ABIPROST 0.3 mg/ml EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Abiprost 0.3 mg/ml eye drops solution in single-dose container

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 Abiprost and what is it used for
2. What you need to know before you use Abiprost
3. How to use Abiprost
4. Possible side effects
5. Storage of Abiprost
6. Contents of the pack and further information

1. What is Abiprost and what is it used for

Abiprost 0.3 mg/ml single-dose is a medicine for glaucoma. Abiprost belongs to a group of medicines called prostamides.

Abiprost 0.3 mg/ml eye drops single-dose 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 keeps the inside of the eye healthy. 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 Abiprost

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:

Consult your doctor or pharmacist before starting to use Abiprost.

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 low blood pressure or a slow heart rate
• you have had a viral infection or inflammation of the eye

During treatment, Abiprost may cause loss of fat around the eye, which can cause deepening of the eyelid sulcus, sinking of the eyes (enophthalmos), drooping of the eyelids (ptosis), stretching of the skin around the eye (involution of dermatocalasis), and the white part of the eye becomes more visible (inferior scleral exposure). The changes are usually mild, but if they become more pronounced, they can affect your field of vision. The changes may disappear if you stop using Abiprost. Abiprost may also cause darkening and growth of the 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

Abiprost has not been studied in children under 18 years of age and therefore should not be used in patients under 18 years of age.

Other medicines and Abiprost

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.

Abiprost may pass into breast milk, so you should not use it if you are breastfeeding.

Driving and using machines

After instilling Abiprost, blurred vision may occur for a short time. Do not drive or use machines until you can see clearly.

3. How to use Abiprost

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

The recommended dose is one drop in each eye that needs treatment, once a day, in the evening. Abiprost should only be used in the eye.

If you use Abiprost with another eye medicine, wait at least 5 minutes between using Abiprost and the other eye medicine.

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

Wash your hands before using it. Make sure the single-dose container is intact before using this medicine. The solution should be used immediately after opening the container. To avoid contamination, do not let the tip of the single-dose container touch the eye or any other surface.

1. Take a single-dose container and hold it in an upright position (with the cap facing up) and twist the cap until it comes off.
2. Gently pull the lower eyelid down to form a pouch. Invert the single-dose container and squeeze until one drop falls into the eye or eyes to be treated.
3. Discard the single-dose container after use, even if there is still solution inside.

Wipe away any excess that runs down your cheek.

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 you use more Abiprost 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Abiprost

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

If you stop using Abiprost

Abiprost should be used every day for it to work well. If you stop using Abiprost, the pressure in the eye may increase, so consult your doctor before stopping treatment.

If you have any other questions about 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.

Very common side effects

These may affect more than 1 in 10 people

Affecting the eye

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

Common side effects

These may affect between 1 and 9 people in 100Affecting 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 side effects

These may affect between 1 and 9 people in 1,000

Affecting the eye

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

Affecting the body

• Headaches

• Growth of hair around the eye

Side effects of unknown frequency

Affecting the body

• Asthma
• Worsening of asthma
• Worsening of chronic obstructive pulmonary disease (COPD)
• Breathing difficulties
• Symptoms of allergic reaction (inflammation, redness of the eye, and skin rash).
• Dizziness
• High blood pressure
• Discoloration of the skin (periorbital)

Affecting the eye

• Sticky eyes
• Eye discomfort

In addition to the side effects mentioned above, the following side effects have been observed with the multidose formulation with preservative of bimatoprost and may occur in patients using Abiprost 0.3 mg/ml single-dose:

• Burning sensation in the eye
• Allergic reaction in the eye
• Inflammation of the eyelid
• 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)
• Inflammation of the iris
• Lid 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 liver function tests in the blood

Other side effects reported with phosphate-containing eye drops:

This medicine contains 0.38 mg of phosphate in each single-dose.

If you have severe damage to the clear layer on the front of the eye (cornea), treatment with phosphates, in very rare cases, may cause blurred vision due to calcium deposits.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abiprost

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

This medicine is for single use and does not contain preservatives. Do not store the unused solution.

Do not use this medicine after the expiry date which is stated on the single-dose container and on the aluminum pouch after the expiry date (EXP):. The expiry date is the last day of the month shown.

This medicine does not require any special storage temperature. However, once the aluminum pouch is opened, it should be used within 30 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Abiprost 0.3 mg/ml eye drops solution in single-dose container

• The active substance is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.
• The other ingredients are sodium chloride, anhydrous sodium hydrogen phosphate, citric acid monohydrate, and water for injections. 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 pack contents

Abiprost 0.3 mg/ml eye drops solution in single-dose container is a clear and transparent solution supplied in plastic single-dose containers, each containing 0.4 ml of solution.

Each 5 single-dose containers are packaged in an aluminum pouch.

Each carton contains 30 single-dose containers.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Tiedra Farmacéutica, S.L.

C/ Colón, 7

30510 Yecla

Murcia

Spain

Manufacturer

Laboratorios Lesvi, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Date of last revision of this leaflet: February 2022

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)