Visumidriatic

VISUMIDRIATIC 5mg/ml Eye Drops, solution
VISUMIDRIATIC 10mg/ml Eye Drops, solution
VISUMIDRIATIC 5mg/ml Eye Drops, solution in single-dose container
VISUMIDRIATIC 10mg/ml Eye Drops, solution in single-dose container
Tropicamide
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 using 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 the active substance tropicamide.

What it is used for:
VISUMIDRIATIC is used when dilation of the pupil is required:

• for examination of the internal structures of the eye
• to diagnose visual disturbances
• in inflammatory conditions of the cornea (the front part of the eye), the iris (the coloured part surrounding the pupil), and the choroid (a thin internal membrane rich in blood vessels): keratitis, iritis, iridocyclitis, uveitis. It replaces atropine in all such cases.

Consult your doctor if you do not notice improvement or if symptoms worsen after the prescribed duration of treatment.

2. What you need to know before using VISUMIDRIATIC

Do not use VISUMIDRIATIC

• if you are allergic to tropicamide, to similar substances, or to any of the other ingredients of this medicine (listed in section 6)
• if you have increased intraocular pressure due to reduced or closed angle between the iris and 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 medical supervision.
This medicine is for external ocular (ophthalmic) use only.

It is important to wash your hands before administration to avoid microbial contamination of the eyes. Wash your hands again afterwards to prevent accidental ingestion of the medicine that may have come into contact with your hands. If administering VISUMIDRIATIC to a child, for the same reasons, also wash the child’s hands thoroughly.

During the medicine’s effect, excessive light entering the eyes due to pupil dilation may cause variable disturbances from person to person. You should therefore protect your eyes, preferably with lenses that filter intense light.

To minimize systemic absorption, press gently on the tear sac (inner corner of the eye near the nose) with your finger for about one minute after instillation.

To rule out the risk of glaucoma, an examination should be performed to assess the depth of the space between the cornea and the lens (anterior chamber of the eye).

Use with caution:

• if you are elderly
• if you have elevated intraocular pressure
• if you have urethral or prostatic problems, as the medicine may cause urinary retention
• if you have heart conditions (coronary or cardiac insufficiency)
• if you have cerebral disorders or brain damage – particularly Down's syndrome, paralysis, or corneal diseases (e.g. keratoconus).

Children and adolescents

The use of tropicamide in children is well established.
Newborns and infants may be particularly sensitive to the effects of pupil-dilating drugs such as tropicamide, which may cause potentially dangerous central nervous system disturbances, increasing the risk of adverse effects. Excessive use in children may lead to symptoms of systemic toxicity.

Administer VISUMIDRIATIC with extreme caution in infants, newborns, premature babies, or in children with Down's syndrome, spastic paralysis, brain damage, or keratoconus.

Other medicines and VISUMIDRIATIC

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

No interactions with other medicines are known.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
This medicine should be administered during pregnancy only if clearly needed and under direct medical supervision.

Breastfeeding
During breastfeeding, this medicine should be used only if necessary and under direct medical supervision.

Driving and using machines

As a consequence of pupil dilation, tropicamide may cause disturbances in vision.

• You must not drive or operate machinery for as long as the medicine’s effects last.

VISUMIDRIATIC 10mg/ml Eye Drops solution in 10 ml bottle and VISUMIDRIATIC 5mg/ml Eye Drops solution in 10 ml bottle contain benzalkonium chloride as a preservative (1 mg per ml, equivalent to approximately 3 micrograms per drop). Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience any abnormal sensation, burning, or pain in the eye after using this medicine, speak to your doctor.

3. How to use VISUMIDRIATIC

Use this medicine exactly as instructed by your doctor. If you have any doubts, you must
consult your doctor or pharmacist.
Contact lens wearers
If you or your child wears contact lenses, you must remove them before applying
VISUMIDRIATIC.
After applying VISUMIDRIATIC, you must wait 15 minutes before reinserting the contact lenses.
Instructions for using the multidose bottle:

1. Wash your hands.
2. To open the container, press down on the closure cap and unscrew it at the same time.
3. If you wear contact lenses, remove them before applying the eye drops and reinsert them again after 15 minutes (see section “VISUMIDRIATIC contains benzalkonium chloride”).
4. Turn the bottle upside down and apply the eye drops by pressing gently; do not touch the eye, eyelid, surrounding areas, or other surfaces with the tip of the bottle.
5. Close the bottle carefully after use.

Instructions for using the single-dose container:

1. Wash your hands.
2. Open the aluminum protective pouch.
3. Remove one vial from the strip and unscrew the cap with a slight twisting motion.
4. Hold the vial between your thumb and other fingers, with the vial pointing downward.
5. Tilt your head backward. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye. The drop should be instilled here.
6. Hold the tip of the vial close to the eye. Using a mirror may be helpful.
7. Do not touch the eye, eyelid, surrounding areas, or other surfaces with the tip of the vial.
8. Gently squeeze the vial to release one drop of VISUMIDRIATIC at a time.

If you are using the eye drops in both eyes, repeat the steps for the other eye.
Discard the vial and any remaining content.
Store the strip containing unused vials back in the aluminum pouch and in the original packaging.
For refraction (visual acuity examination)
Recommended dose:
Adults: 1 drop of VISUMIDRIATIC 10 mg/ml into the eye; repeat administration after 5 minutes.
Children and adolescents: 1 drop of VISUMIDRIATIC 5 mg/ml or 10 mg/ml into the eye. Repeat administration after 5 minutes.
Tropicamide has been found inadequate for cycloplegia in children. In such cases, a more potent agent such as atropine may be required.
In young children, do not use VISUMIDRIATIC at a concentration higher than 5 mg/ml.
For fundus examination (internal eye examination)
The dosage is: 1 or 2 drops of VISUMIDRIATIC 5 mg/ml or 10 mg/ml, 15–20 minutes before the examination.
Press with your finger on the lacrimal sac for 1 minute after instillation to minimize systemic absorption.
Wash your hands before and after instillation (see also section 2 “Warnings and precautions”).
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 accidentally swallowed, contact your doctor immediately or go to the nearest hospital.
The use, especially if prolonged, of topical products may lead to sensitization reactions. If this occurs, discontinue treatment and inform your doctor, who will initiate appropriate therapy.
If you forget to use VISUMIDRIATIC
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects with unknown frequency:

• transient eye irritation
• blurred vision
• excessive sensitivity to light (photophobia)
• slight increase in intraocular pressure
• glaucoma (elevated pressure inside the eye with visual field disturbances and optic nerve damage) in predisposed patients
• hypersensitivity reactions
• cases of psychiatric disorders characterized by loss of contact with reality, disturbances in thinking, and bizarre behaviour (psychotic reactions)
• cardiorespiratory collapse. Following ocular instillation, drugs that dilate the pupil may cause, especially in children (particularly in newborns or premature or very small infants) and elderly patients, systemic toxic effects in other parts of the body typical of this class of drugs (anticholinergic/atropine-like); in particular:
• dry mouth
• thirst
• increased heart rate (tachycardia)
• cardiorespiratory collapse
• gastrointestinal and urinary tract disturbances
• headache
• allergic reactions

Paediatric population:
Tropicamide may cause central nervous system disturbances, potentially dangerous in newborns and children (see section 4.4 Special warnings and precautions for use). With the use of cycloplegic agents, an increased risk of systemic toxicity has been observed in newborns, in children born very small or prematurely, or in children affected by Down's syndrome, spastic paralysis, or brain damage (see section 4.4 Special warnings and precautions for use).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: 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 date stated on the packaging after "Exp."
The expiry date refers to the last day of that month.
The expiry date applies to the product while still in its original, undamaged packaging and stored correctly.
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 multidose bottle tightly closed.
Do not use the product in the multidose bottle more than 30 days after first opening 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 specific storage temperature.
Do not refrigerate or freeze.
Store in the foil pouch and in the original packaging.
After first opening the aluminium foil pouch: store at a temperature not exceeding 25°C and use within 30 days. Single-dose containers not used within 30 days of opening the pouch must be discarded.
The single-dose container does not contain preservatives; the product should be used immediately after opening the container, which must then be discarded, even if only partially used.

Do not dispose of any medicines via 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 10 ml bottle
Active substance:
tropicamide
Each 1 ml of eye drops contains: tropicamide 10 mg
Other components: sodium chloride, benzalkonium chloride, water for injections.

VISUMIDRIATIC 5mg/ml Eye Drops, solution 10 ml bottle
Active substance:
tropicamide
Each 1 ml of eye drops contains: tropicamide 5 mg
Other components: sodium chloride, benzalkonium chloride, water for injections.

VISUMIDRIATIC 5mg/ml Eye Drops, solution in single-dose container
Active substance:
tropicamide
Each 1 ml of eye drops contains: tropicamide 5 mg
Other components: sodium chloride, hydrochloric acid, water for injections.

VISUMIDRIATIC 10mg/ml Eye Drops, solution in single-dose container
Active substance:
tropicamide
Each 1 ml of eye drops contains: tropicamide 10 mg
Other components: hydrochloric acid, water for injections.

Description of the appearance of VISUMIDRIATIC and contents of the pack
VISUMIDRIATIC Eye Drops, solution is presented as a solution in packs containing:
1 dropper bottle in LDPE of 10 ml of eye drops at 10 mg/ml or 5 mg/ml with a white HDPE closure cap.

VISUMIDRIATIC Eye Drops, solution in single-dose containers is presented as a solution in packs containing:
10 single-dose containers in transparent LDPE of 0.3 ml of eye drops at 5 mg/ml, packed 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, packed in grey PET/Al/PE pouches. Each PET/Al/PE pouch contains 5 single-dose containers of 0.5 ml in LDPE.

Marketing Authorization 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), Italy

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