Allertec Effect

Leaflet attached to the packaging: patient information

ALLERTEC EFFECT, 20 mg, tablets

Bilastine

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Allertec Effect and what is it used for
• 2. Important information before using Allertec Effect
• 3. How to use Allertec Effect
• 4. Possible side effects
• 5. How to store Allertec Effect
• 6. Contents of the pack and other information

1. What is Allertec Effect and what is it used for

Allertec Effect contains the active substance bilastine, which has antihistamine properties. Allertec Effect is used for the symptomatic treatment of seasonal and perennial allergic rhinitis and conjunctivitis, as well as urticaria. Allertec Effect is indicated for use in adults and adolescents 12 years of age and older to relieve symptoms of hay fever (runny nose, stuffy nose, sneezing, itching, and red and watery eyes) and other forms of allergic rhinitis and conjunctivitis (swelling, itching, red and watery eyes). The medicine may also be used to treat itchy skin rashes (hives). Bilastine inhibits the formation of hives and skin redness for 24 hours after taking a single dose, which improves sleep quality and quality of life. Without consulting a doctor, the medicine should not be used for more than 10 days. If symptoms do not improve after 3 days, you should contact your doctor.

2. Important information before using Allertec Effect

When not to use Allertec Effect

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

Warnings and precautions

Before starting to use Allertec Effect, you should discuss it with your doctor or pharmacist if you have moderate or severe kidney impairment, low potassium, magnesium, or calcium levels in your blood, if you have or have had heart rhythm disorders or very slow heart rate, if you are taking medicines that may affect your heart rhythm, if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in certain types of heart disease, and also if you are taking other medicines (see "Allertec Effect and other medicines"). The medicine does not have sedative properties. You should notexceed the recommended dose. If symptoms persist, you should consult your doctor.

Children

This medicine should not be given to children under 12 years of age.

Allertec Effect and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take and those that are available without a prescription. In particular, you should inform your doctor about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (a medicine that reduces the activity of the immune system, used in patients after organ transplantation or in cases of autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic).

Allertec Effect with food, drink, and alcohol You should not take the medicine with food or grapefruit juice or other fruit juices

because it reduces the effect of Allertec Effect. To avoid reducing the effect of the medicine, you should:

• swallow the tablet and wait for 1 hour before eating or drinking fruit juice (see section 2. "Allertec Effect with food, drink, and alcohol").
• after eating or drinking fruit juice, wait 2 hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine. There are no data or limited data on the use of bilastine in pregnant or breastfeeding women, as well as on its effects on fertility.

Driving and using machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive vehicles in adults. However, the reaction to treatment may vary from person to person. Therefore, before starting to drive vehicles or operate machines, you should check how this medicine affects you.

Allertec Effect contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to use Allertec Effect

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist. The recommended dose for adults, including the elderly, and adolescents 12 years of age and older is 1 tablet(20 mg) per day. The method of administration is:

• Oral tablet.
• The tablet should be taken 1 hour before or 2 hours after any meal or fruit juice (see section 2. "Allertec Effect with food, drink, and alcohol").
• The tablet should be swallowed with a glass of water.

Without consulting a doctor, the medicine should not be used for more than 10 days. If symptoms do not improve after 3 days, you should contact your doctor.

Use in children

This medicine should not be given to children under 12 years of age.

Overdose of Allertec Effect

If you or anyone else has taken too many Allertec Effect tablets, you should immediatelycontact your doctor or pharmacist or go to the emergency department of the nearest hospital. You should take the packaging or leaflet with you.

Missed dose of Allertec Effect

You should nottake a double dose to make up for a missed dose. If you miss a dose, you should take the missed dose as soon as possible and then return to your regular dosing schedule. If you have any further questions about using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You should immediately contact your doctor and stop using Allertec Effect if you experience allergic reactions, the symptoms of 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.

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

Common(occurring in less than 1 in 10 people):

• headache
• drowsiness

Uncommon(occurring in less than 1 in 100 people):

• abnormal ECG
• blood test changes indicating liver function disorders
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disorders
• weight gain
• nausea (feeling sick)
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (feeling dizzy or spinning)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial rash
• fever
• ringing in the ears (tinnitus)
• sleep disorders
• blood test changes indicating kidney function disorders
• increased lipid levels in the blood

Frequency not known(cannot be estimated from available data):

• palpitations
• tachycardia (fast heart rate)
• vomiting

Side effects that may occur in children are:

Common(occurring in less than 1 in 10 people):

• rhinitis (irritation of the nose)
• allergic conjunctivitis (irritation of the eyes)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen)

Uncommon(occurring in less than 1 in 100 people):

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling sick)
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Allertec Effect

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Allertec Effect contains

• The active substance of the medicine is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium aluminometasilicate, magnesium stearate, anhydrous colloidal silica.

What Allertec Effect looks like and contents of the pack

Allertec Effect tablets are round, white or almost white, biconvex, with a diameter of about 7 mm. The pack contains 10 or 20 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. + 48 22 364 61 01

Manufacturer/Importer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia

Date of last revision of the leaflet: