Latanoprost Sandoz

Package leaflet: Information for the patient

Latanoprost Sandoz 50 micrograms/ml eye drops, solution

Latanoprost
Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Latanoprost Sandoz is and what it is used for
2. What you need to know before using Latanoprost Sandoz
3. How to use Latanoprost Sandoz
4. Possible side effects
5. How to store Latanoprost Sandoz
6. Contents of the pack and other information

1. What Latanoprost Sandoz is and what it is used for

Latanoprost Sandoz contains the active substance latanoprost. Latanoprost belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow into the bloodstream of the fluid inside the eye.
Latanoprost Sandoz is used to treat:

• a condition known as open-angle glaucoma
• ocular hypertension in adults.

Both of these conditions are related to increased pressure inside the eye, which may eventually damage vision.
Latanoprost Sandoz is also used to treat elevated intraocular pressure and glaucoma in children of all ages and in newborns.

2. What you need to know before using Latanoprost Sandoz

Latanoprost Sandoz can be used in adult women and men (including the elderly) and in children from birth up to 18 years of age. The use of Latanoprost Sandoz in premature newborns (gestational age less than 36 weeks) has not been investigated.
Do not use Latanoprost Sandoz

• If you are allergic to latanoprost or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Tell your doctor, the doctor treating your child, or pharmacist before you use Latanoprost Sandoz or before giving it to your child if you think any of the following conditions apply to you or your child:

• if you or your child are about to undergo or have recently undergone eye surgery (including cataract surgery)
• if you or your child have severe or poorly controlled asthma
• if you or your child have dry eyes
• if you or your child have eye disorders, such as eye pain, irritation or inflammation, blurred vision
• if you or your child wear contact lenses (you can still use Latanoprost Sandoz, but follow the instructions for contact lens wearers in section 3)
• if you or your child have had or currently have a viral eye infection caused by the herpes simplex virus (HSV)

Other medicines and Latanoprost Sandoz
Tell your doctor, the doctor treating your child, or pharmacist if you or your child are taking or have recently taken any other medicines.
The concomitant use of two or more prostaglandin analogues is not recommended, as it may cause an increase in intraocular pressure.
Pregnancy, breast-feeding and fertility
Do not use Latanoprost Sandoz if you are pregnant or breast-feeding.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy.
Driving and using machines
When using Latanoprost Sandoz, you may experience blurred vision for a short period of time. If this occurs, do not drive or operate any tools or machinery until your vision clears again.
Latanoprost Sandoz contains benzalkonium chloride and phosphates
This medicine contains 0.2 mg of benzalkonium chloride per ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.
This medicine contains 6.34 mg of phosphates per ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use Latanoprost Sandoz

Always use this medicine exactly as prescribed by your doctor or the doctor treating your child, or as advised by the pharmacist. If you have any doubts, consult your doctor, the doctor treating your child, or the pharmacist.

Dosage
The usual dose for adults (including the elderly) and children is:
one drop once daily in the eye (or eyes) to be treated.
The optimal time for administration is in the evening. Do not use Latanoprost Sandoz more than once a day, as more frequent administration may reduce the effectiveness of treatment.
Use Latanoprost Sandoz as directed by your doctor or the doctor treating your child until they decide to discontinue treatment.

Contact lens wearers
If you or your child wears contact lenses, they must be removed before instilling Latanoprost Sandoz. After using Latanoprost Sandoz, wait 15 minutes before reinserting the contact lenses.

Instructions for use

The DROP-TAINER® bottle is designed to ensure the release of an accurate dose of medicine. Read the complete instructions carefully before using the DROP-TAINER® bottle.

1. If you are using other topical ophthalmic medicines, these should be administered at least 5 minutes before or after Latanoprost Sandoz.
2. Wash your hands before each use.
3. Before using the medicine for the first time, make sure the safety seal on the bottle is intact.
4. Tear off the safety seal to break the seal.
5. Before each use, shake once and remove the screw cap.
6. Invert the bottle and hold it between your thumb and middle finger, with the tips of the fingers pointing towards you.

7. Tilt your head backwards and position the bottle above the affected eye.
8. Place a finger of the other hand under the eye. Gently pull down until a "V"-shaped pouch forms between the eye and the lower eyelid. Do not touch the eye with the dropper tip.
9. Place the index finger of the hand holding the bottle on the bottom of the bottle. Press the bottom of the bottle to dispense one drop of the medicine. Do not squeeze the sides of the bottle. Keep your head tilted backwards and close your eye to allow absorption of the medicine into the eye.
10. Repeat steps 6 to 9 with the other eye if instructed to do so.
11. Replace the screw cap by rotating it until the bottle is firmly closed.

If you use Latanoprost Sandoz with other eye drops
Wait at least 5 minutes between the administration of Latanoprost Sandoz and other eye drops.
If you use more Latanoprost Sandoz than you should
If too many drops are instilled into an eye, this may cause mild eye irritation, tearing and redness. These effects should pass, but if you are concerned, consult your doctor or the doctor treating your child.
Contact your doctor as soon as possible if you or your child accidentally swallow Latanoprost Sandoz.
If you forget to use Latanoprost Sandoz
Take your usual dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you are unsure about anything, consult your doctor or pharmacist.
If you stop using Latanoprost Sandoz
If you intend to stop treatment with Latanoprost Sandoz, you must speak with your doctor or the doctor treating your child.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Latanoprost Sandoz:

Very common side effects (may affect more than 1 in 10 people)

• Gradual change in eye colour due to increased 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, green-brown), you are more likely to experience this change than if you have eyes of a single colour (blue, grey, green or brown). Any change in eye colour may develop over years, although it is usually noticeable within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Latanoprost Sandoz in only one eye. There appear to be no problems associated with the change in eye colour. The change in eye colour does not progress after stopping treatment with Latanoprost Sandoz.
• Eye redness
• Burning sensation, gritty sensation in the eye, itching, stinging sensation, and sensation of a foreign body in the eye. If you experience eye irritation severe enough to cause excessive tearing or if you are considering stopping this medicine, consult your doctor, pharmacist or nurse immediately (within one week). Your treatment may need to be reviewed to ensure you continue to receive appropriate treatment for your condition.
• Gradual changes in the eyelashes of the treated eye and in the fine hair around the treated eye, particularly observed in people of Japanese origin. These changes include increased pigmentation (darkening), length, thickness, and number of eyelashes.

Common side effects (may affect up to 1 in 10 people)

• Light sensitivity (photophobia)
• Conjunctivitis
• Inflammation of the eyelids (blepharitis)
• Eye irritation or changes to the surface of the eye
• Eye pain

Uncommon side effects (may affect up to 1 in 100 people)

• Swelling of the eyelids
• Dry eyes
• Inflammation or irritation of the surface of the eye (keratitis)
• Inflammation of the coloured part of the eye (uveitis)
• Blurred vision
• Swelling of the retina (macular edema)
• Rash
• Chest pain (angina), awareness of heartbeat (palpitations)
• Asthma, shortness of breath (dyspnoea)
• Migraine, dizziness
• Muscle pain, joint pain

Rare side effects (may affect up to 1 in 1,000 people)

• Inflammation of the iris, the coloured part of the eye (iritis)
• Symptoms of swelling or scratching/damage to the surface of the eye
• Swelling around the eyes (periorbital edema)
• Eyelashes growing in the “wrong” direction, which may cause eye irritation
• Growth of an additional row of eyelashes
• Scarring of the surface of the eye
• Fluid-filled area within the coloured part of the eye (iris cysts)
• Localised skin reaction on the eyelids
• Darkening of the skin of the eyelids
• Worsening of asthma symptoms
• Severe itching of the skin
• Development of a viral eye infection caused by the Herpes simplex virus (HSV)

Very rare side effects (may affect up to 1 in 10,000 people)

• Worsening of angina pectoris in patients already affected by heart disease
• Sunken appearance of the eye (deepening of the eye socket)

Side effects observed more frequently in children than in adults are: runny and itchy nose, fever.

In very rare cases, some patients with severe damage to the transparent membrane at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Latanoprost Sandoz

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 and on the bottle after EXP.
The expiry date refers to the last day of the month.
Store in a refrigerator (2-8°C).
Keep the bottle in the outer packaging to protect the medicine from light.
Storage conditions after first opening:
do not store above 25°C.
Validity after first opening:
Latanoprost Sandoz must be used within 4 weeks after first opening of the bottle, but not beyond
the expiry date.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Latanoprost Sandoz contains
The active substance is latanoprost.
Each ml of solution contains 50 micrograms of latanoprost (equivalent to 0.005% weight/volume).
Each drop contains approximately 1.5 micrograms of latanoprost.
The other components are: benzalkonium chloride, monosodium dihydrogen phosphate monohydrate (E339), sodium chloride, anhydrous disodium phosphate (E339), and water for injections.

Description of the appearance of Latanoprost Sandoz and package contents
Eye drops, solution.
Latanoprost Sandoz is a clear, colourless solution.
DROP-TAINER® bottle made of natural LDPE with a dropper in natural LDPE, a turquoise screw cap made of polypropylene (PP), and a protective overwrap made of polyvinyl chloride (PVC) around the neck and screw cap of the DROP-TAINER®.

Pack sizes:
1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml solution
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.P.A.
Largo U. Boccioni, 1
21040 Origgio (Varese)
Italy

Manufacturers
S.A. ALCON-COUVREUR N.V., Rijksweg 14, B-2870 Puurs, Belgium
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Latanoprost Sandoz 50 Mikrogramm/ml - Augentropfen
Belgium: Latanoprost Sandoz 0.05 mg/ml oogdruppels, oplossing
Denmark: Latanoprost "Sandoz"
Estonia: Latizolil
Finland: Latanoprost Sandoz 50 mikrog/ml silmätipat, liuos
France: LATANOPROST SANDOZ 50 microgrammes/ml, collyre en solution
Germany: Latanoprost-1 A Pharma 50 Mikrogramm/ml Augentropfen, Lösung
Italy: LATANOPROST SANDOZ
Latvia: Latizolil 50 mikrogrami/ml acu pilieni, šķīdums
Netherlands: Latanoprost Sandoz 0.05 mg/ml, oogdruppels, oplossing
Norway: Latanoprost Sandoz 50 mikrogram/ml øyedråper, oppløsning
Poland: Polprost
Spain: Latanoprost Sandoz 50 microgramos/ml colirio en solución
Sweden: Latanoprost Sandoz 50 mikrogram/ml ögondroppar, lösning
United Kingdom: Latanoprost 0.005% w/v eye drops, Solution