Verpillo

Package Leaflet: Information for the Patient

VERPYLLO, 20 mg, tablets

Bilastine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is VERPYLLO and what is it used for

VERPYLLO contains the active substance bilastine, which has antihistamine properties.
VERPYLLO is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose, and red or itchy eyes) and other forms of allergic rhinitis.
The medicine may also be used to treat itchy skin rashes (hives or urticaria).
VERPYLLO is indicated for use in adults and adolescents 12 years of age and older.

2. Important information before taking VERPYLLO

When not to take VERPYLLO

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

Warnings and precautions

Before taking VERPYLLO, the patient should discuss it with their doctor or pharmacist if they have moderate to severe kidney problems and are taking other medicines (see "VERPYLLO with other medicines").

Children

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

Do notexceed the recommended dose. If symptoms persist, consult a doctor.

VERPYLLO with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
In particular, the patient should inform their doctor about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used to treat pain or tightness in the chest - coronary artery disease)
• cyclosporin (a medicine that reduces the activity of the immune system, used in patients to prevent transplant rejection or in cases of autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (in the treatment of AIDS)
• rifampicin (an antibiotic)

VERPYLLO with food, drink, and alcohol

The patient should not take the medicine with food or grapefruit juice, or other fruit juices, as this reduces the effect of bilastine. To avoid reducing the effect of the medicine, the patient should:

• swallow the tablet and wait one hour before eating or drinking fruit juice, or
• after eating or drinking fruit juice, wait two hours before taking the tablet. Bilastine at the recommended dose (20 mg) does not increase drowsiness caused by alcohol consumption.

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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

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 response to treatment may vary from patient to patient. Therefore, before driving or operating machinery, the patient should check how the medicine affects them.

3. How to take VERPYLLO

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents 12 years of age and older is one tablet (20 mg bilastine) per day.

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

The patient should not take VERPYLLO for more than 10 days without consulting their doctor.
If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Use in children

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

Other pharmaceutical forms and strengths of this medicine are intended for children aged 6 to 11 years.
Bilastine should not be given to children under 6 years of age or with a body weight below 20 kg, as there are insufficient data on its use.

Overdose of VERPYLLO

In case of overdose, the patient should immediatelycontact their doctor or pharmacist or go to the emergency department of the nearest hospital. They should take the medicine packaging or leaflet with them.

Missed dose of VERPYLLO

Do nottake a double dose to make up for a missed dose.
If a dose is missed, the patient should take the missed dose as soon as possible and then continue with their regular dose at the usual time.

Stopping VERPYLLO treatment

Usually, after stopping VERPYLLO treatment, no side effects occur.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, VERPYLLO can cause side effects, although not everybody gets them.
If the patient experiences symptoms of an allergic reaction, including difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin, they should stop taking the medicine and seek medical help immediately.

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

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

Frequency not known: cannot be estimated from the available data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting.

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store VERPYLLO

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What VERPYLLO contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine (as bilastine monohydrate).

• The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal silicon dioxide, anhydrous.

What VERPYLLO looks like and contents of the pack

VERPYLLO, 20 mg, tablets are round, white tablets.
Each pack contains 10 tablets.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

Manufacturer

NOUCOR HEALTH, S.A.
Av. Camí Reial 51-57
08184 Palau-solità i Plegamans
Barcelona
Spain

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

Germany:
Bilastin STADA 20 mg Tablets
Belgium:
Bilastine EG 20 mg tablets
Bulgaria:
Bilergia 20 mg tablets
Estonia:
Bilastine STADA
Greece:
Bilastine/Stada
Spain:
Bilastina STADA 20 mg comprimidos EFG
France:
BILASTINE EG 20 mg, comprimé
Croatia:
Selbixo 20 mg tablets
Hungary:
Bilastine Stada 20 mg tabletta
Italy:
BILASTINA EG
Lithuania:
Bilastine STADA 20 mg tabletės
Luxembourg:
Bilastine EG 20 mg comprimés
Latvia:
Bilastine STADA 20 mg tabletes
Poland:
VERPYLLO
Portugal:
Bilastina Ciclum
Slovakia:
Bilastin STADA 20 mg tablets

Date of last revision of the leaflet: