Loritin

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LORATADINE

Available from:

Actavis h.f. Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland

ATC code:

R06AX13

INN (International Name):

LORATADINE 10 mg

Pharmaceutical form:

TABLET

Composition:

LORATADINE 10 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-10-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LORITIN 10MG TABLETS
Loratadine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Loritin is and what it is used for
2.
What you need to know before you use Loritin
3.
How to use Loritin
4.
Possible side-effects
5.
How to store Loritin
6.
Contents of the pack and other information
1.
WHAT LORITIN IS AND WHAT IT IS USED FOR
Loritin contains the active substance loratadine and belongs to a
class of medicines known as
antihistamines. Antihistamines reduce allergic symptoms by preventing
the effects of a substance
called histamine which is produced in the body.
Loritin is an anti-allergic product which relieves allergic symptoms
such as a runny nose, itchy eyes,
severe itching (urticaria) and allergic rhinitis. Relief of these
symptoms lasts a full day so you can
resume your normal daily activities and sleep normally. Loritin is
used to relieve allergic symptoms,
sever itching and allergic rhinitis in adults, children over 12 years
of age and children 2 to 12 years of
age.
Please note that your doctor may have prescribed the medicinal product
for a different therapeutic
indication and/or at a different dosage that is stated in the package
leaflet. Always follow the doctor’s
prescription and the instructions on the pharmacy label.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LORITIN
DO NOT USE LORITIN:
-
if you are allergic (hypersensitive) to loratadine or to any of the
other ingredients of Loritin.
WARNINGS AND PRECAUTIONS

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Loritin 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 10 mg Loratadine
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Loritin is indicated for the symptomatic treatment of allergic
rhinitis and chronic idiopathic
urticaria.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children over 12 years of age _
10 mg once daily (one tablet once daily).
_Paediatric population _
Children 2 to 12 years of age are dosed by weight: Body weight more
than 30 kg: 10 mg once daily
(one tablet once daily).
Body weight 30 kg or less: 5 mg once daily (½ a tablet once daily).
The 10 mg strength tablet is not appropriate in children with a body
weight less than 30 kg.
The safety and efficacy of Loritin have not been established in
children below 2 years of age.
_Patients with hepatic impairment _
Patients with severe liver impairment should be administered a lower
initial dose because they may
have reduced clearance of loratadine. An initial dose of 10 mg every
other day is recommended for
adults and children weighing more than 30 kg, and for children
weighing 30 kg or less, 5 mg every
other day is recommended.
_Elderly patients and patients with renal impairment _
No dosage adjustments are required in the elderly or in patients with
renal insufficiency.
Method of administration
The tablet may be taken at any time during the day, without regard to
mealtime.
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4.3
CONTRA-INDICATIONS
Loritin is contraindicated in patients who are hypersensitive to the
active substance or to any of the
excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE.
_Hepatic impairment _
Loritin should be administered with caution in patients with severe
liver impairment (see 4.2).
_Galactose intolerance, Lapp lactase deficiency, glucose-galactose
malabsorption _
Since Loritin Tablets contain lactose, they are