Ketosprai forte

Leaflet attached to the packaging: patient information

Ketospray Forte

100 mg/ml spray for the skin, solution
Ketoprofen

You should read the contents of the leaflet 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 decomposition under the influence of light).
• Do not expose the treated skin area to sunlight (even on cloudy days) or UVA 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 airtight) or on large areas of the body.
• The use of topical medicines, especially long-term, may cause an allergic reaction, especially during intense sun exposure.
• The recommended treatment time should not be exceeded due to the increased risk of skin inflammation and photosensitivity reactions.
• 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 (photosensitivity). 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 photosensitivity;
• to wash your hands thoroughly after each use of Ketospray Forte.
• If the patient has had asthma or allergies, Ketospray Forte should be taken under close medical supervision. Patients with asthma coexisting with chronic sinusitis and/or nasal polyps are particularly at risk of allergic reactions after using acetylsalicylic acid or other NSAIDs.
• The medicine should not be used on areas of skin with weeping changes, eczema, ulceration, or skin infection, as well as on mucous membranes (mouth, genital area, or anus), 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 application 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 not be 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 is associated with the use of Ketospray Forte on the skin.
It is not known whether ketoprofen passes into breast milk. Therefore, Ketospray Forte should not be used in breastfeeding women.

Driving and using machines

There is no data on the effect of ketoprofen, used topically on the skin, on the ability to drive vehicles and operate machinery.

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 button 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 flames.
• 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

Overdosing on 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 (headache and dizziness, nausea, 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 exacerbation of chronic renal failure.
• Frequency not known (cannot be estimated from 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, during the use of Ketospray Forte, other side effects may occur.

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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Ketospray Forte

There are no special precautions for storage.
Store in the outer packaging.
Use within 6 months of first opening the packaging.
Store in a place out of sight and reach of children.
Do not use Ketospray Forte after the expiry date stated on the carton and bottle.
The expiry date refers to the last day of the stated 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.
It is available in 15 ml and 30 ml bottles made of orange glass, closed with a plastic-metal pump dispenser protected with a cap, containing 12.5 ml and 25 ml of solution, respectively.
The bottles are placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw
tel.: (22) 702 82 00
fax: (22) 702 82 02
e-mail: [email protected]

Manufacturer

Pharbil Waltrop GmbH
Im Wirrigen 25, D-45731 Waltrop, Germany
Date of last update of the leaflet:
A patient leaflet in a format suitable for the blind and visually impaired is available at the marketing authorization holder's headquarters.