Dorzolamide+timolol misom labs

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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.

Table of contents

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

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

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

• Dorzolamide belongs to a group of medicines known as "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines known as "beta-blockers".

These medicines reduce intraocular pressure through two different mechanisms.
Dorzolamidum+Timololum Misom Labs is indicated in 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 Misom Labs

When not to use Dorzolamidum+Timololum Misom Labs

• 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 been diagnosed with respiratory disorders such as asthma or severe chronic obstructive pulmonary disease (a serious lung disease which may cause wheezing, difficulty breathing, 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 acidosis 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 Misom Labs, discuss it with your
doctor or pharmacist.
Inform your doctor about any current or past eye conditions or medical problems, including:

• 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);
• hyperthyroidism, because timolol may mask its signs and symptoms.

Before undergoing surgery, inform the attending physician that you are using Dorzolamidum+Timololum Misom Labs, as timolol may alter the effects of certain anesthetic drugs.
Also inform your doctor about any allergies or allergic reactions, including such conditions as urticaria, facial swelling, swelling of the lips, tongue, and/or throat, which may cause difficulty in 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 Misom Labs is causing an allergic reaction or hypersensitivity (e.g. skin rash, severe skin reaction, eye redness, or itching), 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 symptoms.
After administration into the eye, Dorzolamidum+Timololum Misom Labs may have effects on the whole body.

Children
Experience with the use of medicines containing dorzolamide and timolol in infants and children is limited.

Elderly patients
In clinical studies with a medicine containing dorzolamide and timolol, similar effects were observed in elderly and younger patients.

Patients with liver function disorders
Inform your doctor about any current or past liver diseases.

Dorzolamidum+Timololum Misom Labs and other medicines
Dorzolamidum+Timololum Misom Labs may interact with other medicines the patient is taking, including other eye drops used in glaucoma treatment. This also applies to other ophthalmic anti-glaucoma medicines. Inform your doctor if you are taking or plan to take medicines that lower blood pressure, heart medications, or antidiabetic drugs. Inform your doctor or pharmacist about all medicines currently or recently taken (including those available without a prescription), as well as any medicines the patient plans to use. This is particularly important if:

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

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Dorzolamidum+Timololum Misom Labs during pregnancy unless the doctor considers it necessary.
Do not use Dorzolamidum+Timololum Misom Labs during breastfeeding.
Timolol may pass into human milk. Consult a doctor before taking any medicine during breastfeeding.

Driving and operating machinery
No studies on the effect on the ability to drive or operate machinery have been conducted. Some adverse effects associated with the use of Dorzolamidum+Timololum Misom Labs, such as blurred vision, may affect the ability to drive and/or operate machinery. Until these symptoms have completely resolved, the patient should not drive or operate machinery.

Dorzolamidum+Timololum Misom Labs contains benzalkonium chloride
This medicine contains approximately 0.002 mg of benzalkonium chloride per drop, equivalent to 0.075 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Soft contact lenses should be removed before instillation and at least 15 minutes should elapse before reinserting them.
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 sensations in the eye, stinging, or eye pain occur after using the medicine, contact a doctor.

3. How to use Dorzolamidum+Timololum Misom Labs

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

Instructions for use
Opening the container for the first time

1. Before first use, check that the tamper-evident ring located between the container and the cap is intact (Fig. 1).

2. Before first opening, remove the tamper-evident ring to break the seal (Fig. 2).

3. To open the container, unscrew the cap by turning it counterclockwise (Fig. 3).

4. After each use, securely screw the cap back on (Fig. 4).

Using the eye drops

1. Wash your hands before starting.
2. Hold the container pointing downwards, between your thumb and fingers.
3. Tilt your head backwards and gently pull down the lower eyelid to form a pouch between the eyelid and the eye. The drop should be instilled into this pouch (Fig. 5).

4. Gently press the base of the container to release one drop of Dorzolamidum+Timololum Misom Labs solution at a time. DO NOT TOUCH THE EYE, EYELID, SURROUNDING AREAS OF THE EYE, OR ANY OTHER SURFACES WITH THE DROPPER TIP. This may contaminate the remaining drops in the container (Fig. 6).

5. Do not squeeze the container; it is designed so that gently pressing the bottom is sufficient (Fig. 7).

6. Replace the cap by screwing it on until the container is securely closed.
7. After using Dorzolamidum+Timololum Misom Labs, press a finger against the inner corner of the eye near the nose or close the eyelids for 2 minutes. This helps prevent the medicine from passing into the rest of the body (Fig. 8).

8. Close the eye briefly and press with a finger on the inner corner of the eye for about one minute. This helps prevent the drops from draining through the tear duct (Fig. 9).

9. After all doses have been used, some medicine will remain in the container. This is normal, as extra medicine has been added so that the patient receives the full amount of Dorzolamidum+Timololum Misom Labs prescribed by the doctor. Do not attempt to remove the excess medicine from the container.

Use of more than the recommended dose of Dorzolamidum+Timololum Misom Labs
If too many drops are instilled into the eye or if the contents of the bottle are swallowed, symptoms such as dizziness, difficulty breathing, or a sensation of slowed heart rate may occur. Seek immediate medical attention.

Missed dose of Dorzolamidum+Timololum Misom Labs
This medicine 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, 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 Misom Labs
Before discontinuing this medicine, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Dorzolamidum+Timololum Misom Labs may cause adverse effects,
although not everyone experiences them.
Serious adverse effects:
If any of the following adverse effects occur, stop using this
medicine and seek immediate medical help, as they may be symptoms of a drug reaction.
Generalised allergic reactions, including subcutaneous swelling, may occur in the facial area and
limbs and may cause airway obstruction and difficulty swallowing, dyspnoea,
urticaria or itchy rash, localised and generalised rash, pruritus, and severe, sudden and
life-threatening allergic reaction.
During clinical trials or after the marketing of Dorzolamidum+Timololum Misom
Labs, the following adverse effects have been reported related to it or to one of its active ingredients:
Very common (may affect more than 1 in 10 people):

• Burning and stinging sensation in the eye, altered taste perception.

Common (may affect up to 1 in 10 people):

• Redness of the eyeballs and skin around the eye(s)
• tearing or itching of the eye(s)
• corneal abrasions (damage to the front layer of the eyeball)
• swelling and/or irritation of the eyeballs and skin around the eye(s)
• sensation of a foreign body in the eye
• reduced corneal sensitivity (inability to feel a foreign body in the eye and absence of pain sensation)
• eye pain
• dry eyes
• blurred vision
• headache, sinusitis (feeling of pressure or fullness in the nose)
• malaise, nausea, fatigue and feeling of tiredness

Uncommon (may affect up to 1 in 100 people):

• Dizziness,
• depression,
• iritis,
• visual disturbances, including refractive changes (in some cases due to discontinuation of medicines used to treat excessive pupil constriction),
• bradycardia,
• fainting,
• breathing difficulties (dyspnoea),
• dyspepsia,
• nephrolithiasis

Rare (may affect up to 1 in 1,000 people):

• Systemic lupus erythematosus (an autoimmune disease which may cause inflammation of internal organs),
• tingling or numbness of 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,
• choroidal detachment following filtration surgery, which may cause visual disturbances,
• ptosis (eyelids half-closed),
• double vision,
• formation of scabs on the eyelids,
• corneal oedema (with subjective visual disturbances),
• low intraocular pressure,
• tinnitus,
• hypotension,
• changes in heart rhythm or 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,
• palpitations (faster and/or irregular heartbeat),
• heart attack,
• Raynaud's phenomenon, oedema of hands and feet or cold hands and feet and poor circulation in upper and lower limbs,
• leg muscle cramps and/or leg pain while walking (claudication),
• dyspnoea,
• respiratory failure,
• catarrh or blocked nose,
• nosebleeds,
• narrowing of the airways in the lungs causing breathing difficulties,
• 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, pruritus, 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, resulting in
adverse effects similar to those observed after oral administration of
beta-adrenergic blocking agents. Adverse effects occur less frequently after topical
ophthalmic administration than after oral or injectable administration of these medicines.
Among the additional adverse effects listed are reactions typical of the therapeutic class of beta-adrenergic blocking agents used in eye diseases.
Not known (frequency cannot be estimated from available data):
Low blood sugar levels, heart failure, cardiac arrhythmias, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual dysfunction, hallucinations, sensation of a foreign body in the eye (feeling that something is in the eye).
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Effects of Medicinal Products
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, more information on the safety of the medicine can be collected.
Adverse effects can also be reported to the responsible entity.

5. How to store Dorzolamidum+Timololum Misom Labs

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 container,
marked as EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Dorzolamidum+Timololum Misom Labs can be used for 28 days after first opening
the container.
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 pack and other information

What Dorzolamidum+Timololum Misom Labs contains

• The active substances in the medicine are dorzolamide and timolol.
• Each millilitre of solution contains 20 mg of dorzolamide and 5 mg of timolol.
• One drop (approximately 0.04 mL) contains 0.8 mg of dorzolamide and 0.2 mg of timolol.
• The other ingredients are hydroxyethylcellulose (E 467), mannitol (E 421), sodium citrate (E 331), sodium hydroxide (for pH adjustment) (E 524), and water for injections. Benzalkonium chloride is added as a preservative.

What Dorzolamidum+Timololum Misom Labs looks like and contents of the pack
Dorzolamidum+Timololum Misom Labs is a clear, colourless or almost colourless, slightly viscous solution practically free from particles, supplied in a white container with a white dropper insert and a blue cap. Each container contains 5 mL of solution. It is available in packs of 1 x 5 mL, 2 x 5 mL, 3 x 5 mL, 4 x 5 mL and 6 x 5 mL in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Brown & Burk IR Limited
22 Northumberland Road,
Ballsbridge, Dublin 4, Ireland

Importer
Eurofins Analytical Services Hungary Kft.
Anonymus u.6.,
1045 Budapest
Hungary