Ketospray forte

Package leaflet: Information for the patient

Caution! Keep the 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 of the same medicinal product.
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

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

Table of contents of the leaflet:

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 a group of medicines called 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 a known 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 conditions such as: rashes or acne, skin infections or open wounds.
• Immediately discontinue use if skin reactions occur, including skin reactions following concomitant use of products containing octocrylene (octocrylene is an excipient 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 lacquers, 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 discontinuation of the medicine.

Warnings and precautions

• Exercise caution when using this medicine in patients with renal impairment, circulatory system failure or hepatic function disorders, as there is a risk of systemic adverse effects.
• If a rash or any skin reaction occurs after application of Ketospray Forte, treatment should be immediately discontinued and a doctor should be consulted.
• Do not apply under occlusive dressings (waterproof or air-impermeable), or to large areas of the body.
• Application, especially prolonged, of topically acting 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 overcast) or to UVA radiation in solariums may cause severe skin reactions (photosensitivity). Therefore, it is necessary to:
• protect treated skin areas by wearing appropriate 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 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 prone to allergic reactions after administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Do not apply to areas of skin affected by exudative lesions, eczema, ulceration or skin infection, or to areas with disrupted continuity, 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. from the gastrointestinal tract, nasal mucosa or genital tract), consult a doctor.

Children
The efficacy and safety of Ketospray Forte in children has 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 lowest 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 unknown whether the same risk applies to topical application of Ketospray Forte.
It is unknown whether ketoprofen passes into human breast milk. Therefore, the 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 propylene glycol
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 this medicine for longer than 7 days. If there is no improvement, consult a doctor.
The maximum daily dose is 18 sprays, equivalent to 360 mg of ketoprofen.

Instructions for use of the medicine:

• Hold the medicine bottle in an upright position.
• When using the spray 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 applicator. One press releases one dose of the medicine.
• Gently rub in the medicine and allow it to dry completely. Wipe the nozzle with a soft cloth after use to prevent clogging.
• Do not use this medicine near open flames.
• Wash hands thoroughly after application. Avoid contact with eyes, mucous membranes, and broken or damaged skin.

Overdose of Ketospray Forte
Overdose is unlikely due to the topical route of administration.
If an excessive dose is applied, wash the skin surface with water.
In case of accidental ingestion, systemic adverse effects may occur of varying severity depending on the amount ingested (e.g. pain, dizziness, vomiting, abdominal pain, drowsiness). Ingestion of large amounts may lead to respiratory depression, coma, seizures, gastrointestinal bleeding, elevated or decreased blood pressure, or acute kidney failure. There is no specific antidote available. In such cases, seek immediate medical attention from a doctor or pharmacist.

Missed dose of Ketospray Forte
If a dose is missed, apply the medicine as soon as possible, then continue with the regular dosing schedule.
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Ketospray Forte may cause adverse reactions, although not everyone experiences them.
Adverse reactions following topical application of ketoprofen occur uncommonly or rarely. These include allergic skin reactions, severe skin reactions induced 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, the use of the medicine is contraindicated.

• Uncommon (less than 1 in 100 people): redness, rash, itching, and burning sensation.
• Rare (less than 1 in 1000): photosensitivity reactions, urticaria, severe skin reactions such as bullous or acneiform eruptions, which may spread beyond the site of application 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 (affecting 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 symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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) 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

No special storage instructions are required.
Use within one year after first opening the container.
Keep out of sight and reach of children.
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 dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging 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 clear, colourless or slightly yellowish solution.
It is available in a 25 ml amber glass bottle with a dosing pump, packed in a cardboard box.

For further 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
Stălpii 12-14, Camera 09A, Etaj 1, Sector 5, Bucharest, Romania

Manufacturer:
Pharbil Waltrop GmbH
Im Wirrigen 25
D-45731 Waltrop
Germany

Temmler Italia S.R.L.
Via delle Industrie 2-20061 Carugate (MI)
Italy

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Romania, country of export: 12619/2019/02
Parallel Import Licence Number: 410/15