Ketoprofen Ziaia

Package Leaflet: Information for the Patient

Ketoprofen Ziaja, 25 mg/g, 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Ketoprofen Ziaja is a medicine with anti-inflammatory and analgesic effects for topical use. The active substance of the medicine (ketoprofen) belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

Indications for use – local treatment:

• Musculoskeletal pain caused by sports injuries (sprains and strains)
• Muscle and joint inflammation
• Lower back pain in discopathy
• Rheumatic pain

With the doctor's consent, the medicine can be used in physiotherapy, e.g. during iontophoresis (using current) or phonophoresis (using ultrasound) treatments. Ketoprofen Ziaja is indicated for use in adults and children over 15 years of age.

2. Important information before using Ketoprofen Ziaja

When not to use Ketoprofen Ziaja

• do not expose the treated skin area to sunlight (even on cloudy days) or UVA rays in a solarium, during and 2 weeks after stopping the use of the medicine,
• on damaged or diseased skin,
• on mucous membranes and around the eyes,
• in children under 15 years of age.

Stop using the medicine immediately if skin reactions occur, including skin reactions after concurrent use of products containing octocrylene (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).

Warnings and precautions

• before starting to use Ketoprofen Ziaja, discuss it with your doctor or pharmacist,
• avoid contact of the medicine with mucous membranes, eyes and wounded skin, do not use under occlusive dressings (limiting air access),
• use with caution in patients with circulatory disorders, kidney or liver dysfunction,
• after each use of Ketoprofen Ziaja, wash your hands thoroughly, unless your hands are the treatment area,
• when using ketoprofen, be cautious in patients with asthma.

Exposure to sunlight (even on cloudy days) or UVA rays on skin areas where Ketoprofen Ziaja has been applied may cause severe skin reactions (photosensitivity). Therefore, for up to two weeks after stopping the use of the medicine, it is necessary to protect the treated skin areas by wearing clothing. Additionally, it is recommended to wash your hands thoroughly after each use of the medicine. Treatment should be stopped immediately if any skin reactions occur after using Ketoprofen Ziaja.

Children

Do not use in children under 15 years of age.

Ketoprofen Ziaja and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take. There is no description of the interaction between ketoprofen used topically and other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Ketoprofen Ziaja if you are in the last 3 months of pregnancy. During the first 6 months of pregnancy, do not take Ketoprofen Ziaja 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 Ketoprofen Ziaja may cause side effects in the unborn child. It is not known whether the same risk is caused by the application of Ketoprofen Ziaja to the skin. It is not recommended to use Ketoprofen Ziaja during breastfeeding.

Driving and using machines

Ketoprofen Ziaja used on the skin has no effect on the ability to drive and use machines.

Ketoprofen Ziaja contains ethanol 96%

This medicine contains 320 mg of alcohol (ethanol) in each gram of gel. It may cause a burning sensation on damaged skin.

Ketoprofen Ziaja contains a fragrant substance

This medicine contains a fragrant substance (lavender oil) with d-limonene and linalool. These substances may cause allergic reactions.

3. How to use Ketoprofen Ziaja

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Ketoprofen Ziaja is for use on the skin. Adults and adolescents over 15 years of age

• Use 2 to 3 times a day.
• Apply a small amount of gel to the skin in the painful area and massage for a few minutes. The amount of gel used depends on the size of the painful area.
• Treatment should not last longer than 7 days.
• The maximum daily dose is 15 g.

After using the medicine, wash your hands, unless your hands are the treatment area.

Use in children and adolescents

Do not use the medicine in children under 15 years of age.

Using more than the recommended dose of Ketoprofen Ziaja

Do not increase the recommended dose of Ketoprofen Ziaja without consulting your doctor. Overdose of Ketoprofen Ziaja used topically is unlikely. Accidental ingestion If the gel is accidentally ingested, the following may occur: drowsiness, nausea, vomiting. Ingestion of large doses may cause respiratory arrest, coma, convulsions, gastrointestinal bleeding, increased or decreased blood pressure, kidney dysfunction. If the medicine is accidentally ingested, contact your doctor or pharmacist as soon as possible.

Missing a dose of Ketoprofen Ziaja

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon (affects 1 to 10 users in 1,000)

• allergic skin reactions such as redness, itching, rash, burning

Rare (affects 1 to 10 users in 10,000)

• severe skin reactions such as blistering or pustular rash, which may spread or become generalized
• severe skin reactions during sunlight exposure, blistering dermatitis, urticaria, photosensitivity

Very rare (affects less than 1 user in 10,000)

• worsening of existing kidney dysfunction
• swelling of the face, lips, tongue, throat or trachea, causing difficulty in breathing or swallowing (angioedema)
• gastric or duodenal ulcer disease, gastrointestinal bleeding, diarrhea
• severe hypersensitivity reactions (anaphylactic reactions)

Frequency not known (cannot be estimated from the available data)

• local skin reactions that may spread beyond the application site
• shortness of breath (asthma) in patients allergic to acetylsalicylic acid or other NSAIDs

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketoprofen Ziaja

Store below 25°C. Do not freeze. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) stated on the packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ketoprofen Ziaja contains

• The active substance is ketoprofen. One gram of gel contains 25 mg of ketoprofen.
• The other ingredients are: ethanol 96%, carbomer 5984, tromethamine, lavender oil (d-limonene, linalool), purified water.

What Ketoprofen Ziaja looks like and contents of the pack

Ketoprofen Ziaja is a transparent gel with a lavender scent. Packaging: aluminum tube with a membrane, with a polyethylene cap (PE), containing 50 g or 100 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

ZIAJA Ltd Pharmaceutical Works sp. z o.o. ul. Jesienna 9 80-298 Gdańsk tel. +48 58 521 34 00

Date of last revision of the leaflet: