Bimagam 0,03 % Solution

BIMAGAM 0,03 % is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. BIMAGAM 0,03 % 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 the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight.

Do not use BIMAGAM 0,03 % if you are hypersensitive (allergic) to bimatoprost or any of the other ingredients of BIMAGAM 0,03 % (listed in section 6) if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride.

Warnings and precautions

Special care should be taken with BIMAGAM 0,03 %:

• if you have any breathing problems
• if you have liver or kidney problems
• if you have had a cataract surgery in the past
• if you have dry eye
• if you have or have had any problems with your cornea (front transparent part of the eye)
• if you wear contact lenses (see “BIMAGAM 0,03 % contains benzalkonium chloride”)
• if you have or have had low blood pressure or low heart rate
• if you have had a viral infection or inflammation of the eye

BIMAGAM 0,03 % 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. Hair may grow in areas where BIMAGAM 0,03 % solution has been repeatedly in contact with the skin surface. This is why it is important to apply BIMAGAM 0,03 % as instructed and to avoid it running onto the cheek or other skin areas.

Children and adolescents

BIMAGAM 0,03 % has not been tested in children under the age of 18 and therefore should not be used by patients under 18 years.

Other medicines and BIMAGAM 0,03 %

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your health care provider for advice before taking this medicine. The safety of BIMAGAM 0,03 % in pregnancy has not been established. BIMAGAM 0,03 % should not be used during pregnancy unless your doctor still recommends it. BIMAGAM 0,03 % may get into breast milk so you should not breastfeed while you are taking BIMAGAM 0,03 %.

Do not share medicines prescribed for you with any other person. Always use BIMAGAM 0,03 % exactly as your health care provider has told you. Check with your health care provider if you are not sure.

Duration of administration

Your doctor will tell you how long your treatment with BIMAGAM 0,03 % will last. Do not stop treatment early. If you have the impression that the effect of BIMAGAM 0,03 % is too strong or too weak, tell your doctor or pharmacist.

Method of administration

BIMAGAM 0,03 % should only be applied to the eye. The recommended dose is one drop of BIMAGAM 0,03 % in each eye that needs treatment, once every day, in the evening, following the instructions for use below (see “Instructions for use”). If you use BIMAGAM 0,03 % with another eye medicine, wait at least five minutes between using BIMAGAM 0,03 % 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.
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. If a drop misses your eye, try again. Wipe off any excess that runs down the cheek. 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 BIMAGAM 0,03 % than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you use more BIMAGAM 0,03 % 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 put too many drops in your eye or swallow any of the contents of the container, among other effects, you may become nauseous, light-headed or feel very tired.

If you forget to use BIMAGAM 0,03 %, 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 forgotten individual doses. If you stop using BIMAGAM 0,03 %, BIMAGAM 0,03 % should be used every day to work properly. If you stop using BIMAGAM 0,03 % the pressure inside your eye may go up, therefore talk to your health care provider before stopping this treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

BIMAGAM 0,03 % can have side effects. Not all side effects reported for BIMAGAM 0,03 % are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using BIMAGAM 0,03 %, please consult your health care provider for advice. Tell your doctor if you notice any of the following:

Frequent side effects

Affecting the eye

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

Affecting the body

• Abnormal liver function tests

Less frequent side effects

Affecting the eye

• Inflammation within the eye
• Retinal bleeding
• Eyelid twitching

Affecting the body:

• Hair growth around the eye
• Weakness
• Swelling in the arms and/or legs
• Colds

Side effects where the frequency is not known

Affecting the eye

• Eye discomfort
• Eyelid shrinking, moving away from the surface of the eye
• Eyes appear sunken
• Skin redness around the eye
• Swollen eyelid
• Macular oedema (swelling of the retina within the eye leading to worsening vision)

Affecting the body

• Abnormal hair growth
• Skin discolouration
• Nausea
• Symptoms of allergic reaction (swelling, redness of the eye and rash of the skin)
• Dizziness
• Headaches
• Asthma
• Worsening of asthma
• Shortness of breath
• Increased blood pressure

Other side effects reported with eye drops containing phosphates Less frequently, 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. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your health care provider. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BIMAGAM 0,03 %.

• Store all medicines out of reach of children.
• Store unopened container at or below 25 °C in the original carton, until required for use.
• Opened container must be stored at or below 25 ºC. Do not use more than 28 days after opening.
• Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 4 weeks (28 days) 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 use this medicine after the expiry date which is printed on the carton and bottle after EXP. The expiry date refers to the last day of that month.
• Keep bottle tightly closed when you are not using it to prevent contamination.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).