1% (10 mg / ml) eye drops , solution, single dose container cyclopentolate hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cyclopentolate Bausch & Lomb is and what it is used for 
2. What you need to know before you take Cyclopentolate Bausch & Lomb 
3. How to take Cyclopentolate Bausch & Lomb 
4. Possible side effects 
5. How Cyclopentolate Bausch & Lomb should be stored 
6. Contents of the packaging and other information 

1. What Cyclopentolate Bausch & Lomb is and what it is used for

Cyclopentolate Bausch & Lomb dilates the pupil of one in your eye and affects the sphincter of the eye’s radiating body to relax. The sphincter controls the coupling of the lens of the eye and thereby the accommodation of the eye (distance setting). A relaxation of the sphincter, therefore, means that accommodation is disconnected.

The maximum effect remains for 30-60 minutes and then disappears relatively quickly. Return to normal accommodation then takes place for 24 hours.

Your doctor or ophthalmologist can use it to do more detailed examinations of your eye or to treat certain types of eye inflammation.

This medicine is intended for children over 1 year of age, adults, and the elderly.

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

2. What you need to know before taking Cyclopentolate Bausch & Lomb

Do not take Cyclopentolate Bausch & Lomb:

  • if you are allergic to cyclopentolate hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer from glaucoma ( glaucoma ) with a narrow chamber angle (which can cause a sudden increase in pressure in the eye when the pupil is widened).

Warnings and cautions

Talk to your doctor or ophthalmologist before taking Cyclopentolate Bausch & Lomb.

Children

Do not use Cyclopentolate Bausch & Lomb in newborns or infants under 1 year of age, as there is a risk of serious side effects.

Talk to your doctor before using this medicine in children over 1 year of age or children with Down syndrome, brain damage, or epilepsy, as there is a risk of serious side effects.

Other medicines and Cyclopentolate Bausch & Lomb

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or eye specialist for advice before taking this medicine. Your doctor or eye specialist will decide if you should use these eye drops or take another medicine.

Cyclopentolate hydrochloride passes into breast milk and the risk of effects on the baby can not be ruled out. Cyclopentolate Bausch & Lomb should therefore not be used during breast-feeding.

Contact lenses

Your doctor will ask you to remove your contact lenses before taking the eye drops. There is no information on how this product affects contact lenses. Therefore, do not wear contact lenses until the effect of the eye drops has completely disappeared.

Driving and using machines

As with all eye drops, you may experience blurred vision after taking the drops. Wait until you see clearly again before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

3. How to take Cyclopentolate Bausch & Lomb

Always take this medicine exactly as your doctor or ophthalmologist has told you. If you are not sure, talk to your doctor, ophthalmologist, or pharmacist.

The drops come in single-dose containers that are sufficient for the treatment of both eyes if necessary. Then discard the single-dose container.

Adults

Dose one is determined by your doctor who adjusts it for you. The recommended dose for adults is 1-2 drops in each eye as needed.

Children

For children, the dose is determined by a doctor or ophthalmologist. For children, always use the lowest possible dose needed to give the desired effect. See sections “Children” and “Possible side effects”.

Instructions for using Your 
doctor or eye specialist will usually give you the eye drops, but if you take the eye drops yourself, follow these instructions carefully:

  1. Wash your hands.
  2. Use a mirror because it will help you see what you are doing
  3. Wipe the eyes thoroughly with a napkin and unscrew the closure of the single-dose container.
  4. Carefully pull down the lower eyelid and carefully drip 1 or 2 drops into the eye socket.
  5. Close the eye and blink a few times to make sure the solution covers the eye.
  6. Close the eyelids. You should gently press on the inner corner of the eye for 3 minutes. This will prevent the solution from running into the nose and throat. This is especially true for children, the elderly, and at-risk patients.
  7. Repeat steps 4, 5, and 6 for the other eye. Then discard the single-dose container even if there is a solution left in it.

If you take more Cyclopentolate Bausch & Lomb then you should

If you take more Cyclopentolate Bausch & Lomb than you should If a child has inadvertently ingested a medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Cyclopentolate Bausch & Lomb

If you forget to take Cyclopentolate Bausch & Lomb, take it as soon as possible and then continue as before. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Contact a doctor immediately if you have seizures, hallucinations, or symptoms of a severe allergic reaction / anaphylactic shock.

Symptoms of severe allergic reaction / anaphylactic shock include difficulty breathing or swallowing, swelling of the face, lips, throat, or tongue, and severe hives.

The following side effects may occur:

Common (affects more than 1 user in 100) :

  • flushing
  • fever
  • increased cardiac activity
  • confusion
  • hallucinations
  • aroused state of mind
  • constipation
  • transient burning after installation
  • Tamsyn
  • impaired myopia
  • photosensitivity

Uncommon (affects less than 1 user in 100) :

  • allergic reaction
  • difficulty urinating

Has been reported (occurs in an unknown number of users) :

  • severe allergic reaction / anaphylactic shock
  • seizures
  • acute glaucoma (increased fluid pressure in your eyes)
  • decreased movement in the gastrointestinal tract
  • armored
  • swollen abdomen

Additional side effects are in children

Children are at increased risk of side effects due to overdose. 
Children over 1 year of age and children with central nervous system disorders (eg epilepsy, brain damage, Down syndrome) are at increased risk of side effects, especially due to overdose. Seizures have been reported in children with epilepsy.

5. How to store Cyclopentolate Bausch & Lomb

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. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze. Store in the original package. Sensitive to light.

The drops come in single-dose containers that are sufficient for the treatment of both eyes if necessary. Then discard the single-dose container.

The medicine 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. Each Bausch & Lomb container contains approximately 0.5 ml of solution with cyclopentolate hydrochloride 1% (5 mg).
  • The other ingredients are hydrochloric acid and sterilized water.

This medicine does not contain any preservatives because it is a sterile single-dose container.

What the medicine looks like and the contents of the pack

Each carton contains 20 single-dose containers.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder 
BAUSCH HEALTHCARE IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24 – D24PPT3 – Ireland

Manufacturer 
Laboratoire Chauvin SA

ZI Ripotier

07200 Aubenas – France

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Local representative 
Bausch & Lomb Nordic AB 
Söder Mälarstrand 45 
118 25 Stockholm

Muhammad Nadeem

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