Verpyllo

Package leaflet: information for the patient

VERPYLLO, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Contents of the leaflet

1. What VERPYLLO is and what it is 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 VERPYLLO is and what it is used for

VERPYLLO contains the active substance bilastin, which is an antihistamine.
VERPYLLO is used to relieve symptoms of allergic rhinitis (sneezing, itching, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (wheals or urticaria).
VERPYLLO is indicated for use in adults and adolescents aged 12 years and older.

2. Important information before using VERPYLLO

When not to use VERPYLLO

• 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 starting to use VERPYLLO, discuss this with a doctor or pharmacist if the patient has
moderate to severe kidney function impairment, low blood levels of potassium, magnesium or calcium,
if the patient has or has had heart rhythm disorders or very slow heart rate, 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 and additionally the patient is taking other medicines (see "VERPYLLO with other medicines").

Children
This medicine should not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.

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

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used to treat chest pain or angina – coronary artery disease)
• cyclosporine (a medicine that reduces immune system activity, used in patients to prevent transplant rejection or in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic)

VERPYLLO with food, drink and alcohol
Do not take the medicine with food or with grapefruit juice or other fruit juices, as this may reduce the effectiveness of bilastine. To avoid reduced effectiveness of the medicine:

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• wait two hours after eating 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
There are no data or limited data available on the use of bilastine during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

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

3. How to take VERPYLLO

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 patients, and adolescents aged 12 years and older, is 1 tablet (20 mg of bilastine) once daily.

• Tablet 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").
• Swallow the tablet with a glass of water.

Do not take VERPYLLO for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Use in children
This medicine must not be given to children under 12 years of age.
Other dosage forms and strengths of this medicine are available for children aged 6 to 11 years.
Bilastine must not be given to children under 6 years of age weighing less than 20 kg, due to insufficient data on use.
Taking more VERPYLLO than recommended
If more VERPYLLO has been taken than recommended, immediately contact a doctor or pharmacist or go to the nearest hospital emergency department. Bring the medicine pack or leaflet with you.
If you miss a dose of VERPYLLO
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.
Stopping VERPYLLO
Usually, no adverse effects occur when stopping VERPYLLO.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If the patient develops symptoms of an allergic reaction, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) skin swelling and redness,
the medicine should be discontinued immediately and medical help sought without delay.

Adverse effects that may occur in adults and adolescents include:

Common: may affect fewer than 1 in 10 people

• Headache
• Drowsiness

Uncommon: may affect fewer than 1 in 100 people

• Abnormal ECG findings
• Blood test abnormalities indicating liver function disorders
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Heart rhythm disturbances
• Weight gain
• Nausea
• Anxiety
• Dryness or discomfort in the nose
• Abdominal pain
• Diarrhoea
• Gastritis (inflammation of the stomach mucosa)
• Dizziness (dizziness or sensation of spinning)
• Weakness
• Increased thirst
• Dyspnoea (breathing difficulties)
• Dry mouth
• Indigestion
• Itching
• Cold sores
• Fever
• Tinnitus (ringing in the ears)
• Sleep disturbances
• Blood test abnormalities indicating kidney function disorders
• Increased blood lipid levels

Frequency not known: cannot be estimated from available data

• Palpitations (awareness of heart beating)
• Tachycardia (rapid heartbeat)
• Vomiting

Adverse effects that may occur in children include:

Common: may affect fewer than 1 in 10 people

• Nasopharyngitis (nasal mucosa irritation)
• Allergic conjunctivitis (allergy-related eye conjunctiva inflammation)
• Headache
• Stomach ache (abdominal pain, epigastric pain)

Uncommon: may affect fewer than 1 in 100 people

• Eye irritation
• Dizziness
• Loss of consciousness
• Diarrhoea
• Nausea
• Swelling of the lips
• Rash
• Urticaria
• Fatigue

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

5. How to store VERPYLLO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box
after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or in household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What VERPYLLO contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine (in the form of 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 Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Poland
Tel. +48 22 737 79 20

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

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany: Bilastin STADA 20 mg Tabletten
Belgium: Bilastine Eurogenerics 20 mg tabletten
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 tablete
Hungary: Semitin 20 mg tabletta
Italy: BILASTINA EG
Lithuania: Bilastine STADA 20 mg tabletės
Luxembourg: Bilastine Eurogenerics 20 mg comprimés
Latvia: Bilastine STADA 20 mg tabletes
Poland: VERPYLLO
Portugal: Bilastina STADA
Slovakia: Bilastin STADA 20 mg tablety