Ketoangin

Patient Information Leaflet

Ketoangin, 1 mg/ml, oral spray, solution
Ketoprofen
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 7 days, consult your doctor.

Contents of the leaflet

1. What Ketoangin is and what it is 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 Ketoangin is and what it is used for

Ketoangin contains the active substance ketoprofen in the form of ketoprofen lysine salt. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to relieve pain and inflammation.
Ketoangin is indicated for the symptomatic treatment of inflammatory conditions and irritation of the oral and pharyngeal mucosa associated with pain (e.g. gingivitis, stomatitis, pharyngitis), including those occurring after dental procedures: conservative treatments or extractions.
This medicine is intended for use in adults and adolescents aged above 15 years.

2. Important information before using Ketoangin

When not to use Ketoangin

• if the patient is allergic to ketoprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a respiratory disease called bronchial asthma;
• if the patient has previously experienced an allergic reaction after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), causing asthma attacks, breathing difficulties due to temporary narrowing of the airways (bronchospasm), or nasal polyps, cold-like symptoms (acute rhinitis), skin allergic reactions such as urticaria or swelling of the face around the eyes and lips, or tongue (angioedema);
• if the patient is pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Using this medicinal product, especially long-term, may lead to sensitization (increased response to subsequent doses of the same drug) or local irritation.
In such cases, treatment should be discontinued and medical advice sought; the doctor will determine appropriate management.
Inform a pharmacist or doctor if the patient has an infection – see the section below titled "Infections".
Do not use this medicine chronically.

Infections
Ketoangin may mask symptoms of infection such as fever and pain. Therefore, Ketoangin may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms of infection persist or worsen, immediate medical advice must be sought.

Children and adolescents
This medicine should not be used in children and adolescents under 15 years of age.

Ketoangin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Ketoangin should not be used during pregnancy or suspected pregnancy, or during breastfeeding.

Driving and operating machinery
There are no data on the effect of the medicine on the ability to drive or operate machinery.

Ketoangin contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).

Ketoangin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per sprayed dose, meaning the medicine is considered "sodium-free".

3. How to use Ketoangin

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for use in adults and adolescents aged above 15 years.
Instructions for use

• Hold the bottle upright and insert the applicator into the mouth.
• Direct the spray stream precisely onto the affected area.
• Press the pump to release the medicine.

The recommended dose is 1–2 sprays up to 3 times daily.
A single sprayed dose contains approximately 0.2 ml of solution, corresponding to 0.32 mg of ketoprofen lysine salt (0.2 mg ketoprofen).
Do not exceed the recommended dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If signs of infection (such as pain) persist or worsen, consult a doctor immediately (see section 2).
If there is no improvement within 7 days, or if the patient feels worse, contact a doctor.
Use of more than the recommended dose of Ketoangin
No cases of overdose have been reported with this medicine.
If more medicine has been used than recommended, contact a doctor or pharmacist.
In case of accidental swallowing or absorption of an excessive dose, seek medical advice immediately from a doctor or the nearest hospital.
Missed dose of Ketoangin
If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose.
Do not use a double dose to make up for a missed dose.
If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:
Very rare (may affect up to 1 in 10,000 patients):

• throat irritation;
• allergic symptoms such as swelling of the face, especially around the mouth and eyes, tongue or throat (angioedema); this occurs particularly in individuals allergic to non-steroidal anti-inflammatory drugs (NSAIDs).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
ul. Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ketoangin

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Use the medicine within 21 weeks after first opening the bottle. Discard unused medicine.
Medicines must 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 packaging and other information

What Ketoangin contains

• The active substance is ketoprofen in the form of ketoprofen lysine salt. 1 ml of oral aerosol contains 1 mg of ketoprofen, equivalent to 1.6 mg of ketoprofen lysine salt.
• The other components are: glycerol 85%, xylitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, monosodium phosphate monohydrate, poloxamer, mint flavour 987201/T13 (ethanol, peppermint oil, cornmint 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 amber glass, externally coated with PVC, fitted with a metering pump made of polyethylene and an oral applicator made of polypropylene, packed in a cardboard box.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +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