VISUMIDRIATIC 5 mg /Ml Глазные Капли, Раствор

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1. VISUMIDRIATIC 5mg/ml Eye drops, solution, 10mg/ml Eye drops, solution, 5mg/ml Eye drops, solution in single-dose container, 10mg/ml Eye drops, solution in single-dose container
   1. What you need to know before using VISUMIDRIATIC
2. VISUMIDRIATIC 10mg/ml Eye drops solution bottle of 10 ml and VISUMIDRIATIC 5mg/ml
   1. How to use VISUMIDRIATIC
   2. Possible side effects
   3. How to store VISUMIDRIATIC
   4. Package Contents and Other Information

VISUMIDRIATIC 5mg/ml Eye drops, solution, 10mg/ml Eye drops, solution, 5mg/ml Eye drops, solution in single-dose container, 10mg/ml Eye drops, solution in single-dose container

Tropicamide
Read this leaflet carefully before you use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VISUMIDRIATIC is and what it is used for

2. What you need to know before you use VISUMIDRIATIC

3. How to use VISUMIDRIATIC

4. Possible side effects

5. How to store VISUMIDRIATIC

6. Contents of the pack and other information

1. What VISUMIDRIATIC is and what it is used for

VISUMIDRIATIC belongs to a group of medicines that dilate the pupil. It contains
tropicamide as its active ingredient.

What it is used for:
VISUMIDRIATIC is used when it is necessary to dilate the pupil:

• for examining the components of the eye
• to diagnose vision impairments
• in inflammations of the cornea (front part of the eye), iris (the colored part surrounding the pupil) and choroid (thin internal film with high blood distribution): keratitis, iritis, iridocyclitis, uveitis. It replaces atropine in all cases. If you do not notice improvements or if your symptoms worsen after the prescribed days of therapy, consult your doctor.

2. What you need to know before using VISUMIDRIATIC

Do not use VISUMIDRIATIC

• if you are allergic to tropicamide, similar substances or any of the other ingredients of this medicine (listed in section 6)
• if you have increased internal eye pressure due to narrowing or closure of the space (angle) between the iris and the cornea (narrow-angle or closed-angle glaucoma).
• Inform your doctor if either of these applies to you.

Warnings and precautions
Consult your doctor before using VISUMIDRIATIC and use it under their supervision.
The medicine is exclusively for ocular (ophthalmic) use.
It is important to wash your hands before administration to avoid contaminating your eyes
with microbes. Also wash your hands afterwards to avoid accidental, i.e. unwanted, ingestion of the
medicine that may have come into contact with your hands. If you administer VISUMIDRIATIC to a
child, for the same reasons, wash their hands thoroughly as well.
During the effect of the medicine, the excessive amount of light reaching the eyes due to
pupil dilation can cause disturbances varying from subject to subject. You should therefore
protect your eyes preferably with lenses capable of filtering intense light.
To avoid excessive general absorption, compress the lacrimal sac with your fingers for one
minute after instillation.
To eliminate the risk of glaucoma, you must undergo an examination to assess the depth of the area
between the cornea and the crystalline lens, the lens located inside the eye (anterior chamber).
Use with caution:

• if you are elderly
• if you have high pressure inside your eye
• if you have uretro-prostatic problems because the medicine may cause urinary retention
• if you have heart problems (coronary and cardiac insufficiency)
• if you have brain problems or damage - in particular Down syndrome, paralysis and corneal diseases (keratoconus).

Children and adolescents
The use of tropicamide in children is well established.
Neonates and young children may be particularly sensitive to the effects of
drugs that dilate the pupil, such as tropicamide, which, especially in neonates and children,
can cause disturbances of the central nervous system potentially dangerous with an increased
probability of developing undesirable effects. Excessive use in children can induce symptoms of
general (systemic) toxicity.
Administer VISUMIDRIATIC with extreme caution to children during early infancy, in
neonates and premature babies, or to children suffering from Down syndrome, spastic paralysis or brain damage
or keratoconus.

Other medicines and VISUMIDRIATIC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
No interactions with other medicines are known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
In pregnant women, the medicine should be administered only if necessary under the direct
supervision of a doctor.
Breastfeeding
During breastfeeding, the medicine should be administered only if necessary under the direct supervision of a
doctor.

Driving and using machines
As a result of the pupil dilation effect, tropicamide causes visual disturbances.

• You must not drive or operate machinery for the entire duration of the medicine's effect.

VISUMIDRIATIC 10mg/ml Eye drops solution bottle of 10 ml and VISUMIDRIATIC 5mg/ml

Eye drops solution bottle of 10 mlcontain benzalkonium chlorideas a preservative 1 mg per
ml (equivalent to approximately 3 micrograms per drop). Benzalkonium chloride can be absorbed by
soft contact lenses and may lead to a change in their color. Remove contact lenses
before using this medicine and wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the outermost transparent layer of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use VISUMIDRIATIC

Use this medicine following the doctor's instructions exactly at all times. If you have any doubts, consult your doctor or pharmacist.

Contact lens wearers
If you or your child wear contact lenses, you must remove them before applying VISUMIDRIATIC.
After applying VISUMIDRIATIC, wait 15 minutes before re-applying contact lenses.

Instructions for use of the multi-dose bottle:

• 1. Wash your hands
• 2. To open the container, press and simultaneously unscrew the closing cap.
• 3. If you are using contact lenses, remove them before applying the eye drops and reapply them after 15 minutes (see the paragraph “VISUMIDRIATIC contains benzalkonium chloride”).
• 4. Turn the bottle upside down and apply the eye drops by pressing; do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle.
• 5. Carefully close the bottle after use.

Instructions for use of the single-dose container:

• 1. Wash your hands.
• 2. Open the aluminum protective pouch
• 3. Remove a vial from the strip and unscrew the cap with a slight rotation.
• 4. Hold the vial in your hand, between your thumb and other fingers, and hold it pointing downwards.

• 5. Tilt your head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there.
• 6. Hold the tip of the vial close to your eye. Using a mirror may be helpful.
• 7. Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the vial.
• 8. Apply slight pressure to the vial to release one drop of VISUMIDRIATIC at a time.

If you use the eye drops in both eyes, repeat the steps for the other eye.
Discard the vial and any remaining contents.
Store the strip with the intact vials in the aluminum pouch and in the original packaging.

For refraction (visual acuity test)
The recommended dose is:

Adults: 1 drop of VISUMIDRIATIC 10 mg/ml in the eye; repeat the administration after 5 minutes.

Children and adolescents: 1 drop of VISUMIDRIATIC 5mg/ml or 10mg/ml in the eye. Repeat the administration after 5 minutes.
Tropicamide has proven inadequate for cycloplegia in children. In such cases, the use of a more potent agent, such as atropine, may be necessary.
In young children, do not use VISUMIDRIATIC in a concentration higher than 5mg/ml.

For fundus examination (inside of the eye)
The dosage is: 1 or 2 drops of VISUMIDRIATIC 5mg/ml or 10 mg/ml 15-20 minutes before the examination.
Compress the lacrimal sac with your fingers for 1 minute after instillation to avoid excessive absorption in other areas of the body.
Wash your hands before and after instillation (see also “Warnings and precautions” paragraph 2).

If you use more VISUMIDRIATIC than you should
If you apply too many drops of VISUMIDRIATIC, rinse your eyes thoroughly with lukewarm water.
If the contents of the bottle are inadvertently ingested, immediately notify your doctor or go to the nearest hospital.
The use, especially if prolonged, of topical products can cause sensitization reactions. If this occurs, stop treatment and inform your doctor who will subject you to appropriate therapy.

If you forget to use VISUMIDRIATIC
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects with unknown frequency:

• temporary eye irritation.
• blurred vision
• excessive sensitivity to light (photophobia)
• mild increase in pressure inside the eye
• glaucoma (high pressure inside the eye with changes in the visual field and optic nerve) in predisposed patients
• hypersensitivity reactions
• cases of mental disorders characterized by loss of contact with reality, altered thinking, bizarre behavior (psychotic reactions)
• cardiorespiratory collapse. Following ocular instillation, drugs that dilate the pupil can cause, especially in children (especially in newborns or premature or very small children) and in the elderly, toxic effects in other areas of the body (systemic) typical of this type of drug (anticholinergic); in particular:
• dry mouth
• thirst
• increased heart rate (tachycardia)
• cardiorespiratory collapse
• gastrointestinal and urinary tract disorders
• headache
• allergic reactions

Paediatric population:
Tropicamide can cause central nervous system disorders, potentially dangerous in
newborns and children (see section 4.4 Special warnings and precautions for use). With
the use of cycloplegic drugs, an increased risk of systemic toxicity has been observed in
newborns, in very small or premature babies or in children with Down syndrome, spastic
paralysis or brain damage (see section 4.4 Special warnings and precautions for
use).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store VISUMIDRIATIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry datewhich is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not use this medicine if you notice that the solution is not clear.

VISUMIDRIATIC 5 mg/ml Eye drops, solution

VISUMIDRIATIC 10 mg/ml Eye drops, solution
This medicine does not require any special storage conditions.
Do not refrigerate or freeze.
Keep the multi-dose container tightly closed.

Do not use the product in the multi-dose container after 30 days from the first opening of the
container.

VISUMIDRIATIC 5 mg/ml Eye drops, solution in single-dose container

VISUMIDRIATIC 10 mg/ml Eye drops, solution in single-dose container
This medicine does not require any particular storage temperature.
Do not refrigerate or freeze.
Store in the sachet and in the original packaging.
After the first opening of the aluminium sachet: store at a temperature not exceeding
25°C and use within 30 days. Containers not used after 30 days from opening the
sachet must be discarded.
The single-dose container does not contain preservatives; the product must be used immediately after opening
the container, which should also be discarded even if only partially used.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What VISUMIDRIATIC contains
VISUMIDRIATIC 10mg/ml Eye Drops, solution bottle of 10 ml
The active ingredientis: tropicamide
1 ml of eye drops contains: tropicamide 10 mg

The other ingredientsare: sodium chloride, benzalkonium chloride, water for injections.

VISUMIDRIATIC 5mg/ml Eye Drops, solution bottle of 10 ml
The active ingredientis: tropicamide
1 ml of eye drops contains: tropicamide 5 mg

The other ingredientsare: sodium chloride, benzalkonium chloride, water for injections

VISUMIDRIATIC 5mg/ml Eye Drops, solution in single-dose container
The active ingredientis: tropicamide
1 ml of eye drops contains: tropicamide 5 mg

The other ingredientsare: sodium chloride, hydrochloric acid, water for injections.

VISUMIDRIATIC 10mg/ml Eye Drops, solution in single-dose container
The active ingredientis: tropicamide
1 ml of eye drops contains: tropicamide 10 mg

The other ingredientsare: hydrochloric acid, water for injections.

Description of the appearance of VISUMIDRIATIC and contents of the pack
VISUMIDRIATIC Eye Drops, solution is presented in the form of a solution, in packs of:
1 dropper bottle in LDPE of 10 ml of eye drops at 10mg/ml or 5mg/ml and a white closing cap
in HDPE.
VISUMIDRIATIC Eye Drops, solution in single-dose container is presented in the form of a solution, in
packs of:
10 single-dose containers in transparent LDPE of 0.3 ml of eye drops at 5mg/ml contained in grey
PET/Al/PE pouches. Each PET/Al/PE pouch contains 5 single-dose containers of 0.3 ml in
LDPE.
2x5 single-dose containers in transparent LDPE of 0.5 ml of eye drops at 10 mg/ml contained in grey
PET/Al/PE pouches. Each PET/Al/PE pouch contains 5 single-dose containers of 0.5 ml in
LDPE.

Marketing Authorisation Holder
VISUFARMA S.p.A.
Via Alberto Cadlolo, 21
00136 Rome - Italy

Manufacturer

VISUMIDRIATIC 5mg/ml Eye Drops, solution - 10 ml Bottle

VISUMIDRIATIC 10mg/ml Eye Drops, solution - 10 ml Bottle

VISUMIDRIATIC 10 mg/ml Eye Drops, solution in single-dose container
Farmigea S.p.a.
Via Giovan Battista Oliva, 6/8
56121, Ospedaletto (PI)

VISUMIDRIATIC 5mg/ml Eye Drops, solution in single-dose container
C.O.C. Farmaceutici S.r.l.
Via Modena, 15
Sant’Agata Bolognese (BO)