ABISAX 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Abisax20 mg tablets EFG

bilastine

Read this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Abisax and what is it used for
2. What you need to know before you take Abisax
3. How to take Abisax
4. Possible side effects
5. Storage of Abisax
6. Contents of the pack and other information

1. What is Abisax and what is it 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, nasal discharge, nasal congestion, and red and itchy eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before you take Abisax

Do not take Abisax

• 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 taking Abisax if you have moderate or severe kidney problems, low blood potassium levels, low blood magnesium levels, low blood calcium levels, if you have or have had heart rhythm problems or if your heart rate is very slow, if you are taking medicines that may affect your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medicines (see "Other medicines and Abisax").

Children

Do not give this medicine to children under 12 years of age

Do notexceed the recommended dose. If symptoms persist, talk to your doctor.

Other medicines and Abisax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, please inform your doctor if you are taking any of the following medicines:

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (for angina pectoris)
• Cyclosporin (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for AIDS)
• Rifampicin (an antibiotic)

Taking Abisax with food, drinks, and alcohol

These tablets must notbe taken with food or with grapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

• take the tablet and wait for one hour before eating or taking fruit juices, or
• if you have eaten or taken fruit juice, wait for two hours before taking the tablet.

Bilastine, at the recommended dose (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant or breastfeeding women or on its effects on fertility.

If you are pregnant or breastfeeding, 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.

Driving and using machines

It has been shown that bilastine 20 mg does not affect performance during driving in adults. However, each patient's response to the medicine may be different. Therefore, check how this medicine affects you before driving or using machines.

Abisax contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Abisax

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose in adults, including elderly patients and adolescents from 12 years of age, is one tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after 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 only to facilitate breaking the tablet to make it easier to swallow.

Regarding the duration of treatment, your doctor will determine the type of disease you are suffering from and will tell you for 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 from 6 to 11 years of age with a minimum body weight of 20 kg. Ask your doctor or pharmacist.

Do not give this medicine to children under 6 years of age with a body weight below 20 kg, as there is not enough data available.

If you take more Abisax than you should

If you, or anyone else, have taken too much of this medicine, contact your doctor immediatelyor go to the nearest hospital emergency department. Please remember to take this medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount taken).

If you forget to take Abisax

Do nottake 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 continue with 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, whose signs 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.

Other side 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 or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling weak
• thirst
• shortness of breath
• 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 the available data

• palpitations (feeling your heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Side 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 sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https//: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abisax

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 pack after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are: microcrystalline cellulose 102, sodium carboxymethyl starch type A (potato), anhydrous colloidal silica, magnesium stearate.

Appearance of the product and pack contents

Abisax tablets are oval, 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 only to facilitate breaking the tablet to make it easier to swallow, but not 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 packaged in cardboard boxes.

Package sizes: 30 or 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:June 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es