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MINIMS CYCLOPENTOLATE HYDROCHLORIDE 1.0%W/V

Active substance(s): CYCLOPENTOLATE HYDROCHLORIDE

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P9UK01 76856
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

Nazwa produktu
Product Name

ULOTKA PIL

Minims Cyclopentolate
Hydrochloride 0,5% and
1% DRP

Kolor nadruku Colours

Black

Kraj
Country (ISO)

United Kingdom (UK)

Opracowane przez
Designed by
Nr korekty
Proof No

9

Data
Date

15.04.2015

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76856

Kod farmaceutyczny
Pharmacode

-

Kod wersji
Valeant version code

P1UK01

Inny kod
Other code

76856 (Data Matrix)

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd
PMR_ICN-14-0750-A & PMR_ICN-14-0749-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

- g/m2

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 for single use only and provided in 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.

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2015-04-15 14:20:09

P9UK01 76856
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

Nazwa produktu
Product Name

2.
3.
4.
5.
6.

ULOTKA PIL

Minims Cyclopentolate
Hydrochloride 0,5% and
1% DRP

Kolor nadruku Colours

Black

Kraj
Country (ISO)

United Kingdom (UK)

Opracowane przez
Designed by
Nr korekty
Proof No

9

Data
Date

15.04.2015

Nr wykrojnika
Spec No

5338

Kod Wytwórcy
Manufacturer code

76856

4. Possible side effects

Kod farmaceutyczny
Pharmacode

-

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.

Kod wersji
Valeant version code

P1UK01

Inny kod
Other code

76856 (Data Matrix)

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

160 x 240 mm

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Condensed Bold

Use a mirror, this will help you to see what you are doing.
Carefully dry your eyes using a tissue, and twist off the cap from the Minims body of the unit.
Pull your lower eyelid down gently, and then carefully place 1 or 2 drops inside your lower eyelid.
Close your eye and blink a few times to make sure your eye is covered by the liquid.
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® Pilocarpine Nitrate 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.

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd
PMR_ICN-14-0750-A & PMR_ICN-14-0749-A
Packing Site: Laboratoire Chauvin, Aubenas, France

Akceptacja Techniczna Technical Approval

- g/m2

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
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

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 for single use only and provided in 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:
Bausch & Lomb UK 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 03468/0070 (UK)
Minims® Cyclopentolate Hydrochloride 1% w/v:
PL 03468/0071 (UK) ; PA 555/18/1 (Ireland)
DATE OF PREPARATION: April 2015
Art. 76856

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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.

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