Name
KETODOL 25 mg + 200 mg tablets
ketoprofen and sucralfate


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

Ketodol is used in case of pain of various origins and nature:
• heachache;
• toothache;
• nerve pain (neuralgia);
• bone, joint and muscle pain;
• menstrual cramps.


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 had allergic reactions in the past such as severe breathing difficulties (bronchospasm), asthmatic attacks, internal inflammation of the nose (rhinitis), allergic skin reactions (urticaria) or if substances with the same mechanism of action as Ketodol (for example acetylsalicylic acid or other NSAIDs) have previously caused allergic-type reactions. In fact, particularly serious allergic reactions (anaphylactic), 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 supply an adequate amount of blood to the body (heart failure);
• if you suffer from open sores developing on the inner lining of the stomach (active peptic ulcer) or have suffered in the past from bleeding, ulceration or perforation of the stomach and intestines;
• if you have suffered in the past from bleeding or perforation in the stomach and intestine due to previous therapy with NSAIDs;
• 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 increased urine output (intensive diuretic therapy);
• in case of chronic digestive difficulties;
• if you suffer from stomach inflammation (gastritis);
• in case of low number of white blood cells and platelets (leukopenia and thrombocytopenia);
• in case of hereditary alterations in the formation of hemoglobin (porphyria);
• if you suffer from chronic inflammation of the liver (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 or allergy reactions to the sun, it is recommended not to expose yourself to the sun during use.

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

Ask your doctor or pharmacist for advice before using KETODOL if:
• suffer from a disease of the intestine (ulcerative colitis, Crohn's disease) as these conditions could worsen;
• suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps, because the use of this medicine may contribute to triggering asthma attacks or bronchospasms;
• has problems with kidney function since the medicine is eliminated mainly through the kidneys;
• have an infection – see section < > below;
• is in intensive care and especially if he receives enteral nutrition, or if he has predisposing factors such as delayed gastric emptying;
• take other medications that may increase the risk of gastrointestinal events, ulceration or bleeding such as:
• oral corticosteroids,
• warfarin (anticoagulant),
• drugs for depression (SSRI antidepressants),
• anti-platelet agents such as aspirin (see “Other medicines and Ketodol”).

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

Infections
KETODOL may 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 bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.

Contact your doctor:
• in case of any abdominal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment;
• for adequate monitoring and appropriate instructions, if you suffer from high blood pressure and/or congestive heart failure, if you have suffered from liver disease in the past or if you have abnormal liver function values;
• if you have certain risk factors associated with cardiovascular disease (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 some sugars;
• for adequate monitoring of potassium levels in the blood, if you suffer from diabetes, kidney failure or if you are being treated with medicines that increase the concentration of potassium in the blood.

Elderly patients
Use the medicine with caution because it may cause an increase in side effects, especially bleeding and perforation in the stomach and intestines, 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 doses of NSAIDs.

At the beginning of treatment, renal function must be carefully monitored in patients with heart failure, chronic inflammation of the liver (cirrhosis) and severe kidney disease (nephrosis), in subjects treated with diuretics or suffering from chronic renal failure, especially if elderly. In these patients, the use of ketoprofen may cause a reduction in blood flow to the kidneys and lead to renal failure.

Children and adolescents
Do not give 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.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration possible.
Serious side effects
The following side effects are serious or may become serious. If you experience any of the following symptoms, stop taking Ketodol and contact your doctor immediately:
• serious skin reactions (some of them fatal) such as:
- death of skin cells, accompanied by malaise, chills, muscle aches 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 redness of the skin (exfoliative dermatitis);
• constant stomach pain, which gets worse on an empty stomach (gastric ulcers);
• vomiting blood, blood in the stool (gastrointestinal bleeding);
• swelling of the throat (larynx edema and/or glottis edema), difficulty breathing (dyspnoea), intense awareness of the 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 (constipation), flatulence (gas), inflammation of the stomach (gastritis).
• Skin irritation, itching.
• Swelling (accumulation of fluid under the skin), feeling tired.

Rare side effects (may affect up to 1 in 1000 people) include:
• Anemia due to hemorrhage, low white blood cell count (seen in blood test).
• Lack of sensation and tingling sensation in some parts of the body, involuntary muscle movements.
• Blurred vision.
• Ringing in the ears, loss of balance (vertigo).
• Wheezing and difficulty breathing (asthma).
• Oral ulcerations, colitis.
• Inflammation of the liver (hepatitis), increased transaminases and bilirubin (seen in blood tests), yellowing of the skin (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 the available data):
• Significant reduction in white blood cells, reduction in the number of platelets, inability of the bone marrow to produce the normal amount of blood cells, anemia due to destruction of red blood cells (seen in blood tests).
• Allergic hypersensitivity reactions (including anaphylactic shock).
• Reduction of sodium levels in the blood (hyponatremia) and increase of potassium levels in the blood (hyperkalemia).
• Depression, hallucinations, confusion, mood changes, insomnia.
• Disease of the membranes of the brain and spinal cord of viral origin (aseptic meningitis), involuntary muscle contraction (convulsions), alteration of the sense of taste.
• Poor heart function, atrial fibrillation (a form of arrhythmia that causes the heartbeat to be irregular).
• Increased blood pressure (hypertension), enlarged blood vessels, inflammation of blood vessels (vasculitis).
• Severe respiratory distress (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).
• Allergic reactions to the sun (photosensitivity), hair loss (alopecia), urticaria, even widespread with swelling, blistering eruptions, inflammation and redness of the skin (dermatitis, eczema, erythema).
• Difficulty urinating, decreased kidney function, inflammation of the kidneys, 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.