Minims Cyclopentolate Hydrochloride 1.0%w/v – patient leaflet, side effects, dosage

1. What Minims® Cyclopentolate Hydrochloride eye

Minims® Cyclopentolate Hydrochloride contains a mydriatic agent. It is use Your doctor or eye specialist may use it to examine your eye more close These eye drops are also used to treat some types of inflammation of th 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 i

2. What you need to know before you use Minims®

Do not use Minims® Cyclopentolate Hydrochloride eye drops

• if you are allergic to the active substance (cyclopentolate hydrochlo
• if you have high pressure of liquid inside the eye (closed angle glau
• in babies under 28 days old (unless your doctor decides that it is ne Warnings and precautions

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 spe

at they are used for ydrochloride eye drops drops are and what they are used for d to enlarge the pupil of the eye and to paralyse the lens temporarily. ly.

e eye.

t is necessary.

Cyclopentolate Hydrochloride eye drops ride) or any of the other ingredients (listed in section 6). coma)

cessary).

cialist.

Pregnancy and breast-feeding

Tell your doctor or eye specialist, he/she may decide to use these drops Contact lenses

Your doctor will ask you to remove your contact lenses prior to the adm product on contact lenses. Therefore, do not wear your contact lenses u Driving and using machines

As with all eye drops, your vision may be blurred after putting the drop

3. How to use Minims® Cyclopentolate Hydrochlorid

Always use this medicine exactly as your doctor or pharmacist has told yo The drops are for single use only and provided in single use Minims units, any unused portion.

Dosage

• The normal adult dose is 1 or 2 drops of solution in each eye, as re

  6-8 hours, depending on the treatment.

• The normal child dose (over 3 months old-12 years) is 1 drop of Mini above 12 years, the same dose as adults is recommended. Children s Method of administration

The doctor or eye specialist will normally put the drops in your eye for y instructions carefully:

1. 1. Wash your hands.
2. 2.

   Use a mirror, this will help you to see what you are doing.

   or to prescribe you an alternative.

   inistration of the drops. There is no information on the effect of this ntil the effects of the drops have completely worn off.

   s in. Wait until your vision is clear before driving or using machines. e eye drops u. Check with your doctor or pharmacist if you are not sure. to treat both eyes if necessary. Once opened, use immediately. Discard quired. The administration of the drops can be repeated every ms® Cyclopentolate Hydrochloride 1% w/v in each eye. For children hould be observed for 45 minutes after the administration of the drops.

   ou, but if you are putting the eye drops in yourself, then follow these

P9UK0

6 77260

1. 3. Carefully dry your eyes using a tissue, and twist off the cap from th
2. 4. Pull your lower eyelid down gently, and then carefully place 1 or 2
3. 5. Close your eye and blink a few times to make sure your eye is cove
4. 6. Close the eyelids. It is advisable to press gently on the inner corner into your nose and throat. This is especially advisable in children, t
5. 7. Repeat steps 4, 5 and 6 for the other eye if necessary, then throw a If you use more Minims® Cyclopentolate Hydrochloride than you s after receiving the drops, tell your doctor or eye specialist or contact yo

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not ev The following side effects may occur:

• temporary irritation following the administration of the drops in yo
• increase of the pressure of liquid inside your eyes
• allergic reaction (including red eyes, watering of the eyes) has bee
• anaphylactic reaction and anaphylactic shock may occur. The symp swelling of the face, lips, throat or tongue.

The following side effects may occur when using an unusual dosage, es

• temporary effect on your balance
• temporary effects on your vision and speech
• confusion
• hallucinations

• unusual behaviour

  e Minims body of the unit.

  drops inside your lower eyelid.

  red by the liquid.

  of your eyelid for 3 minutes. This will help stop the solution draining he elderly and population at risk.

  way the Minims unit, even if some solution remains.

  hould, an overdose is very unlikely to occur. If you suddenly feel unwell ur nearest emergency department immediately.

  erybody gets them.

  ur eyes n rarely reported toms of severe allergic reaction are difficulty breathing or swallowing, pecially in children:

• necrotising colitis (in preterm infants). It is an intestinal disease w feeding and vomiting
• seizure

If any of the side effects gets serious, please seek immediate medical a tell your doctor or pharmacist.

Reporting of side effects

UK: If you get any side effects, talk to your doctor or pharmacist. This in possible side effects not listed in this leaflet. You can also report side eff www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the G provide more information on the safety of this medicine. Malta: If you develop any side effects, including any that are not listed i report side effects directly via the national reporting system at the web effects, you can help provide more information about the safety of this

5. How to store Minims® Cyclopentolate Hydrochlor

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 over date refers to the last day of that month.

Do not store above 25°C. Do not freeze. Store in the original package in o The drops are for single use only and provided in single use Minims units, Discard any unused portion.

Do not throw away any medicines via wastewater or household waste. A These measures will help protect the environment.

ith swelling or bloating of the abdomen, bloody stool, diarrhea, poor ttention. If you notice any side effects not listed in this leaflet, please cludes any ects directly via the Yellow Card Scheme at:

oogle Play or Apple App Store. By reporting side effects you can help n this leaflet, please contact your doctor or pharmacist. You can also site www. medicinesauthority.gov.mt/adrportal. By reporting side medicine.

ide eye drops wrap of each unit and on the carton after the letters “EXP”. The expiry rder to protect from light.

to treat both eyes if necessary. Once opened, use immediately.

sk your pharmacist how to throw away medicines you no longer use.

6. Contents of the pack and other information

What Minims® Cyclopentolate Hydrochloride contains

• The active substance is cyclopentolate hydrochloride. Each Minims of cyclopentolate hydrochloride 0.5% w/v (2.5 mg) or 1% w/v (5 m
• The other ingredients are hydrochloric acid (for pH adjustment) and
• This medicine does not contain a preservative as it is a sterile singl 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

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

unit contains approximately 0.5 ml eye drops solution g).

purified water.

e use unit.

MT: Bausch Health Ireland Limited

3013 Lake Drive Citywest Business Campus, Dublin 24,

D24PPT3, Ireland