Bilastine Medreg

Package leaflet: Information for the patient

Bilastina Medreg 20 mg tablets

bila\stine
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Bilastina Medreg is and what it is used for
2. What you need to know before taking Bilastina Medreg
3. How to take Bilastina Medreg
4. Possible side effects
5. How to store Bilastina Medreg
6. Contents of the pack and other information

1. What Bilastina Medreg is and what it is used for

Bilastina Medreg contains the active substance bilastine, which is an antihistamine. Bilastina Medreg is used to relieve symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, and eye redness and watering) and other forms of allergic rhinitis. It can also be used for the treatment of itchy skin rashes (such as urticaria).

2. What you need to know before taking Bilastina Medreg

Do not take Bilastina Medreg
if you are allergic to bilastine or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bilastina Medreg if you have moderate or severe kidney impairment, low blood levels of potassium, magnesium or calcium, if you have or have had heart rhythm problems, if your heart rate is very low, if you are taking medicines that could affect your heart rhythm, if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on the electrocardiogram) which may occur in certain heart conditions and you are also taking other medicines (see "Other medicines and Bilastina Medreg").

Children
This medicine is not intended for children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Bilastina Medreg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
In particular, consult your doctor if you are taking any of the following medicines:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (used to treat chest pain or tightness – angina pectoris)
• Cyclosporine (used to reduce the activity of the immune system to prevent transplant rejection or to reduce the activity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (used to treat AIDS)
• Rifampicin (an antibiotic)

Bilastina Medreg with food, drinks and alcohol
The tablets must not be taken with food or grapefruit juice or other fruit juices, as this reduces the effect of bilastine. To avoid this, you may:

• take the tablet and wait one hour before consuming food or fruit juices;
• if you have consumed food or fruit juices, wait two hours before taking the tablet.
  Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Data on the use of bilastine in pregnant women and during breastfeeding, as well as data on the effects of bilastine on fertility, are limited or not available.

Driving and using machines
It has been demonstrated that doses of 20 mg of bilastine do not affect driving ability in adults.
However, individual patient response to the medicine may vary. Therefore, it is important to assess how the medicine affects you personally before driving or operating machinery.

Bilastina Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Bilastina Medreg

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults, including elderly patients and adolescents aged 12 years and older, is
1 tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after eating food or drinking fruit juices (see section 2, “Bilastina Medreg with food, drinks and alcohol”).
• Swallow the tablet with a glass of water.

Duration of treatment:
Regarding the duration of treatment, your doctor will assess your condition and decide how long you should take Bilastina Medreg.
Use in children
Other formulations of this medicine—bilastina 10 mg orodispersible tablets or
bilastina 2.5 mg/mL oral solution—may be more suitable for children aged 6 to 11 years weighing at least 20 kg. Please consult your doctor or pharmacist.
Bilastina must not be used in children under 6 years of age weighing less than 20 kg, as sufficient data are not available.
If you take more Bilastina Medreg than you should
If you or someone else has taken an excessive amount of Bilastina Medreg tablets, contact your
doctor or pharmacist immediately or go to the nearest hospital emergency department.
Remember to bring the package or the patient information leaflet of this medicine with you.
If you forget to take Bilastina Medreg
Do not take a double dose to make up for the missed dose.
If you forget to take a dose, take it as soon as possible and then continue with your regular dosing schedule.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice symptoms of an allergic reaction, which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin swelling and redness, stop taking the medicine and contact your doctor immediately.

Other side effects that may occur in adults and adolescents are the following:
Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• abnormal electrocardiogram (ECG)
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling of sickness)
• anxiety
• sensation of dryness or discomfort in the nose
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores (oral herpes)
• fever
• tinnitus (ringing in the ears)
• difficulty falling asleep
• blood tests showing changes in kidney function
• increased blood lipids.

Not known: frequency cannot be estimated from the available data

• palpitations (awareness of heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Side effects that may occur in children are the following:
Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain / upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling of sickness)
• swelling of the lips
• eczema
• urticaria
• fatigue

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bilastina Medreg

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the cardboard box and on the blister packs
after Scad. and EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bilastina Medreg contains

• The active substance is bilastina. Each tablet contains 20 mg of bilastina.
• The other components are: mannitol (E 421), microcrystalline cellulose, sodium starch glycolate, magnesium aluminium metasilicate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Bilastina Medreg and the contents of the pack
Bilastina Medreg are white to off-white, round biconvex tablets (7 mm in diameter).
Bilastina Medreg is available in blisters containing 10, 20, 30, 50 or 100 tablets, packed in cardboard cartons.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Bilastina Medreg
Poland: Bilastine Medreg
Czech Republic: Bilastine Medreg
Romania: Bilastină Gemax Pharma 20 mg tablets
Slovakia: Bilastine Medreg
Sweden: Bilastine Medreg