GENISIA 1 mg /G Single-Dose Ophthalmic Gel

Зміст інструкції

1. GENISIA 1 mg/g ophthalmic gel in single-dose container
   1. What is GENISIA and what is it used for
   2. What you need to know before you use GENISIA
   3. How to use GENISIA
   4. Possible side effects
   5. How to store GENISIA
   6. Contents of the pack and other information

GENISIA 1 mg/g ophthalmic gel in single-dose container

Timolol
Equivalent medicine

Read this leaflet carefully before using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is GENISIA and what is it used for

GENISIA is a beta-blocker medicine administered via ocular route.
GENISIA is used for the treatment of some eye conditions that cause high intraocular pressure
(glaucoma and ocular hypertension).

2. What you need to know before you use GENISIA

Do not use GENISIA

• if you are allergic to timolol maleate, to beta-blockers or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from or have suffered in the past from respiratory diseases such as asthma or severe chronic obstructive pulmonary disease (severe lung disease that can cause shortness of breath, difficulty breathing and/or persistent cough),
• if you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeat),
• in case of untreated pheochromocytoma (severe high blood pressure caused by high levels of a hormone),
• in case of corneal dystrophies (degenerative diseases of the cornea).

Warnings and precautions
Talk to your doctor or pharmacist before using GENISIA.

Do not suddenly stop the therapy without your doctor's advice.
Do not inject, do not ingest.
If you use GENISIA you should undergo regular checks of intraocular pressure and the cornea.
Before using this medicine, tell your doctor if you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or feeling of tightness, shortness of breath or suffocation), heart failure, low blood pressure,
• heart rhythm disorders, such as slowed heartbeat,
• respiratory diseases, asthma or chronic obstructive pulmonary disease (severe lung disease that can cause shortness of breath, difficulty breathing and/or persistent cough),
• peripheral arterial circulation disorders (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, as timolol maleate may mask the signs and symptoms of low blood sugar levels,
• hyperactivity of the thyroid gland, as timolol maleate may mask its signs and symptoms,
• treated pheochromocytoma,
• psoriasis,
• corneal disease,
• metabolic disease.

Precautions for use of contact lenses
Avoid using contact lenses during treatment as fewer tears are secreted, this is generally related to the use of beta-blocker medicines.
If you need to undergo surgery, tell your doctor that you are using GENISIA, as timolol maleate may affect the effects of some medicines used during anesthesia.

Other medicines and GENISIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If your doctor has prescribed you another eye drop, you should instillthis eye drop 15 minutes beforeGENISIA.
GENISIA may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma.
Tell your doctor if you are taking or might take medicines to lower blood pressure, medicines for the heart or to treat diabetes, quinidine (used to treat heart conditions and some types of malaria) or antidepressants, such as fluoxetine and paroxetine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not use GENISIA in case of pregnancy unless your doctor considers it necessary.
Do not use GENISIA in case of breastfeeding. Timolol maleate may be excreted in breast milk.
Ask your doctor for advice before taking any medicine during breastfeeding.

Driving and using machines
Temporary blurred vision may occur after administration of GENISIA. In this case, do not drive or use machines until your vision returns to normal.
GENISIA may also cause other side effects (dizziness and fatigue) that may affect your ability to drive or use machines. If you have any doubts, consult your doctor.

Sport
For those who practice sports: the use of the medicine without therapeutic need constitutes doping and may still result in a positive doping test.

3. How to use GENISIA

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one drop in the affected eye(s) once a day, in the morning. Each
single-dose container contains enough gel to treat both eyes.

Use in children and adolescents
There is no experience in children and adolescents. Therefore, the use of this ophthalmic gel is not
recommended in these patients.

Route of administration
This medicine must be administered into the eye (ophthalmic use).
For single use only.

• 1) Wash/hygienize your hands.
• 2) Open the aluminum pouch containing the single-dose containers.
• 3) Separate the single-dose container from the strip and put the closed containers back into the aluminum pouch.

• 4) Make sure the single-dose container is intact before use.
• 5) Turn the single-dose container upside down and shake it gently back and forth.

• 6) Open by twisting the top and pulling. After opening, do not touch the tip of the single-dose container.

• 7) Instill one drop of eye drops into the pocket between the eye and the eyelid by gently squeezing the bottle. To avoid contamination, ensure that the tip of the bottle does not come into contact with any surface.

After using GENISIA ophthalmic gel, press a finger against the inner corner of the affected eye, near the
nose for 2 minutes. This helps to prevent timolol maleate from passing into the rest of the body.

• 8) Dispose of the single-dose container after use.

If you use more GENISIA than you should
Among other effects, you may feel dizzy, or you may have difficulty breathing or feel that your
heartbeat is slowed.

Consult your doctor or pharmacist immediately.
If you forget to use GENISIA
Do not use a double dose to make up for a missed dose. Instill the forgotten dose as soon as
possible. However, if it is almost time to apply the next dose, simply skip the forgotten dose.

If you stop using GENISIA
The pressure inside your eye may increase and damage your vision.

Do not suddenly stop therapy without asking your doctor for advice.
If you have any further questions on the use of 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.
You can usually continue to take the gel unless the effects are severe. If you are concerned, speak to your
doctor or pharmacist. Do not stop using GENISIA without talking to your doctor.
As with other medicines applied to the eyes, timolol maleate is absorbed into the bloodstream. This can
cause side effects similar to those observed with beta-blockers given by “intravenous” and/or “oral” routes.
The incidence of side effects after topical ophthalmic administration is lower than when the medicines are, for
example, taken by mouth or injected.
The side effects listed include reactions seen within the class of beta-blockers used to treat eye conditions.
The frequency of the individual effect listed cannot be defined on the basis of available data:

• Systemic lupus erythematosus, systemic allergic reactions including widespread swelling under the skin (which can occur in areas such as the face and limbs, and can obstruct the airways, causing difficulty swallowing or breathing), urticaria (or itchy rash), localized and widespread rash, itching, severe, life-threatening allergic reaction.
• Low blood glucose levels.
• Sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (muscle disorder), dizziness, altered sensitivity (tingling) and headache.
• Signs and symptoms of eye irritation (e.g. burning, pain, itching, tearing, redness), conjunctival redness, conjunctivitis, eyelid inflammation, corneal inflammation, blurred vision and detachment of the layer under the retina containing blood vessels following filtering surgery which can cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), lowering of the upper eyelid (making the eye half-closed), double vision, changes in refraction (sometimes due to discontinuation of therapy with miotic eye drops).
• Slowing of the heartbeat, chest pain, palpitations, edema (fluid retention), changes in the rhythm or rate of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid retention), arrhythmia, heart attack, cardiac failure, leg cramps and/or leg pain when walking (claudication).
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (predominantly in patients with pre-existing lung disease), difficulty breathing, cough.
• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rashes with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido, impotence.
• Muscle weakness / fatigue.
• Positive antinuclear antibody results.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 GENISIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, the sachet and the
single-dose containers after SCAD. The expiry date refers to the last day of that month when
packaged intact and correctly stored.
Do not store at a temperature above 25°C.
Keep the single-dose containers in the sachet and in the carton to protect them from light.
The product does not contain preservatives. GENISIA must be used immediately after opening;
any remaining contents must be discarded.
After opening the sachet: use the single-dose containers within 1 month.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GENISIA contains

• The active ingredient is timolol. Each g of gel contains 1 mg of timolol as timolol maleate.
• The other ingredients are sorbitol (E 420), polyvinyl alcohol, carbomer 974 P, sodium acetate trihydrate, L-lysine monohydrate, purified water.

Description of the appearance of GENISIA and contents of the pack
GENISIA is an opalescent ophthalmic gel, from colorless to slightly yellow, contained in 5 single-dose containers
inserted in a polyester/aluminum/polyethylene sachet inside a cardboard box.
Each single-dose container contains 0.4 g of ophthalmic gel.
Each pack contains 10, 30 or 90 single-dose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
SIFI S.p.A.
Via Ercole Patti, 36
95025 Aci Sant’Antonio (CT)
Italy
Detailed and up-to-date information for this product is available by scanning the QR
The same information is also available at the following URL: https://qr.sifigroup.com/1G103700/
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