TIMOGEL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Timolol
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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, contact your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

What this leaflet contains:

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

1. WHAT TIMOGEL IS AND WHAT IT IS USED FOR

This medicinal product is a beta-blocker administered by ocular route.
It is used in the treatment of certain types of ocular diseases involving intraocular hypertension
(glaucoma and ocular hypertension).

2. WHAT YOU SHOULD KNOW BEFORE USING TIMOGEL

Do not use TIMOGEL ophthalmic gel in single-dose container

• if you are allergic to timolol maleate, to other beta-blockers, or to any of the other ingredients of this medicine (listed in section 6),
• if you have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a severe lung disease that may cause shortness of breath, difficulty breathing, and/or long-lasting cough),
• if you have a slow heartbeat, heart failure, or cardiac rhythm disorders (irregular heartbeats),
• in case of: untreated pheochromocytoma (excessive production of a hormone causing severe arterial hypertension),
• in case of corneal dystrophies (degenerative diseases of the cornea).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using TIMOGEL.
Do not stop treatment suddenly without consulting your doctor.
Do not inject, do not swallow.
If you are using TIMOGEL, you must undergo regular checks of intraocular pressure and cornea.
Before using this medicine, inform your doctor if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, low blood pressure,
• cardiac rhythm disorders, including slow heartbeat,
• respiratory problems, asthma, or chronic obstructive pulmonary disease (a lung disease that may cause shortness of breath, difficulty breathing, and/or long-lasting cough),
• peripheral arterial circulation disorders (such as Raynaud's disease or Raynaud's syndrome),
• in diabetes, timolol maleate may mask signs and symptoms of low blood sugar,
• timolol maleate may mask signs and symptoms of overactivity of the thyroid gland,
• pheochromocytoma,
• psoriasis,
• corneal disease,
• metabolic disorders.

Precautions regarding contact lens use

• avoid wearing contact lenses during treatment, as tear secretion is reduced; this is generally associated with the use of beta-blocking medicines.

Inform your doctor before undergoing surgery that you are taking TIMOGEL, since timolol maleate may alter the effects of certain medicines used during anesthesia.

Other medicines and TIMOGEL
If your doctor has prescribed any other type of eye drop, you must instill this eye drop 15 minutes before TIMOGEL.
TIMOGEL may interact with or be affected by other medicines you are taking, including other eye drops for glaucoma treatment.
Inform your doctor if you are taking or intend to take medicines to lower blood pressure, heart medications, or medicines to treat diabetes, quinidine (used to treat heart conditions and certain types of malaria), or antidepressants known as fluoxetine and paroxetine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
Do not use TIMOGEL during pregnancy unless your doctor considers it necessary.
Do not use TIMOGEL during breastfeeding. Timolol maleate may be excreted in breast milk.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
After ocular administration of TIMOGEL, transient blurred vision may occur. Wait until your vision has returned to normal before driving or operating machinery. TIMOGEL may also cause other adverse effects (dizziness and fatigue) that could potentially affect your ability to drive or use machinery. If you have any doubts, consult your doctor.

Sports
The active substance in this medicine may lead to a positive result in anti-doping tests.

3. HOW TO USE TIMOGEL

Always use this medicine exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.

Dosage

• Adults: The usual dose is one drop in the affected eye(s) once daily in the morning. A single unit-dose container contains enough gel to treat both eyes.
• Children and adolescents: There is no experience in children and adolescents. The use of this ophthalmic gel is therefore not recommended in these patients.
• Elderly patients: No dosage adjustment is necessary.

Frequency of administration
Apply one drop into the affected eye(s) once daily in the morning.

Method of administration
This medicine is for ocular use only.
For single use only.

• Wash your hands thoroughly before using your ophthalmic gel;
• shake the container vigorously with the opening facing downwards before instilling a drop;
• avoid contact between the tip of the container and the eye or eyelids;
• gently pull down the lower eyelid of the affected eye while looking upwards, and instil the drop into the eye;
• after using TIMOGEL, press a finger against the inner corner of the eye, near the nose, for 2 minutes. This helps prevent timolol maleate from spreading throughout the rest of the body;
• discard the unit-dose container after use. Do not keep the container for later use.

If you use more TIMOGEL than you should
Among other effects, you may feel dizzy, have difficulty breathing, or feel that your heartbeat has slowed down.
CONTACT YOUR DOCTOR OR PHARMACIST IMMEDIATELY.

If you forget to use TIMOGEL
Do not use a double dose to make up for the missed dose. Instil the missed dose as soon as possible. However, if it is almost time for the next dose, simply skip the missed dose.

If you stop using TIMOGEL
The pressure inside your eye may increase and cause damage to your vision.
DO NOT STOP TREATMENT SUDDENLY WITHOUT CONSULTING YOUR DOCTOR.

If you have any questions about the use of TIMOGEL, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, TIMOGEL ophthalmic gel in single-dose container may cause adverse reactions, although not everyone experiences them.
Usually, you can continue using the gel unless the reactions are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using TIMOGEL without first discussing it with your doctor.
As with other medicines applied to the eyes, timolol maleate is absorbed into the bloodstream.
This may cause adverse reactions similar to those observed with beta-blocking agents administered intravenously and/or orally.
The incidence of adverse reactions after topical ophthalmic administration is lower than when medicines are, for example, taken orally or injected.
The adverse reactions listed below include those observed within the class of beta-blockers used to treat eye disorders:

• Systemic allergic reactions including generalized swelling under the skin (which may occur in areas such as the face and limbs, and may obstruct the airways, causing difficulty in swallowing or breathing), urticaria (or itchy rash), localized and generalized skin rash, pruritus, and severe, life-threatening anaphylactic reactions.
• Low blood glucose levels
• Sleep disturbances (insomnia), depression, nightmares, memory loss
• Fainting, stroke, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), dizziness, unusual sensations (such as pins and needles), and headache.
• Signs and symptoms of eye irritation (e.g. burning, stinging sensation, itching, tearing, redness), conjunctival redness, conjunctivitis, eyelid inflammation, corneal inflammation, blurred vision, and retinal pigment epithelial detachment following filtering surgery, which may lead to visual disturbances; reduced corneal sensitivity, dry eyes, corneal erosion (damage to the outer layer of the eyeball), drooping of the upper eyelid (resulting in the eye being half-closed), double vision, changes in refraction (sometimes due to discontinuation of therapy with miotic drops).
• Slowed heart rate, chest pain, palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (a heart condition with shortness of breath and swelling of the feet and legs due to fluid accumulation), cardiac arrhythmia, myocardial infarction, heart failure, leg cramps and/or leg pain when walking (claudication).
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Constriction of the pulmonary airways (predominantly in patients with pre-existing lung disease), breathing difficulties, cough.
• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rashes with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Muscle pain not caused by physical exertion, systemic lupus erythematosus.
• Sexual dysfunction, decreased libido, impotence.
• Muscle weakness / fatigue.
• Positive antinuclear antibody test results.

If any of the adverse reactions occur, inform your doctor, pharmacist, or nurse.
This includes any adverse reaction not listed in this leaflet.
Reporting of adverse reactions
If you experience any adverse reaction, talk to your doctor, pharmacist, or nurse.
This includes possible adverse reactions not listed in this leaflet. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. HOW TO STORE TIMOGEL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet, and single-dose container after EXP. The expiry date refers to the last day of the month.
Store the single-dose containers inside the sachet and outer container to protect them from light.
Use the single-dose container immediately after opening and dispose of it after use.
After opening the sachet: use the single-dose containers within 1 month.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What TIMOGEL contains
• The active substance is timolol; 1 g of gel contains 1 mg of timolol as timolol maleate.
• The excipients are sorbitol, polyvinyl alcohol, carbomer 974 P, sodium acetate trihydrate, lysine monohydrate, water for injections.

Description of the appearance of TIMOGEL and the contents of the pack
TIMOGEL is an opalescent ophthalmic gel, colourless to slightly yellow, supplied in single-dose containers packed in sachets of 10 units. Each single-dose container holds 0.4 g of product.
A pack contains 30 (3 x 10) or 90 (9 x 10) single-dose containers.
Not all pack sizes are marketed.

Marketing Authorization Holder
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE

Selling Agent
THEA FARMA S.p.A.
Via Giotto, 36 – 20145 MILANO

Manufacturer
LABORATOIRE UNITHER
RUE ANDRE DUROUCHEZ
80052 AMIENS CEDEX 2
FRANCE
Or
LABORATOIRE UNITHER
ZI DE LA GUÉRIE
50211 COUTANCES Cedex
FRANCE

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, Germany, Italy, Netherlands, Portugal, Spain: TIMOGEL
Belgium, Bulgaria, Greece, Luxembourg, Romania: GELTIM
Denmark, Iceland: TIMOSAN DEPOT
Finland: TIMOSAN
France: GELTIM LP
United Kingdom: TIOPEX
Ireland: TIMOFLUID

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