Label: information for the user

GANFORT 0.3mg/ml + 5mg/ml eye drops in solution

Bimatoprost/timolol

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, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.See section 4.

1.What is GANFORT and for what it is used

2.What you need to know before starting to use GANFORT

3.How to use GANFORT

4.Possible adverse effects

5Storage of GANFORT

6.Contents of the package and additional information

GANFORT contains two different active principles (bimatoprost and timolol) that reduce high eye pressure. Bimatoprost belongs to a group of medications called prostamides, a prostaglandin analogue. Timolol belongs to a group of medications called beta-blockers.

The eye contains a clear, watery liquid that maintains the interior of the eye. This liquid drains continuously from 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 and, in the long term, your vision could be damaged (a disease called glaucoma). GANFORT acts by reducing the production of liquid and also increasing the amount that drains. This reduces the pressure inside the eye.

GANFORT eye drops are used for the treatment of high eye pressure in adults, including elderly people. This high pressure can cause glaucoma. Your doctor will prescribe GANFORT if other eye drops containing beta-blockers or prostaglandin analogues have not had a sufficient effect on their own.

Do not use GANFORT eye drops in solution

-if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients in this medication (listed in section 6);

-if you have respiratory problems, such as asthma and/or severe chronic obstructive pulmonary disease (a lung disease that can cause wheezing, difficulty breathing, and/or persistent coughing) or other types of respiratory problems.

-if you have heart problems such as low heart rate, heart block, or heart failure.

Warnings and precautions

Before starting treatment with this medication, inform your doctor if you have or have had in the past

• coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or feeling of choking), heart failure, low blood pressure;
• heart rate abnormalities, such as low heart rate;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
• hyperthyroidism, as timolol may mask the signs and symptoms of thyroid diseases;
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• eye problems;
• separation of one of the layers of the interior of the eyeball after surgery to reduce eye pressure;
• known risk factors for macular edema (inflammation of the retina that causes a worsening of vision), for example, cataract surgery.

Inform your doctor before undergoing surgery that you are using GANFORT, as timolol may modify the effects of some medications used during anesthesia.

GANFORT may cause darkening and growth of eyelashes, as well as darkening of the skin around the eyelid. Over time, the color of the iris may also darken. These changes may be permanent and more noticeable if only one eye is being treated. GANFORT may cause hair growth in contact with the skin surface.

Children and adolescents

GANFORT should not be used in children and adolescents under 18 years of age.

Other medications and GANFORT

GANFORT may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment.Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Inform your doctor if you are using or plan to use medications to lower blood pressure, for the heart, for diabetes treatment, quinidine (used to treat heart conditions and some types of malaria) or for depression, known as fluoxetine and paroxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. Do not use GANFORT if you are pregnant unless your doctor recommends it.

Do not use GANFORT if you are breastfeeding. Timolol may pass into breast milk. Consult your doctor before using any medication during breastfeeding.

Driving and operating machinery

GANFORT may cause blurred vision in some patients. Do not drive or operate machinery until symptoms have disappeared.

GANFORT contains benzalkonium chloride

GANFORT contains a preservative called benzalkonium chloride.

This medication contains0.15mg of benzalkonium chloride in each3 ml of solutionequivalent to0.05 mg/ml.

Benzalkonium chloride may be absorbed bysoft contact lenses and may alter thecolor of contact lenses. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front of the eye). Consult your doctor if you feel a strange sensation, stinging, or pain in the eye after using this medication.

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

The recommended dose is one drop administered once a day, either in the morning or in the evening, in each eye that requires treatment. Use this medication every day at the same time.

Usage Instructions

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

5.

1.Wash your hands. Tilt your head back and look up towards the ceiling.

2.Gently pull your lower eyelid down until a small space is created.

3.Invert the container and press it to release one drop into each eye that requires treatment.

4.Release your lower eyelid and close your eye.

5.With your eye closed, press the corner of your closed eye (the area where it meets your nose) with your finger and maintain pressure for 2 minutes. This helps prevent GANFORT from entering the rest of your body.

If the drop falls outside the eye, try again.

To prevent contamination, avoid letting the tip of the container touch your eye or any other surface. Replace the cap and close the container immediately after use.

If you use GANFORT with another eye medication, wait at least 5 minutes between administering GANFORT and the other medication. Use any eye ointment or gel last.

If you use more GANFORT than you should

If you use more GANFORT than you should, it is unlikely to cause serious harm. Apply the next dose at the usual time. If you are concerned, speak with your doctor or pharmacist.

If you forget to use GANFORT

If you forget to use GANFORT, apply one drop as soon as you remember and then return to your regular routine. Do not use a double dose to make up for missed doses.

If you interrupt treatment with GANFORT

GANFORT should be used daily for it to be effective.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Generally, you can continue using the eye drops unless the side effects are serious. If you are concerned, speak with a doctor or pharmacist. Do not stop using GANFORT without speaking with your doctor.

The following side effects may occur with GANFORT formulations (multidose and/or single-dose):

Very common side effects

May affect more than 1 in 10 people

That affect the eye

Redness.

Common side effects

May affect up to 1 in 10 people

That affect the eye

Burning, itching, stinging, conjunctival irritation (the transparent layer of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, feeling like something is in the eye, small erosions on the surface of the eye with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, hair growth around the eye, darkening of the eyelids, darker color around the eyes, headache, longer eyelashes, eye irritation, watery eyes, inflamed eyelids, reduced vision.

That affect other parts of the body

Nasal discharge, headache.

Uncommon side effects

May affect up to 1 in 100 people

That affect the eye

Abnormal sensation in the eye, iris inflammation, conjunctivitis (inflammation of the transparent layer of the eye), painful eyelids, tired eyes, eyelashes growing inward, darkening of the iris color, sunken eyes, drooping eyelid, retracted eyelid (pulling away from the surface of the eye, causing incomplete eyelid closure) eyelid skin tightness, darkening of the eyelashes.

That affect other parts of the body

Shortness of breath.

Side effects of unknown frequency

That affect the eye

Macular cystoid edema (inflammation of the retina causing vision impairment), eye inflammation, blurry vision, eye discomfort.

That affect other parts of the body

Difficulty breathing/wheezing (production of sounds while breathing), allergic reaction symptoms (swelling, eye redness, skin rash), changes in taste, dizziness, decreased heart rate, high blood pressure, sleep disturbances, nightmares, asthma, hair loss, skin discoloration (periocular), fatigue.

As the following additional side effects have been seen in patients using timolol or bimatoprost eye drops, it is possible that they may occur with GANFORT. As other eye medications, timolol is absorbed into the bloodstream. This can cause side effects similar to those observed with intravenous or oral beta-blockers. The likelihood of experiencing side effects with eye drop use is lower than when medications are taken, for example, orally or injected. Among the listed side effects are reactions observed with bimatoprost and timolol when used to treat eye conditions:

• Severe allergic reactions with inflammation and difficulty breathing that can be potentially fatal.
• Hypoglycemia.
• Depression; memory loss; hallucination.
• Loss of consciousness; stroke; decreased cerebral blood flow; worsening of myasthenia gravis (increased muscle weakness); feeling of numbness.
• Decreased sensitivity on the eye surface; double vision; ptosis; separation of one of the eye layers after eye surgery for pressure reduction; eye surface inflammation, retinal hemorrhage, eye interior inflammation, increased blinking.
• Heart failure; irregular or interrupted heartbeat; bradycardia or tachycardia, excess fluid, mainly water, accumulating in the body; chest pain.
• Low blood pressure; swelling or coldness of the hands, feet, and extremities, caused by blood vessel constriction.
• Cough, worsening of asthma, worsening of known lung disease called chronic obstructive pulmonary disease (COPD).
• Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth.
• Red scaly patches on the skin; skin rash.
• Muscle pain.
• Decreased libido, sexual dysfunction.
• Weakness.
• Increased results in blood tests indicating how the liver is functioning.

Other side effects reported with eye drops containing phosphate

This medicine contains 2.85 mg of phosphates in each 3 ml of solution equivalent to 0.95 mg/ml. If you suffer from severe damage to the transparent layer of the front part of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches on the cornea due to calcium.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Once opened, the solutions may become contaminated, which can cause eye infections. Therefore, discard the container 4 weeks after first opening it, even if there is still some solution left. To remember, write the date you opened the container in the space provided on the box.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose ofthe containers and the medications that you no longerneed. In this way, you will help protect the environment.

Composition of GANFORT

• The active ingredients are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to maleate of timolol 6.8 mg/ml.

• The other components are benzalkonium chloride (preservative), sodium chloride, sodium dihydrogen phosphate heptahydrate, citric acid monohydrate, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to adjust the solution to the correct pH level.

Appearance of the product and contents of the package

GANFORT is a colourless or slightly yellow, transparent solution in a plastic container. Each package contains 1 plastic container or 3 plastic containers each with a screw cap. Each container contains 3 milliliters of solution, which fills approximately half of the container. The contents are sufficient for 4 weeks of treatment. Some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Date of the last review of this leaflet:<{MM/AAAA}><{mes AAAA}

The detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.