Tavegil 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clemastine hydrogen fumarate

Available from:

Thornton & Ross Ltd

ATC code:

R06AA04

INN (International Name):

Clemastine hydrogen fumarate

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5013054200192

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Clemastine hydrogen fumarate 1.34 mg
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without a prescription. However, you still
need to use Tavegil
Tablets carefully to get the best results.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– You must contact a doctor if your symptoms worsen or do not
improve.
– If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tavegil Tablets are and what they are used for
2. Before you use Tavegil Tablets
3. How to use Tavegil Tablets
4. Possible side effects
5. How to store Tavegil Tablets
6. Further information
1. WHAT TAVEGIL TABLETS ARE AND WHAT THEY ARE USED FOR
Tavegil Tablets contain clemastine 1 mg as the active ingredient,
which belongs to a group
of antihistamines. Tavegil Tablets are used to treat:
• allergic rhinitis (inflammation of the nasal mucous membranes)
including hay fever,
perennial rhinitis and vasomotor rhinitis.
• allergic skin disease (dermatoses), including pruritus (intense
itching), atopic eczema
and contact dermatitis.
• angioneurotic oedema (rapid swelling of the skin, mucosal tissues,
internal organs
or brain) and drug allergy.
2. BEFORE YOU TAKE TAVEGIL TABLETS
Do not take Tavegil Tablets if you have:
• an allergy (hypersensitivity) to any of the ingredients of Tavegil
Tablets (see Section 6 and
Section 2 “Important information about some of the ingredients of
Tavegil Tablets”),
• an allergy (hypersensitivity) to other arylalkylamine
antihistamines (ask your doctor if you
are unsure what these are)
• Porphyria, a metabolism disorder which affects red blood cells and
may cause blistering
of the skin, abdominal pains and mental problems.
Do not give Tavegil Tablets to children below one year of age.
Take special care with Tavegil Tablets if y

Summary of Product characteristics

OBJECT 1
TAVEGIL TABLETS
Summary of Product Characteristics Updated 16-Sep-2016 |
GlaxoSmithKline Consumer Healthcare
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, 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.
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)
Tavegyl tablets con