GELTIM 1 mg / g. 30 doses

What is Geltim and what it is used for
This drug is a beta-blocker for ocular application.
It is used to treat certain types of eye diseases including increased intraocular pressure (glaucoma and ocular hypertension).

2. What you need to know before using GELTIM
Do not use GELTIM eye gel in a single dose pack:
If you are allergic to timolol maleate, beta-blockers and any of the other ingredients of this medicine (listed in section 6);
If you currently have or have had respiratory problems such as asthma, severe chronic obstructive bronchitis (a severe lung disease that may cause wheezing, difficulty in breathing and / or prolonged cough);
If you have slow heartbeat, heart failure or heart rhythm disturbances (irregular heartbeat);
In the case of untreated phaeochromocytoma (overproduction of a hormone causing severe arterial hypertension);
In case of treatment with phlectafenin (a medicine used to treat pain);
In the case of treatment with sultopride (a medicine used in psychiatric treatment);
In the case of corneal dystrophies (degenerative diseases of the cornea).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using GELTIM.
Do not stop the treatment suddenly without consulting your doctor.
Do not inject, not swallow through the mouth.
If you use GELTIM, you will need to perform regular intraocular and corneal tests.

Before using this medicine, tell your doctor if you have or have had a history of:
Ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath or choking), heart failure, low blood pressure;
Heart rhythm disorders such as slow heartbeat;
Breathing problems, asthma or chronic obstructive pulmonary disease (pulmonary disease that can cause wheezing, difficulty in breathing and / or prolonged persistent cough);
Diseases of poor circulation (such as Raynaud's disease or Raynaud's syndrome);
Diabetes, as timolol maleate may mask the signs and symptoms of low blood sugar;
Thyroid overactivity, as timolol maleate may mask the signs and symptoms;
Treated pheochromocytoma;
Psoriasis;
Corneal disease;
Metabolic disease.
Precautions for carrying lenses
Avoid wearing contact lenses during treatment because fewer tears will be secreted, which is generally associated with beta-blockers.
Tell your doctor before surgery that you are using GELTIM as timolol maleate may alter the effects of some medicines used in anesthesia.

Other medicines and Geltim
If your doctor has prescribed other eye drops, you should apply these eye drops 15 minutes before GELTIM.
GELTIM may affect or be affected by other medicines you are using, including other eye drops, for the treatment of glaucoma.
Tell your doctor if you are using or intending to use blood pressure lowering medicines, 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, have recently taken or might take any other medicines, especially flupaphenin and sulpotride.

Pregnancy and breastfeeding
Do not use GELTIM if you are pregnant unless your doctor thinks it necessary.
Do not use GELTIM if you are breast-feeding. Timolol maleate may pass into your breast milk. If you are breast-feeding, talk to your doctor before taking any medicine.

Driving and using machines
You may temporarily have a blurred vision after eye application. Wait until your normal vision returns before driving or using machines. GELTIM can also cause other side effects (dizziness, fatigue) that may affect your ability to drive and use machines. If you have any concerns, please consult your doctor.

Sports
The active ingredient of this drug can result in a positive result in drug and doping research.

3. How to use GELTIM
Always use this medicine exactly as your doctor told you. If you are not sure, ask your doctor or pharmacist.

Dosage
Adults
The usual dose is one drop in the affected eye (s), once a day, in the morning. Each single dose pack contains enough gel to treat both eyes.

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

Elderly patients
No dose adjustment is necessary.
Frequency of application
Apply one drop in the affected eye (s), once a day, in the morning.

Mode of application
This medicine is for use in the eyes (eye application).
For single use only.
Wash your hands carefully before using your eye gel;
Shake the single-dose packing vigorously by holding it down with the pipette before placing the drop in the eye;
Avoid entering the tip of the pipette in contact with the eye or eyelids;
Gently pull the lower eyelid of the affected eye downward by looking up and placing the drop in the eye;
After using GELTIM, press the corner of your eye, nose, for 2 minutes. This helps to prevent timolol maleate from entering elsewhere in your body;
After use, discard the single-dose pack. Do not store it for reuse.
If you use more GELTIM than you should
Among other effects, you may feel dizzy, have difficulty breathing, or your heart rate may slow down.
IMMEDIATELY CONSULT YOUR DOCTOR OR PHARMACY.

If you forget to use GELTIM
Do not take a double dose to make up for the missed dose. Put 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 GELTIM
The pressure in your eye may increase and damage your eyesight.
Do not stop the treatment without your doctor's 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, GELTIM eye gel in single-dose packs can cause side effects, although not everyone gets them.
You can usually continue taking the drops if the reactions are not severe. If you are worried talk to a doctor or pharmacist. Do not stop using GELTIM without talking to your doctor.
Like other medicines used in the eyes, timolol maleate is absorbed into the blood. This may cause such side effects as "intravenous" and / or "oral", as appropriate, beta-blocking agents. The incidence of adverse reactions following topical ophthalmic administration is lower than when the medication is taken by mouth, for example, or injected.
The listed side effects include reactions seen in the beta-blocker class used to treat ophthalmic disorders:
General allergic reactions including subcutaneous edema (which may occur in areas such as the face and extremities and may affect the airway which may cause difficulty in swallowing or breathing), hives (or rash with itching), localized or generalized rash, Itching, severe, sudden, life-threatening allergic reaction;
Low blood glucose levels;
Difficulties with sleep (insomnia), depression, nightmares, loss of memory;
Seizures, stroke, decreased blood supply to the brain, increased signs and symptoms of myasthenia gravis (dizziness), vertigo, unusual sensations (such as needles) and headaches;
Signs and symptoms of eye irritation (eg burning, stinging, itching, tearing, redness), conjunctival flushing, conjunctivitis, eyelid inflammation, corneal inflammation, blurred vision and detachment of the layer under the retina containing the blood vessels after Filtering surgery that can cause visual disturbances, reduced corneal sensitivity, dry eye, corneal erosion (eyeball front layer damage), upper eyelid (leaving the eye open), double vision, change refractive (and sometimes due to the withdrawal of treatment with miotic drops);
Heart beat, chest pain, palpitations, swelling, changes in rhythm or heart rate, congestive heart failure (heart disease with sneezing and swelling of the feet and legs due to fluid collection), type of heart rhythm disturbance , Heart attack, heart failure, leg cramps and / or leg pain when walking (limping);
Low blood pressure, Raynaud's phenomenon, cold hands and feet;
Narrowing of the airways in the lungs (mainly in patients with existing disease), difficulty in breathing, coughing;
Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting;
Hair loss, skin rash with a silver-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash;
Muscle pain, not caused by physical effort, disseminated lupus erythematosus;
Sexual dysfunction, decreased libido, impotence;
Muscle weakness / fatigue;
Positive results for antinuclear antibodies.
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet.
How to store GELTIM
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, sachet and single-dose pack after EXP. The expiry date refers to the last day of that month.
Store single-dose packs in the sachet and carton to protect from light.
Use the single-dose pack immediately after opening and discard it after use. After opening the sachet, use single-dose packs within 1 month.
Do not dispose of medicines in the sewers. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What GELTIM contains
The active substance is timolol. 1 g of gel contains 1 mg of timolol in the form of timolol maleate.
Excipients are sorbitol, polyvinyl alcohol, carbomer 974P, sodium acetate trihydrate, lysine monohydrate, water for injections.
What GELTIM looks like and what the package contains
GELTIM is a opaque, colorless to pale yellow eye gel contained in single-dose packs packed in sachets of 10, each unit dose containing 0.4 g of product.
The pack contains 30 (3x10) or 90 (9x10) single dose packs. Not all pack sizes may be marketed.

 

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