0.1 mg / ml, eye drops , solution
Bimatoprost
What LUMIGAN 0.1 mg / ml is and what it is used for
LUMIGAN is a drug used in glaucoma ( glaucoma ) and belongs to a class of drugs called prostanoids.
LUMIGAN eye drops are used to lower high blood pressure. This medicine can be used alone or in combination with other eye drops called beta-blockers, which also lower the pressure.
There is a clear liquid in the eye that nourishes the eye. Fluid constantly flows out of the eye and new ones form continuously. If the fluid cannot drain out fast enough, the pressure inside the eye increases. This drug works by increasing the amount of fluid that flows out, which reduces the pressure inside the eye. If the elevated eye pressure is not lowered, it can lead to a disease called glaucoma, and over time, vision can be damaged.
What you need to know before you use LUMIGAN 0.1 mg / ml
Do not use LUMIGAN 0.1 mg / ml
- if you are allergic to bimatoprost or any of the other ingredients of this medicine (listed in section 6).
- if you have had to stop using eye drops before due to a side effect caused by the preservative benzalkonium chloride.
Warnings and cautions
Talk to your doctor or pharmacist before using LUMIGAN 0.1 mg/ml.
Talk to your doctor about:
- you have trouble breathing
- you have liver or kidney problems
- you have had cataract surgery
- you have dry eyes
- you have or have had problems with your cornea (the front transparent part of the eye)
- you use contact lenses (see “LUMIGAN 0.1 mg / ml contains benzalkonium chloride”)
- you have, or have had, low blood pressure or slow heart rate
- you have had an inflammation or viral infection in the eye.
Treatment with LUMIGAN can cause the eyelashes to grow and become darker and also cause the skin around the eyelid to darken. The color of the iris can also get darker with time. These changes can be permanent. The change can be more noticeable if only one eye is treated.
Children and young people
LUMIGAN has not been tested on children under 18 years of age and should therefore not be used by patients under 18 years of age.
Other medicines and LUMIGAN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. LUMIGAN should not be used during pregnancy unless your doctor tells you to.
LUMIGAN can pass into breast milk. Therefore, you should not breastfeed during treatment with LUMIGAN.
Driving and using machines
Your vision may become blurred shortly after you drop LUMIGAN. Do not drive or use machines until you can see again.
LUMIGAN 0.1 mg / ml contains benzalkonium chloride
This medicine contains 0.6 mg benzalkonium chloride in each 3 ml solution, equivalent to 0.2 mg/ml.
Do not use the drops if you have your contact lenses on. A preservative in LUMIGAN called benzalkonium chloride may be absorbed by soft contact lenses and contact lens can change the color. You should remove contact lenses before using this medicine and wait at least 15 minutes after drip before reinserting the lenses. Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or problems with the cornea (the transparent layer on the front of the eye). Talk to your doctor if you experience an abnormal feeling, tingling, or pain in the eye after using this medicine.
How to use LUMIGAN 0.1 mg / ml
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
LUMIGAN should only be administered to the eye. The recommended dose is one drop of LUMIGAN in the evening, once daily in each eye to be treated.
If you are taking LUMIGAN with other ophthalmic medicines, wait at least 5 minutes between using LUMIGAN and the other eye medicine.
Do not use more than once a day as this may reduce the effectiveness of treatment.
Instructions for use:
You must not use the bottle if the seal on the neck of the bottle has broken before you start using it.
- Wash your hands. Bend your head back and look up at the ceiling.
- Carefully pull down the lower eyelid until a small pocket is formed.
- Turn the bottle upside down and press so that a drop ends up in each eye to be treated.
- Release the lower eyelid and close the eyes for 30 seconds.
Wipe off any liquid that runs down the cheek.
If a drop comes out of the eye, try again.
To prevent infection and avoid eye damage, do not allow the drop tip of the bottle to come in contact with the eye or anything else. Unscrew the bottle cap firmly immediately after use.
If you use more LUMIGAN 0.1 mg / ml than you should
If you use more LUMIGAN than you should, it is unlikely to seriously harm you. Administer the next dose at the usual time. If you have any further questions, ask your doctor or pharmacist.
If you forget to use LUMIGAN 0.1 mg / ml
If you forget to use LUMIGAN, drip into a single drop as soon as you remember and then return to your routine. Do not take a double dose to make up for a forgotten dose.
If you stop using LUMIGAN 0.1 mg / ml
LUMIGAN should be used every day to get the intended effect. If you stop using LUMIGAN, the pressure in your eye may increase. Therefore, talk to your doctor before stopping this treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects are
These can affect 1 or more users out of 10
Affects the eye
- Slight redness (up to 29% of patients)
Common side effects are
These can affect 1 to 9 users out of 100
Affects the eye
- Small changes on the eye surface, with or without inflammation
- Irritation
- Itching in the eye
- Longer eyelashes s
- Irritation when a drop reaches the eye
- Eye pain
Affects the skin
- Red and itchy eyelids
- Darker skin tone around the eye
- Hair growth around the eye
Uncommon side effects are
These can affect 1 to 9 users out of 1,000
Affects the eye
- Darker color in the iris
- Tired eyes
- Swelling on the surface of the eye
- Dimsyn
- Dropping the lash s
Affects the skin
- Dry skin
- Crusts at the edge of the eyelid
- Swelling of the eyelid
- Itching
Affects the body in general
- Headache
- Nausea
Side effects are without known frequency
Affects the eye
- Macular edema (swelling of the retina in the back of the eye which can lead to impaired vision)
- Darker eyelid color
- The eyes look sunken
- Dryness
- Sticky eyes
- A feeling of debris in the eye
- Swelling of the eye
- Increased tear flow
- Discomfort in the eye
- Light sensitivity
Affects the body in general
- Asthma
- Deterioration of asthma
- Exacerbation of chronic obstructive pulmonary disease (COPD)
- Respiratory distress
- Symptoms of allergic reaction (swelling, redness of the eye and rash)
- Dizziness
- High blood pressure
- Discoloration of the skin around the eye
In addition to the side effects of LUMIGAN 0.1 mg/ml, the following side effects have been observed with the use of another medicine containing a higher concentration of bimatoprost (0.3 mg/ml):
- Burning sensation in the eye
- Allergic reaction in the eye
- Inflamed eyelids
- Difficulty seeing clearly
- Impaired vision
- Swelling in the transparent layer that covers the eye
- Increased tear flow
- Darker lash s
- Bleeding in the retina
- Inflammation inside the eye
- Cystic macular edema (retina swells inside the eye leading to impaired vision)
- Twitching of the eyelids
- The eyelid shrinks and moves from the surface of the eye
- Reddening of the skin around the eye
- Weakness
- Elevated values on the blood tests that show how your liver works
Other side effects have been reported with eye drops containing phosphate
In very rare cases, patients with severe damage to the transparent surface of the front of the eye (cornea) have developed cloudy spots on the cornea due to limescale deposits during treatment.
How to store LUMIGAN 0.1 mg / ml
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. day. The expiration date is the last day of the specified month.
You must discard the bottle no later than four weeks after first opening it, even if there are still a few drops left. It prevents infection. To help you remember this, write down the date you opened it 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.
Contents of the package and other information
Content declaration
- The active substance is bimatoprost. One ml of solution contains 0.1 mg of bimatoprost.
- The other ingredients are benzalkonium chloride ( preservative ), sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate and purified water. Small amounts of hydrochloric acid or sodium hydroxide can be added to keep the acidity ( pH level) normal.
What the medicine looks like and contents of the pack
LUMIGAN is a clear, colorless eye drop solution packed in cartons containing either 1 or 3 plastic bottles with screw caps. Each bottle is approximately half full and contains 3 ml of solution. This is enough for 4 weeks of treatment. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
Further information on this medicine can be obtained from the representative of the marketing authorization holder.
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