Prosdrop

Prosdrop

latanoprost

Manufacturer:

Rafarm

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Contents
Latanoprost.
Description
The active substance is latanoprost.
1 ml eye drops solution contains 50 micrograms latanoprost.
2.5 ml of eye drops, solution (content of a bottle) contains 125 micrograms of latanoprost.
PROSDROP is a clear, colourless, aqueous solution with pH from 6.2 to 7.1 and osmolality 240 - 325 mOsmol/kg.
Excipients/Inactive Ingredients: The other ingredients are: benzalkonium chloride, sodium chloride, disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injection.
Action
PROSDROP belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Indications/Uses
PROSDROP is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within the eye, eventually affecting the eye sight.
PROSDROP is also used to treat increased eye pressure and glaucoma in all ages of children and babies.
Dosage/Direction for Use
Always use this medicine exactly as the doctor (or the doctor treating the child) has told. Check with the doctor (or the doctor treating the child) or pharmacist if the patient is not sure.
The usual dosage for adults (including the elderly) and children is one drop once a day in the affected eye(s). The best time to do this is in the evening.
Do not use PROSDROP more than once a day, because the effectiveness of the treatment can be reduced if the patient administers it more often.
Use PROSDROP as instructed by the doctor or the doctor treating the child until told to stop.
Contact lens wearers: If the patient or the child wears contact lenses, they should be removed before using PROSDROP. After using PROSDROP the patient should wait 15 minutes before putting the contact lenses back into the eyes.
Instructions for use: Follow the steps as follows to help the patient use PROSDROP properly: 1. Wash the hands and sit or stand comfortably.
2. Before opening the bottle for the first time, make sure the cap is intact.
3. Open the bottle by turning the cap to the left.
4. Tilt the head back and gently pull down the lower eyelid to form a pouch between the eye and eyelid.
5. Hold the bottle upside down and gently press with the thumb and forefinger in the middle of the bottle until one drop falls into the pouch, as indicated by the doctor. Do not let the eye or eyelid touch the dropper. Then compress the tear duct for about 1 minute (by pressing a finger against the corner of the eye by the nose) and close the eye(s) and keep it/them closed during this time. This ensures that the drop is absorbed by the eye and that the amount of medicine draining through the tear duct to the nose will probably be reduced.
6. Repeat steps 4 and 5 in the other eye if the doctor has told the patient to do this.
7. Twist the cap back onto the bottle. Do not overtighten the cap.
If the patient uses PROSDROP with other eye drops: Wait at least 5 minutes between using PROSDROP and taking other eye drops.
If the patient uses more PROSDROP than they should: If the patient puts too many drops into the eye, it may lead to some minor irritation in the eye and the eyes may water and turn red. This should pass, but if the patient is worried contact the doctor or the doctor treating the child for advice.
Contact the doctor as soon as possible if the patient or the child swallows PROSDROP accidentally.
If the patient forgets to use PROSDROP: Carry on with the usual dosage at the usual time. Do not take a double dose to make up for a forgotten dose.
If the patient stops using PROSDROP: The patient should speak to the doctor (or the doctor treating the child) if they want to stop using PROSDROP.
If the patient has any further questions on the use of this medicine, ask the doctor (or the doctor treating the child) or pharmacist.
Contraindications
Do not use PROSDROP: if the patient is allergic to latanoprost or any of the other ingredients of this medicine (listed in Description); if the patient is pregnant or trying to become pregnant; if the patient is breast feeding.
Special Precautions
PROSDROP can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. PROSDROP has not been investigated in prematurely born infants (less than 36 weeks gestation).
Talk to the doctor (or the doctor treating the child) or the pharmacist before taking PROSDROP or before giving this to the child if the patient thinks any of the following apply to them or the child: If the patient or the child is about to have or have had eye surgery (including cataract surgery).
If the patient or the child suffers from eye problems (such as eye pain, irritation or inflammation, blurred vision).
If the patient or the child suffers from dry eyes.
If the patient or the child has severe asthma or the asthma is not well controlled.
If the patient or the child wears contact lenses. The patient can still use PROSDROP, but follow the instruction for contact lens wearers in Dosage & Administration.
If the patient has suffered or is currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
PROSDROP contains benzalkonium chloride: PROSDROP contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.
If the patient or the child wears contact lenses, they should be removed before using PROSDROP. After using PROSDROP the patient should wait 15 minutes before putting the contact lenses back in. See the instructions for contact lens wearers in Dosage & Administration.
Driving and using machines: When the patient uses PROSDROP they might have blurred vision, for a short time. If this happens to the patient, do not drive or use any tools or machines until the vision becomes clear again.
Use In Pregnancy & Lactation
Pregnancy: Do not use PROSDROP when the patient is pregnant. Tell the doctor immediately if the patient is pregnant, thinks she is pregnant, or is planning to become pregnant.
Breast-feeding: Do not use PROSDROP when the patient is breast-feeding.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are known side effects of using PROSDROP: Very common (likely to affect more than 1 in 10 people): A gradual change in the eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If the patient has mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) they are more likely to see this change than if they have eyes of one colour (blue, grey, green or brown eyes). Any changes in the eye colour may take years to develop although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if the patient uses PROSDROP in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after PROSDROP treatment is stopped.
Redness of the eye.
Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).
A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye, seen mostly in people of Japanese origin. These changes involve an increase of the colour (darkening), length, thickness and number of the eye lashes.
Common (likely to affect less than 1 in 10 people): Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain and light sensitivity (photophobia).
Uncommon (likely to affect less than 1 in every 100 people): Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.
Skin rash.
Rare (likely to affect less than 1 in every 1000 people): Inflammation of the iris, the coloured part of the eye (iritis/uveitis); swelling of the retina (macular oedema), symptoms of swelling or scratching/damage to the surface of the eye, swelling around the eye (periorbital oedema) misdirected eyelashes or an extra row of eyelashes.
Skin reactions on the eyelids, darkening of the skin of the eyelids.
Asthma, worsening of asthma and shortness of breath (dyspnoea).
Very rare (likely to affect less than 1 in 10,000 people): Worsening of angina in patients who also have heart disease, chest pain, sunken eye appearance (eye sulcus deepening).
Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye (iris cyst), headache, dizziness, awareness of heart rhythm (palpitations), muscle pain, joint pain and developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Side effects seen more often in children compared to adults are runny itchy nose and fever.
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.
If the patient gets any side effects, talk to the doctor (or the doctor treating the child) or pharmacist. This includes any possible side effects not listed in this monograph.
Drug Interactions
PROSDROP may interact with other medicines. Tell the doctor (or the doctor treating the child) or pharmacist if the patient or the child is taking, has recently taken or might take any other medicines including those medicines (or eye drops) obtained without a prescription.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Store the unopened bottle in a refrigerator (2°C to 8°C), in the outer carton in order to protect from light. Do not freeze.
After first opening the bottle store below 25°C and use within 4 weeks. When the patient is not using PROSDROP, keep the bottle in the outer carton, in order to protect it from light.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01EE01 - latanoprost ; Belongs to the class of prostaglandin analogues. Used in the treatment of glaucoma.
Presentation/Packing
Eye drops 0.05 mg/mL (clear, colourless, aqueous solution) x 2.5 mL x 1's.
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