Dozholamid + Timolol Misom

Leaflet accompanying the packaging: information for the user

Dorzolamid+Timolol Misom, 20 mg/mL + 5 mg/mL, eye drops, solution in a container

single-dose
Dorzolamidum + Timololum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dorzolamid+Timolol Misom and what is it used for
• 2. Important information before using Dorzolamid+Timolol Misom
• 3. How to use Dorzolamid+Timolol Misom
• 4. Possible side effects
• 5. How to store Dorzolamid+Timolol Misom
• 6. Contents of the packaging and other information

1. What is Dorzolamid+Timolol Misom and what is it used for

Dorzolamid+Timolol Misom contains two active substances: dorzolamid and timolol.

• Dorzolamid 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 through two different mechanisms.
Dorzolamid+Timolol Misom 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 Dorzolamid+Timolol Misom

When not to use Dorzolamid+Timolol Misom

• if the patient is allergic to dorzolamid hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6).
• if the patient currently or in the past has had respiratory system disorders, such as asthma or severe chronic obstructive pulmonary disease (severe lung disease that may cause wheezing, breathing difficulties and/or prolonged coughing),
• if the patient has a slow heart rate, heart failure or heart rhythm disorders (irregular heartbeat),
• if the patient has severe kidney disease or severe kidney function disorders or a history of kidney stones,
• if the patient has excessive acidification of the blood due to the accumulation of chloride ions in the body (hyperchloremic acidosis). In case of doubt, whether this medicine can be used, you should consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Dorzolamid+Timolol Misom, you should discuss it with your doctor or pharmacist.
You should inform your doctor about all current or past eye disorders and diseases:

• ischemic heart disease (its symptoms include, among others, chest pain or a feeling of pressure in the chest, shortness of breath or a 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 levels);
• hyperthyroidism, as timolol may mask its objective and subjective symptoms.

Before surgery, you should inform your doctor about the use of Dorzolamid+Timolol Misom, as timolol may change the effect of some anesthetics.
You should also tell your doctor about any allergies and allergic reactions, including those such as hives, facial swelling, lip swelling, tongue and/or throat swelling, which can cause breathing and swallowing difficulties.
You should inform your doctor if you have experienced muscle weakness or been diagnosed with myasthenia (Myasthenia gravis).
In case of eye irritation or any new eye problems, such as eye redness or eyelid swelling, you should see a doctor immediately.
If you suspect that Dorzolamid+Timolol Misom is causing an allergic reaction or hypersensitivity (e.g. skin rash, severe skin reaction, eye redness or itching), you should stop using this medicine and contact your doctor immediately.
You should inform your doctor in case of eye infection, eye injury, eye surgery or a reaction that is accompanied by the appearance of new or worsening of existing symptoms.
After administration to the eye, Dorzolamid+Timolol Misom may have a systemic effect.

Children

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

Elderly patients

In studies using a medicine containing dorzolamid and timolol, it caused similar effects in older and younger people.

Patients with liver function disorders

You should inform your doctor about any current or past liver diseases.

Dorzolamid+Timolol Misom and other medicines

Dorzolamid+Timolol Misom may affect other medicines you are taking, including other eye drops used to treat glaucoma. This also applies to other anti-glaucoma eye medicines.
You should tell your doctor about taking or planning to take blood pressure-lowering medicines, heart medicines or anti-diabetic medicines. You should 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 medicines you plan to use. This is especially important in the case of:

• taking medicines that lower blood pressure or are used to treat heart diseases (such as calcium channel blockers, beta-adrenergic receptor blockers or digoxin);
• taking medicines used to treat heart rhythm disorders or 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 medicines with a parasympathomimetic effect, which may be used to treat urination disorders. Parasympathomimetic medicines are also sometimes used to restore normal motility (mobility) of the intestines;
• taking narcotics, such as morphine, used to treat moderate or 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, you should consult your doctor or pharmacist before using this medicine.

Use during pregnancy

Dorzolamid+Timolol Misom should not be used during pregnancy, unless your doctor considers it necessary.

Use during breastfeeding

Dorzolamid+Timolol Misom should not be used during breastfeeding. Timolol may pass into breast milk. Before taking any medicine during breastfeeding, you should consult your doctor.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines. Some side effects associated with the use of Dorzolamid+Timolol Misom, such as blurred vision, may affect the ability to drive and/or use machines. Until these symptoms have completely resolved, the patient should not drive or use machines.

3. How to use Dorzolamid+Timolol Misom

This medicine should always be used as directed by your doctor. In case of doubts, you should consult your doctor or pharmacist. The doctor determines the correct dose of the medicine and the duration of treatment.
The recommended dose is one drop into 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.
The dose of the medicine should not be changed without consulting a doctor.
In case of difficulties with the administration of the drops, you should ask a family member or caregiver for help.
No part of the container should come into contact with the eye or its surroundings. This can lead to eye damage. It can also lead to bacterial contamination, which can cause eye infection leading to serious damage to the eye and even vision loss. To avoid possible contamination of the single-dose container, you should wash your hands before using this medicine and avoid touching the tip of the dropper with any surface.
A new single-dose container should be opened directly before each use; each container contains a sufficient amount of solution for both eyes, if your doctor has prescribed the use of drops in both eyes. The opened container with the remaining contents should be discarded immediately after use.

Instructions for use

Open the foil sachet containing single-dose containers. Record the date of first opening on the sachet.
Each time you use Dorzolamid+Timolol Misom

• 1. Wash your hands
• 2. Remove the strip with containers from the sachet
• 3. Separate one single-dose container from the strip.
• 4. Put the strip with the remaining containers back in the sachet and fold the edge to close the sachet.
• 5. To open the container, twist the tip. (Figure A)
• 6. Hold the container between your thumb and index finger. Remember that the container tip should not protrude more than 5 mm above the edge of your index finger. (Figure B)
• 7. Tilt your head back or lie down. Place your hand on your forehead. Your index finger should be in line with your eyebrow or rest on the bridge of your nose. Look up. Pull the lower eyelid down with your other hand. Do not let any part of the container touch your eye or its surroundings. Gently squeeze the container to let one drop fall into the space between the eyelid and the eye (Figure C). Do not blink while administering the drop. Each single-dose container contains a sufficient amount of solution for both eyes.
• 8. Close your eye and press the inner corner of your eye with your finger for about two minutes. This will help prevent the medicine from entering the entire body (Figure D).
• 9. Wipe off any excess solution from the skin around your eye.

If your doctor has prescribed the use of drops in both eyes, you should repeat steps 7 to 9 for the second eye.
After administering the drop to the eye(s), you should discard the used single-dose container, even if there is still solution left in it, to avoid contamination of the preservative-free solution.
The remaining containers should be stored in the foil sachet; the remaining containers can be used within 15 days of opening the sachet. If there are any containers left after 15 days from opening the sachet, you should safely discard them and open a new sachet. It is essential to continue using the eye drops as directed by your doctor.
In case of doubts about how to administer the medicine, you should ask your doctor, pharmacist or nurse.

Using a higher dose of Dorzolamid+Timolol Misom than recommended

In case of administration of too many drops or ingestion of the contents of the bottle, among other symptoms, dizziness, breathing difficulties or a feeling of slow heart rate may occur. You should contact your doctor immediately.

Missing a dose of Dorzolamid+Timolol Misom

This medicine should be taken as directed by your doctor.
In case of missing a dose, you should take it as soon as possible. However, if there is not much time left before the next dose, you should not take the missed dose and return to the regular dosing schedule.
You should not take a double dose to make up for the missed dose.

Stopping the use of Dorzolamid+Timolol Misom

Before stopping this medicine, you should consult your doctor.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dorzolamid+Timolol Misom can cause side effects, although not everybody gets them.
Serious side effects:
If you experience any of the following side effects, you should stop using this medicine and seek medical help 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, sudden and life-threatening allergic reaction.
During clinical trials or after the marketing of the eye drop solution containing dorzolamid and timolol, the following side effects have been reported in relation to it or one of its active substances:
Very common (may affect more than 1 in 10 people) :

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

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 erosion (damage to the front layer of the eyeball)
• swelling and/or irritation of the eyeballs and skin around the eye(s)
• feeling of a foreign body in the eye
• decreased sensitivity of the cornea (not feeling a foreign body in the eye and not feeling pain)
• eye pain
• dry eyes
• 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 the withdrawal of medicines used to treat excessive constriction of the eye pupil),
• slow heart rate,
• fainting,
• breathing difficulties (shortness of breath),
• indigestion,
• 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 the hands or feet,
• insomnia,
• nightmares,
• memory loss,
• worsening of the symptoms of myasthenia (muscle disorder),
• decreased libido,
• stroke,
• transient myopia which may resolve after withdrawal of the medicine,
• choroidal detachment 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 symptoms of 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 the hands and feet or cold hands and feet and impaired circulation in the upper and lower limbs,
• muscle cramps in the legs and/or leg pain when walking (claudication),
• shortness of breath,
• respiratory failure,
• runny nose or stuffy nose,
• nosebleeds,
• bronchospasm (constriction of the airways in the lungs, causing breathing difficulties),
• cough,
• throat irritation,
• dry mouth,
• diarrhea,
• contact dermatitis,
• hair loss,
• white-silver rash (psoriasis-like rash),
• Peyronie's disease (which can cause penis curvature), allergic reactions, such as rash, hives, itching, in rare cases also swelling of the lips, eyelids and mouth,
• wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

As with other 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 the use of eye drops locally than after oral administration or injections of these medicines.
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 the available data):
Low blood sugar levels, heart failure, heart rhythm disorders, 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, 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.
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 Dorzolamid+Timolol Misom

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, sachet and single-dose container, marked as EXP. The first two digits indicate the month, the next four digits indicate the year. The expiry date indicates the last day of the specified month.
Store in a temperature below 25°C.
Store single-dose containers in the original foil sachet to protect from light.
The shelf life of unopened single-dose containers of Dorzolamid + Timolol Misom is 15 days after the first opening of the sachet.
After this time, you should discard all unused single-dose containers.
After opening a single-dose container, use it immediately and discard the container with the remaining solution directly after the first use.
Medicines should not be disposed of via wastewater or household waste. You should 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 Dorzolamid+Timolol Misom contains

• The active substances of the medicine are dorzolamid and timolol.
• Each milliliter of solution contains 20 mg of dorzolamid (as 22.26 mg of dorzolamid hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate)
• The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide (to adjust pH) and water for injections.

What Dorzolamid+Timolol Misom looks like and contents of the packaging

Dorzolamid+Timolol Misom is a clear, colorless, slightly viscous solution.
Each foil sachet contains 15 or 10 single-dose containers made of low-density polyethylene, containing 0.2 ml of solution.
Pack sizes:
10 x 0.2 ml (1 sachet containing 10 single-dose containers)
15 x 0.2 ml (1 sachet containing 15 single-dose containers)
30 x 0.2 ml (2 sachets containing 15 single-dose containers or 3 foil sachets containing 10 single-dose containers)
50 x 0.2 ml (5 sachets containing 10 single-dose containers)
60 x 0.2 ml (4 sachets containing 15 single-dose containers or 6 sachets containing 10 single-dose containers)
90 x 0.2 ml (6 sachets containing 15 single-dose containers or 9 sachets containing 10 single-dose containers)
100 x 0.2 ml (10 sachets containing 10 single-dose containers)
120 x 0.2 ml (8 sachets containing 15 single-dose containers or 12 sachets containing 10 single-dose containers).
Not all pack sizes may be marketed.

Marketing authorization holder

Misom Labs Limited
Malta Life Sciences Park,
LS2.01.06, Industrial Estate,
San Gwann, SGN 3000, Malta.
+356 7922 2799

Importer

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

Date of last revision of the leaflet