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

Bimatoprost/timolol

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.

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.

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

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 drooping, eyelid shrinking (moving away from the surface of the eye leading to incomplete closure of the eyelids),skin tightness of the eyelids, 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

UK

By reporting side effects you can help provide more information on the safety of this medicine.

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.