Nipas

Leaflet attached to the packaging: patient information

NIPAS

32 mg, tablets for dental use

Acetylsalicylic acid

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

This medicine should always be used exactly as described in this patient leaflet. Nipas is available without a prescription. The medicine is intended for use only by dental surgeons.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a doctor or pharmacist.
• 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.
• If there is no improvement or the patient feels worse, they should contact their dental surgeon.

Table of contents of the leaflet

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

1. What is Nipas and what is it used for

The active substance of Nipas is acetylsalicylic acid.
The medicine has anti-inflammatory, anti-edema, and analgesic effects.
Nipas is used in dentistry for the following indications

• dry socket (ASD) and periapical and diffuse alveolar abscess,
• conditions after the removal of small abscessed cysts,
• conditions after tooth drilling and damage to the alveolar socket after procedures.

2. Important information before using Nipas

When not to use Nipas

• if the patient is allergic to acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a bleeding disorder,
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting to use Nipas, the patient should discuss it with their dental surgeon.
Particular caution should be exercised in patients taking anticoagulant medicines.

Nipas and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Acetylsalicylic acid is an antagonist of vitamin K, weakening its effect and potentially causing hypoprothrombinemia, reducing blood clotting.
Nipas can be used in combination with antibiotics or sulfonamides.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Nipas should not be used in the third trimester of pregnancy. It should be used with caution in the first and second trimesters of pregnancy.
Breastfeeding
It is not recommended to breastfeed during long-term treatment with high doses of acetylsalicylic acid. Short-term use or single doses of the medicine do not pose a risk to the breastfed infant.

Driving and operating machinery

Nipas used as recommended does not affect psychophysical fitness, the ability to drive vehicles, or operate machinery.

Nipas contains propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

Nipas contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Nipas

Nipas is intended for use only by dental surgeons.
After initial rinsing of the alveolar socket with warm 3% sodium bicarbonate solution or 0.9% sodium chloride solution (physiological saline solution), without prior scraping, 1 to 3 tablets are placed in the alveolar socket. Then, the alveolar socket is covered with a tampon for 20 minutes. After this time, the tablets swell and dissolve, covering the nerve endings and protecting the alveolar socket walls from saliva.

4. Possible side effects

Like all medicines, Nipas can cause side effects, although not everybody gets them.
No side effects are known during local use of Nipas.
However, some people may experience side effects during treatment.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Nipas

Store at a temperature below 25°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. Patients should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Nipas contains

• The active substance of the medicine is acetylsalicylic acid 32 mg.
• The other ingredients are: lactose monohydrate 17 mg, propyl parahydroxybenzoate 3 mg, talc.

What Nipas looks like and what the packaging contains

Nipas is a white, flat, triangular tablet with rounded corners.
The medicine is available in a polypropylene container with a polyethylene lid, a tamper-evident seal, and a desiccant. The container contains 50 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
ul. Dożynkowa 10

• 52-311 Wrocław, Poland Phone: +48 71 71 06 201

Date of last update of the leaflet:28.10.2022