Actatense Tablets

ACTATENSE has analgesic (to relieve pain), antipyretic (to prevent or reduce fever) and antihistaminic (allergy treatment) properties. ACTATENSE tablets are used for the relief of mild to moderate pain and pain associated with tension and fever.

Do not take ACTATENSE

• if you are hypersensitive (allergic) to paracetamol, codeine phosphate, caffeine or doxylamine succinate or any of the other ingredients of ACTATENSE (listed in section 6).
• if you have impaired liver function.
• if you have problems with breathing and impaired lung function.
• if you have heart failure as a result of chronic lung disease.
• if you are having an asthma attack.
• if you had an operation on your bile ducts.
• if you recently had a head injury or have increased pressure in the brain (possibly after a head injury or brain disease).
• if you have used monoamine oxidase inhibitors (certain medicines used for treatment of depression) or within 14 days of stopping such treatment.
• if you are pregnant or breastfeeding your baby.
• if you are alcohol dependent.
• in children under the age of 12 years.

Warnings and precautions

Paracetamol may be fatal in overdose. Dosages in excess of those recommended may cause severe liver damage. Exceeding the prescribed dose, together with prolonged and continuous use of ACTATENSE, may lead to dependency and addiction. Do not take together with any other paracetamol or codeine containing products.

Special care should be taken with ACTATENSE

• if you are an asthmatic.
• if you have kidney or liver disease.
• if you have weakness in skeletal muscles (myasthenia gravis).
• if you are in shock.
• if you have enlarged prostate (prostatic hypertrophy).
• if you have inflammatory or obstructive bowel disorders or obstruction of the gastric outlet.
• if you have hyperthyroidism or hypothyroidism (over or under active thyroid).
• if your adrenal glands do not produce adequate amounts of steroid hormones (adrenocortical insufficiency).
• if you have a history of sores that develop in the lining of the stomach (peptic ulceration).
• if you have high pressure in your eye (glaucoma).
• if you have heart rhythm problems or heart and blood vessel disease (cardiac arrhythmias or other cardiovascular disease).
• if you have epilepsy.
• if you have urinary retention.
• if you are malnourished or dehydrated.

Children

ACTATENSE tablets should NOT be used in children under 12 years of age.

Other medicine and ACTATENSE

Always tell your healthcare professional if you are taking any other medicines (this includes complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take ACTATENSE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose for adults and children over 12 years is: Take 1 to 2 tablets with water every 4 hours, with a maximum of 8 tablets daily. Do NOT exceed the recommended maximum dose. Do not use continuously for more than 10 days without consulting your doctor. If your symptoms worsen or do not improve with treatment, please consult your doctor or pharmacist.

Children

ACTATENSE should not be given to children below the age of 12 years.

Elderly patients

The dosage should be reduced in elderly and debilitated patients. Patients with liver and kidney impairment The dosage in renal functional impairment must be reduced and should be taken under medical supervision.

How and when should you take ACTATENSE

ACTATENSE is for oral use. If you have the impression that the effect of ACTATENSE is too strong or too weak, tell your doctor or pharmacist.

If you take more ACTATENSE than you should

Prompt treatment is essential. A delay in starting treatment may mean that the antidote is given too late to be effective. ACTATENSE tablets contain paracetamol and codeine which may be fatal in overdose. In the event of overdosage or suspected overdose, and notwithstanding the fact that the person may be asymptomatic, contact the nearest doctor, hospital or Poison Centre immediately. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Liver damage may become apparent 12 to 48 hours, or later after ingestion. Acute renal failure may develop even in the absence of severe liver damage. In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take ACTATENSE

If you forget to take ACTATENSE tablets, do not take a double dose to make up for the missed dose.

If you stop taking ACTATENSE

ACTATENSE contains codeine and can cause addiction if you take it continuously for many days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms. Withdrawal symptoms such as restlessness, difficulty in sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking ACTATENSE.

ACTATENSE may have side effects. Not all side effects reported for ACTATENSE are included in this leaflet. Should your general health worsen of if you experience any untoward effects while receiving ACTATENSE, please inform your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking ACTATENSE and tell your doctor immediately or, preferably, go to the casualty department at your nearest hospital:

• symptoms of an allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching and feeling unwell.
• nausea and vomiting.
• fainting.

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

Talk to your doctor straight away if you notice the following serious side effects:

• severe stomach pain, which may reach to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect.
• you get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis or thrombocytopenia).
• you get serious skin reactions (Steven Johnson syndrome or toxic epidermal necrolysis).

The following side-effects have been reported, which may be related to the use of ACTATENSE:

Frequent side effects:

• gastrointestinal symptoms such as difficulty in emptying the bowels (constipation), feeling sick (nausea) or being sick (vomiting), drowsiness.

Less frequent side effects:

• hypersensitivity (allergy) which can be severe
• gastrointestinal disturbances
• excitement
• restlessness
• sleeplessness (insomnia)
• nightmares
• loss of appetite (anorexia)
• nervousness
• dizziness
• spinning sensation (vertigo)
• confusion
• facial flushing
• dry mouth
• sweating
• tinnitus (ringing in the ear)
• irregular heartbeat
• irregular and difficult breathing
• diarrhoea
• rashes
• sudden decrease in amount of urine
• unusual tiredness or weakness
• visual disturbances including blurred vision
• difficulty passing urine
• shortness of breath
• tremor and fits
• low blood pressure (lightheadedness or fainting when standing up)
• tingling sensation in hands
• increased pressure in the head
• high body temperature
• headache.

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 ACTATENSE.

Store all medicines out of reach of children. Store at or below 25 °C and protect from light. Keep ACTATENSE in the outer container until required for use. Do not use after the expiry date stated on the label/carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).