GANFORT 0.3 mg/mL + 5 mg/mL eye drops, single-dose container

2. What you need to know before you start using GANFORT single-dose

Do not use GANFORT single-dose 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 had respiratory problems, such as asthma and/or chronic obstructive pulmonary disease (severe 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 a slow heart rate, heart block, or heart failure.

Warnings and precautions

Before starting treatment with this medicine, tell your doctor if you have or have had

• coronary heart disease (symptoms may include chest pain or discomfort, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure;
• changes in heart rate, such as a slow 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 disease;
• diabetes, as timolol may mask the signs and symptoms of hypoglycemia;
• severe allergic reactions;
• liver or kidney problems;
• problems with the surface of the eye;
• separation of one of the layers of the inside of the eyeball after surgery to reduce eye pressure;
• known risk factors for macular edema (inflammation of the retina that causes vision to deteriorate), such as cataract surgery.

Tell your doctor before undergoing surgical anesthesia that you are using GANFORT single-dose, as timolol may alter the effects of some medicines 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, the color of the iris may also darken. These changes may be permanent and more noticeable if only one eye is being treated. GANFORT single-dose may cause hair growth when it comes into 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 medicines and GANFORT single-dose

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

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to use GANFORT single-dose

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one drop administered once a day, either in the morning or at night, in each eye that needs 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 of the single-dose containers from the strip.
2. Hold the single-dose container in an upright position (with the cap facing up) and twist the cap until it comes off.
3. Gently pull the lower eyelid down to form a pouch. Invert the single-dose container and squeeze gently until one drop falls into the eye or affected eyes.
4. Keeping the eye closed, press the lacrimal sac of the eye (where it meets the nose) with your finger 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 still solution inside.

If the drop falls outside 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 putting them back in.

If you use GANFORT single-dose with another eye medicine, wait at least 5 minutes between administering GANFORT single-dose and the other medicine. Use any eye ointment or gel 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, talk to 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 and then return to 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 for it to work properly.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You can usually continue to use the eye drops, unless the side effects are serious. If you are concerned, talk to a doctor or pharmacist. Do not stop using GANFORT single-dose without talking to your doctor.

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

Very common side effects

May affect more than 1 in 10 people

Affecting the eye

redness.

Common side 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, dryness of the eyes, feeling of 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, hair growth around the eye, darkening of the eyelids, darker color around the eyes, headache, longer eyelashes, eye irritation, watery eyes, inflamed eyelids, reduced vision.

Affecting other parts of the body

runny nose, headache.

Uncommon side 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, eyelashes growing inward, darkening of the iris color, sunken eyes, drooping eyelid, retracted eyelid (moving away from the eye surface, causing incomplete closure of the eyelids), tightness of the eyelid skin, darkening of the eyelashes.

Affecting other parts of the body

shortness of breath.

Side effects of unknown frequency

Affecting the eye

cystoid macular edema (inflammation of the retina that causes vision to deteriorate), eye inflammation, blurred vision, eye discomfort.

Affecting other parts of the body

difficulty breathing/wheezing (production of sounds when breathing), symptoms of an allergic reaction (swelling, redness of the eye, and skin rash), changes in taste, dizziness, slow heart rate, high blood pressure, sleep disturbances, nightmares, asthma, hair loss, skin discoloration (periorbital), 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 with other eye medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with beta-blockers given by injection or orally. The likelihood of side effects with eye drop use is lower than when medicines are taken, for example, orally or injected. The side effects listed include those observed with bimatoprost and timolol when used to treat eye conditions:

• Severe allergic reactions with inflammation and difficulty breathing that can be potentially life-threatening.
• Hypoglycemia.
• Depression; memory loss; hallucination.
• Fainting; stroke; decreased blood flow to the brain; worsening of myasthenia gravis (increased muscle weakness); tingling sensation.
• Decreased sensitivity on the surface of the eye; double vision; ptosis; separation of one of the layers of the eyeball after surgery to reduce eye pressure; inflammation of the surface of the eye, hemorrhage in the back of the eye (retinal hemorrhage), inflammation inside the eye, increased blinking.
• Heart failure; irregular heartbeat or interruption of heartbeat; bradycardia or tachycardia, excess fluid, mainly water, that accumulates in the body; chest pain.
• Low blood pressure; swelling or coldness of the hands, feet, and limbs, caused by the constriction of blood vessels.
• Cough, worsening of asthma, worsening of 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 sex drive, sexual dysfunction.
• Weakness.
• Increased results of some blood tests that indicate how the liver is working.

Other side effects reported with phosphate-containing eye drops

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 layer of the front of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches on the cornea due to calcium.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side 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 expiration date stated on the single-dose container and on the carton after EXP. The expiration date is the last day of the month indicated.

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

This medicine does not require any special storage temperature. Keep the single-dose containers in the bag and put the bag back in the carton to protect them from light and moisture. Once the single-dose container is removed from the bag, use it within 7 days.

All single-dose containers should be kept in the bag and discarded 10 days after the first opening of the bag.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of GANFORT single-dose

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

• The other ingredients 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 level.

Appearance of the Product and Package Contents

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

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

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

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstraße

67061 Ludwigshafen

Germany

For further information on this medicinal product, please contact the local representative of the marketing authorization holder.

Date of Last Revision of this Leaflet: <{MM/AAAA}> <{month AAAA}

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.