Bimatoprost Polpharma 0,3 mg/ml, oogdruppels, oplossing

Bimatoprost XXX is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

Bimatoprost XXX eye drops are 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 high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

Do not use Bimatoprost XXX:

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

Warnings and precautions:

Talk to your doctor of pharmacist before using Bimatoprost XXX

• 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 had any problems with your cornea (front transparent part of the eye)
  • You wear contact lenses (see “Bimatoprost XXX contains”)
  • You have or have had low blood pressure or low heart rate
  • You have had a viral infection or inflammation of the eye

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

Other medicines and Bimatoprost XXX:

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy and breastfeeding and fertility

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 using this medicine.

Bimatoprost XXX may get into breast milk so you should not breastfeed while you are using this medicine.

Driving and using machines:

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

Bimatoprost XXX 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. The preservative, benzalkonium chloride, may cause eye irritation and can discolour soft contact lenses.

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

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

If you use Bimatoprost XXX with another eye medicine, wait at least 5 minutes between using Bimatoprost XXX and the other eye medicine.

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

Instructions for use:

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.

1. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.
2. 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 XXX than you should

If you use more Bimatoprost XXX 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 XXX

If you forget to use Bimatoprost XXX, 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 Bimatoprost XXX

Bimatoprost xxx should be used every day to work properly. If you stop using Bimatoprost XXX 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.

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

Side effects where frequency is not known

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.

This medicinal product does not require any special storage conditions.

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 4 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.

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 protect the environment.

What Bimatoprost XXX contains

• The active substance is bimatoprost. One ml of solution contains 0.3 mg of bimatoprost.

• The other ingredients are: disodium phosphate 12-hydrate, citric acid monohydrate, sodium chloride, benzalkonium chloride (preservative), and purified water. Small amounts of 1M hydrochloric acid and/or 1M sodium hydroxide may be added to keep acidity levels (pH levels) normal. See section 2 Bimatoprost XXX contains benzalkonium chloride

What Bimatoprost XXX looks like and contents of the pack

Bimatoprost XXX is a clear, colourless eye drop solution practically free from particles. It is supplied in a carton containing one, three or six plastic bottles. Each bottle contains 3 millilitres of solution. Not all pack sizes may be marketed.

In het register ingeschreven onder:

RVG 112513, Bimatoprost Pholparma 0,3 mg/ml oogdruppels, oplossing

Houder van de vergunning voor het in de handel brengen

Zakłady Farmaceutyczne POLPHARMA SA 19 Pelplińska Street; 83-200 Starogard Gdański

Polen

Fabrikant

S.C. Rompharm Company, S.R.L.

Str. Eroilor, Nr. 1A

75100 Otopeni

Roemenië

Deze bijsluiter is voor het laatst goedgekeurd in november 2013.