Bilastine Teva 10 mg orodispersible tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Bilastina Teva 10 mg orodispersible tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because 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, consult your doctor or pharmacist.
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This medicine has been prescribed for you or your child only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you or your child 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 the 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
- How to store Bilastina Teva
- Contents of the pack and other information
1. What Bilastina Teva is and what it is used for
Bilastina Teva contains bilastine as the active substance, which is an antihistamine.
Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, 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 10 mg orodispersible tablets are indicated for children from 6 years of age with a minimum body weight of 20 kg, as well as for 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 or your child have moderate or severe renal or hepatic impairment, low levels of potassium, magnesium, or calcium in the blood, if you have or have had heart rhythm problems or a very low heart rate, 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 some forms of heart disease, or if you or your child are taking other medicines (see “Other medicines and Bilastina Teva”).
Children
Do not administer this medicine to children under 6 years of age weighing less than 20 kg, as sufficient data are not available.
Other medicines and Bilastina Teva
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines.
Some medicines should not be taken together, and others may require dose adjustments when used concomitantly.
Always inform your doctor or pharmacist if you or your child are taking or receiving any of the following medicines in addition to Bilastina Teva:
- Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol)
- Erythromycin (an antibiotic)
- Diltiazem (to treat chest pain or pressure—angina pectoris)
- Cyclosporine (to reduce the activity of the immune system, thereby 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 tablets must not be taken with food or with grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:
- Take or administer the tablet and wait one hour before your child eats or drinks fruit juice, or
- if you or your child have eaten food or drunk fruit juice, wait two hours before taking the orodispersible tablet.
Bilastine, at the recommended adult dose (20 mg), does not increase the drowsiness caused by alcohol.
Pregnancy, breastfeeding, and fertility
There are no data or the data are extremely limited on the use of bilastine in pregnant or 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 demonstrated that bilastine 20 mg does not impair driving performance in adults.
However, individual patient responses to the medicine may vary.
Therefore, assess how this medicine affects you or your child before driving, operating machinery, or riding a bicycle.
Bilastina Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; hence, it is essentially “sodium-free”.
3. How to take Bilastina Teva
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use in adults and adolescents aged 12 years and older
The recommended dose in adults, including elderly patients, and adolescents aged 12 years and older, is 20 mg (two 10 mg tablets) once daily.
Use in children
The recommended dose in children aged 6 to 11 years with a minimum body weight of 20 kg is one 10 mg tablet once daily. 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.
- Please place the tablet in your mouth or in your child's 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 administering it to your child. 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 taken one hour before or two hours after eating any food or drinking fruit juice. See section 2, “Taking Bilastina Teva with food, drinks and alcohol”.
Since the duration of treatment depends on the underlying condition affecting you or your child, your doctor will determine how long you should take Bilastina Teva.
If you take more Bilastina Teva than you should
If you or your child 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 patient information leaflet with you.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 administer the daily dose to your child on time, give it as soon as you remember on the same day. Then, administer the next dose the following day at the usual time as directed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you stop treatment with 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 may cause adverse effects, although not everyone experiences them.
If you or your child 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 administering this medicine and seek immediate medical attention.
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
- Diarrhea
- Nausea (feeling of wanting to vomit)
- Swelling of the lips
- Eczema
- Urticaria (hives)
- Fatigue
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
- Tiredness
- Increased appetite
- Irregular heartbeat
- Weight gain
- Nausea (feeling of wanting to vomit)
- Anxiety
- Dry nose or nasal discomfort
- Abdominal pain
- Diarrhea
- Gastritis (inflammation of the stomach wall)
- Vertigo (a sensation of dizziness or spinning)
- Feeling of weakness
- Thirst
- Dyspnea (difficulty breathing)
- Dry mouth
- Indigestion
- Itching
- Cold sore (herpes labialis)
- Fever
- Tinnitus (ringing in the ears)
- Difficulty sleeping
- Blood tests showing changes in kidney function
- Increase in blood fats
Frequency not known: cannot be estimated from available data
- Palpitations (awareness of heartbeats)
- Tachycardia (rapid heartbeat)
- Vomiting
Reporting of adverse effects
If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if these are possible adverse effects 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after CAD/EXP. 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 unused medicines and their packaging at the Punto Sigre collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you 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 10 mg of bilastina.
- The other components are:
Manitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 “Bilastina Teva contains sodium”), magnesium aluminium metasilicate, sucralose, strawberry flavour, magnesium stearate, anhydrous colloidal silica.
Appearance of the medicinal product and contents of the pack
Bilastina Teva 10 mg orodispersible tablets EFG are round, biconvex tablets, approximately 7.5 mm in size, white to off-white in colour, smooth to mottled, marked with "10" on one side and plain on the other.
The tablets are packed in blisters of 10, 20, 30 or 50 tablets.
Only some pack sizes may be marketed.
Marketing Authorisation 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 Authorisation 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 Medical Devices (AEMPS) (http://www.aemps.gob.es/)