Alyne

Package leaflet: Information for the user

ALYNE 20 mg tablets

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

Contents of this leaflet:

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

1. What ALYNE is and what it is used for

ALYNE contains the active substance bilastine, which is an antihistamine. ALYNE is used to
relieve symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used for the treatment of itchy skin rashes (urticaria).

2. What you need to know before taking ALYNE

Do not take ALYNE
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 ALYNE if you have moderate or severe renal impairment, if you have low levels of potassium, magnesium or calcium in the blood, if you suffer or have suffered from heart rhythm problems, if your heart rate is very low, if you are taking medicines that may affect heart rhythm, if you have or have had a specific heart rhythm disorder (known as QTc interval prolongation on electrocardiogram), which may occur in certain types of heart disease and you are taking other medicines (see "Other medicines and ALYNE").

Children
This medicine must not be taken by children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and ALYNE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
In particular, consult your doctor if you are taking any of the following medicines:

• ketoconazole tablets (used to treat Cushing's syndrome, a condition in which the body produces excessive cortisol);
• 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 HIV);
• rifampicin (an antibiotic).

ALYNE with food, beverages and alcohol
The tablets must not be taken with food or with 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 juice;
• 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
Data on the use of bilastine in pregnant or breastfeeding women, and data on the effects of bilastine on fertility, are unavailable or limited.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. Consult your doctor or pharmacist before taking any medicine.

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

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

3. How to take ALYNE

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adults, including the elderly, and adolescents aged 12 years and older, is 1 tablet (20 mg) daily.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after eating food or drinking fruit juice (see section 2, “ALYNE with food, drinks and alcohol”).
• Swallow the tablet with a glass of water.
• The break line is provided only to help you split the tablet if you have difficulty swallowing it whole.

The duration of treatment depends on the type, duration and course of your symptoms.
ALYNE must not be used for more than 10 days without medical advice.
You should speak to a doctor if you do not feel better or if you feel worse after 3 days.

Use in children
ALYNE 20 mg tablets must not be used in children under 12 years of age.
Other pharmaceutical forms of this medicine—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution—may be more suitable for children aged 6 to 11 years with a body weight of at least 20 kg. Please consult your doctor or pharmacist.
Do not administer this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.

If you take more ALYNE than you should
If you or someone else has taken an excessive amount of ALYNE, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the package or the package leaflet of this medicine with you.

If you forget to take ALYNE
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 further 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 gets them.
If you experience 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:
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 indicating changes in liver function;
• dizziness;
• stomach pain;
• fatigue;
• increased appetite;
• irregular heartbeat;
• increased body weight;
• nausea (feeling unwell);
• anxiety;
• nasal dryness or irritation;
• abdominal pain;
• diarrhoea;
• gastritis (inflammation of the stomach lining);
• vertigo (a sensation of dizziness or spinning);
• feeling weak;
• thirst;
• dyspnoea (difficulty breathing);
• dry mouth;
• indigestion;
• itching;
• cold sores (oral herpes);
• fever;
• tinnitus (ringing in the ears);
• difficulty falling asleep;
• blood tests indicating changes in kidney function;
• increased blood lipids.

Frequency not known: cannot be estimated from the available data

• palpitations (awareness of heart beat);
• tachycardia (fast heartbeat);
• vomiting.

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

• rhinitis (nasal irritation);
• allergic conjunctivitis (allergic inflammation of the conjunctiva);
• headache;
• stomach ache (abdominal pain/upper abdominal pain).

Uncommon: may affect up to 1 in 100 people

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

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

5. How to store ALYNE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 ALYNE contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other components are: microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate.

Description of the appearance of ALYNE and contents of the pack
Tablets.
White to almost white, oval, biconvex, film-coated tablets, with 'BN' and '2' engraved on one side separated by a breakline, and smooth on the other side.
The breakline on the tablet is intended only to facilitate breaking and ease swallowing, and not to divide the tablet into equal doses.
ALYNE 20 mg tablets are available in blister packs (transparent PVC-aluminium foil).
Pack sizes: 6, 7, 10, 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Bilastin Puren 20 mg Tabletten
Italy: ALYNE
Poland: Bellix Allergy
Portugal: Bilastina Aurovitas