Dozholamidum+timololum Misom Labs

Leaflet accompanying the packaging: information for the user

Dorzolamidum+Timololum Misom Labs, 20 mg/mL + 5 mg/mL, eye drops, solution

Dorzolamidum + Timololum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dorzolamidum+Timololum Misom Labs and what is it used for
• 2. Important information 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 packaging and other information

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

Dorzolamidum+Timololum Misom Labs 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 blockers".

These medicines reduce intraocular pressure by two different mechanisms.
Dorzolamidum+Timololum Misom Labs is recommended for the treatment of glaucoma to reduce elevated intraocular pressure, when the use of eye drops containing only a beta-adrenergic receptor blocker is not sufficient.

2. Important information before using Dorzolamidum+Timololum Misom Labs

When not to use Dorzolamidum+Timololum Misom Labs

Warnings and precautions

Before starting to use Dorzolamidum+Timololum Misom Labs, discuss it with your doctor or pharmacist.
Tell your doctor about all current or past eye disorders and diseases:

• ischemic heart disease (symptoms include chest pain or feeling of pressure in the chest, shortness of breath or feeling of suffocation), heart failure, low blood pressure;
• heart rate disorders, such as slow heart rate;
• breathing difficulties, asthma, or chronic obstructive pulmonary disease;
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as timolol may mask the objective and subjective symptoms of hypoglycemia (low blood sugar);
• hyperthyroidism, as timolol may mask its objective and subjective symptoms.

Before surgery, inform the anesthesiologist about the use of Dorzolamidum+Timololum Misom Labs, as timolol may affect the action of certain anesthetics.
Also, tell your doctor about any allergies and allergic reactions, such as hives, facial swelling, lip swelling, tongue swelling, and/or throat swelling, which may cause breathing and swallowing difficulties.
Tell your doctor if you have experienced muscle weakness or been diagnosed with myasthenia gravis (Myasthenia gravis).
If you experience eye irritation or any new eye problems, such as eye redness or eyelid swelling, seek medical attention immediately.
If you suspect that Dorzolamidum+Timololum Misom Labs is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, eye redness, or itching), stop using the medicine and contact your doctor immediately.
Tell your doctor if you have an eye infection, have had eye trauma, have had eye surgery, or have experienced a reaction that involves the appearance of new or worsening symptoms.
After administering the medicine to the eye, Dorzolamidum+Timololum Misom Labs may have a systemic effect.

Children

Experience with the use of a medicine containing dorzolamide and timolol in infants and children is limited.

Elderly patients

In studies using a medicine containing dorzolamide and timolol, it caused similar effects in elderly and younger patients.

Patients with liver function disorders

Tell your doctor about any current or past liver diseases.

Dorzolamidum+Timololum Misom Labs and other medicines

Dorzolamidum+Timololum Misom Labs may affect other medicines you are taking, including other eye drops used to treat glaucoma. This also applies to other ophthalmic anti-glaucoma medicines. Tell your doctor about any medicines that lower blood pressure, heart medicines, or anti-diabetic medicines. Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken (including those available without a prescription), as well as any medicines you plan to take. This is especially important in the case of:

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

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 Dorzolamidum+Timololum Misom Labs during pregnancy, unless your doctor considers it necessary.
Do not use Dorzolamidum+Timololum Misom Labs during breastfeeding.
Timolol may pass into breast milk. Before taking any medicine during breastfeeding, consult your doctor.

Driving and operating machinery

No studies have been conducted on the effect on the ability to drive or operate machinery. Some side effects associated with the use of Dorzolamidum+Timololum Misom Labs, such as blurred vision, may affect the ability to drive 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 about 0.002 mg of benzalkonium chloride per drop, which corresponds to 0.075 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before administering the drops and wait at least 15 minutes before putting them back on.
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 abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Dorzolamidum+Timololum Misom Labs

Always use this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. Your doctor will determine the correct dose and duration of treatment.
Usually, one drop is instilled into the conjunctival sac of the affected eye(s) in the morning and evening.
If this medicine is used with other eye drops, the drops should be administered at intervals of at least 10 minutes.
Do not change the dose of the medicine without consulting your doctor.
Do not touch the tip of the dropper bottle to the eye or its surroundings. The medicine may become contaminated with bacteria, which can cause eye infection leading to serious damage to the eye, even vision loss. To avoid possible contamination of the container, wash your hands before using the medicine and avoid touching the dropper tip to any surface. If you think the medicine may have become contaminated or if you experience an eye infection, contact your doctor immediately regarding further use of the current packaging.

Instructions for use

Opening the container for the first time

• 1. Before first use, make sure the tamper-evident ring, which is located between the container and the cap, is not damaged (fig. 1).

• 2. Before opening the container for the first time, tear off 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, screw the cap back onto the container (fig. 4).

Using the eye drops

• 1. Before starting, wash your hands.
• 2. Hold the container with the tip pointing downwards, between your thumb and fingers.
• 3. Tilt your head back and gently pull the lower eyelid down to create a pocket between the eyelid and the eye. The drop should fall into this pocket (fig. 5).

• 4. Gently squeeze the base of the container to release one drop of Dorzolamidum+Timololum Misom Labs solution at a time. DO NOT TOUCH THE DROPPER TIP TO THE EYE, EYELID, EYE SURROUNDINGS, OR OTHER SURFACES. This may cause contamination of the remaining drops in the container (fig. 6).

• 5. Do not squeeze the container; it is designed to release a drop with a gentle pressure on the bottom (fig. 7).

• 6. Replace the cap, turning it until the container is properly closed.
• 7. After using Dorzolamidum+Timololum Misom Labs, press your finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This will help prevent the medicine from entering the rest of the body (fig. 8).

• 8. Close your eye for a moment and press your inner corner of the eye with your finger for about a minute. This will help prevent the drop from flowing out of the eye into the tear duct (fig. 9).

• 9. After using all the doses in the container, some medicine will remain. Do not worry, as extra medicine has been added, and you will receive the full amount of Dorzolamidum+Timololum Misom Labs prescribed by your doctor. Do not attempt to remove excess medicine from the container.

Using a higher dose of Dorzolamidum+Timololum Misom Labs than recommended

In case of administering too many drops or swallowing the contents of the bottle, among other symptoms, dizziness, breathing difficulties, or a feeling of slow heart rate may occur. Contact your doctor immediately.

Missing a dose of Dorzolamidum+Timololum Misom Labs

Take this medicine as directed by your doctor.
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose and return to your regular dosing schedule.
Do not take a double dose to make up for the missed dose.

Stopping the use of Dorzolamidum+Timololum Misom Labs

Before stopping this medicine, consult your doctor.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dorzolamidum+Timololum Misom Labs can cause side effects, although not everybody gets them.
Severe side effects:
If you experience any of the following side effects, stop using the medicine and seek medical attention immediately, as they may be symptoms of an allergic reaction to the medicine.
Generalized allergic reactions, including swelling under the skin, may occur in the face and limbs and cause respiratory tract obstruction and swallowing difficulties, shortness of breath, hives, or itching rash, local and generalized rash, itching, and severe, life-threatening allergic reaction.
During clinical trials or after the marketing of Dorzolamidum+Timololum Misom Labs, the following side effects have been reported in relation to it or one of its active substances:

• Burning or stinging sensation in the eye, change in taste sensation.

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

• Redness of the eyeball and skin around the eye (eye),
• tearing or itching of the eye (eye),
• corneal erosion (damage to the front layer of the eyeball),
• swelling and/or irritation of the eyeball and skin around the eye (eye),
• feeling of a foreign body in the eye,
• decreased corneal sensitivity (not feeling a foreign body in the eye and not feeling pain),
• eye pain,
• dry eye,
• blurred vision,
• headache, sinusitis (feeling of tension or fullness in the nose),
• malaise, nausea, weakness, and fatigue.

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

• Dizziness,
• depression,
• uveitis,
• vision disorders, including refractive changes (in some cases caused by discontinuation of medicines used to treat excessive constriction of the pupil),
• slow heart rate,
• fainting,
• breathing difficulties (shortness of breath),
• nausea,
• kidney stones.

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

• Systemic lupus erythematosus (an autoimmune disease that can 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,
• subretinal fluid accumulation after filtration surgery, which can cause vision disorders,
• ptosis (eyelids are half-closed),
• double vision,
• formation of crusts on the eyelids,
• corneal edema (with subjective vision disorders),
• low eye pressure,
• ringing in the ears,
• low blood pressure,
• changes in heart rhythm or rate,
• congestive heart failure (heart disease characterized by shortness of breath and swelling of the feet and legs due to fluid accumulation),
• edema (fluid accumulation),
• cerebral ischemia (reduced blood flow to the brain),
• chest pain,
• palpitations (faster and/or irregular heartbeat),
• heart attack,
• Raynaud's phenomenon, swelling of hands and feet, or cold hands and feet, and poor circulation in the upper and lower limbs,
• leg cramps and/or leg pain when walking (claudication),
• shortness of breath,
• respiratory failure,
• runny nose or stuffy nose,
• nosebleeds,
• bronchospasm (constriction of airways in the lungs, causing breathing difficulties),
• cough,
• throat irritation,
• dry mouth,
• diarrhea,
• contact dermatitis,
• hair loss,
• white-silver rash (psoriasiform rash),
• Peyronie's disease (which can cause penile curvature), allergic reactions, such as rash, hives, itching, and in rare cases, swelling of the lips, eyelids, and mouth,
• severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis.

As with other locally administered eye medicines, timolol is absorbed into the bloodstream, which can cause side effects similar to those observed after oral administration of beta-adrenergic receptor blockers. Side effects occur less frequently after local administration of eye drops than after oral administration or injections.
Among the additional side effects listed, reactions typical of the therapeutic group of beta-adrenergic blockers used in eye diseases are included.
Unknown (frequency cannot be estimated from available data):
Low blood sugar, heart failure, irregular heart rhythm, abdominal pain, vomiting, muscle pain unrelated to physical exertion, sexual function disorders, hallucinations, feeling of a foreign body in the eye (feeling that something is in the eye,

Reporting side effects

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

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 specified month.
Store below 30°C.
Dorzolamidum+Timololum Misom Labs can be used for 28 days after first opening the container.
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 packaging and other information

What Dorzolamidum+Timololum Misom Labs contains

• The active substances of the medicine are dorzolamide and timolol.
• Each milliliter of solution contains 20 mg of dorzolamide and 5 mg of timolol.
• One drop (about 0.04 mL) contains 0.8 mg of dorzolamide and 0.2 mg of timolol.
• Other ingredients are hydroxyethyl cellulose (E 467), mannitol (E 421), sodium citrate (E 331), sodium hydroxide (to adjust pH) (E 524), and water for injections. Benzalkonium chloride is added as a preservative.

What Dorzolamidum+Timololum Misom Labs looks like and contents of the packaging

Dorzolamidum+Timololum Misom Labs is a clear, colorless or almost colorless, slightly viscous solution, practically free from particles, available in a white container with a white nozzle and 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 authorization holder

Misom Labs Limited
84, St. Francis Street,
Balzan BZN 1424,
Malta
+356 7922 2799

Importer

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

Date of last revision of the leaflet