Source: Registered Drug Product Database (NG) Publisher: Krishat Pharma Industries Limited, KM 15, Lagos-Ibadan Expressway, Ibadan, Oyo State, NIGERIA, Email: info@krishatpharma.com
KRISTOLIN EXPECTORANT is contraindicated in individuals with knownhypersensitivity to the product or any of its constituents.
KRISTOLIN EXPECTORANT is contraindicated in individuals with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by the physician.
KRISTOLIN EXPECTORANT should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOI) or those patients who have received treatment with MAOIs within the last two weeks.
Not to be used in children under the age of 12 years.
This product may cause drowsiness. If affected individuals should not drive or operate machinery.
Subjects with moderate to severe renal or hepatic dysfunction or urinary retention should exercise caution when using this product (see Pharmacokinetics – Renal/Hepatic Dysfunction).
This product contains diphenhydramine and therefore should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This product contains diphenhydramine and therefore may potentiate the effects of alcohol, codeine, antihistamines and other CNS depressants.
As diphenhydramine possesses some anticholinergic activity, the effects of anticholinergics (eg, some psychotropic drugs and atropine) may be potentiated by this product. This may result in tachycardia, dry mouth, gastrointestinal disturbances (eg, colic), urinary retention and headache.
Although diphenhydramine has been in widespread use for many years without ill consequence, it is known to cross the placenta and has been detected in breast milk. KRISTOLIN EXPECTORANT should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing foetus or suckling infant.
This product may cause drowsiness. If affected, the patient should not drive or operate machinery.
Side effects associated with the use of KRISTOLIN EXPECTORANT areuncommon.
Diphenhydramine may cause: drowsiness; dizziness; gastrointestinal disturbance; dry mouth; nose and throat; difficulty in urination or blurred vision.
Less frequently it may cause palpitations, tremor, convulsions or parasthesia. Hypersensitivity reactions have been reported, in particular, skin rashes, erythema, urticaria and angiodema.
Adverse reactions to menthol at the low concentration present in KRISTOLIN EXPECTORANT are not anticipated.
There are no significant incompatibilities with the product.
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