ZIMED 0.3 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Zimed 0.3 mg/ml eye drops, solution

Bimatoprost

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

? Keep this package leaflet, 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

? If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Zimed 0.3 mg/ml eye drops, solution and what is it used for
2. What you need to know before you use Zimed 0.3 mg/ml eye drops, solution
3. How to use Zimed 0.3 mg/ml eye drops, solution
4. Possible side effects
5. Storage of Zimed 0.3 mg/ml eye drops, solution
6. Contents of the pack and other information

1. What is Zimed 0.3 mg/ml eye drops, solution and what is it used for

Zimed 0.3 mg/ml eye drops, solution is a medicine for glaucoma. Zimed 0.3 mg/ml eye drops, solution belongs to a group of medicines called prostamides.

Zimed 0.3 mg/ml eye drops, solution is used to reduce high pressure in the eye. This medicine can be used alone or with other eye drops called beta-blockers that also reduce pressure.

The eye contains a clear, watery liquid that fills the inside of the eye. This liquid is constantly drained out of the eye and new liquid is produced to replace it. If the liquid does not drain quickly enough, the pressure inside the eye increases. This medicine works by increasing the drainage of the liquid. This reduces the pressure inside the eye. If this pressure is not reduced, it could lead to a disease called glaucoma and damage your vision.

This medicine does not contain preservatives.

2. What you need to know before you use Zimed 0.3 mg/ml eye drops, solution

Do not use this medicine:

? If you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start using Zimed 0.3 mg/ml eye drops, solution.

Tell your doctor or pharmacist if:

? You have any breathing problems

? You have liver or kidney problems

? You have had cataract surgery in the past

? You have low blood pressure or a slow heart rate

? You have had a viral infection or inflammation of the eye

If you have a history of hypersensitivity to silver, you should not use this product.

During treatment, Zimed 0.3 mg/ml eye drops, solution may cause fat loss around the eye that can lead to deepening of the eyelid sulcus, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involution of the dermatocalasis), and the white part of the eye becoming more visible (inferior scleral exposure). The changes are usually mild, but if they worsen, they can affect your field of vision. The changes may disappear if you stop using Zimed 0.3 mg/ml eye drops, solution.

Zimed 0.3 mg/ml eye drops, solution may also cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. The color of the iris may darken. These changes may be permanent and more noticeable if only one eye is being treated.

Children and adolescents

Zimed 0.3 mg/ml eye drops, solution has not been studied in children under 18 years of age and should not be used in patients under 18 years of age.

Using Zimed 0.3 mg/ml eye drops, solution with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Zimed 0.3 mg/ml eye drops, solution may pass into breast milk, so you should not use it if you are breastfeeding.

Driving and using machines

After using Zimed 0.3 mg/ml eye drops, solution, blurred vision may occur for a short time. Do not drive or use machines until your vision is clear.

3. How to use Zimed 0.3 mg/ml eye drops, solution

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

The recommended dose is one drop in each eye that needs treatment, once a day, in the evening. Zimed 0.3 mg/ml eye drops, solution should only be used in the eye.

If you are using Zimed 0.3 mg/ml eye drops, solution with another eye medicine, wait at least 5 minutes between using Zimed 0.3 mg/ml eye drops, solution and the other eye medicine.

Do not use the medicine more than once a day, as this may reduce the effectiveness of the treatment.

Instructions for use:

Do not use the container if the protective seal is broken before using it for the first time.

Before using the product in the patient's eye, it is recommended to discard the first drops to check the force needed to obtain only one drop as recommended for treatment. It is also recommended not to touch the blue tip, as once the protective seal is broken and the white cap is removed, the bottle is completely open and ready to apply drops.

• Wash your hands. Tilt your head back and look up at the ceiling.
• Gently pull down the lower eyelid until a small pocket is formed.
• Invert the container and squeeze it to release one drop into each eye that needs treatment.
• Release the lower eyelid and keep the eye closed for 30 seconds.

Wipe away any excess that runs down your cheek.

After use and before replacing the cap, the bottle should be shaken once downwards, without touching the dropper tip, to remove any residual liquid that remains on the tip.

If you wear contact lenses, you should remove them before using this medicine. Wait 15 minutes after using the drops before putting your lenses back in.

If the drop falls outside the eye, try again.

To help prevent infections and avoid eye injuries, avoid touching the tip of the container to the eye or any other surface. Replace the cap and close the container immediately after use.

If you use more Zimed 0.3 mg/ml eye drops, solution than you should

If you use more of this medicine than you should, it is unlikely to cause you any serious harm. Apply the next dose at the usual time. If you are concerned, talk to your doctor or pharmacist.

In case of overdose or accidental ingestion, go immediately to a medical center or talk to a doctor, pharmacist, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to take the container and the package leaflet of the medicine to the healthcare professional.

If you forget to use Zimed 0.3 mg/ml eye drops, solution

If you forget to apply this medicine, use one drop as soon as you remember, and then return to your usual routine. Do not apply a double dose to make up for the forgotten dose.

If you stop using Zimed 0.3 mg/ml eye drops, solution

Zimed 0.3 mg/ml eye drops, solution should be used every day for it to work well. If you stop using Zimed 0.3 mg/ml eye drops, solution, the pressure in the eye may increase, so talk to your doctor before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Very common(may affect more than 1 in 10 people)

Affecting the eye

• Mild redness (up to 24% of people)
• Fat loss in the eye area that can cause deepening of the eyelid sulcus, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (involution of the dermatocalasis), and the white part of the eye becoming more visible (inferior scleral exposure).

Common(may affect up to 1 in 10 people)

Affecting the eye

• Small erosions on the surface of the eye, with or without inflammation
• Irritation
• Itching in the eyes
• Pain
• Dryness
• Feeling of having something in the eye
• Longer eyelashes
• Darker skin around the eye
• Red eyelids

Uncommon(may affect up to 1 in 100 people)

Affecting the eye

• Tired eyes
• Sensitivity to light
• Darker iris
• Inflamed and itchy eyelids
• Excessive tearing
• Inflammation of the clear layer that covers the surface of the eye
• Blurred vision

Affecting the body

• Headaches
• Hair growth around the eye

Frequency not known(cannot be estimated from the available data)

Affecting the eye

• Sticky eyes
• Eye discomfort

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of the lung disease called chronic obstructive pulmonary disease (COPD)
• Breathing difficulties
• Symptoms of an allergic reaction (inflammation, redness of the eye, and skin rash)
• Dizziness
• Increased blood pressure
• Discoloration of the skin (around the eye)

In addition to the side effects of Zimed 0.3 mg/ml eye drops, solution, the following side effects have been observed with other multi-dose formulations of bimatoprost with preservatives and may occur in patients using Zimed 0.3 mg/ml eye drops, solution:

• Burning sensation in the eye
• Allergic reaction in the eye
• Eyelid inflammation
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Cystoid macular edema (inflammation of the retina inside the eye that leads to worsening of vision)
• Iris inflammation
• Eyelid twitching
• The eyelid has contracted and separated from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increased levels of some blood test values that indicate how the liver is working

Other side effects reported with eye drops containing phosphate:

This medicine contains 0.99 mg of phosphate per milliliter of solution.

If you have severe corneal damage (the transparent layer on the front of the eye), treatment with phosphates, in very rare cases, can cause blurred vision due to calcium accumulation.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zimed 0.3 mg/ml eye drops, solution

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 label of the container and on the carton after EXP:. The expiry date is the last day of the month shown.

Store below 25°C. Store in the original container and keep the container in the outer packaging to protect it from light.

You should throw away the container, at the latest, 28 days after you first opened it, even if there are still some drops left. This will help prevent infections. To remind you, write the date you opened the container on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Dispose of the container and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zimed 0.3 mg/ml eye drops, solution

? The active ingredient is bimatoprost.

One milliliter of solution contains 0.3 mg of bimatoprost.

? The other ingredients are sodium chloride, disodium phosphate heptahydrate, citric acid monohydrate, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain the normal level of acidity (pH levels).

Appearance of the product and contents of the pack

Zimed 0.3 mg/ml eye drops, solution is a sterile, colorless, and transparent solution supplied in a plastic bottle with a screw cap. Each bottle contains 3 ml of solution. The contents are sufficient for 4 weeks of treatment.

Each pack contains one or three bottles. Not all pack sizes may be marketed.

Novelia system with a low-density polyethylene bottle closed with a white nozzle subassembly and cap (high-density polyethylene and silicone).

Marketing authorization holder and manufacturer

Marketing authorization holder

Medicom Healthcare Ireland Limited

3rd Floor 40

Mespil Road

Dublin 4, D04 C2N4

Ireland

Manufacturer

Famar Health Care Services Madrid SAU

Avda. Leganés, 62

28923 Alcorcón (Madrid)

Spain

or

Pharma Stulln GmbH

7 of 7

Werksstraße 3

92551 Stulln

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

France: Bimatoprost Zimed sans conservateur 0.3 mg/mL collyre en solution

Germany: Bimatoprost Stulln 0.3 mg/mL Augentropfen, Lösung

Italy: Bimatoprost Medicom 0.3 mg/ml collirio, soluzione

Netherlands: Bimatoprost Stulln 0.3 mg/ml oogdruppels, oplossing

Spain: Zimed 0.3 mg/ml colirio en solución

United Kingdom (Northern Ireland): Zimed Preservative Free 0.3 mg/mL, eye drops, solution

Date of last revision of this leaflet: July 2022

No Registration: 84523

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/