Ketoprofen Dompé

PATIENT INFORMATION LEAFLETEnclosed leaflet: Information for the user

Ketoprofen Dompé 50 mg coated granules, in sachet

Ketoprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days in the case of adolescents or 5 days in the case of adults, there is no improvement or the patient feels worse, contact a doctor.

Table of contents of the leaflet

1
What is Ketoprofen Dompé and what is it used for

• 2. Important information before taking Ketoprofen Dompé
• 3. How to take Ketoprofen Dompé
• 4. Possible side effects
• 5. How to store Ketoprofen Dompé
• 6. Contents of the pack and other information

1. What is Ketoprofen Dompé and what is it used for

The active substance of this medicine is ketoprofen (in the form of ketoprofen lysinate), which belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs).
These medicines relieve short-term discomfort by changing the body's response to pain and swelling.
Ketoprofen lysinate is a salt of ketoprofen, which is rapidly and completely absorbed by the body.
Ketoprofen Dompé is recommended for short-term symptomatic treatment of acute pain of mild or moderate intensity, such as headache, toothache, menstrual pain, pain after minor sprains and strains.
Ketoprofen Dompé is indicated for use in adults and adolescents from 16 years of age.

If symptoms persist for more than 3 days in adolescents or 5 days in adults, or if the patient feels worse, consult a doctor.

2. Important information before taking Ketoprofen Dompé

When not to take Ketoprofen Dompé:

• if the patient is allergic to ketoprofen, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had hypersensitivity reactions (allergy) caused by the use of ketoprofen or substances with a similar mechanism of action, such as salicylic acid or other NSAIDs (other anti-inflammatory drugs), such as asthma (inflammation of the airways and constriction of the airways), bronchospasm (constriction of the airways), allergic rhinitis (allergic inflammation of the nasal mucosa), hives, rashes, nasal polyps, angioedema (swelling of the skin and mucous membranes) or other allergic reactions. In these patients, severe anaphylactic reactions have been observed, which in rare cases have led to death (see section 4 "Possible side effects");
• if the patient has asthma (inflammation of the airways and constriction of the airways);
• if the patient has severe heart disease, in which the heart does not work as well as it should;
• if the patient has stomach ulcers (ulcers in the stomach or upper part of the intestine) or bleeding, or has had recurrent stomach ulcers or bleeding (two or more separate, proven episodes of bleeding or ulceration);
• if the patient has had gastrointestinal bleeding (bleeding from the stomach or intestine), ulcers, perforation of the gastrointestinal tract, or chronic indigestion (disorders of digestion);
• if the patient has had gastrointestinal bleeding or perforation due to previous NSAID treatment;
• if the patient has leukopenia (low white blood cell count) or thrombocytopenia (low platelet count);
• if the patient has Crohn's disease (inflammation of the intestine) or ulcerative colitis (inflammation of the intestine with ulcers);
• if the patient has gastritis (inflammation of the stomach lining);
• if the patient has severe liver failure (weakened liver function due to cirrhosis of the liver or severe hepatitis) or severe kidney failure (weakened kidney function);
• if the patient has a bleeding disorder (tendency to bleed) or other coagulation disorders (problems with stopping bleeding);
• if the patient is being treated with high doses of diuretics;
• if the patient is in the third trimester of pregnancy(see section 2 "Pregnancy and breastfeeding");
• If the patient is under 16 years of age.

Warnings and precautions

Taking the medicine in the smallest effective dose for the shortest necessary time to relieve symptoms may minimize the risk of side effects (see section 3 "How to take Ketoprofen Dompé" and below: risk of gastrointestinal and cardiovascular complications).
If the patient notices symptoms of rash, redness, and skin tenderness around body orifices (mucous membranes) or allergic reactions after taking Ketoprofen Dompé, they should stop taking the medicine and consult a doctor immediately.
If the patient notices symptoms of gastrointestinal bleeding (such as bright red, black, or tarry stools, vomiting blood or dark particles that look like coffee grounds), they should stop taking the medicine and consult a doctor immediately.
If the patient notices symptoms of ulcers or perforation (symptoms may include severe abdominal pain, chills, nausea, vomiting, heartburn) after taking Ketoprofen Dompé, they should stop taking the medicine and consult a doctor immediately.
In elderly patients, more side effects may occur after taking NSAIDs, especially gastrointestinal ones, which can be fatal (see section 3 "How to take Ketoprofen Dompé"). Elderly patients should use the product with caution.
Taking anti-inflammatory and analgesic medicines, such as ketoprofen, may be associated with a slightly increased risk of heart attack or stroke, especially when taken in high doses and for a long time. Do not exceed the recommended dose or recommended treatment duration.
Do not take Ketoprofen Dompé with other products containing NSAIDs (e.g. ibuprofen, aspirin, celecoxib).
Skin reactions:
Very rarely, after taking NSAIDs, severe, sometimes life-threatening skin reactions have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see section 4 "Possible side effects"). The risk of such reactions is likely to be highest in the initial treatment period – in most cases, they occurred within the first month of treatment. After the first signs of rash, mucous membrane changes, or any other symptoms of hypersensitivity, the Ketoprofen Dompé medicine should be discontinued.
The patient should stop taking the medicine if they experience any vision disturbances, such as blurred vision.
Taking painkillers for headaches for too long can make them worse.
Before starting to take Ketoprofen Dompé, the patient should discuss it with their doctor or pharmacist:

• if the patient is pregnant, trying to become pregnant, or breastfeeding (see section 2 "Pregnancy and breastfeeding");
• if the patient has fluid retention or edema;
• if the patient has high blood pressure, heart failure, arterial disease, and/or cerebrovascular disease;
• if the patient has uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to the heart's inability to pump blood efficiently), proven ischemic heart disease (heart disease that occurs after reduced blood flow caused by blocked coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of the arteries and blood vessels of the brain), as the patient may only take Ketoprofen Dompé after a thorough medical examination;
• if the patient has hematopoietic disorders (which change the formation and maturation of blood cells), systemic lupus erythematosus (an autoimmune disease), or mixed connective tissue disease, as Ketoprofen Dompé should be used with caution in these cases;
• if the patient has phenylketonuria, a genetic disorder in which the body is unable to break down a substance called phenylalanine;
• if the patient has liver disease;
• if the patient has kidney disease;
• if the patient has allergies (e.g. hay fever);
• if the patient has chronic obstructive pulmonary disease (COPD);
• if the patient has porphyria (a rare blood disorder characterized by a change in the activity of one of the liver enzymes), as taking the medicine may trigger an attack of the disease;
• if the patient has an infection- see "Infections" below.

Infections

Ketoprofen Dompé may mask the symptoms of infection, such as fever and pain. As a result, Ketoprofen Dompé may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient is taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.

Children and adolescents

Ketoprofen Dompé should not be given to children under 16 years of age.

Ketoprofen Dompé and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines that can be obtained without a prescription and herbal products.

It is not recommended to take Ketoprofen Dompé with the following medicines:

• Other anti-inflammatory medicines, such as NSAIDs, selective cyclooxygenase-2 inhibitors, and salicylates in high doses (more than 3 g per day);
• Medicines that slow down blood clotting (e.g. heparin and warfarin);
• Medicines that inhibit platelet aggregation (e.g. ticlopidine and clopidogrel);
• Lithium (a medicine used to treat certain types of mental illness and depression);
• Methotrexate at a dose of 15 mg per week or higher (a medicine used to treat cancer and other autoimmune diseases);
• Medicines used to treat epilepsy (e.g. hydantoin);
• Certain antibiotics used to treat bacterial infections (e.g. sulfonamides).

Caution should be exercised when taking Ketoprofen Dompé with the following medicines:

• Medicines that may increase potassium levels in the blood (e.g. potassium chloride and other potassium salts, heparin, cyclosporine, tacrolimus, and trimethoprim);
• Antiretroviral medicines used to treat HIV infections (e.g. tenofovir, zidovudine);
• Diuretics, as their effect may be reduced;
• Medicines used to treat high blood pressure (e.g. ACE inhibitors and angiotensin II antagonists, beta-blockers);
• Methotrexate at a dose of less than 15 mg per week (a medicine used to treat cancer and other autoimmune diseases);
• Medicines used to treat inflammatory conditions (e.g. corticosteroids);
• Pentoxifylline (a medicine used to treat muscle pain);
• Medicines used to treat diabetes (e.g. sulfonylurea derivatives);
• Medicines used to treat heart failure and to regulate heart rhythm (e.g. cardiac glycosides).

Ketoprofen Dompé combinations to consider:

• Medicines used to lower blood pressure (e.g. beta-blockers, ACE inhibitors, diuretics);
• Medicines used to induce abortion (e.g. mifepristone and gemeprost) or when using an intrauterine device, as their effectiveness may be reduced;
• Medicines used after organ transplantation to prevent rejection (e.g. cyclosporine, tacrolimus);
• Medicines that improve blood flow, such as anticoagulants (e.g. aspirin, warfarin, heparin, ticlopidine or clopidogrel, thrombolytic agents):
• Probenecid (a medicine used to treat gout);
• Certain antibiotics (e.g. quinolones);
• Medicines used to treat epilepsy (e.g. phenytoin);

Taking Ketoprofen Dompé with alcohol

During treatment with ketoprofen lysinate, the patient should avoid drinking alcohol.
Alcohol may cause irritation of the throat, stomach, and intestines, resulting in an increased risk of bleeding and ulcers when NSAIDs are taken with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Ketoprofen Dompé should not be taken during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the mother and her baby and prolong labor. During the first six months of pregnancy, Ketoprofen Dompé should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this time or when the patient is trying to become pregnant, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Ketoprofen Dompé may cause kidney problems in the unborn baby, which can lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is necessary for a period longer than a few days, the doctor may recommend additional monitoring.
Taking the medicine close to the delivery date may cause changes in circulation and respiratory problems in the newborn.
Therefore, DO NOT TAKE Ketoprofen Dompé during the third trimester of pregnancy (see "When not to take Ketoprofen Dompé").
Breastfeeding
There is no available data on the penetration of ketoprofen into human milk.
Ketoprofen is not recommended for use in breastfeeding women.
Fertility
Taking NSAIDs, including Ketoprofen Dompé, may impair female fertility and is not recommended in women trying to become pregnant.
The patient should stop taking Ketoprofen Dompé if they experience problems with becoming pregnant or during fertility tests.

Driving and using machines

If after taking Ketoprofen Dompé the patient feels drowsy, dizzy, or experiences blurred vision or convulsions, they should not drive vehicles, operate machinery, or perform other activities that require high physical and mental fitness (see section 4 "Possible side effects").

Ketoprofen Dompé contains aspartame

This medicine contains 0.70 mg of aspartame in each sachet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Ketoprofen Dompé contains sucrose (in lemon flavor) and glucose (in lime flavor)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Ketoprofen Dompé contains sodium (in lime flavor, lemon flavor, and frescofort)

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, which means the medicine is considered "sodium-free".

3. How to take Ketoprofen Dompé

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Use the smallest effective dose for the shortest necessary time to relieve symptoms.
The recommended dose is 1 sachet, up to a maximum of 2 times a day, as needed.
There should be an interval of at least 8 hours between doses.
Do not exceed the recommended dose.

Duration of treatment

Adults: If after 5 days there is no improvement or the patient feels worse, consult a doctor.
Adolescents: If after 3 days there is no improvement or the patient feels worse, consult a doctor.

Use in children

Ketoprofen Dompé should not be used in children under 16 years of age.

Use in elderly patients

Ketoprofen Dompé should be used with caution in elderly patients.
The doctor will reduce the dose to the smallest possible.

Impaired liver or kidney function

In patients with mild to moderate liver or kidney impairment, the doctor may reduce the dose to the smallest effective one.
Ketoprofen Dompé should not be used in patients with severe liver or kidney impairment.

Method of administration

Ketoprofen Dompé is taken orally.
The contents of the sachet can be poured directly onto the tongue. It dissolves in saliva, so the medicine does not need to be taken with water.

Taking a higher dose of Ketoprofen Dompé than recommended

In case of accidental ingestion of a higher dose of Ketoprofen Dompé than recommended, the patient may feel drowsy or nauseous. Consult a doctor immediately, even if the patient feels well.
There is no specific antidote for ketoprofen overdose. In case of suspected significant overdose, gastric lavage and symptomatic and supportive treatment are recommended.

Missing a dose of Ketoprofen Dompé

If a dose of Ketoprofen Dompé is missed, take it as soon as possible.
Do not take a double dose to make up for the missed dose. Always maintain an interval of at least 8 hours between doses and do not exceed the maximum of 2 sachets per day.

Stopping treatment with Ketoprofen Dompé

The patient should stop taking the medicine as soon as they feel better.
If the patient has any further doubts about taking this medicine, they should consult their pharmacist.

4. Possible side effects

Like all medicines, Ketoprofen Dompé can cause side effects, although not everybody gets them.
The most commonly observed adverse events are related to the gastrointestinal tract.
Stop taking Ketoprofen Dompé and consult a doctor immediatelyif at any time during treatment with this medicine the patient experiences:

• symptoms of gastrointestinal bleeding, such as: bright red, black, or tarry stools, vomiting blood or dark particles that look like coffee grounds;
• symptoms of rash [including maculopapular rash (skin rash with spots), purpura (purple spots on the skin due to improper blood clotting), acute generalized exanthematous pustulosis (skin rash with pustules), dermatitis (skin irritation), severe skin reactions: (including Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis) and blistering of the skin, mouth, and eyes;

Other side effects of Ketoprofen Dompé may include:

Frequent(may occur in up to 1 in 10 people)

• indigestion, nausea, abdominal pain, vomiting

Uncommon(may occur in up to 1 in 100 people)

• headache, dizziness, drowsiness
• constipation, diarrhea, bloating (passing gas), gastritis (inflammation of the stomach lining), abdominal discomfort
• edema and peripheral edema (swelling due to fluid retention in the body), chills, fatigue
• itching and skin rashes

Rare(may occur in up to 1 in 1,000 people)

• hemorrhagic anemia (decreased hemoglobin in the blood, a substance that carries oxygen in the blood, due to bleeding)
• numbness
• blurred vision
• tinnitus (ringing in the ears)
• asthma (inflammation of the airways and constriction of the airways)
• stomatitis (inflammation of the mouth mucosa), gastric ulcers (ulcers in the stomach or upper part of the intestine), colitis (inflammation of the colon)
• hepatitis (inflammation of the liver), increased transaminase activity (increased levels of certain enzymes that indicate liver function), increased bilirubin levels in the blood (a substance that indicates liver function), jaundice (yellowing of the skin or whites of the eyes)
• weight gain

Very rare(may occur in up to 1 in 10,000 people)

• facial edema, asthenia (weakness)
• dyskinesia (involuntary movements), fainting
• hypotension (low blood pressure)
• laryngeal edema (swelling of the larynx)
• hematuria (blood in the urine)

Unknown(frequency cannot be estimated from available data)

• thrombocytosis (increased platelet count), agranulocytosis (significant decrease in the number of a certain type of white blood cell), bone marrow failure (decreased production of blood cells by the bone marrow), hemolytic anemia (decreased hemoglobin in the blood, a substance that carries oxygen in the blood, due to destruction of red blood cells), leukopenia (low white blood cell count), neutropenia (decreased number of a certain type of white blood cell), aplastic anemia (decreased hemoglobin in the blood, a substance that carries oxygen in the blood, due to insufficient production of blood cells by the bone marrow), leukocytosis (increased white blood cell count), thrombocytopenic purpura (presence of purple spots on the skin due to decreased platelet count)
• anaphylactic reactions (severe allergic reactions, including anaphylactic shock), hypersensitivity (allergy)
• depression, hallucinations (perceiving sensations that do not exist), confusion, mood swings, excitement, insomnia
• seizures (involuntary movements), taste disorders (change in taste perception), tremors, hyperkinesia (involuntary and uncontrolled movements)
• periorbital edema (swelling around the eyes)
• heart failure (inability of the heart to pump enough blood to meet the body's needs), atrial fibrillation (change in heart rhythm), palpitations (increased awareness of heartbeat)
• hypertension (high blood pressure), vasodilation, vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis (inflammation of small blood vessels)
• bronchospasm, particularly in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), laryngeal spasm, acute respiratory failure (reported in a single case that led to death in a patient with asthma and hypersensitivity to acetylsalicylic acid)
• gastrointestinal bleeding, perforation of the gastrointestinal tract (in some cases leading to death, especially in the elderly), gastric ulcers (ulcers in the stomach), duodenal ulcers (ulcers in the upper part of the intestine), heartburn, oral edema, pancreatitis, hyperacidity, abdominal pain
• hypersensitivity to light (sensitivity to sunlight or UV lamps), alopecia (hair loss), urticaria, rash, and erythema
• renal failure (decreased kidney function), interstitial nephritis, nephrotic syndrome (kidney changes involving protein loss in the urine), kidney disease, fluid retention/sodium retention with possible edema (fluid and sodium accumulation leading to swelling), acute tubular necrosis, and renal papillary necrosis (severe kidney damage)
• aseptic meningitis (inflammation of the membranes covering the brain, not caused by infection), vasculitis of the lymphatic vessels
• hyperkalemia (increased potassium levels in the blood) and hyponatremia (decreased sodium levels in the blood).

Reporting side effects

If side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ketoprofen Dompé

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ketoprofen Dompé contains

• The active substance of the medicine is ketoprofen. Each sachet contains 50 mg of ketoprofen (in the form of ketoprofen lysinate).
• The other ingredients are: Povidone (E 1201), anhydrous colloidal silica (E 551), hypromellose, methacrylic acid butyl ester copolymer, sodium lauryl sulfate, stearic acid (E 570), magnesium stearate (E 572), aspartame (E 951), mannitol (E 421), xylitol (E 967), talc (E 553B), lemon flavor (contains maltodextrin, modified starch E 1450, glucose, butylated hydroxyanisole E 320, bergamot oil, sodium) and lime flavor (contains sucrose, maltodextrin, modified starch E 1450, sodium) and frescofort flavor (contains gum arabic, sodium).

What Ketoprofen Dompé looks like and contents of the pack

Ketoprofen Dompé is a granule with a color ranging from white to ivory, in sachets.
Each pack contains 10 sachets.

Marketing authorization holder

Dompé farmaceutici S.p.A
Via San Martino 12
20122 Milano
Italy
+39 02 583 831

Manufacturer

Dompé farmaceutici S.p.A.
Via Campo di Pile
67100 L'Aquila
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Bulgaria
Ketoprofen Dompé 50 mg coated granules in sachet
Croatia
Ketoprofen Dompé 50 mg coated granules in sachet
Poland
Ketoprofen Dompé
Romania
Ketoprofen Dompé 50 mg granules in sachet
Italy
Ketoprofene Dompé

Date of last revision of the leaflet