Miostat

Package Leaflet: Information for the User

Miostat

0.1 mg/ml, solution for intraocular administration
Carbachol chloride

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. 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 not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Miostat and what is it used for
• 2. Important information before using Miostat
• 3. How to use Miostat
• 4. Possible side effects
• 5. How to store Miostat
• 6. Package contents and other information

1. What is Miostat and what is it used for

Miostat is a medicine used by a doctor during eye surgery when immediate and complete constriction of the pupil is desired. Maximum constriction of the pupil usually occurs within a few minutes of administration. Miostat is used only during eye surgery.

2. Important information before using Miostat

When not to use Miostat

• -if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Miostat, discuss it with your doctor. Be particularly cautious and inform your doctor if the patient has any of the following conditions:

• Heart disease
• Asthma
• Urinary retention or difficulty urinating
• Stomach ulcers (peptic ulcers)
• Thyroid dysfunction
• Excessive intestinal motility
• Parkinson's disease
• Recent eye surgery. Using Miostat may exacerbate inflammation.
• Iritis (acute or chronic inflammation of the colored part of the eye).

Miostat and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take. Large doses of medicines like Miostat (strong cholinergic agonists) may enhance the effects of cardiac glycosides (such as digoxin) or alter the effects of certain muscle relaxants used during anesthesia.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Miostat may cause blurred vision and sensitivity to light. Do not drive or operate machinery until these symptoms have resolved.

The bottle stopper contains natural rubber (latex)

The bottle stopper contains natural rubber (latex), which may cause severe allergic reactions.

Miostat contains sodium and potassium

The medicine contains less than 1 mmol (23 mg) of sodium per 1.5 ml vial, which means it is considered "sodium-free". The medicine contains less than 1 mmol (39 mg) of potassium per dose, which means it is considered "potassium-free".

3. How to use Miostat

Miostat should be administered before eye surgery only by a doctor.

About 0.5 ml of Miostat is injected into the anterior chamber of the eye during surgery. The effect of Miostat may last up to 24 hours after eye surgery.

Using more Miostat than recommended

If a larger dose of Miostat is administered than recommended, the doctor may need to inject an anticholinergic medicine to counteract the symptoms of overdose. These symptoms may include: headache, increased salivation, fainting, slow heart rate, decreased blood pressure, abdominal cramps, vomiting, asthma, and diarrhea. If there are any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Miostat can cause side effects, although not everybody gets them. The following side effects have been observed with Miostat:
Uncommon side effects (may affect up to 1 in 100 people)

• Nervous system disorders: headache
• Eye disorders: increased intraocular pressure.

Additionally, the following side effects have been reported after the medicine was placed on the market, and their frequency cannot be estimated from the available data:

• Eye disorders: vision disturbances, corneal disorders, eye surface clouding, eye inflammation, corneal edema, decreased pupil size, blurred vision, eye pain, eye redness
• Gastrointestinal disorders: vomiting.

The following side effects may also occur:
Eye disorders:
Rarely:retinal detachment
Skin and subcutaneous tissue disorders:
Uncommon:excessive sweating
Renal and urinary disorders:
Uncommon:urinary urgency

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Miostat

Keep the medicine out of sight and reach of children. Store at a temperature below 30°C. Do not use this medicine after the expiry date stated on the carton and vial after: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Miostat contains

The active substance of Miostat is carbachol. 1 ml of solution contains 0.1 mg of carbachol (as carbachol chloride). The other ingredients are: sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium citrate dihydrate, sodium hydroxide, and (or) hydrochloric acid to adjust the pH, and water for injections.

What Miostat looks like and contents of the package

Miostat is available in PVC blister packs containing glass vials with a rubber stopper and aluminum cap, each containing 1.5 ml of a clear, colorless solution for intraocular administration.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Alcon Polska Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
Importer, where the batch is released:
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Alcon Polska Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel.: 22 820 34 50

Date of last revision of the leaflet: 07/2021