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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What GANFORT single-dose is and what it is used for
2. What you need to know before using GANFORT single-dose
3. How to use GANFORT single-dose
4. Possible side effects
5. How to store GANFORT single-dose
6. Contents of the pack and other information

1. What GANFORT single-dose is and what it is used for

GANFORT single-dose 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 internal structure of the eye. This fluid continuously drains from the eye, and new fluid is produced to replace it. If the fluid does not drain sufficiently quickly, pressure inside the eye increases, and over time your vision may become damaged (a condition known as glaucoma). GANFORT single-dose works by reducing the production of fluid and also increasing the amount that is drained. This reduces the pressure within the eye.

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

This medicine does not contain preservatives.

2. What you need to know before using GANFORT unidose

Do not use GANFORT unidose 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 respiratory problems such as asthma and/or chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough), or any other type 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;
• heart rhythm disorders, such as slow heart rate;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• circulation disorders (such as Raynaud's disease or Raynaud's syndrome);
• overactivity of the thyroid gland, as timolol may mask the signs and symptoms of thyroid disorders;
• diabetes, as timol0l may mask the signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• eye surface problems;
• separation of one of the layers inside the eyeball after surgery to reduce eye pressure;
• known risk factors for macular edema (swelling of the retina causing worsening of vision), such as cataract surgery.

Inform your doctor before undergoing surgical anesthesia that you are using GANFORT unidose, as timolol may alter the effects of certain medications used during anesthesia.

GANFORT unidose may cause darkening and growth of eyelashes, as well as darkening of the skin around the eye. 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 unidose may cause increased hair growth where the solution comes into contact with the skin surface.

Children and adolescents

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

Other medicines and GANFORT unidose

GANFORT unidose may interact with 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 plan to take medicines to lower blood pressure, for heart conditions, for the treatment of diabetes, quinidine (used to treat heart conditions and some 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use GANFORT unidose during pregnancy unless recommended by your doctor.

Do not use GANFORT unidose while breastfeeding. Timolol may pass into breast milk. Consult your doctor before using any medicine during breastfeeding.

Driving and use of machines

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

3. How to use GANFORT single-dose

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

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. Separate one single-dose container from the strip.
2. Hold the single-dose container in an upright position (with the cap facing upwards) and twist the cap until it comes off.
3. Gently pull down the lower eyelid to form a pouch. Invert the single-dose container and gently squeeze until one drop falls into the affected eye or eyes.
4. Keeping the eye closed, press your finger against the tear duct (where it joins the nose) for 2 minutes. This action will help prevent GANFORT single-dose from passing into the rest of the body.
5. Discard the single-dose container after use, even if there is some solution remaining inside.

If the drop misses the eye, try again. Wipe away any excess solution from the cheek.

If you wear contact lenses, remove them before using this medicine. Wait 15 minutes after applying the eye drops before reinserting your lenses.

If you use GANFORT single-dose together with another eye medicine, leave at least 5 minutes between the administration of GANFORT single-dose and the other medicine. Apply any eye ointments or gels last.

If you use more GANFORT single-dose than you should

If you use more GANFORT single-dose 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 single-dose

If you forget to use GANFORT single-dose, apply one drop as soon as you remember, then continue with your usual routine. Do not use a double dose to make up for forgotten doses.

If you stop using GANFORT single-dose

GANFORT single-dose 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 single-dose without talking to your doctor.

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

Very common adverse effects

May affect more than 1 in 10 people

Affecting the eye:

• redness.

Common adverse effects

May affect up to 1 in 10 people

Affecting the eye:

• burning, itching, stinging, conjunctival irritation (irritation of the transparent layer of the eye), sensitivity to light, eye pain, sticky eyes, dry eyes, sensation of having something in the eye, small erosions on the surface of the eye 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

Affecting the eye:

• 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 (moving 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

Affecting the eye:

• cystoid macular oedema (retinal swelling causing worsening of 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, elevated blood pressure, sleep disturbances, nightmares, asthma, alopecia, skin discolouration (periocular), fatigue.

The following additional adverse effects have been observed in patients using eye drops containing timolol or bimatoprost and may therefore also occur with GANFORT. As with other eye medications, 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. The adverse effects listed include 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.
• Hypoglycaemia.
• Depression; memory loss; hallucinations.
• 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 glaucoma surgery; 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 the 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 limbs, caused by constriction of blood vessels.
• Cough; worsening of asthma; worsening of a known lung disease called chronic obstructive pulmonary disease (COPD).
• Diarrhoea; stomach pain; nausea and vomiting; indigestion; dry mouth.
• Red, scaly 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 deposition.

Reporting of adverse effects

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

5. Storage of GANFORT single-dose

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

Do not use GANFORT single-dose after the expiry date stated on the single-dose container and on the carton after EXP. The expiry date refers to the last day of the month indicated.

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

This medicine does not require any special storage temperature. Store the single-dose containers in the pouch and return the pouch to the carton to protect them from light and moisture. Once the single-dose container has been removed from the pouch, use it within 7 days.

All single-dose containers should be kept within the pouch and discarded 10 days after the pouch is first opened.

Medicines must 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 single-dose

• 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 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.

Nature of the product and pack contents

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

The carton contains 5 single-dose containers in 1 aluminium pouch.

The carton contains 3 or 9 aluminium pouches, each with 10 single-dose containers, making a total of 30 or 90 single-dose containers in the carton, respectively.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization 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.europa.eu.