Ketospray forte

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If any of the side effects worsen, or if you experience any side effects not listed in this leaflet, including those not mentioned herein, inform your doctor or pharmacist. See section 4.

Table of Contents:

1. What Ketospray Forte is and what it is used for
2. Important information before using Ketospray Forte
3. How to use Ketospray Forte
4. Possible side effects
5. How to store Ketospray Forte
6. 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).
Ketospray Forte is indicated for 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 known hypersensitivity (allergy) 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 "Pregnancy and breastfeeding").
• Do not apply to areas of skin affected by pathological changes such as rash or acne, skin infections or open wounds.
• Immediately discontinue use if skin reactions occur, including skin reactions following concurrent use of products containing octocrylene (octocrylene is one of the excipients used in various cosmetics and hygiene products such as: shampoos, aftershaves, shower gels and bath products, 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 cloudy) and to UV radiation in solariums during treatment and for two weeks after discontinuation of the medicine.

Warnings and precautions

• Exercise caution when using this medicine in patients with renal impairment, circulatory failure or hepatic dysfunction, as systemic adverse effects may occur.
• If a rash or any skin reaction occurs after applying Ketospray Forte, treatment with this medicine should be stopped immediately and a doctor should be consulted.
• Do not apply under occlusive dressings (waterproof or air-impermeable) or over large body surface areas.
• Use, especially prolonged use, of topical medicines 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 cloudy) or to UVA radiation in solariums may cause serious 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 has a history of 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 susceptible to allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Do not apply to areas of skin with exudative lesions, eczema, ulceration or skin infection, or to areas with disrupted skin integrity, as well as 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. gastrointestinal, nasal 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, recently used, or planned for 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 smallest effective 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 not known whether the same risk applies when using Ketospray Forte topically on the skin.
It is not known whether ketoprofen passes into human breast milk. Therefore, use of Ketospray Forte is not recommended in breastfeeding women.

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

Ketospray Forte contains propylene glycol
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 15 years of age.
The usual dose is 3 to 6 sprays applied to the affected area, two to three times daily.
Do not use the medicine 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:

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

Use of more than the recommended dose of Ketospray Forte
Overdose is unlikely due to the topical route of administration.
If more than the 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 (headache, 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. In such cases, seek immediate medical advice from 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 your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Ketospray Forte can cause adverse reactions, although not everyone experiences them.
Adverse reactions following local application of ketoprofen occur uncommonly or rarely. These include allergic skin reactions, severe skin reactions caused by sunlight exposure, and respiratory tract 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): erythema, rash, itching, burning sensation.
• Rare (less than 1 in 1,000 people): photosensitivity reactions, urticaria, severe skin 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 treated, the degree of tissue absorption, 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 effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, 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

Keep this medicine out of the sight and reach of children.
Store in the outer packaging.
Use within one year after first opening the container.
Do not use Ketospray Forte after the expiry date stated on the packaging.
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 properly dispose of medicines no longer in use. This will help 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 ingredients are: propylene glycol, isopropyl alcohol, macrogol 15 hydroxystearate,
disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium hydroxide,
peppermint essential oil, purified water.

What Ketospray Forte looks like and contents of the pack
Ketospray Forte is a colourless to slightly yellowish, clear solution.
It is available in a 25 ml amber glass bottle with a dosing pump, in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, country of export:
G.T.S. SOLUTION SRL
Calea Rahovei, Nr. 266-268, Corp 3, Axele A-B 1/2, Stâlpii 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, 20061 Carugate, Italy

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in Romania, country of export: 12619/2019/02
Parallel import authorisation number: 759/15