Ketoprofen Lgo

Package Leaflet: Information for the User

Ketoprofen LGO, 25 mg/g, Gel

Ketoprofen

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Ketoprofen LGO and what is it 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 package and other information

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

Ketoprofen LGO is a medicine with anti-inflammatory and analgesic effects. The active substance of the medicine – ketoprofen – belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine is used locally on the skin:

• for post-traumatic muscle and joint pain,
• for rheumatic pain.

2. Important information before using Ketoprofen LGO

When not to use Ketoprofen LGO:

• if the patient has been diagnosed with hypersensitivity (allergy) to ketoprofen, acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac), tiaprofenic acid, fenofibrate, UV filters, perfumes, or any other components of this medicine (listed in section 6). Do not use if the patient has 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 a hypersensitivity reaction to sunlight and in case of any hypersensitivity reaction to sunlight in the past;
• use of the medicine should be stopped immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (octocrylene is a protective agent against sunlight present in many 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, added to delay their decomposition under the influence of light). The treated skin area should not be exposed to sunlight (even on cloudy days) and UV rays in a solarium during treatment and for 2 weeks after stopping the use of the medicine;
• on damaged or diseased skin (e.g., open wound, rash, acne);
• on mucous membranes and around the eyes;
• on the skin area 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 to use Ketoprofen LGO, the doctor, pharmacist, or nurse should be consulted:

• contact between the medicine and mucous membranes, eyes, and damaged skin should be avoided; if redness occurs, the use of the medicine should be stopped;
• the medicine should be used with caution in patients with circulatory disorders, kidney or liver dysfunction;
• during long-term use, it is recommended to wear protective gloves;
• if skin changes occur at the site of application, the use of the medicine should be stopped;
• the medicine contains an auxiliary substance - lavender oil. Caution should be exercised in patients with epilepsy;
• there is a possibility of severe skin allergic reactions after exposure of the treated skin area to sunlight and after concurrent use with octocrylene. If any skin reaction occurs, the use of the medicine should be stopped immediately and a doctor should be consulted. During the use of the medicine and for 2 weeks after stopping its use, the skin should be protected from sunlight, even on cloudy days. This also applies to solarium. It is also necessary to wash hands thoroughly after each application of the gel.

Children and adolescents

Ketoprofen LGO should not be used in children and adolescents under 15 years of age.

Ketoprofen LGO and other medicines

The doctor should be informed about all medicines currently or recently used by the patient, as well as about medicines that the patient plans to use. No interactions with other medicines have been observed.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Ketoprofen LGO should not be used if the patient is in the last 3 months of pregnancy. During the first 6 months of pregnancy, Ketoprofen LGO should not be taken 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. Oral forms (e.g., tablets) of ketoprofen may cause side effects in the unborn child. It is not known whether the same risk occurs when using Ketoprofen LGO on the skin. Ketoprofen LGO should not be used during breastfeeding.

Driving and using machines

The effect of the medicine on the ability to drive and use machines has not been described.

3. How to use Ketoprofen LGO

This medicine should always be used as directed by the doctor. In case of doubts, the doctor, pharmacist, or nurse should be consulted. Gel for local application on the skin. Note: The recommended dose of Ketoprofen LGO should not be increased without consulting a doctor. In case of doubts, the doctor, pharmacist, or nurse should be consulted. Ketoprofen LGO is intended for use on the skin only. The medicine should not be swallowed. To open the tube, the cap should be unscrewed and the aluminum protective membrane should be torn off.

Use in adults and children over 15 years of age:

A small amount of gel should be applied to the skin in the painful area and massaged for a few minutes. Use 2 to 3 times a day. No more than 15 g of gel (7.5 g corresponds to a 14 cm strip of squeezed-out gel) can be used per day. After each use, the tube should be tightly closed and hands washed, unless the hands are the area being treated. The medicine should be used for a short time. The treatment time may vary for each patient and depends on the severity of symptoms. However, treatment should not last longer than 1 week. A dressing should not be applied to the treated skin area. If the patient feels that the effect of Ketoprofen LGO is too strong or too weak, they should consult their doctor, pharmacist, or nurse.

Using a higher dose of Ketoprofen LGO than recommended

The recommended dose of Ketoprofen LGO should not be increased without consulting a doctor. Overdose of Ketoprofen LGO used locally is unlikely. If the gel is accidentally swallowed, the following symptoms may occur: drowsiness, nausea, vomiting. Taking large doses may cause respiratory arrest, coma, convulsions, gastrointestinal bleeding, increased or decreased blood pressure, kidney dysfunction. If the medicine is swallowed, a doctor, pharmacist, or nurse should be consulted as soon as possible.

Missing a dose of Ketoprofen LGO

A double dose should not be used to make up for a missed dose.

Stopping the use of Ketoprofen LGO

In case of any further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, Ketoprofen LGO can cause side effects, although not everybody gets them. Side effects are ranked according to frequency, defined as follows:

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

Uncommon:
allergic skin reactions such as redness, itching, rash.
Rare:
blistering skin inflammation, urticaria, hypersensitivity to light, severe skin reactions such as blistering or pustular rash, which can spread or become generalized, severe skin reactions during exposure to sunlight.
Very rare:
worsening of existing kidney dysfunction.
Not known:
local skin reactions that can spread beyond the application site, asthma attack in patients allergic to acetylsalicylic acid or other NSAIDs.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ketoprofen LGO

There are no special instructions for storing the medicine. The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the tube and carton. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the package and other information

What Ketoprofen LGO contains

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

What Ketoprofen LGO looks like and what the package contains

The medicine is a gel, packaged in an aluminum tube with a protective membrane and a polypropylene cap, placed in a carton. Package sizes: 40 g – 1 tube of 40 g, 50 g – 1 tube of 50 g, 75 g – 1 tube of 75 g, 100 g – 1 tube of 100 g. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorium Galenowe Olsztyn Sp. z o.o., ul. Spółdzielcza 25 A, 11-001 Dywity, Date of preparation of the leaflet:July 2023