Roletra 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loratadine

Available from:

Sun Pharma UK Ltd

ATC code:

R06AX13

INN (International Name):

Loratadine

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5015525162824

Patient Information leaflet

If you are pregnant or breast-feeding think you may be pregnant, or
are planning to
have a baby, ask your doctor or pharmacist for advice before taking
this medicine.
Do not take One A Day Allergy Tablets if you are pregnant.
Do not take One A Day Allergy Tablets if you are breast-feeding.
Loratadine is excreted in breast milk.
USE IN CHILDREN
Frequency not known
weight increased
Google Play or Apple App Store. By reporting side effects you can help
provide more
information on the safety of this medicine.
or search for MHRA Yellow Card in the
This leaflet was last revised December 2017.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Roletra 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
Excipients with known effect:
Each tablet also contains 78.25mg lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets
White to off-white, round, uncoated tablets debossed with "R" on one
side and
"10" on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Roletra 10 mg tablets are indicated for the symptomatic treatment of
allergic
rhinitis and chronic idiopathic urticaria in adults and children over
the age of 2
years with a body weight more than 30kg.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age:
10mg once daily (one tablet once daily)
Paediatric population
Children 2 to 12 years of age are dosed by weight:
Body weight more than 30kg: 10mg once daily (one tablet once daily).
Body weight 30kg or less: The 10mg strength tablet is not appropriate
in
children with a body weight less than 30kg. There are other
formulations more
suitable for children 2 to 12 years old with body weight 30 kg or
less.
Safety and efficacy of Roletra 10 mg tablets in children under 2 years
of age
has not been established. No data are available.
Patients with hepatic treatment
Patients with severe liver impairment should be administered a lower
initial
dose because they may have reduced clearance of loratadine. An initial
dose
of 10mg every other day is recommended for adults and children
weighing
more than 30kg.
Patients with renal impairment
No dosage adjustments are required in patients with renal
insufficiency.
Older people
No dosage adjustments are required in older people.
Method of administration
Oral use. The tablet may be taken without regard to mealtime.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Roletra 10 mg Tablets should be administered with