Ganfort 0.3 mg/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Bimatoprost/timolol

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

Contents of the leaflet:

1. What GANFORT is and what it is used for

2. What you need to know before using GANFORT

3. How to use GANFORT

4. Possible side effects

5. Storage of GANFORT

6. Contents of the pack and other information

1. What GANFORT is and what it is used for

GANFORT contains two different active substances (bimatoprost and timolol) that reduce elevated eye pressure. Bimatoprost belongs to a group of medicines called prostamides, an analogue of prostaglandins. Timolol belongs to a group of medicines called beta-blockers.

The eye contains a clear, aqueous fluid that maintains the inside of the eye. This fluid is continuously drained from the eye and new fluid is produced to replace it. If the fluid does not drain quickly enough, the pressure inside the eye increases, and over time your vision may become damaged (a condition known as glaucoma). GANFORT works by reducing the production of fluid and also increasing the amount of fluid that is drained. This reduces the pressure inside the eye.

GANFORT eye drops are used to treat elevated intraocular pressure in adults, including elderly people. This elevated pressure may lead to glaucoma. Your doctor will prescribe GANFORT if other eye drops containing beta-blockers or prostaglandin analogues have not been sufficiently effective on their own.

2. What you need to know before using GANFORT

Do not use GANFORT eye drops solution

• if you are allergic to bimatoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6);
• if you currently have or have previously had breathing problems such as asthma and/or severe chronic obstructive pulmonary disease (a lung condition that may cause wheezing, difficulty breathing, and/or persistent cough), or other types of respiratory problems;
• if you have heart problems such as slow heart rate, heart block, or heart failure.

Warnings and precautions

Before starting treatment with this medicine, inform your doctor if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure;
• disturbances in heart rate, such as slow heart rate;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disorders;
• diabetes, as timolol may mask signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• problems affecting the surface of the eye;
• separation of one of the layers inside the eyeball following surgery to reduce eye pressure;
• known risk factors for macular edema (swelling of the retina causing worsening vision), for example, cataract surgery.

Inform your doctor before undergoing surgical anesthesia that you are using GANFORT, as timolol may alter the effects of certain 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 increased hair growth when the medication comes into contact with the skin.

Children and adolescents

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

Other medicines and GANFORT

GANFORT may affect or be affected by other medicines you are taking, including other eye drops used to treat glaucoma. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Inform your doctor if you are taking or planning to take medicines for lowering blood pressure, for heart conditions, for the treatment of diabetes, quinidine (used to treat heart conditions and certain types of malaria), or medicines used to treat depression known as fluoxetine and paroxetine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine during breastfeeding.

Driving and using machines

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

GANFORT contains benzalkonium chloride

GANFORT contains a preservative called benzalkonium chloride.

This medicine contains 0.15 mg of benzalkonium chloride in each 3 ml of solution, equivalent to 0.05 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may change their color. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer on the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use GANFORT

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

The recommended dose is one drop administered once daily, either in the morning or in the evening, in each eye requiring treatment. Use this medicine every day at the same time.

Instructions for use

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

5.

1. Wash your hands. Tilt your head backwards and look up at the ceiling.
2. Gently pull down the lower eyelid until a small pocket is formed.
3. Invert the container and squeeze it to release one drop into each eye requiring treatment.
4. Release the lower eyelid and close the eye.
5. With the eye closed, press your finger against the inner corner of the closed eye (the area where it joins the nose) and maintain pressure for 2 minutes. This helps prevent GANFORT from reaching the rest of the body.

If the drop misses the eye, try again.

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

If you are using GANFORT with another eye medicine, wait at least 5 minutes between administering GANFORT and the other medicine. Apply any eye ointments or gels last.

If you use more GANFORT than you should

If you use more GANFORT than you should, it is unlikely to cause you any 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 usual routine. Do not use a double dose to make up for forgotten doses.

If you stop using GANFORT

GANFORT should be used every day to work properly.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone gets them. Generally, you may continue using the eye drops unless the effects are serious. If you are concerned, speak to a doctor or pharmacist. You must not stop using GANFORT without talking to your doctor.

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

Very common adverse effects

May affect more than 1 in 10 people

Eye-related

redness.

Common adverse effects

May affect up to 1 in 10 people

Eye-related

burning, itching, stinging, conjunctival irritation (irritation of the transparent layer of the eye), light sensitivity, eye pain, sticky eyes, dry eyes, sensation of a foreign body in the eye, minor erosions on the eye surface with or without inflammation, difficulty seeing clearly, redness and itching of the eyelids, increased eyelash growth, darkening of the eyelids, darker colour around the eyes, headache, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.

Affecting other parts of the body

runny nose, headache.

Uncommon adverse effects

May affect up to 1 in 100 people

Eye-related

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

Affecting other parts of the body

shortness of breath.

Adverse effects of unknown frequency

Eye-related

cystoid macular edema (retinal swelling causing worsening vision), eye inflammation, blurred vision, eye discomfort.

Affecting other parts of the body

difficulty breathing/wheezing (making sounds when breathing), symptoms of allergic reaction (swelling, eye redness, skin rash), taste disturbances, dizziness, decreased heart rate, high blood pressure, sleep disturbances, nightmares, asthma, alopecia, skin discolouration (periocular), fatigue.

As the following additional adverse effects have been observed in patients using eye drops containing timolol or bimatoprost, they may also occur with GANFORT. Like other medicines applied to the eyes, timolol is absorbed into the bloodstream. This may cause adverse effects similar to those seen with intravenous and/or oral beta-blockers. The likelihood of experiencing adverse effects with eye drops is lower than when medicines are taken orally or by injection. Among the listed adverse effects are those observed with bimatoprost and timolol when used to treat eye conditions:

• Severe allergic reactions with swelling and breathing difficulties, which may be potentially life-threatening.
• Hypoglycemia.
• Depression; memory loss; hallucination.
• Fainting; stroke; reduced blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation.
• Decreased sensitivity on the eye surface; double vision; ptosis; separation of one of the layers of the eyeball after surgery to reduce eye pressure; inflammation of the eye surface, bleeding at the back of the eye (retinal haemorrhage), inflammation inside the eye, increased blinking.
• Heart failure; irregularities or interruption of heartbeat; bradycardia or tachycardia; fluid retention, mainly water, accumulating in the body; chest pain.
• Low blood pressure; swelling or coldness of the hands, feet and limbs, caused by constriction of blood vessels.
• Cough; worsening of asthma; worsening of a known lung disease called chronic obstructive pulmonary disease (COPD).
• Diarrhea; stomach pain; nausea and vomiting; indigestion; dry mouth.
• Scaly red patches on the skin; skin rash.
• Muscle pain.
• Decreased sexual desire, sexual dysfunction.
• Weakness.
• Increase in certain blood test results indicating how the liver is functioning.

Other adverse 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 have severe damage to the transparent front layer of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches in the cornea due to calcium deposits.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of GANFORT

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

Do not use this medicine after the expiry date which appears on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Once opened, the solutions may become contaminated, which could lead to ocular infections. Therefore, the container must be discarded 4 weeks after first opening, even if some solution remains. To help you remember, write down the date you opened the container in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of GANFORT

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

• The other components are benzalkonium chloride (preservative), sodium chloride, sodium hydrogen 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 pack

GANFORT is a colourless or slightly yellow, clear eye drop solution in a plastic container. Each pack contains 1 plastic container or 3 plastic containers, each with a screw cap. Each container holds 3 millilitres of solution, filling approximately half of the container. The contents are sufficient for 4 weeks of treatment. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet: <{MM/YYYY}> <{month YYYY}>

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu/.