Dorzolamide + timolol stulln

Patient Information Leaflet

Dorzolamidum + Timololum Stulln, 20 mg/mL + 5 mg/mL, eye drops, solution
in single-dose container
Dorzolamidum + Timololum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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 Dorzolamidum + Timololum Stulln is and what it is used for
2. Important information 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 disease which may cause wheezing, breathing difficulties, and/or long-lasting 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 any current or past eye disorders and the following medical conditions:

• ischemic heart disease (symptoms include chest pain or pressure, shortness of breath, or a choking sensation), 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 signs and symptoms of hypoglycemia (low blood sugar levels);
• hyperthyroidism, because timolol may mask its signs and 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 hives, facial swelling, swelling of the lips, tongue, and/or throat, which may cause difficulty breathing or swallowing.
Inform your doctor if the patient has experienced muscle weakness or has been diagnosed with myasthenia gravis.
If eye irritation or any new eye problem occurs, such as eye redness or eyelid swelling, consult 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, or skin redness and 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.
Studies on the use of Dorzolamidum + Timololum Stulln in patients wearing contact lenses have not been conducted.
Patients wearing soft contact lenses should consult a doctor before using this medicine.

Children
Experience with ophthalmic solutions containing dorzolamide and timolol with a preservative in infants and children is limited.

Use in elderly patients
In clinical studies, 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.

Dorzolamidum + Timololum Stulln and 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 or recently taken, as well as any medicines the patient intends to use. This is particularly important in the following cases:

• taking antihypertensive drugs or medications for heart conditions (such as calcium channel blockers, beta-adrenergic receptor antagonists, or digoxin);
• taking medications for cardiac arrhythmias or those used to restore normal 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 taking 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 this 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.

3. How to use Dorzolamidum + Timololum Stulln

This medicine should always be used exactly as directed by the doctor. If in 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 at the same time as Dorzolamidum + Timololum Stulln, wait at least 10 minutes before administering the next medicine.
Do not change the dose of this medicine without consulting your doctor.
If you have difficulty administering the drops, ask for help from a family member or caregiver.
Avoid allowing any part of the single-dose container to touch the eye or surrounding area. This may cause eye injury and also contaminate the container with bacteria, which could lead to eye infection resulting in serious eye damage or even loss of vision. To avoid possible contamination of the single-dose container, wash your hands before using this medicine and avoid contact between the tip of the container and any surface. A new single-dose container should be opened immediately before each use. Each container holds enough solution to administer the correct dose to both eyes, if your doctor has instructed you to use it in both eyes.
After opening, any remaining contents of the single-dose container must be discarded immediately after use.

Instructions for use

1. Wash your hands.
2. Open the aluminium pouch and remove the blister pack of single-dose containers.
3. Detach one single-dose container from the blister (Fig. 1).
4. Open the container by unscrewing the cap. Do not touch the tip after opening the container (Fig. 2).
5. Tilt your head backwards (Fig. 3).
6. Pull the lower eyelid downwards with one finger, holding the single-dose container in the other hand. Squeeze the container so that one drop enters the eye (Fig. 4).
7. 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 being absorbed into the rest of the body (Fig. 5). If necessary, repeat steps 5 to 7 to administer the drop to the other eye.
8. Discard the single-dose container after use.
9. Return any unused single-dose containers to the aluminium pouch, close it by folding the edge, and place the pouch back into the cardboard box. If any single-dose containers remain in the pouch after 3 months from the date of opening, dispose of them in an environmentally safe manner and open a new pouch. It is important that eye drops are used continuously as directed by the doctor.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

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

Missed dose of Dorzolamidum + Timololum Stulln
Dorzolamidum + Timololum Stulln should be used as directed by the doctor. If a dose is missed, administer it as soon as possible. However, if the next scheduled dose is due soon, do not administer 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Treatment with the drops can usually be continued unless the side effects 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 limbs and may cause airway obstruction and difficulty swallowing or breathing, urticaria or itchy rash, localised and generalised rash, itching, and severe, sudden, life-threatening allergic reaction.

The following side effects have been reported during clinical trials or after marketing of the medicinal product containing dorzolamide and timolol without preservatives or with one of their active ingredients:

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

Common (may affect up to 1 in 10 people):
Redness of the eyes and surrounding skin (eyes), tearing or itching of the eye(s), corneal abrasions (damage to the front layer of the eyeball), swelling and/or irritation of the eyes and skin around the eyes, sensation of a foreign body in the eye, decreased 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, fatigue and feeling of tiredness.

Uncommon (may affect up to 1 in 100 people):
Dizziness, depression, uveitis, visual disturbances, including refractive changes (in some cases due to discontinuation of miotic drugs), bradycardia, fainting, breathing difficulties (dyspnoea), dyspepsia, and kidney stones (often characterised by sudden onset of severe, cramping pain in the lower back and/or side, groin, or abdomen).

Rare (may affect up to 1 in 1,000 people):
Systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs), tingling or numbness in the hands or feet, insomnia, nightmares, memory loss, worsening of objective and subjective symptoms of myasthenia (a muscle disorder), decreased libido, stroke, transient myopia which may resolve after discontinuation of the medicine, detachment following 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, hypotension, cardiac arrhythmia, changes in heart rhythm or rate, congestive heart failure (a heart condition characterised by breathlessness and swelling of the 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, swelling of the hands and feet or cold hands and feet, and poor circulation in the upper and lower limbs, leg muscle cramps and/or leg pain during 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, silvery-white rash (psoriasis-like rash), Peyronie's disease (which may lead to penile curvature), allergic reactions such as rash, urticaria, itching, and in rare cases, swelling of the 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 side effects similar to those observed after oral administration of beta-adrenergic blocking agents. Side effects occur less frequently after topical ocular administration than after systemic administration, such as oral or injectable routes.

Among the additional side effects listed above are reactions typical of the therapeutic class of beta-adrenergic blocking agents used in ophthalmic disorders.

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects 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
Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dorzolamidum + Timololum Stulln

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine for longer than 3 months after opening the aluminium sachet.
Dorzolamidum + Timololum Stulln does not contain a preservative. After opening, the contents of the single-dose container must be used immediately and must not be stored. Any solution remaining in the single-dose container after use should be discarded.
Do not use this medicine after the expiry date stated on the cardboard box, on the sachet, and on the single-dose container after: Expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package 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.

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. Each single-dose container contains 0.2 mL or 0.3 mL of solution.
Dorzolamidum + Timololum Stulln is available in packs containing 10, 20, 30, 50, 60, 100 or 120 single-dose containers.
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, contact the local representative of the Marketing Authorisation Holder:
Pharm Supply Sp. z o.o.
ul. Marconich 2/9
02-954 Warsaw
Tel. (+48) 22 6423331
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Dorzolamid + Timolol Stulln sine Austria
DORTIRUS France
Dorzocomp-Stulln sine Germany
DORZYLEA Greece
Dorzolamide + Timolol Stulln zonder conserveermiddel Netherlands
Dorzolamidum + Timololum Stulln Poland
Dorzolamida/Timolol Stulln PF Spain