Label: information for the user

Zimed 0.3 mg/ml eye drops solution

Bimatoprost

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

?Keep this label, as you may need to read it again.

?If you have any questions, consult your doctor or pharmacist.

?This medication has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

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.Storage of Zimed 0.3 mg/ml eye drops solution

6.Contents of the package and additional information

Zimed 0.3 mg/ml eye drops solution is a medication for glaucoma. Zimed 0.3 mg/ml eye drops solution belongs to a group of medications called prostaglandins.

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

The eye contains a clear, watery liquid that occupies the inner part of the eye. This liquid drains continuously out of the eye and new liquid is generated to replace it. If the liquid does not drain at a sufficient speed, the pressure inside the eye increases. This medication acts by increasing the drainage of the liquid. This reduces the pressure inside the eye. If this pressure is not reduced, it could cause a disease called glaucoma and damage your vision.

This medication does not contain preservatives.

Do not use this medication:

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

Warnings and precautions

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

Talk to your doctor or pharmacist if:

?You have any respiratory problems

?You have liver or kidney problems

?You have had cataract surgery in the past

?You have or have had low blood pressure or a low heart rate

?You have had a viral infection or eye inflammation

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

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

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

Children and adolescents

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

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

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

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

If you use Zimed 0.3 mg/ml eye drop solution with another eye medication, wait at least 5 minutes between the use of Zimed 0.3 mg/ml eye drop solution and the other eye medication.

Do not use the medication more than once a day, as it 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 pour the first drops out of the eye to check the force needed to obtain only one drop as recommended for treatment. It is also recommended not to touch the blue tip since 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.

-Gently pull down the lower eyelid until a small space is created.

-Invert the container and press it to release one drop in each eye that requires 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 putting the cap back on, the bottle should be shaken once downwards, without touching the tip of the dropper, to remove any residual liquid that may be left in the tip.

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

If the drop falls outside the eye, try again.

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

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

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

Incase of overdose or accidental ingestion, go immediately to a medical center or consult a doctor, pharmacist, or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.It is recommended to bring the container and the medication leaflet to the healthcare professional.

If you forgot to use Zimed 0.3 mg/ml eye drop solution

If you forgot to apply this medication, use one drop as soon as you remember, and then return to your usual routine. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment with Zimed 0.3 mg/ml eye drop solution

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

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

Affecting the eye

• Mild redness (affecting up to 24% of people)
• Loss of fat in the eye area that can cause deepening of the eyelid groove, sunken eyes (enophthalmos), drooping eyelids (ptosis), stretching of the skin around the eye (dermatochalasis involution) and making the lower white part of the eye more visible (exposure of the inferior sclera).

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
• Sensation 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
• Swollen and itchy eyelids
• Excessive tearing
• Inflammation of the transparent layer covering the surface of the eye
• Blurred vision

Affecting the body

• Headaches
• Excessive hair growth 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 chronic obstructive pulmonary disease (COPD)
• Difficulty breathing
• Allergic reaction symptoms (inflammation, redness of the eye and skin rash)
• Dizziness
• Increased blood pressure
• Decoloration of the skin (periocular)

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

• Burning sensation in the eye
• Allergic reaction in the eye
• Swollen eyelid
• Difficulty seeing clearly
• Worsening of vision
• Darker eyelashes
• Retinal hemorrhage
• Inflammation inside the eye
• Macular edema (inflammation of the retina inside the eye that leads to worsening of vision)
• Inflammation of the iris
• Fasciculations of the eyelid
• 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 tests that indicate how the liver is functioning

Other side effects reported with eye drops containing phosphate:

This medicine contains 0.99 mg of phosphate per milliliter of solution

If you suffer from 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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: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 use this medication after the expiration date that appears on the label of the container and on the box after CAD:. The expiration date is the last day of the month indicated.

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

You should dispose of the container, at the latest, 28 days after opening it for the first time, even if there are still some drops left. This will help prevent infections. To remember, write the date you opened the container in the space provided on the box.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Zimed 0.3 mg/mL eye drops solution

?The active ingredient is bimatoprost.

One mL of solution contains 0.3 mg of bimatoprost.

?The other components are sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain a normal pH level.

Appearance of the product and contents of the package

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 package contains one or three bottles. It is possible that not all package sizes will be marketed.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medicom Healthcare Ireland Limited

Joyce House

21-23 Holles Street

Dublin 2, D02 YP92,

Ireland

Responsible for manufacturing

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)with the following names:

France: Bimatoprost Zimedwithout preservative 0.3 mg/mL eye drops solution

Germany: Bimatoprost Stulln®0.3 mg/mL eye drops, solution

Italy: Bimatoprost Medicom 0.3 mg/ml eye drops, solution

Netherlands: Bimatoprost Stulln®0.3 mg/ml eye drops, solution

Spain: Zimed 0.3 mg/mL eye drops solution

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

Last review date of this leaflet: July 2022

NoRegistration: 84523

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