PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Ketospray Forte (KETOSpray)
100 mg/ml, cutaneous spray, solution
Ketoprofenum
Ketospray Forte and KETOSpray are different trade names of the same medicinal product.
Please read the leaflet carefully before using the medicine, as it contains information
important for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If any of the adverse effects worsen, or if you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Ketospray Forte is and what it is used for
Important information before using Ketospray Forte
How to use Ketospray Forte
Possible side effects
How to store Ketospray Forte
Contents of the pack and other information

1. What Ketospray Forte is and what it is used for

Ketospray Forte contains the active substance ketoprofen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
The indication for use of Ketospray Forte is local, symptomatic treatment of pain and inflammation of soft tissues (including following dislocations, sprains and contusions).

2. Important information before using Ketospray Forte

When not to use Ketospray Forte

If the patient has a known allergy (hypersensitivity) to ketoprofen, tiaprofenic acid, fenofibrate, UV filters, perfumes, or to any of the other ingredients of this medicine (listed in section 6).
If the patient has ever experienced an allergic reaction to acetylsalicylic acid and (or) to any other NSAID (e.g. asthma, allergic rhinitis).
During the last three months of pregnancy (see section on pregnancy and breastfeeding).
Do not apply to areas of skin affected by pathological changes such as rash or acne, skin infection, or open wounds.
Immediately discontinue use if skin reactions occur, including skin reactions following concomitant use of products containing octocrylene (octocrylene is one of the excipients used in various cosmetics and hygiene products such as: shampoos, after-shave products, shower gels and bath preparations, skin creams, lipsticks, anti-wrinkle creams, make-up removers, hair sprays, to delay photodegradation).
Avoid exposing treated skin areas to sunlight (even when the sky is overcast) and to UV radiation in solariums during treatment and for two weeks after stopping the medicine.

Warnings and precautions

Exercise caution when using this medicine in patients with renal impairment, circulatory system failure, or hepatic function disorders, as systemic adverse effects may occur.
If a rash or any skin reaction occurs after applying Ketospray Forte, treatment should be immediately discontinued and a doctor should be consulted.
Do not use under occlusive dressings (waterproof or air-impermeable) or on large areas of the body.
The use of topical medicines, especially prolonged use, may cause allergic reactions, particularly during periods of intense sun exposure.
Do not exceed the recommended duration of treatment due to increased risk of skin inflammation and photosensitivity reactions.
Exposure of skin areas treated with Ketospray Forte to sunlight (even when the sky is overcast) or to UVA radiation in solariums may cause severe skin reactions (photosensitivity). Therefore, it is essential to:
- protect treated skin areas by wearing clothing during treatment and for two weeks after its completion, to avoid the risk of photosensitivity;
- thoroughly wash hands after each application of Ketospray Forte.
If the patient suffers from bronchial asthma or allergies, Ketospray Forte should be used under strict medical supervision. Patients with asthma associated with chronic sinusitis and (or) nasal polyps are particularly at risk of allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Do not apply to areas of skin affected by exudative lesions, eczema, ulceration, skin infection, or skin discontinuity, and do not apply to mucous membranes (oral cavity, genital or anal areas), eyes, or ears.
If the patient has a tendency to bleeding or active bleeding (e.g. from the gastrointestinal tract, nasal mucosa, or genital tract), consult a doctor.

Children
The efficacy and safety of Ketospray Forte in children have not been established. Ketospray Forte should not be used in children under 15 years of age.

Ketospray Forte and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines you plan to use.
Drug interactions between Ketospray Forte, applied topically to the skin, and other medicines are unlikely because the plasma concentration of ketoprofen after topical application is very low.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Ketospray Forte must not be used in women during the last three months of pregnancy (third trimester).
During the first six months of pregnancy (first and second trimesters), the medicine should not be used unless the physician considers its use absolutely necessary. If treatment is required during this period, the lowest possible dose for the shortest possible duration is recommended.
The medicine should be used with caution and only when strictly necessary.
Oral formulations (e.g. tablets) containing ketoprofen may cause adverse effects in the unborn child. It is unknown whether the same risk applies to topical application of Ketospray Forte.
It is unknown whether ketoprofen passes into breast milk. Therefore, use of Ketospray Forte is not recommended in breastfeeding women.

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

Ketospray Forte contains:
100 mg of propylene glycol in 1 ml of solution. Propylene glycol may cause skin irritation.

3. How to use Ketospray Forte

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Ketospray Forte is intended for use in adults and children over the age of 15.
The usual dose is 3 to 6 sprays applied to the affected area, two to three times daily.
This medicine should not be used for longer than 7 days. If there is no improvement, consult a doctor.
The maximum daily dose is 18 sprays, corresponding to 360 mg of ketoprofen.
Instructions for use of the medicine:

Hold the medicine bottle in an upright position.
When using the medicine for the first time, press the dosing pump 3 to 4 times to prime the dispenser and ensure proper spray function.
Direct the spray nozzle toward the affected area and press the plunger. One press releases one dose of the medicine.
Gently rub the medicine into the skin and allow it to dry completely. Wipe the pump nozzle gently with a soft cloth after use to prevent clogging.
Do not use the medicine near open flames.
Wash hands thoroughly after application. Avoid contact with eyes, mucous membranes, and broken or damaged skin.

Use of a higher than recommended dose of Ketospray Forte
Overdose is unlikely due to the topical route of administration.
If a larger than recommended dose is applied, wash the skin area with water.
In case of accidental ingestion, systemic adverse effects of varying severity may occur, depending on the amount ingested (e.g. pain, dizziness, vomiting, abdominal pain, drowsiness). Ingestion of large amounts may lead to respiratory depression, coma, convulsions, gastrointestinal bleeding, elevated or lowered blood pressure, or acute kidney failure. There is no specific antidote available. In such cases, seek immediate medical attention or contact a doctor or pharmacist.
Missed dose of Ketospray Forte
If a dose is missed, apply the medicine as soon as possible, then continue according to the regular dosing schedule.
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Ketospray Forte can cause adverse reactions, although not everyone will experience them.
Adverse reactions following local application of ketoprofen occur uncommonly or rarely.
These include allergic skin reactions, severe skin reactions caused by exposure to sunlight, and respiratory reactions (there is a possibility of asthma attack, particularly in individuals hypersensitive to acetylsalicylic acid and/or other non-steroidal anti-inflammatory drugs). In such cases, use of the medicine is contraindicated.

Uncommon (less than 1 in 100 people): redness, rash, itching, burning sensation.
Rare (less than 1 in 1,000 people): photosensitivity reactions, urticaria, severe reactions such as bullous or acneiform eruptions, which may spread beyond the application site or present as generalized reactions.
Very rare (less than 1 in 10,000 people): cases of exacerbation of chronic renal failure.
Frequency not known (cannot be estimated from available data): anaphylactic shock (immediate allergic reaction), angioedema (severe allergic reaction causing swelling of the face or throat), hypersensitivity reactions.

Other possible adverse effects (involving the gastrointestinal tract and kidneys) result from the penetration of the active substance through the skin and therefore depend on: the dose of ketoprofen applied, the skin surface area, the degree of tissue absorption, the duration of treatment, and whether or not an occlusive dressing is used. Other adverse reactions may occur in some individuals during treatment with Ketospray Forte.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ketospray Forte.

Store in the outer packaging.
Use within 1 year after first opening.
Keep 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 month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the package and other information

What Ketospray Forte contains
The active substance in Ketospray Forte is ketoprofen.
1 ml of the medicinal product contains 100 mg of ketoprofen.
1 dose from the dispenser (0.2 ml) contains 20 mg of ketoprofen.
Other components of the medicinal product are: propylene glycol, isopropyl alcohol, macrogol 15 hydroxystearate,
disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium hydroxide, peppermint oil, purified water.

What Ketospray Forte looks like and contents of the pack
Ketospray Forte is a colourless to slightly yellowish, clear solution.
30 ml amber glass bottle equipped with a metering pump, in a cardboard carton.

For further detailed information, please contact the Marketing Authorisation Holder or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
G.T.S. SOLUTION SRL
Calea Rahovei, Nr. 266-268, Corp 3, Axele A-B 1/2
Stălpii 12-14, Camera 09A, Etaj 1, Sector 5
Bucharest, Romania

Manufacturer:
PHARBIL WALTROP GmbH
Im Wirrigen 25
45731 Waltrop
Germany
TEMMLER ITALIA S.R.L.
Via delle Industrie 2, Carugate
20061 Italy

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Number of Marketing Authorisation in Romania, country of export: 12619/2019/02
Number of parallel import authorisation: 176/21