Bilastine 20 mg. 20 tablets

1. What Bilastine is and what it is used for

Bilastine contains the active substance bilastine, which is an antihistamine. Bilastine 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 can also be used to treat itchy skin rashes (hives or urticaria).

2. What you need to know before you take Bilastine

Do NOT take Bilastine

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 Bilastine if you have moderate or severe kidney damage, low levels of potassium, magnesium, calcium in your blood, if you have or have had heart rhythm problems or if your heart rate is very slow, if you are taking medicines that can affect your heart rhythm, if you have or have had a certain change in your heart rhythm (known as prolongation of the QTc interval on an electrocardiogram) which can occur in some forms of heart disease and are also taking other medicines (see “Other medicines and Bilastine Teva”).

Children

Do not give this medicine to children under 12 years of age.

Do not exceed the recommended dose. Consult your doctor if symptoms persist.

Other medicines and Bilastine

Please 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 angina)

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

ritonavir (for the treatment of AIDS)

rifampicin (an antibiotic)

Bilastine Teva with food, drink and alcohol

These tablets should not be taken with food or with 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 taking food or fruit juice or

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

At the recommended dose (20 mg), bilastine does not increase the drowsiness caused by alcohol.

Pregnancy, breast-feeding and fertility

There are no or limited amount of data on the use of bilastine in pregnant women and 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 before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Bilastine at a dose of 20 mg has been shown not to affect driving 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.

Bilastine Teva contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be essentially sodium-free.

3. How to take Bilastine Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 for oral use.

The tablet should be taken one hour before or two hours after food or fruit juice (see section 2 “Bilastine with food, drink and alcohol”).

Swallow the tablet with a glass of water.

Regarding the duration of treatment, your doctor will determine the type of disease you are suffering from and will determine how long you should take Bilastine Teva.

Use in children

Other formulations of this medicine - bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution - may be more suitable for children aged 6 to 11 years weighing at least 20 kg. Ask your doctor or pharmacist.

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

If you take more Bilastine than you should

If you or someone else has taken too much Bilastine Teva, 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 Bilastine

Do not take a double dose to make up for

the missed dose.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience symptoms of an allergic reaction, the 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, 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

Abnormal ECG recording

Blood tests showing changes in liver function

Dizziness

Stomach pain

Fatigue

Increased appetite

Irregular heartbeat

Weight gain

Nausea (feeling sick)

Anxiety

Dryness or discomfort in the nose

Stomach pain

Diarrhoea

Gastritis (inflammation of the stomach lining)

Vertigo (feeling dizzy or spinning)

Feeling weak

Thirst

Dyspnoea (difficulty breathing)

Dry mouthIndigestionItching

Cold sores

Fever

Tinnitus (ringing in the ears)

Difficulty sleeping

Blood tests showing changes in kidney function

increased blood fats

Not known (frequency cannot be estimated from the available data)

palpitations (feeling your heart beating)

tachycardia (rapid heartbeat)

vomiting

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

rhinitis (nasal irritation)

allergic conjunctivitis (eye irritation)

headache

stomach ache (abdominal/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

eye irritation

dizziness

fainting

diarrhoea

nausea (feeling sick)

swelling of the lips

eczema

urticaria (hives)

tiredness

Reporting side effects

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

5. How to store Bilastine Teva

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister 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 protect the environment.

6. Contents of the pack and other information

What Bilastine Teva contains

The active substance is bilastine. Each tablet contains 20 mg bilastine.

The other ingredients are: mannitol (E421), microcrystalline cellulose, sodium starch glycolate, magnesium aluminometasilicate, magnesium stearate, colloidal anhydrous silica.

What Bilastine Teva looks like and contents of the pack

Bilastine Teva tablets are round, white to off-white biconvex tablets with a diameter of approximately 7 mm.

The tablets are available in blisters of 10, 20, 30, 50 or 100 tablets or unit dose blisters of 10 x 1, 20 x 1 or 30 x 1 tablets.

Not all pack sizes may be marketed.