Astrapain Syrup

ASTRAPAIN SYRUP is used for the relief of mild to moderate pain, associated with fever.

Do not take ASTRAPAIN SYRUP:

• if you are hypersensitive (allergic) to paracetamol, codeine phosphate, promethazine hydrochloride or any other ingredients of ASTRAPAIN SYRUP (listed in section 6).
• if you are hypersensitive (allergic) to opiates or phenothiazines
• if you are sensitive to one antihistamine and may be sensitive to others
• if you suffer from kidney or liver problems
• if you have an attack of bronchial asthma, respiratory depression, especially in the presence of cyanosis (bluish discolouration of skin due to lack of oxygen) and excessive bronchial (relating to air passages in the lungs) secretion.
• If you are an alcoholic.
• If you have heart failure secondary to chronic lung disease, head injuries where the intracranial pressure (pressure inside the skull) is raised.
• do not give to children under the age of 2 years or to comatose - patients.
• If you are pregnant.
• If you are breastfeeding.
• If you are taking monoamine oxidase inhibitors or within 14 days of stopping such treatment

Warnings and precautions

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.

Take special care with ASTRAPAIN SYRUP:

• if you take more than the recommended dose as it can cause severe liver damage.
• If no symptomatic improvement results, a doctor should be consulted.
• Do not drive or operate any tools or machines because this medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.
• Pigments should be examined periodically for abnormal skin pigmentation or eye changes.
• Do not exceed the prescribed dose because exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.
• The use of promethazine may be associated with the sudden infant death syndrome.

Do not share medicines prescribed for you with any other person. Always take ASTRAPAIN SYRUP exactly as described in this leaflet or as your doctor or pharmacist or nurse have told you. Check with your doctor or pharmacist or nurse if you are not sure.

The usual dose is:

DO NOT EXCEED THE RECOMMENDED DOSAGE

Not recommended for children under 2 years of age.

Children 2 to 5 years: 5 ml three times a day.

Children 6 years and older: 5 to 10 ml three times a day.

Do not use continuously for more than 5 days for pain and 3 days for fever.

Shake the bottle before use.

If you have the impression that the effect of ASTRAPAIN SYRUP is too strong or too weak, talk to your doctor or pharmacist.

If you take more ASTRAPAIN SYRUP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

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

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

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

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

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
• Drowsiness and confusion
• Sedation (which can vary from slight drowsiness to deep sleep and including inability to concentrate)
• Lassitude (lack of energy, fatigue, lethargy)
• Dizziness
• Hypertension (high blood pressure)
• Muscular weakness and in-coordination

Less frequent side effects:

• Neutropenia (too few white blood cells)
• Pancytopenia (too few blood cells of all types)
• Leucopenia (too few white blood cells)
• If taken in excess, this medicine may cause liver damage which may be fatal
• Skin rashes and other allergic reactions may occur. The rash is usually erythematous (red skin rash) or urticaria (allergic skin reaction / nettle - rash) but sometimes more serious and may be accompanied by fever and mucosal (tissues that produce mucus) lesions (deterioration of tissue due to injury or disease).
• Dryness of mouth
• Sweating
• Facial flushing
• Dizziness
• Restlessness
• Changes of mood may occur
• Difficulty in passing urine
• Ureteric spasm (Colic/spasm of the ureter/kidney duct)
• Biliary spasm (spasm of bile duct)
• Bradycardia (abnormally slow pulse rate)
• Palpitations (rapid irregular action heart)
• Respiratory depression (abnormally slow and/or shallow breathing)
• Orthostatic hypotension (drop in blood pressure when standing up)
• Hypothermia (abnormally low body temperature)
• Miosis (Contraction of the pupil of eye) may occur
• Raised intracranial pressure (pressure in side the skull) may occur
• Due to the histamine releasing effect, reactions such as urticaria (allergic skin reaction / nettle - rash) and pruritis (itching) may occur in infants and children.
• Blood dyscrasias (serious blood disorder)
• Agranulocytosis (severe decrease in a particular type of white blood cells)
• Leucopenia (too few white blood cells)
• Haemolytic anaemia (lack of red blood cells due to destruction of circulation cells).
• Epigastric pain (pain in upper, middle region of stomach).
• Headache
• Tinnitus (ringing in the ears)
• Elation of depression
• Irritability
• Nightmares
• Dryness of the mouth
• Tightness of the chest and tingling
• Dizziness and weakness of the hands may occur
• In infants and children it may act as a cerebral stimulant. Symptoms of stimulation include insomnia (inability to sleep), nervousness, tachycardia (increased rate of heart beat), tremors, muscle twitching and convulsions.
• Large doses may precipitate fits in epileptics.
• Photosensitivity reactions (increase in the reactivity of the skin to light) may occur.
• Allergic reactions anaphylaxis (sudden, life threatening severe allergic reaction) may occur.
• Anorexia (loss of appetite), or increased appetite
• Difficulty in passing urine may also occur.
• Extrapyramidal symptoms may develop.

Frequency unknown side effects:

• Drug - induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicine.

Post Marketing Experience: Drug - induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicine. If a patient develops SCAR (Severe cutaneous adverse reactions), treatment with ASTRAPAIN SYRUP must immediately be discontinued and appropriate treatment instituted.

• Store in well closed containers, at or below 25°C.

• Protect from light.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Store in the original container.

• Do not store in a bathroom.

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

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).