Patient leaflet - Latanoprost 50 micrograms/ml eye drops, solution in a single-dose Container
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine 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.
This medicine 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 your eye, eventually affecting your eye sight.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
Do not use this medicine:
- if you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if you think any of the following apply to you:
- If you are about to have or have had eye surgery (including cataract surgery)
- If you suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision)
- If you suffer from dry eyes
- If you have severe asthma or the asthma is not well controlled
- If you wear contact lenses. You can still use this medicine, but follow the instruction for contact lens wearers in Section 3
- If you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
Children
This medicine has not been investigated in children (below 18 years).
Other medicines and this medicine
This medicine may interact with other medicines. Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding and fertility
You should not use this medicine if you are pregnant or breast-feeding unless your doctor considers it necessary. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
When you use this medicine you might have blurred vision, for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again.
This medicine contains phosphate buffers
This medicine contains 6.3mg/ml phosphates which is equivalent to 0.24mg/drop.
If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
3. HOW TO USE THIS MEDICINE
Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dosage for adults (including the elderly) is one drop once a day in the affected eye(s). The best time to do this is in the evening. Do not use this medicine more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Use this medicine as instructed by your doctor until they tell you to stop.
Contact lens wearers
If you wear contact lenses, they should be removed before using this medicine. After using this medicine you should wait 15 minutes before putting the contact lenses back into the eyes.
Instructions for use
There are 3 sachets in each carton box. Only one sachet should be opened each time. Use all strips before opening the next sachet.
Separate the single-dose container from the strip before use.
- 1. Wash your hands and sit or stand comfortably.
- 2.
Use your finger to gently pull down the lower
eyelid of your affected eye.
- 3.
Place the tip of the single-dose container close to,
but not touching your eye.
- 4.
Squeeze the single-dose container gently so that
only one drop goes into your eye, then release the lower eyelid.
- 5. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.
- 6. Repeat in your other eye if your doctor has told you to do this.
- 7.
Throw away the single-dose container after use.
Do not keep it to use it again.
If you use this medicine with other eye drops
Wait at least 5 minutes between using this medicine and taking other eye drops.
If you use more of this medicine than you should
If you put 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 you are worried contact your doctor for advice.
Contact your doctor as soon as possible if you swallow this medicine accidentally.
If you forget to use this medicine
Carry on with the usual dosage at the usual time. Do not take a double dose to make up for the dose you have forgotten. If you are unsure about anything talk to your doctor or pharmacist.
If you stop using this medicine
You should speak to your doctor if you want to stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following are known side effects of using this medicine:
Very common
(may affect more than 1 in 10 people):
A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris.
- If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes).
- Any changes in your 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 you use this medicine 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 this medicine 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). If you experience eye irritation severe enough to make your eyes water excessively, or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse promptly (within a week). You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition.
- 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 your eye lashes.
Common (may affect up to 1 in 10 people):
- Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis. Uncommon (may affect up to 1 in 100 people):
- Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).
- Skin rash.
- Chest pain (angina), awareness of heart rhythm (palpitations).
- Asthma, shortness of breath (dyspnoea).
- Chest pain.
- Headache, dizziness.
- Muscle pain, joint pain.
- Nausea, vomiting.
Rare (may affect up to 1 in 1000 people):
- Inflammation of the iris (iritis), 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, scarring of the surface of the eye, fluid filled area within the coloured part of the eye (iris cyst).
- Skin reactions on the eyelids, darkening of the skin of the eyelids.
- Worsening of asthma.
- Severe itching of the skin.
- Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Very rare (may affect up to 1 in 10,000 people):
- Worsening of angina in patients who also have heart disease.
- Sunken eye appearance (eye sulcus deepening). 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.
Reporting of side effects
If you get any side effects, talk to your doctor, 
pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Latanoprost 50 micrograms/ml eye drops, solution in a single-dose container
Latanoprost
5. HOW TO STORE THIS MEDICINE
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 carton, sachet and single dose container. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
Store the opened sachet in the outer carton in order to protect content from light.
After first opening of the sachet: use the single-dose containers within 20 days.
After first opening of the single dose container: use immediately and discard the single-dose container after use.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What this medicine contains
The active substance is 50 micrograms/ml latanoprost.
The other excipients are: carboxymethyl cellulose sodium, D-mannitol, tyloxapol, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, hydrochloric acid (for
pH-adjustment), water for injection.
What this medicine looks like and contents of the pack
This medicine is a clear to light-yellow solution. Each carton contains 3 sachets of 10 single-dose containers (30 single-dose containers per carton). Marketing Authorisation Holder
Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany
This leaflet was last revised in 01/2025
Type: Leaflet
Reason for request: Small amendment to Section 2 & 3 Version no: 2.1
Date of revision: 9.1.24
Colours: As swatch(es)
Font(s): 8pt Myriad Pro
For submission only