Dorzolamide + timolol stulln

Package leaflet: Information for the user

Dorzolamidum + Timololum Stulln, 20 mg/mL + 5 mg/mL, eye drops, solution
Dorzolamidum + Timololum
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Dorzolamidum + Timololum Stulln is and what it is used for

Dorzolamidum + Timololum Stulln contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-adrenergic receptor blockers" (beta-blockers). These medicines reduce intraocular pressure through two different mechanisms.

Dorzolamidum + Timololum Stulln is indicated for the treatment of glaucoma to reduce elevated intraocular pressure when treatment with eye drops containing only a beta-adrenergic receptor blocker is insufficient.

2. Important information before using Dorzolamidum + Timololum Stulln

When not to use Dorzolamidum + Timololum Stulln:

• if the patient is allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient currently has or has previously had respiratory disorders such as asthma or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, breathing difficulties, and/or persistent cough);
• if the patient has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (irregular heartbeat);
• if the patient has severe kidney disease or severe impairment of kidney function, or a history of kidney stones;
• if the patient has excessive blood acidification due to accumulation of chloride ions in the body (hyperchloremic acidosis).

If in doubt whether this medicine can be used, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Dorzolamidum + Timololum Stulln, discuss this with your doctor.
Inform your doctor about all current or previous eye disorders and the following medical conditions:

• ischemic heart disease (symptoms include chest pain or pressure, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure;
• disturbances in heart rate, such as bradycardia;
• breathing problems, asthma, or chronic obstructive pulmonary disease;
• conditions associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, because timolol may mask the objective and subjective symptoms of hypoglycemia (low blood sugar);
• hyperthyroidism, because timolol may mask its objective and subjective symptoms.

Before undergoing surgery, inform the attending physician about the use of Dorzolamidum + Timololum Stulln, as timolol may alter the effects of certain anesthetic drugs.
Also inform your doctor about any allergies or allergic reactions, including urticaria, facial swelling, swelling of the lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if the patient experiences muscle weakness or has been diagnosed with myasthenia gravis.
If eye irritation or any new eye problem occurs, such as redness of the eye or eyelid swelling, contact a doctor immediately.
If the patient suspects that Dorzolamidum + Timololum Stulln is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, skin redness, or itchy eyes), discontinue use of this medicine and contact a doctor immediately.
Inform your doctor if an eye infection occurs, if the eye has been injured, after eye surgery, or if a reaction occurs accompanied by new symptoms or worsening of existing ones.
After ocular administration, Dorzolamidum + Timololum Stulln may cause systemic effects.
Before using this medicine, individuals wearing soft contact lenses should seek medical advice.
Children
Experience with ophthalmic solutions containing dorzolamide and timolol with a preservative in infants and children is limited.
Use in elderly patients
Studies using ophthalmic solutions containing dorzolamide and timolol with a preservative showed similar effects in elderly and younger patients.
Use in patients with liver function disorders
Inform your doctor about any current or past liver diseases.
Interaction of Dorzolamidum + Timololum Stulln with other medicines
Dorzolamidum + Timololum Stulln may affect the action of other medicines, or other medicines taken by the patient may affect the action of Dorzolamidum + Timololum Stulln. This also applies to other ophthalmic anti-glaucoma medications. Inform your doctor if you are taking or plan to take antihypertensive drugs, cardiac medications, or antidiabetic agents. Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use. This is particularly important when:

• taking antihypertensive drugs or medications for heart conditions (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
• taking medications used for cardiac arrhythmias or to restore regular heart rhythm (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
• using other ophthalmic drops containing beta-adrenergic receptor antagonists;
• taking other carbonic anhydrase inhibitors, such as acetazolamide;
• taking monoamine oxidase inhibitors (MAOIs);
• taking parasympathomimetic (cholinergic) drugs, which may be used for urinary disorders; parasympathomimetic drugs are also sometimes used to restore normal intestinal motility;
• taking narcotics such as morphine, used to treat moderate to severe pain;
• taking antidiabetic medications;
• taking antidepressants such as fluoxetine and paroxetine;
• taking chemotherapeutic sulfonamides;
• taking quinidine (a drug used in the treatment of heart conditions and certain forms of malaria).

Pregnancy and breastfeeding
Before using any medicine, consult a doctor or pharmacist.
Use during pregnancy
Dorzolamidum + Timololum Stulln should not be used during pregnancy unless considered necessary by a doctor.
Use during breastfeeding
Dorzolamidum + Timololum Stulln should not be used during breastfeeding. Timolol may pass into human milk. Before taking any medicine during breastfeeding, consult the attending physician.
Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive or operate machinery. Some adverse effects associated with the use of Dorzolamidum + Timololum Stulln, such as blurred vision, may affect the ability to drive and/or operate machinery. Patients who feel unwell or have blurred vision should not drive or operate machinery.
Dorzolamidum + Timololum Stulln contains benzalkonium chloride
The medicine contains 0.375 mg of benzalkonium chloride in each 5 mL and 0.75 mg of benzalkonium chloride in each 10 mL, corresponding to a concentration of 0.075 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion. Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal eye sensations, stinging, or eye pain occur after using the medicine, contact a doctor.

3. How to use Dorzolamidum + Timololum Stulln

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist. The doctor will determine the appropriate dose and duration of treatment.
The recommended dose is one drop into the affected eye(s) in the morning and evening.
If other eye drops are being used simultaneously, wait at least 10 minutes before administering the next product.
Do not change the dose of this medicine without consulting your doctor.
Avoid contact of the container tip with the eye or surrounding areas. The medicine may become
contaminated with bacteria, which could lead to eye infection causing serious damage or even loss of vision. To avoid possible contamination of the container, wash your hands before using this medicine and avoid contact between the dropper tip and any surface. If the patient suspects the medicine may have become contaminated or if an eye infection occurs, contact your doctor immediately regarding further use of the current bottle.

Instructions for use
If you have difficulty administering the drops, ask for help from a family member or caregiver.

1. Wash your hands first and unscrew the cap from the bottle.
2. Tilt your head backward and gently pull down the lower eyelid to form a small pocket between the eyelid and the eyeball. (Figure 1)
3. Squeeze the bottle, held upside down, to release one drop into the eye. (Figure 2) Do not touch the eye or eyelid with the dropper tip.
4. After instilling Dorzolamidum + Timololum Stulln into the eye, close the eye and press gently on the inner corner of the eye with a finger for about 2 minutes. This helps prevent the medicine from spreading into the rest of the body.
5. To instill the medicine into the other eye, if so directed by your doctor, repeat steps 2 to 4. Replace and tightly screw on the cap after using the medicine.

Use of more than the recommended dose of Dorzolamidum + Timololum Stulln
If too many drops are instilled into the eye or if the contents of the container are swallowed, symptoms such as dizziness, breathing difficulties, or a sensation of slowed heartbeat may occur. Seek immediate medical advice.

Missed dose of Dorzolamidum + Timololum Stulln
Dorzolamidum + Timololum Stulln should be used exactly as prescribed by your doctor.
If a dose is missed, administer it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.
Do not use a double dose to make up for a missed dose.

Stopping Dorzolamidum + Timololum Stulln
Consult your doctor before stopping this medicine.
If you have any further questions 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.
Treatment with the drops can usually be continued unless the adverse reactions are severe. If you have any concerns, contact your doctor or pharmacist. Do not stop using Dorzolamidum + Timololum Stulln without consulting your doctor.
Generalised allergic reactions, including subcutaneous swelling, may occur in the facial area and extremities and may cause airway obstruction and difficulty swallowing or breathing, urticaria or itchy rash, localised and generalised rash, itching, and severe, sudden and life-threatening allergic reaction.
During clinical trials or after marketing of the medicinal product, the following adverse reactions have been reported with eye drops containing dorzolamide and timolol, with or without a preservative, or with one of their active ingredients:

Very common (may occur in more than 1 in 10 people):
Burning and stinging sensation in the eye, altered taste sensation

Common (may occur in less than 1 in 10 people):
Redness of the eyeballs and surrounding skin (eyes), tearing or itchy eyes, corneal erosions (damage to the front layer of the eyeball), swelling and/or irritation of the eyeballs and surrounding skin (eyes), foreign body sensation in the eye, reduced corneal sensitivity (inability to feel a foreign body in the eye or inability to feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of pressure or fullness in the nose), nausea, weakness and fatigue.

Uncommon (may occur in less than 1 in 100 people):
Dizziness, depression, iritis, visual disturbances, including refractive changes (in some cases due to discontinuation of miotic drugs), bradycardia (slow heart rate), fainting, breathing difficulties (dyspnoea), indigestion, and kidney stones (often characterised by sudden onset of severe, colicky pain in the lower back and/or side, groin or abdomen).

Rare (may occur in less than 1 in 1000 people):
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness of the hands or feet, insomnia, nightmares, memory loss, worsening of objective and subjective symptoms of myasthenia (muscle disorder), decreased libido, stroke, transient myopia which may resolve after discontinuation of the medicine, detachment after filtration procedures of the layer beneath the retina containing blood vessels, possibly leading to visual disturbances, drooping eyelids (eyelids half-closed), double vision, formation of scabs on the eyelids, corneal oedema (with subjective visual disturbances), low intraocular pressure, tinnitus, low blood pressure, arrhythmia (irregular heart rhythm), changes in heart rhythm or heart rate, congestive heart failure (heart disease characterised by breathlessness and swelling of feet and legs due to fluid accumulation), oedema (fluid accumulation), cerebral ischaemia (reduced blood flow to the brain), chest pain, strong heartbeat which may be fast or irregular (palpitations), myocardial infarction, Raynaud's disease, oedema of hands and feet or cold hands and feet and poor circulation in upper and lower limbs, leg cramps and/or leg pain while walking (claudication), dyspnoea, respiratory failure, rhinitis (nasal discharge or sensation of blocked nose), nosebleeds, narrowing of the airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, white-silvery rash (psoriasiform rash), Peyronie's disease (which may lead to penile curvature), allergic reactions such as rash, urticaria, itching, and in rare cases possible swelling of lips, eyelids and oral cavity, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Like other medicines administered locally to the eyes, timolol is absorbed into the bloodstream, which may result in adverse reactions similar to those observed after oral administration of beta-adrenergic blocking agents. Adverse reactions occur less frequently after topical use of eye drops than after systemic administration, for example orally or by injection. Among the additional adverse reactions listed above are those typical of the therapeutic class of beta-adrenergic blocking agents used in ophthalmic disorders.

Frequency unknown (frequency cannot be estimated from available data):
Low blood glucose levels, hallucinations, heart failure, type of cardiac arrhythmia, tachycardia (increased heart rate), increased blood pressure, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual dysfunction.

Reporting of adverse reactions
If any adverse effects 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 of the 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dorzolamidum + Timololum Stulln

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the bottle
after: Expiry date. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
5 mL bottles: Dorzolamidum + Timololum Stulln can be used for 4 weeks after first opening the bottle.
10 mL bottles: Dorzolamidum + Timololum Stulln can be used for 8 weeks after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Dorzolamidum + Timololum Stulln contains

• The active substances are dorzolamide and timolol. Each millilitre of solution contains 20 mg of dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (6.83 mg of timolol maleate).
• The other ingredients are: hydroxyethylcellulose (4000 - 5000 mPa∙s), mannitol, sodium citrate, sodium hydroxide (for pH adjustment), and water for injections. Benzalkonium chloride is added to the medicine as a preservative.

What Dorzolamidum + Timololum Stulln looks like and contents of the pack
Dorzolamidum + Timololum Stulln is a clear, almost colourless, slightly viscous solution practically free from visible particles.
Packs are available containing 1, 3 or 6 bottles with dropper, each containing 5 mL of eye drops, solution, or 1, 2 or 3 bottles with dropper, each containing 10 mL of eye drops, solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Pharm Supply Sp. z o.o.
ul. Marconich 2/9
02-954 Warsaw
Poland
Tel. (+48) 22 6423331
E-mail: [email protected]

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Dorzolamid + Timolol Stulln Austria
Dorzolamide + Timolol Stulln France
Dorzocomp-Stulln Germany
Dorzolamide + Timolol Stulln Netherlands
Dorzolamidum + Timololum Stulln Poland
Dorzolamida /Timolol Stulln Spain