OKI
OKI PAIN AND FEVER 25 MG Effervescent Tablets 12 Tablets in PAP/PE/AL/PE Sachet
OKI PAIN AND FEVER 25 MG Effervescent Tablets 12 Tablets in PAP/PE/AL/PE Sachet
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Description
Description
OKi pain and fever 25 mg effervescent tablets
Ketoprofen
What is it and what is it for?
The active ingredient in this medicine is ketoprofen lysine salt, which belongs to a group of medicines called nonsteroidal 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 ketoprofen salt 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 cramps, and fever in adults aged 18 years and older.
Contact your doctor if you do not feel better or if you feel worse after 3 days for fever and 5 days for pain.
What you need to know before taking the medicine
Do not take OKi pain and fever:
- if you are allergic (hypersensitive) to ketoprofen or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from asthma or have had allergic reactions (hypersensitivity) to NSAIDs (e.g. acetylsalicylic acid, ibuprofen) in the past
- in the third trimester of pregnancy (from the 29th week onwards). See section 2 “Pregnancy and breastfeeding”
- if you have a serious heart disease that causes your heart to malfunction
- if you suffer from 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 treatment with an NSAID
- 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), an active bleeding disorder or a tendency to bleed during treatment with medicines to prevent blood clots (anticoagulants)
- if you have severe kidney or liver problems
Warnings and precautions
If you notice any signs of a rash, red and painful skin around body openings (mucous membranes) or allergic reactions after taking OKi pain and fever, stop taking this medicine and tell your doctor immediately.
If you notice signs of bleeding in your stomach or intestines (e.g. bright red stools, black tarry stools, vomit containing blood or dark particles resembling coffee grounds), stop taking this medicine and tell 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 pain and fever, stop taking this medicine and tell your doctor immediately.
Elderly patients may experience increased side effects when taking NSAIDs, particularly stomach and intestinal problems, which can be fatal. Elderly patients should use this medicine with caution.
Side effects may be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms.
Anti-inflammatory/pain-relieving medications such as ketoprofen may be associated with a small increased risk of heart attack or stroke, particularly when taken in high doses and over long periods of time. Do not exceed the recommended duration of treatment or dose.
Tell 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 increased risk of these conditions (for example, if you have diabetes, high blood cholesterol levels or are a smoker).
Tell your doctor if you experience palpitations, which are sensations of rapid, uncomfortable, or irregular heartbeat.
The use of OKi pain and fever with other medicinal products containing NSAIDs (e.g. ibuprofen, acetylsalicylic acid, celecoxib) should be avoided.
Stop taking this medicine if you experience vision problems, such as blurred vision.
Because it's intended to treat symptoms such as fever, OKi Pain and Fever may mask more serious underlying conditions. If symptoms persist, tell your doctor.
Taking painkillers for long-term relief can make headaches worse.
Talk to your doctor or pharmacist before taking OKi pain and fever:
- if you are pregnant , trying to conceive or are breastfeeding (see section 2 “Pregnancy and breastfeeding”)
- if you have fluid retention and swelling
- if you have a blood disease (e.g. anemia)
- if you suffer from liver disease
- if you suffer from kidney disease
- if you suffer from allergies (e.g. hay fever)
- if you suffer from hepatic porphyria (a rare blood disease characterised by an alteration in the activity of one of the liver enzymes) because the medicine may cause an attack.
- if you have an infection – see section “Infections” below.
Infections
OKi Pain and Fever may mask the symptoms of infections such as fever and pain. It is therefore possible that OKi Pain and Fever may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and 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, contact your doctor immediately.
Children and adolescents
Do not give 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 time necessary to relieve symptoms.
Stop taking OKi pain and fever and see a doctor immediately if, at any time during treatment with OKi pain and fever, you develop:
• signs of intestinal bleeding such as bright red stools (faeces), black tarry stools, vomit containing blood or dark particles resembling coffee grounds
• signs of skin rashes, severe skin reactions and blistering of the skin, mouth and eyes
• signs of a serious allergic reaction , such as:
- unexplained difficulty breathing or wheezing
- dizziness or rapid heartbeat
- 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, mouth ulcers, headache, vomiting, unexplained bleeding and bruising, severe tiredness
• indigestion, stomach or abdominal pain, constipation, diarrhea, flatulence or feeling unwell, chest pain, or a rapid or irregular heartbeat
• liver and kidney problems associated with swelling of the arms and legs.
Side effects associated with OKi pain and fever 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, diarrhea, flatulence, inflammation of the stomach lining
• swelling due to fluid accumulation
• itching and skin rashes irritations
• fatigue
Rare (may affect up to 1 in 1,000 people)
• iron deficiency (anemia) caused by bleeding
• numbness, tingling
• blurred vision
• noise in the ear (tinnitus)
• asthma
• inflammation of the lining of the mouth
• 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)
• alteration of blood cell and platelet counts
• allergic reactions (anaphylaxis)
• impairment of the glands located above the kidneys (adrenal glands)
• high blood pressure, flushing (vasodilation)
• heart failure
• kidney failure, inflammation in the kidneys, abnormal kidney function test results
• colitis
• worsening of gastrointestinal conditions
• dark or black stools
• presence of blood in vomit
• stuffy and runny nose (rhinitis)
• swelling of the throat
• swelling of the deeper layers of the skin, caused by excess fluid (for example on the face or hands)
• breathing difficulties (dyspnea)
• headache
• breathing difficulty caused by narrowing of the airways
• uncontrolled muscle contractions (convulsions)
• sensitivity to sunlight or UV lamps
• taste alterations
• behavioral changes
• hair loss
• itchy skin rash
• bleeding in the stomach and/or intestines, symptoms of which may include severe stomach pain, chills, nausea, vomiting, vomit containing blood or dark particles resembling coffee grounds, heartburn, bright red or tarry black stools
Reporting of side effects
If you experience 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.
OKI
OKI PAIN AND FEVER 25 MG Effervescent Tablets 12 Tablets in PAP/PE/AL/PE Sachet
OKI PAIN AND FEVER 25 MG Effervescent Tablets 12 Tablets in PAP/PE/AL/PE Sachet
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