Mova Nitrat Pipette

PATIENT LEAFLET: INFORMATION FOR THE USER

MOVA NITRAT PIPETTE, 10 mg/ml, eye drops, solution

(Silver nitrate)

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

• Keep this leaflet, you may need to read it again.
• In case of 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 any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Mova Nitrat Pipette and what is it used for
• 2. Important information before using Mova Nitrat Pipette
• 3. How to use Mova Nitrat Pipette
• 4. Possible side effects
• 5. How to store Mova Nitrat Pipette
• 6. Contents of the pack and other information

1. What is Mova Nitrat Pipette and what is it used for

Mova Nitrat Pipette contains silver nitrate as the active substance. The medicine is used to prevent infection of the anterior segment of the eye in newborns, especially those caused by Neisseriagonorrhoeae– gonococcal conjunctivitis (Crede's procedure) and infections caused by Chlamydia spp.and Staphylococcus spp.The procedure should be used in every newborn immediately after birth.

2. Important information before using Mova Nitrat Pipette

When not to use Mova Nitrat Pipette

Warnings and precautions

Before starting to use Mova Nitrat Pipette, discuss it with your doctor or pharmacist. With repeated application of Mova Nitrat Pipette, corneal damage leading to blindness may occur.

Mova Nitrat Pipette and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. No interactions.

Mova Nitrat Pipette with food and drink

Not applicable.

Pregnancy, breastfeeding, and fertility

Not applicable.

Driving and using machines

Not applicable.

Important information about some ingredients of Mova Nitrat Pipette

Not applicable.

3. How to use Mova Nitrat Pipette

This medicine should always be used exactly as advised by your doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. Instill one drop of Mova Nitrat Pipette into the conjunctival sac of each eye. Before use, remove the foil, take off the top cap, shake, and tear off the butterfly-shaped tip. Administer the medicine into the conjunctival sac of each eye by gently pressing the pipette, intended for single use.

Using more than the recommended dose of Mova Nitrat Pipette

In case of accidental instillation of more than one drop of Mova Nitrat Pipette into the conjunctival sac of the eye, symptoms of overdose may occur, such as redness and swelling of the eyelids. The treatment involves rinsing the eyes with distilled water. In case of doubts related to the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Silver nitrate eye drops cause conjunctival irritation in most children, lasting about 24 hours, but not leading to serious consequences. When administering 1% silver nitrate aqueous solution in doses multiple times higher than the recommended dose, corneal damage leading to blindness may occur. If any of the side effects get worse or if any side effects not listed in this leaflet occur, tell your doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring 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.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mova Nitrat Pipette

Store below 25°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mova Nitrat Pipette contains

• The active substance is silver nitrate.
• The other ingredients are: purified water.

What Mova Nitrat Pipette looks like and contents of the pack

Mova Nitrat Pipette eye drops are a colorless, clear solution. Aluminum foil sachets containing LDPE pipettes packed in a cardboard box. 5 or 10 sachets containing 10 pipettes each. Each pipette contains 5 mg of silver nitrate.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warsaw Tel: (22) 345 93 00

Manufacturer

Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany

Date of leaflet approval: April 2022