Loratadine 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loratadine

Available from:

Actavis UK Ltd

ATC code:

R06AX13

INN (International Name):

Loratadine

Dosage:

10mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5012617020581

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Loratadine Tablets
10mg x 30’s (UK)
148x210 (Reel Fed)
50946881
Leaflet for Blisters
2771
R.Wrey
06/04/18
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DATE SENT:
DATE RECEIVED:
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ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
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2.
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6.
1.
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FMD info
NA (not a carton)

No
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Yes
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Details
LORATADINE 10MG 30 TABLETS PIL - UK
Black
Profile
BBBA1879
S.Anson
18.04.18
148 x 210
8pt
Actavis UK
n/a
n/a
1
Version 2
01.11.2017
LORATADINE 10MG TABLETS
_Continued over page_
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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 tablets belong to a group of medicines
called antihistamines.
Loratadine tablets are used to relieve:
• allergy symptoms such as runny and blocked
nose, sneezing, wa

Summary of Product characteristics

OBJECT 1
LORATADINE 10MG TABLETS
Summary of Product Characteristics Updated 31-Dec-2018 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
LORATADINE 10mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 10mg Loratadine.
Excipient with known effect:
Each tablet contains 75mg lactose monohydrate
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet.
White, or almost white 8mm round, flat tablets, with the letter
“L” on one side and a central division line
on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
Loratadine Tablets are 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. The tablet may be taken without regard to mealtime.
Children 2 to 12 years of age with:
Body weight more than 30 kg: 10 mg once daily.
Body weight 30 kg or less: T