Latanoprost Dr. Reddy's 50 microgram/ml Oogdruppels, oplossing

[Invented name] can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. [Invented name] has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use [Invented name] if you are

• Allergic (hypersensitive) to latanoprost or any of the other ingredients of [Invented name] (see section 6 for the list of ingredients in your medicine).
• Pregnant or trying to become pregnant
• Breast feeding.

Take special care with [Invented name]

Talk to your doctor or the doctor treating your child or your pharmacist before you use [Invented name] or before you give this to your child if you think any of the following apply to you or your child:

• If you or your child are about to have or have had eye surgery (including cataract surgery).

• If you or your child suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision)
• If you or your child suffers from dry eyes
• If you or your child have severe asthma or the asthma is not well controlled
• If you or your child wear contact lenses. You can still use [Invented name], 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)

-

Taking other medicines

[Invented name] may interact with other medicines. Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have taken any other medicines including those medicines (or eye drops) obtained without a prescription.

Pregnancy

Do not use [Invented name] when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant.

Breast-feeding

Do not use [Invented name] when you are breast feeding.

Driving and using machines

When you use [Invented name] 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.

Important information about some of the ingredients of [Invented name]

[Invented name] 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 you or your child wear contact lenses, they should be removed before using [Invented name]. After using [Invented name] you should wait 15 minutes before putting the contact lenses back in. See the instructions for contact lens wearers in Section 3.

Always use [Invented name] exactly as your doctor or the doctor treating your child has told you. You should check with your doctor or the doctor treating your child or pharmacist if you are 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 [Invented name] more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Use [Invented name] as instructed by your doctor or by the doctor treating your child until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, they should be removed before using [Invented name]. After using [Invented name] you should wait 15 minutes before putting the contact lenses back into the eye.

Instructions for use

1. Wash your hands and sit or stand comfortably.
2. Unscrew the protective cap. The protective cap should be retained.
3. Use your finger to gently pull down the lower eyelid of your affected eye.

1. Place the tip of the bottle close to, but not touching your eye.
2. Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.
3. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.
4. Repeat in your other eye if your doctor has told you to do this.
5. Put the protective cap back on the bottle

If you use [Invented name] with other eye drops

Wait at least 5 minutes.between using [Invented name] and taking other eye drops

If you use more [Invented name] 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 or the doctor treating your child for advice.

Contact your doctor as soon as possible if you or your child swallows [Invented name] accidentally.

If you forget to use [Invented name]

Carry on with the usual dosage at the usual time. Do not use 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 [Invented name]

You should speak to your doctor or the doctor treating your child if you want to stop taking [Invented name].

Like all medicines, [Invented name] can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:

Very common	affects more than 1 user in 10
Common:	affects 1 to 10 users in 100
Uncommon:	affects 1 to 10 users in 1,000
Rare:	affects 1 to 10 users in 10,000
Very rare:	affects less than 1 user in 10,000
Not known:	frequency cannot be estimated from the available data

Very common effects:

• 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 [Invented name] 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 [Invented name] 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 your eye lashes.

Common effects:

• Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain.

Uncommon effects:

• Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.
• Skin rash.

Rare effects:

• 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 (growing inwards) 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 effects:

• Worsening of angina in patients who also have heart disease. Chest pain.

Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye (iris cyst), headache, dizziness, palpitations, muscle pain and 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.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please contact you doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use [Invented name] after the expiry date, which is stated on the carton and bottle. The expiry date refers to the last day of that month.

Store the unopened bottle in a refrigerator (between 2°C and 8°C), protected from light.

After opening the bottle it is not necessary to store the bottle in a refrigerator but do not store it above 25°C. Use within 4 weeks of opening. When you are not using [Invented name], keep the bottle in the outer carton, in order to protect it from light.

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.

6 FURTHER INFORMATION

What [Invented name] contains

The active substance is latanoprost.

1 ml of eye drops contains 50 micrograms latanoprost.

The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate (E339a) and anhydrous disodium hydrogen phosphate (E339b) dissolved in water for injections.

What [Invented name] looks like and contents of the pack

[Invented name] Eye Drops, Solution is a clear, colourless liquid.

[Invented name] is available in a pack size of 1 carton.

Each carton contains one bottle of [Invented name]. Each bottle contains 2.5ml of [Invented name] Eye Drops, Solution.

Marketing Authorisation Holder and Manufacturer

Dr Reddy’s Laboratories (UK) Ltd

6, Riverview Road, Beverley,

East Yorkshire, HU17 0LD

Engeland

Nummer van de vergunning voor het in de handel brengen

RVG 109337

This medicinal product is authorised in the Member States of the EEA under the following names

To be completed nationally

This leaflet was last approved in {MM/YYYY }.