Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Minims Cyclopentolate?
Minims Cyclopentolate contains the active ingredient cyclopentolate hydrochloride.
Minims Cyclopentolate is used to temporarily dilate (enlarge) the pupil of the eye
and to stop the movement of the muscles that change the shape of the lens. It is
usually used at the beginning of an eye examination so that your doctor can examine
your eye(s).
2. What should I know before I use Minims Cyclopentolate?
Do not use if you have ever had an allergic reaction to cyclopentolate or any of the
ingredients listed at the end of the CMI. Do not use if you have narrow angle glaucoma,
shallow anterior chamber, Down's syndrome, heart or blood vessel conditions, are aged
over 65 years, are at risk of having high pressure in your eye, your child is a premature
baby, small infant less than 3 months old, has brain damage or brain syndromes. Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Minims Cyclopentolate and affect how it works.
4. How do I use Minims Cyclopentolate?
Your doctor will normally instil the drops into your eyes for you. The usual dose
is one or two drops instilled into the eye.
5. What should I know while using Minims Cyclopentolate?
Things you should do
|
If you have 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.
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.
|
Things you should 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.
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how Minims
Cyclopentolate affects you. It may cause blurred vision for a short time when it is
instilled into the eye. Allow enough time to regain clear vision before driving or
using machines.
|
Looking after your medicine
|
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.
|
6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually minor and
temporary. Do not be alarmed by this list. You may not experience any of them. Less
serious side effects include: blurred vision and/or problems seeing clearly, local
irritation, stinging or the feeling of having something in the eye, burning or painful
sensation, red, watery and itchy eyes and sensitivity to light. Serious side effects
include: allergic reaction, angle closure glaucoma and effects to the body as a whole.
Active ingredient:
Cyclopentolate hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Minims Cyclopentolate. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Minims Cyclopentolate.
Where to find information in this leaflet:
1. Why am I using Minims Cyclopentolate?
Minims Cyclopentolate contains the active ingredient cyclopentolate hydrochloride. Minims Cyclopentolate belongs to a class of medicines called antimuscarinic agents.
Minims Cyclopentolate is used to temporarily dilate (enlarge) the pupil of the eye
and to stop the movement of the muscles that change the shape of the lens. It is usually used at the beginning of an eye examination so that your doctor can
examine your eye(s).
2. What should I know before I use Minims Cyclopentolate?
Warnings
Do not use Minims Cyclopentolate if:
You are allergic to cyclopentolate, or any of the ingredients listed at the end of
this leaflet. Always check the ingredients to make sure you can use this medicine.
You have or suspect you have narrow angle glaucoma (high pressure in the eye). Cyclopentolate
can increase the pressure in the eye.
You have a shallow anterior chamber (when the part of the eye between the cornea and
the iris is narrow)
You are aged over 65 years.
You are at risk of having high pressure in your eye.
Your child is a premature baby, small infant less than 3 months old, has brain damage
or brain syndromes.
You have Down's syndrome.
You have cardiovascular disorders (heart or blood vessel conditions).
Check with your doctor if:
You have had an allergy to any other medicines, foods, preservatives or dyes.
You have any other medical conditions, especially:
glaucoma (high pressure in the eye)
epilepsy (condition where you have repeated fits or convulsions)
prostate disorders
ataxia (poor balance or coordination)
dementia (condition where you have memory loss)
rhinitis sicca (dry nose)
gut disorders where the gut is partly blocked or narrow, or where the large intestine
is inflamed
myasthenia gravis (a condition in which the muscles become weak and tire easily)
obstructive urinary tract disorders
You have hyperaemia (high blood flow e.g., red eyes)
You are easily affected by belladonna alkaloids (some medicines used to treat lung
disease, nausea and vomiting)
You take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
This medicine has been developed for use in the eye only. It should not be swallowed
or injected.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Use in children
Minims Cyclopentolate should be used with caution in children.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and Minims Cyclopentolate may interfere with each other. These medicines
may be affected by Minims Cyclopentolate or may affect how well it works. These include:
Medicines to treat glaucoma
Antihistamines
Some medicines used to treat depression
Some medicines used to treat mental illness
Some medicines used to treat Parkinson's disease
Some medicines used to treat irregular heartbeats
Some medicines used to treat nausea and vomiting.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Minims Cyclopentolate.
4. How do I use Minims Cyclopentolate?
Your doctor will normally instil the drops into your eyes for you. If your doctor
instructs you to instil the drops, please follow the directions below.
How much to use
Use Minims Cyclopentolate 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 Minims Cyclopentolate
If you are wearing contact lenses, remove them before putting the drops in your eye.
You may find it easier to put drops in your eye while you are sitting or lying down.
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.
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 or 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 or 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 at least 15 minutes before replacing your contact lenses.
If you use too much Minims Cyclopentolate
Overdose or accidental swallowing of Minims Cyclopentolate may possibly cause side
effects due to absorption, particularly in infants or young children.
If you think that you or anyone else may have swallowed Minims Cyclopentolate or used
too much Minims Cyclopentolate, you should immediately:
phone the Poisons Information Centre
(in Australia phone
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Minims Cyclopentolate?
Things you should 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.
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.
Things you should 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Minims
Cyclopentolate affects you.
Minims Cyclopentolate may cause blurred vision for a short time when it is instilled
into the eye. Allow enough time to regain clear vision before driving or using machines.
Looking after your medicine
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.
When to discard your medicine
Discard each single dose unit and any remaining solution in it immediately after use.
Do not save unused contents.
Getting rid of any unwanted medicine
If your doctor tells you to stop using the eye drops or it is out of date or damaged,
take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Serious side effects
|
What to do
|
Symptoms of an allergic reaction, such as:
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.
Symptoms of angle closure glaucoma, such as:
Severe headache
Severe eye pain
Nausea or vomiting
Blurred vision
Halos or coloured rings around lights
Eye redness.
Symptoms of toxicity or effects to the body as a whole, such as:
mental or behaviour changes, such as restlessness, hallucinations, hyperactivity,
confusion or agitation
nervous system effects, such as poor balance or muscle control, fits or seizures,
drowsiness, speech difficulty, dizziness or involuntary shaking
dry mouth
skin effects, such as dry skin, skin rash, flushing or skin redness
temperature changes or fever
effects on the gut, such as swelling, infection, feeding problems in infants, constipation,
slow gut movement, nausea or vomiting
difficulty in passing urine
heart rate changes
sudden loss of breathing or heart function
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Some side effects (for example, an increase in the pressure of the eye) can only be
found when your doctor or optometrist does tests from time to time.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects online (in Australia, go to
www.tga.gov.au/reporting-problems ). By reporting side effects, you can help provide more information on the safety
of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Minims Cyclopentolate contains
Active ingredient (main ingredient)
|
cyclopentolate hydrochloride (0.5% w/v or 1% w/v)
|
Other ingredients (inactive ingredients)
|
Purified water
Hydrochloric acid
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Do not take this medicine if you are allergic to any of these ingredients.
The eye drops do not contain any preservatives.
What Minims Cyclopentolate looks like
Minims Cyclopentolate is available in two strengths:
Minims Cyclopentolate Hydrochloride 0.5% eye drops (AUST R 32265)
Minims Cyclopentolate Hydrochloride 1% eye drops (AUST R 32267).
Minims Cyclopentolate comes in single dose units (tubes) containing 0.5mL of a clear,
colourless solution. Each tube is wrapped in a polyester/paper blister. The blisters
are packed in cartons of 20 units.
Who distributes Minims Cyclopentolate
In Australia, Minims Cyclopentolate is supplied by:
Bausch & Lomb (Australia) Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067
Phone: 1800 251 150
This leaflet was prepared in April 2025.