KETOPROFEN LGO

Patient Information Leaflet

Ketoprofen LGO, 25 mg/g, gel
Ketoprofenum
Please read this leaflet carefully 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 further questions, please consult your doctor, pharmacist, or nurse.
• 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Ketoprofen LGO is and what it is used for

Ketoprofen LGO is a medicine with anti-inflammatory and analgesic properties. The active substance, ketoprofen, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
The medicine is applied topically to the skin:

• for traumatic pain in muscles and joints,
• for rheumatic pain.

2. Important information before using Ketoprofen LGO

When not to use Ketoprofen LGO:

• if the patient has a known allergy (hypersensitivity) to ketoprofen, acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac), tiaprofenic acid, fenofibrate, UV filters, perfumes, or any of the other ingredients of this medicine (listed in section 6). Do not use if the patient has previously experienced allergic symptoms such as rhinitis, urticaria, or asthma (shortness of breath) during treatment with acetylsalicylic acid or other NSAIDs;
• if the patient has previously experienced photosensitivity reactions, or has any history of light sensitivity reactions;
• treatment must be stopped immediately if skin reactions occur, including skin reactions after concomitant use of products containing octocrylene (octocrylene is an ingredient in various cosmetics and hygiene products such as shampoos, after-shave lotions, shower gels and bath products, skin creams, lipsticks, anti-wrinkle creams, make-up removers, hair sprays, added to delay their breakdown by light). The treated area of skin must not be exposed to sunlight (even on cloudy days) or UV radiation in solariums during treatment and for 2 weeks after stopping the medicine;
• on damaged or diseased skin (e.g. open wounds, eczema, acne);
• on mucous membranes and around the eyes;
• on areas of skin where a dressing will be applied;
• in children and adolescents under 15 years of age;
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Ketoprofen LGO, discuss this with your doctor, pharmacist, or nurse:

• avoid contact of the medicine with mucous membranes, eyes, and broken skin; if redness occurs, discontinue use;
• use with caution in patients with circulatory disorders, or impaired kidney or liver function;
• during prolonged use, protective gloves are recommended;
• if skin changes occur at the site of gel application, discontinue use;
• the medicine contains a excipient - lavender oil. Exercise caution in patients with epilepsy;
• severe skin allergic reactions may occur when the treated skin area is exposed to sunlight, and when used concomitantly with octocrylene (a sunscreen agent present in many cosmetics). If any skin reaction occurs, discontinue use immediately and consult a doctor. During treatment and for 2 weeks after stopping the medicine, protect the skin from sunlight, even on cloudy days. This also applies to solarium use. Hands must be thoroughly washed after each application of the gel.

Children and adolescents
Ketoprofen LGO must not be used in children and adolescents under 15 years of age.
Ketoprofen LGO and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines planned for use.
No interactions with other medicines have been observed.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Ketoprofen LGO if the patient is in the last 3 months of pregnancy.
During the first 6 months of pregnancy, Ketoprofen LGO should not be used unless the doctor considers it absolutely necessary. If treatment during this period is required, the lowest effective dose for the shortest possible duration should be used.
Oral formulations (e.g. tablets) of ketoprofen (Ketoprofenum) may cause adverse effects in the unborn child. It is not known whether the same risk applies when using Ketoprofen LGO topically on the skin.
Do not use Ketoprofen LGO during breastfeeding.
Driving and operating machinery
No effects of the medicine on the ability to drive or operate machinery have been reported.

3. How to use Ketoprofen LGO

This medicine should always be used as directed by a physician. If in doubt, consult your
doctor, pharmacist, or nurse.
Topical gel for application to the skin.
Caution! Do not increase the recommended dose of Ketoprofen LGO without consulting your doctor.
If in doubt, contact your doctor, pharmacist, or nurse.
Ketoprofen LGO is intended for topical use on the skin only.
Do not swallow the medicine.
To open the tube, unscrew the cap and break the aluminum protective seal covering the tube opening.
Use in adults and children aged 15 years and above:
Apply a small amount of gel to the skin over the painful area and massage gently for several minutes.
Use 2 to 3 times daily.
No more than 15 g of gel should be applied within 24 hours (7.5 g corresponds to a strip of approximately 14 cm of expressed gel).
After each application, close the tube tightly and wash your hands, unless the hands are the treated area.
This medicine should be used short-term. The duration of treatment may vary for each patient and depends on the severity of symptoms. Treatment should not last longer than 1 week.
Do not cover the treated area with a dressing or bandage.
If you feel that the effect of Ketoprofen LGO is too strong or too weak, contact your doctor, pharmacist, or nurse.
Use of a higher than recommended dose of Ketoprofen LGO
Do not exceed the recommended dose of Ketoprofen LGO without consulting your doctor.
Overdose with topically applied Ketoprofen LGO is unlikely.
In case of accidental ingestion, symptoms such as drowsiness, nausea, and vomiting may occur. Ingestion of large amounts may lead to respiratory depression, coma, seizures, gastrointestinal bleeding, increased or decreased blood pressure, and impaired kidney function.
If the gel has been swallowed, contact your doctor, pharmacist, or nurse immediately.
Missed dose of Ketoprofen LGO
Do not use a double dose to make up for a missed dose.
Stopping Ketoprofen LGO
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are listed according to their frequency of occurrence, defined as follows:

• not very common (in more than 1 in 1,000 patients but less than 1 in 100 patients),
• rare (in more than 1 in 10,000 patients but less than 1 in 1,000 patients),
• very rare (in less than 1 in 10,000 treated patients),
• unknown (frequency cannot be estimated from the available data).

Not very common: allergic skin reactions such as: erythema, itching, rash.
Rare: bullous dermatitis, urticaria, photosensitivity, severe skin reactions such as bullous or papular rash, which may spread or become generalized, severe skin reactions during exposure to sunlight.
Very rare: worsening of pre-existing renal function disorders.
Frequency unknown: local skin reactions which may spread beyond the site of application, asthma attack in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 of the 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ketoprofen LGO

There are no special requirements for storing this medicine.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and cardboard packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ketoprofen LGO contains

• The active substance is ketoprofen (Ketoprofenum). 1 g of gel contains 25 mg of ketoprofen.
• Other ingredients (excipients) are: carbomer, tromethamine, lavender oil, ethanol 96%, purified water.

What Ketoprofen LGO looks like and contents of the pack
Ketoprofen LGO is a gel packed in a laminated aluminium tube with a protective membrane and a polylpropylene cap, placed in a cardboard box.
Pack sizes:
40 g – 1 tube containing 40 g
50 g – 1 tube containing 50 g
75 g – 1 tube containing 75 g
100 g – 1 tube containing 100 g
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25 A
11-001 Dywity
Date of preparation of the leaflet: July 2023