Ketosprai Forte

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Ketospray Forte(KETOSpray)

100 mg/ml, spray for the skin, solution

Ketoprofen
Ketospray Forte and KETOSpray are different trade names for the same medicine.

You should read the leaflet carefully before using the medicine because it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ketospray Forte and what is it 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 packaging and other information

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

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

2. Important information before using Ketospray Forte

When not to use Ketospray Forte

• If the patient has been diagnosed with hypersensitivity (allergy) to ketoprofen, tiaprofenic acid, fenofibrate, UV filters, perfumes, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had an allergic reaction to acetylsalicylic acid and/or any other NSAID (e.g., asthma, allergic rhinitis).
• In the last three months of pregnancy (see section on pregnancy and breastfeeding).
• Do not use on areas of skin with pathological changes, such as: rash or acne, skin infection, or open wounds.
• Stop using the medicine immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (octocrylene is one of the auxiliary substances used in various cosmetics and hygiene products such as shampoos, aftershave products, shower gels and bath products, skin creams, lip balms, anti-wrinkle creams, makeup removers, hair lacquers, to delay breakdown under the influence of light).
• Avoid exposing the treated skin area to sunlight (even on cloudy days) and UV rays in solariums during treatment and for two weeks after stopping the medicine.

Warnings and precautions

• Caution should be exercised if the medicine is used in patients with renal, cardiovascular, or liver function disorders, as there is a possibility of systemic side effects.
• In case of rash or any skin reactions after using Ketospray Forte, treatment with this medicine should be stopped immediately and a doctor should be consulted.
• The medicine should not be used under occlusive dressings (waterproof or non-permeable to air) and on large areas of the body.
• The use of topical medicines, especially long-term, may cause an allergic reaction, especially during intense sun exposure.
• Do not exceed the recommended treatment time due to the increased risk of skin inflammation and sensitivity to sunlight.
• Exposing areas of skin where Ketospray Forte has been applied to sunlight (even on cloudy days) or UVA rays in solariums may cause severe skin reactions (sunlight sensitivity). Therefore, it is necessary:
• to protect the treated skin areas by wearing clothing during treatment and for two weeks after its completion to avoid the risk of sunlight sensitivity;
• to wash your hands thoroughly after each use of the medicine.
• If the patient has had asthma or allergies, Ketospray Forte should be taken under strict medical supervision. Patients with asthma coexisting with chronic sinusitis and/or nasal polyps are particularly at risk of allergic reactions after taking acetylsalicylic acid or other NSAIDs.
• The medicine should not be used on areas of skin with weeping changes, eczema, ulcers, or skin infections, as well as on damaged skin and on: mucous membranes (mouth, genital, or anal areas), eyes, or ears.
• If the patient has a tendency to bleed or has active bleeding (e.g., from the gastrointestinal tract, nasal mucosa, or genital tract), they should consult a doctor.

Children

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

Ketospray Forte and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The occurrence of interactions between Ketospray Forte, used topically on the skin, and other medicines is unlikely, as the concentration of ketoprofen in the blood after topical use is very low.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
Ketospray Forte should notbe used in women during the last three months of pregnancy (III trimester).
During the first six months of pregnancy (I and II trimester), the medicine should not be used unless the doctor considers its use absolutely necessary. If treatment is necessary during this period, the smallest possible dose should be used for the shortest possible time.
The medicine should be used with caution and only in cases where it is absolutely necessary.
Oral forms (e.g., tablets) containing ketoprofen may cause side effects in the unborn child. It is not known whether the same risk occurs with the use of Ketospray Forte on the skin.
It is not known whether ketoprofen passes into breast milk in nursing women. Therefore, the use of Ketospray Forte is not recommended in breastfeeding women.

Driving and using machines

There are no data on the effect of ketoprofen, used topically on the skin, on the ability to drive and use machines.

What Ketospray Forte contains

100 mg of propylene glycol in 1 ml of liquid. Propylene glycol may cause skin irritation.

3. How to use Ketospray Forte

This medicine should always be used as directed by your doctor. If you are unsure, you should consult a doctor or pharmacist.
Ketospray Forte is used in adults and children over 15 years of age.
The usual dose is 3 to 6 sprays of the medicine on the affected area, two to three times a day.
The medicine should not be used for more than 7 days. If there is no improvement, you should consult a doctor.
The maximum daily dose is 18 sprays, which corresponds to 360 mg of ketoprofen.
Instructions for using the medicine.

• The bottle with the medicine should be held in a vertical position.
• When using the medicine for the first time, the pump dispenser should be pressed 3 to 4 times to fill the dispenser and obtain the correct spray.
• The outlet of the pump dispenser should be directed at the affected area and the plunger pressed. One press releases one dose of the medicine.
• The medicine should be gently rubbed in and left to dry, and the tip of the pump dispenser should be wiped with a soft cloth to prevent clogging.
• The medicine should not be used near open fire sources.
• After using the medicine, you should wash your hands. You should avoid contact with the eyes, mucous membranes, and damaged skin.

Using a higher dose of Ketospray Forte than recommended

Overdose of the medicine is unlikely due to the topical route of administration.
In case of using a higher dose of the medicine than recommended, the skin surface should be washed with water.
In case of accidental ingestion of the medicine, systemic side effects of varying severity may occur, depending on the amount of medicine taken (headaches and dizziness, nausea, vomiting, abdominal pain, drowsiness). Ingestion of large doses may cause respiratory depression, coma, convulsions, gastrointestinal bleeding, increased or decreased blood pressure, acute renal failure. There is no specific antidote. In such a case, you should immediately consult a doctor or pharmacist.

Missing a dose of Ketospray Forte

If a dose of the medicine is missed, it should be used as soon as possible, and then the usual dosing schedule should be followed.
A double dose should not be used to make up for a missed dose of the medicine.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketospray Forte can cause side effects, although not everybody gets them.
Side effects after topical use of ketoprofen occur infrequently or rarely.
They include allergic skin reactions, severe skin reactions caused by sunlight, and respiratory reactions (there is a possibility of an asthma attack, especially in people allergic to acetylsalicylic acid and/or other NSAIDs). In such cases, the use of the medicine is contraindicated.

• Uncommon (less than 1 in 100 people): redness, rash, itching, and burning.
• Rare (less than 1 in 1,000 people): photosensitivity reactions, urticaria, severe reactions such as blistering or pustular rash, which may spread beyond the application site or take the form of a generalized reaction.
• Very rare (less than 1 in 10,000 people): cases of worsening chronic renal failure.
• Frequency not known (cannot be estimated from the available data): anaphylactic shock (immediate allergic reaction), angioedema (severe allergic reaction causing facial or throat swelling), hypersensitivity reactions.

Other possible effects (related to the gastrointestinal tract and kidneys) result from the penetration of the active substance through the skin and are therefore dependent on: the dose of ketoprofen used, the skin surface area, the degree of absorption into the tissue, the duration of treatment, and the use or non-use of a dressing. In some people, other side effects may occur when using Ketospray Forte.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Ketospray Forte

Store in the outer packaging.
Use within 1 year of first opening.
Store out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ketospray Forte contains

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

What Ketospray Forte looks like and what the packaging contains

Ketospray Forte is a colorless to slightly yellowish, clear solution.
A 30 ml brown glass bottle with a pump dispenser, in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 12619/2019/02
Parallel import authorization number: 176/21

Date of leaflet approval: 01.08.2023

[Information about the trademark]