MINIMS CYCLOPENTOLATE HYDROCHLORIDE 1.0%W/V

Active substance: CYCLOPENTOLATE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Minims® Cyclopentolate Hydrochloride 0.5% w/v
Minims® Cyclopentolate Hydrochloride 1% w/v
Eye Drops, solution
Cyclopentolate Hydrochloride
Read all this leaflet carefully before you start using your
medicine. It contains a summary of the information available on
your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
Remember this medicine is for you. Do not give it to someone
else.
In this leaflet:
1. What Minims® Cyclopentolate Hydrochloride eye drops are
and what they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information

1. What Minims® Cyclopentolate Hydrochloride eye
drops are and what they are used for
Minims® Cyclopentolate Hydrochloride contains a mydriatic
agent. It is used to enlarge the pupil of the eye and to paralyse
the lens temporarily.
Your doctor or eye specialist may use it to examine your eye
more closely.
These eye drops are also used to treat some types of
inflammation of the eye.
This medicine is not indicated for babies under 28 days old.
However, your doctor or eye specialist can use it if he/she
decides that it is necessary.

2. Before you use your eye drops
Do not use these drops
if you are allergic to the active substance (cyclopentolate
hydrochloride) or any of the other ingredients (refer to the
end of this leaflet).
if you have high pressure of liquid inside the eye (closed
angle glaucoma)
in babies under 28 days old (unless your doctor decides that
it is necessary)
Take special care
Ask yourself the following questions:
Are your eyes red or inflamed?
Is it to be used in very young children (under 3 months old)?
Are you very ill?
Are you elderly?
If the answer to any of these questions is yes, tell your doctor or
eye specialist.
If you are pregnant, may be pregnant, or are breastfeeding
Tell your doctor or eye specialist, he/she may decide to use
these drops or to prescribe you an alternative.
Contact lenses
Your doctor will ask you to remove your contact lenses prior to
the administration of the drops. There is no information on the
effect of this product on contact lenses. Therefore, do not wear
your contact lenses until the effects of the drops have
completely worn off.
Driving and using machines
As with all eye drops, your vision may be blurred after putting
the drops in. Wait until your vision is clear before driving or
using machines.

3. How to use your eye drops
The drops are in special single use “Minims” units, to treat both
eyes if necessary. Once opened, use immediately. Discard any
unused portion.
Dosage
The normal adult dose is 1 or 2 drops of solution in each eye,
as required. The administration of the drops can be repeated
every 6-8 hours, depending on the treatment.
The normal child dose (over 3 months old) is 1 drop of
Minims® Cyclopentolate Hydrochloride 0.5% w/v in each
eye. Children should be observed for 45 minutes after the
administration of the drops.
Method of administration
The doctor or eye specialist will normally put the drops in your
eye for you, but if you are putting the eye drops in yourself, then
follow these instructions carefully:
1. Wash your hands.
2. Use a mirror, this will help you to see what you are doing.
3. Carefully dry your eyes using a tissue, and twist off the cap

from the Minims body of the unit.
4. Pull your lower eyelid down gently, and then carefully place 1
or 2 drops inside your lower eyelid.
5. Close your eye and blink a few times to make sure your eye
is covered by the liquid.
6. Close the eyelids. It is advisable to press gently on the inner
corner of your eyelid for 3 minutes. This will help stop the
solution draining into your nose and throat. This is especially
advisable in children, the elderly and population at risk.
7. Repeat steps 4, 5 and 6 for the other eye if necessary, then
throw away the Minims unit, even if some solution remains.
If you use more Minims® Cyclopentolate Hydrochloride
than you should, an overdose is very unlikely to occur. If you
suddenly feel unwell after receiving the drops, tell your doctor or
eye specialist or contact your nearest emergency department
immediately.

4. Possible side effects
The following side effects may occur:
temporary irritation following the administration of the drops
in your eyes.
increase of the pressure of liquid inside your eyes.
allergic reaction (including red eyes, watering of the eyes...)
has been rarely reported.
The following side effects may occur when using an unusual
dosage, especially in children:
temporary effect on your balance
temporary effects on your vision and sense of touch
confusion
fever
flushing of the face
hallucinations
skin rash
drowsiness
unusual behaviour
tachycardia
If any of the side effects gets serious, please seek immediate
medical attention. If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. How to store your eye drops
Keep out of the reach and sight of children.
Do not use the eye drops after the expiry date which is stated
on the overwrap of each unit and on the carton after the letters
“EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Store in the original
package in order to protect from light.
The drops are in special single use “Minims” units, to treat both
eyes if necessary. Once opened, use immediately. Discard any
unused portion.
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. Further information
What do your eye drops contain
The active ingredient is cyclopentolate hydrochloride. Each
Minims unit contains approximately 0.5 ml eye drops solution
of cyclopentolate hydrochloride 0.5% w/v (2.5 mg) or 1% w/v
(5 mg).
The other ingredients are hydrochloric acid (for pH
adjustment) and purified water.
This medicine does not contain a preservative as it is a sterile
single use unit.
Contents of the pack
Each carton contains 20 units.
Marketing Authorisation Holder:
Chauvin Pharmaceuticals Ltd.
106 London Road - Kingston-upon-Thames - KT2 6TN - UK
Tel: +44 (0)20 8781 2900 / Fax: +44 (0)20 8781 2901
Manufacturer:
Laboratoire Chauvin - Z.I.Ripotier - 07200 Aubenas - France
Marketing Authorisation Numbers:
Minims® Cyclopentolate Hydrochloride 0.5% w/v :
PL 0033/5005R (UK) ; PA 118/12/2 (Ireland)
Minims® Cyclopentolate Hydrochloride 1% w/v :
PL 0033/5006R (UK) ; PA 118/12/3 (Ireland)
DATE OF PREPARATION: August 2008
Art. 76554 GB240E01-05.07

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)