50 micrograms/ml eye drops, solution
latanoprost
What Latanoprost Sandoz is and what it is used for
Latanoprost Sandoz contains the active substance latanoprost. Latanoprost Sandoz belongs to a group of medicines called prostaglandin analogs. It works by increasing the natural outflow of fluid inside the eye to the bloodstream.
Latanoprost Sandoz is used to treating a condition called open-angle glaucoma and ocular hypertension in adults.
Both of these conditions cause elevated pressure in the eye that eventually affects vision.
Latanoprost Sandoz is also used to treat high blood pressure and glaucoma in infants and children of all ages.
Latanoprost contained in Latanoprost Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Latanoprost Sandoz
Latanoprost Sandoz can be used by adult men and women (including the elderly) and for children from birth to 18 years of age. Latanoprost Sandoz has not been tested in premature infants (born before week 36).
Do not use Latanoprost Sandoz
- if you are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Latanoprost Sandoz if you think any of the following apply to you or your child:
- if you or your child is going to have or have had eye surgery (including cataract surgery)
- if you or your child has severe asthma or uncontrolled asthma
- if you know that you or your child suffers from dry eyes
- if you or your child suffers from eye problems (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 special instructions for contact lenses users in section 3)
- if you have or suffer from a viral infection of the eye caused by the herpes simplex virus .
Other medicines and Latanoprost Sandoz
Tell your doctor, the doctor treating your child, or the pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Concomitant use of two or more prostaglandin analogs is not recommended, as this may lead to an increase in intraocular pressure.
Pregnancy, breastfeeding and fertility
Do not use Latanoprost Sandoz if you are pregnant or breastfeeding.
Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.
Driving and using machines
When you take Latanoprost Sandoz you may have blurred vision for a short time. If this happens, do not drive or use any tools or machines until you see them again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Latanoprost Sandoz contains benzalkonium chloride and phosphate
This medicine contains 0.2 mg benzalkonium chloride per ml. Benzalkonium chloride can be absorbed by soft contact lenses and may discolor the contact lenses.
Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
This medicine contains 6.34 mg of phosphate per ml. If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How to use Latanoprost Sandoz
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or doctor treating your child or pharmacist.
Dosage
The usual dosage for adults (including the elderly) and children is:
One drop daily in the diseased eye (s).
It is best to dose in the evening. Do not use Latanoprost Sandoz more than once a day, as the effect of treatment may be impaired if dosed more often.
Use Latanoprost Sandoz exactly as you were told by your doctor or the doctor treating your child until your doctor tells you to stop.
For you who wear contact lenses
If you or your child wear contact lenses, they should be removed before dosing with Latanoprost Sandoz. After taking Latanoprost Sandoz, wait 15 minutes before inserting contact lenses into the eyes.
Instructions for use
The DROP-TRAINER ® bottle is designed to guarantee the administration of an accurate dose of medicine. Before using the DROP-TRAINER ® bottle, read the entire instruction manual carefully.
If you are also using other medicines that are applied to the eye, these should be applied at least 5 minutes before or 5 minutes after Latanoprost Sandoz.
2. Wash your hands before using this medicine.
Before using the medicine for the first time, make sure that the safety seal in the bottle is intact.
4. Tear off the safety closure to open the seal.
5. Shake the bottle once and unscrew the cap before each use.
6. Turn the bottle upside down and hold it between your thumb and forefinger so that your fingertips are pointing towards yourself.
7. Tilt your head back and hold the bottle above the diseased eye.
8. Place one of the fingers of the opposite hand under the eye. Gently pull down with your finger so that a V-shaped pocket appears between the finger and the lower eyelid. Do not touch the eye with the tip of the dropper bottle.
9. Hold the bottle in your hand and place your index finger against the bottom of the bottle. Press your index finger against the bottom of the bottle to drip a drop of the drug into the eye. Do not squeeze the sides of the bottle. Keep your head tilted back and close your eye to allow the medicine to be absorbed into your eye.
10. Repeat steps 6-9 for the other eye, if prescribed.
11. Close the bottle by screwing on the cap tightly.
If you use Latanoprost Sandoz with other eye drops
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Latanoprost Sandoz:
Very common (may affect more than 1 user in 10):
- A gradual change in eye color due to an increasing amount of brown pigment in the colored part of the eye called the iris . If you have a mottled eye color (blue-brown, gray-brown, yellow-brown or green-brown), the color change is more likely to occur than if you have eyes in one color (blue, gray, green, or brown eyes). The change in the color of the eye can take several years, but it usually occurs within 8 months after starting treatment. The color change may be permanent and may become more obvious if you use Latanoprost Sandoz in only one eye. No eye problems could be detected due to the color change. The change in eye color does not continue after stopping treatment with Latanoprost Sandoz.
- Reddening of the eyes
- Burning, grit, itching , stinging sensation or feeling of foreign particles in the eye. If you get an eye irritation that is so severe that your eyes water profusely or that makes you stop taking this medicine, talk to a doctor, pharmacist or nurse immediately (within a week). Your treatment may need to be re-evaluated to ensure that you still receive the right treatment for your illness.
- A gradual change of the eyelashes and the fine hairs around the treated eye, is seen mainly in people of Japanese origin. These changes include darker, longer, thicker and more eyelashes .
Common (may affect up to 1 in 10 people):
- Light sensitivity
- Inflammation of the conjunctiva of the eye
- Eyelid inflammation ( blepharitis )
- Irritation or damage to the surface of the eye
- Eye pain
Uncommon (may affect up to 1 in 100 people):
- Eyelid swelling
- Dry eyes
- Inflammation or irritation of the eye surface ( keratitis )
- Inflammation of the colored part of the eye ( uveitis )
- Dimsyn
- Swelling of the retina (macular edema)
- Rash
- Chest pain (angina), palpitations
- Asthma , shortness of breath
- Headache, dizziness
- Muscle pain, joint pain
Rare (may affect up to 1 in 1,000 people):
- Inflammation of the iris , the colored part of the eye ( iritis )
- Symptoms such as swelling or scratched / damaged eye surface
- Swelling around the eyes (periorbital edema )
- Eyelashes grow in the wrong direction which can cause eye irritation
- An extra row of eyelashes grows out
- Scarring on the surface of the eye
- Fluid-filled bladder in the colored part of the eye (iris cyst)
- Local skin reaction on the eyelids
- Darker skin color on the eyelids
- Worsened
- asthma symptoms
- Severe itchy skin
- Development of a viral infection in the eye caused by the herpes simplex virus
Very rare (may affect up to 1 in 10,000 people):
- Exacerbated angina in patients who also have heart disease
- Sunken eyes (deepening of the eye socket)
Side effects that are more common in children compared to adults are runny and itchy nose and fever.
In very rare cases, some patients with severe damage to the thin, clear membrane on the front of the eye (cornea) have developed cloudy spots on the cornea due to the accumulation of calcium during treatment.
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 bottle after EXP. or EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Store in the outer carton. Sensitive to light.
Storage instructions after first opening:
Do not store above 25 ° C.
Shelf life after first opening:
Latanoprost Sandoz should be used within 4 weeks of first opening the bottle but before the expiry date.
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 pack and other information
Content declaration
The active substance is latanoprost. One ml solution contains 50 micrograms latanoprost (equivalent to 0.005% w / v). One drop contains about 1.5 micrograms of latanoprost.
The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate (E339), sodium chloride, anhydrous disodium phosphate (E339), and water for injections.
What the medicine looks like and contents of the pack
Eye drops, solution.
Latanoprost Sandoz is a clear, colorless solution.
4 ml uncolored DROP-TRAINER ® bottle of LDPE plastic with an uncolored LDPE drip insert and a turquoise
screw cap made of polypropylene (PP) and with shrink wrap of polyvinyl chloride (PVC) around the neck and screw cap of the DROP-TRAINER ® bottle.
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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
SAAlcon-Couvreur NV, Rijksweg 14, B-2870 Puurs, Belgium