeine containing products, including TENSTON SA CAPSULES later in your pregnancy because these medicines may cause problems in your unborn baby,
• For pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

Do not share medicines prescribed for you with any other person. Always take TENSTON SA CAPSULES exactly as your doctor has instructed you. Your doctor will decide which dose is applicable to you. You should check with your doctor or pharmacist if you are unsure. The usual adult dose of TENSTON SA CAPSULES is 1 to 2 capsules four times daily. Children: 12 years and older is 1 capsule four times daily.

Your doctor will tell you how long your treatment with TENSTON SA CAPSULES will last. However, it is not recommended to use continuously for more than ten days. If you have the impression that the effect of TENSTON SA CAPSULES is too strong or too weak, tell your doctor or pharmacist.

If you take more TENSTON SA CAPSULES than you should TENSTON SA CAPSULES contains paracetamol, which may be fatal in overdose. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Immediate medical attention is critical. Even if you do not show symptoms of an overdose, go immediately to your nearest hospital or poison centre. Symptoms of paracetamol overdosage in the first 24 hours include pallor (unhealthy pale appearance), nausea, vomiting, loss of appetite and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage. Liver damage may lead to brain damage, coma and death. Kidney failure may develop even in the absence of severe liver damage and heart rhythm problems (dysrhythmias) have also been reported.

If you forget to take TENSTON SA CAPSULES If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses. If you stop taking TENSTON SA CAPSULES TENSTON SA CAPSULES contain codeine (one of the active ingredients). When you stop taking it you may get withdrawal symptoms. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling of being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. You should talk to your doctor if you think you are suffering from withdrawal symptoms.

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

If any of the following happens, stop taking TENSTON SA CAPSULES and tell your doctor immediately or go to the casualty department of 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
• Fainting
• Blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS), severe cutaneous adverse reactions (SCARS) such as toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), Drug reaction with eosinophilia and systemic symptoms (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE)

These are all very serious side effects. If you have them, you may have had a serious reaction to TENSTON SA CAPSULES. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent: Drowsiness (a feeling of being sleepy and lethargic)
• Less frequent: Blood disorders including agranulocytosis (lowered white blood cell count), leukopenia (low level of white blood cells) and thrombocytopenia (low blood platelet count).
• No bacteria in urine (Sterile pyuria)
• Abdominal pain including risk of inflammation of pancreas, which causes severe pain in the abdomen and back (Acute pancreatitis).
• Inflammation of the liver (you may feel nauseas, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine),
• Frequency not known: Blood disorders including eosinophilia (high level of white blood cells) and aplastic anaemia (a rare condition in which the body stops producing enough new blood cells).
• Hearing loss
• High blood pressure.
• Headache, inability to sleep, restlessness, dizziness, excitement, and muscle tremor (involuntary movements).
• Tinnitus (ringing of the ears)
• Caffeine increases gastric secretions (such as stomach acid) and may cause stomach ulcers
• Drug dependency can occur after prolonged use of codeine
• Codeine may cause nausea, vomiting, constipation, and dry mouth
• Hyperalgesia (a condition where there is an increased sensitivity to pain stimuli, resulting in a heightened perception of pain)
• Kidney problems (you may have blood in your urine, cloudy urine, change in how frequent you want to urinate)
• Sweating
• paraesthesia (tingling or pricking / “pins and needles”), weakness, headache, excitement, dizziness, ataxia (slurred speech, stumbling, falling, and incoordination)
• Scintillating scotoma (visual aura or blind spot that affects a part of your vision), other vision disturbances.
• Tachycardia (rapid heartbeat), extrasystoles (skipped heartbeats). Hypotension (low blood pressure), cardiac dysrhythmias (improper heartbeat)

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, nurse or pharmacist. 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. By reporting side effects, you can help provide more information on the safety of TENSTON SA CAPSULES.

For reporting of side effects directly to Adcock Ingram Limited, contact +27 11 635 0134 or email [email protected].

• Store all medicines out of reach of children.

• Store at or below 25 °C. Protect from light and moisture.

• Do not use after the expiry date stated on the bottle.

• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).