Loratadine 10mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Loratadine

متاح من:

Ranbaxy (UK

ATC رمز:

R06AX13

INN (الاسم الدولي):

Loratadine

جرعة:

10mg

الشكل الصيدلاني:

Tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 03040100; GTIN: 5015525162817

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORATADINE 10 MG TABLETS
(loratadine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Loratadine Tablets are and what they are used for
2.
What you need to know before you take Loratadine Tablets
3.
How to take Loratadine Tablets
4.
Possible side effects
5.
How to store Loratadine Tablets
6.
Contents of the pack and other information
1.
WHAT LORATADINE TABLETS ARE AND WHAT THEY ARE USED FOR
Loratadine belongs to the class of medicines called anti-histamines,
which are used to treat
various allergic conditions.
Loratadine tablets are used to relieve symptoms associated with
seasonal allergic rhinitis (hay
fever) and perennial allergic rhinitis (year round allergy symptoms).
Symptoms of these conditions
can include sneezing, runny nose, nasal itching, in addition to
burning, itching and watering of the
eyes.
Loratadine tablets are also used to relieve symptoms of chronic
idiopathic urticaria (skin rash
consisting of hives and wheals).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORATADINE TABLETS
DO NOT TAKE LORATADINE TABLETS:_ _

if you are allergic to loratadine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist, or nurse before taking Loratadine
tablets if:

you have severe liver problems

you are due to have any skin tests for allergies. Do not take
Loratadine Tablets for two days
before having these tests. This is because it may affect the test
results.
If any of t

خصائص المنتج

OBJECT 1
LORATADINE 10 MG TABLETS
Summary of Product Characteristics Updated 17-Jan-2018 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Loratadine 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
Loratadine 10mg Tablets is indicated for the symptomatic treatment of
allergic rhinitis and chronic
idiopathic urticaria.
4.2 Posology and method of administration
Adults and children over 12 years of age: 10mg once daily (one tablet
once daily). The tablet may be
taken without regard to mealtime.
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 30 kg or less: The 10mg strength tablet is not appropriate
in children with a body weight less
than 30kg.
Efficacy and safety of Loratadine 10 mg Tablets in children under 2
years of age has not been established.
The use is therefore not recommended in these patients.
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, and for children weighing 30kg or
less, 5mg every other day is
recommended.
No dosage adjustments are required in older people or in patients with
renal insufficiency.
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
Loratadine 10 mg Tablets should be administered with caution in
patients with severe liver impairment
(see section 4.2).
The administration of Loratadine 10 mg Tablets should be discon