OKI PAIN AND FEVER*12EFF TABS

OKi dolore e febbre 25 mg effervescent tablets
Ketoprofen

What it is and what it is used for
The active ingredient in this medicine is ketoprofen lysine salt, which belongs to a group of medicines called "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs). These medicines provide short-term relief by modifying the body's response to pain, swelling, and high temperature. Ketoprofen lysine salt is a salt of ketoprofen that is rapidly and completely absorbed by the body. It is used to relieve mild to moderate pain, such as muscle and joint pain, headache, pain associated with sore throat, toothache and menstrual pain, and fever in adults aged 18 years and over.

Consult your doctor if you do not feel better or if you feel worse after 3 days in case of fever and 5 days in case of pain.

What you need to know before taking the medicine
Do not take OKi dolore e febbre:
- if you are allergic (hypersensitive) to ketoprofen or any of the other ingredients of this medicine (listed in section 6)
- if you have asthma or have previously experienced allergic reactions (hypersensitivity) to NSAIDs (e.g., acetylsalicylic acid, ibuprofen)
- in the third trimester of pregnancy (from the 29th week onwards). See section 2 "Pregnancy and breastfeeding"
- if you have a severe heart condition that causes heart malfunction
- if you have or have had intestinal problems in the past such as:
- active or recurrent peptic ulcer
- stomach or intestinal ulcers
- intestinal bleeding
- perforation in the stomach or esophagus (gastrointestinal perforation)
- any of the above conditions caused by NSAID treatment
- pain or discomfort during digestion, which may include nausea, vomiting, heartburn, bloating, and stomach discomfort (chronic dyspepsia)
- inflammation of the stomach lining (gastritis)
- if you have a low blood cell count (leukocytopenia or thrombocytopenia), active bleeding, or a tendency to bleed while on medication to prevent clots (anticoagulants)
- if you have severe kidney or liver problems

Warnings and precautions
If you notice signs of skin rash, reddened and painful skin around the body orifices (mucous membranes) or allergic reactions after taking OKi dolore e febbre, stop taking this medicine and inform your doctor immediately.

If you notice signs of bleeding in the stomach or intestines (e.g. bright red stools, black tarry stools, vomit containing blood or dark particles similar to coffee grounds), stop taking this medicine and inform your doctor immediately.

If you notice signs of ulceration or perforation (symptoms of which may include severe stomach pain, chills, nausea, vomiting, heartburn) after taking OKi dolore e febbre, stop taking this medicine and inform your doctor immediately.

Elderly people may experience more side effects when taking NSAIDs, particularly affecting the stomach and intestines, which can be fatal. Elderly patients should use this medicine with caution.

Side effects can be minimised by taking the lowest dose for the shortest possible time needed to relieve symptoms.

Anti-inflammatory/pain relief medicines such as ketoprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly if taken in high doses and for long periods of time. Do not exceed the duration of treatment or the recommended dose.

Inform your doctor or pharmacist before taking this medicine if you have high blood pressure, a weakened heart, arterial disease and/or problems with the blood vessels supplying the brain, or if you are at an increased risk of developing such diseases (for example, if you have diabetes, high blood cholesterol levels, or are a smoker).

Inform your doctor if you experience palpitations, i.e. sensations of a rapid, uncomfortable and irregular heartbeat.

The use of OKi dolore e febbre with other NSAID-containing medicines (e.g. ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.

Stop taking this medicine if you experience vision problems, such as blurred vision.

As it is intended for the treatment of symptoms such as fever, OKi dolore e febbre could mask more serious underlying conditions. If symptoms persist, inform your doctor.

Long-term use of painkillers to relieve headaches can worsen headaches.

Talk to your doctor or pharmacist before taking OKi dolore e febbre:
- if you are pregnant, trying to conceive or breastfeeding (see section 2 "Pregnancy and breastfeeding")
- if you experience fluid retention and swelling
- if you have a blood disorder (e.g. anaemia)
- if you have liver disease
- if you have kidney disease
- if you have allergies (e.g. hay fever)
- if you have hepatic porphyria (a rare blood disorder characterised by altered activity of one of the liver enzymes) as the medicine may trigger an attack.
- if you have an infection - see section Infections below.

Infections
OKi dolore e febbre can mask the symptoms of infections such as fever and pain. Therefore, OKi dolore e febbre may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Children and adolescents
Do not administer ketoprofen lysine salt to children under 18 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can be minimized by taking the lowest dose for the shortest possible time needed to relieve symptoms.

Stop taking OKi dolore e febbre and consult a doctor immediately if, at any time during treatment with OKi dolore e febbre, you develop:
• signs of intestinal bleeding such as bright red stools (faeces), black tarry stools, vomit containing blood or dark particles similar to coffee grounds
• signs of skin rashes, severe skin reactions and blistering on skin, mouth and eyes
• signs of a severe allergic reaction, such as:
- unexplained breathing difficulties or wheezing
- dizziness or accelerated heart rate
- swelling of the lips, face, throat or tongue
• worsening of Crohn's disease and colitis (a chronic inflammatory bowel disease characterized by symptoms such as abdominal pain, diarrhoea, fever and weight loss)

Tell your doctor if you experience:
• fever, sore throat, oral ulcers, headache, vomiting, unexplained bleeding and bruising, severe exhaustion
• indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence or malaise, chest pain or fast and irregular heartbeat
• liver and kidney problems associated with swelling of the arms and legs.

Side effects associated with OKi dolore e febbre may include: Common (may affect up to 1 in 10 people)
• digestive difficulties (dyspepsia), nausea, abdominal pain, vomiting

Uncommon (may affect up to 1 in 100 people)
• headache, dizziness, drowsiness
• constipation, diarrhoea, flatulence, inflammation of the stomach lining
• swelling due to fluid accumulation
• itching and irritating skin rashes
• fatigue

Rare (may affect up to 1 in 1,000 people)
• iron deficiency (anaemia) caused by bleeding
• numbness, tingling
• blurred vision
• ringing in the ear (tinnitus)
• asthma
• inflammation of the mouth lining
• stomach ulcers
• liver inflammation (hepatitis), increased liver enzymes, yellowing of the skin or whites of the eyes (jaundice)
• weight gain

Not known (frequency cannot be estimated from the available data)
• changes in blood cell and platelet count
• allergic reactions (anaphylaxis)
• impairment of the glands located above the kidneys (adrenal glands)
• high blood pressure, redness (vasodilation)
• heart failure
• kidney failure, inflammation in the kidneys, abnormalities in kidney function test results
• colitis
• worsening of gastrointestinal conditions
• dark or black stools
• blood in vomit
• blocked and runny nose (rhinitis)
• throat swelling
• swelling of the deeper layers of the skin, caused by excess fluid (e.g. on the face or hands)
• breathing difficulties (dyspnoea)
• headache
• breathing difficulties caused by narrowing of the airways
• uncontrolled muscle contractions (convulsions)
• sensitivity to sunlight or UV lamps
• taste disturbances
• behavioural changes
• hair loss
• itchy rash
• bleeding from the stomach and/or intestines, symptoms of which may include intense stomach pain, chills, nausea, vomiting, vomit containing blood or dark particles similar to coffee grounds, heartburn, bright red or black tarry stools

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.