Minims Tropicamide 10 mg/ml eye drops solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Minims Tropicamide 10 mg/ml eye drops solution in single-dose container

tropicamide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Minims Tropicamide is and what it is used for
2. What you need to know before using Minims Tropicamide
3. How to use Minims Tropicamide
4. Possible side effects
5. How to store Minims Tropicamide
6. Contents of the pack and other information

1. What Minims Tropicamide is and what it is used for

Minims Tropicamide eye drops is a medicine applied topically to the eyes. This medicine contains the active substance tropicamide. It is used to enlarge the pupil of the eye and to temporarily paralyse the internal eye muscles. Your doctor or ophthalmologist may use it to examine your eye or to facilitate ocular surgical procedures.

Minims Tropicamide may be used alone or in combination with other ophthalmic medicines.

Minims Tropicamide is indicated for use in adults (including elderly people), adolescents, and children over 6 years of age.

2. What you need to know before using Minims Tropicamide

Do not use Minims Tropicamide:

• If you are allergic to tropicamide or to any of the other ingredients of this medicine (listed in section 6);
• If you have or suspect you may have glaucoma. This is especially important in elderly patients.

Do not use this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before using Minims Tropicamide.

Warnings and precautions

Consult your doctor or pharmacist before using Minims Tropicamide:

• If you have red eyes (symptoms of inflammation);
• If you notice signs of skin irritation or allergic skin reaction after using this medicine;
• If you have increased pressure inside the eye;
• If you have renal or hepatic impairment;
• If you are unable to take medications known as tropane alkaloids (belladona alkaloids), as you may be more likely to experience side effects.

Take special care when Minims Tropicamide is administered to children. If this medicine is used incorrectly over a prolonged period, it may be absorbed into the systemic circulation, especially in children. Close the eyelids and gently press on the inner corner of the eye for 2 minutes to reduce systemic absorption. This will prevent the solution from draining into the nose and throat. This is especially recommended in children.

Children and adolescents

Consult your doctor about the use of Minims Tropicamide in children and adolescents, so that they can decide whether this medicine is suitable for you or your child.

The use of Minims Tropicamide is not recommended in children under 6 years of age.

Other medicines and Minims Tropicamide

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This is especially important if you are taking medicines for the treatment of depression (antidepressants), anxiety (central nervous system depressants), or heart conditions (hypotensives and cardiovascular medicines).

No interactions are known between tropicamide used topically in the eye and other medicines. However,

Minims Tropicamide could intensify the effect of other medicines of the same class (mydriatics and cycloplegics).

If you use Minims Tropicamide together with other topical ophthalmic products, you should wait at least 5 minutes between the administration of each medicine. Ophthalmic gels and ointments should always be administered last.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor may decide to prescribe this eye drop or recommend an alternative treatment.

It is unknown whether tropicamide is excreted in human breast milk following ophthalmic use.

There are no data on the effects of tropicamide on fertility in humans.

Driving and using machines

This medicine may cause blurred vision and light sensitivity. This may affect your depth perception and, therefore, have a negative effect on your ability to drive. Do not drive or operate machinery until your vision is clear.

3. How to use Minims Tropicamide

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine should not be used for longer than recommended by your doctor. This medicine may be used alone or in combination with other ophthalmic medicines.

This medicine is for local use in the eyes. You may use a mirror to help you see what you are doing.

The usual dose for adults (including elderly patients), adolescents, and children aged 6 years and older is 1 drop, followed by a second drop after an interval of 5 minutes. An additional drop may be required after 30 minutes.

Instructions for use:

1. Wash your hands.
2. Remove contact lenses (if applicable).
3. Carefully dry the eye with a tissue. Unscrew and discard the cap to separate it from the body of the Minims Tropicamide unit (Figure 1).

Figure 1

1. Gently pull down your lower eyelid and then carefully instill 1 drop inside the lower eyelid (Figures 2 and 3). Avoid touching the eye with the tip of the container to prevent eye injury and contamination of the solution.

Figure 2 Figure 3

1. Close your eyelids and gently press on the inner corner of the eyelid for 2 minutes. This will prevent the solution from draining into the nose and throat (Figure 4).

Figure 4

1. Repeat steps 4 and 5 in the other eye if necessary; then discard the unit, even if some solution remains.
2. Wash your hands after using the product.

The eye drops are for single use only and are supplied in single-dose units, to be used in both eyes if necessary. Once the single-dose container has been opened, it should be used immediately. Discard any unused portion.

If you are using Minims Tropicamide together with other topical ophthalmic products, you should wait at least 5 minutes between the administration of each medication. Ophthalmic gels and ointments should always be administered last.

Use in children under 6 years of age

The use of Minims Tropicamide is not recommended in children under 6 years of age.

If you use more Minims Tropicamide than you should

It is very unlikely that an overdose will occur.

Symptoms of overdose may include: skin redness and dryness (rash may occur in children), blurred vision, rapid and irregular pulse, fever, abdominal swelling in infants, seizures, hallucinations, or loss of coordination.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Go to the hospital, as serious adverse reactions may occur (especially in children).

If you forget to use Minims Tropicamide

Do not apply a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 patients

• Eye pain
• Blurred vision

Frequency not known: cannot be estimated from the available data

• Photophobia (sensitivity to light)
• Itching of the eye (transient)
• Increased pressure within the eye
• Dry mouth
• Allergic reactions (hypersensitivity)
• Nausea
• Dizziness
• Headache
• Fainting
• Low blood pressure

Systemic adverse effects of tropicamide may include: skin flushing, dry skin, changes in heart rate, decreased sweating, decreased gastrointestinal motility and constipation, inability to completely empty the bladder, and decreased nasal, bronchial, and lacrimal secretions.

Additional adverse effects in children

Very common: may affect more than 1 in 10 patients

• Blurred vision

Frequency not known: cannot be estimated from the available data

• Increased pressure within the eye

With this class of drugs, especially in children, behavioral changes have been reported, including confusion, excitement, hallucinations, increased drowsiness, rapid breathing, and changes in pulse rate, which require medical advice and urgent medical attention.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Minims Tropicamide

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

Do not store above 25 °C. Do not freeze.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the cardboard box and on the outer bag, following «EXP». The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Contents of Minims Tropicamide

• The active substance is tropicamide. One ml of eye drops contains 10 mg of tropicamide.
• The other components are sodium hydroxide, hydrochloric acid and purified water.

Nature and contents of the container

Minims Tropicamida is a sterile, single-use, clear and colourless solution which practically contains no visible particles, presented in a sealed conical container with a screw cap. Each unit is individually wrapped in a polypropylene/paper pouch. Each container holds approximately 0.5 ml of solution.

Each carton contains 20 sterile single-dose containers of 0.5 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

Laboratoire Chauvin

Zone Industrielle de Ripotier, 50 Avenue Jean Monnet,

07200, Aubenas, France

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4, 28108 Alcobendas

Madrid, Spain.

Tel: 91 – 657 63 00

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

This leaflet was last reviewed in December 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): https://www.aemps.gob.es/