Bilastine Teva 20 mg orodispersible tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Bilastina Teva 20 mg orodispersible tablets EFG
Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Bilastina Teva is and what it is used for
- What you need to know before taking Bilastina Teva
- How to take Bilastina Teva
- Possible side effects
5 Storage of Bilastina Teva
- Contents of the pack and other information
1. What Bilastina Teva is and what it is used for
Bilastina Teva contains the active substance bilastine, which is an antihistamine.
Bilastine is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itching of the nose, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).
Bilastina Teva 20 mg orodispersible tablets are indicated for use in adults and adolescents.
2. What you need to know before taking Bilastina Teva
Do not take Bilastina Teva:
- if you or your child are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Bilastina Teva if you have moderate or severe renal impairment, low levels of potassium, magnesium, or calcium in the blood, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medicines that may affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease, or if you are taking other medicines (see “Other medicines and Bilastina Teva”).
Children
Do not administer this medicine to children under 12 years of age.
Other medicines and Bilastina Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
In particular, always inform your doctor if you are taking any of the following medicines:
- Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol)
- Erythromycin (an antibiotic)
- Diltiazem (to treat pain or pressure in the chest—angina pectoris)
- Cyclosporine (to reduce the activity of your immune system, thus preventing 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 Bilastina Teva with food, drinks, and alcohol
These orodispersible tablets should not be taken with food or grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:
- take the orodispersible tablet and wait one hour before eating or drinking fruit juices, or
- if you have eaten food or drunk fruit juice, wait two hours before taking the orodispersible tablet.
Bilastine, at the recommended dose in adults (20 mg), does not increase drowsiness caused by alcohol.
Pregnancy, breastfeeding, and fertility
There are no data or the data are very limited on the use of bilastine in pregnant and breastfeeding women and on its effects on fertility.
If you are pregnant or breastfeeding, or planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
It has been shown that bilastine 20 mg does not affect driving performance in adults.
However, individual patient response to the medicine may vary.
Therefore, check how this medicine affects you before driving or operating machinery.
Bilastina Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; that is, essentially “sodium-free”.
3. How to take Bilastina Teva
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose in adults, including elderly patients and adolescents aged 12 years and older, is 20 mg once daily.
Use in children
For children aged 6 to 11 years with a minimum body weight of 20 kg, there are other more suitable pharmaceutical forms of this medicine – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution.
Consult your doctor or pharmacist.
Do not administer this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.
- The tablet is for oral use.
- Place the tablet in your mouth. It will rapidly disperse in saliva and can then be swallowed easily.
- Alternatively, you may disperse the tablet in a teaspoon of water before taking it. Make sure no residue remains in the spoon.
- You should use water only for dispersion; do not use grapefruit juice or any other fruit juice.
- The tablet should be administered one hour before or two hours after eating any food or fruit juice. See section 2, “Bilastina Teva with food, drink and alcohol”.
As the duration of treatment will depend on the type of illness you have, your doctor will determine how long you should take Bilastina Teva.
If you take more Bilastina Teva than you should
If you, or anyone else, take more than the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the package leaflet with you.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Bilastina Teva
Do not take a double dose to make up for forgotten doses.
If you forget to take your daily dose on time, take it as soon as possible, and then return to your regular dosing schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you stop taking Bilastina Teva
In general, no effects are expected after discontinuation of treatment with Bilastina Teva.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you experience allergic reactions whose symptoms 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 this medicine and contact your doctor immediately.
Adverse effects that may occur in adults and adolescents:
Common: may affect up to 1 in 10 people
- headache
- drowsiness
Uncommon: may affect up to 1 in 100 people
- electrocardiogram abnormalities
- blood tests showing changes in liver function
- dizziness
- stomach pain
- fatigue
- increased appetite
- irregular heartbeat
- weight gain
- nausea (feeling sick)
- anxiety
- dry nose or nasal discomfort
- abdominal pain
- diarrhoea
- gastritis (inflammation of the stomach lining)
- vertigo (a sensation of dizziness or spinning)
- feeling of weakness
- thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- cold sores (herpes labialis)
- fever
- tinnitus (ringing in the ears)
- difficulty sleeping
- blood tests showing changes in kidney function
- increased blood fats
Frequency not known: cannot be estimated from available data
- palpitations (awareness of heartbeats)
- tachycardia (rapid heartbeat)
- vomiting
Other adverse effects that may occur in children:
Common: may affect up to 1 in 10 people
- rhinitis (nasal irritation)
- allergic conjunctivitis (eye irritation)
- headache
- stomach pain (abdominal pain/upper abdominal pain)
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)
- fatigue
Reporting of adverse effects
If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilastina Teva
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP/CAD. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilastina Teva
- The active substance is bilastina.
Each tablet contains 20 mg of bilastina.
- The other components are:
Manitol, microcrystalline cellulose, sodium croscarmellose (see section 2 “Bilastina Teva contains sodium”), magnesium aluminium silicate, sucralose, strawberry flavour, magnesium stearate, colloidal anhydrous silica.
Nature of the product and contents of the container
Bilastina Teva 10 mg orodispersible tablets EFG are oval-shaped tablets of approximately 10.3 x 5.5 mm, white to off-white in colour, smooth to slightly mottled, biconvex, marked with "20" on one side and plain on the other.
The tablets are packed in blisters of 10, 20, 30 or 50 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Teva B.V.
Swensweg 5, 2031GA Haarlem
The Netherlands
Manufacturer responsible:
Saneca Pharmaceuticals a.s.
Nitrianska 100 920 27 Hlohovec
Slovak Republic
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11 Edificio Albatros B 1st floor
28108 Alcobendas – Madrid (Spain)
Date of the most recent revision of this package leaflet: September 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)