Patient Information Leaflet

Minims®FPhenylephrine Hydrochloride 100mg/mlEye Drops Solution

Phenylephrine Hydrochloride

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

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

This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

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

Minims fenilefrina hydrochloride 100 mg/ml contains hydrochloride of phenylephrine, an active substance that is used to dilate the pupil of your eye.

This eye drop is used to dilate the pupil (mydriasis), in the case of an eye examination or during eye surgery.

Do not use Minims Fenilefrina hydrochloride eye drops:

• if you are allergic to the active ingredient (fenilefrina) or any of the other components of this medication as listed in section6.
• if you experience an increase in pressure (angle-closure glaucoma).
• in newborns.
• in children under 12 years old.
• if you have high blood pressure.
• if you have heart disease, rapid heartbeats (tachycardia), dilations in main blood vessels (aneurysms), diabetes, or have a thyroid disease.
• If you are receiving treatment with antidepressants (IMAO, tricyclic antidepressants) or blood pressure medications (including beta-blockers). Consult the section “Other medications and Minims Fenilefrina hydrochloride”.

Warnings and precautions

Speak with your doctor or pharmacist before using Minims Fenilefrina hydrochloride eye drops.

• If you have high blood pressure (hypertension) or a vascular disease, atherosclerosis, or if you have a contraindication for the use of medications that increase blood pressure in general, repeated administrations should be avoided.
• Use with caution in elderly patients and in individuals with pre-existing high blood pressure due to a higher risk of adverse effects on the heart and blood vessels.
• Minims Fenilefrina hydrochloride 100 mg/ml should not be used in children under 12 years old, as children appear to be more sensitive to the risk of severe adverse effects.
• Minims Fenilefrina hydrochloride 100 mg/ml is not recommended for use in children 12 to 18 years old, as there is no adequate clinical experience.
• If you have asthma.
• Before each use, it is necessary for the ophthalmologist to evaluate the depth of the anterior chamber to reduce the risk of angle-closure glaucoma.
• Be cautious in case of hyperemia (excessive blood in the eye), as there may be increased blood absorption.
• The transparency of the cornea may decrease if this medication is instilled when the cornea has been damaged or removed.
• Do not use contact lenses when using this product.
• For single use only. The dose of Minims Fenilefrina hydrochloride should be discarded immediately after use.
• In the case of concomitant treatment with other eye drops containing active substances, a period of 15 minutes should be maintained between administrations.

Other medications and Minims Fenilefrina hydrochloride

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

• If you use medications to treat high blood pressure (particularly beta-blockers) because fenilefrina may reverse the blood pressure-reducing effect of these medications and may increase blood pressure.
• Inform your doctor if you are receiving treatment for depression.
• This medication should be used with caution if you are taking antidepressants such as MAO inhibitors or within 10 days of taking these medications. When tricyclic antidepressants are used, there is a higher risk of adverse effects on the heart and blood vessels. This risk is still present for several days after stopping treatment with these antidepressants.
• There is a higher risk of cardiac arrhythmias with concomitant use of certain anesthetics (halothane) or other heart medications (cardiac glycosides or quinidine).

Pregnancy, breastfeeding, and fertility

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

There is little or no information on the use of fenilefrina in pregnant women or breastfeeding women. This medication should not be used during pregnancy or breastfeeding unless absolutely necessary.

No animal reproduction studies have been conducted with topical fenilefrina.

Driving and operating machinery

Due to the effect on vision (pupil dilation), use may have adverse effects on the ability to drive and operate machinery. Do not drive vehicles or operate machinery until vision is normal.

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

The recommended dose is 1, 2, or 3 instillations every few minutes.

Minims Fenilefrina hydrochloride is designed for single use and must be discarded immediately after use.

Do not touch the eye with the tip of the container Minims Fenilefrina hydrochloride.Minims Fenilefrina hydrochloride.

After administration of the eye drops, the following measures should be taken to reduce systemic absorption:

• Keep the eyelids closed for 2 minutes;
• Keep the lacrimal sac closed by pressing it with your finger for 2 minutes.

If you use more Minims Fenilefrina hydrochloride than you should.

In the case of an ocular overdose, the dilation of the pupil can be easily and quickly eliminated by a miotic.

Accidental oral ingestion may cause side effects such as headache, palpitations, and hypertension.

These symptoms should be treated symptomatically.

In the case of a phenylephrine overdose, a severe toxic reaction may occur quickly, but this will be of short duration. Therefore, treatment is mainly symptomatic. Immediate injection of a rapid-acting alpha-adrenergic blocker such as fentolamine (2-5 mg, IV) is recommended.

In case of overdose, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20 immediately.

If you forget to use Minims Fenilefrina hydrochloride.

Do not take a double dose to compensate for a missed dose.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following side effects have been reported:

Eye Effects

Symptoms of allergy such as conjunctivitis and keratitis may appear, with redness, burning, itching, and photophobia. If such symptoms occur, treatment should be discontinued. Pupil constriction (miosis) may occur after treatment is discontinued.

Systemic Effects

With frequent and long-term administration, it is possible for the medication to be absorbed into the bloodstream and the following adverse effects may occur: headache, palpitations, hypertension, rapid heart rate, shortness of breath (lack of breath), dizziness. Severe cardiovascular reactions, including coronary artery spasms, cardiac arrhythmias, and myocardial infarction, have been reported after topical use of phenylephrine hydrochloride 100 mg/ml solution. In patients with pre-existing cardiovascular disease, these reactions were sometimes fatal.

Additional Adverse Effects in Children:Unknown frequency (cannot be estimated from available data) fluid or swelling in the lungs

Reporting Adverse Effects

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

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

Store at temperatures below 25°C in the original container to protect it from light.

Do not use this medication after the expiration date that appears on the box after “EXP”. The expiration date is the last day of the month indicated.

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

Composition of Minims Fenilefrina hydrochloride

• The active ingredient is fenilefrina hydrochloride: 100 mg/ml.
• The other excipients are: edetate disodium, sodium metabisulphite and purified water.

Appearance of the product and contents of the packaging

MINIMS containers and polypropylene lids, containing 0.5 ml of solution. Each MINIMS is packaged in a polypropylene pouch. Boxes of 5 and 20 MINIMS.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer:

Laboratoire Chauvin

Z.I.Ripotier

07200 Aubenas – France

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

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 428108 Alcobendas

Madrid

Tel: 91 – 657 63 00

Date of the last review of this leaflet:September/2024

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/