Visumidriatic phenylephrine

Package leaflet: Information for the patient

VISUMIDRIATIC FENILEFRINA 100 mg/ml + 5 mg/ml

Eye drops, solution
Phenylephrine hydrochloride, tropicamide 10 ml bottle
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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What VISUMIDRIATIC FENILEFRINA is and what it is used for
2. What you need to know before using VISUMIDRIATIC FENILEFRINA
3. How to use VISUMIDRIATIC FENILEFRINA
4. Possible side effects
5. How to store VISUMIDRIATIC FENILEFRINA
6. Contents of the pack and other information

1. What VISUMIDRIATIC FENILEFRINA is and what it is used for
VISUMIDRIATIC FENILEFRINA is an ophthalmic (eye) medicine that causes dilation of the pupil. It contains two active substances: tropicamide and phenylephrine hydrochloride.

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

• for examination of the inside of the eye (fundus)
• to diagnose visual disturbances
• in inflammations of the iris, the coloured part around the pupil (iriditis, iridocyclitis)
• in inflammations involving both the iris and the choroid, a thin internal layer richly supplied with blood vessels (uveitis).

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

2. What you need to know before using VISUMIDRIATIC FENILEFRINA

Do not use VISUMIDRIATIC FENILEFRINA

• if you are allergic to tropicamide, phenylephrine hydrochloride, or 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, the transparent membrane covering the iris (narrow-angle or closed-angle glaucoma)
• in children under 12 years of age
• during breastfeeding

Warnings and precautions
Consult your doctor before using VISUMIDRIATIC FENILEFRINA and use it under medical supervision.
The use, especially if prolonged, of VISUMIDRIATIC FENILEFRINA may lead to sensitization phenomena (hypersensitivity).
If this occurs, you must stop treatment and start an appropriate therapy.
We recommend that after instillation, you apply digital pressure for about one minute on the lacrimal sac to prevent excessive absorption of the medicine into other parts of the body. During this time, you should protect your eyes from bright light.
To avoid a glaucoma attack, you must undergo a thorough examination before starting treatment to assess the width of the space between the iris and cornea (iridocorneal angle).
This medicine can be used in patients with open-angle glaucoma because the short-term dilation of the pupil (mydriasis) may reduce adhesions and thus lower intraocular pressure.
Use this medicine with great caution if you have:

• heart disorders
• high blood pressure (hypertension)
• altered blood sugar levels (diabetes)
• overactivity of the thyroid gland (hyperthyroidism) Even if your blood pressure is normal or if your blood pressure is high but controlled with appropriate medical therapy, this medicine may rarely cause a sudden increase in arterial pressure. Particular caution should also be taken if you are:
• an elderly patient, in whom a sudden increase in intraocular pressure (glaucoma attack) may more easily occur

VISUMIDRIATIC FENILEFRINA must not be used in children under 12 years of age,
as children appear to be more susceptible to the risk of serious side effects.
The use of VISUMIDRIATIC FENILEFRINA is not recommended in children aged between 12 and 18 years, due to lack of adequate clinical experience.
Children and adolescents
This medicine is contraindicated in children under 12 years of age.
VISUMIDRIATIC FENILEFRINA may cause disturbances of the cardiovascular and nervous systems, which may be dangerous in early infancy and in children.
Other medicines and VISUMIDRIATIC FENILEFRINA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use VISUMIDRIATIC FENILEFRINA with caution if you are being treated with medicines that:

• treat depression (antidepressants)
• reduce heart rate and blood pressure (beta-blockers)

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

• Use the medicine only when necessary and under direct medical supervision.
• Do not breastfeed while using VISUMIDRIATIC FENILEFRINA; the medicine is contraindicated during breastfeeding.

Driving and using machines
Avoid driving or performing operations requiring attention during the period of action of the medicine.
VISUMIDRIATIC FENILEFRINA Eye Drops, solution contains sodium metabisulfite.
This medicine contains sodium metabisulfite, which may cause allergic-type reactions and severe asthma attacks in sensitive individuals, particularly in asthmatics.
VISUMIDRIATIC FENILEFRINA Eye Drops, solution contains benzalkonium chloride.
This medicine contains 0.2 mg of benzalkonium chloride per ml (equivalent to 2 mg per 10 ml).
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. 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 most superficial transparent layer of the eye). If you experience an abnormal sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use VISUMIDRIATIC FENILEFRINA

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults:
to dilate the pupil: 1-2 drops as prescribed by the doctor.
for therapy: according to medical instructions determined on a case-by-case basis.
If you use more VISUMIDRIATIC FENILEFRINA than you should
If you accidentally ingest or take an excessive dose of VISUMIDRIATIC FENILEFRINA, contact your doctor immediately or go to the nearest hospital.
If you accidentally ingest this medicine or use it for prolonged periods at high doses, it may cause toxic effects. Should this occur, you must stop treatment and appropriate therapy must be initiated.
If you forget to use VISUMIDRIATIC FENILEFRINA
Do not use a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• increased internal eye pressure (intraocular pressure)
• tremor
• pallor
• sweating
• increased heart rate (tachycardia) and palpitations
• increased systolic and diastolic blood pressure
• collapse
• dry mouth (xerostomia)
• thirst
• disorders affecting the stomach, intestine and kidney (reduced tone)
• headache (cephalalgia)
• eye irritation
• allergic reactions.

Additional side effects in children and elderly patients
Tropicamide may cause:

• disturbances of the nervous system, which may be dangerous in early infancy and children (see section “Warnings and precautions”).
• mental disorders characterized by loss of contact with reality, altered thinking, bizarre behaviour (psychotic and mental reactions)
• cardiorespiratory collapse (a serious condition involving the heart and lungs leading to fainting).
  Following the instructions provided in this leaflet reduces the risk of side effects.
  Phenylephrine may cause additional side effects in children:
• fluid or swelling in the lungs – Frequency not known (frequency cannot be estimated from the available data)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/web/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 FENILEFRINA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The
expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear.
The expiry date refers to the product in its original packaging, correctly stored.
Store below 25°C.
Keep the bottle tightly closed.
Do not use this medicine more than 30 days after first opening the container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What VISUMIDRIATIC FENILEFRINA contains
VISUMIDRIATIC FENILEFRINA Eye Drops, solution (10 ml bottle)
The active substances are: tropicamide, phenylephrine hydrochloride.
100 ml of solution contain: tropicamide 500 mg, phenylephrine hydrochloride 10 g.
The other components are: sodium metabisulfite, disodium edetate, benzalkonium chloride, citric acid,
disodium phosphate dodecahydrate, hydrochloric acid, sodium hydroxide, water for injections.
Description of the appearance of VISUMIDRIATIC FENILEFRINA and package contents
VISUMIDRIATIC FENILEFRINA Eye Drops is a solution presented in a 10 ml dropper bottle made of LDPE with a white HDPE closure cap.
Marketing Authorization Holder
VISUFARMA S.p.A.
Via Alberto Cadlolo, 21
00136 Rome
Manufacturer
VISUMIDRIATIC FENILEFRINA Eye Drops, solution, 10 ml bottle
Farmigea S.p.A.
Via Giovan Battista Oliva, 6/8
56121, Ospedaletto (PI)