Minims Phenylephrine Hydrochloride 100 mg/ml solution for eye drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Minims®Phenylephrine hydrochloride 100 mg/ml eye drops, solution

Phenylephrine hydrochloride

Read all of this 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 further 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 may harm them.

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

Contents of this leaflet

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

1. What Minims Phenylephrine Hydrochloride Eye Drops is and what it is used for

Minims Phenylephrine Hydrochloride 100 mg/ml contains phenylephrine hydrochloride, an active substance used to enlarge the pupil of your eye.

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

2. What you need to know before Minims Phenylephrine Hydrochloride Eye Drops are administered

Do not use Minims Phenylephrine Hydrochloride Eye Drops:

• if you are allergic to the active substance (phenylephrine) or to any of the other ingredients of this medicine listed in section 6.
• if you experience increased eye pressure (closed-angle glaucoma).
• in newborns.
• in children under 12 years of age.
• if you have high blood pressure.
• if you have heart disease, rapid heartbeat (tachycardia), dilation of major blood vessels (aneurysms), diabetes, or a thyroid disorder.
• if you are receiving treatment with antidepressants (MAO inhibitors, tricyclic antidepressants) or antihypertensive medicines (including beta-blockers). See section “Other medicines and Minims Phenylephrine Hydrochloride”.

Warnings and precautions

Talk to your doctor or pharmacist before using Minims Phenylephrine Hydrochloride.

• If you have high blood pressure (hypertension) or vascular disease, atherosclerosis, or a contraindication to using medicines 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 an increased risk of cardiovascular side effects.
• Minims Phenylephrine Hydrochloride 100 mg/ml should not be used in children under 12 years of age, as children appear to be more sensitive to the risk of serious side effects.
• The use of Minims Phenylephrine Hydrochloride 100 mg/ml is not recommended in children aged 12 to 18 years, as there is insufficient clinical experience.
• If you have asthma.
• Prior to each use, an ophthalmologist must evaluate the depth of the anterior chamber to reduce the risk of closed-angle glaucoma.
• Be cautious in cases of hyperemia (excessive blood in the eye), as systemic absorption may be increased.
• Corneal transparency may decrease if this medicine is instilled when the cornea is damaged or removed.
• Do not wear contact lenses while using this product.
• For single use only. The Minims Phenylephrine Hydrochloride dose must be discarded immediately after use.
• In case of concomitant treatment with other eye drops containing active substances, a 15-minute interval must be maintained between administrations.

Other medicines and Minims Phenylephrine Hydrochloride

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

• If you are using medicines to treat high blood pressure (particularly beta-blockers), because phenylephrine may reverse the blood pressure-lowering effect of these medicines and may increase blood pressure.
• Inform your doctor if you are receiving treatment for depression.
• This medicine should be used with caution if you are taking antidepressants such as MAO inhibitors, or within 10 days after taking these medicines. When tricyclic antidepressants are used, there is an increased risk of cardiovascular adverse effects. This risk persists for several days after discontinuation of these antidepressants.
• There is an increased risk of cardiac arrhythmias when used concomitantly with certain anesthetics (halothane) or other heart medicines (cardiac glycosides or quinidine).

Pregnancy, breastfeeding and fertility

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

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

Animal reproductive studies have not been conducted with topical phenylephrine.

Driving and using machines

Due to its effect on vision (pupil dilation), this medicine may adversely affect your ability to drive or operate machinery. Do not drive or operate machinery until your vision has returned to normal.

3. How to use Minims Phenylephrine Hydrochloride eye drops

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

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

Minims Phenylephrine Hydrochloride is designed for single use and must be discarded immediately after use.

Do not touch the eye with the tip of the Minims Phenylephrine Hydrochloride container.

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

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

If you use more Minims Phenylephrine Hydrochloride than you should

In case of ocular overdose, pupil dilation can be rapidly and easily reversed with a miotic agent.

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

These effects should be treated symptomatically.

In case of phenylephrine overdose, a serious toxic reaction may occur rapidly, but it will be of short duration. Therefore, treatment is primarily symptomatic. Immediate injection of a fast-acting alpha-adrenergic blocking agent such as phentolamine (2–5 mg, IV) is recommended.

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

If you forget to use Minims Phenylephrine Hydrochloride

Do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

The following side effects have been reported:

Ocular effects

Allergic symptoms such as conjunctivitis and keratitis may occur, with redness, burning, itching, and photophobia. If such symptoms occur, treatment should be discontinued. Contraction of the pupil (miosis) may occur after stopping treatment.

Systemic effects

In case of frequent and long-term administration, absorption into the bloodstream is possible, and the following adverse effects may occur: headache, palpitations, hypertension, rapid heartbeat, difficulty breathing (shortness of breath), dizziness. Serious cardiovascular reactions have been reported after topical use of phenylephrine hydrochloride 100 mg/ml solution, including coronary artery spasm, cardiac arrhythmias, and myocardial infarction. In patients with pre-existing cardiovascular disease, these reactions have sometimes been fatal.

Additional adverse effects in children: Frequency not known (cannot be estimated from available data): fluid or swelling in the lungs

Reporting of adverse effects

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

5. Storage of Minims Phenylephrine Hydrochloride Eye Drops

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

Store below 25°C in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please 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

Composition of Minims Phenylephrine Hydrochloride

• The active substance is phenylephrine hydrochloride: 100 mg/ml.
• The other excipients are: disodium edetate, sodium metabisulfite, and purified water.

Appearance of the product and contents of the pack

MINIMS containers with polypropylene caps, containing 0.5 ml of solution. Each MINIMS is individually packed in a polypropylene pouch. Pack sizes: boxes of 5 and 20 MINIMS.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer:

Laboratoire Chauvin

Z.I. Ripotier

07200 Aubenas – France

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder.

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, nº 4

28108 Alcobendas

Madrid

Tel: 91 – 657 63 00

Date of the most recent review of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/