Plegik
ItalyTable of Contents
Patient Information Leaflet
PLEGIK 10 mg/ml eye drops, solution
Cyclopentolate hydrochloride
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What PLEGIK is and what it is used for
- What you need to know before using PLEGIK
- How to use PLEGIK
- Possible side effects
- How to store PLEGIK
- Contents of the pack and other information
1. What PLEGIK is and what it is used for
PLEGIK contains cyclopentolate hydrochloride, a substance belonging to a class of medicines called anticholinergics.
It is used to dilate the pupil of the eye (known as a mydriatic effect) and to paralyze the ciliary muscle of the eye, thereby preventing accommodation (known as a cycloplegic effect) in patients over 3 years of age.
Therapeutic indications:
Diagnostic use: Fundus examination and refraction tests.
Therapeutic use: As a mydriatic in the treatment of iritis, iridocyclitis, choroiditis, and uveitis.
Consult 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 to any of the other ingredients of this medicine (listed in section 6).
- if you have high pressure inside the eye or a condition called narrow-angle glaucoma.
- in children with organic brain syndromes (including congenital neurological developmental disorders predisposing to epileptic seizures).
PLEGIK must not be administered to children under 3 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using PLEGIK.
PLEGIK may be used only as an eye drop.
Consult your doctor if:
- you have heart problems, such as coronary or cardiac insufficiency;
- you have inflammation of the eye or a lesion of the ocular mucosa; in this case, avoid using PLEGIK;
- you wear contact lenses.
Before using this product, your doctor will check your intraocular pressure.
Caution is advised in elderly patients due to an increased risk of systemic adverse effects,
and in patients with paralytic ileus, benign prostatic hyperplasia, coronary or cardiac insufficiency,
ataxia, sensitivity to belladonna alkaloids, or hyperemia (due to the possibility of increased
systemic absorption).
Cyclopentolate hydrochloride increases the eye's sensitivity to light; therefore, wearing sunglasses is recommended to protect the eyes from ultraviolet radiation.
This eye drop solution must be administered with caution in patients with glaucoma.
Complete recovery of ocular accommodation may take up to 24 hours.
Children and adolescents
PLEGIK must not be given to patients under 3 years of age.
Caution is advised when using PLEGIK in children due to the risk of systemic effects and in cases of hyperemia, as systemic absorption may increase.
Children with spastic paralysis or mental disability are more likely to experience side effects from cyclopentolate hydrochloride.
Another risk, particularly in children, is the absorption of the compound through the nasal mucosa after being carried by tear secretion and drained through the nasolacrimal duct.
Therefore, the inner corner of the eye should be compressed for several minutes (2 to 3 minutes) after applying the eye drop 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 may antagonize the miotic and antiglaucoma effects of long-acting cholinergic ophthalmic antiglaucoma agents such as demecarium, echothiophate, and isoflurophate.
Cyclopentolate may interfere with belladonna alkaloids and with the antiglaucoma action of carbachol and pilocarpine.
In case of systemic absorption, the effects of cyclopentolate and other antimuscarinic agents may be enhanced when used concomitantly with other drugs having antimuscarinic properties, such as amantadine, certain antihistamines, phenothiazine antipsychotics (phenothiazines), and tricyclic antidepressants.
Monoamine oxidase inhibitors (MAOIs) may potentiate the antimuscarinic effects of cyclopentolate when it is systemically absorbed.
When using two ophthalmic medicines simultaneously, an interval of 5 to 10 minutes should be observed between administrations.
Interactions have been observed with cyclopentolate during concomitant use of this drug with other medicines having similar or opposing effects (called acetylcholinesterase inhibitors and cholinomimetics).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Since systemic absorption of the active substance may occur, PLEGIK should be used during pregnancy and breastfeeding only if the expected therapeutic benefits outweigh the potential risks.
The use of cyclopentolate during pregnancy and breastfeeding is not recommended.
Driving and use of machines
Your vision may be blurred for some time after using PLEGIK. Do not drive or operate machinery until your vision has cleared.
This medicine contains 0.1 mg of benzalkonium chloride per ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
3. How to use PLEGIK
Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Method of administration:
Open the dropper cap and apply slight pressure to dispense the liquid drop by drop at the recommended dose.
Like other eye drops, use Cicloplegicedol within 28 days after first opening the bottle.
Recommended dose:
Adults and elderly
Cycloplegic refraction
Instill 1 drop of PLEGIK eye drops, followed by a second drop five minutes later.
The examination should be performed approximately 30 to 40 minutes after the last administration.
Iritis, iridocyclitis, choroiditis, and uveitis
Instill one drop 3 or 4 times daily. The duration of treatment must be determined by the ophthalmologist based on the patient's clinical condition.
Use in children and adolescents
Cycloplegic refraction
Children aged 3 to 18 years: instill one drop of PLEGIK into the eye, 40 minutes before the examination. The dose may be repeated if necessary after 15 minutes.
Iritis, iridocyclitis, choroiditis, and uveitis
Dosage and duration of treatment must be determined by the ophthalmologist according to the patient's clinical condition.
Children should be monitored for 30 minutes after instillation of PLEGIK eye drops.
After using PLEGIK, press a finger against the inner corner of the eye near the nose (the lacrimal sac) for 1–2 minutes to prevent the product from spreading into the rest of the body.
If you have further questions about the use of this medicine, ask your doctor.
If a drop misses the eye, try again.
Instructions for use:
Each time you use PLEGIK:
- Wash your hands.
- Open the bottle by unscrewing the cap counterclockwise.
Take special care to avoid touching the tip of the dropper bottle to the eye, the skin around the eye, or your fingers.
- Tilt your head backward and turn the bottle upside down above the eye.
- Pull the lower eyelid downward to form a small pocket and look upward. Gently squeeze the bottle to release one drop of eye drops into the space between the lower eyelid and the eye.
- Close the eye briefly and press with a 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.
- Remove any excess solution from the skin around the eye.
- Repeat steps 3 to 6 for the other eye, if your doctor has instructed you to do so.
- Screw the cap back on tightly by turning it until it firmly touches the bottle.
If you use more PLEGIK than you should
This product may be dangerous if used for prolonged periods or in excessive doses.
If you accidentally take an excessive dose of PLEGIK, contact your doctor immediately or go to the nearest hospital, taking the PLEGIK packaging with you.
If you accidentally swallow the medicine, contact your doctor immediately or go to the nearest hospital, taking the PLEGIK packaging with you.
If you forget to use PLEGIK
Do not use a double dose to make up for the missed dose. Apply the next dose at the usual time. If you are concerned, consult your doctor or pharmacist.
From that point on, continue with your normal dosing schedule.
However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule.
If you stop treatment with PLEGIK
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you are using another eye drop at the same time, wait at least 5 minutes between using PLEGIK and the other medicine.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects not known (cannot be estimated from available data):
- Confusion, disorientation, hallucinations (seeing, hearing or perceiving non-existent things), irritability, agitation, behavioural changes, incoherent speech, mental disorders (psychosis);
- Disorders of the nervous system such as ataxia (loss of muscular coordination), tremor, seizures, dysarthria (difficulty speaking), dizziness, headache;
- Increased heart rate (tachycardia);
- Dry mouth, nausea, vomiting, stomach swelling, constipation, especially in children;
- Skin disorders (including facial skin redness, localised redness, rash, contact dermatitis, urticaria);
- Increased urine volume in the bladder due to inability to empty the bladder (urinary retention);
- Fever, thirst, unusual weakness or tiredness;
- Conjunctivitis (redness and discomfort in the eyes), blepharoconjunctivitis (inflammation of the eyelid associated with conjunctivitis);
- Allergic reaction manifesting as persistent irritation, swelling of the mouth, tongue, face and throat with breathing difficulty (angioedema), blurred vision and/or ocular hyperemia;
- Photosensitivity (sensitivity to light), transient sensation of eye burning upon application, visual disturbances, increased pressure inside the eye, inflammation of the cornea (punctate keratitis).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
- Store below 25°C.
- Once opened, the solutions may become contaminated, which could cause eye infections. For this reason, even if you have not used all 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 moisture.
- Since this is a medicine for exclusive ocular use, its dropper container must not be used for any other purpose.
- Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the pack and other information
What PLEGIK contains
The active substance is cyclopentolate hydrochloride 10 mg/ml.
The other components are boric acid, potassium chloride, edetate disodium, 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 contained in a sterile plastic bottle with a screw-cap dropper, 10 ml capacity filled with 5 ml.
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati, 40 – 20121 Milan, Italy
Manufacturer
Laboratorio Edol – Produtos Farmacêuticos, S.A.
Rua Quinta Do Salrego No 22-22a, Portela De Carnaxide, Carnaxide, 2790-144
Rua Casal Do Canas 6-6a, Carnaxide, 2790-204
Portugal