Ketoangin

Package Leaflet: Information for the Patient

KETOANGIN, 1 mg/ml, oral spray, solution
Ketoprofen

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse after 7 days, consult your doctor.

Table of Contents of the Leaflet:

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

1. What is KETOANGIN and what is it used for

KETOANGIN contains the active substance ketoprofen in the form of ketoprofen lysinate. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to relieve pain and inflammation.
KETOANGIN is used to treat symptomatic inflammatory conditions and irritation of the oral mucosa and throat with accompanying pain (e.g., gingivitis, oral mucositis, pharyngitis), also resulting from dental procedures: conservative or involving extraction.

2. Important information before using KETOANGIN

When not to use KETOANGIN

• if you are allergic to ketoprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if you have had a respiratory disease called bronchial asthma;
• if you have had an allergic reaction after using acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), causing: asthma attacks, breathing difficulties due to temporary bronchospasm, or nasal polyps, common cold (acute rhinitis), allergic skin reactions, such as: hives or facial swelling around the eyes and lips, tongue (angioedema);
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Using this medicinal product, especially for a long time, may lead to sensitization (increased response to subsequent administrations of the same dose of the medicine) or local irritation.
In such cases, you should stop using the medicine and consult a doctor who will determine the appropriate treatment.
You should inform your pharmacist or doctor if you have an infection - see below, the section titled "Infections".
You should not use this medicine for a long time.

Infections

KETOANGIN may mask the symptoms of an infection, such as fever and pain. Therefore, KETOANGIN may delay the use of appropriate infection treatment, and consequently, lead to an increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection, and the symptoms of the infection persist or worsen, you should consult a doctor immediately.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

KETOANGIN and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use KETOANGIN during pregnancy or breastfeeding.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

KETOANGIN contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

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

KETOANGIN contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per actuated dose, i.e., the medicine is considered "sodium-free".

3. How to use KETOANGIN

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The medicine is intended for use in adults.

Instructions for use

• Hold the bottle and insert the applicator into the mouth.
• Aim the spray directly at the affected area.
• Press the actuator to release the medicine.

The recommended dose is 1-2 doses of the medicine up to 3 times a day.
A single actuated dose contains approximately 0.2 ml of solution, which corresponds to 0.32 mg of ketoprofen lysinate (0.2 mg of ketoprofen).
Do not exceed the recommended dose.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms.
If the symptoms of an infection (such as pain) persist or worsen, consult a doctor immediately (see section 2).
If there is no improvement or you feel worse after 7 days, consult your doctor.

Using a higher dose of KETOANGIN than recommended

No cases of overdose have been reported during the use of this medicine.
If you use a higher dose than recommended, consult your doctor or pharmacist.
In case of accidental ingestion/absorption of an excessive dose of this medicine, inform your doctor or consult the nearest hospital immediately.

Missing a dose of KETOANGIN

If you forget to use a dose, do so as soon as you remember, unless it is almost time for the next dose.
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very rare(may affect up to 1 in 10,000 people):

• throat irritation;
• allergic symptoms, such as facial swelling, especially around the mouth and eyes, tongue, or throat (angioedema); this occurs especially in people allergic to nonsteroidal anti-inflammatory drugs (NSAIDs).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
ul. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KETOANGIN

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Use the medicine within 21 weeks of first opening the bottle. Dispose of any unused medicine.
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 KETOANGIN contains

• The active substance is ketoprofen in the form of ketoprofen lysinate. 1 ml of oral spray contains 1 mg of ketoprofen, which corresponds to 1.6 mg of ketoprofen lysinate.
• The other ingredients are: glycerol 85%, xylitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium phosphate anhydrous, poloxamer, peppermint flavor 987201/T13 (ethanol, peppermint oil, spearmint oil, menthol), purified water.

What KETOANGIN looks like and contents of the pack

KETOANGIN is a solution. One bottle contains 15 ml of solution.
The bottle is made of orange glass, coated with PVC on the outside, equipped with a polyethylene metering pump and a polypropylene oral applicator, in a cardboard box.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
phone: +48 22 732 77 00

Manufacturer

Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore
Italy
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

Date of last revision of the leaflet: