Prospect: Patient Information

Minims Tropicamide 10 mg/ml Eye Drops in Single-Use Vial

tropicamide

Read this entire prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

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

2.What you need to know before starting to use Minims Tropicamide

3.How to use Minims Tropicamide

4.Possible adverse effects

5.Storage of Minims Tropicamide

6.Contents of the package and additional information

Minims Tropicamidain eye drop form is a medication that is applied topically to the eyes. This medication contains the active ingredient tropicamide. It is used to dilate the pupil of the eye and temporarily paralyze the internal muscles of the eye. Your doctor or ophthalmologist may use it to examine your eye or to facilitate eye surgery procedures.

Minims Tropicamida may be used alone or in combination with other eye drops.

Minims Tropicamida is indicated for use inadults (including the elderly), adolescents, and children over 6years old.

Do not use Minims Tropicamida:

• If you are allergic to tropicamida or any of the other components of this medication (including those listed in section 6);
• If you have or think you may have glaucoma. This is especially important in older patients.

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

Warnings and precautions

Consult your doctor or pharmacist before using Minims Tropicamida:

-If you have red eyes (symptoms of inflammation);

-If you notice signs of skin irritation or allergic skin reaction after using this medication;

-If you experience increased pressure within the eye;

-If you have kidney or liver insufficiency;

-If you cannot use medications called tropane alkaloids (belladonna alkaloids), as you may be more likely to experience side effects.

Be especially careful if Minims Tropicamida is administered to children. If this medication is used incorrectly for a prolonged period, it may be absorbed into the systemic circulation, especially in children.Closure of the eyelids and gentle pressure on the inner angle of the eyelid for 2minutes will reduce systemic absorption.This will prevent the solution from entering the nose and throat. This is especially recommended for children.

Children and adolescents

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

Minims Tropicamida is not recommended for use in children under 6 years old.

Other medications and Minims Tropicamida

Inform your doctor or pharmacist if you are using, have used recently, or may use any other medication.

This is especially important if you are taking medications for depression (antidepressants), anxiety (central nervous system depressants), and heart disease (hypotensives and cardiovascular medications).

No interactions between topical ocular tropicamida and other medications are known.However,

Minims Tropicamida may intensify the effect of other medications of the same class (mydriatics and cycloplegics).

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

The excretion of tropicamida in human breast milk after topical ocular use is unknown.

No data are available on the effects of tropicamida on human fertility.

Driving and operating machinery

This medication may cause blurred vision and light sensitivity. This can affect your perception of depth and, therefore, has a negative impact on your ability to drive. Do not drive or operate machinery until your vision is clear.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication should not be used for a longer period than recommended by your doctor. This medication may be used alone or in combination with other eye medications.

This medication should be used locally in the eyes. You may use a mirror, which will help you see what you are doing.

The normal dose for adults (including the elderly), adolescents, and children aged 6 years and older is 1 drop, followed by a second drop after a 5-minute interval. You may need to instill 1 additional drop after 30 minutes.

Usage Instructions:

1. Wash your hands.
2. Remove your contact lenses (if applicable).
3. Gently pat the eye dry with a paper towel.Twist and pull the cap to separate it from the Minims Tropicamide body (Figure1).

Figura 1

1. Gently pull down your lower eyelid and then carefully apply 1 drop inside the inner corner of the eyelid (Figures 2 and 3).Avoid touching the eye with the tip of the container to avoid eye damage and contaminate the solution.

Figura 2 Figura 3

1. Close your eyelids and press gently on the inner corner of the eyelid for 2 minutes.This will prevent the solution from going towards the nose and throat (Figure4).

Figura 4

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

The eye drop is for single use and is provided in single-use units, to be used in both eyes if necessary. Once the single-use container is opened, it must be used immediately. Discard any unused portion.

If you use Minims Tropicamide with other topical eye medications, you should wait at least 5 minutes between the administration of each medication.Eye gels and ointments should always be administered last.

Use in children under 6 years

Minims Tropicamide is not recommended for use in children under 6 years.

If you use more Minims Tropicamide than you should

A overdose is very unlikely to occur.

The symptoms of an overdose may include: skin redness and dryness (may present with rash in children), blurred vision, rapid and irregular pulse, fever, abdominal swelling in infants, convulsions, hallucinations, or loss of coordination.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Go to the hospital, as severe adverse reactions may occur (especially in children).

If you forgot to use Minims Tropicamide

You should not apply a double dose to compensate for the missed dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common:may affect more than 1 in 10 patients

• Eye pain
• Blurred vision

Unknown frequency:cannot be estimated from available data

• Photophobia (light sensitivity)
• Transient ocular itching
• Increasedintraocular pressure
• Dry mouth
• Allergic reactions (hypersensitivity)
• Nausea
• Dizziness
• Headache
• Fainting
• Decreased blood pressure

Among the systemic side effects of tropicamide, the following may be included: skin redness, skin dryness, cardiac frequency alterations, decreased sweating, decreased gastrointestinal motility and constipation, inability to fully empty the bladder, and decreased nasal, bronchial, and lacrimal secretions.

Additional side effects in children

Very common:may affect more than 1 in 10 patients

• Blurred vision

Unknown frequency:cannot be estimated from available data

• Increasedintraocular pressure

With this class of drugs, especially in children, changes in behavior, confusion, excitement, hallucinations, increased somnolence, rapid breathing, and changes in heart rate have been reported, requiring urgent medical advice and attention.

Reporting of side effects

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

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

Do not store at a temperature above 25°C. Do not freeze.

Store in the original packaging to protect it from light and humidity.

Do not use this medication after the expiration date that appears on the carton box and on the pouch of the packaging, after «EXP». The expiration date is the last day of the month indicated.

Do not use this medication if you observe any visible signs of deterioration.

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. Ask your pharmacist how to dispose of the medications you no longer need. By doing so, you will help protect the environment.

Contents of Minims Tropicamida

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

Appearance of the product and contents of the packaging

Minims Tropicamida is a transparent and colorless, sterile, and single-use solution that practically contains no visible particles and is presented in a conical and sealed container with a screw cap. Each unit is wrapped in a polypropylene/paper bag. Each container contains approximately 0.5ml of solution.

Each box contains 20 sterile single-use containers of 0.5ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Responsible for manufacturing

Laboratoire Chauvin

Zone Industrielle de Ripotier, 50 Avenue Jean Monnet,

07200, Aubenas, France

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization.

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4, 28108 Alcobendas

Madrid, Spain.

Phone: 91 – 657 63 00

This medication is authorized in the member states of the European Economic Area with the following names:

This leaflet was last revised in December 2021

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