1% eye drops, solution 
cyclopentolate hydrochloride

1. What Cyclogyl is and what it is used for

Cyclogyl 1% eye drops, the solution contains the active substance cyclopentolate hydrochloride.

Cyclogyl dilates the pupil and temporarily paralyzes the pupil’s muscles. Cyclogyl is used in eye examinations or the treatment of certain eye inflammations.

Cyclopentolate hydrochloride contained in Cyclogyl may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Cyclogyl

Do not use Cyclogyl

  • if you are allergic to cyclopentolate hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you have a shallow anterior chamber of the eye or a narrow anterior chamber angle, do not use Cyclogyl due to the risk of acute high pressure in the eye ( acute glaucoma ).

Warnings and cautions

Talk to your doctor or pharmacist before using Cyclogyl.

Consult a physician as the use of this medicine may cause:

  • high pressure in the eye, especially if you have a shallow anterior chamber of the eye or a narrow anterior chamber angle. You should have your eye pressure checked before starting treatment.
  • behavioral changes, especially in the elderly, but reactions can occur at any age.
  • photosensitivity – protect the eyes in bright light.

If you have a fever or are in a hot climate, talk to your doctor before using Cyclogyl.

Children

  • Do not use Cyclogyl in newborns or infants under 1 year of age as there is a risk of serious side effects (see section “Possible side effects”).
  • If Cyclogyl is given to children over 1 year of age or to children with Down syndrome, brain damage, or established epilepsy, consult a physician as the use of this medicine may cause serious side effects. See also “How to use Cyclogyl”.
  • children must be kept under close supervision for at least 30 minutes after the eye drops have been given.
  • food intolerance when Cyclogyl is used in infants; therefore do not feed the baby for 4 hours after the eye drops have been given.
  • if Cyclogyl misses the eye, wash it off immediately.

Other medicines and Cyclogyl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking:

  • antihistamine is
  • antidepressants
  • eye drops containing pilocarpine ( eye drops used to treat high pressure in the eye)

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cyclogyl should not be used during pregnancy unless clearly necessary.

Cyclogyl should not be used during breast-feeding.

Driving and using machines

This type of medicine can cause drowsiness, blurred vision, and photosensitivity. If you get any of these, do not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cyclogyl contains benzalkonium chloride

If you wear contact lenses:

Remove the contact lenses (hard or soft) before using Cyclogyl and wait at least 15 minutes before reinserting the lenses.

Cyclogyl contains a preservative (benzalkonium chloride) that can irritate the eyes and has been found to discolor soft contact lenses. Avoid contact with soft contact lenses.

3. How to use Cyclogyl

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults and the elderly

Dose one is determined by the doctor who adjusts it individually for you.

Older

Always use the lowest possible dose needed to give the desired effect.

Children

Do not use Cyclogyl in newborns or infants under 1 year of age as there is a risk of serious side effects. For children and adolescents, always use the lowest possible concentration and the lowest possible number of drops needed to give the desired effect. See also sections ‘Warnings and precautions’, ‘If you have used too much Cyclogyl’ and ‘Possible side effects’.

Use Cyclogyl only as eye drops.

How to use Cyclogyl correctly

If the safety collar is loose when the cover has been removed, it must be removed before using the product.

Use
  1. Bring out the bottle of Cyclogyl.
  2. Wash your hands and sit in front of a mirror.
  3. Unscrew the lid.
  4. Hold the bottle upside down between your thumb and forefinger (picture 1).
  5. Tilt your head back. Pull down the lower eyelid with a clean finger so that a “pocket” is formed between the eyelid and the eye. The drop should end up here.
  6. Hold the tip of the bottle close to the eye. Use a mirror if it helps.
  7. Do not touch the eye or eyelid, surrounding areas, or other surfaces with the drip tip. It may contaminate the eye drops in the bottle.
  8. Do not squeeze the bottle: it is designed so that only light pressure on the bottom is needed (Fig. 2).
  9. Gently press on the bottom of the bottle to release one drop of Cyclogyl at a time (Figure 3).
  10. After using Cyclogyl, close your eyes and gently press with a finger in the corner of your eye at your nose for 2 minutes (Fig. 4). It prevents Cyclogyl from entering the rest of the body.
  11. If you use Cyclogyl in both eyes, repeat steps 4-10 for the other eye.
  12. Screw on the lid firmly immediately after use.

If a drop misses the eye, wipe it off immediately and try again.

If you are using other eye drops or ointments, wait at least 5 minutes between each medicine. Eye ointments should be used last.

If you use more Cyclogyl than you should

If you have used too much Cyclogyl, rinse everything out with warm water. Do not take any more drops until it is time for your next regular dose.

Symptoms of eye overdose may include redness of the face, redness and dryness of the skin (children may get a rash), blurred vision, rapid and irregular heartbeat, fever, bloated stomach in infants, cramps, hallucinations, loss of coordination, faster heartbeat, enlarged pupil, dry mucous membranes, vomiting, overactivity alternating with dizziness, spasms and respiratory arrest.

If you forget to use Cyclogyl

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop using Cyclogyl

Do not stop using this medicine prematurely, even if your symptoms have disappeared. If you stop using this medicine too soon, the symptoms may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported with Cyclogyl:

Common (affects up to 1 in 10 people):

Eye effects: photosensitivity, temporary burning in the eye when the drops are given (eye pain), and impaired myopia.

Common side effects: hallucination, confusion, anxiety, fever, flushing, rapid heartbeat, constipation and aroused mood.

Uncommon (affects up to 1 in 100 people) :

General side effects: dry mouth, allergic reactions (hypersensitivity), and inability to urinate.

Rare (affects up to 1 in 1,000 people) :

Eye effects: acute high pressure in the eye ( acute glaucoma ).

No known frequency (cannot be calculated from the available data) :

Eye effects: larger pupil (prolonged drug effect), eye irritation, blurred vision, and visual hallucinations.

Common side effects: food hypersensitivity, disorientation, restlessness, psychosis, altered behavior, incoherent speech, loss of near memory, dizziness, headache, drowsiness, hyperactivity, inability to recognize other people, slower heart rate, difficulty breathing, nausea, vomiting, nausea, vomiting, redness of the skin, difficulty walking, fatigue and an abnormal feeling.

Also, it can cause a lack of coordination, cramps, rashes, bloated stomachs in infants, faster heart rate, dilated blood vessels, reduced intestinal motility, reduced production of saliva and sweat, and dry mucous membranes in the throat, trachea, and nasal passages. Severe reactions manifest as low blood pressure with weak breathing which quickly worsens.

Additional side effects are in children

Premature infants and young children, young children, and children with central nervous system disorders (eg epilepsy, brain damage, Down syndrome) are at increased risk of toxic effects. This can manifest as disorders of the central nervous system (similar to those listed above, eg, inconsistent speech, restlessness, hallucinations, hyperactivity, disorientation), disorders of the heart, lungs, and stomach.

Hypersensitivity to food may occur after the use of this medicine in children.

A local allergic reaction to this medicine in the form of a skin rash has been seen in children.

5. How to store Cyclogyl

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 carton after “EXP”. The expiration date is the last day of the specified month.

Discard the bottle 4 weeks after opening.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is cyclopentolate hydrochloride. One ml of solution contains 10 mg of cyclopentolate hydrochloride.
  • The other ingredients are benzalkonium chloride ( preservative ), boric acid, potassium chloride, disodium edetate, sodium carbonate monohydrate, and/or hydrochloric acid for pH adjustment and purified water.

What the medicine looks like and the contents of the pack

Cyclogyl is a colorless to a yellowish solution supplied in a 15 ml plastic bottle (DROPTAINER) with a screw cap.

Marketing Authorisation Holder

Alcon Nordic A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Manufacturer

SA Alcon-Couvreur NV

Rijksweg 14

2870 Puurs

Belgium

Muhammad Nadeem

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