Инструкция по применению FUKITALMIK
Содержание инструкции
Fucithalmic 1% eye drops, solution
Fusidic acid
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 Fucithalmic is and what it is used for
- 2. What you need to know before you use Fucithalmic
- 3. How to use Fucithalmic
- 4. Possible side effects
- 5. How to store Fucithalmic
- 6. Contents of the pack and other information
1. What Fucithalmic is and what it is used for
Fucithalmic contains the active ingredient fusidic acid which belongs to the group of medicines called
ocular anti-infectives.
Fucithalmic is indicated for:
- the treatment of bacterial eye infections caused by microorganisms sensitive to it: conjunctivitis, blepharitis (inflammation of the eyelid), keratitis (inflammation of the cornea), dacryocystitis (inflammation of the tear sac), hordeolum (acute inflammation of the sebaceous glands at the base of the eyelashes);
- preoperative prophylaxis in ophthalmic surgery, and in conjunction with the removal of foreign bodies from the eye.
See your doctor if you do not feel better or if you feel worse.
2. What you need to know before using Fucithalmic
Do not use Fucithalmic
- if you are allergic to fusidic acid or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Fucithalmic.
- If bacterial resistance has been found following the use of fusidic acid.
- As with all antibiotics, prolonged or recurrent use of fusidic acid may increase the risk of developing bacterial resistance.
- You should not use contact lenses during treatment with Fucithalmic. Fusidic acid microcrystals may cause scratches to the contact lens or cornea. Contact lenses can be used 12 hours after the end of treatment.
Other medicines and Fucithalmic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interaction studies have been performed.
General interactions are unlikely as the general exposure following the application of
Fucithalmic eye drops is negligible.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Fucithalmic eye drops can be used during pregnancy.
Fucithalmic eye drops are not thought to cause effects during pregnancy, as
general exposure is negligible.
Breastfeeding
Fucithalmic eye drops can be used during breastfeeding.
Fusidic acid is not thought to cause effects on breastfeeding, as the general exposure of
breastfeeding women is negligible.
Driving and using machines
Fucithalmic eye drops administered topically does not alter or alters negligibly the ability to
drive vehicles or use machines.
However, you should be aware that Fucithalmic eye drops may still cause blurred
vision after application.
Fucithalmic contains benzalkonium chloride.This medicine contains 0.11 mg of benzalkonium chloride per
dose. Benzalkonium chloride can be absorbed by soft contact lenses and may lead to
a change in their colour. Contact lenses should not be used during treatment with
Fucithalmic, see the section "Warnings and precautions". Contact lenses can be used 12
hours after the end of treatment.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or corneal (the clear outer layer of the eye) disorders. If you experience any abnormal eye sensation, burning or pain after using this medicine, talk to your doctor.
3. How to use Fucithalmic
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Bacterial infections
In bacterial infections, the recommended dose is one drop of Fucithalmic to be instilled into the sac
conjunctival every 12 hours.
Treatment should be continued for another 2 days after recovery.
On the first day, Fucithalmic may be instilled more frequently, for example one drop every 4 hours.
Surgical prophylaxis
In surgical prophylaxis, the recommended dose is one drop of Fucithalmic every 12 hours, in the 24-48 hours
preceding the surgery.
If you take more Fucithalmic than you should
In case of ingestion/accidental intake of an excessive dose of Fucithalmic, immediately notify
your doctor or go to the nearest hospital.
If you have any doubts 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.
The most frequently reported side effects during treatment are various reactions at the application site such as pain, itching and irritation / discomfort to the eyes/around the eyes followed by
blurred vision. In some patients, the incidence of angioedema (swelling of the face,
lips, mouth, tongue or throat) has been reported.
Below are the side effects in order of frequency:
Common (may affect up to 1 in 10 people)
- Pain at the application site (including eye burning and stinging)
- Itching at the application site
- Discomfort / irritation at the application site
- Blurred vision (transient)
Uncommon (may affect up to 1 in 100 people)
- Hypersensitivity
- Angioedema
- Skin rash
- Eyelid edema
- Increased tearing
Rare (may affect up to 1 in 1,000 people)
- Exacerbated conjunctivitis
- Urticaria
The observed safety profile is similar in children and adults.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Fucithalmic
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 packaging after “Exp.”.
Do not store at a temperature above 25°C.
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 Fucithalmic contains
- The active ingredient is fusidic acid. 1 g of eye drops contains 10.17 mg of fusidic acid hemihydrate (equivalent to 10 mg of anhydrous fusidic acid).
- The other ingredients are: benzalkonium chloride, disodium edetate, mannitol, carbopol, water for injections.
Description of the appearance of Fucithalmic and contents of the pack
Eye drops, solution.
Pack of 5 g at a concentration of 1%.
Marketing Authorisation Holder
Amdipharm Limited
3 Burlington Road, Dublin 4- Temple Chambers
Ireland
Manufacturer
LEO Laboratories Ltd., 285 Cashel Road – DUBLIN 12 (Ireland).
- Страна регистрации
- Форма выпускаSustained-release eye drop, 1%
- Код АТХS01AA13
- 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 FUKITALMIKФорма выпуска: Powder for injectable solution, 50 MGДействующее вещество: ЦефуроксимПроизводитель: LABORATOIRES THEAОтпускается по рецептуФорма выпуска: Eye drops, solution, <3 mg/mlДействующее вещество: netilmicinПроизводитель: GENETIC S.P.A.Отпускается по рецептуФорма выпуска: Eye drops, solution, 15 MG/GДействующее вещество: АзитромицинПроизводитель: LABORATOIRES THEAОтпускается по рецепту
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Часто задаваемые вопросы
FUKITALMIK требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество FUKITALMIK — Фузидиевая кислота. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
FUKITALMIK производится компанией AMDIPHARM LTD. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Фузидиевая кислота) включают APROKAM, ARQUETA, ATSYTER. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















