Abisax 20 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the patient
Abisax 20 mg tablets EFG
bilastine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given 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 adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Abisax is and what it is used for
- What you need to know before taking Abisax
- How to take Abisax
- Possible side effects
- How to store Abisax
- Contents of the pack and other information
1. What Abisax is and what it is used for
This medicine contains the active substance bilastine, which is an antihistamine. Abisax is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, runny nose, 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).
2. What you need to know before starting to take Abisax
Do not take Abisax
- If you are allergic to bilastine or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Abisax 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 electrocardiogram), which may occur in certain types of heart disease and you are also taking other medicines (see "Other medicines and Abisax").
Children
Do not administer this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Abisax
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, please discuss with your doctor if you are taking any of the following medicines:
- Ketoconazole (a medicine for fungal infections)
- Erythromycin (an antibiotic)
- Diltiazem (used to treat angina)
- Cyclosporine (to reduce the activity of your immune system, to prevent transplant rejection or to reduce the activity of autoimmune diseases and allergic disorders such as psoriasis, atopic dermatitis or rheumatoid arthritis)
- Ritonavir (used to treat AIDS)
- Rifampicin (an antibiotic)
Taking Abisax with food, drinks and alcohol
These tablets must 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 tablet and wait one hour before eating or drinking fruit juice, or
- if you have eaten food or drunk fruit juice, wait two hours before taking the tablet.
Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.
Pregnancy, breastfeeding and fertility
There are no data or the data are limited regarding the use of bilastine in pregnant or breastfeeding women, or 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 using any medicine.
Driving and using machines
It has been shown that bilastine 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, check how this medicine affects you before driving or operating machinery.
Abisax contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".
3. How to take Abisax
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults, including elderly patients and adolescents aged 12 years and older, is 1 tablet (20 mg) daily.
- The tablet is for oral use.
- The tablet should be taken one hour before or two hours after eating any food or fruit juice (see section 2, "Taking Abisax with food, drinks and alcohol").
- Swallow the tablet with a glass of water.
- The score line is intended only to facilitate breaking the tablet if you have difficulty swallowing it whole.
Regarding the duration of treatment, your doctor will determine the type of condition you have and advise you on how long you should take bilastine.
Use in children
Other forms of this medicine, such as bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution, may be more suitable for children aged 6 to 11 years with a minimum body weight of 20 kg. 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.
If you take more Abisax than you should
If you, or anyone else, exceed 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 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 Abisax
Do not take a double dose to make up for a missed dose.
If you forget to take your 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.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you experience symptoms of an allergic reaction, which 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 taking this medicine immediately and seek medical attention right away.
Other adverse effects that may occur 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
- changes in electrocardiogram
- 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 instability)
- feeling of weakness
- thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- cold sores
- 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 heartbeat)
- tachycardia (rapid heartbeat)
- vomiting
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 ache (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 you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for 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 Abisax
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to 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 Abisax
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other components are: microcrystalline cellulose 102, sodium carboxymethylstarch type A (from potato), colloidal anhydrous silica, magnesium stearate.
Appearance of the product and contents of the pack
Abisax tablets are oval-shaped, white to off-white, and scored, marked with a "2" on one side of the score line and a "0" on the other side of the score line on one face, and smooth on the other face (length 10.1 mm and width 5.1 mm).
The score line is intended only to facilitate tablet splitting for easier swallowing and is not intended to divide the tablet into equal doses.
The tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters.
Each blister contains 10 tablets. The blisters are packed in cardboard boxes.
Pack sizes: 30 or 50 tablets.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany
Manufacturer responsible:
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
56617 Vysoké Mýto
Czech Republic
Further information on this medicinal product can be requested from the local representative of the Marketing Authorization Holder:
Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Country | Medicinal product name |
Czech Republic | Bilastine Glenmark |
Poland | CLABILLA |
Spain | Abisax 20 mg tablets EFG |
Date of the most recent review of this leaflet: June 2025.
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es