Summary of Product Characteristics (SmPC) - 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)
Excipients with known effect:
Lactose Monohydrate 107.66mg/Tablet
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
White, uncoated, round, 7 mm in diameter with beveled edges, smooth on one side and marked with “OT” and scored 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. Urticaria. 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.
Oral administration only.
Maximum duration of use: Clemastine fumarate should not be used for more than 14 days without consulting a doctor. Do not exceed the recommended dose
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.
- children due to the risk of excitability in this special population (see section 4.8)
- epilepsy or history of seizures
- in the elderly, who are more likely to experience adverse effects such as paradoxical excitation. Avoid use in elderly patients with confusion.
- Do not exceed recommended dosage and duration of use without consulting a health care provider (See Dosage and Administration).
Excipient Warning
Patients with rare hereditary problems of galactose intolerance, total lactase 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 Central Nervous System
(CNS) depressants including hypnotics, monoamine-oxidase inhibitors
(MAOI’s), antidepressants, anxiolytics, opioid analgesics and alcohol.
Patients should be advised to avoid alcoholic drinks.
As clemastine has some anticholinergic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated.
4.6 Fertility, pregnancy and lactation
TAVEGIL should not be given during pregnancy and breast-feeding.
4.7 Effects on ability to drive and use machines
TAVEGYL has moderate influence on the ability to drive and use machines, due to the antihistamine sedative effect of clemastine, however, patients should be warned not to take charge of vehicles or machinery until the effect of TAVEGIL treatment on the individual is known.
4.8 Undesirable effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies
are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000). or not known (can not to beestimated from available data). Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is not known but likely to be rare or very rare
| MedDRA SOC | Adverse Reaction | Frequency |
| Immune system disorders | Anaphylactic shock | Rare |
| Hypersensitivity reactions | Rare | |
| Psychiatric disorders | Excitability, especially in children | Rare |
| Nervous system disorders | Sedation | Common |
| Dizziness | Uncommon | |
| Headache | Rare | |
| Fatigue | Common | |
| Cardiac disorder | Tachycardia | Very rare |
| Palpitations | Very rare | |
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | Rare |
| Gastrointestinal disorder | Abdominal pain | Rare |
| Nausea | Rare | |
| Dry mouth | Rare | |
| Constipation | Very rare | |
Skin and Subcutaneous tissue disorders | Skin rash | Rare |
| General system disorders | Asthenia | Rare |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms: the effects of antihistamine overdose may vary from CNS depression to stimulation such as depressed level of consciousness,
excitability, hallucinations, or convulsions. Anticholinergic symptoms such as dry mouth, mydriasis or flushing, gastrointestinal reactions and tachycardia may also develop.
Treatment: Treatment consists of symptomatic therapy or as recommended by the national poisons centres, where applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines: H1-receptor, ATC code R06AA04
Mechanism of action and pharmacodynamic effects
TAVEGIL (clemastine) is an H1-recptor antagonist. 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 antihistaminic and antipruritic effect with a fast onset and long duration of action up to 12 hours.
5.2 Pharmacokinetic properties
Absorption
Following oral administration TAVEGIL (clemastine) is almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are attained within 2-4 hours. The antihistaminic activity of the drug reaches its peak after 5 to 7 hours; it usually persists for 10 to 12 hours, in some cases, however, for up to 24 hours.
Distribution
Plasma protein binding of clemastine amounts to 95%.
Biotransformation
Clemastine undergoes extensive metabolism in the liver.
Elimination
Elimination from plasma occurs biphasically, with half-lives of 3.6 ± 0.9 hours and 37 ± 16 hours. The major route of metabolite excretion (45 to 65%) is through the kidneys into urine, where only trace amounts of the parent compound are found. In lactating women, small amounts of the drug may pass into breast milk.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction at therapeutically relevant doses.
In a rat study, a reduction in pup survival, at doses more than 200X the therapeutic dose, was observed when mothers were treated through lactation.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Monohydrate
Povidone
Maize Starch
Talc (acid washed)
Magnesium Stearate.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
PVC/PVDC blister pack (50 or 60 tablets).
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0561
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08 June 2000
10 DATE OF REVISION OF THE TEXT
20/04/2021