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Vizitrav eye drops 2.5 ml.

Product Code: Vizitrav eye drops 2.5 ml.
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What Vizitrav is and what it is used for

Vizitrav eye drops are used to treat high pressure in the eye in adults, adolescents and children 2 months of age and older. This pressure can lead to a condition called glaucoma.

Your eyeballs contain a clear, watery fluid that nourishes the inside of the eye. The fluid always drains from the eye and more fluid is always produced.

If the eye fills faster than it empties, the pressure in the eye increases. If the pressure becomes too high, it can damage your vision.

Visitrav contains travoprost, a member of a group of medicines used to treat glaucoma called prostaglandin analogues. It works by increasing the outflow of fluid, which reduces the pressure in the eye. It can be used alone or with other drops, such as beta-blockers, which also reduce pressure.

Visitrav eye drops, solution, is a sterile solution that does not contain a preservative.

2. What you need to know before you use Vizitrav

• Do not use Visitrav if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if this applies to you.

Warnings and precautions

• Visitrav may increase the length, density, color and / or number of your lashes. Changes in the eyelids, including abnormal hair growth or tissue around the eye, have also been reported.
• Visitrav may change the color of your iris (the colored part of your eye). This change can be permanent. There may also be a change in the color of the skin around the eye.
• If you have had cataract surgery, talk to your doctor before using Visitrav.
• If you have or have had eye inflammation (iritis and uveitis), talk to your doctor before using Visitrav.
• Visitrav may in rare cases cause shortness of breath, wheezing or an increase in asthma symptoms. If you are concerned about any changes in your breathing when using this medicine, talk to your doctor as soon as possible.
• Visitrav can be absorbed through the skin. If any of the medicinal products come into contact with the skin, it should be washed immediately. This is especially important for women who are pregnant or trying to become pregnant.
• If you wear soft contact lenses, do not use the drops when the lenses are in your eyes. After using the drops, wait 15 minutes before putting your lenses back on.

Children and adolescents
Visitrav can be used in children aged 2 months to <18 years with the same dosage as in adults. The use of Visitrav is not recommended for children under 2 months of age.

Other medicines and Visitrav
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, lactation and fertility
Do not use Visitrav if you are pregnant. If you think you may be pregnant, tell your doctor immediately. If you can become pregnant, you must use adequate contraception while using this medicine.

Do not use Visitrav if you are breast-feeding. This medicine may pass into breast milk. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines
You may find that your vision is blurred for some time after using Visitrav. Do not drive or use machines until this is over.

Visitrav contains macrogolglycerol hydroxystearate 40 and propylene glycol

This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

This medicine contains propylene glycol, which may cause skin irritation.

3. How to use Visitrav

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

Use Visitrav only to apply drops to your eyes or to your child's.

The recommended dose is 1 drop in the affected eye or eyes once a day - in the evening.

Use Visitrav in both eyes only if your doctor tells you to.

Use this medicine for as long as your doctor or the doctor treating your child tells you.

Instructions for use
• Remove the multi-dose container from the carton and write the date of opening of the carton and the bottle in the space provided.
• Take the medicine bottle and a mirror.
• Wash your hands.
• Remove the cap.
• Turn the bottle upside down with your thumb on the shoulder of the bottle and the other fingers on the bottom of the bottle. Squeeze the bottle repeatedly before first use - approximately 10 times until the first drop appears.
• Tilt your head or your child's back. Pull down the lower eyelid with a clean finger until a "pocket" forms between the eyelid and the eye. The drop must fall
Do not touch the eye or eyelid, adjacent areas or other surfaces with the dropper. This can infect the drops.
• Gently push down the bottom of the bottle to drop one drop of the medicine.
• If the drop misses the eye, try again.
• After using the medicine, press the corner of the eye to the nose with your finger. This helps to stop the medicine from entering the rest of the body.
• If you use drops for both eyes, repeat the same steps for the other eye.
• Close the cap of the multi-dose pack tightly immediately after use.
• Do not use more than one bottle of the medicine at a time. Do not open the cap until you need to use the multi-dose pack.
• You must throw away the bottle 4 weeks after first opening to prevent infections and use a new bottle.

If you or your child have used more Visitrav than you should
Wash all medicine from the eye with warm water. Do not take more drops until it is time for your next regular dose.

If you forget to use Visitrav
Continue with the next scheduled dose. Do not take a double dose to make up for a forgotten dose. Do not use more than one drop in the affected eye (s) on the same day.

If you stop using Visitrav
Do not stop taking this medicine without first talking to your doctor or the doctor who is treating your child. This is because the pressure in your eye or that of your child will not be able to be controlled, which can lead to vision loss.

If you or your child use eye preparations such as eye drops or ointment

Wait at least 5 minutes between applying Visitrav and other eye preparations.

If you have any further questions on the use of this medicine, ask your doctor, the doctor who is treating your child or your pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have side effects, you can usually continue to use the drops, unless the side effects are serious. If you have any concerns, talk to your doctor or pharmacist. Do not stop using Visitrav without talking to your doctor.

The following side effects have been seen with travoprost.

Very common (may affect more than 1 in 10 people):
- Ocular side effects:
• redness of the eye.

Common (may affect up to 1 in 10 people):
- Ocular side effects:
• changes in the color of the iris (the colored part of the eye);
• pain in the eye;
• eye discomfort;
• dry eye;
• itching in the eye;
• eye irritation.

Uncommon (may affect up to 1 in 100 people):
- Ocular side effects:
• corneal disorders;
• inflammation of the eye;
• inflammation of the iris;
• inflammation of the inside of the eye;
• inflammation of the surface of the eye with / without damage to the surface;
• sensitivity to light;
• secretion from the eye;
• inflammation of the eyelids;
• redness of the eyelids;
• swelling around the eye;
• itching of the eyelids;
• reduced vision;
• blurred vision;
• increased tearing;
• infection or inflammation of the conjunctiva (conjunctivitis);
• unusual turning of the lower eyelid outwards;
• blurring of the eye;
• formation of crusts on the eyelids;
• eyelash growth;
• discoloration of the eyelashes;
• tired eyes.

- Reactions related to the body:
• aggravation of allergic symptoms;
• headache;
• dizziness;
• irregular heartbeat;
• shortness of breath;
• asthma;
• stuffy nose;
• throat irritation;
• darkening of the skin around the eye (s);
• darkening of the skin;
• unusual hair texture;
• excessive hair growth.

Rare (may affect up to 1 in 1,000 people):
- Ocular side effects:
• seeing flashing lights;
• eczema of the eyelids;
• swelling of the eyes;
• presence of colored rings in the field of view past light sources;
• reduced visual sensitivity;
• inflammation of the eyelid glands;
• pigmentation in the inner part of the eye;
• increase in pupil size;
• change in the texture of the lashes.

- Reactions related to the body:
• viral infection of the eye;
• bad taste;
• irregular or low heart rate;
• increased or decreased blood pressure;
• cough;
• change of voice;
• gastrointestinal discomfort or ulcer;
• constipation;
• dry mouth;
• redness or itching of the skin;
• rash;
• change in hair color;
• loss of eyelashes;
• musculoskeletal pain;
• general weakness.
Not known (cannot be estimated from the available data)

- Ocular side effects:
• inflammation of the back of the eye;
• The eyes look sunken.

- Reactions related to the body:
• depression;
• anxiety;
• feeling of false movement;
• noise in the ears;
• chest pain;
• worsening of asthma;
• diarrhea;
• stomach ache;
• nausea;
• itching;
• abnormal hair growth;
• joint pain;
• painful or involuntary urination;
• increase in the tumor marker for prostate cancer.

In children and adolescents, the most common side effects seen with travoprost are red eyes and eyelash growth. Both side effects were more common in children and adolescents than in adults.

How to store Visitrav

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice that the multi-dose pack is broken or damaged before it is first opened.

After first opening, this medicine does not require any special storage conditions.

You should discard the bottle 4 weeks after first opening to prevent infections. Write the date on which you opened the bottle in the space provided on the label of each bottle and package.

Do not throw away any medicines 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. Contents of the package and additional information

What Vnzntrav contains
The active substance is: travoprost. Each ml of solution contains 40 micrograms of travoprost.
The other ingredients are: macrogolglycerol hydroxystearate 40, sodium chloride, propylene glycol (E1520), boric acid (E284), mannitol (E421), sodium hydroxide for pH adjustment and purified water.

What Visitrav looks like and contents of the pack

Visitrav is available as a 2.5 ml clear, colorless aqueous solution in a carton containing 5 ml of a white multidose pack (PP) with a pump (PP, HDPE, LDPE) and an orange pressure cylinder and cap (HDPE).

The product is available in the following types of packaging:
1 x 2.5 ml (one 2.5 ml multi-dose pack).
3 x 2.5 ml (three 2.5 ml multi-dose packs).

The cartons contain 1 or 3 bottles.

Not all pack sizes may be marketed.

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