Drynol 20mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bilastine

Available from:

PCO Manufacturing Ltd.

ATC code:

R06AX; R06AX29

INN (International Name):

Bilastine

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use; bilastine

Authorization status:

Authorised

Authorization date:

2017-03-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DRYNOL
® 20 MG TABLETS
bilastine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU ONLY.

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 Drynol is and what it is used for
2.
What you need to know before you take Drynol
3.
How to take Drynol
4.
Possible side effects
5.
How to store Drynol
6.
Contents of the pack and other information
1.
WHAT DRYNOL IS AND WHAT IT IS USED FOR
Drynol contains the active substance bilastine which is an
antihistamine. Drynol 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 DRYNOL 20
MG TABLETS
DO NOT TAKE DRYNOL:
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 Drynol if you
have moderate or severe renal impairment and in addition
you are taking other medicines (see ”Other medicines and
Drynol”).
CHILDREN
DO NOT GIVE THIS MEDICINE TO CHILDREN UNDER 12 YEARS OF
AGE
DO NOT exceed the recommended dose. If symptoms persist,
consult your doctor.
OTHER MEDICINES AND DRYNOL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
In particular, please discuss with your doctor if you are taking
any of the following medicin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Drynol 20mg 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.
_Product imported from the Czech Republic:_
Oval biconvex scored white tablets.
The score line is only to facitlitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA0865/018/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0865/018/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
microcrystalline cellulose,
sodium starch glycolate type A (from potato starch),
colloidal anhydrous silica,
magnesium stearate.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters with 30 tablets in a carton.
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6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit