TIMOGEL 1 mg /G Żel
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TIMOGEL 1 mg/g ophthalmic gel in single-dose container
Timolol
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 only for you personally. Never give it to others. In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
- If any side effects occur, contact your doctor, pharmacist or nurse. This includes any possible undesirable 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 IS TIMOGEL AND WHAT IS IT USED FOR
This medicine is a beta-blocker administered via ocular route.
It is used for the treatment of some types of eye diseases concerning intraocular hypertension
(glaucoma and ocular hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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 components of this medicine (listed in section 6),
- if you have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (a severe lung disease that can cause shortness of breath, difficulty breathing and/or long-lasting cough).
- If you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeats)
- in case of: untreated pheochromocytoma (excessive production of a hormone that causes severe high blood pressure),
- in case of corneal dystrophies (degenerative disease of the cornea).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using TIMOGEL
Do not suddenly stop the therapy without your doctor's advice.
Do not inject, do not swallow.
If you use TIMOGEL 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 tightness, shortness of breath or suffocation), heart failure, low blood pressure
- heart rhythm disorders, as well as slowing of the heartbeat,
- respiratory problems, asthma or chronic obstructive bronchopneumonia (lung disease that can cause shortness of breath, difficulty breathing and/or long-lasting cough),
- problems with peripheral arterial circulation (such as Raynaud's disease or Raynaud's syndrome)
- in diabetes, timolol maleate may mask the signs and symptoms due to a low blood sugar concentration,
- timolol maleate may mask signs and symptoms of hyperthyroidism,
- pheochromocytoma,
- psoriasis,
- corneal disease
- metabolic disease
Precautions for the 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.
Tell your doctor before undergoing surgery that you are taking TIMOGEL, as
timolol maleate may alter the effects of some medicines used during anesthesia.
Other medicines and TIMOGEL
If your doctor has prescribed you any other type of eye drops, you must instillthis eye drop 15 minutes
beforeTIMOGEL;
TIMOGEL may influence or be influenced by other medicines you are taking, including other
eye drops for the treatment of glaucoma.
Tell your doctor if you are taking or intend to take medicines to lower blood
pressure, heart medicines or medicines to treat diabetes, quinidine (used to treat
heart conditions and some types of malaria), antidepressants known as fluoxetine and paroxetine..
Tell your doctor or pharmacist if you are taking or have recently taken or may take
other medicines.
Pregnancy and breastfeeding
Do not use TIMOGEL in case of pregnancy unless your doctor considers it necessary.
Do not use TIMOGEL in case of breastfeeding. Timolol maleate may be excreted into
milk.
Ask your doctor for advice before taking any medicine during breastfeeding.
Driving and using machines
Following the ocular administration of TIMOGEL, transient blurring of
vision may occur. Wait until your vision has returned to normal before driving vehicles
or using machines. TIMOGEL may also cause other side effects (dizziness and
fatigue) likely to affect the ability to drive vehicles or use
machinery. If you have any doubts, consult your doctor.
Sport
The active ingredient of this medicine may cause positive results in doping tests.
3. HOW TO USE TIMOGEL
Always use this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
Dosage
- AdultsThe usual dose is one drop in the affected eye(s) once a day, in the morning. A single single-dose container contains enough gel to treat both eyes.
- Children and adolescentsThere is no experience in children and adolescents. Therefore, the use of this ophthalmic gel is not recommended in these patients.
- Elderly patientsNo dosage adjustment is necessary.
Frequency of administration
Apply one drop in the affected eye(s) once a day, in the morning.
Method of administration
This medicine must be administered into the eye (ophthalmic use).
For single use only.
- wash your hands thoroughly before using your ophthalmic gel;
- shake the container vigorously, with the opening facing downwards, before applying a drop
- avoid contact of the container tip with the eye or eyelids;
- gently lower the lower eyelid of the affected eye while looking upwards, and instill the drop into the eye;
- after using TIMOGEL, press a finger on the corner of the eye, near the nose for 2 minutes. This helps to prevent timolol maleate from spreading throughout the rest of the body
- dispose of the single-dose container after use. Do not keep the container for further use.
If you use more TIMOGEL than you should
Among other effects, you may feel dizzy, or may have difficulty breathing or feel that your heartbeat is slowed down.
IMMEDIATELY CHECK WITH YOUR DOCTOR OR PHARMACIST.
If you forget to use TIMOGEL
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 TIMOGEL
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 doubts about the use of TIMOGEL, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, TIMOGEL ophthalmic gel in a single-dose container can cause side effects, although not everyone will experience them.
You can usually continue to use the gel unless the effects are severe. If you are concerned, contact your doctor or pharmacist. Do not stop using TIMOGEL 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 taken by
“intravenous” and/or “oral” route.
The incidence of side effects after topical ophthalmic administration is lower than
when 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:
- 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), hives (or itchy rash), localized and widespread skin rash, itching, life-threatening danger from sudden allergic reaction.
- 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 (muscle disorder), dizziness, unusual sensations (such as pins and needles) and headache.
- Signs and symptoms of eye irritation (e.g., burning, stinging, 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, heart 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 diseases), 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, skin rash.
- Muscle pain not caused by exercise, systemic lupus erythematosus.
- Sexual dysfunction, decreased libido, impotence.
- Muscle weakness / fatigue.
- Positive antinuclear antibody results.
If any of these side effects occur, inform your doctor, pharmacist or nurse.
Reporting of side effects
If you experience any side effects, speak to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TIMOGEL
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 container after EXP. The expiry date refers to the last day of the month.
Store the single-dose containers inside the sachet and the 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 used. These measures will help protect the environment
6. PACKAGE CONTENTS AND OTHER INFORMATION
What TIMOGEL contains
. the active ingredient 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 contents of the pack
TIMOGEL is an opalescent ophthalmic gel, from colorless to slightly yellow, presented in single-dose
containers packaged in a pouch of 10 units, each single-dose container contains 0.4 g of
product.
One pack contains 30 (3 x 10) or 90 (9x10) single-dose containers.
Not all pack sizes are marketed
Marketing Authorisation Holder
LABORATOIRES THEA
12, RUE LOUIS BLERIOT
63017 CLERMONT-FERRAND CEDEX 2
FRANCE
Marketing Authorisation Holder
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 authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Germany, Italy, Netherlands, Portugal, Spain: TIMOGEL
Belgium, Bulgaria, Greece, Luxembourg, Romania: GELTIM
Denmark, Iceland: TIMOSAN DEPOT
Finland: TIMOSAN
France: GELTIM LP
Great Britain: TIOPEX
Ireland: TIMOFLUID
This leaflet was last revised on:
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- Kraj rejestracji
- Postać farmaceutycznaGel, 1 MG/G
- Kod ATCS01ED01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TIMOJELPostać farmaceutyczna: Eye drops, solution, 5MG/MLSubstancja czynna: timololProducent: IMMEDICA PHARMA ABWymaga receptyPostać farmaceutyczna: Eye drops, solution, 0.25%Substancja czynna: timololProducent: FARMIGEA S.P.A.Wymaga receptyPostać farmaceutyczna: Single-dose ophthalmic gel, 1 MG/GSubstancja czynna: timololProducent: SIFI S.P.A.Wymaga recepty
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TIMOJEL wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w TIMOJEL jest timolol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
TIMOJEL jest produkowany przez LABORATOIRES THEA. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie TIMOJEL jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić TIMOJEL w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (timolol) to m.in. KUSIMOLOL, DROPTIMOL, JENISIA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
