Bimatoprost Tiefenbacher 0.3 mg/ml, oogdruppels, oplossing

BIMATOPROST TIEFENBACHER is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

BIMATOPROST TIEFENBACHER is used to reduce high pressure in the eye. This medicine may be used on its own or with other drops called beta-blockers which also reduce pressure.

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. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye.If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

Do not use BIMATOPROST TIEFENBACHER 0.3 mg/ml:

- if you are allergic (hypersensitive) to bimatoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using BIMATOPROST TIEFENBACHER 0.3 mg/ml. Talk to your doctor, if:

• You have any breathing problems.
• You have liver or kidney problems.
• You have had a cataract surgery in the past
• You have dry eye
• You have or have had any problems with your cornea (front transparent part of the eye)
• You wear contact lenses (see “Important information about some of the ingredients of BIMATOPROST TIEFENBACHER 0.3 mg/ml”)
• You have or have had low blood pressure or low heart rate

• You have had a viral infection or inflammation of the eye

BIMATOPROST TIEFENBACHER 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.

Children and adolescents

BIMATOPROST TIEFENBACHER has not been tested in children under the age of 18 and therefore BIMATOPROST TIEFENBACHER should not be used by patients under 18 years.

Other medicines and BIMATOPROST TIEFENBACHER 0.3 mg/ml

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

BIMATOPROST TIEFENBACHER may get into breast milk so you should not breast-feed while you are taking BIMATOPROST TIEFENBACHER.

Driving and using machines:

Your sight may become blurred for a short time just after using BIMATOPROST TIEFENBACHER. You should not drive or use machines until your sight is clear again.

Important information about some of the ingredients of BIMATOPROST TIEFENBACHER 0.3mg/ml

BIMATOPROST TIEFENBACHER 0.3 mg/ml contains benzalkonium chloride

Do not use the drops when you are wearing your lenses. Wait 15 minutes after using the drops before you put your lenses back in. A preservative in BIMATOPROST TIEFENBACHER called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses.

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

BIMATOPROST TIEFENBACHER should only be applied to the eye. The recommended dose is one drop of BIMATOPROST TIEFENBACHER in the evening, once daily in each eye that needs treatment.

If you use BIMATOPROST TIEFENBACHER with another eye medicine, wait at least five minutes between using BIMATOPROST TIEFENBACHER and the other eye medicine.

Do not use more than once a day as the effectiveness of treatment may be reduced.

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.

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 for 30 seconds.

Wipe off any excess that runs down the cheek.

If a drop misses your eye, try again.

To help prevent infections, 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 more BIMATOPROST TIEFENBACHER 0.3 mg/ml than you should

If you use more BIMATOPROST TIEFENBACHER 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 BIMATOPROST TIEFENBACHER 0.3 mg/ml

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

If you stop using BIMATOPROST TIEFENBACHER 0.3 mg/ml

BIMATOPROST TIEFENBACHER should be used every day to work properly. If you stop using BIMATOPROST TIEFENBACHER the pressure inside your eye may go up, therefore talk to your doctor before stopping this treatment.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Very common side effects (may affect more than 1 in 10 people)

Affecting the eye

• Longer eyelashes (up to 45% of people)
• Slight redness (up to 44% of people)
• Itchiness (up to 14% of people)

Common side effects (may affect up to 1 in 10 people)

Affecting the eye

• An allergic reaction in the eye
• Tired eyes
• Sensitivity to light
• Darker skin colour around the eye
• Darker eyelashes
• Pain
• A feeling that something is in your eye
• Sticky eyes
• Darker iris colour
• Difficulty in seeing clearly
• Irritation
• Burning

• Inflamed, red and itchy eyelids
• Tears
• Dryness
• Worsening of vision
• Blurred vision
• Swelling of the see-through layer which covers the surface of the eye
• Small breaks in the surface of the eye, with or without inflammation

Affecting the body

• Headaches
• An increase in blood-test results that show how your liver is working
• Increased blood pressure

Uncommon side effects (may affect up to 1 in 100 people)

Affecting the eye

• Cystoid macular oedema (swelling of the retina within the eye leading to worsening vision)
• Inflammation within the eye
• Retinal bleeding
• Swollen eyelids
• Eyelid twitching
• Eyelid has moved away from surface of eye
• Skin redness around the eye

Affecting the body

• Nausea
• Dizziness
• Weakness
• Hair growth around the eye

Very rare side effects (may affect up to 1 in 10,000 people)

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Side effects where the frequency is unknown

Affecting the eye

• Eyes appear sunken

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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

Do not use this medicine 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.

You must throw away the bottle, at the latest, four weeks after you first opened it, even if there are still some drops left. This will prevent infections. To help you remember, write down the date you opened it in the space on the box.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What BIMATOPROST TIEFENBACHER 0.3 mg/ml contains

• The active substance is bimatoprost. One ml of solution contains 0.3 mg bimatoprost. One drop contains approximately 7.5 micrograms bimatoprost.
• The other ingredients are benzalkonium chloride (preservative), citric acid monohydrate, dibasic sodium phosphate heptahydrate, sodium chloride and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to keep the level of acid (pH levels) normal.

What BIMATOPROST TIEFENBACHER 0.3 mg/ml looks like and contents of the pack

BIMATOPROST TIEFENBACHER is a clear, colourless solution, practically free from particles in a pack containing either 1 plastic bottle or 3 plastic bottles each with a screw cap. Each bottle is approximately half full and contains either 2.5 millilitres or 3 millilitres of solution. This is enough for 4 weeks’ usage.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ALFRED E. TIEFENBACHER (GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Manufacturer

S.C. ROMPHARM COMPANY S.R.L.

Eroilor Street, no. 1A

Otopeni 075100, Ilov.

Romania

This medicinal product is authorised in the Member States of the EEA under the following names:

Nederland - Bimatoprost Tiefenbacher 0,3 mg/ml, oogdruppels, oplossing България - Bimatoprost Tiefenbacher

Eesti - Bimatoprost Tiefenbacher

Magyarország - Bimatoprost Tiefenbacher 0.3 mg/ml oldatos, szemcsepp Lietuva - Bimatoprost Tiefenbacher 0.3 mg/ml akių lašai (tirpalas) Latvija - Bimatoprost Tiefenbacher

Polska - Bimatoprost Tiefenbacher

România - Bimatoprost Tiefenbacher 0,3 mg/ml picături oftalmice, soluţie Slovenská republika - Bimatoprost Tiefenbacher 0,3 mg/ml očná roztoková, instilácia

Deze bijsluiter is voor het laatst goedgekeurd in oktober 2013.