Patient Information Leaflet: Package Insert

Abisax20 mg EFG Tablets

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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains the active ingredient bilastine, which is an antihistamine. Abisax is used to relieve symptoms of allergic rhinoconjunctivitis (runny nose, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Do not take Abisax

• if you are allergic to bilastine or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Abisax if you have moderate or severe renal insufficiency and are also taking other medications (see "Other medications and Abisax").

Children

Do not administer this medication to children under 12 years of age

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Abisax

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Particularly, please consult with your doctor if you are taking any of the following medications:

Abisax and food, drinks, and alcohol

These tabletsmust not be taken withfood or with grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you can:

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

Pregnancy, breastfeeding, and fertility

There are no data, or these are limited, on the use of bilastine in pregnant women and during lactation, or on its effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been demonstrated that bilastine 20 mg does not affect performance during driving in adults. However, the response of each patient to the medication may be different. Therefore, check how this medication affects you before driving or operating machinery.

Abisax contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents 12 years of age or older, is 1 tablet (20 mg) per day.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience symptoms of an allergic reaction, which may include difficulty breathing, dizziness, fainting, 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 seek immediate medical attention.

Other side effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

• Headache
• Drowsiness

Rare: may affect up to 1 in 100 people

• Electrocardiogram alterations
• Blood tests showing changes in liver function
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Irregular heartbeat
• Weight gain
• Nausea (urge to vomit)
• Anxiety
• Runny nose or nasal discomfort
• Abdominal pain
• Diarrhea
• Gastritis (inflammation of the stomach lining)
• Dizziness (a sensation of dizziness or instability)
• Weakness
• Thirst
• Shortness of breath
• Dry mouth
• Indigestion
• Itching
• Herpes labial
• Fever
• Tinnitus (ringing in the ears)
• Difficulty sleeping
• Blood tests showing changes in kidney function
• Increased blood fats

Unknown frequency: cannot be estimated from available data

• Palpitations (feeling the heartbeat)
• Tachycardia (rapid heartbeat)
• Vomiting

Side effects that may appear in children:

Frequent: may affect up to 1 in 10 people

• Runny nose
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain/upper abdominal pain)

Rare: may affect up to 1 in 100 people

• Eye irritation
• Dizziness
• Loss of consciousness
• Diarrhea
• Nausea (urge to vomit)
• Swelling of the lips
• Eczema
• Urticaria (hives)
• Fatigue

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Abisax

• The active ingredient is bilastine. Each tablet contains 20 mg of bilastine.
• The other components are: microcrystalline cellulose 102, sodium carboxymethyl starch (type A, potato), anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the package

Abisax tablets are oval-shaped, white to off-white, scored, marked with a “2” on one side of the score and a “0” on the other side of the score on one face and smooth on the other face (length 10.1 mm and width 5.1 mm).

The score is only for facilitating the breaking of the tablet and making it easier to swallow, but not for dividing 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.

Packaging sizes: 30 or 50 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31, Gröbenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:May 2022.

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es