Ganfort - patient leaflet, side effects, dosage

1. What GANFORT is and what it is used for

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

Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your sight (an illness called glaucoma). GANFORT works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye.

GANFORT eye drops are used to treat high pressure in the eye in adults, including the elderly. This high pressure can lead to glaucoma. Your doctor will prescribe you GANFORT when other eye drops containing beta-blockers or prostaglandin analogues have not worked sufficiently on their own.

2. What you need to know before you use GANFORT

Do not use GANFORT eye drops, solution

• – if you are allergic to bimatoprost, timolol, beta-blockers or any of the other ingredients of

GANFORT (listed in section 6)

• – if you have now or have had in past respiratory problems such as asthma and/or severe chronic

obstructive pulmonary disease (lung disease which may cause wheeziness, difficulty in breathing and/ or long-standing cough) or other types of breathing problems

• – if you have heart problems such as low heart rate, heart block, or heart failure

Warnings and precautions

Before you use this medicine, tell your doctor if you have now or have had in the past

• – coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure,

• – disturbances of heart rate such as slow heart beat

• – breathing problems, asthma or chronic obstructive pulmonary disease

• – poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)

• – overactivity of the thyroid gland as timolol may mask signs and symptoms of

thyroid disease

• – diabetes as timolol may mask signs and symptoms of low blood sugar

• – severe allergic reactions

• – liver or kidney problems

• – eye surface problems

• – separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye

• – known risk factors for macular oedema (swelling of the retina within the eye leading to

worsening vision), for example, cataract surgery

Tell your doctor before surgical anaesthesia that you are using GANFORT as timolol may change effects of some medicines used during anaesthesia.

GANFORT may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye. GANFORT may cause hair growth when in contact with the skin surface.

Children and adolescents

GANFORT should not be used in children and teenagers under 18.

Other medicines and GANFORT

GANFORT can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine, medicines to treat diabetes, quinidine (used to treat heart conditions and some types of malaria) or medicines to treat depression known as fluoxetine and paroxetine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use GANFORT if you are pregnant unless your doctor still recommends it.

Do not use GANFORT if you are breast-feeding. Timolol may get into your breast milk. Ask your doctor for advice before taking any medicine during breast-feeding.

Driving and using machines

GANFORT may cause blurred vision in some patients. Do not drive or use machines until the symptoms have cleared.

GANFORT contains Benzalkonium chloride

Ganfort contains a preservative called benzalkonium chloride.

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

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

3. How to use GANFORT

Always use GANFORT exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one drop once a day, either in the morning or in the evening in each eye that needs treatment. Use at the same time each day.

Instructions for use

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

5.

• 1. Wash your hands. Tilt your head back and look at the ceiling.

• 2. Gently pull down the lower eyelid until there is a small pocket.

• 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.

• 4. Let go of the lower lid, and close your eye.

• 5. Whilst keeping the eye closed, press your finger against the corner of the closed eye (the site where the eye meets the nose) and hold for 2 minutes. This helps to stop GANFORT getting into the rest of the body.

If a drop misses your eye, try again.

To avoid contamination, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle straight after you have used it.

If you use GANFORT with another eye medicine, leave at least 5 minutes between putting in GANFORT and the other medicine. Use any eye ointment or eye gel 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. Put your next dose in at the usual time. If you are worried, talk to your doctor or pharmacist.

If you forget to use GANFORT

If you forget to use GANFORT, use a single drop as soon as you remember, and then go back to your regular routine. Do not use a double dose to make up for a forgotten dose.

If you stop using GANFORT

GANFORT should be used every day to work properly.

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

4. Possible side effects

Like all medicines, GANFORT can cause side effects, although not everybody gets them. You can usually carry on taking the drops, unless the effects are serious. If you’re worried, talk to a doctor or pharmacist. Do not stop using Ganfort without speaking to your doctor.

The following side effects may be seen with GANFORT (multi-dose and/or single-dose):

Very common side effects

These may affect more than 1 user in 10

Affecting the eye

redness.

Common side effects

These may affect 1 to 9 users in 100

Affecting the eye

burning, itching, stinging, irritation of the conjunctiva (see-through layer of the eye), sensitivity to light, eye pain, sticky eyes, dry eyes, a feeling of something in the eye, small breaks in the surface of the eye with or without inflammation, difficulty in seeing clearly, redness and itching of the eyelids, hair growing around the eye, darkening of the eyelids, darker skin colour around the eyes, longer eyelashes, eye irritation, watery eyes, swollen eyelids, reduced vision.

Affecting other parts of the body

runny nose, headache.

Uncommon side effects

These may affect 1 to 9 users in 1,000

Affecting the eye

abnormal sensation in the eye, iris inflammation, swollen conjunctiva (see-through layer of the eye), painful eyelids, tired eyes, in-growing eyelashes, darkening of iris colour, eyes appear sunken, eyelid has moved away from the surface of the eye, darkening of eyelashes.

Affecting other parts of the body shortness of breath.

Side effects where the frequency is not known

Affecting the eye

cystoid macular oedema (swelling of the retina within the eye leading to worsening vision), eye swelling, blurred vision, ocular discomfort.

Affecting other parts of the body

difficulty breathing / wheezing, symptoms of allergic reaction (swelling, redness of the eye and rash of the skin), changes in your taste sensation, dizziness, slowing of heart rate, high blood pressure, difficulty sleeping, nightmare, asthma, hair loss, skin discolouration (periocular), tiredness.

Additional side effects have been seen in patients using eye drops containing timolol or bimatoprost and so may possibly be seen with GANFORT. Like other medicines applied into eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with ”intravenous” and /or “oral” beta-blocking agents. The chance of having side effects after using eye drops is lower than when medicines are for example, taken by mouth or injected. Listed side effects include reactions seen within bimatoprost and timolol when used for treating eye conditions:

• Severe allergic reactions with swelling and difficulty breathing which could be life-threatening
• Low blood sugar
• Depression; memory loss; hallucination
• Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation
• Decreased sensation of your eye surface; double vision; drooping eyelid; separation of one of the layers within the eyeball after surgery to reduce the pressure in the eye; inflammation of the surface of the eye, bleeding in the back of the eye (retinal bleeding), inflammation within the eye, increased blinking
• Heart failure; irregularity or stopping of the heartbeat; slow or fast heartbeat; too much fluid, mainly water, accumulating in the body; chest pain
• Low blood pressure, swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels
• Cough, worsening of asthma, worsening of the lung disease called chronic obstructive

pulmonary disease (COPD)

• Diarrhoea; stomach pain; feeling and being sick; indigestion; dry mouth
• Red scaly patches on skin; skin rash
• Muscle pain
• Reduced sexual urge; sexual dysfunction
• Weakness
• An increase in blood test results that show how your liver is working

Other side effects reported with eye drops containing phosphates

This medicine contains 2.85 mg phosphates in each 3 ml of solution which is equivalent to 0.95 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store GANFORT

Keep GANFORT out of the sight and reach of children.

Do not use GANFORT after the expiry date which is stated on the bottle label and the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What GANFORT contains

• The active substances are bimatoprost 0.3 mg/ml and timolol 5 mg/ml corresponding to timolol maleate 6.8 mg/ml.
• The other ingredients are benzalkonium chloride (a preservative), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to bring the solution to the correct pH (acidity) level.

What GANFORT looks like and contents of the pack

GANFORT is a colourless to slightly yellow, clear eye drop solution in a plastic bottle. Each pack contains either 1 or 3 plastic bottles each with a screw-cap. Each bottle is about half full and contains 3 millilitres of solution. This is enough for 4 weeks’ usage. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgiqu­e/Belgien/ Luxembourg/Lu­xemburg Allergan NV/SA

Ísland Teva Pharma Iceland ehf. Sími: +354 550 3300

Tél/Tel: +32 (0)2 351 24 24

Nederland Allergan BV Tel: +32 (0)2 351 24 24

Italia Allergan S.p.A Tel: + 39 06 509 562 90

Etnrapua

A.iepraw Etnrapua EOOfl

Ten.: +359 (0) 800 20 280

Česká republika Allergan CZ s.r.o. Tel: +420 800 188 818	Latvija AbbVie SIA Tel: +371 67605000
Danmark/Norge/Su­omi/Finland/Sve­rige Allergan Norden AB Tlf/Puh/Tel: + 4580884560 (DK); +47 80 01 04 97 (NO); + 358 800 115 003 (FI); +46 (0)8 594 100 00 (SE)	Lietuva: AbbVie UAB Tel: + 370 5 205 3023
Deutschland Allergan GmbH Tel: +49 69 92038 1050	Magyarorszag Allergan Hungary Kft. Tel.: +36 80 100 101

Österreich

Pharm-Allergan GmbH

Tel: +43 1 99460 6355

This leaflet was last revised in < {MM/YYYY }> <{month YYYY }

Detailed information on this medicine is available on the European Medicines Agency web site:.