Latanoprost STADA

50 micrograms/ml eye drops, solution
Latanoprost

What Latanoprost STADA is and what it is used for

Latanoprost Stada belongs to the group of drugs prostaglandin analogs. It works by increasing the natural outflow of fluid inside the eye to the bloodstream.

Latanoprost Stada is used to treat conditions called open-angle glaucoma and ocular hypertension ( glaucoma ) in adults. Both of these diseases cause an elevated pressure in the eye that can eventually affect vision.

Latanoprost Stada is also used to lower eye pressure and glaucoma in infants and children of all ages.

Latanoprost contained in Latanoprost Stada 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 STADA

Do not use Latanoprost STADA

Latanoprost Stada can be used by adults (including the elderly), and for children from birth to 18 years of age. Latanoprost Stada has not been tested in premature infants (born before week 36).

Do not use Latanoprost Stada

  • 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 the doctor treating your child or pharmacist before you or your child use Latanoprost Stada if you think any of the following apply to you or your child:

  • 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 know that you or your child suffers from dry eyes.
  • If you or your child have severe asthma or uncontrolled asthma .
  • If you or your child wears contact lenses, you can still use Latanoprost Stada, but follow the special instructions in section 3.
  • If you have or have had a viral infection of the eye caused by the herpes simplex virus ( HSV ).

Other medicines and Latanoprost STADA

Latanoprost Stada may interact with other medicines. Tell your doctor, or the doctor treating your child or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The unborn baby can be affected. Latanoprost Stada should not be used during pregnancy.

Breast-feeding

Talk to your doctor before using Latanoprost Stada.

The child can be affected. Latanoprost Stada should not be used during breastfeeding.

Driving and using machines

When you use Latanoprost Stada, 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 STADA contains benzalkonium chloride

This medicine contains 0.2 mg benzalkonium chloride per ml eye drops solution.

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. See instructions for contact lens wearers in Section 3.

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.

How to use Latanoprost STADA

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or doctor who is treating your child or pharmacist.

The usual dose for adults (including the elderly) and children is one drop daily in the affected eye (s). It is best to do this in the evening.

Do not use Latanoprost Stada more than once a day, as the effect of treatment may be impaired if dosed more often.

Use Latanoprost Stada 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, they should be removed before dosing with Latanoprost Stada. After taking Latanoprost Stada, wait 15 minutes before inserting contact lenses into the eyes.

Instructions for use

Follow the steps below to help you use Latanoprost Stada correctly:

  1. Wash your hands and sit or stand comfortably.
  2. Turn off the cap.
  3. Using your finger, gently lower the lower eyelid into the affected eye.
  4. Place the top of the bottle close to, but do not touch, the eye.
  5. Gently press on the bottle so that only one drop comes into contact with the eye. Then release the lower eyelid.
  6. Press one finger against the inner corner of the affected eye (against the nose). Hold for 1 minute while keeping your eye closed.
  7. Repeat in your other eye if your doctor has said so.
  8. Replace the bottle cap.

If you use Latanoprost Stada with other eye drops

Wait at least 5 minutes between dosing one with Latanoprost Stada 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:

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 Stada 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 Stada.
  • Redness of the whites of the eyes.
  • Eye irritation (burning, grit, itching , tingling sensation or feeling of a foreign particle 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 treating eye, this is mostly seen in people of Japanese origin. These changes include darker, longer, thicker and more lashes .

Common (may affect up to 1 in 10 people):

  • Irritation or damage to the surface of the eye.
  • Eyelid inflammation ( blepharitis ).
  • Eye pain.
  • Photosensitivity ( photophobia )
  • Inflammation of the conjunctiva.

Uncommon (may affect up to 1 in 100 people):

  • Swollen eyelids, dry eyes, inflamed or irritated eye surface ( keratitis ), blurred vision, inflammation of the colored part of the eye ( uveitis ), swelling of the retina (macular edema).
  • Rash.
  • Chest pain (angina), palpitations.
  • Asthma , shortness of breath ( dyspnoea ).
  • Chest pain
  • Headache, dizziness.
  • Muscle and joint pain.

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

  • Inflammation of the iris ( iritis ), symptoms of swelling or lacerations / damage to the surface of the eye, swelling around the eye (periorbital edema ), misaligned eyelashes or an extra row of eyelashes , abrasion on the surface of the eye, fluid-filled blister in the colored part of the eye ( iris cyst ).
  • Skin reactions on the eyelids, darker skin on the eyelids.
  • Exacerbation of asthma .
  • Severe itching of the skin.
  • Development of a viral infection of the eye caused by the herpes simplex virus ( HSV ).

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

  • Exacerbated angina in patients who also have heart disease
  • Sunken eyes (depression 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.

Additional side effects in children and adolescents

Side effects that are more common in children compared to adults are runny and itchy nose and fever.

How to store Latanoprost STADA

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. The expiration date is the last day of the specified month.

Store an unopened bottle in a refrigerator (2 ° C – 8o C) in the outer carton to protect from light.

When opened, the bottle should be stored at a maximum of 25o C. Four weeks after opening the bottle, it should be discarded, even if the contents are not empty.

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.

1 ml eye drops, the solution contains 50 micrograms latanoprost.

2.5 ml eye drops, solution (1 bottle) contains 125 micrograms latanoprost.

One drop contains about 1.5 micrograms of latanoprost.

The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, anhydrous disodium hydrogen phosphate, sodium chloride, purified water.

What the medicine looks like and contents of the pack

Latanoprost Stada eye drops are a clear and colorless solution in a plastic bottle with a drip top and child-resistant screw cap in plastic.

Each bottle of Latanoprost contains 2.5 ml of eye drop solution corresponding to approximately 80 drops of the solution.

Latanoprost Stada is available in pack sizes of 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel, Germany

Other manufacturers

Jadran Galenski Laboratory dd

Svilno 20

51000 Rijeka, Croatia

HBM Pharma sro

Sklabinská 30

036 80 Martin, Slovakia

Centrafarm Services BV

New Donk 9

47879 AC Etten Leur, The Netherlands

Eurogenerics NV

Heizel Esplanade B22

1020 Brussels, Belgium

Genus Pharmaceuticals Ltd.

Park View House, 65 London Road

Newbury, Berhshire, RG14, England

Stada Arzneimittel GmbH

Muthgasse 36

1190 Vienna, Austria

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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