Package leaflet: Information for the patient

Ketoprofen Ziaja, 25 mg/g, gel
Ketoprofenum
Please read the entire 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Ketoprofen Ziaja and what is it used for
Important information before using Ketoprofen Ziaja
How to use Ketoprofen Ziaja
Possible side effects
How to store Ketoprofen Ziaja
Contents of the pack and other information

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

Ketoprofen Ziaja is a non-steroidal anti-inflammatory and analgesic medicine intended for
topical use. The active substance (ketoprofen) belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Indications – local treatment for:

Musculoskeletal pain caused by sports injuries (sprains and post-traumatic injuries)
Inflammation of muscles and joints
Low back pain in discopathy
Rheumatic pain

With a doctor's approval, the medicine may be used in physiotherapy, e.g. during iontophoresis
(using electric current) or phonophoresis (using ultrasound).
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

if the patient is allergic to ketoprofen or to any of the other ingredients of this medicine (listed in section 6), as well as tiaprofenic acid, fenofibrate (a cholesterol-lowering medicine), UV filters or perfumes,
if the patient has previously experienced allergic reactions during treatment with acetylsalicylic acid or other NSAIDs, manifesting as rhinitis, urticaria or asthma (shortness of breath),
if the patient has previously experienced photosensitivity reactions,
do not expose the treated skin area to sunlight (even when the sky is cloudy) or to UV radiation in solariums during treatment and for 2 weeks after discontinuation of the medicine,
on damaged or diseased skin,
on mucous membranes and around the eyes,
if the patient is in the last 3 months of pregnancy (third trimester),
in children under 15 years of age.

The medicine must be discontinued immediately if skin reactions occur, including
skin reactions following concomitant use of products containing octocrylene (one
of the excipients used in various cosmetics and hygiene products such as shampoos,
aftershaves, shower gels and bath products, skin creams, lipsticks, anti-wrinkle creams,
make-up removers, hair lacquers to delay light-induced degradation).

Warnings and precautions

before starting treatment with Ketoprofen Ziaja, consult a doctor or pharmacist,
avoid contact of the medicine with mucous membranes, eyes and broken skin; do not apply under occlusive dressings (which limit air access),
use with caution in patients with circulatory disorders, impaired kidney or liver function,
after each application of Ketoprofen Ziaja, hands should be thoroughly washed unless the hands are the treated area,
exercise caution when using ketoprofen in patients with bronchial asthma.

Exposure to sunlight (even when the sky is cloudy) or UVA radiation on areas of skin treated with
Ketoprofen Ziaja may cause severe skin reactions (photosensitivity). Therefore, for two weeks after
discontinuation of the medicine, treated skin areas should be protected by wearing appropriate clothing.
Additionally, hands should be thoroughly washed after each application of the medicine.
Treatment must be immediately discontinued if any skin reactions develop after application of
Ketoprofen Ziaja.

Children
Do not use in children under 15 years of age.

Ketoprofen Ziaja and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any
medicines planned for use.
No interaction has been reported between topically applied ketoprofen and other medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Ketoprofen Ziaja must not be used if the patient is in the last 3 months of pregnancy.
During the first 6 months of pregnancy, Ketoprofen Ziaja should not be used unless the doctor considers
its use absolutely necessary. If treatment is required during this period, the lowest possible dose for the
shortest possible duration is recommended.
Oral formulations (e.g. tablets) of Ketoprofen Ziaja may cause adverse effects in the unborn child.
It is unknown whether the same risk applies when Ketoprofen Ziaja is applied to the skin.
Use of Ketoprofen Ziaja is not recommended during breastfeeding.

Driving and operating machinery
Ketoprofen Ziaja applied to the skin has no effect on the ability to drive or operate machinery.

Ketoprofen Ziaja contains ethanol 96%
This medicine contains 320 mg of alcohol (ethanol) per gram of gel. It may cause stinging on damaged skin.

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

3. How to use Ketoprofen Ziaja

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Ketoprofen Ziaja is intended for topical application to the skin.
Adults and adolescents over 15 years of age

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

After applying the medicine, wash your hands unless the hands are the treated area.
Use in children and adolescents
Do not use this medicine in children under 15 years of age.
Use of more than the recommended dose of Ketoprofen Ziaja
Do not increase the recommended dose of Ketoprofen Ziaja without consulting a doctor.
Overdose with topically applied Ketoprofen Ziaja is unlikely.
Accidental ingestion
If the gel is accidentally ingested, symptoms may include drowsiness, nausea, and vomiting. Ingestion
of large amounts may cause respiratory depression, coma, convulsions, gastrointestinal bleeding, increased or decreased blood pressure, and impaired kidney function.
If the medicine is accidentally ingested, contact a doctor or pharmacist immediately.
Missed dose of Ketoprofen Ziaja
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Not common (occurs in 1 to 1,000 people)

Allergic skin reactions such as redness, itching, rash, burning sensation

Rare (occurs in 1 to 10,000 people)

Severe skin reactions such as bullous or acneiform rash, which may spread or become generalized
Severe skin reactions during exposure to sunlight, including vesicular dermatitis, urticaria, photosensitivity

Very rare (occurs in less than 1 in 10,000 people)

Worsening of pre-existing kidney function disorders
Swelling of the face, lips, tongue, throat or larynx causing difficulty in breathing or swallowing (angioedema)
Peptic ulcer of the stomach and/or duodenum, gastrointestinal bleeding, diarrhoea
Severe hypersensitivity reactions (anaphylactic reactions)

Frequency not known (cannot be estimated from available data)

Local skin reactions which may spread beyond the site of application
Asthma attack in patients hypersensitive to acetylsalicylic acid or other NSAIDs

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps 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 must not be disposed of via the sewage system 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.
Pack: aluminium tube with a membrane, with a polyethylene cap (PE), containing 50 g or 100 g of gel, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
tel. +48 58 521 34 00