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KARVOL DECONGESTANT CAPSULES

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Karvol Decongestant Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Chlorobutanol
Levomenthol
Pine Oil Sylvestris
Terpineol
Thymol
Pumilio Pine Oil

3

mg/capsule
2.25
35.55
9.0
66.6
3.15
103.05

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 include 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
Preclinical safety data
Not applicable

5.3

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/40gsm
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
Not applicable

7

MARKETING AUTHORISATION HOLDER
Crookes Healthcare Limited
1 Thane Road West
Nottingham
NG2 3AA
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00327/5914R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/06/1989

10

/

22/07/2002

DATE OF REVISION OF THE TEXT
11/09/2007

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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