Patient leaflet - Bilastine 20 mg 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 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 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 using Bilastine if you have moderate or severe renal impairment, low blood levels of potassium, magnesium, calcium, if you have or had heart rhythm problems or if your heart rate is very low, if you are taking medicines that may affect the heart rhythm, if you have or had a certain abnormal pattern to your heart beat (known as prolongation of the QTc interval on the Electrocardiogram) which can occur in some forms of heart disease and in addition you are taking other medicines (see “Other medicines and Bilastine”).
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 Bilastine
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 (to treat pain or tightness in the chest area – angina pectoris)
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)
Bilastine with food, drink and alcohol
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. Bilastine, at the recommended dose (20 mg), does not increase the drowsiness produced by alcohol.
Pregnancy, breast-feeding and 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. Ask your doctor or pharmacist for advice before taking any medicine.
There are no or limited amount of data from the use of bilastine in pregnant women and during breast-feeding and on the effects on fertility.
Driving and using machines
It has been demonstrated that bilastine 20 mg does not affect the driving performance in adults. However, the response from each patient to the medicine may be different. Therefore, you should check how this medicine affects you, before driving or operating machinery.
Bilastine contains sodium:
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Bilastine
Always take this medicine exactly as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose in adults, including the elderly and adolescents aged 12 years and over, is 1 tablet (20 mg) a day.
- The tablet is for oral use.
- The tablet must be taken one hour before or two hours after intake of food or fruit juice (see section 2, Bilastine with food, drink and alcohol”).
- Swallow your tablet with a glass of water.
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 Bilastine.
Use in children
Other pharmaceutical forms of this medicine – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution - may be more suitable for children 6 to 11 years of age with a body weight of at least 20 kg. Ask your doctor or pharmacist.
Do not give bilastine to children under 6 years of age with a body weight below 20 kg since no sufficient data are available.
If you take more Bilastine than you should
If you, or anyone else, have taken too many Bilastine tablets, 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 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 medicine, 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 in breathing, dizziness, collapsing or losing consciousness, swelling of your face, lips, tongue or throat, and/or swelling and redness of the skin, stop taking the medicine and seek urgent medical advice straight away.
Side effects that may be experienced in adults and adolescents are:
Common: may affect up to 1 in 10 people
- headache
- drowsiness
Uncommon: may affect up to 1 in 100 people
- 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
Frequency not known: cannot be estimated from the available data
- palpitations (feeling your heart beat)
- tachycardia (fast heart beat)
- vomiting
Side effects that may be experienced in children are:
Common: may affect up to 1 in 10 people
- rhinitis (nasal irritation)
- allergic conjunctivitis (eye irritation)
- headache
- stomach pain (abdominal /upper abdominal pain)
Uncommon: may affect up to 1 in 100 people
- eye irritation
- dizziness
- loss of consciousness
- diarrhoea
- nausea (the feeling of being sick)
- lip swelling
- eczema
- urticaria (hives)
- fatigue
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Bilastine
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Bilastine contains
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other ingredients are: mannitol (E 421), cellulose microcrystalline, sodium starch glycolate, magnesium aluminometasilicate, magnesium stearate, silica colloidal anhydrous.
What Bilastine looks like and contents of the pack
Bilastine tablets are round, white to off-white biconvex, approx. 7 mm diameter. The tablets are supplied in PVC/PVdC-aluminium or OPA-Al-PVC/Al blisters of 10, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Axunio Pharma GmbH
Van-Der-Smissen-Strasse 1
22767 Hamburg, Germany
Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 01 Hlohovec
Slovakia