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Инструкция по применению ALPAGAN
Содержание инструкции
ALPHAGAN 0.2% p/v (2 mg/ml) eye drops, solution
brimonidine tartrate
Read this leaflet carefully before you start using 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 pass it on to others, even if they have the same symptoms as you.
- . If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What ALPHAGAN is and what it is used for
- 2. What you need to know before you use ALPHAGAN
- 3. How to use ALPHAGAN
- 4. Possible side effects
- 5. How to store ALPHAGAN
- 6. Contents of the pack and other information
1. What is ALPHAGAN and what is it used for
Alphagan is used to reduce the pressure inside the eye. The active ingredient in ALPHAGAN is brimonidine tartrate, which belongs to a group of medicines called alpha-2-adrenergic receptor agonists and works by reducing pressure within the eyeball. It can be used alone, when beta-blocker eye drops are contraindicated, or with another eye drop, when a single medication is not sufficient to reduce the increase in eye pressure in the treatment of open-angle glaucoma or ocular hypertension.
2. What you need to know before using ALPHAGAN
Do not use Alphagan
- If you are allergic (hypersensitive) to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6). If you are taking monoamine oxidase inhibitors (MAOIs) or other antidepressants. Tell your doctor if you are taking any antidepressant medicine.
- If you are breastfeeding.
- In newborns/children (from birth up to two years of age). Warnings and precautionsTalk to your doctor before using ALPHAGAN:
- If you suffer from or have suffered from depression, reduced mental ability, reduced blood flow to the brain, heart problems, reduced blood flow to the limbs or blood pressure disorders.
- If you have or have had kidney or liver problems in the past.
Children and Adolescents
The use of ALPHAGAN is not recommended in children aged between 2 and 12 years.
ALPHAGAN should usually not be used in adolescents aged between 12 and 17 years
because clinical studies have not been conducted in this age group.
Other medicines and ALPHAGAN
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Tell your doctor if you are taking any of the following medicines:
painkillers, sedatives, opioids, barbiturates or are a regular consumer of alcohol.
anaesthetics.
for treating a heart condition or for lowering blood pressure.
that can affect metabolism such as chlorpromazine, methylphenidate and reserpine.
that act on the same receptor as ALPHAGAN, for example isoprenaline and prazosin.
monoamine oxidase inhibitors (MAOIs) and other antidepressants.
medicines for any other condition, even if it is not related to your eye problems.
or if the dose of any of your current medicines has changed.
This may affect your treatment with ALPHAGAN.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine. Do not use
ALPHAGAN if you are pregnant unless your doctor considers it necessary.
Do not use ALPHAGAN if you are breastfeeding.
Driving and using machines
- ALPHAGAN can cause blurred or abnormal vision. This effect may be worse at night or in poor lighting conditions.
- In some patients ALPHAGAN can also cause drowsiness or fatigue.
- If you experience any of these symptoms, do not drive or use machines until the symptoms have disappeared.
ALPHAGAN contains Benzalkonium chloride
ALPHAGAN contains 0.25 mg of benzalkonium chloride in each 5 ml of solution, equivalent to 0.05
mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
a change in their colour. Remove your contact lenses before using this medicine and wait 15
minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the transparent outer layer of the eye). If you experience any
abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.
3. How to use ALPHAGAN
Always use ALPHAGAN exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
Adults
The recommended dosage is one drop twice a day in the affected eye(s), approximately
12 hours apart. Do not change the dosage or stop using ALPHAGAN without consulting your
doctor.
Children under 12 years
ALPHAGAN should not be administered to children under 2 years of age.
The use of ALPHAGAN is not recommended in children (from 2 years up to 12 years of age).
Instructions for use
ALPHAGAN is an eye drop. Always wash your hands before applying eye drops. Your prescription will
state how many drops to use for each dose. If you are using ALPHAGAN with another eye drop, wait
5-15 minutes before applying the second eye drop.
Apply the eye drop as follows:
- 1. Tilt your head back and look up.
- 2. Gently pull down your lower eyelid to form a small pocket.
- 3. Turn the bottle upside down and apply gentle pressure to release one drop of eye drops into your eye.
- 4. While keeping your eye closed, press your finger on the corner of your closed eye (the part where the eye meets the nose) and hold for one minute.
If the drop does not enter your eye, repeat the operation.
To avoid eye infections, the tip of the bottle must not touch the eye or come into contact with
other surfaces. Immediately after using the bottle, replace and tighten the cap.
If you use more ALPHAGAN than you should
Adults
In adults who have instilled more drops than prescribed, the reported adverse effects are
those already known with the use of ALPHAGAN.
Adults who have accidentally ingested ALPHAGAN have experienced a lowering of
blood pressure, which in some patients was followed by an increase in blood pressure.
Children
Serious adverse effects have been reported in children who have accidentally ingested
ALPHAGAN. Symptoms included drowsiness, instability, low body temperature, pallor, and
difficulty breathing. If this occurs, contact your doctor immediately.
Adults and Children
If ALPHAGAN has been accidentally ingested or if you have used more ALPHAGAN than you should,
contact your doctor immediately.
If you forget to use ALPHAGAN
If you forget to administer a dose, take it as soon as you remember. If it is already time
for your next dose, skip the missed dose and follow your normal dosing schedule.
If you stop using ALPHAGAN
For it to work correctly, ALPHAGAN must be taken every day. Do not stop using
ALPHAGAN until your doctor deems it appropriate.
If you have any doubts about using this product, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With ALPHAGAN, the following side effects can be observed at the ocular level.
Ocular disorders
Very common (may affect more than 1 in 10 people):
- Eye irritation (red eye, burning, stinging sensation, foreign body sensation in the eye, itching, follicles or white spots on the clear layer covering the surface of the eye)
- Blurred vision
- Allergic eye reaction
Common (may affect up to 1 in 10 people):
- Local irritation (inflammation and swelling of the eyelid, swelling of the clear layer covering the surface of the eye, sticky eyes, pain and tearing)
- Sensitivity to light
- Erosion and discoloration of the surface of the eye
- Dry eye
- Whitening of the clear layer covering the surface of the eye
- Abnormal vision
- Inflammation of the clear layer covering the surface of the eye
Very rare (may affect up to 1 in 10,000 people):
- Eye inflammation
- Reduction in pupil size
Side effects with unknown frequency (frequency cannot be estimated from available data):
- Itching of the eyelids
Body disorders
Very common (may affect more than 1 in 10 people):
- Headache
- Dry mouth
- Fatigue/drowsiness
Common (may affect up to 1 in 10 people):
- Dizziness
- Flu-like symptoms
- Symptoms involving the stomach and digestion
- Taste alteration
- General weakness
Uncommon (may affect up to 1 in 100 people):
- Depression
- Palpitations or changes in heartbeat
- Dry nose
- General allergic reactions
Rare (may affect up to 1 in 1,000 people):
- Shortness of breath
Very rare (may affect up to 1 in 10,000 people):
- Insomnia
- Fainting
- High blood pressure
- Low blood pressure
Side effects with unknown frequency (frequency cannot be estimated from available data):
- Skin reactions including redness, facial swelling, itching, rash and widening of blood vessels
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 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 ALPHAGAN
- Keep this medicine out of the reach and sight of children.
- Do not store above 25°C.
- Do not use this medicine if the safety seal of the bottle is broken before use.
- Do not use this medicine after the expiry date that is reported on the bottle label and on the box after Exp:. The expiry date refers to the last day of the month.
- Dispose of the bottle 28 days after first opening, even if some of thesolution remains.Do not dispose of any medicine in wastewater 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 ALPHAGAN contains
- The active substance is brimonidine tartrate. One ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
- The other ingredients are benzalkonium chloride as a preservative, polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water and sodium hydroxide or hydrochloric acid to adjust the pH.
Description of the appearance of ALPHAGAN and contents of the pack
ALPHAGAN is a clear, light green-yellow to slightly green-yellow solution eye drop contained in
a plastic bottle. Each bottle contains 2.5 ml, 5 ml or 10 ml of medicinal product.
ALPHAGAN is available in packs of 1, 3 or 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport, County Mayo, Ireland
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
| Austria | Alphagan 0.2% eye drops |
| Germany | o Alphagan 0.2% m/V (2mg/ml) eye drops |
| Belgium, Finland, Greece,Iceland, Luxembourg, Norway, Portugal | c Alphagan |
| Denmark, Ireland, Italy, Netherlands, Sweden, United Kingdom | a Alphagan 0.2% |
| France | ALPHAGAN 0.2% (2mg/ml), solution eye drops |
| Spain | m Alphagan 2 mg/ml eye solution |
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- Страна регистрации
- Форма выпускаEye drops, solution, 2,5 ML
- Код АТХS01EA05
- 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 ALPAGANФорма выпуска: Eye drops, solution in single-dose container, 2 MG/MLДействующее вещество: БримонидинПроизводитель: OMNIVISION ITALIA SRLОтпускается по рецептуФорма выпуска: Eye drops, solution, 2 MG/MLДействующее вещество: БримонидинПроизводитель: BRUSCHETTINI S.R.L.Отпускается по рецептуФорма выпуска: Eye drops, solution, 2 MG/MLДействующее вещество: БримонидинПроизводитель: MYLAN S.P.A.Отпускается по рецепту
Аналоги ALPAGAN в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог ALPAGAN в Польша
Аналог ALPAGAN в Украина
Аналог ALPAGAN в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
ALPAGAN требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество ALPAGAN — Бримонидин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
ALPAGAN производится компанией ABBVIE 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 ALPAGAN 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 ALPAGAN 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 (Бримонидин) включают BRIMOFREE, BRIMOFTAL, BRIMONIDINA MYLAN JENERIKS. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
