COSOPT iMulti 25 mg. 10 ml

What COSOPT iMulti is and what it is used for

COSOPT iMulti 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-blockers'.
These drugs reduce the pressure in the eyes in different ways.

COSOPT iMulti is prescribed to reduce intraocular pressure in the treatment of glaucoma when the beta-blocker drug used alone is not adequate.

COSOPT iMulti eye drops, solution is a sterile solution that does not contain a preservative.

2. What you need to know before using COSOPT iMulti

Do not use COSOPT iMulti

if you are allergic to dorzolamide hydrochloride, timolol or any of the other ingredients of this medicine (listed in section 6).
if you have or have had respiratory problems in the past, such as asthma or severe chronic obstructive bronchitis (severe white-faced disease that can cause shortness of breath, difficulty breathing and / or prolonged cough).
if you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeat)
if you have severe kidney disease or problems with a previous history of kidney stones.
if you have excessive acidity of the blood caused by the accumulation of chlorides in the blood (hyperchloraemic acidosis).
If you are not sure if you should use this medicine, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor before using COSOPT iMulti if you have or have had:

coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure.
heart rate disorders, such as slow heart rate.
breathing problems, asthma or chronic obstructive pulmonary disease.
poor circulatory disease (such as Raynaud's disease or Raynaud's syndrome).
Diabetes like timolol can mask the signs and symptoms of low blood sugar.
overactivity of the thyroid gland, as timolol may mask signs and symptoms.
any allergies or anaphylactic reactions
muscle weakness or diagnosed as myasthenia gravis
if you wear soft contact lenses, COSOPT iMulti has not been studied in patients wearing contact lenses.
If you have a history of contact hypersensitivity to silver, you should not use this medicine, as the dosed drops may contain traces of silver from the container.

Tell your doctor if you are about to have surgery that you are using COSOPT iMulti, as timolol may change the effect of some medicines used during anesthesia.

When COSOPT iMulti is placed in the eye it can affect the whole body.

Talk to your doctor if during treatment with COSOPT iMulti you:

you develop eye irritation or new eye problems such as redness of the eyes or swelling of the eyelids.
you suspect that COSOPT iMulti causes an allergic reaction or hypersensitivity (eg skin rash, severe skin reaction or redness and itching of the eye). Stop using this medicine and contact your doctor immediately.
you develop an eye infection, you develop visual disturbances, you are about to have eye surgery or you develop a reaction involving new or worsening symptoms.
Use in children
Experience with the use of COSOPT (containing preservative) in infants and children is limited.

Old age
In studies with COSOPT (containing a preservative), the effects were similar in young and elderly patients.

Use in patients with hepatic impairment
Tell your doctor if you have liver problems or if you have had any in the past
such.

Other medicines and COSOPT iMulti

COSOPT iMulti may or may not be affected by other medicines you may use, including other eye drops for the treatment of glaucoma. Tell your doctor if you use or intend to use medicines to lower blood pressure, medicines to treat heart disease or medicines to treat diabetes. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you:
you are taking medicines to lower your blood pressure or to treat heart disease (such as calcium antagonists, beta-blockers or digoxin).
you are taking medicines to treat abnormal or irregular heartbeat, such as calcium antagonists, beta-blockers or digoxin.
use other eye drops containing a beta-blocker.
you are taking another carbonic anhydrase inhibitor such as acetazolamide.
you are also taking a monoamine oxidase inhibitor (MAO inhibitors).
you are taking a parasympathomimetic, which may be prescribed to make urination easier. Parasympathomimetics are a type of medication that is sometimes used to restore normal bowel movements.
you are taking drugs such as
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.

Use during pregnancy
If you are pregnant, do not use COSOPT iMulti unless your doctor decides it is necessary.

Use during lactation
If you are breast-feeding, do not use COSOPT iMulti. Timolol may pass into your breast milk. If you are breast-feeding, talk to your doctor before taking any medicine.

Driving and using machines
The effects on the ability to drive and use machines have not been studied. There are side effects associated with the use of COSOPT iMulti, such as blurred vision, which may impair your ability to drive and use machines. Do not drive or use machines until you feel well or see clearly.

3. How to use COSOPT iMulti

Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist. The correct dosage and duration of treatment will be determined by your doctor.

The recommended dose is one drop in the affected eye (s) in the morning and evening.

If you use COSOPT iMulti at the same time as other eye drops, the drops should be applied at least 10 minutes apart.

Do not change the dose of the medicine without consulting your doctor.

If you have difficulty applying eye drops, seek help from a family member or caregiver.

Do not allow the multi-dose pack to touch the eye or the area around your eye. This can hurt your eye. It is also possible for your eye to become contaminated with bacteria, which can cause an infection with serious consequences, even loss of vision. To prevent possible contamination of the multi-dose package, wash your hands before using this medicine and avoid contact with the surface of the multi-dose package with any surface.

Instructions for use

Before instilling the eye drops:

Wash your hands before opening the bottle.
Do not use this medicine if you notice that the protective ring on the neck of the bottle is broken before using it for the first time.
When using the bottle for the first time, before using a drop in the eye, you should practice using the bottle by slowly squeezing one drop out.
When you are sure that you can place a drop, choose a position in which you feel most comfortable placing the drops (you can sit, lie on your back or face a mirror).
Each time you open a new bottle, drip one drop out to activate the bottle.
Drip:

1. Hold the bottle just below the cap and turn the cap to open the bottle. Do not touch anything with the top of the bottle to avoid contamination
solution.
2. Tilt your head back and hold the bottle over your eye.
3. Pull the lower eyelid and look up. Gently squeeze the bottle in the middle and drip one drop into the eye.
Note that there may be a few seconds delay between squeezing and releasing the drop. Do not squeeze too hard.
4. Close the eye and press its inner corner with your finger for about two minutes. This helps prevent the drop from reaching the rest of the body.
5. If your doctor has told you to instill a drop in the other eye, repeat instructions 2 - 4. Sometimes only one eye needs to be treated and your doctor will advise you if this applies to you and which eye needs to be treated.
6. After each use and before re-application, the bottle should be shaken once down without touching the tip of the dropper to remove residual liquid from it. This is necessary to ensure the release of subsequent drops.
7. Wipe off excess solution from the skin around the eye.
8. At the end of the shelf life of the drug of 2 months, there will be a small amount of COSOPT iMulti in the bottle. Do not try to use excess medicine left in the bottle after completing the course of treatment. Do not use eye drops for more than 2 months after first opening the bottle.

If you are not sure how to use your medicine, ask your doctor, pharmacist or nurse.

If you use more COSOPT iMulti than you should
If you put too many drops in your eyes or swallow any part of the contents of the package, along with other effects, you may feel dizzy, short of breath, slow heart rate.
Contact your doctor immediately.

If you forget to use COSOPT iMulti
It is important that you use COSOPT iMulti as prescribed by your doctor.
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue using your medicine as usual.
Do not take a double dose to make up for a forgotten dose.

If you stop using
Rare (may affect up to 1 in 10,000 people):

Effects on the eye: temporary myopia, which may disappear after stopping treatment, detachment of the layer under the retina containing the blood vessels, as a result of filtration surgery, which may cause visual disturbances, drooping eyelids (the eye appears half-closed), double vision, crusting of the eyelids, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye
Common side effects: palpitations, which may be rapid or irregular (palpitations), Raynaud's phenomenon, swelling or coldness of the hands and feet, restriction of blood flow to the limbs, leg cramps and / or pain in the legs when walking ( claudication), cough, throat irritation, dry mouth, insomnia, nightmares, memory loss, tingling or numbness of the hands or feet, worsening of the signs and symptoms of myasthenia gravis (muscle disease), decreased sexual desire, systemic lupus erythematosus immunological disease that can cause inflammation of the internal organs), tinnitus, rhinitis, nosebleeds, diarrhea, contact dermatitis, hair loss, silver-white skin rash (psoriasis rash), Peyronie's disease (which can cause twisting penis), allergic reactions such as rash, hives, itching, in rare cases -swelling of the lips, eyes and mouth, wheezing.
Like other medicines that are given to the eyes, timolol is absorbed into the bloodstream. This can cause side effects that are similar to those of oral beta-blockers. The frequency of side effects after topical application to the eyes is lower than when taking these drugs, for example, by mouth or when injecting them. The additional side effects listed include those seen in the class of beta-blockers used to treat eye conditions.
5. How to store COSOPT iMulti

Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.

Store below 25 ° C.

After first opening the bottle, the solution can be used within 2 months. The bottle should be kept tightly closed.

Do not use this medicine if you notice that the ring is broken before using the pack for the first time.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What COSOPT iMulti contains

The active substances are dorzolamide and timolol.
Each ml contains 20 mg dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg timolol maleate).

The other ingredients are hydroxyethylcellulose, mannitol, sodium citrate, sodium hydroxide and water for injections.
What COSOPT iMulti looks like and contents of the pack

KOSOPT iMulti is a clear, colorless to almost colorless, slightly viscous, without visible particles solution, placed in a white plastic bottle with a white applicator for Novelia dropper and a white plastic screw cap.

Packaging: 1, 2 or 3 bottles in a cardboard box

Not all pack sizes may be marketed.

 

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