PLEGIK 10 mg /Ml Krople Do Oczu, Roztwór
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Treść ulotki
PLEGIK 10 mg/ml eye drops, solution
Cyclopentolate hydrochloride
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 PLEGIK is and what it is used for
- 2. What you need to know before you use PLEGIK
- 3. How to use PLEGIK
- 4. Possible side effects
- 5. How to store PLEGIK
- 6. Contents of the pack and other information
1. What is PLEGIK and what is it used for
PLEGIK contains cyclopentolate hydrochloride, a substance belonging to a category of
medicines called anticholinergics.
It is used for the dilation of the eye pupil (called mydriatic action) and to
block the ciliary muscle present in the eye making focusing impossible (called
cycloplegic action) in patients over 3 years of age.
Therapeutic indications:
Diagnostic use: Examination of the fundus and refraction tests.
Therapeutic use: As a mydriatic in the treatment of iritis, iridocyclitis, choroiditis and uveitis.
See your doctor if you do not feel better or if you feel worse.
2. What you need to know before using PLEGIK
Do not use PLEGIK
- if you are allergic to cyclopentolate or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from high pressure inside the eye or a condition called glaucoma (narrow-angle).
- in children with organic brain syndromes (including congenital neurological development disorders that predispose to seizures).
PLEGIK should not be administered to children under 3 years of age.
Warnings and precautions
Consult your doctor or pharmacist before using PLEGIK.
PLEGIK can be used onlyas an eye drop.
Consult your doctor if:
- you suffer from heart problems, such as coronary and cardiac insufficiency;
- you have an inflammation of the eye or a lesion of the eye mucosa, in which case avoid using PLEGIK
- you wear contact lenses.
Before using the product, your doctor will check your eye pressure.
Care must be taken in the elderly due to an increased risk of adverse systemic effects,
in patients with paralytic ileus, with benign prostatic hypertrophy, coronary or cardiac insufficiency,
ataxia, sensitivity to belladonna alkaloids and hyperemia (due to the possibility of increased
systemic absorption).
Cyclopentolate hydrochloride increases the sensitivity of the eye to light, so it is recommended to wear
sunglasses to protect your eyes from the action of ultraviolet radiation.
This eye drop solution should be administered with caution in patients with glaucoma.
Complete recovery of eye accommodation may take up to 24 hours.
Children and adolescents
PLEGIK should not be given to patients under 3 years of age.
Caution is advised when used in children given the risk of systemic effects and in cases of hyperemia
as increased systemic absorption may occur.
Children with spastic paralysis or mental disability are more likely to be affected
by the side effects of cyclopentolate hydrochloride.
Another risk, especially in children, is the absorption of compounds at the level of the nasal mucosa
after being carried away by tear secretion and drained through the tear duct.
Therefore, the corner of the eye should be compressed for a few minutes (2 to 3 minutes) after
application of the eye drops to the conjunctiva.
Other medicines and PLEGIK
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Cyclopentolate can antagonize the myotic and antiglaucoma action of ophthalmic agents
antiglaucoma cholinergic long-acting agents, such as: demecarium, ecothiopate and isofluorophosphate.
Cyclopentolate can interfere with belladonna alkaloids and with the antiglaucoma action
of carbacol and pilocarpine.
In case of systemic absorption, the effects of cyclopentolate and other antimuscarinic agents
may be increased with the concomitant use of other drugs with antimuscarinic properties,
such as amantadine, some antihistamines, phenothiazine antipsychotics (phenothiazines) and
tricyclic antidepressants.
Mono-amine oxidase inhibitors (MAOIs) may enhance the antimuscarinic effects of
cyclopentolate when absorbed systemically.
If using two ophthalmic medicines simultaneously, an interval of
5 to 10 minutes should be taken between administrations.
Interactions have been found with cyclopentolate during the simultaneous use of this
drug with other drugs having a similar or opposite effect (called acetylcholinesterase inhibitors and cholinergics).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Since there is systemic absorption of the active ingredient, pregnant and breastfeeding women
should use PLEGIK only when the expected therapeutic benefits outweigh the possible risks.
The use of cyclopentolate during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Vision may be blurred for a while after using PLEGIK. Do not drive or use
machinery until your vision returns to normal.
This medicine contains 0.1 mg of benzalkonium chloridein each ml of solution.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changing their color. Remove contact lenses before using this medicine and wait
15 minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes
or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation
in the eye, burning or pain after using this medicine, talk to your doctor.
3. How to use PLEGIK
Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Method of administration:
Open the cap of the dropper container, and exert a slight pressure on it to allow
the liquid to come out drop by drop at the recommended dose.
As with other eye drops, use Cicloplegicedol within 28 days after the first opening of the bottle.
The recommended dose is:
Adults and elderly
Cycloplegic refraction
Apply 1 drop of PLEGIK eye drops, followed by another drop, five minutes
later. The examination should be performed approximately 30/40 minutes after the last administration.
Iritis, iridocyclitis, choroiditis and uveitis
Apply one drop 3 or 4 times a day. The duration of treatment should be determined
by the ophthalmologist based on the patient's clinical condition.
Use in children and adolescents
Cycloplegic refraction
Children aged between 3 and 18 years: one drop of PLEGIK instilled into the eye, 40 minutes
before the examination. The dosage may be repeated, if necessary, after 15 minutes.
Iritis, iridocyclitis, choroiditis and uveitis
The dosage and duration of treatment must be determined by the ophthalmologist based on the
patient's clinical condition.
Children should be monitored for 30 minutes after the instillation of the PLEGIK eye drops.
After using PLEGIK, press a finger against the corner of the eye near the nose (called the lacrimal sac) for 1-2 minutes in order to prevent the product from spreading throughout the body.
If you have further questions on the use of this medicine, ask your doctor
If a drop misses the eye, try again.
Instructions for use:
Each time you use PLEGIK
- 1. Wash your hands.
- 2. Open the bottle by unscrewing the cap by rotating it counterclockwise.
Take particular care to avoid touching the tip of the dropper bottle to the
eye, the skin around the eye or your fingers.
- 3. Tilt your head back and turn the bottle upside down over your eye
- 4. Pull down the lower eyelid to form a small pocket and look up. Exert slight pressure on the bottle to drop a drop of eye drops into the space between the lower eyelid and the eye.
- 5. Close your eye for a moment and exert pressure with your finger on the inner corner of the eye for about 1-2 minutes. This helps prevent the eye drops from draining through the tear duct.
- 6. Remove any residual solution present on the skin around the eye.
- 7. Repeat steps 3 to 6 for the other eye, if your doctor has advised you to do so;
- 8. Screw the cap back on by rotating it until it touches the bottle firmly.
If you use more PLEGIK than you should
The product, if used for long periods and at excessive doses, may be dangerous.
In case of accidental ingestion of an excessive dose of PLEGIK, immediately notify your
doctor or go to the nearest hospital, bringing the PLEGIK packaging with you.
If you accidentally ingest the medicine,immediately notify your doctor or go to the
nearest hospital, bringing the PLEGIK packaging with you.
If you forget to use PLEGIK
Do not use a double dose to make up for a missed dose. Apply the next dose at the
normal time. If you are concerned, consult your doctor or pharmacist.
From then on, follow the normal dosing schedule.
However, if it is almost time for the next dose, skip the missed dose and follow the normal
dosing schedule.
If you stop treatment with PLEGIK
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you are using other eye drops at the same time, allow at least 5 minutes between the use of
PLEGIK and the other medicine.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Unknown side effects (frequency cannot be estimated from available data):
- Confusion, disorientation, hallucinations (seeing, hearing or perceiving things that are not there), irritability, agitation, behavioral changes, incoherent speech, mental disorders (psychosis);
- Nervous system disorders such as ataxia (loss of muscle coordination), tremor, convulsions, dysarthria (difficulty speaking), dizziness, headache;
- Fast heartbeat (tachycardia);
- Dry mouth, nausea, vomiting, increased stomach volume, constipation, especially in children;
- skin disorders (including redness of the face, local redness, rash, contact dermatitis, urticaria);
- increased amount of urine in the bladder caused by the inability to empty the bladder (urinary retention);
- Fever, thirst, unusual weakness or fatigue;
- conjunctivitis (redness and discomfort of the eyes), blepharoconjunctivitis (inflammation of the eyelid associated with conjunctivitis);
- allergic reaction manifesting with persistent irritation, swelling of the mouth, tongue, face and throat with difficulty breathing (angioedema), blurred vision and/or eye hyperemia;
- Photosensitivity (sensitivity to light), burning sensation in the eye (transient) upon application, visual disturbances, increased pressure inside the eye, inflammation of the cornea (punctate keratitis).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 PLEGIK
- 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 “Exp.”. The expiry date refers to the last day of that month.
- Store at a temperature not exceeding 25°C.
- Once opened, the solutions may become contaminated, which can cause eye infections. For this reason, even if you have not used all of the solution, you must discard the bottle 28 days after first opening.
- Store in the original packaging.
- Store the bottle in an upright position.
- Keep the container tightly closed in the outer packaging, protected from light and humidity
- As this is a medicine for exclusive ocular use, its dropper container must not be used for other purposes.
- 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.
- Keep the product in an upright position.
6. Contents of the pack and other information
What PLEGIK contains
The active ingredient is cyclopentolate hydrochloride 10 mg/ml
The other ingredients are boric acid, potassium chloride, disodium edetate, sodium carbonate,
sodium chloride, benzalkonium chloride, water for injections, hydrochloric acid solution or sodium
hydroxide solution (for pH adjustment).
Description of the appearance of PLEGIK and contents of the pack
PLEGIK is a clear and colourless eye drop solution packaged in a sterile plastic bottle with a
screw cap dropper, containing 10 ml filled up to 5 ml.
Marketing Authorisation Holder
DOC Generici S.r.l, Via Turati, 40 – 20121 Milano
Manufacturer
Laboratorio Edol – Produtos Farmacèuticos, S.A.
Av. 25 de Abril, 6-6a
2795-225 Linda-a-Velha
Portugal
Laboratorio Edol – Produtos Farmacèuticos, S.A.
Rua Quinta Do Salrego N 22-22a, Portela De Carnaxide, Carnaxide, 2790-144
Rua Casal Do Canas 6-6a, Carnaxide, 2790-204
Portugal
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- Kraj rejestracji
- Postać farmaceutycznaEye drops, solution, 10 MG/ML
- Kod ATCS01FA04
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki PLEJIKPostać farmaceutyczna: Eye drops, solution, 1%Substancja czynna: atropineProducent: FARMIGEA S.P.A.Wymaga receptyPostać farmaceutyczna: Injectable solution, 0.2 MG/ML+3.1 MG/ML+10 MG/MLSubstancja czynna: tropicamide, combinationsProducent: LABORATOIRES THEAWymaga receptyPostać farmaceutyczna: Ophthalmic insert, 0.28 MG/5.4 MGSubstancja czynna: tropicamide, combinationsProducent: LABORATOIRES THEAWymaga recepty
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Często zadawane pytania
PLEJIK wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w PLEJIK jest cyclopentolate. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
PLEJIK jest produkowany przez DOC GENERICI SRL. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie PLEJIK jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić PLEJIK w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (cyclopentolate) to m.in. ATROPINA FARMIJEA, MYDRANE, MYDRIASERT. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
