Package leaflet: Information for the user

Ketoprofen Dompé 50 mg coated granules, in sachet
Ketoprofenum
Read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days in adolescents or 5 days in adults, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet
1 What Ketoprofen Dompé is and what it is 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 Ketoprofen Dompé is and what it is used for
The active substance in this medicine is ketoprofen (in the form of ketoprofen lysine salt), which belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs).
These medicines relieve short-term discomfort by altering the body's response to pain and inflammation.
Ketoprofen lysine salt is a form of ketoprofen that is rapidly and completely absorbed by the body.
Ketoprofen Dompé is indicated for short-term symptomatic treatment of acute mild to moderate pain, such as headache, toothache, menstrual pain, or pain due to minor sprains and strains.
Ketoprofen Dompé is indicated for use in adults and adolescents aged 16 years and older.
If symptoms persist beyond 3 days in adolescents or 5 days in adults, or if you feel worse, consult your doctor.

2. Important information before taking Ketoprofen Dompé

When not to take Ketoprofen Dompé:

if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced hypersensitivity reactions (allergy) after taking ketoprofen or substances with a similar mechanism of action, such as salicylic acid or other NSAIDs (other anti-inflammatory drugs), including asthma (inflammation and narrowing of the airways), bronchospasm (airway constriction), allergic rhinitis (allergic inflammation of the nasal mucosa), urticaria, skin rashes, nasal polyps, angioedema (swelling of the skin and mucous membranes), or other allergic reactions. Severe anaphylactic reactions, sometimes fatal, have been observed in such patients (see section 4 "Possible side effects");
if you have bronchial asthma (inflammation and narrowing of the airways);
if you have severe heart disease, in which the heart does not function properly;
if you currently have gastric ulcers (sores in the stomach or upper intestine) or gastrointestinal bleeding, or if you have had recurrent gastric ulcers or bleeding in the past (two or more separate, confirmed episodes of bleeding or ulceration);
if you have previously experienced gastrointestinal bleeding (bleeding from the stomach or intestine), ulceration, gastrointestinal perforation, or chronic dyspepsia (digestive disorders);
if you have previously had gastrointestinal bleeding or perforation due to prior NSAID treatment;
if you have leukopenia (low white blood cell count) or thrombocytopenia (low platelet count);
if you have Crohn's disease (inflammatory bowel disease) or ulcerative colitis (inflammatory bowel disease with ulcers);
if you have gastritis (inflammation of the stomach lining);
if you have severe liver impairment (reduced liver function due to cirrhosis or severe hepatitis) or severe renal impairment (reduced kidney function);
if you have a bleeding tendency (predisposition to bleeding) or other coagulation disorders, or if you have hemostatic disorders (problems stopping bleeding);
if you are being treated with high-dose diuretics;
if you are in the third trimester of pregnancy (see section 2 "Pregnancy and breastfeeding");
If you are under 16 years of age.

Warnings and precautions
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms may minimize the risk of adverse effects (see section 3 "How to take Ketoprofen Dompé" and below: risk of gastrointestinal and cardiovascular complications).
If you develop symptoms of rash, redness, and pain around body orifices (mucous membranes) or allergic reactions after taking Ketoprofen Dompé, you should stop taking the medicine and immediately inform your doctor.
If you notice symptoms of gastrointestinal bleeding (e.g. bright red or black, tarry stools, vomiting blood or dark particles resembling coffee grounds), you should stop taking the medicine and immediately contact your doctor.
If you experience symptoms of ulceration or perforation (symptoms may include severe abdominal pain, chills, nausea, vomiting, heartburn) after taking Ketoprofen Dompé, you should stop taking the medicine and immediately inform your doctor.
Elderly patients may experience more adverse effects from NSAIDs, especially gastrointestinal effects, which can be fatal (see section 3 "How to take Ketoprofen Dompé"). Elderly patients should use this product cautiously.
Taking anti-inflammatory and analgesic medicines such as ketoprofen may be associated with a slightly increased risk of heart attack or stroke, particularly when used at high doses and for prolonged periods. Do not exceed the recommended dose or duration of treatment.
Avoid using Ketoprofen Dompé with other products containing NSAIDs (e.g. ibuprofen, aspirin, celecoxib).
Skin reactions:
Very rarely, severe, sometimes fatal skin reactions have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see section 4 "Possible side effects"). The risk of such reactions is likely highest during the initial period of treatment—most cases occurred within the first month of treatment. Ketoprofen Dompé should be discontinued at the first signs of rash, mucosal lesions, or any other symptoms of hypersensitivity.
You should discontinue the medicine if you experience any visual disturbances, such as blurred vision.
Prolonged use of analgesic medicines for headache may worsen the headaches.
Before starting Ketoprofen Dompé, discuss with your doctor or pharmacist:

if you are pregnant, trying to become pregnant, or breastfeeding (see section 2 "Pregnancy and breastfeeding");
if you have fluid retention or edema;
if you have high blood pressure, weakened heart function, arterial disease, and/or cerebrovascular disease (disease of blood vessels supplying the brain);
if you have uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate cardiac pumping), confirmed ischemic heart disease (heart disease due to reduced blood flow caused by blocked coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of brain arteries and blood vessels), as in such cases Ketoprofen Dompé should only be used after careful evaluation by a doctor;
if you have hematopoietic disorders (affecting blood cell formation and maturation), systemic lupus erythematosus (an autoimmune disease), or mixed connective tissue disease, as Ketoprofen Dompé should be used cautiously in these conditions;
if you have liver disease;
if you have kidney disease;
if you have allergies (e.g. hay fever);
if you have chronic obstructive pulmonary disease (COPD);
if you have hepatic porphyria (a rare blood disorder characterized by altered activity of a liver enzyme), as administration of the medicine may trigger an attack;
if you have an infection - see section "Infections" below.

Infections
Ketoprofen Dompé may mask symptoms of infection, such as fever and pain. Therefore, Ketoprofen Dompé may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox.
If you take this medicine during an existing infection and symptoms persist or worsen, you should immediately consult your doctor.
Children and adolescents
Ketoprofen Dompé should not be given to children under 16 years of age.
Ketoprofen Dompé and other medicines
Inform 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 available without a prescription and herbal products.
It is not recommended to use Ketoprofen Dompé in combination with the following medicines:

Other anti-inflammatory drugs, such as NSAIDs, selective cyclooxygenase-2 inhibitors, and high-dose salicylates (over 3 g per day);
Medicines that slow blood clotting (e.g. heparin and warfarin);
Medicines that inhibit platelet aggregation (e.g. ticlopidine and clopidogrel);
Lithium (a medicine used to treat certain psychiatric disorders and depression);
Methotrexate at doses 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).

Exercise caution when using Ketoprofen Dompé in combination with the following medicines:

Medicines that may increase blood potassium levels (e.g. potassium chloride and other potassium salts, heparin, cyclosporine, tacrolimus, and trimethoprim);
Antiretroviral medicines used to treat HIV infection (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 receptor antagonists, beta-blockers);
Methotrexate at doses 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. sulfonylureas);
Medicines used to treat heart failure and to regulate heart rhythm (e.g. cardiac glycosides).

Combinations with Ketoprofen Dompé that should be considered:

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 transplant rejection (e.g. cyclosporine, tacrolimus);
Medicines improving blood flow, such as anticoagulants (e.g. aspirin, warfarin, heparin, ticlopidine or clopidogrel, thrombolytics):
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 lysine salt, alcohol consumption should be avoided.
Alcohol may irritate the throat, stomach, and intestines, thereby increasing the risk of bleeding and ulceration when NSAIDs are taken concurrently with alcohol.
Pregnancy, breastfeeding, and effects on fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ketoprofen Dompé during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both you and your baby and may delay or prolong labor. During the first 6 months of pregnancy, Ketoprofen Dompé should not be used unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From the 20th week of pregnancy, Ketoprofen Dompé may cause kidney problems in the unborn child, which may lead to reduced amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, your doctor may recommend additional monitoring.
Use of the medicine close to delivery may cause circulatory and respiratory disturbances in the unborn child.
Therefore, Ketoprofen Dompé should NOT be taken during the third trimester of pregnancy (see section "When not to take Ketoprofen Dompé").
Breastfeeding
There are no available data on the passage of ketoprofen into human milk.
Ketoprofen is not recommended for use in breastfeeding women.
Fertility
The use of NSAIDs, including Ketoprofen Dompé, may impair female fertility and is not recommended for women attempting to conceive.
You should discontinue Ketoprofen Dompé if you experience difficulty conceiving or during fertility investigations.
Driving and operating machinery
If after taking Ketoprofen Dompé you feel drowsy, dizzy, experience blurred vision, or seizures, you should not drive, operate machinery, or perform any other activities requiring high levels of psychomotor performance (see section 4 "Possible side effects").
Ketoprofen Dompé contains aspartame
This medicine contains 0.70 mg of aspartame per 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 improper excretion.
Ketoprofen Dompé contains sucrose (in lemon flavor) and glucose (in lime flavor)
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Ketoprofen Dompé contains sodium (in lime, lemon, and frescofort flavors)
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, meaning the medicine is considered "sodium-free."

3. How to use Ketoprofen Dompé

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
The recommended dose is 1 sachet, up to two times daily, as needed.
There should be an interval of at least 8 hours between doses.
Do not exceed the recommended dose.
Duration of use
Adults: If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.
Adolescents: If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Use in children
Ketoprofen Dompé must 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 may reduce the dose to the lowest possible.
Impaired liver or kidney function
In patients with mild to moderate impairment of liver or kidney function, the doctor may reduce the dose to the lowest effective.
Ketoprofen Dompé must not be used in patients with severe impairment of liver or kidney function.
Method of administration
Ketoprofen Dompé is administered orally.
The contents of the sachet should be placed directly on the tongue. The granules must not be chewed. The granules should be moistened with saliva and immediately swallowed, with or without water.
Overdose of Ketoprofen Dompé
If an overdose of Ketoprofen Dompé is accidentally taken, the patient may feel drowsy or experience nausea. Immediate medical advice should be sought, even if feeling well.
There is no known specific antidote for ketoprofen overdose. In case of suspected significant overdose, gastric lavage and symptomatic and supportive treatment are recommended.
Missed dose of Ketoprofen Dompé
If a dose of Ketoprofen Dompé is missed, it should be taken as soon as possible.
Do not take a double dose to make up for a missed dose. Always maintain a minimum interval of 8 hours between doses, and do not exceed the maximum of 2 sachets per day.
Discontinuation of Ketoprofen Dompé
The patient should stop taking this medicine as soon as they feel better.
If there are any further doubts regarding the use of this medicine, consult a pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The most commonly observed adverse events are related to the gastrointestinal tract.
Treatment with Ketoprofen Dompé should be discontinued and medical advice should be sought immediately
if at any time during treatment with this medicine the patient experiences:

signs of gastrointestinal bleeding , such as: bright red stool, tarry black stool, vomiting blood or dark particles resembling coffee grounds;
skin rash symptoms [including maculopapular rash (skin rash with spots and bumps), purpura (purple skin lesions caused by abnormal blood accumulation), acute generalized exanthematous pustulosis (skin rash with pustule formation), dermatitis (skin irritation), severe skin reactions: (including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis) and formation of blisters on the skin, mouth and eyes;
signs of severe allergic reaction , such as:
- difficulty breathing or unexplained wheezing;
- dizziness or rapid heartbeat;
- swelling of lips, face, throat or tongue (which may cause breathing or swallowing difficulties);
worsening of Crohn's disease and ulcerative colitis (chronic inflammatory bowel disease with symptoms of abdominal pain, diarrhea, fever and weight loss).

Other adverse reactions associated with Ketoprofen Dompé may include:
Common (may occur in up to 1 in 10 people)

digestive disturbances (dyspepsia), nausea, abdominal pain, vomiting

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

headache, dizziness, drowsiness
constipation, diarrhea, flatulence (passing gas), gastritis (inflammation of the stomach lining), abdominal discomfort
oedema and peripheral oedema (swelling due to fluid retention), chills, fatigue
itching and skin rash

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

haemorrhagic anaemia (reduced haemoglobin concentration in blood, the substance that carries oxygen in blood, caused by bleeding)
numbness
blurred vision
tinnitus (ringing in the ears)
asthma (inflammation of the bronchi and narrowing of the airways)
stomatitis (inflammation of the mucous membrane of the mouth), gastric ulcers (sores in the stomach or upper intestine), colitis (inflammation of the inner lining of the large intestine)
hepatitis, increased transaminase activity (elevated levels of certain enzymes indicating liver function), increased blood bilirubin concentration (a substance indicating 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 oedema, asthenia (weakness)
dyskinesia (involuntary movements), fainting
hypotension (low blood pressure)
laryngeal oedema (swelling of the throat due to fluid accumulation)
haematuria (presence of blood in urine)

Not known (frequency cannot be estimated from available data)

thrombocytosis (reduced number of blood platelets), agranulocytosis (marked decrease in a type of white blood cells), bone marrow failure (reduced blood cell production by the bone marrow), haemolytic anaemia (reduced haemoglobin concentration in blood, the substance that carries oxygen in blood, caused by destruction of red blood cells), leukopenia (low white blood cell count), neutropenia (reduced number of a type of white blood cells), aplastic anaemia (reduced haemoglobin concentration in blood, the substance that carries oxygen in blood, caused by insufficient blood cell production by the bone marrow), leukocytosis (increased white blood cell count), thrombocytopenic purpura (skin lesions caused by reduced platelet count)
anaphylactic reactions (severe allergic reactions, including shock), hypersensitivity (allergy)
depression, hallucinations (perception of sensations that do not exist), confusion, mood swings, agitation, insomnia
convulsions (involuntary body movements), taste disturbances (altered taste perception), tremor, hyperkinesia (involuntary and uncontrolled movements)
periorbital oedema (swelling around the eyes)
heart failure (inability of the heart to pump enough blood to meet the body's needs), atrial fibrillation (irregular 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 confirmed hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), laryngospasm, acute respiratory failure (single case reported resulting in death in a patient with asthma and sensitivity to acetylsalicylic acid)
gastrointestinal bleeding, gastrointestinal perforation (in some cases leading to death, particularly in elderly patients), gastric ulcer (sore in the stomach), duodenal ulcer (sore in the upper part of the intestine), heartburn, lip swelling, pancreatitis, hyperacidity (excess acid in the stomach), stomach discomfort, stomach pain, erosive gastritis (severe inflammation of the stomach lining), tongue oedema
photosensitivity (sensitivity to sunlight or UV lamps), alopecia (hair loss), urticaria, erythema and rash
acute renal failure (reduced kidney function), tubulointerstitial nephritis, nephritic syndrome (kidney inflammation), nephrotic syndrome (kidney changes involving protein loss in urine), glomerulonephritis (inflammatory kidney disease), water/sodium retention with possible oedema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (serious kidney damage), oliguria (reduced urine production), abnormal kidney function test results
aseptic meningitis (inflammation of the membranes covering the brain, not caused by infection), lymphangitis
Hyperkalaemia (increased potassium concentration in blood) and hyponatraemia (decreased sodium concentration in blood).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ketoprofen Dompé

Keep this medicine out of 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 indicated.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What Ketoprofen Dompé contains

The active substance is ketoprofen. Each sachet contains 50 mg of ketoprofen (in the form of ketoprofen lysine salt).
The other components are: Povidone (E 1201), colloidal anhydrous silica (E 551), hypromellose, basic butyl methacrylate copolymer, sodium lauryl sulfate, stearic acid (E 570), magnesium stearate (E 572), mannitol (E 421), xylitol (E 967), talc (E 553B), lemon flavour (contains maltodextrin, modified starch E 1450, glucose, butylated hydroxyanisole E 320, bergamot oil, sodium), citrus flavour (contains sucrose, maltodextrin, modified starch E 1450, sodium), and frescofort flavour (contains arabic gum, sodium).

What Ketoprofen Dompé looks like and contents of the pack
Ketoprofen Dompé is a granulate ranging in colour from white to ivory, in sachets.
Each pack contains 10 sachets.
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria Ketoprofen Dompé 50 mg obviti granuli v sashe
Croatia Ketoprofen Dompé 50 mg obložene granule u vrećici
Poland Ketoprofen Dompé
Romania Ketoprofen Dompé 50 mg granule drajefiate în plic
Italy Ketoprofene Dompé