QUALIDOFTA <2 mg/ml Глазные капли, раствор
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Инструкция по применению QUALIDOFTA
Содержание инструкции
QUALIDOFTA 2 MG/ML COLLIRIO, SOLUZIONE IN CONTENITORE MONODOSE
Brimonidine tartrate
Generic medicine
Read this leaflet carefully before you start using 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 they have the same symptoms as you, as it may 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 QUALIDOFTA is and what it is used for
- 2. What you need to know before you use QUALIDOFTA
- 3. How to use QUALIDOFTA
- 4. Possible side effects
- 5. How to store QUALIDOFTA
- 6. Contents of the pack and other information
1. What is QUALIDOFTA and what is it used for
The active ingredient in QUALIDOFTA is brimonidine tartrate, which works by reducing the
pressure inside the eyeball.
QUALIDOFTA is used to reduce pressure inside the eye in patients suffering from
open-angle glaucoma (an eye disease, characterized by the presence of chronic and progressive
damage to the optic nerve) and ocular hypertension (elevated pressure of the fluid
of the eye).
It can be used alone, when beta-blocker eye drops are contraindicated, or in combination
with another eye drop, when a single medicine is not sufficient to reduce the increase in
pressure.
2. What you need to know before using QUALIDOFTA
Do not use QUALIDOFTA
- If you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6).
- If you are taking medicines that are monoamine oxidase inhibitors (MAOIs) or certain antidepressants (such as tricyclic antidepressants or mianserin). Tell your doctor if you are taking any antidepressant medicines (see “Other medicines and QUALIDOFTA”).
- If you are breastfeeding (see “Pregnancy and breastfeeding”).
FI Qualidofta 2112-00 Pag. 1of 6
- In newborns and children (under 2 years of age).
Warnings and precautions
Talk to your doctor or pharmacist before using QUALIDOFTA
- If you suffer from or have suffered from depression, reduced blood flow to the brain and reduced mental ability (cerebral insufficiency), reduced blood flow in the coronary arteries (coronary insufficiency), a disease that affects blood vessels (Raynaud's disease), an inflammatory disease of small and medium-caliber arteries and veins (thromboangiitis obliterans), or excessive reduction of blood pressure when moving from a sitting or lying position to an upright position (orthostatic hypotension).
- If you have or have had kidney or liver problems in the past.
Children and adolescents
Do not use QUALIDOFTA in newborns and children up to two years of age (see “Do not use
QUALIDOFTA”). QUALIDOFTA is not recommended for children aged between 2 and 17 years
(see “Do not use QUALIDOFTA”)
Other medicines and QUALIDOFTA
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:
QUALIDOFTA”).
medicines that have a depressive effect on the central nervous system (sedatives,
opioids, barbiturates, anesthetics).
medicines that can affect the metabolism of catecholamines, such as
chlorpromazine, methylphenidate and reserpine.
medicines to lower blood pressure (antihypertensives) or increase heart function (cardiac glycosides).
medicines that act on the same receptor as QUALIDOFTA, for example isoprenaline and
prazosin.
Tell your doctor if you consume alcohol.
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 QUALIDOFTA if you are breastfeeding.
Driving and using machines
QUALIDOFTA can cause drowsiness or fatigue. QUALIDOFTA can cause blurred vision or
visual disturbances. This effect may seem worse at night or in conditions of
reduced lighting.
If you experience any of these symptoms, do not drive vehicles or use machinery until the symptoms
disappear.
FI Qualidofta 2112-00 Pag. 2of 6
3. How to use QUALIDOFTA
Use this medicine following the instructions of your doctor exactly. If you have any doubts,
consult your doctor or pharmacist.
Adults
The recommended dose is one drop twice a day in the affected eye(s), at intervals of
approximately 12 hours.
Children under 17 years of age
QUALIDOFTA should not be administered to children under 2 years of age.
The use of QUALIDOFTA is not recommended in children (from 2 years up to 17 years of age).
Instructions for use
QUALIDOFTA is an eye drop. If you are using this medicine with another eye drop, wait 5-15
minutes before applying the second eye drop.
Wash your hands thoroughly before administering the eye drop.
When administering the eye drop, make sure that the tip of the single-dose container does not
touch the eye or the surrounding areas.
Apply the eye drop as follows:
- 1. Separate a single-dose container from the strip.
- 2. Open it by rotating the cap on itself.
- 3. Apply 1 drop into the conjunctival sac. After application, while keeping your eye closed, press your finger on the corner of the closed eye (the part where the eye meets the nose) and hold for one minute.
- 4. Dispose of the single-dose container and any remaining contents.
To avoid contamination of the eye or the eye drop, the tip of the single-dose container must not
come into contact with any surfaces.
If you use more Qualidofta 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 QUALIDOFTA (see “Possible side effects”).
Adults who have accidentally ingested QUALIDOFTA have experienced a
lowering of blood pressure, which in some patients was followed by an increase
in blood pressure.
FI Qualidofta 2112-00 Page 3of 6
Children
Serious adverse effects have been reported in children who have accidentally ingested
QUALIDOFTA. Symptoms included decreased consciousness, drowsiness, decreased
muscle tone, decreased heart rate, low body temperature,
pallor and difficulty breathing, absence of breathing (apnea). If this occurs, contact
your doctor immediately.
Adults and Children
If the contents of QUALIDOFTA have been accidentally ingested or if you have used more
QUALIDOFTA than you should, contact your doctor immediately.
If you forget to use QUALIDOFTA
If you forget to use QUALIDOFTA, apply the forgotten dose as soon as you remember.
However, if you do not remember the forgotten dose until shortly before the time scheduled for the
next dose, skip the forgotten dose and continue with the next dose at the scheduled time.
Do not use a double dose to make up for a missed dose. If you have any doubts,
ask your doctor or pharmacist.
If you stop using QUALIDOFTA
For it to work correctly, QUALIDOFTA must be taken every day. Do not stop
using QUALIDOFTA until your doctor considers it appropriate.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, QUALIDOFTA can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
- Eye irritation (red eye, burning, stinging sensation, feeling of a foreign body in the eye, itching, small white spots on the clear layer covering the surface of the eye). Blurred vision. Allergic inflammation of the eyelids, allergic inflammation of the conjunctiva, allergic reaction of the eye.
- Headache. Drowsiness.
- Fatigue
- Dry mouth
Common (may affect up to 1 in 10 people):
- Local irritation (redness and swelling of the eyelid, inflammation of the eyelid margin, swelling of the membrane covering the eyeball, discharge, pain and tearing). Sensitivity to light. Erosion and discoloration of the surface of the eye. Dry eye. Clearing of the clear layer covering the surface of the eye. Abnormal vision. Inflammation of the membrane covering the surface of the eye (conjunctivitis).
- Dizziness
- General weakness.
- Symptoms involving the stomach and intestines. Alteration of taste.
FI Qualidofta 2112-00 Pag. 4di 6
- Upper respiratory tract symptoms.
Uncommon (may affect up to 1 in 100 people):
- General allergic reactions
- Palpitations or changes in heart rate (including increased or decreased heart rate)
- Depression
- Dry nose
Rare (may affect up to 1 in 1000) :
- Shortness of breath (dyspnea)
Very rare (may affect up to 1 in 10000:
- Fainting
- High blood pressure (hypertension)
- Low blood pressure (hypotension)
- Insomnia
- Inflammation of the iris of the eye (iritis)
- Reduction in pupil size (miosis)
Side effects with unknown frequency (frequency cannot be estimated from available data):
- Skin reactions including redness, facial swelling, itching, rash and dilation of blood vessels.
- Itching of the eyelids
- Inflammation of the anterior segments of the eye (iridocyclitis)
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 QUALIDOFTA
Keep QUALIDOFTA out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the label of the
vial and on the pack after Exp.
The expiry date refers to the last day of that month.
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
FI Qualidofta 2112-00 Page 5of 6
What QUALIDOFTA contains
- The active ingredient is brimonidine tartrate. One (1) ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
- The other ingredients are: 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 QUALIDOFTA and contents of the pack
Qualidofta is an eye drop in a clear solution tending towards green-yellow contained in
single-dose containers in LDPE of 0.5 ml closed in laminated aluminum sachets containing each 10
single-dose containers. Each single-dose container contains 0.35 ml of medicinal product.
QUALIDOFTA single-dose is available in packs of 60 vials.
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)
Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany
FI Qualidofta 2112-00 Page 6of 6
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- Страна регистрации
- Форма выпускаEye drops, solution, <2 mg/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 QUALIDOFTAФорма выпуска: Eye drops, solution, 2,5 MLДействующее вещество: БримонидинПроизводитель: ABBVIE S.R.L.Отпускается по рецептуФорма 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 рецепту
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Аналог QUALIDOFTA в Испания
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Часто задаваемые вопросы
QUALIDOFTA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество QUALIDOFTA — Бримонидин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
QUALIDOFTA производится компанией FIDIA FARMACEUTICI S.P.A.. 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 QUALIDOFTA 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 QUALIDOFTA 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 ALPAGAN, BRIMOFREE, BRIMOFTAL. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
