Ilaxten 20mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Bilastine

Dostupné z:

A. Menarini Farmaceutica Internazionale SRL

ATC kód:

R06AX29

INN (Medzinárodný Name):

Bilastine

Dávkovanie:

20mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 03040100; GTIN: 5038227000386

Príbalový leták

ARTWORK
PDF 1.5
DATE
30/11/2020
OPERATOR
RI016
DRAFT
01
MN_v.08a-2020
PLEASE ENSURE ARTWORK IS CHECKED WITH THIS SETTINGS: PRINT PRODUCTION
>> OUTPUT PREVIEW >> OVERPRINT PREVIEW TURNED ON AND COLOR PROFILE
SIMULATION SET TO “COATED FOGRA 39”
Product: PIL ILAXTEN 20MG
Part code:
109R9A
Country of destination: UK
Production site: MMLS L’AQUILA
Pantone colours:

BLACK
format/dimention: 003F 150X254 MM
Font Type: HELVETICA LT STD COND.
Font Size: 8 Spacing: 8
Pharmacode: XIIXIIXXX
BIANCA/FRONT
109R9A
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ILAXTEN 20 MG TABLETS
bilastine
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 ILAXTEN is and what it is used for
2. What you need to know before you take ILAXTEN
3. How to take ILAXTEN
4. Possible side effects
5. How to store ILAXTEN
6. Contents of the pack and other information
1. WHAT ILAXTEN IS AND WHAT IT IS USED FOR
ILAXTEN contains the active substance bilastine which is an
antihistamine. ILAXTEN is used to relieve the symptoms of
hayfever (sneezing, itchy, runny, blocked-up nose and red and watery
eyes) and other forms of allergic rhinitis. It may also
be used to treat itchy skin rashes (hives or urticaria).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ILAXTEN 20 MG TABLETS
DO NOT TAKE ILAXTEN
if you are allergic to bilastine or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Ilaxten if you have
moderate or severe renal impairment and in additio

Súhrn charakteristických

OBJECT 1
Ilaxten 20 mg tablets
Summary of Product Characteristics Updated 15-May-2021 | A. Menarini
Farmaceutica Internazionale SRL
•
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
Ilaxten 20 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 20 mg of bilastine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Oval biconvex scored white tablets (length 10 mm, width 5 mm).
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and
perennial) and urticaria.
Ilaxten is indicated in adults and adolescents (12 years of age and
over).
4.2 Posology and method of administration
Posology
Adults and adolescents (12 years of age and over)
20 mg bilastine (1 tablet) once daily for the relief of symptoms of
allergic rhinoconjunctivitis (SAR and
PAR) and urticaria.