Label: information for the user

GANFORT 0.3mg/ml + 5mg/ml eye drops in solution, in single-dose container

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 for you and should not be given 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 single-dose and for what it is used

2.What you need to know before starting to use GANFORT single-dose

3.How to use GANFORT single-dose

4.Possible adverse effects

5.Storage of GANFORT single-dose

6.Contents of the container and additional information

GANFORT unidosis 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 unidosis acts by reducing the production of liquid and also increasing the amount that drains. This reduces the pressure inside the eye.

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

This medication does not contain preservatives.

Do not use GANFORT single-dose eye drops in solution

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

-if you currently have or have had in the past respiratory problems, such as asthma and/or chronic obstructive pulmonary disease (serious lung disease that can cause wheezing, difficulty breathing and/or persistent cough), 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 alterations, 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 surgical anesthesia that you are using GANFORT single-dose, as timolol may modify the effects of some medications used during anesthesia.

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

Children and adolescents

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

Other medications and GANFORT single-dose

GANFORT single-dose 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 single-dose if you are pregnant unless your doctor recommends it.

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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.

Instructions for use

Wash your hands before using it. Ensure the single-use vial is intact before using this medication. The solution must be used immediately after opening the vial. To avoid contamination, do not let the tip of the single-use vial touch the eye or any other surface.

1.Separate one of the single-use vials from the strip.

2.Hold the single-use vial in a vertical position (with the cap facing upwards) and turn the cap until it comes loose.

3.Gently pull the lower eyelid downwards to form a pouch. Invert the single-use vial and press gently until one drop falls into the affected eye or eyes.

4.Keeping the eye closed, press with your finger the lacrimal sac of the eye (where it meets the nose) for 2 minutes. This action will help prevent GANFORT single-use from passing into the rest of the body.

5.Dispose of the single-use vial after use, even if there is solution remaining inside.

If the drop falls outside the eye, try again. Clean any excess solution from the cheek.

If you wear contact lenses, remove them before using this medication. Wait 15 minutes after applying the eye drop before putting your lenses back in.

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

If you use more GANFORT single-use than you should

If you use more GANFORT single-use than you should, it is unlikely to cause any serious harm.

Apply the next dose at the usual time. If you are concerned, speak with your doctor or pharmacist.

If you forgot to use GANFORT single-use

If you forgot to use GANFORT single-use, apply one drop as soon as you remember and then return to your usual routine. Do not use a double dose to make up for the missed dose.

If you interrupt treatment with GANFORT single-use

GANFORT single-use should be used every day for it to work properly.

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

Like all medicines, this medicine can have 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 single-dose without speaking with your doctor.

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

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, eyelid redness and itching, eyelash 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

Runny nose, 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 (moving away from the surface of the eye, causing incomplete eyelid closure), eyelid skin tightness, darkening of 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, and 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 blood. This can cause side effects similar to those observed with intravenous or oral beta-blockers. The likelihood of experiencing side effects with eye drops 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 may 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, accumulated in the body; chest pain.
• Low blood pressure; swelling or coldness of hands, feet, and extremities, caused by blood vessel constriction.
• Cough, worsening of asthma, worsening of 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 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, evenif it ispossibleside effects that do 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

Maintain this medication out of the sight and reach of children.

Do not use GANFORT single-dose vials after the expiration date that appears on the single-dose vial and on the box after EXP. The expiration date is the last day of the month indicated.

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

This medication does not require any special storage temperature. Store the single-dose vials in the pouch and put the pouch back in the box to protect them from light and moisture. Once the single-dose vial is removed from the pouch, use within 7 days.

All single-dose vials must be kept inside the pouch and discarded 10 days after the first opening of the pouch.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the vials and medications that you no longer need. By doing so, you will help protect the environment.

Composition of GANFORT single-dose

• 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 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 (acidity) level.

Appearance of the product and contents of the package

GANFORT single-dose is a colorless to slightly yellow solution supplied in single-dose plastic containers, each containing 0.4 ml of solution.

The box contains 5 single-dose containers in 1 aluminum foil pouch.

The box contains 3 or 9 aluminum foil pouches, each containing 10 single-dose containers, with a total of 30 or 90 single-dose containers in the box, respectively.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder.

Last update of this leaflet: <{MM/AAAA}><{month YYYY}

For more detailed information on this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.eu.