Package leaflet: Information for the patient

NIPAS
32 mg, orodispersible tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before using the medicine, because
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 exclusively by dental practitioners.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your doctor or pharmacist.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse, contact the dentist.

Table of contents of the leaflet

What Nipas is and what it is used for
Important information before taking Nipas
How to take Nipas
Possible side effects
How to store Nipas
Contents of the pack and other information

1. What Nipas is and what it is used for

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

dry socket (alveolar osteitis) and apical and diffuse inflammation of the dental socket,
conditions following removal of small abscessed cysts,
conditions following tooth extractions and trauma to the dental socket after procedures.

2. Important information before using the medicine Nipas

When not to use the medicine Nipas

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

Warnings and precautions
Before starting to use the medicine Nipas, consult with a dentist.
Special caution is required in patients taking anticoagulant medicines.

Interaction of Nipas with other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Acetylsalicylic acid is a vitamin K antagonist, weakens its effect, and may cause hypoprothrombinemia, thereby reducing blood coagulation.
Nipas may be used in combination with antibiotics or sulfonamides.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use the medicine Nipas during the third trimester of pregnancy. Use with caution during the first and second trimesters of pregnancy.

Breastfeeding
Breastfeeding is not recommended 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
When used as directed, the medicine Nipas does not affect psychophysical performance, ability to drive vehicles, or operate machinery.

Nipas contains propyl parahydroxybenzoate
This medicine may cause allergic reactions (including delayed-type reactions).

Nipas contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Nipas

Nipas is intended for use only by dental practitioners.
After initial irrigation of the tooth socket with warm 3% sodium hydrogen carbonate solution or
0.9% sodium chloride solution (so-called physiological saline), and without prior curettage,
1 to 3 tablets are placed into the socket. The socket is then covered with a cotton pellet for 20 minutes.
During this time, the tablets swell and dissolve, covering the nerve endings and protecting the socket walls from exposure to saliva.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in all
individuals.
No adverse effects are known during local application of the medicinal product Nipas.
However, in some individuals adverse effects may occur during use of the product.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nipas

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

6. Contents of the packaging and other information

What Nipas contains

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

What Nipas looks like and contents of the pack
Nipas is a white, flat, triangular tablet with rounded corners.
The medicine is available in a polypropylene container with a polyethylene cap, tamper-evident seal, and desiccant. The container contains 50 tablets.

Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Dożynkowa 10
52 - 311 Wrocław
Poland
Tel.: +48 71 71 06 201