Bilergia 20 mg. 20 tablets

1. What Bilergia is and what it is used for

Bilergia contains the active substance bilastine, which is an antihistamine. Bilergia is used to relieve the symptoms of hay fever (sneezing, itching, runny or blocked nose and red and watery eyes) and other forms of allergic rhinitis. It is also used to treat itchy skin rashes (hives or urticaria).

2. What you need to know before you take Bilergia

Do not take Bilergia

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 taking Bilergia if you suffer from moderate to severe kidney impairment and if you are also taking other medicines (see "Other medicines and Bilergia").

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 Bilergia

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 medicines:

ketoconazole (an antifungal medicine);

erythromycin (an antibiotic);

diltiazem (for the treatment of chest pain or tightness - angina);

ciclosporin (for reducing the activity of the immune system, thus avoiding rejection in transplants or reducing disease activity in autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis);

ritonavir (for the treatment of AIDS);

rifampicin (an antibiotic);

Food, drink and alcohol interactions

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

take the tablet and wait one hour before eating food or fruit juice or

if you have eaten food or fruit juice, you should wait 2 hours before taking the tablet.

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

Pregnancy, breast-feeding and fertility

There are no or limited data on the use of bilastine in pregnant women, during breast-feeding and on the effects on fertility.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

It has been shown that the administration of 20 mg bilastine does not affect the ability to drive in adults. However, each patient's response to the medicine may be different. Therefore, you should check how this medicine affects you before driving or using machines.

3. How to take Bilergia

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose for adults, including the elderly and adolescents aged 12 years and over, is 1 tablet (20 mg) per day.

The tablet is taken orally.

The tablet should be taken one hour before or two hours after food or fruit juice (see section 2, "Bilargia with food, drinks and alcohol").

The tablet is swallowed with a glass of water.

Regarding the duration of treatment, your doctor will determine the type of your illness and will determine how long you should take Bilergia.

Use in children

Other doses or pharmaceutical forms of this medicine may be more suitable for use in children aged 6 to 11 years.

Do not give this medicine to children under 6 years of age weighing less than 20 kg, as there is insufficient data.

If you take more Bilergia than you should

If you or someone else has taken too much Bilergia, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take this medicine pack or this leaflet with you.

If you forget to take Bilergia

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 return to your normal dosing schedule.

If you stop taking Bilergia

No effects are usually expected after stopping treatment with Bilergia.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and seek emergency medical help immediately if you experience symptoms of an allergic reaction: signs of which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or swelling and redness of the skin. If you notice any of these with

serious side effects, stop taking the medicine and seek emergency medical attention immediately.

Side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

headache

sleepiness

Uncommon: may affect up to 1 in 100 people, 1 to 10 people in 1,000

ECG abnormalities;

blood tests showing changes in liver function;

dizziness;

stomach pain;

tiredness;

increased appetite;

irregular heartbeat;

weight gain;

nausea (feeling sick);

anxiety;

dry or uncomfortable nose;

abdominal pain;

diarrhoea;

gastritis (inflammation of the stomach lining);

vertigo (feeling dizzy or spinning);

feeling weak;

thirst;

dyspnoea (difficulty breathing);

dry mouth;

indigestion;

itching;

cold sores;

fever;

tinnitus (ringing in the ears);

sleep disturbances;

blood tests showing changes in kidney function;

increased levels of lipids in the blood.

Not known; frequency cannot be estimated from the available data

palpitations (sensation of the heart beating);

tachycardia (rapid heartbeat);

vomiting.

Side effects that may occur in children

Common: may affect up to 1 in 10 people

rhinitis (irritation of the nose);

allergic conjunctivitis (inflammation of the eyes caused by an allergic reaction);

headache;

stomach pain (pain in the upper abdomen);

Uncommon: may affect up to 1 in 100 people

eye irritation;

dizziness;

loss of consciousness;

diarrhoea;

nausea (feeling sick);

swelling of the lips;

eczema;

urticaria (hives);

tiredness.

Reporting of side effects

If you get any side effects, tell your doctor or pharmacist.

By reporting side effects, you can help to provide more information on the safety of this medicine.

5. How to store Bilergia

Keep out of the reach and sight of children.

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

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Bilergia contains

The active substance is bilastine. Each tablet contains 20 mg bilastine (as monohydrate).

The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal anhydrous silica.

What Bilergia looks like and contents of the pack

Bilergia 20 mg tablets are white, round tablets.

Each pack contains 10, 20, 30, 40, 50 or 100 tablets.

Not all pack sizes may be marketed.