Cycloftthal

Package leaflet: Information for the user

Cykloftyal, 10 mg/ml, eye drops, solution
Cyclopentolate hydrochloride
It is important to read this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Cykloftyal is and what it is used for
2. Important information before using Cykloftyal
3. How to use Cykloftyal
4. Possible side effects
5. How to store Cykloftyal
6. Contents of the pack and other information

1. What Cykloftyal is and what it is used for

Cykloftyal eye drops contain the active substance cyclopentolate hydrochloride at a concentration of 10 mg/ml.
Cyclopentolate hydrochloride is a substance whose action causes paralysis of the iris muscles and ciliary muscle, resulting in pupillary dilation and paralysis of accommodation.

Cykloftyal is used:

• for fundus examination and refractometry in adults, adolescents, and children over 3 months of age
• as a mydriatic agent in the treatment of iritis, iridocyclitis, choroiditis, and uveitis in adults.

2. Important information before using Cykloftyal

When not to use Cykloftyal

• if the patient is allergic to cyclopentolate hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• in elderly patients (over 65 years of age);
• in children under 3 months of age;
• in cases of narrow-angle glaucoma, as use of the medicine may lead to an acute attack;
• in children with organic brain disorders (including congenital or developmental nervous system abnormalities or disorders, particularly those predisposing to epileptic seizures).

Warnings and precautions
Before starting treatment with Cykloftyal, consult your doctor or pharmacist.
Exercise caution in elderly patients due to increased risk of systemic adverse effects, in patients with paralytic ileus, benign prostatic hyperplasia, coronary insufficiency or myocardial damage, ataxia, hypersensitivity to belladonna alkaloids, or ocular congestion (due to the possibility of increased systemic absorption).
Cyclopentolate hydrochloride increases eye sensitivity to light; therefore, wearing sunglasses is recommended to protect the eyes from ultraviolet radiation.
Cykloftyal should be used with caution in patients with glaucoma.
Complete recovery of accommodation may take up to 24 hours.

Children and adolescents
Cykloftyal should not be used in newborns and children under 3 months of age due to the possible association between induced cycloplegia and the development of amblyopia, as well as due to the risk of systemic toxicity in newborns.
Caution is advised in children due to the risk of systemic effects and in cases of ocular surface congestion, which may lead to increased systemic absorption.
Children with spastic paralysis or intellectual disability are more susceptible to adverse effects of cyclopentolate hydrochloride.
Another risk, particularly in children, is absorption of cyclopentolate through the nasal mucosa, where it reaches via the nasolacrimal duct together with tear fluid. Therefore, to minimize systemic absorption of cyclopentolate hydrochloride, the lacrimal sacs (inner corner of the eye) should be compressed for approximately 2–3 minutes after instillation into the eye.

Cykloftyal and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Medicines whose effects may be altered by Cykloftyal or which may affect its action include, among others:

• long-acting cholinergic anti-glaucoma agents such as: demecarium, echothiophate, and isofluorphate,
• belladonna alkaloids,
• carbachol,
• pilocarpine,
• amantadine,
• certain antihistamines,
• antipsychotics (phenothiazines, tricyclic antidepressants),
• monoamine oxidase inhibitors (MAOIs).

When using two ophthalmic medicines simultaneously, an interval of 5 to 10 minutes should be maintained between administrations.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, planning pregnancy, or suspects she may be pregnant, she should consult her doctor or pharmacist before using this medicine.
Since the active substance is absorbed systemically, women who are pregnant or breastfeeding should use Cykloftyal only if the physician determines that the expected therapeutic benefits for the mother outweigh the potential risks to the child.
There are no animal study results assessing the risk of negative effects on embryonic and fetal development.

Driving and operating machinery
This medicine causes visual disturbances. Patients should not drive or operate machinery after using this medicine.

Cykloftyal contains boric acid and benzalkonium chloride
Cykloftyal contains benzalkonium chloride (0.1 mg per 1 ml, 0.003 mg per drop).
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, consult a doctor.
Cykloftyal contains boric acid (7.5 mg per 1 ml, 0.225 mg per drop).

3. How to use Cykloftyal

This medicine should always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.

Adults under 65 years of age

• Cycloplegia and ophthalmic examinations: instill one drop of Cykloftyal ophthalmic solution, and repeat after an interval of 5 minutes. The examination should be performed approximately 30–40 minutes after the last instillation.
• Iritis, iridocyclitis, choroiditis and chorioretinitis: instill one drop 3 to 4 times daily. The duration of treatment should be determined by the ophthalmologist based on clinical observation of the patient.

Adults over 65 years of age: Use contraindicated.

Children and adolescents
Children over 3 months of age and adolescents:

• Cycloplegia and ophthalmic examinations: instill one drop of Cykloftyal ophthalmic solution into the eye 40 minutes before the examination. If necessary, the dose may be repeated after 15 minutes.

Children and adolescents should be observed for 30 minutes after instillation of Cykloftyal eye drops.
Resistance to cycloplegia may occur in young children (over 3 months to 6 years of age), in patients with dark skin and/or dark irises; therefore, dose adjustment may be required in patients from these groups.

Children under 3 months of age:
Cykloftyal ophthalmic solution must not be used in newborns and infants under three months of age due to the possible association between induced cycloplegia and the development of amblyopia, as well as due to the risk of systemic toxicity in newborns.

Method of administration:
Always wash your hands and assume a comfortable position before using Cykloftyal.

Apply Cykloftyal as follows:

1. Open the bottle by unscrewing the cap by turning it counterclockwise;
2. Tilt your head backward and gently pull down the lower eyelid to create a small pocket between the eyelid and the eye;

3. Invert the bottle and gently squeeze to instill one drop into the eye as directed by your doctor. Do not touch the eye or eyelid with the dropper tip;

4. Close the eye, press gently with a finger on the inner corner of the eye near the nose, and maintain pressure for about 2–3 minutes with the eye closed. This prevents the medicine from draining into the body;
5. If your doctor has prescribed Cykloftyal for both eyes, repeat steps 2–4 for the other eye;
6. Immediately after use, close the bottle tightly with the cap. Do not overtighten.

Use of more than the recommended dose of Cykloftyal
In case of overdose, contact your doctor or nearest hospital immediately, and bring the Cykloftyal packaging with you.

Missed dose of Cykloftyal
If there is still a long time until the next scheduled dose, use Cykloftyal immediately and then continue treatment as directed.
However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule.
Do not use a double dose to make up for a missed dose.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Cykloftyal may cause adverse effects, although not everyone experiences them.
The frequency of occurrence is defined as follows: very common (≥1/10),
common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
very rare (<1/10,000), frequency not known (cannot be estimated from available data).

• Local effects requiring contact with a doctor if they persist:
  Eye disorders
  Frequency not known: light sensitivity (photophobia), eye burning (transient) after application; with repeated use, an allergic reaction may develop, manifested by persistent eye irritation, blurred vision, and eye redness; visual disturbances, increased intraocular pressure, eyelid and conjunctival inflammation, conjunctivitis, punctate keratitis.
• Systemic effects due to systemic absorption requiring contact with a doctor:

Frequency not known: confusion, hallucinations, unusual feeling of weakness or fatigue,
fever, facial flushing, increased thirst or dry mouth, abdominal bloating,
especially in children, skin rash, rapid heartbeat, urinary retention.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cykloftyal

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and bottle after "EXP":
The expiry date refers to the last day of the stated month.
Period of use after first opening the bottle: 28 days
Do not store above 25 ⁰C.
Do not freeze.
Keep the bottle tightly closed.
Store the bottle in the outer packaging to protect from light and moisture.
For ocular use only. The dropper must not be used for any other purpose.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Cykloftyal contains

• The active substance is cyclopentolate hydrochloride.
• The other ingredients are: boric acid, potassium chloride, disodium edetate, sodium carbonate, benzalkonium chloride, water for injections, sodium hydroxide 40% (for pH adjustment), hydrochloric acid 10% (for pH adjustment), sodium chloride.

What Cykloftyal looks like and contents of the pack
An opaque white LDPE bottle with an LDPE dropper and a white HDPE screw cap with a tamper-evident seal, packed in a cardboard box.
Each bottle contains 5 ml of solution.
Pack size: 1 x 5 ml.
The solution is clear and colourless.

Marketing Authorisation Holder
Verco S.A.
Skwer kard. S. Wyszyńskiego 5, lok. 6U
01-015 Warszawa
Tel.: +48 22 811 41 61
Fax: +48 22 833 51 43

Manufacturer
Laboratório Edol – Produtos Farmacêuticos, S.A.
Av. 25 de Abril, n°. 6-6A
2795-225 Linda-a-Velha
Portugal

Laboratório Edol – Produtos Farmacêuticos, S.A.
Rua Quinta do Salrego 22-22A, Portela de Carnaxide, Carnaxide, 2790-144, Portugal and Rua Casal do Canas nº6-6A, Carnaxide, 2790-204
Portugal

XXXXXX.XX.XX