Active ingredient: Each film-coated tablet contains 36.9 mg dexketoprofen trometamol, equivalent to 25 mg dexketoprofen.

Excipients: Corn starch, microcrystalline cellulose PH 101 and PH 102, sodium starch glycolate (Primojel) Type A, glycerol monostearate, Opadry II White 85F18422: polyvinyl alcohol, talc, macrogol/PEG 3350, titanium dioxide

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

KETAVEL is a painkiller from the group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

Treatment of signs and symptoms of osteoarthritis (destruction and calcification of the joints), rheumatoid arthritis (inflammatory joint disease) and ankylosing spondylitis (painful progressive rheumatism, mostly accompanied by stiffening of the spinal joints), as well as acute gouty arthritis (painful joint inflammation due to gout), acute musculoskeletal pain (e.g. low back pain), postoperative pain (pain after surgery) and dysmenorrhea (painful menstruation). It is indicated for the treatment of periods).

KETAVEL contains 25 mg dexketoprofen (as trometamol) and is available in packs of 20 tablets.

They are white, round, film-coated tablets with a score on one side.

Instructions for proper use and dosage/frequency of administration

Always take KETAVEL exactly as your doctor tells you. When you are not sure, consult your doctor or pharmacist.

The dose of KETAVEL you need depends on the type, severity and duration of your pain. Your doctor will tell you how many tablets you should take per day and for how long.

The recommended dose is usually 1 tablet (25 mg) every 8 hours, not to exceed 3 tablets (75 mg) per day.

If your pain is severe and you need faster pain relief, take the tablet on an empty stomach (at least 30 minutes before a meal) as it will be easier to absorb (see Chapter 2 “Using KETAVEL with food and drink”).

Like all medicines, KETAVEL may cause side effects, although not everyone may experience them, and side effects may also occur in people who are sensitive to the substances contained in KETAVEL.

Possible side effects are listed below in order of how often they occur. This table shows how many patients may experience these side effects:

If any of the following occur, stop using KETAVEL and IMMEDIATELY inform your doctor or go to the emergency department of the nearest hospital.

If you have previously had a side effect due to long-term use of anti-inflammatory drugs, especially if you are elderly, if you notice any abdominal/intestinal side effects at the beginning of treatment (e.g. abdominal pain, burning, bleeding),

Stop using KETAVEL as soon as you notice a skin rash or any lesion in the oral or genital area or any allergy symptoms.