Ketonal

Package Leaflet: Information for the Patient

Ketonal, 25 mg/g (2.5%), Gel

Ketoprofen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any further questions, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ketonal and what is it used for
• 2. Important information before using Ketonal
• 3. How to use Ketonal
• 4. Possible side effects
• 5. How to store Ketonal
• 6. Contents of the pack and other information

1. What is Ketonal and what is it used for

Ketonal gel contains the active substance ketoprofen - a non-steroidal anti-inflammatory drug.
The medicine has analgesic and anti-inflammatory effects.
Ketonal gel is intended for topical use on the skin.
The use of Ketonal gel is indicated in adults in the following cases:
lower back pain, muscle pain, and rheumatic pain, sprains and overuse injuries,
musculoskeletal pain and swelling caused by sports injuries,
pain in mild to moderate arthritis.

2. Important information before using Ketonal

When not to use Ketonal

if you have ever had an allergic reaction to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs, UV filters, or perfumes, or to any of the other ingredients of this medicine (listed in section 6).
Allergic reactions may include symptoms of asthma, nasal mucositis, rash, or urticaria (itching rash).
if you have had a history of hypersensitivity to sunlight.
if you are under 15 years old.
if you are in the last 3 months of pregnancy.
if the skin in the area where the medicine is to be applied is damaged or diseased (eczema, acne, various dermatoses, open wounds, and infected wounds).
Do not use ketoprofen in the form of a gel under an occlusive dressing.
Stop using the medicine immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (octocrylene is one of the excipients 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 their degradation under the influence of light).
During treatment and for 2 weeks after stopping the application, do not expose the treated skin area to sunlight (even on cloudy days) or UV rays in a solarium.

Warnings and precautions

Before using Ketonal gel, discuss it with your doctor if:
you have kidney, heart, or liver function disorders,
you have had a stroke or have a tendency to bleed,
you have been diagnosed with stomach or duodenal ulcer, or inflammatory bowel disease in the past. Elderly people should use Ketonal gel with caution. If skin changes occur in the patient during use (e.g., rash), including reactions after concurrent use of a product containing octocrylene, Ketonal gel should be stopped immediately and a doctor consulted. During the use of Ketonal gel and for 2 weeks after the end of treatment, avoid exposing the treated area to sunlight and UV rays (e.g., in a solarium). Do not allow the gel to come into contact with mucous membranes, eyes, nose, mouth, or genital areas. If this happens, rinse the medicine off with plenty of water. After applying the gel, wash your hands thoroughly.

• Topical use of ketoprofen may cause asthma attacks in some people. Large amounts of topical gel may cause systemic effects, including hypersensitivity reactions and asthma.
• Exposure to sunlight (even on cloudy days) or UVA rays (e.g., in a solarium) on skin areas where Ketonal gel has been applied may cause severe skin reactions (hypersensitivity to sunlight). Therefore, it is necessary:

• Patient with asthma and chronic rhinitis, chronic sinusitis, and (or) nasal polyps have a higher risk of allergy to acetylsalicylic acid and (or) non-steroidal anti-inflammatory drugs (NSAIDs) than the rest of the population.

Do not exceed the recommended treatment time due to the increasing risk of contact dermatitis and hypersensitivity to light.

Children

The safety and efficacy of ketoprofen in gel form in children have not been established.

Ketonal and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Concomitant use of Ketonal gel and other medicines applied topically to the same skin area is not recommended.
Although the interaction between ketoprofen in gel form and other medicines is unlikely, caution should be exercised in patients treated with high doses of methotrexate (a medicine used mainly in cancer diseases).
Patient receiving coumarin derivatives (anticoagulant medicines) should consult a doctor before starting Ketonal gel.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before using this medicine.
The medicine should not be used during pregnancy. The use of ketoprofen during breastfeeding is not recommended.
Do not use Ketonal gel if you are in the last 3 months of pregnancy. During the first 6 months of pregnancy, do not use Ketonal gel unless your doctor considers it absolutely necessary. If treatment is necessary during this period, the smallest possible dose should be used for the shortest possible time.
Oral forms (e.g., tablets) of Ketonal may cause side effects in the unborn child. It is not known whether the same risk is associated with the use of Ketonal on the skin.

Driving and using machines

The effect of Ketonal gel on the ability to drive and use machines is not known.

Ketonal contains ethanol

Ketonal gel contains approximately 4.07 g of ethanol in the maximum daily dose (15 g of gel), which is equivalent to approximately 271.32 mg of ethanol per 1 g of gel. It may cause a burning sensation on damaged skin.

3. How to use Ketonal

Always use this medicine exactly as your doctor has told you.
In case of doubt, consult a doctor or pharmacist.
Adults and adolescents over 15 years old
A small amount of gel should be applied to the skin in the painful area and gently rubbed into the skin for a few minutes, two or three times a day.
The amount of gel used should be adjusted to the size of the painful area.
The maximum amount of gel that can be applied in a day is 15 g (7.5 g is contained in approximately 9 cm of squeezed gel strip), which corresponds to 375 mg of the active substance - ketoprofen.
During treatment and for 2 weeks after stopping the application, protect the treated skin areas with clothing to avoid the risk of hypersensitivity to sunlight.
If symptoms do not improve after 7 days of using the medicine, worsen, or new symptoms occur, consult a doctor.
After applying the gel, do not cover the affected area with a dressing (so-called occlusive dressing).
Avoid contact of the medicine with eyes and mucous membranes, and wash your hands thoroughly after each application.
Children
Ketonal gel is not recommended for use in children under 15 years old.

Using more than the recommended dose of Ketonal

Overdose of the topical medicine is unlikely.
In case of accidental ingestion of Ketonal gel, seek medical attention immediately, as systemic side effects may occur, the scope and severity of which depend on the amount of medicine taken.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local skin reactions are the most common, which can sometimes spread beyond the application site.
Uncommon (may affect up to 1 in 100 people): local skin reactions, such as redness, itching, rash (itching, red, burning rash), burning sensation, mild, transient skin inflammation.
Rare (may affect up to 1 in 1,000 people): urticaria, rash, hypersensitivity to light, blistering rash, cases of severe reactions, such as blistering or pustular rash, which can spread or become generalized.
Very rare (may affect up to 1 in 10,000 people): anaphylactic reaction (severe allergic reaction - difficulty breathing, dizziness), worsening of chronic kidney failure.
Frequency not known (frequency cannot be estimated from the available data): hypersensitivity reactions, anaphylactic shock, angioedema (allergic reaction - swelling mainly of the face and throat).
Severe contact dermatitis has been reported during exposure to sunlight. Severe, widespread, and prolonged hypersensitivity to light has been reported. Sometimes, even a single use of ketoprofen can cause prolonged hypersensitivity to light.
Topically applied non-steroidal anti-inflammatory drugs may cause interstitial nephritis.
If you experience any of the following symptoms, stop using the medicine immediately and consult a doctor or the nearest hospital:
allergic skin reaction,
asthma attack,
hypersensitivity reaction after exposure of the treated area to sunlight or UV rays,
severe skin reaction that spreads quickly.
Consult a doctor urgently if you experience:
redness of the skin,
itching,
burning sensation,
dryness of the skin due to frequent use.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ketonal

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ketonal contains

The active substance is ketoprofen. 1 gram of gel contains 25 mg of ketoprofen.
The other ingredients are: carbomer, tromethamine, ethanol 96%, lavender essence, purified water.

What Ketonal looks like and contents of the pack

Ketonal gel is a homogeneous, transparent gel with a lavender and alcohol scent.
The gel is available in an aluminum tube, in a cardboard box.
The packs contain 50 g or 100 g of gel.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Lange Göhren 3
39171 Sülzetal, OT Osterweddingen, Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
For more information about this medicine, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

Date of last revision of the leaflet:

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