Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
• Contains paracetamol. Patients should be advised not to take other paracetamol- containing products concurrently. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
• Concomitant use of other decongestants or cold and flu medicines should be avoided.
• The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Underlying liver disease increases the risk of paracetamol-related liver damage.

• Medical advice should be sought before using this product in patients with these conditions: glutathione depletion due to metabolic deficiencies.
• An enlargement of the prostate gland
• Occlusive vascular disease (e.g. Raynaud's phenomenon)
• Cardiovascular disease
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Consult the doctor if taking warfarin.
Chlorphenamine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis and asthma; hepatic impairment; renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness). Avoid use in elderly patients with confusion.
The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.
Concurrent use with drugs which cause sedation such as anxiolytics and hypnotics may cause an increase in sedative effects, therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.
The effects of alcohol may be increased and therefore concurrent use should be avoided.
Should not be used with other antihistamine containing products, including antihistamine containing cough and cold medicines.
Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGM A), particularly in patients with severe renal impairment, sepsis, malnutrition, and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol.
Close monitoring, including measurement of urinary 5-oxoproline, is recommended.




Effects on Driving

4.7 Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness, drowsiness, blurred vision and psychomotor impairment.