Minims ® Cyclopentolate Hydrochloride 1,0 % Solution

MINIMS ® Cyclopentolate eye drops is used to dilate (enlarge) the pupil of the eye and to temporarily paralyse the lens so that your doctor can examine your eye(s). It is usually used at the beginning of an eye examination.

Do not use MINIMS ® Cyclopentolate:

• if you are hypersensitive (allergic) to cyclopentolate or any of the other ingredients of MINIMS ® Cyclopentolate eye drops (listed in section 6).
• if you have or suspect you have narrow-angle glaucoma (high pressure in the eye). Cyclopentolate can increase the pressure in the eye.
• In neonates.
• In sensitive patients, especially in infants, premature births, small children, adults over 65 years old and patients with Down’s syndrome, as well as in children with brain damage.
• In children/infants below 1 year of age.
• In children with brain problems, including congenital or neuro-developmental abnormalities, particularly those which may predispose to epilepsy attacks.

Tell your doctor before being given MINIMS ® Cyclopentolate:

• if you have had an allergy to any other medicines, foods, preservatives or dyes
• if you have or have had glaucoma (high pressure in the eye)
• if it is to be used in very young children (older than1 year)
• if you are elderly
• if you have or your child has Down’s syndrome
• if you have or your child has brain damage or spastic paralysis
• if you have or your child has epilepsy
• if you are or your child is susceptible to belladonna alkaloids
• if you are or your child is particularly susceptible to severe central nervous system disorders.

Do not share medicines prescribed for you with any other person. Always use MINIMS ® Cyclopentolate eye drops exactly as your doctor has told you. Check with our doctor if you are not sure.

Normally, you will not be expected to give yourself MINIMS ® Cyclopentolate eye drops. It will be instilled into your eye(s) by a person who is qualified to do so. Your doctor will determine the strength of the solution and number of drops required.

Adults and Children one year and older

The usual dose is one drop instilled into the eye(s).

If you use more MINIMS ® Cyclopentolate than you should

Overdose or accidental swallowing of the solution may possibly cause side effects due to absorption, especially in infants or young children. If you think that someone may have swallowed any or all of the contents of the container of MINIMS ® Cyclopentolate, or in the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

MINIMS ® Cyclopentolate can have side effects. Not all side effects reported for MINIMS ® Cyclopentolate are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using MINIMS ® Cyclopentolate eye drops, please consult your health care provider for advice.

If any of the following happens, stop using MINIMS ® Cyclopentolate eye drops and tell your doctor immediately or go to the casualty department at your nearest hospital:

• shortness of breath,
• wheezing or difficulty breathing,
• swelling of the face, lips, tongue or other parts of the body,
• rash, itching or hives on the skin, or
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MINIMS ® Cyclopentolate eye drops. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• behavioural changes (these are more common in children),
• seizures or fits (especially in children),
• sleepiness or drowsiness,
• incoherent speech,
• restlessness,
• hallucinations,
• hyperactivity
• disorientation

These are all serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following in your eyes and they become bothersome:

• blurred vision or problems seeing clearly,
• local irritation, stinging or feeling of having something in the eye,
• burning sensation,
• red eyes,
• itching,
• tearing, or
• sensitivity to light

Other side effects have also been reported, tell your doctor if you notice any of the following:

• flushing,
• dry skin or mouth,
• temperature changes,
• if your bladder does not empty completely,
• feeling dizzy,
• incoordination,
• poor balance,
• shaking,
• if your heart beats faster than normal,
• constipation, vomiting, diarrhoea, or
• feeding intolerance in infants.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children.

• Store between 2 °C – 8 °C in a refrigerator
• Protect from light
• Do not freeze
• Keep the units in the outer carton
• Do not use after the expiry date stated on the carton or unit
• Discard each MINIMS ® unit after single use
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).