50 micrograms/ml eye drops, solution
latanoprost
What Latanoprost Actavis is and what it is used for
Latanoprost Actavis belongs to the group of drugs prostaglandin analogs and lowers eye pressure by increasing the natural outflow of aqueous humor inside the eye to the bloodstream.
Latanoprost Actavis is used to treat a condition called open-angle glaucoma and ocular hypertension (glaucoma). Both of these conditions cause elevated pressure in the eye that eventually affects vision.
Latanoprost Actavis is also used to treat high blood pressure and glaucoma in infants and children of all ages.
Latanoprost contained in Latanoprost Actavis 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 Actavis
Latanoprost Actavis can be used by adults (including the elderly), and for children from birth to 18 years of age. Latanoprost Actavis has not been tested in premature infants (born before week 36).
Do not use Latanoprost Actavis
- if you are allergic to latanoprost or any of the other ingredients of this medicine (see section 6.)
Warnings and cautions
If you think the following applies to you or your child, talk to your doctor or your child’s doctor or pharmacist before using (or your child) Latanoprost Actavis.
- if you or your child are about to undergo or have just undergone eye surgery (including cataract surgery).
- if you or your child suffers 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 has severe asthma or uncontrolled asthma .
- If you or your child wear contact lenses, you can still use Latanoprost Actavis, but follow the special instructions in section 3.
- if you or your child have suffered or are suffering from a viral infection in the eye caused by the herpes simplex virus .
Other medicines and Latanoprost Actavis
Latanoprost Actavis may interact with other medicines. Tell your doctor or the doctor treating your child or pharmacist if you or your child are taking or have recently taken any other medicines.
Pregnancy and breastfeeding
Pregnancy
Do not use Latanoprost Actavis if you are pregnant. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.
Breast-feeding
Do not use Latanoprost Actavis if you are breastfeeding.
Driving and using machines
When you use Latanoprost Actavis, you may have blurred vision for a short time. If this happens to you, do not drive or use any tools or machines until your vision is clear 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 Actavis contains benzalkonium chloride and phosphate buffer
This medicine contains 0.2 mg/ml benzalkonium chloride.
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 6.4 mg/ml phosphate.
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 Actavis
Always use this medicine exactly as your doctor or your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose for adults (including the elderly) and children is one drop daily in the diseased eye (s). The best time to do this is in the evening.
Do not use Latanoprost Actavis more than once a day, as the effect of the treatment may be reduced if used too often.
Use Latanoprost Actavis according to the instructions given to you by your doctor or the doctor treating your child until the doctor tells you to stop the treatment.
For you who wear contact lenses
If you or your child wear contact lenses, remove them before using Latanoprost Actavis. After using Latanoprost Actavis, wait 15 minutes before putting the contact lenses back in your eyes.
Instructions for use:
- Wash your hands and sit or stand comfortably.
- Unscrew the lid.
- Use your finger to gently pull down the lower eyelid of the affected eye.
- Place the tip of the bottle close, but without touching the eye.
- Gently squeeze the bottle so that only one drop enters the eye, then release the lower eyelid.
- Press a finger against the inner corner of the eye, hold for 1 minute while closing your eyes.
- Repeat in the other eye if your doctor has told you to do this.
- Put the cap back on the bottle
If you use Latanoprost Actavis and other eye drops
Wait at least 5 minutes between dosing one with Latanoprost Actavis and another eye drop treatment.
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 Actavis:
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 Actavis 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 Actavis.
- Reddening of the eyes.
- Eye irritation (a burning sensation, tingling sensation, itching, stinging or feeling of debris in the eye).
- A gradual change of the eyelashes in the treating eye and fine hair around the treating eye, especially in people of Japanese descent. These changes include an increase in color (darker), length, thickness and number of eyelashes ).
Common side effects are (may affect up to 1 in 10):
- Irritation or erosion of the surface of the eye, eyelid inflammation ( blepharitis ), eye pain and photosensitivity ( photophobia ).
Less common side effects are (may affect up to 1 in 100):
- Swollen eyelids, dry eyes, inflamed or irritated eye surface ( keratitis ), blurred vision and conjunctivitis.
- Chest pain (angina).
- Rash.
Rare side effects are (may affect up to 1 in 1000 people):
- Inflammation of the iris , the colored part of the eye (iritis / uveitis); swelling of the retina (macular edema), symptoms such as swelling or rough / damaged eye surface, swelling around the eye, misaligned eyelashes or an extra row of eyelashes , scarring on the surface of the eye.
- Skin reactions on the eyelids, darker color on the eyelid skin.
- Asthma , worsening asthma or strained breathing ( dyspnoea ).
- Severe itchy skin
Very rare side effects are (may affect up to 1 in 10 000 users):
- Angina pectoris, aggravated angina pectoris, chest pain, sick eyes (deepening of the eye socket)
Has been reported (occurs in an unknown number of users):
- Fluid-filled area within the colored part of the eye ( cyst on the iris ).
- Inflammation of the cornea of the eye caused by the herpes simplex virus ( HSV ), (herpetic keratitis ).
- Headache, dizziness.
- Palpitation.
- Muscle pain, joint pain.
Side effects that are more common in children than in adults are runny, itchy nose, and fever.
Phosphate
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 Actavis
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated after EXP. The expiration date is the last day of the specified month.
Store the bottle in the outer carton. Sensitive to light.
Before opening the bottle:
Store in a refrigerator (2 ° C – 8 ° C). This medicine should also be kept refrigerated during transport from the manufacturer to the pharmacy. However, it is not necessary to keep it refrigerated during transport, for example from the pharmacy to your home.
Opened bottle:
Store at a maximum of 25 ° C and use within 4 weeks.
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
What Latanoprost Actavis contains
- The active substance is latanoprost. One ml of eye drop solution contains 50 micrograms of latanoprost. One drop contains about 1.5 micrograms of latanoprost.
- The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, sodium chloride, purified water.
What the medicine looks like and contents of the pack
Latanoprost Actavis is a clear, colorless eye drop solution in a plastic bottle with a pipette and a plastic cap. Each bottle contains 2.5 ml of eye drop solution corresponding to approximately 80 drops of the solution.
Latanoprost Actavis is available in packs of 1, 3, and 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
HBM Pharma sro
03680 Martin
Sklabinska 30
Slovakia
Pharma Stull
Werks. 3
DE-92551 Stull
Germany
Jadran Galenski Laboratory dd
Svilno 20
Rijeka, 51000
Croatia