1. Name Of The Medicinal Product
Karvol Decongestant Capsules
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Capsule
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of colds in the head and the symptomatic rapid relief of nasal congestion.
4.2 Posology And Method Of Administration
For inhalation.
Snip tip off capsule carefully, pointing top downwards and away from the face.
For Older Children and Adults:
Nightime: Dab contents of one capsule on to bedding or handkerchief nearby but avoiding direct skin contact.
Daytime: Squeeze contents of one capsule on to a tissue or into a pint of hot water and inhale the vapour freely.
For Young Children:
Dab contents of one capsule on to a handkerchief tied down securely in the vicinity, but out of reach of the child.
Elderly:
There is no need to modify the administration of this preparation for use by the elderly.
Children Under 3 Months:
Not recommended for children under 3 months of age.
4.3 Contraindications
Children under 3 months of age.
4.4 Special Warnings And Precautions For Use
Avoid contact with the eyes and prolonged contact with the skin.
If symptoms persist consult your doctor.
Keep all medicines out of the reach of children.
Do not take internally.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions known.
4.6 Pregnancy And Lactation
The safety of Karvol in pregnancy and lactation has not been established, but is not expected to constitute a hazard.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects known.
4.8 Undesirable Effects
No side effects would be anticipated.
4.9 Overdose
Symptoms of overdose may included nausea, vomiting, colic, headache, dizziness, a feeling of warmth, delirium, muscle twitching, epileptiform convulsions, depressed respiration, CNS depression and coma. Initial treatment consists of emptying the stomach by lavage and aspiration. Administer a saline laxative such as sodium sulphate and activated charcoal by mouth. Convulsions may be controlled with diazepam or thiopental sodium.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Menthol, Chlorobutanol, Pine Oil and Terpineol are volatile substances and are thought to produce an irritant effect on the respiratory tract, possibly via a nasal/pulmonary arc.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
PEG – 20 Stearate
Cinnamon Oil
Polysorbate 80 (Tween 80)
Polyethylene Glycol 400 (Macrogol)
Triacetin
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
A capsule contained in a 200 or 250 Fm PVC or 200 or 250 Fm PVC/40 gsm PVDC blister, heat sealed to aluminium foil. Packs of either 1, 2(stencilled card), 4, 5, 6, 8, 10, 12, 14, 15, 16, 18, 20, 22, 24, 25, 26, 28, 30, 32 or 36 capsules in a printed carton.
An amber glass bottle having a thermoset plastic screw cap containing 500 capsules.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Crookes Healthcare Limited
1 Thane Road West
Nottingham
NG2 3AA
United Kingdom
8. Marketing Authorisation Number(S)
PL 0327/5914R
9. Date Of First Authorisation/Renewal Of The Authorisation
16 June 1989 / 24 February 1995
10. Date Of Revision Of The Text
11/09/2007
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