Qualidofta

Package leaflet: Information for the user

QUALIDOFTA 2 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER

Brimonidine tartrate
Generic medicine
Please read all of 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 pass it on to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What QUALIDOFTA is and what it is used for

The active substance in QUALIDOFTA is brimonidine tartrate, which works by reducing the pressure inside the eye.
QUALIDOFTA is used to reduce intraocular pressure in patients with open-angle glaucoma (an eye disease characterised by chronic and progressive optic nerve damage) and ocular hypertension (elevated pressure of the fluid in the eye).
It can be used alone when beta-blocking eye drops are contraindicated, or in combination with another eye drop when a single medicine is not sufficient to reduce elevated pressure.

2. What you need to know before using QUALIDOFTA

Do not use QUALIDOFTA

• If you are allergic to brimonidine tartrate or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressants (such as tricyclic antidepressants or mianserine). Inform your doctor if you are taking any antidepressant medication (see "Other medicines and Qualidofta").
• If you are breastfeeding (see "Pregnancy and breastfeeding").
• In newborns and children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using QUALIDOFTA

• If you suffer or have suffered from depression, reduced blood flow to the brain and impaired mental function (cerebral insufficiency), reduced blood flow in the coronary arteries (coronary insufficiency), a blood vessel disorder (Raynaud's disease), an inflammatory disease affecting small and medium-sized arteries and veins (thromboangiitis obliterans), or excessive drop in blood pressure when moving from a sitting or lying position to standing (orthostatic hypotension).
• If you have or have previously had kidney or liver problems.

Children and adolescents
Do not use QUALIDOFTA in newborns and children up to 2 years of age (see "Do not use Qualidofta"). QUALIDOFTA is not recommended in children and adolescents aged between 2 and 17 years (see "Do not use Qualidofta").

Other medicines and QUALIDOFTA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Inform your doctor if you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAO inhibitors) and other antidepressants (see "Do not use Qualidofta").
• Medicines with a depressant effect on the central nervous system (sedatives, opioids, barbiturates, anesthetics).
• Medicines that may affect catecholamine metabolism, such as chlorpromazine, methylphenidate, and reserpine.
• Medicines used to lower blood pressure (antihypertensives) or to improve heart function (cardiac glycosides).
• Medicines acting on the same receptor as Qualidofta, for example isoprenaline and prazosin.
  Inform your doctor if you consume alcohol.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use QUALIDOFTA if you are breastfeeding.

Driving and using machines
QUALIDOFTA may cause drowsiness or fatigue. QUALIDOFTA may cause blurred vision or visual disturbances. These effects may appear worse at night or under conditions of reduced lighting.
If you experience any of these symptoms, do not drive or operate machinery until the symptoms have resolved.

3. How to use QUALIDOFTA

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart.

Children under 17 years of age
QUALIDOFTA must not be administered to children under 2 years of age.
The use of QUALIDOFTA is not recommended in children (from 2 to 17 years of age).

Instructions for use
QUALIDOFTA is an eye drop solution. If you are using this medicine together with another eye drop, wait 5–15 minutes before applying the second eye drop.

Wash your hands thoroughly before administering the eye drops.

When administering the eye drops, ensure that the tip of the single-dose container does not touch the eye or surrounding areas.

Apply the eye drops as follows:

1. Separate one single-dose container from the strip.
2. Open it by twisting the cap.
3. Instill one drop into the conjunctival sac. After application, while keeping the eye closed, press your finger against the inner corner of the closed eye (where the eye meets the nose) and hold pressure for one minute.

4. Discard the single-dose container and any remaining contents.

To avoid contamination of the eye or the eye drops, the tip of the single-dose container must not come into contact with any surfaces.

If you use more QUALIDOFTA than you should

Adults
In adults who have instilled more drops than prescribed, the adverse reactions reported are those already known with the use of QUALIDOFTA (see "Possible side effects").
Adults who have accidentally ingested QUALIDOFTA have experienced a drop in blood pressure, which in some patients was followed by an increase in blood pressure.

Children
Serious adverse reactions have been reported in children who have accidentally ingested QUALIDOFTA. Symptoms included reduced consciousness, drowsiness, reduced muscle tone, decreased heart rate, low body temperature, pallor, breathing difficulties, and cessation of breathing (apnea). If this occurs, contact your doctor immediately.

Adults and Children
If QUALIDOFTA has been accidentally ingested or if you have used more QUALIDOFTA than prescribed, contact your doctor immediately.

If you forget to use QUALIDOFTA
If you forget to use QUALIDOFTA, administer the missed dose as soon as you remember. However, if you do not remember the missed dose until shortly before the next scheduled dose, skip the missed dose and continue with your next dose at the regular time. Do not use a double dose to make up for a forgotten dose. If you have any doubts, ask your doctor or pharmacist.

If you stop using QUALIDOFTA
For QUALIDOFTA to work properly, it must be used every day. Do not stop using QUALIDOFTA unless your doctor advises you to do so.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, QUALIDOFTA can cause side effects, although not everyone experiences them.

Very common (may affect more than 1 in 10 people):

• Eye irritation (red eye, burning, stinging sensation, sensation of foreign body in the eye, itching, follicles or white specks on the transparent layer covering the surface of the eye). Blurred vision. Allergic inflammation of the eyelids, allergic inflammation of the conjunctiva, allergic reaction of the eye.
• Headache. Drowsiness.
• Fatigue
• Dry mouth

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

• Local irritation (redness and swelling of the eyelid, inflammation of the eyelid margin, swelling of the membrane covering the eyeball, secretion, pain and tearing). Light sensitivity. Erosion and discoloration of the surface of the eye. D ry eye. Lightening of the transparent layer covering the surface of the eye. Abnormal vision. Inflammation of the membrane covering the surface of the eye (conjunctivitis).
• Dizziness
• General weakness.
• Stomach and intestinal symptoms. Taste disturbance.
• Upper respiratory tract symptoms.

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

• General allergic reactions
• Palpitations or changes in heart rhythm (including increased or decreased heart rate)
• Depression
• Dry nose

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

• Shortness of breath (dyspnea)

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

• Fainting
• High blood pressure (hypertension)
• Low blood pressure (hypotension)
• Insomnia
• Inflammation of the iris of the eye (iritis)
• Reduction in pupil size (miosis)

Side effects not known (frequency cannot be estimated from available data):

• Skin reactions including redness, facial swelling, itching, rash and dilation of blood vessels.
• Itching of the eyelids
• Inflammation of the anterior segments of the eye (iridocyclitis)

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
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 QUALIDOFTA

Keep QUALIDOFTA out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the
bottle label and on the carton after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 QUALIDOFTA contains

• The active substance is brimonidine tartrate. One (1) ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine.
• The other components are: polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, and sodium hydroxide or hydrochloric acid to adjust the pH.

Description of the appearance of QUALIDOFTA and the contents of the pack
Qualidofta is a clear eye drop solution with a slight green-yellow tint, contained in single-dose containers made of LDPE, with a volume of 0.5 ml, sealed in laminated aluminum pouches, each containing 10 single-dose containers. Each single-dose container holds 0.35 ml of medicinal product.
QUALIDOFTA single-dose is available in packs containing 60 single-dose containers.

Marketing Authorization Holder
Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica 3/A, 35031 Abano Terme (PD)
Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany