Oftensin

Package Leaflet: Information for the Patient

Oftensin, 2.5 mg/ml, eye drops, solution

Oftensin, 5 mg/ml, eye drops, solution

Timolol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Oftensin and what is it used for

The active substance of Oftensin is timolol. Timolol belongs to a group of medicines called beta-blockers.
Timolol lowers the pressure in the eye by reducing the production of aqueous humor in the eye and increasing its outflow through the uveoscleral tract. Timolol also has a slight effect on episcleral venous pressure.
The medicine does not affect the pupil size or accommodation, so it does not disturb vision.
The effect of the medicine starts about 10-30 minutes after administration, and the maximum decrease in intraocular pressure occurs after 1-2 hours. The effect of the medicine lasts for 24 hours after a single dose.
Indications for use are:
Treatment of increased intraocular pressure in patients with:

• ocular hypertension,
• chronic open-angle glaucoma.

2. Important information before using Oftensin

When not to use Oftensin:

• if you are allergic to timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6);
• if you have asthma or have had asthma in the past;
• if you have severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing and/or prolonged coughing);
• if you have sinus bradycardia;
• if you have sick sinus syndrome;
• if you have second- or third-degree atrioventricular block;
• if you have sinoatrial block;
• if you have cardiogenic shock;
• if you have overt heart failure.

Warnings and precautions

Before starting treatment with Oftensin, discuss with your doctor the following situations:

• if you experience side effects that are observed after oral administration of beta-blockers, as timolol administered topically to the conjunctival sac can penetrate into the bloodstream;
• if you are already taking a beta-blocker orally. It is also not recommended to use two topical beta-blockers at the same time.
• if you have coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or choking), heart failure, decreased blood pressure;
• if you have heart rhythm disturbances, such as slow heart rate;
• if you have respiratory disorders, asthma or chronic obstructive pulmonary disease;
• if you have peripheral circulation disorders (e.g. Raynaud's disease or Raynaud's syndrome);
• if you have diabetes (especially unstable) treated with insulin or oral antidiabetic drugs, as timolol may mask the symptoms of low blood sugar;
• if you have angle-closure glaucoma;
• if you have had filtration surgery;
• if you have hyperthyroidism, as timolol may mask the symptoms of hyperthyroidism.

Risk of anaphylactic reaction
During treatment with timolol, patients with atopic disease or a history of severe anaphylactic reactions to various allergens may exhibit an increased reaction to repeated exposure to these allergens, both accidental and during diagnostic or therapeutic procedures. These patients may not respond to the usual doses of adrenaline used to treat anaphylactic reactions.
Anesthesia during surgical procedures
Before surgical anesthesia, tell your doctor that you are using Oftensin, as timolol may affect the action of some anesthetics.

Children and adolescents

Timolol in the form of eye drops should be used with caution in children and adolescents. In newborns, infants, and small children, timolol should be used with special caution. If coughing, wheezing, abnormal breathing, or abnormal pauses in breathing (apnea) occur, the use of the medicine should be stopped immediately. Contact your doctor as soon as possible. A portable monitor to control apnea may be useful.
Timolol has been studied in infants and children aged 12 days to 5 years who had elevated intraocular pressure or were diagnosed with glaucoma. For more information, consult your doctor.

Oftensin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Oftensin may affect the action of other medicines or its action may be changed by other medicines, including other eye drops used to treat glaucoma. Inform your doctor if you are using or plan to use medicines that lower blood pressure, heart disease medicines, or diabetes medicines.
Some medicines should not be used with timolol, and in other cases, your doctor may recommend a change in dosage.

• other beta-blockers;
• adrenaline;
• cimetidine, ranitidine, haloperidol, and amiodarone, phenothiazine derivatives, reserpine;
• antidepressants, including fluoxetine and paroxetine;
• oral calcium channel blockers (e.g. verapamil, diltiazem, nifedipine);
• cardiac glycosides (e.g. digoxin);
• quinidine;
• guanethidine;
• parasympathomimetics;
• inhalation anesthetics: enflurane, halothane, isoflurane, methoxyflurane, chloroform, cyclopropane, or trichloroethylene;
• antidiabetic medicines (insulin or oral antidiabetic medicines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use the medicine during pregnancy, unless your doctor decides it is necessary.
Do not use the medicine during breastfeeding, as timolol may pass into breast milk.

Driving and using machines

While using timolol in the form of eye drops, visual disturbances and dizziness may occur, which can affect your ability to react. If you experience such side effects, do not drive or operate machinery.

Oftensin contains benzalkonium chloride, phosphates

The medicine contains 0.12 mg of benzalkonium chloride in each ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administration and wait at least 15 minutes before reinserting. In case of eye infection, wearing contact lenses is not recommended.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.
Oftensin 2.5 mg/ml contains 12.72 mg of phosphates in each ml of solution.
Oftensin 5 mg/ml contains 11.78 mg of phosphates in each ml of solution.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.
Timolol is well tolerated by patients using hard contact lenses made of polymethylmethacrylate (PMMA).

3. How to use Oftensin

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Children and adolescents

Before recommending the use of timolol, the doctor should perform a thorough medical examination. The doctor will carefully assess the risk-benefit ratio of using timolol.
If the benefits outweigh the risks, the medicine should be administered at the lowest available concentration once a day.
In children, a 0.1% solution is usually sufficient to lower intraocular pressure. If this dose does not sufficiently lower intraocular pressure, it may be necessary to administer the medicine twice a day with a 12-hour interval. Children, especially newborns, should be closely monitored for 1 to 2 hours after administration of the first dose and carefully monitored for side effects until surgery is performed.
Treatment period
In children and adolescents, the medicine is used for transient treatment.

Adults

Recommended dose of the medicine for adults
Initially, one drop of Oftensin 2.5 mg/ml solution into each affected eye twice a day.
If the treatment result is insufficient, the doctor will recommend using one drop of Oftensin 5 mg/ml solution into each affected eye twice a day.
Intraocular pressure should be regularly controlled.
To lower intraocular pressure, Oftensin can be used with other medicines. However, it is not recommended to use two topical beta-blockers at the same time (see section 2. Important information before using Oftensin).
Since in some patients stabilization of intraocular pressure occurs only after several weeks of treatment with timolol, the assessment of the medicine's effect should be based on intraocular pressure measurements after about 4 weeks of use.
In many cases, if intraocular pressure is stabilized, the doctor may reduce the dose of the medicine, recommending its use once a day.

Changing the current treatment regimen

If you have been using another beta-blocker eye drop before, you should use the usual dose on the last day of its use. The next day, stop the previous medicine and use Oftensin 2.5 mg/ml - one drop into each affected eye twice a day. If the treatment result is not satisfactory, the doctor may increase the dose to one drop of Oftensin 5 mg/ml into each affected eye twice a day.
If you have been using another anti-glaucoma medicine that is not a beta-blocker before, you should continue using it on the same day, adding one drop of Oftensin 2.5 mg/ml into each affected eye twice a day. The next day, stop the previously used anti-glaucoma medicine and continue treatment with Oftensin.
If a higher dose of the medicine is needed, the doctor will recommend using one drop of Oftensin 5 mg/ml into each affected eye twice a day.

Method of administration:

• 1. Wash your hands and take a comfortable sitting or standing position.
• 2. Unscrew the cap.
• 3. Do not touch the dropper tip to any surface.
• 4. Gently pull the lower eyelid of the affected eye down with your finger.

• 5. Hold the upper part of the dropper close to the eye without touching it. Gently squeeze the bottle to release one drop into the eye. Make sure not to squeeze the bottle too hard, so that only one drop gets into the eye.
• 6. Then release the lower eyelid.
• 7. After using the medicine, close your eyes for as long as possible (3-5 minutes) and press the corner of the affected eye near the nose with your finger. This will prevent the medicine from entering other parts of the body. If the drop did not get into the eye, you should administer a second drop.

• 8. Close the bottle.

Eye drop solutions may become contaminated with bacteria if not stored and used properly, causing eye infections. Using contaminated solutions can lead to serious eye damage and even vision loss.

Using a higher dose of Oftensin than recommended

If you use a higher dose of the medicine than recommended, contact your doctor immediately, who will provide appropriate treatment.
Symptoms of overdose may include: decreased blood pressure, slowed heart rate, bronchospasm, and acute heart failure.

Missing a dose of Oftensin

If you miss a dose of the medicine, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.
If you have any further questions about using 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.
Oftensin eye drops are generally well tolerated.
Like other locally used eye medicines, timolol is absorbed into the bloodstream. It may cause the same types of side effects as intravenously or orally administered beta-adrenergic blockers. The frequency of systemic side effects after topical administration to the eye is lower than after oral administration or injection.

• Generalized allergic reactions, including swelling of the skin and mucous membranes, which can occur in areas such as the face and limbs, can block the airways, causing difficulty swallowing or breathing. Urticaria or itchy rash, localized and generalized rash, itching, severe life-threatening allergic reaction.
• Low blood sugar.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations*.
• Fainting, stroke, decreased blood flow to the brain, worsening of myasthenia symptoms (muscle disorder), dizziness, abnormal sensations, such as tingling and numbness, headaches.
• Symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision and retinal detachment, which can cause vision disturbances, decreased corneal sensitivity, dry eye, corneal damage and defects (the transparent layer on the front of the eye), drooping of the upper eyelid (the eye is half-closed), double vision.
• Slow heart rate, chest pain, palpitations, swelling (fluid accumulation), changes in heart rhythm and frequency, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), arrhythmias, cardiac arrest, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Bronchospasm in the lungs (mainly in patients with pre-existing diseases), difficulty breathing, coughing.
• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with a white-silver color (psoriasis-like rash) or worsening of psoriasis, skin rash.
• Muscle pain not caused by physical activity.
• Sexual disorders, decreased libido.
• Weakness and/or fatigue.

*frequency not known (frequency cannot be estimated from the available data)
Other side effects reported in connection with the use of eye drops containing phosphates
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Oftensin

Keep this medicine out of the sight and reach of children.
Store in a temperature not exceeding 25°C, protected from light.
Shelf life after first opening the container: 28 days.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Oftensin contains

• The active substance of Oftensin is timolol. Each ml of solution contains 2.5 mg or 5 mg of timolol in the form of timolol maleate.
• The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, benzalkonium chloride, purified water.

What Oftensin looks like and contents of the pack

The pack contains 5 ml of solution.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warsaw

Date of last revision of the leaflet: