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This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.


A. Menarini Pharmaceuticals Ireland Ltd

2nd Floor, Castlecourt, Monkstown Farm, Monsktown, Glenageary, Co. Dublin, Ireland
Telephone: +353 1 284 6744
Fax: +353 1 284 6769
E-mail: ireland@menarini.ie
Medical Information Direct Line: 1800 283 045


Patient Information Leaflet last updated on medicines.ie: 28/03/2013
XPIL Drynol 20 mg tablets

PATIENT INFORMATION LEAFLET

DRYNOL 20 MG TABLETS

Bilastine

Read all of this leaflet carefully before you start taking this medicine.

  • 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. Do not pass it on to others. It may harm them even, if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What DRYNOL 20 mg tablets are and what they are used for
2. Before you take DRYNOL 20 mg tablets
3. How to take DRYNOL 20 mg tablets
4. Possible side effects
5. How to store DRYNOL 20 mg tablets
6. Further information

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1. WHAT DRYNOL 20 MG IS AND WHAT IT IS USED FOR

DRYNOL tablets contain bilastine which is a antihistamine. DRYNOL 20 mg tablets are used to relieve the symptoms of hayfever (sneezing, itchy, runny, blocked-up nose and red and watery eyes) and other forms of allergic rhinitis. They may also be used to treat itchy skin rashes (hives or urticaria).

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2. BEFORE YOU TAKE DRYNOL 20 MG TABLETS

Do not take DRYNOL 20 mg tablets if you:

are allergic (hypersensitive) to bilastine or any of the other ingredients of DRYNOL 20 mg tablets (see section 6, Further information).

Take special care with DRYNOL 20 mg tablets

If you have moderate or severe renal impairment and you are taking other medicines (see below).

Not suitable for use by children under 12 years of age

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, please discuss with your doctor if you are taking any of the following medicines:

  • Ketoconazole (an antifungal medicine)
  • Erythromycin (an antibiotic)
  • Diltiazem (to treat angina)
  • Cyclosporine (to reduce the activity of your immune system, thus avoiding transplant rejection or reducing disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
  • Ritonavir (to treat AIDS)
  • Rifampicin (an antibiotic)

Taking DRYNOL 20 mg tablets with food and drink

These tablets should not be taken with food or with grapefruit juice or other fruit juices, as this will decrease the effect of bilastine. To avoid this, you can:

  • take the tablet and wait for one hour before taking food or fruit juice or
  • if you have taken food or fruit juice, wait for two hours before taking the tablet.

Pregnancy and breast-feeding

Contact your doctor if you are pregnant, likely to become pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

A study performed to establish the effect of bilastine on the ability to drive demonstrated that treatment with 20 mg bilastine does not affect the driving performance. However very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Intake of alcohol

Bilastine, at the recommended dose (20 mg), does not increase the drowsiness produced by alcohol.

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3. HOW TO TAKE DRYNOL 20 MG TABLETS

Adults, including the elderly and adolescents aged 12 years and over

  • Take one tablet daily.
  • The tablet must be taken on an empty stomach, for example in the morning prior to breakfast. You must not eat for 1 hour after taking bilastine.
  • Swallow your tablet with a glass of water.
  • The score line is not intended to divide the tablet into equal doses. It can be used to break the tablet and make swallowing easier.

Regarding the duration of treatment, your physician will determine the type of disease you are suffering from and will determine for how long you should take DRYNOL.

If you take more DRYNOL 20 mg tablets than you should

If you, or anyone else, have taken too many DRYNOL 20 mg tablets, contact your doctor or pharmacist immediately.

If you forget to take DRYNOL 20 mg tablets

Do not take a double dose to make up for a forgotten dose.

If you forget to take your dose on time, take it as soon as possible, and then go back to your regular dosing schedule.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, DRYNOL 20 mg tablets can cause side effects, although not everybody gets them.

Side effects that may be experienced are:

Common: affects 1 to 10 users in 100

  • headache
  • drowsiness

Uncommon: affects 1 to 10 users in 1,000

  • abnormal ECG heart tracing
  • blood tests which show changes in the way the liver is working
  • dizziness
  • stomach pain
  • tiredness
  • increased appetite
  • irregular heartbeat
  • increased weight
  • nausea (the feeling of being sick)
  • anxiety
  • dry or uncomfortable nose
  • belly pain
  • diarrhoea
  • gastritis (inflammation of the stomach wall)
  • vertigo (a feeling of dizziness or spinning)
  • feeling of weakness
  • thirst
  • dyspnoea (difficulty in breathing )
  • dry mouth
  • indigestion
  • itching
  • cold sores (oral herpes)
  • fever
  • tinnitus (ringing in the ears)
  • difficulty in sleeping
  • blood tests which show changes in the way kidney is working
  • blood fats increased

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5. HOW TO STORE DRYNOL 20 MG

Keep out of the reach and sight of children.

Do not use DRYNOL after the expiry date which is stated on the carton and the blisters after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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6. FURTHER INFORMATION

What DRYNOL 20 mg tablets contains:

  • The active substance is bilastine. Each tablet contains 20 mg of bilastine.
  • The other ingredients are cellulose microcrystalline, sodium starch glycolate type A (derived from potato), colloidal anhydrous silica, magnesium stearate.

What DRYNOL 20 mg tablets looks like and contents of the pack:

DRYNOL 20 mg tablets are white, oval, biconvex and scored.

The tablets are supplied in blister packs of 10, 20 , 30, 40 or 50 tablets

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.
1 Avenue de La Gare
L-1611
Luxembourg

Manufacturer

A.Menarini Manufacturing Logistics and Services S.r.l.
Campo di Pile
L’Aquila
Italy

Local Representative in Ireland A. Menarini Pharmaceuticals Ireland Ltd.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Nasitop 20 mg Tabletten

Belgium: Bellozal 20 mg Tablet

Bulgaria: Fortecal 20 mg Таблетка

Cyprus: Bilaz 20 mg Δισκίο

Czech Republic: Xados 20 mg Tablety

Denmark: Revitelle 20 mg Tablet

Estonia: Opexa

Finland: Revitelle 20 mg Tabletti

France: Bilaska 20 mg Comprimé

Germany: Bilaxten 20 mg Tabletten

Greece: Bilaz 20 mg Δισκίο

Hungary: Lendin 20 mg tabletta

Iceland: Bilaxten 20 mg Tafla

Ireland: Drynol 20 mg tablets

Italy: Olisir 20 mg Compressa

Latvia: Opexa 20 mg Tabletes

Lithuania: Opexa 20 mg Tabletìs

Luxembourg: Bellozal 20 mg Tablet

Malta: Gosall 20 mg tablets

Norway: Zilas 20 mg Tablett

Poland: Clatra

Portugal: Lergonix 20 mg Comprimido

Romania: Borenar 20 mg Comprimate

Slovak Republic: Omarit 20 mg Tableta

Slovenia: Bilador 20 mg tablete

Spain: Ibis 20 mg Comprimido

Sweden: Bilaxten 20 mg Tablett

United Kingdom: Ilaxten 20 mg tablets

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This leaflet was last approved in 03/2013.



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Active Ingredients

 
   Bilastine