KETODOL*20TAB 25MG+200MG

KETODOL 25 mg + 200 mg tablets
ketoprofen and sucralfate

What it is and what it is used for
Ketodol belongs to a category of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
Ketodol contains the active ingredients ketoprofen and sucralfate. Ketoprofen is contained in the central core of the tablet and has analgesic and anti-inflammatory activity; sucralfate is contained in the coating of the tablet and has a protective effect on the inner surface of the stomach (gastric mucosa).
First, sucralfate is released, which protects the gastric mucosa, and immediately after, ketoprofen, which performs its analgesic and anti-inflammatory activity.

Ketodol is used for pains of various origins and natures:
• headache;
• toothache;
• nerve pain (neuralgia);
• bone, joint, and muscle pain;
• menstrual pain.

What you need to know before taking the medicine
Do not take Ketodol
• if you are allergic to ketoprofen or sucralfate or any of the other ingredients of this medicine (listed in section 6);
• if you have previously had allergic reactions such as severe breathing difficulties (bronchospasm), asthmatic attacks, inflammation inside the nose (rhinitis), allergic skin manifestations (urticaria) or if substances with the same mechanism of action as Ketodol (for example, acetylsalicylic acid or other NSAIDs) have previously caused allergic reactions. Indeed, particularly severe (anaphylactic) allergic reactions, rarely fatal, have been observed in these patients (see "Possible side effects");
• in the third trimester of pregnancy, during breastfeeding (see "Pregnancy, breastfeeding and fertility") and in children and adolescents under 15 years of age;
• if you suffer from a severe reduction in the heart's ability to provide an adequate amount of blood to the body (heart failure);
• if you suffer from open sores that develop on the inner lining of the stomach (active peptic ulcer) or have previously suffered from bleeding, ulceration or perforation of the stomach and intestine;
• if you have previously suffered from bleeding or perforation of the stomach and intestine due to previous NSAID therapy;
• in case of easy bleeding tendency;
• in case of severe liver failure;
• in case of severe kidney failure;
• if you have acute kidney damage (renal hypoperfusion);
• if you are taking medicines that cause an increase in urine elimination (intensive diuretic therapy);
• in case of chronic digestive difficulties;
• if you suffer from stomach inflammation (gastritis);
• in case of low white blood cell and platelet counts (leukopenia and thrombocytopenia);
• in case of hereditary abnormalities in hemoglobin formation (porphyria);
• if you suffer from chronic liver inflammation (liver cirrhosis);
• if you are taking antibiotics such as tetracyclines, as these may be ineffective.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketodol. To avoid any hypersensitivity reactions or sun allergies, it is advisable not to expose yourself to the sun during use.

Stop treatment with ketoprofen:
• if you notice bleeding or experience severe stomach or intestinal pain (ulceration);
• at the first appearance of skin allergies (rash), mucosal lesions or any other sign of hypersensitivity or allergic reaction;
• in case of a significant increase in the values of certain liver parameters and transaminases (which are used to evaluate liver function);
• in case of vision disturbances, such as blurred vision.

Ask your doctor or pharmacist for advice before using KETODOL if:
• you suffer from an intestinal disease (ulcerative colitis, Crohn's disease) as these conditions could worsen;
• you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps, because the use of this medicine can contribute to triggering asthmatic crises or bronchospasms;
• you have kidney function problems as the medicine is mainly eliminated by the kidneys;
• you have an infection - see paragraph <> below;
• you are in intensive care and especially if you receive enteral nutrition, or if you have predisposing factors such as delayed gastric emptying;
• you are taking other medicines that could increase the risk of gastrointestinal events, ulceration or bleeding such as:
• oral corticosteroids,
• warfarin (anticoagulant),
• antidepressant drugs (SSRI antidepressants),
• antiplatelet agents such as aspirin (see "Other medicines and Ketodol").

In these cases, the concomitant use of stomach protectors (misoprostol or proton pump inhibitors) is useful.

Infections
KETODOL can hide the symptoms of infections such as fever and pain. It is therefore possible that KETODOL may delay adequate 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, contact your doctor immediately.

Contact your doctor:
• in case of any abdominal symptom (especially gastrointestinal bleeding), particularly in the early stages of treatment;
• for adequate monitoring and appropriate instructions, if you suffer from high blood pressure and/or congestive heart failure, if you have previously suffered from liver disease or if you have abnormal liver function values;
• if you have certain risk factors associated with cardiovascular diseases (high blood pressure, high cholesterol, diabetes mellitus, smoking) before starting long-term treatment;
• before taking this medicine, if you have hereditary problems of intolerance to certain sugars;
• for adequate monitoring of blood potassium levels, if you suffer from diabetes, kidney failure or if you are being treated with medicines that increase blood potassium concentration.

Elderly patients
Use the medicine with caution because you may experience an increase in side effects, especially bleeding and perforations in the stomach and intestine, which can also be fatal (see "How to use Ketodol").
Start treatment with the lowest possible dose, because the risk of gastrointestinal bleeding, ulceration, perforation is greater with increased NSAID doses.

At the beginning of treatment, kidney function should be carefully monitored in patients with heart failure, chronic liver inflammation (cirrhosis) and severe kidney impairment (nephrosis), in subjects undergoing diuretic therapy or suffering from chronic kidney failure, especially if elderly. In these patients, the use of ketoprofen can cause a reduction in blood flow to the kidneys and lead to kidney decompensation.

Children and adolescents
Do not administer the medicine to children and adolescents up to 15 years of age because the safety and efficacy of the medicine have not been established for these age groups.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment.
Serious side effects
The following side effects are serious or can become serious. If any of the following symptoms occur, stop taking Ketodol and contact your doctor immediately:
• severe skin reactions (some of which are fatal) such as:
- death of skin cells, accompanied by malaise, chills, muscle pain and fever (toxic epidermal necrolysis);
- skin rashes with blistering (Stevens-Johnson syndrome);
• severe skin reaction characterized by redness and swelling together with pustule formation (acute generalized exanthematous pustulosis);
• severe inflammation with skin redness (exfoliative dermatitis);
• continuous stomach pain, which worsens on an empty stomach (gastric ulcers);
• vomiting blood, blood in stools (gastrointestinal bleeding);
• throat swelling (laryngeal edema and/or glottal edema), breathing difficulty (dyspnea), intense perception of heartbeat (palpitation) or increased heart rate (tachycardia).

Other side effects are listed below:

Common side effects (may affect up to 1 in 10 people) include:
• Nausea, vomiting, heartburn, indigestion, abdominal pain, stomach pain.

Uncommon side effects (may affect up to 1 in 100 people) include:
• Headache, dizziness, drowsiness.
• Diarrhea, constipation, flatulence (gas), stomach inflammation (gastritis).
• Skin irritation, itching.
• Swelling (fluid accumulation under the skin), feeling of fatigue.

Rare side effects (may affect up to 1 in 1000 people) include:
• Anemia from bleeding, low white blood cell count (seen in blood tests).
• Lack of sensation and tingling in some parts of the body, involuntary muscle movements.
• Blurred vision.
• Ringing in the ears, loss of balance (vertigo).
• Wheezing and breathing difficulty (asthma).
• Oral ulcerations, colitis.
• Liver inflammation (hepatitis), increased transaminases and bilirubin (seen in blood tests), yellowish skin discoloration (jaundice).
• Generalized weakness.
• Weight gain.

Very rare side effects (may affect up to 1 in 10,000 people) include:
• Presence of a mass of foreign material in the stomach (bezoar).

Side effects with unknown frequency (frequency cannot be estimated from available data):
• Significant reduction in white blood cells, reduction in platelet count, inability of the bone marrow to produce normal amounts of blood cells, anemia due to red blood cell destruction (seen in blood tests).
• Allergic hypersensitivity reactions (including anaphylactic shock).
• Reduction in blood sodium levels (hyponatremia) and increase in blood potassium levels (hyperkalemia).
• Depression, hallucinations, confusion, mood changes, insomnia.
• Viral disease of the brain and spinal cord membranes (aseptic meningitis), involuntary muscle contraction (convulsions), altered sense of taste.
• Insufficient heart function, atrial fibrillation (a form of arrhythmia that makes the heartbeat irregular).
• Increased blood pressure (hypertension), increased blood vessels, inflammation of blood vessels (vasculitis).
• Severe breathing difficulty (bronchospasm) particularly in patients with known hypersensitivity to acetylsalicylic acid and NSAIDs.
• Internal inflammation of the nose (rhinitis).
• Worsening of colitis and Crohn's disease, inflammation of the pancreas (pancreatitis).
• Sun allergy reactions (photosensitivity), hair loss (alopecia), widespread urticaria with swelling, blistering eruptions, skin inflammation and redness (dermatitis, eczema, erythema).
• Difficulty urinating, reduced kidney function, kidney inflammation, kidney damage (nephrotoxic syndrome), abnormal kidney function tests (seen in blood tests).
• Arterial thrombotic events (e.g., heart attack or stroke).

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.