What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL03468/0070, PL03468/0071.


Minims Cyclopentolate Hydrochloride 0.5% & 1.0%, Eye drops solution

PATIENT INFORMATION LEAFLET

Minims® Cyclopentolate Hydrochloride 0.5% w/v

Minims® Cyclopentolate Hydrochloride 1% w/v

Eye Drops, solution

Cyclopentolate Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Minims® Cyclopentolate Hydrochloride eye drops are and what they are used for
2. What you need to know before you use Minims® Cyclopentolate Hydrochloride eye drops
3. How to use Minims® Cyclopentolate Hydrochloride eye drops
4. Possible side effects
5. How to store Minims® Cyclopentolate Hydrochloride eye drops
6. Contents of the pack and other 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. What you need to know before you use Minims® Cyclopentolate Hydrochloride eye drops

Do not use Minims® Cyclopentolate Hydrochloride eye drops

  • if you are allergic to the active substance (cyclopentolate hydrochloride) or any of the other ingredients (listed in section 6).
  • 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).

Warnings and precautionsAsk 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.

Pregnancy and breast-feeding

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 Minims® Cyclopentolate Hydrochloride eye drops

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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- 12 years) is 1 drop of Minims® Cyclopentolate Hydrochloride 1% w/v in each eye. For children above 12 years, the same dose as adults is recommended. 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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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
  • anaphylactic reaction and anaphylactic shock may occur. The symptoms of severe allergic reaction are difficulty breathing or swallowing, swelling of the face, lips, throat or tongue.

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 speech
  • confusion
  • hallucinations
  • unusual behaviour
  • necrotising colitis (in preterm infants). It is an intestinal disease with swelling or bloating of the abdomen, bloody stool, diarrhea, poor feeding and vomiting
  • seizures.

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.

Reporting of side effects

UK: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Malta: If you develop any side effects, including any that are not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website www. medicinesauthority.gov.mt/adrportal. By reporting side effects, you can help provide more information about the safety of this medicine.

5. How to store Minims® Cyclopentolate Hydrochloride eye drops

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Minims® Cyclopentolate Hydrochloride contains

  • The active substance 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 Holders:

UK:

Bausch & Lomb UK LTD
106 London Road
Kingston-Upon-Thames
Surrey
KT2 6TN
United Kingdom

MT:

Bausch Health Ireland Limited
3013 Lake Drive Citywest Business Campus
Dublin 24
D24PPT3
Ireland

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); MA 1302/00102 (MT)

DATE OF PREPARATION: March 2020