Tavegil Tablets

1. Name Of The Medicinal Product

TAVEGIL^® TABLETS

2. Qualitative And Quantitative Composition

Clemastine hydrogen fumarate 1.34mg (equivalent to clemastine base 1mg)

For excipients see 6.1

3. Pharmaceutical Form

White, uncoated, round tablets, 7mm in diameter with bevelled edges, branded TAVEGIL on one side with a single breakline on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Allergic rhinitis, including hay fever and perennial rhinitis, vasomotor rhinitis. Allergic dermatoses, including pruritus, atopic eczema and contact dermatitis. Angioneurotic oedema, drug allergy.

4.2 Posology And Method Of Administration

Adults

1mg clemastine base (one tablet) night and morning.

In individual cases the dose may be increased to 6mg clemastine base daily if necessary (six tablets).

Children

	1 to 3 years:	250 microgrammes to 500 microgrammes clemastine base (¼–½) tablet night and morning.
	3 to 6 years:	500 microgrammes clemastine base (½ tablet) night and morning.
	6 to 12 years:	500 microgrammes to 1000 microgrammes clemastine base (½ - 1 tablet) night and morning.

Use in the elderly

No evidence exists that elderly patients require different dosages or show different side effects from younger patients.

4.3 Contraindications

TAVEGIL is contraindicated in patients with a known hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.

TAVEGIL should not be given to porphyric patients.

TAVEGIL should not be given to children below one year of age.

4.4 Special Warnings And Precautions For Use

Antihistamines should be used with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy with urinary retention and bladder neck obstruction.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antihistamines potentiate the sedative effects of hypnotics, monoamine-oxidase inhibitors (MAOI's), tricyclic antidepressants, anxiolytics, opioid analgesics and alcohol. Patients should be advised to avoid alcoholic drinks.

4.6 Pregnancy And Lactation

TAVEGIL should not be given during pregnancy and breast-feeding unless it is strictly indicated.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned not to take charge of vehicles or machinery until the effect of TAVEGIIL treatment on the individual is known.

4.8 Undesirable Effects

Nervous system disorder:

Fatigue: common (>1/100, <1/10)

Drowsiness: common (>1/100, <1/10)

Dizziness: uncommon (>1/1,000, <1/100)

Headache: rare (>1/10,000, <1/1,000)

Psychiatric disorder:

Excitability: rare (>1/10,000, <1/1,000)

Gastrointestinal disorder:

Gastrointestinal disorders: rare (>1/10,000, <1/1,000):

Nausea: rare (>1/10,000, <1/1,000)

Constipation: very rare (<1/10,000).

Dry mouth: rare (>1/10,000, <1/1,000)

Cardiac disorders:

Tachycardia: very rare (<1/10,000)

Palpitations: very rare (<1/10,000)

Skin and subcutaneous tissue disorders:

Skin rash: rare (>1/10,000, <1/1,000)

Immune system disorders:

Hypersensitivity reactions: rare (>1/10,000, <1/1000)

Dyspnoea: rare (>1/10,000, <1/1000)

General system disorders

Asthenia: rare (>1/10,000, <1/1,000)

4.9 Overdose

Symptoms: the effects of antihistamine overdose may vary from CNS depression to stimulation. Anticholinergic symptoms such as dry mouth, fixed dilated pupils or flushing, gastrointestinal reactions and tachycardia may also develop. Treatment: consists of elimination of the drug by gastric lavage or administration of activated charcoal, and symptomatic therapy.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

TAVEGIL is an H₁-recptor antagonist with a long duration of action of up to 12 hours. It belongs to the benzhydryl ether group of antihistamines. TAVEGIL inhibits selectively the histamine receptors of the H₁ type and reduces capillary permeability. It exerts a potent antipruritic effect with a fast onset and long duration of action.

5.2 Pharmacokinetic Properties

TAVEGIL is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma levels are reached within 2-4 hours. The disposition of TAVEGIL occurs with 2 half lives, a short one of 3-4 hours and a longer one of 55 hours in plasma. In urine, the corresponding values are 2.9 and 3.3 hours. TAVEGIL is extensively metabolised. The metabolites are excreted mainly in the urine.

5.3 Preclinical Safety Data

Not stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Polyvinylpyrrolidone

Maize starch

Talc (acid washed)

Magnesium stearate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/PVDC blister pack (50 or 60 tablets). Glass bottle (500 tablets)

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

T/A Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0183

9. Date Of First Authorisation/Renewal Of The Authorisation

8 June 2000

10. Date Of Revision Of The Text

23/02/2011

LEGAL CATEGORY

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