Zimed 0.3 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zimed 0.3 mg/ml eye drops solution

Bimatoprost

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 you should not give it to others, 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.

Leaflet contents

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

1. What Zimed 0.3 mg/ml eye drops solution is and what it is 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 elevated pressure in the eye. This medicine may be used alone or in combination with other eye drops called beta-blockers, which also reduce pressure.

The eye contains a clear, aqueous fluid that fills the inside of the eye. This fluid continuously drains out of the eye, and new fluid is produced to replace it. If the fluid does not drain quickly enough, pressure inside the eye increases. This medicine works by increasing the drainage of fluid, thereby reducing pressure within the eye. If this pressure is not reduced, it may lead to a condition called glaucoma and cause damage to your vision.

This medicine does not contain preservatives.

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

Do not use this medicine:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zimed 0.3 mg/ml eye drops solution.

Talk to your doctor or pharmacist if:

? You have any respiratory problems

? You have liver or kidney problems

? You have previously undergone cataract surgery

? You have or have had 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 loss of fat around the eye, which can lead to deepening of the eyelid groove, sinking of the eyes (enophthalmos), drooping of the upper eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show). These changes are usually mild, but if they become more pronounced, they may affect your field of vision. The changes may resolve 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 individuals under 18 years of age and therefore should not be used in patients under 18 years of age.

Use of Zimed 0.3 mg/ml eye drops solution with other medicines

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

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.

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

Driving and use of machines

After instillation of Zimed 0.3 mg/ml eye drops solution, blurred vision may occur for a short period of time. Do not drive or operate machinery until your vision is clear.

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

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

The recommended dose is one drop in each eye requiring treatment, once daily, in the late afternoon. Zimed 0.3 mg/ml eye drops solution must be used only in the eye.

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

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

Instructions for use:

Do not use the container if the tamper-evident seal is broken before first use.

Before using the product in the patient's eye, it is recommended to dispense the first drops away from the eye to check the pressure required to obtain just one drop, as recommended for treatment. It is also recommended not to touch the blue tip, since once the tamper-evident seal is broken and the white cap is removed, the bottle is fully open and ready to administer drops.

• Wash your hands. Tilt your head backwards 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 requiring treatment.
• Release the lower eyelid and keep the eye closed for 30 seconds.

Wipe away any excess liquid that runs down your cheek.

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

If you wear contact lenses, you must remove them before using this medicine. Wait 15 minutes after using the drops before reinserting your lenses.

If the drop misses the eye, try again.

To help prevent infections and avoid eye injury, ensure the container tip does not touch 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 any serious harm. Apply the next dose at the usual time. If you are concerned, speak to your doctor or pharmacist.

In case of overdose or accidental ingestion, go immediately to a medical center or consult a doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet 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 single drop as soon as you remember, and then continue with your usual routine. Do not apply a double dose to make up for a missed 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 properly. If you stop using Zimed 0.3 mg/ml eye drops solution, the pressure inside the eye may increase; therefore, consult your doctor before stopping treatment.

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 experiences them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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)
• Loss of fat around the eye area, which may cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping of the eyelids (ptosis), stretching of the skin around the eye (dermatocalasis involution), and increased visibility of the lower white part of the eye (inferior scleral show).

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 of 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
• Light sensitivity
• Darker iris
• Swollen and itchy eyelids
• Watery eyes
• Inflammation of the transparent layer covering the surface of the eye
• Blurred vision

Affecting the body

• Headaches
• Growth of hair around the eye

Frequency not known (cannot be estimated from available data)

Affecting the eye

• Sticky eyes
• Ocular discomfort

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Symptoms of allergic reaction (swelling, redness of the eye, skin rash)
• Dizziness
• Increased blood pressure
• Skin discoloration (periocular)

In addition to the adverse effects of Zimed 0.3 mg/ml eye drops solution, the following adverse effects have been observed with other multidose formulations of bimatoprost containing 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 haemorrhage
• Inflammation inside the eye
• Cystoid macular oedema (swelling in the retina within the eye leading to worsening of vision)
• Inflammation of the iris
• Eyelid twitching
• Eyelid contraction and separation from the surface of the eye
• Nausea
• Redness of the skin around the eye
• Weakness
• Increase in some blood test values indicating liver function

Other adverse effects reported with eye drops containing phosphate:

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse 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 stated on the label of the container and on the box after EXP:. The expiry date is the last day of the month indicated.

Store below 25°C. Keep in the original bottle and store the bottle in the outer packaging to protect from light.

The container must be discarded no later than 28 days after first opening, even if some drops remain. This will help prevent infections. To help you remember, write the date you opened the container in the space provided on the box.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. 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 substance is bimatoprost.

One ml of solution contains 0.3 mg of bimatoprost.

• The other components 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 normal acidity levels (pH levels).

Appearance of the product and contents of the pack

Zimed 0.3 mg/ml eye drops solution is a sterile, colourless 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
Werksstraße 3
92551 Stulln
Germany

This medicinal product is authorized in the European Economic Area Member States 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 the most recent revision of this leaflet: July 2022

Registration Number: 84523

Detailed 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/