Consumer medicine information

Minims Cyclopentolate Eye Drops

Cyclopentolate hydrochloride

BRAND INFORMATION

Brand name

Minims Cyclopentolate Eye Drops

Active ingredient

Cyclopentolate hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Cyclopentolate Eye Drops.

What is in this leaflet

This leaflet answers some common questions about Minims Cyclopentolate Eye Drops, including how to use the eye drops.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Minims Cyclopentolate Eye Drops against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Minims Cyclopentolate Eye Drops is used for

Minims Cyclopentolate Eye Drops belongs to a class of medicines called antimuscarinic agents. It 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.

Ask your doctor if you have any questions about why this medicine has been prescribed to you. Your doctor may have prescribed it for another reason.

Before you use Minims Cyclopentolate Eye Drops

When you must not use it

Do not use Minims Cyclopentolate Eye Drops if you have an allergy to:

  • Any medicine containing cyclopentolate
  • Any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • 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

Do not use Minims Cyclopentolate Eye Drops if you have or suspect you have angle closure glaucoma (high pressure in the eye). Cyclopentolate can increase the pressure in the eye.

Do not use this medicine in neonates or infants less than 3 months old.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have had an allergy to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • Glaucoma (high pressure in the eye)
  • Down's syndrome

If this medicine has been prescribed for your child, tell your doctor if he/she has:

  • Brain damage
  • Spastic paralysis

Tell your doctor if you are pregnant or are breast-feeding. Your doctor will discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using Minims Cyclopentolate Eye Drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Cyclopentolate Eye Drops may interfere with each other. These include:

  • Medicines to treat glaucoma
  • Similar drugs (such as atropine, hyoscine and tropicamide) that are used to treat conditions that affect the body rather than just the eye.

These medicines may be affected by Minims Cyclopentolate Eye Drops or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor and pharmacist will have more information on medicines to be careful with or avoid while using Minims Cyclopentolate Eye Drops.

How to use Minims Cyclopentolate Eye Drops

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor for help.

How much to use

Use Minims Cyclopentolate Eye Drops only when prescribed by your doctor. Your doctor will tell you how often to use the eye drops and how many drops to use each time.

The usual dose is one or two drops instilled into the eye(s).

How to use it

Your doctor will normally instil the drops into your eyes for you. If you are instilling your own drops, then follow the directions below.

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing contact lenses, remove them before putting the drops in your eye.

If you are instilling your own drops, then follow these steps to use the eye drops.

  1. Wash your hands well with soap and water.
  2. Shake the container.
  3. Break the seal.
  4. Hold the container upside down in one hand between your thumb and forefinger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch/pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the container close to your lower eyelid. Do not let it touch your eye.
  8. Release the required number of drops into the pouch/pocket formed between your eye and eyelid by gently squeezing the container.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This is very important when administering to children. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body.
  11. Repeat steps 4-10 for the other eye if needed.
  12. Throw away any eye drops left in the container.
  13. Wait 15 minutes before replacing your contact lenses.

If you use too much (overdose)

Overdose or accidental swallowing of the solution may possibly cause side effects due to absorption, particularly 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 Eye Drops, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

While you are using Minims Cyclopentolate Eye Drops

Things you must do

If you experience any irritation, pain, swelling, excessive tear production or light-sensitivity while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes.

Stop using the eye drops and contact your doctor if these symptoms persist.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if you think they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Minims Cyclopentolate Eye Drops affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may cause transient blurred vision at the time of application and sufficient time should be allowed to regain clear vision before driving or operating hazardous machinery.

Your eyes may be sensitive to light while using this medicine. It is recommended that you protect your eyes from light e.g. by wearing sunglasses.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Cyclopentolate Eye Drops.

This medicine helps most people but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Blurred vision and / or problems seeing clearly
  • Local irritation or stinging or feeling of having something in the eye
  • Burning sensation
  • Red eyes
  • Sensitivity to light

The above list includes the more common side effects of your medicine. Please note that they may also be symptoms of an allergic reaction (allergic conjunctivitis).

Tell your doctor immediately or visit Accident and Emergency at your nearest hospital if you notice any of the following:

  • Behavioural changes. These are more common in children.
  • Restlessness
  • Hallucinations
  • Seizures or fits
  • Disorientation.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Minims Cyclopentolate Eye Drops

Storage

Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Disposal

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining containers.

Product description

What it looks like

Minims Cyclopentolate Eye Drops comes in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Cyclopentolate Eye Drops contains 0.5%w/v or 1.0%w/v of cyclopentolate hydrochloride as the active ingredient.

It also contains:

  • Water - Purified
  • Hydrochloric acid

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia Minims Cyclopentolate Eye Drops is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Chatswood, NSW 2067
Phone: 1800 251 150

Minims Cyclopentolate Eye Drops 0.5% AUST R 32265

Minims Cyclopentolate Eye Drops 1.0% AUST R 32267

In New Zealand Minims Cyclopentolate Eye Drops is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Toll free number: 0508375394

Date of preparation

This leaflet was prepared in February 2018

Published by MIMS April 2018

BRAND INFORMATION

Brand name

Minims Cyclopentolate Eye Drops

Active ingredient

Cyclopentolate hydrochloride

Schedule

S4

 

1 Name of Medicine

Cyclopentolate hydrochloride.

2 Qualitative and Quantitative Composition

Minims Cyclopentolate Eye Drops are sterile preservative-free solutions containing cyclopentolate hydrochloride 0.5% (5 mg/mL) or 1% w/v (10 mg/mL) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, solution.
Minims Cyclopentolate Eye Drops are clear colourless solutions, reasonably free from visible particulate matter.

4 Clinical Particulars

4.1 Therapeutic Indications

Minims Cyclopentolate Eye Drops are indicated to produce mydriasis and cycloplegia.

4.2 Dose and Method of Administration

Adults (including the elderly).

Minims Cyclopentolate Eye Drops should be instilled drop wise into the eye according to the recommended dosage below.
One drop as required. Maximum effect is induced 30-60 minutes after instillation.
For refraction and examination of the back of the eye: 1 drop of solution, which may be repeated after five minutes, is usually sufficient.
For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae: 1 drop is instilled every 6-8 hours.
Resistance to cycloplegia can occur in young children, in patients with dark skin and/or patients with dark irides. Therefore, if the 0.5% solution does not induce cycloplegia, the dosage regimen (children) and/or the strength of cyclopentolate used should be increased accordingly.

Children.

< 3 months.

Not recommended.

3 months-12 years.

1 drop of a 0.5% solution to each eye.

12 years-adult.

1 drop of 0.5% or 1% solution to each eye repeated after 10 minutes if necessary.
Children should be observed for 45 minutes after instillation.
Parents are advised to avoid contact of the solution with the child's mouth and to wash their hands and the child's hands after administering the drops.
Systemic absorption of cyclopentolate may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Each Minims Cyclopentolate Eye Drops unit should be discarded after a single use.

4.3 Contraindications

Minims Cyclopentolate Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation.
Do not use in patients with narrow-angle glaucoma or in those with a shallow anterior chamber (see Section 4.4 Special Warnings and Precautions for Use).
Do not use in elderly (> 65 years) patients and other patients who may be predisposed to an increased intraocular pressure.
Do not use in at risk patients, especially premature babies, small infants, adults over 65 years old and patients with Down's syndrome, as well as in children with brain damage (see Section 4.4 Special Warnings and Precautions for Use).
Do not use in children with organic brain syndromes, including congenital or neurodevelopmental abnormalities, particularly those predisposing to epileptic seizures.
Do not use in patients with cardiovascular disorders.

4.4 Special Warnings and Precautions for Use

Minims Cyclopentolate Eye Drops are for topical ophthalmic use only. The solution should not be injected.
Complete recovery of accommodation usually occurs within 24 hours, however in some individuals complete recovery may require several days.
Eyes may become sensitive to light while using Minims Cyclopentolate Eye Drops. Patients should be advised to protect their eyes, e.g. by wearing sunglasses.
Cyclopentolate may cause CNS disturbances when administered topically to the eye. This is especially true in younger age groups and other patients at special risk, such as debilitated or aged patients, but may occur at any age.
Caution is advised in case of open-angle glaucoma, epilepsy, in patients with prostate disorders, ataxia, and in case of senile dementia.
Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly if therapy is likely to be intense or protracted (see Section 4.3 Contraindications).
Tachycardia and cardiac symptoms are sometimes observed, therefore the product should not be used in patients with cardiovascular disease (see Section 4.3 Contraindications).
Caution is also advised in hyperaemia as increased systemic absorption may occur.
Cyclopentolate should only be used with special care for in patients with rhinitis sicca, mechanical stenosis of the gastrointestinal tract, toxic megacolon, myasthenia gravis, and obstructive urinary tract disorders.
Resistance to cycloplegia can occur in young children, in patients with dark irides, see Section 4.2 Dose and Method of Administration.
Extreme caution is advised for use in individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Atropine-like effects have been reported as side effects.

Use in the elderly.

Minims Cyclopentolate Eye Drops should be used with caution in elderly patients where increased intraocular pressure may be encountered and/or where they may be more susceptible to the CNS effects of cyclopentolate, see Section 4.3 Contraindications.

Paediatric use.

Minims Cyclopentolate Eye Drops should be used with caution in very young children. Increased susceptibility to cyclopentolate has been reported in infants, young children and in children with spastic paralysis or brain damage. Cyclopentolate should not, therefore, be used in premature and small infants (see Section 4.3 Contraindications), and should be used with great caution in young children.
Use of cyclopentolate has been associated with psychotic reactions, and behavioural disturbances in paediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children and in children with brain damage (see Section 4.8 Adverse Effects (Undesirable Effects)).
Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 45 minutes after administration of this medicine.
Cyclopentolate should be used with caution in children as convulsions including grand mal have been reported.

Necrotic colitis in premature children.

Particular caution should be used when used in children because cases of necrotic colitis have been reported following administration of cyclopentolate eye drops in premature babies (see Section 4.8 Adverse Effects (Undesirable Effects)). In such a case, immediate medical evaluation is needed.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although negligible cyclopentolate passes into the bloodstream after ocular instillation, drug interactions are nevertheless possible. The anticholinergic effects of other pharmaceuticals (e.g. antihistamines, phenothiazines, tricyclic and tetracyclic antidepressants, amantadine, quinidine, disopyramide, metoclopramide) could be increased.
The interactions observed with cyclopentolate administered by any route should therefore be taken into account.
Cyclopentolate may interfere with the antiglaucoma action of carbachol or pilocarpine; also, concurrent use of this medication may antagonise the antiglaucoma and miotic action of ophthalmic cholinesterase inhibitors.
The mydriatic effect of cyclopentolate hydrochloride is ended by the use of parasympathomimetic drugs such as physostigmine or pilocarpine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been performed to evaluate the potential fertility impairing effects of cyclopentolate.
(Category B2)
Safety for use in pregnancy has not been established, therefore, Minims Cyclopentolate Eye Drops should be used only when considered essential.
 It is not known whether cyclopentolate and/or its metabolites are excreted in milk. Safety for use in lactation has not been established, therefore, Minims Cyclopentolate Eye Drops should be used only when considered essential.

4.7 Effects on Ability to Drive and Use Machines

Cyclopentolate has a marked effect on the ability to drive and use machines.
Minims Cyclopentolate Eye Drops may cause transient blurring of vision on instillation (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients should be advised not to drive or operate hazardous machinery until vision is clear.

4.8 Adverse Effects (Undesirable Effects)

Local effects.

Local irritation may result following the use of this product. The frequency of this effect occurring is dependent on the concentration instilled.
Allergic conjunctivitis or blepharoconjunctivitis may rarely occur, manifesting as diffusely red eyes with lacrimation and itching.
Increased intraocular pressure may occur in predisposed patients.
Other local effects include: burning, photophobia, blurred vision, irritation, hyperaemia and punctate keratitis.

Systemic effects.

Systemic cyclopentolate toxicity may be dose related. Systemic adverse effects from cyclopentolate are not uncommon, especially in children, although this information is based on postmarketing reports for which frequencies are not accurately known.
Toxicity is usually transient and is manifested mainly by CNS disturbances. These reactions may include ataxia, convulsion, somnolence, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation with regard to time and place, and failure to recognise people.
Peripheral effects typical of anticholinergics, such as flushing or dryness of the skin and mucous membranes, as well as temperature changes have been also observed rarely with topical cyclopentolate in children and adults.
Other systemic effects include anaphylactic reaction and anaphylactic shock, gastrointestinal effects such as necrotising colitis, gastroenteritis and feeding intolerance in infants; skin rash; dry mouth; urinary retention; vertigo; incoordination; poor balance and tremor.
Tachycardia has also been observed.

Post marketing experience.

Adverse reactions are listed by system organ class and frequency. The following convention has been used for the classification of frequencies: 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); not known (cannot be estimated from the available data).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Overdose is rare but symptoms can include those mentioned (see Section 4.8 Adverse Effects (Undesirable Effects)).
In isolated cases, ocular topical application of eye drops containing cyclopentolate can lead to central nervous system disorders and general systemic manifestations, especially in children with central nervous system disorders.

a) Central nervous manifestations.

Restlessness, incoherent speech, optical hallucinations, memory loss, disorientation, ataxia, very rarely epileptiform seizures, exhaustion, sleep.

b) General systemic manifestations.

Dry mouth, flushing of the face, tachycardia, increase in temperature, urinary blockage, pupil dilation, loss of accommodation.
Treatment is supportive, and as required to control symptoms of anticholinergic overdose. Physostigmine or pilocarpine can be administered as an antidote. Specific therapies may be required, e.g. benzodiazepines for seizures.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Cyclopentolate hydrochloride is a synthetic tertiary amine, antimuscarinic compound with actions similar to atropine.
It blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilatation (mydriasis) and paralysis of accommodation (cycloplegia). It acts more quickly than atropine and has a shorter duration of action; the maximum effect is produced 30 to 60 minutes after instillation; accommodation recovers within 24 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

As a group, the synthetic tertiary amine antimuscarinic compounds are well absorbed following oral administration. Cyclopentolate may be absorbed systemically either by transcorneal absorption, direct topical absorption through the skin or by absorption from the nasal or nasolacrimal system.

5.3 Preclinical Safety Data

Genotoxicity.

No studies have been performed to evaluate the potential mutagenic and clastogenic effects of cyclopentolate.

Carcinogenicity.

No studies have been performed to evaluate the potential carcinogenic effects of cyclopentolate.

6 Pharmaceutical Particulars

6.1 List of Excipients

Purified water, hydrochloric acid.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate. Do not freeze. Protect from light.

6.5 Nature and Contents of Container

Minims Cyclopentolate Eye Drops are available in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. Pack size: cartons of 20 x 0.5 mL units.

6.6 Special Precautions for Disposal

Each Minims Cyclopentolate Eye Drops unit should be discarded after a single use.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: 2-(dimethylamino) ethyl (RS)-2-(1-hydroxycyclopentyl)- 2-phenylacetate hydrochloride.
Molecular formula: C17H25NO3.HCl.
Molecular weight: 327.9.
Cyclopentolate is present as a racemic mixture.

CAS number.

5870-29-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes