ALYNE 20 mg Coated Tablet
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Инструкция по применению ALYNE
Содержание инструкции
Alyne 20 mg tablets
Generic medicine
Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even 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 you take 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 is Alyne and what is it used for
Alyne contains the active ingredient bilastine, which is an antihistamine. Alyne is used to relieve
the symptoms of hay fever (sneezing, itching, runny nose, stuffy nose and redness and
watering eyes) and other forms of allergic rhinitis. It can also be used for the treatment
of itchy skin rashes (urticaria).
2. What you need to know before you take Alyne
Do not take Alyne
If you are allergic to bilastine or 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
kidney impairment and are taking other medicines (see “Other medicines and Alyne”).
Children
This medicine should not be taken by children under 12 years of age.
Do notexceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Alyne
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
In particular, talk to your doctor if you are taking any of the following medicines:
- ketoconazole tablets (used to treat Cushing's syndrome, when the body produces an excess of cortisol);
- erythromycin (an antibiotic);
- diltiazem (for treating chest pain or tightness - angina pectoris);
- cyclosporine (to reduce the activity of the immune system in order to prevent rejection after transplantation or to reduce the activity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis);
- ritonavir (for treating HIV);
- rifampicin (an antibiotic).
Alyne with food, drinks and alcohol
The tablets must notbe taken with food or with grapefruit juice or other fruit juices, as this decreases the effect of bilastine. To avoid this happening, you can:
- take the tablet and wait one hour before consuming food or fruit juice;
- if you have consumed food or fruit juice, wait for 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 relating to the use of bilastine in pregnant women and during breastfeeding and data relating to
the effects of bilastine on fertility are limited or unavailable.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before taking this medicine. Ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
It has been shown that doses of 20 mg of bilastine do not affect the ability to drive in adults.
However, the response to the medicine by each patient may be different. Therefore, it is
important to check the effect of the medicine on yourself before driving or using
machinery.
Alyne contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.
3. How to take Alyne
Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults, including the elderly and adolescents aged 12 years and over, is 1
tablet (20 mg) per day.
- The tablet is for oral use.
- The tablet must be taken one hour before or two hours after you have taken food or fruit juice (see section 2, “Alyne with food, drinks and alcohol”).
- Swallow the tablet with a glass of water.
- The dividing line is present only to help you break the tablet if you have difficulty swallowing it whole.
The duration of treatment depends on the type, duration and course of your condition.
Alyne should not be used for more than 10 days without medical advice.
You should talk to a doctor if you do not feel better or if you feel worse after 3 days.
Use in children
Alyne 20 mg tablets should 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 from 6 to 11 years of age with a
body weight of at least 20 kg, ask your doctor or pharmacist.
Do not administer this medicine to children under 6 years of age with a body weight
less than 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 immediatelyyour
doctor or pharmacist or go to the nearest hospital emergency room. Remember to bring with
If you forget to take Alyne
Donot take a double dose to make up for a missed dose.
If you forget to take a dose, take it as soon as possible and then return to your regular dosing schedule.
If you have any doubts about the use of this medicine, ask 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, the signs of which can 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, 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 showing changes in liver function;
- dizziness;
- stomach pain;
- fatigue;
- increased appetite;
- irregular heartbeat;
- increased body weight;
- nausea (feeling unwell);
- anxiety;
- dryness or irritation of the nose;
- abdominal pain;
- diarrhoea;
- gastritis (inflammation of the stomach lining);
- vertigo (a sensation of spinning or whirling);
- 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 showing changes in kidney function;
- increased fats in the blood.
Frequency not known: cannot be estimated from the available data
- palpitations (feeling your heartbeat);
- 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 pain (pain in the abdomen/upper abdomen).
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, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting system at
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 Alyne
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after SCAD. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage precautions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Alyne contains
- The active ingredient is bilastine. Each tablet contains 20 mg of bilastine.
- The other ingredients 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.
Uncoated tablets of white to almost white colour, oval, biconvex, imprinted with ‘BN’ and ‘2’
separated by a score line on one side, and smooth on the other side.
The score line on the tablet is only to facilitate breaking and swallowing,
not to divide the tablet into equal doses.
Alyne 20 mg tablets is available in blister packs (transparent PVC-aluminium foil).
Packs:6, 7, 10, 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
- 21047 - Saronno (VA) Italy
Manufacturer
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 authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Bilastine Aurobindo 20 mg tabletten/comprimés/Tabletten
Germany: Bilastin Puren 20 mg Tabletten
Italy: Alyne
Poland: Bellix Allergy
Portugal: Bilastina Aurovitas
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- Страна регистрации
- Форма выпускаCoated tablet, 20 MG
- Код АТХR06AX29
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги ALYNEФорма выпуска: Coated tablet, 20 MGДействующее вещество: БиластинПроизводитель: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.Отпускается по рецептуФорма выпуска: Coated tablet, 20 mgДействующее вещество: БиластинПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается по рецепту
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Аналог ALYNE в Испания
Аналог ALYNE в Польша
Аналог ALYNE в Украина
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ALYNE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ALYNE — Биластин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ALYNE производится компанией AUROBINDO PHARMA (ITALIA) S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения ALYNE с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить ALYNE в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Биластин) включают AYRINAL, BILASTINA AUROBINDO, BILASTINA EG. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
