KRISFED Syrup Ref.[115646] Active ingredients: Chlorphenamine

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.

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.

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.

Krisfed syrup contains 6.3% v/v ethanol (alcohol), i.e., up to 497 mg per 10 ml (4 mg), equivalent to 12.6 ml beer, 5.3 ml wine per dose. This should be taken into consideration as it is harmful for those suffering from alcoholism. To be taken into account in pregnant and breast feeding women, children and high risk groups such as patients with liver disease or epilepsy.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicine.

Krisfed syrup contains 2.36 g of sucrose per 5 ml. This should be taken into account in patients with diabetes mellitus.

Long term use increases the risk of dental caries and it is essential that adequate dental hygiene is maintained.

Methyl, ethyl and propyl hydroxybenzoates (E218, E214 and E216) may cause allergic reactions (possibly delayed).

Keep out of the reach and sight of children.

Concurrent use of chlorphenamine and hypnotics or anxiolytics may cause an increase in sedative effects, concurrent use of alcohol may have a similar effect therefore medical advice should be sought before taking chlorphenamine concurrently with these medicines.

Chlorphenamine inhibits phenytoin metabolism and can lead to phenytoin toxicity.

The anticholinergic effects of chlorphenamine are intensified by MAOIs (see Contra-indications).

Pregnancy

There are no adequate data from the use of chlorphenamine in pregnant women. The potential risk for humans is unknown, Use during the third trimester may result in reactions in the newborn or premature neonates. Not to be used during pregnancy unless considered essential by a physician.

Lactation

Chlorphenamine maleate and other antihistamines may inhibit lactation and may be secreted in breast milk. Not to be used during lactation unless considered essential by a physician.

The anticholinergic properties of chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.

The following convention has been utilised for the classification of the frequency of adverse reactions: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse reactions identified during post-marketing use with chlorphenamine are listed below. As these reactions are reported voluntarily from a population of uncertain size, the frequency of some reactions is unknown but likely to be rare or very rare:

^* Children and the elderly are more susceptible to neurological anticholinergic effects and paradoxical excitation (eg increased energy, restlessness, nervousness)

Not known.