Oftensin

Patient Information Leaflet

Oftensin, 2.5 mg/ml, eye drops, solution
Oftensin, 5 mg/ml, eye drops, solution
Timololum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Oftensin is and what it is 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 Oftensin is and what it is used for

The active substance in Oftensin is timolol. Timolol belongs to a group of medicines called β-adrenolytic agents.
Timolol reduces intraocular pressure by decreasing the production of aqueous humour in the eyeball and simultaneously increasing its outflow via the uveoscleral pathway. Timolol also exerts a slight effect on episcleral venous pressure.
The medicine does not affect pupil size or accommodation, thus it does not disturb vision.
The effect of the medicine begins approximately 10–30 minutes after instillation, with the maximum reduction in intraocular pressure occurring after 1–2 hours. The effect lasts up to 24 hours after a single dose.
Oftensin is indicated for the treatment of elevated intraocular pressure in patients with:

• ocular hypertension,
• chronic open-angle glaucoma.

2. Important information before using Oftensin

When not to use Oftensin:

• if the patient is allergic to timolol, β-adrenolytics, or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has previously had bronchial asthma;
• if the patient currently has or has previously had severe chronic obstructive pulmonary disease (a serious lung disease which may cause wheezing, difficulty breathing, and/or long-lasting cough);
• if the patient has sinus bradycardia;
• if the patient has sick sinus syndrome;
• if the patient has second- or third-degree atrioventricular block;
• if the patient has sinoatrial block;
• if the patient has cardiogenic shock;
• if the patient has overt heart failure.

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

• if the patient experiences adverse effects observed after oral administration of β-adrenolytic drugs, as timolol administered locally into the conjunctival sac may be absorbed into the bloodstream;
• if the patient is already taking an oral β-adrenolytic drug. Concomitant use of two drugs from this group administered locally is also not recommended.
• if the patient has ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath, or angina);
• if the patient has heart failure, low blood pressure;
• if the patient has cardiac arrhythmias, such as slowed heart rate;
• if the patient has respiratory disorders, asthma, or chronic obstructive pulmonary disease;
• if the patient has peripheral circulatory disorders (e.g. Raynaud's disease or Raynaud's syndrome);
• if the patient has diabetes (especially unstable diabetes) treated with insulin or oral antidiabetic drugs, as timolol may mask symptoms of hypoglycemia;
• if the patient has angle-closure glaucoma;
• if the patient has undergone filtration surgery;
• if the patient has hyperthyroidism, as timolol may mask subjective and objective symptoms.

Risk associated with anaphylactic reaction
During treatment with timolol, patients with atopic disease or a history of severe anaphylactic reactions to various allergens may exhibit an intensified reaction upon repeated exposure to these allergens, whether accidental or during diagnostic or therapeutic procedures. Such patients may not respond to doses of adrenaline usually used in treating anaphylactic reactions.
Anaesthesia during surgical procedures
Before undergoing surgical anaesthesia, inform the doctor about the use of Oftensin, as timolol may alter the effects of certain drugs used during anaesthesia.

Children and adolescents
Timolol in the form of eye drops should be used with caution in children and adolescents. Timolol should be used with particular caution in newborns, infants, and young children. If coughing, respiratory sounds, abnormal breathing, or abnormal breathing pauses (apnoea) occur, treatment should be stopped immediately. Contact a doctor as quickly as possible. A portable monitor for detecting apnoea may be helpful.
The use of timolol has been studied in infants and children aged 12 days to 5 years who had elevated intraocular pressure or diagnosed glaucoma. For detailed information, consult your doctor.

Oftensin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Oftensin may affect the action of other medicines, or its effect may be altered by other medicines, including other eye drops used in glaucoma treatment. Inform your doctor if the patient is using or intends to use medicines that lower blood pressure, medicines used in heart diseases, or medicines used in diabetes treatment.
Some medicines should not be used together with timolol; in other cases, the doctor may recommend adjusting the dosage.
Inform your doctor if the patient is taking any of the following medicines:

• other β-adrenolytic drugs;
• adrenaline;
• cimetidine, ranitidine, haloperidol, 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;
• inhaled anaesthetics: enflurane, halothane, isoflurane, methoxyflurane, chloroform, cyclopropane, or trichloroethylene;
• antidiabetic drugs (insulin or oral antidiabetic drugs).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy unless the doctor decides it is necessary.
Do not use this medicine during breastfeeding, as timolol may pass into breast milk.

Driving and operating machinery
When using timolol in the form of eye drops, visual disturbances and dizziness may occasionally occur, which could impair psycho-physical performance. If such adverse effects occur, do not drive or operate machinery.

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

3. How to use Oftensin

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Children and adolescents
Before prescribing timolol, a doctor should perform a thorough medical examination.
The doctor will carefully assess the risk-benefit ratio associated with the use of timolol.
If benefits outweigh risks, the medicine should be administered at the lowest available concentration,
once daily.
In children, a 0.1% solution is usually sufficient to reduce intraocular pressure. If this dose does not
adequately lower intraocular pressure, administration twice daily with a 12-hour interval may be
necessary. Children, especially newborns, should be closely observed for one to two hours after the
first dose and carefully monitored for adverse effects until surgical intervention is performed.
Duration of treatment
In children and adolescents, Oftensin is used for transient treatment.
Adults
Recommended dose for adults
Initially, one drop of Oftensin 2.5 mg/ml solution in each affected eye twice daily.
If the treatment response is inadequate, the doctor may recommend using one drop of Oftensin
5 mg/ml solution in each affected eye twice daily.
Intraocular pressure should be monitored regularly.
To reduce intraocular pressure, Oftensin may be used concomitantly with other medicines. However,
concomitant topical administration of two β-adrenolytic agents is not recommended (see section 2.
Important information before using Oftensin).
Since intraocular pressure stabilization may occur only after several weeks of timolol treatment,
evaluation of the medicine’s effect should be based on intraocular pressure measurements taken
approximately 4 weeks after initiation of treatment.
In many cases, once intraocular pressure has stabilized, the doctor may reduce the dose by
recommending administration once daily.
Changing from previous treatment
If the patient has previously used another β-adrenolytic eye drop, they should instill their usual dose
on the last day of treatment. The next day, discontinue the previous medicine and start using Oftensin
2.5 mg/ml – one drop in each affected eye twice daily. If the treatment response is unsatisfactory, the
doctor may increase the dose to one drop of Oftensin 5 mg/ml in each affected eye twice daily.
If the patient has previously used a single anti-glaucoma medicine that is not a β-adrenolytic agent,
continue using that medicine on the same day and add one drop of Oftensin 2.5 mg/ml in each affected
eye twice daily. The next day, discontinue the previously used anti-glaucoma medicine and continue
treatment with Oftensin.
If a higher dose is required, the doctor will recommend using one drop of Oftensin 5 mg/ml in each
affected eye twice daily.
Method of administration:

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

5. Hold the upper part of the dropper close to the eye without touching the eye. Gently squeeze the bottle so that one drop enters the eye. Ensure that the bottle is not squeezed too hard, so that no more than one drop enters the eye.
6. Then release the lower eyelid.
7. After applying the medicine, close the eyes for as long as possible (3–5 minutes) and press with a finger on the corner of the affected eye near the nose. This prevents the medicine from entering other parts of the body. If the drop did not enter the eye, instill a second drop.

8. Close the bottle.

Eye solutions may become contaminated with bacteria due to improper storage or handling, leading to eye infections. Using such contaminated solutions may cause serious eye damage and, as a consequence, loss of vision.
Use of a higher than recommended dose of Oftensin
If more medicine is used than recommended, contact a doctor immediately for appropriate treatment.
Symptoms of overdose may include: reduced arterial blood pressure, slowed heart rate, bronchospasm,
and acute heart failure.
Missed dose of Oftensin
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose. Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Oftensin eye drops are generally well tolerated.
Like other topically applied ophthalmic medicines, timolol is absorbed into the bloodstream. It may cause the same types of adverse reactions as intravenously and/or orally administered β-adrenergic receptor blocking agents. The frequency of systemic adverse reactions after topical ocular administration is lower than after oral or injectable administration.
The listed adverse reactions also include those observed across the entire group of β-adrenolytic agents used in ophthalmology.

• Generalized allergic reactions, including subcutaneous tissue swelling, which may occur in areas such as the face and limbs, potentially obstructing airways and causing difficulty in swallowing or breathing. Urticaria or itchy rash, localized and generalized rash, pruritus, severe life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty falling asleep (insomnia), depression, nightmares, memory loss, hallucinations*.
• Fainting, stroke, reduced blood flow to the brain, worsening of objective and subjective symptoms of myasthenia (muscle disorders), dizziness, abnormal sensations such as tingling and numbness, headache.
• Subjective and objective symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), blepharitis, keratitis, blurred vision, and serous retinal detachment following filtration surgery, which may lead to visual disturbances, decreased corneal sensitivity, dry eyes, corneal damage and defects (in the anterior layer of the eyeball), drooping of the upper eyelid (eye half closed), double vision.
• Slowed heart rate, chest pain, palpitations, edema (fluid accumulation), changes in heart rhythm and rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), cardiac arrhythmias, cardiac arrest, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Airway narrowing in the lungs (mainly in patients with pre-existing respiratory conditions), breathing difficulties, cough.
• Taste disturbances, nausea, dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white-silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Muscle pain not caused by physical activity.
• Sexual dysfunction, decreased libido.
• Weakness and (or) fatigue.

*Frequency not known (frequency cannot be determined from available data)
Other adverse reactions reported with ophthalmic solutions containing phosphates
In patients with severe corneal epithelial damage (cornea), phosphates may very rarely lead during treatment to corneal clouding due to calcium deposits.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Oftensin

Keep this medicine out of sight and reach of children.
Store below 25°C and protect from light.
Usable period after first opening of 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oftensin contains

• The active substance is timolol. Each ml of solution contains 2.5 mg or 5 mg of timolol in the form of timolol maleate.
• Other ingredients are: disodium 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 Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa