Bilamax Flas 20 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Bilamax Flas 20 mg orodispersible tablets EFG
bilastine
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, 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 effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Bilamax Flas is and what it is used for
- What you need to know before taking Bilamax Flas
- How to take Bilamax Flas
- Possible side effects
- How to store Bilamax Flas
- Contents of the pack and other information
1. What Bilamax Flas is and what it is used for
Bilamax Flas contains bilastine as the active substance, which is an antihistamine.
This medicine is used to relieve the 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).
Bilamax Flas 20 mg tablets are indicated for use in adults and adolescents.
2. What you need to know before taking Bilamax Flas
Do not take Bilamax Flas
- if you 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 Bilamax Flas if you have moderate or severe renal impairment, low blood levels of potassium, magnesium or calcium, 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, or if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease and are also taking other medicines (see “Other medicines and Bilamax Flas”).
Children
Do not give this medicine to children under 12 years of age.
Other medicines and Bilamax Flas
Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.
In particular, please discuss with your doctor if you are taking any of the following medicines:
- Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
- Erythromycin (an antibiotic)
- Diltiazem (to treat chest pain or pressure – angina pectoris)
- Cyclosporine (to reduce the activity of your immune system, to prevent transplant rejection or to reduce disease activity in autoimmune and allergic disorders such as psoriasis, atopic dermatitis or rheumatoid arthritis)
- Ritonavir (to treat AIDS)
- Rifampicin (an antibiotic)
Taking Bilamax Flas with food, drinks and alcohol
These tablets should 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 the 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 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 very limited on the use of bilastine in pregnant and breastfeeding women and on its effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor 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 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.
Bilamax Flas contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.
3. How to take Bilamax Flas
Follow exactly the instructions for using this medicine as given 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, other more suitable pharmaceutical forms are available—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 orodispersible tablet is for oral use.
- Place the tablet in the mouth. It will rapidly disperse in saliva and can then be easily swallowed.
- Alternatively, you may disperse the tablet in a teaspoon of water before taking it. Make sure no sediment residue remains in the spoon.
- You should use water only for dispersion; do not use grapefruit juice or any other fruit juice.
- You should take the tablet one hour before or two hours after consuming food or fruit juice. See section 2, “Taking Bilamax Flas with food, drinks and alcohol”.
Regarding duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take Bilamax Flas.
If you take more Bilamax Flas than you should
If you, or anyone else, exceed the recommended dose of this medicine, inform your doctor or pharmacist 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 Bilamax Flas
Do not take a double dose to make up for forgotten doses.
If you forget to take your dose, take it as soon as possible and then continue with your regular dosing schedule.
If you stop taking Bilamax Flas
Generally, no effects occur after discontinuation of treatment with Bilamax Flas.
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 skin swelling and redness, stop using this medicine and seek immediate medical attention.
Adverse effects that may occur in adults and adolescents:
Frequent: 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
- diarrhea
- gastritis (inflammation of the stomach lining)
- 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
- increased blood lipids (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:
Frequent: 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 sick)
- swelling of the lips
- eczema
- urticaria (hives)
- fatigue
Reporting of adverse effects
If you experience 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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilamax Flas
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 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 Sigre Point located at the pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilamax Flas
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other components are mannitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 “Bilamax Flas contains sodium”), magnesium aluminium silicate, sucralose, strawberry flavour, magnesium stearate, colloidal anhydrous silica.
Appearance of the product and contents of the pack
Bilamax Flas 20 mg orodispersible tablets are white to off-white, smooth to slightly mottled, biconvex, oval tablets, approximately 10.3 x 5.5 mm in size, marked with “20” on one side and plain on the other, with a strawberry odour.
The tablets are packed in blisters of 10, 20, 30 or 50 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent review of this leaflet: January 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88682/P_88682.html
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