ALLERTEC EFFECT

Patient Information Leaflet

ALLERTEC EFFECT, 20 mg, tablets
Bilastinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of Contents

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

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

Allertec Effect contains the active substance bilastin, which has antihistamine properties. Allertec Effect is used as an antiallergic agent to relieve symptoms affecting the nose, eyes, and skin.
Allertec Effect is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis and conjunctivitis, as well as urticaria.
Allertec Effect is used in adults and adolescents aged 12 years and older to relieve symptoms of hay fever (runny nose, nasal congestion, sneezing, itching, red and watery eyes) and other forms of allergic rhinitis and allergic conjunctivitis (swelling, itching, red and watery eyes). The medicine may also be used to treat itchy skin rashes (wheals or urticaria). Bilastin prevents the formation of wheals and skin redness for 24 hours after a single dose, thereby improving sleep quality and quality of life.
Without medical consultation, this medicine should not be used for longer than 10 days.
If symptoms do not improve after 3 days, contact your doctor.

2. Important information before using Allertec Effect

When not to use Allertec Effect

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

Warnings and precautions
Before taking Allertec Effect, consult a doctor or pharmacist if the patient has
moderate or severe kidney impairment, low blood levels of potassium, magnesium, or calcium,
if the patient has or has had heart rhythm disorders or very slow heartbeat,
if the patient is taking medicines that may affect heart rhythm, or if the patient has or has had
an abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram),
which may occur in certain types of heart disease. This is especially important if the patient
is taking other medicines (see "Allertec Effect and other medicines").
This medicine has no sedative properties.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.

Children
Allertec Effect must not be given to children under 12 years of age.

Allertec Effect and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
including medicines obtained without a prescription, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (used in coronary heart disease)
• cyclosporine (an immunosuppressant used in organ transplant patients or in autoimmune and allergic conditions 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
Do not take the medicine with food or grapefruit juice or other fruit juices, as this may reduce the effectiveness of Allertec Effect. To avoid reduced effectiveness, either:

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• wait two hours after a meal or drinking fruit juice before taking the tablet.

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor before using this medicine.
There are no data or limited data available on the use of bilastine during pregnancy, breastfeeding, or its effect on fertility.

Driving and operating machinery
It has been demonstrated that bilastine at a dose of 20 mg does not affect the ability to drive in adults.
However, individual responses to treatment may vary. Therefore, before driving or operating machinery,
patients should assess how this medicine affects them.

Allertec Effect contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to take Allertec Effect

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose for adults, including elderly individuals, and adolescents aged 12 years
and older is 1 tablet (20 mg) once daily.
Method of administration:

• Tablet for oral use.
• The tablet should be taken one hour before or two hours after any meal or fruit juice consumption (see section 2. "Allertec Effect with food, drink and alcohol").
• Swallow the tablet with a glass of water.

Without medical consultation, this medicine should not be used for longer than 10 days.
If symptoms do not improve after 3 days, consult a doctor.
Use in children
This medicine should not be given to children under 12 years of age.
Taking more Allertec Effect than recommended
If the patient or anyone else has taken too many Allertec Effect tablets, seek immediate
advice from a doctor or pharmacist or go to the nearest hospital emergency department.
Bring the medicine pack or leaflet with you.
If you forget to take Allertec Effect
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible, then return to taking the medicine at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will get them.
You should contact a doctor immediately and stop taking Allertec Effect if allergic reactions occur, the symptoms of which 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.

Other adverse reactions that may occur in adults and adolescents include:
Common (affects less than 1 in 10 people):

• headache
• drowsiness

Uncommon (affects less than 1 in 100 people):

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

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

• palpitations
• tachycardia (rapid heartbeat)
• vomiting

Adverse reactions that may occur in children include:
Common (affects less than 1 in 10 people):

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach ache (abdominal pain, epigastric pain)

Uncommon (affects less than 1 in 100 people):

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling sick)
• swelling of the lips
• rash
• urticaria (hives)
• fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Allertec Effect

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
No special storage precautions are required.
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

What Allertec Effect contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium aluminium silicate, magnesium stearate, and colloidal anhydrous 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 approximately 7 mm.
The pack contains 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation 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