Ketoprofen Dompé

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Ketoprofen Dompé, 50 mg, granules for oral solution, in sachet

ketoprofen (in the form of ketoprofen lysinate)

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

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

Ketoprofen Dompé, 50 mg, granules for oral solution, in sachet contains the active substance "ketoprofen", which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is used to relieve pain and inflammation.
Ketoprofen Dompé is used
in adultsfor the symptomatic treatment of pain and inflammation in conditions such as:

• rheumatoid arthritis (a chronic inflammatory disease of immunological origin affecting the joints),
• chronic inflammation of the spine,
• painful arthritis,
• rheumatic diseases affecting structures outside the joints,
• inflammation after injury,
• painful inflammatory conditions in the mouth (including teeth), throat, nose, ears, urinary tract, and respiratory tract.

in adolescents from 16 years of agefor the symptomatic and short-term treatment of pain and inflammation with or without fever in conditions such as:

• bone and joint disorders,
• post-operative pain,
• ear inflammation.

2. Important information before taking Ketoprofen Dompé

When not to take Ketoprofen Dompé

• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other NSAIDs (e.g. aspirin, ibuprofen);
• if the patient has asthma;
• if the patient has severe heart failure;
• if the patient has severe kidney or liver disorders;
• if the patient has stomach ulcers or bleeding, Crohn's disease, ulcerative colitis (gastrointestinal disease) or inflammation of the stomach lining;
• in patients with recurrent stomach ulcers, bleeding into the stomach or intestines, ulcers, perforation, chronic gastrointestinal disorders, perforation of the gastrointestinal tract in their medical history;
• if the patient has a low blood cell count (leukopenia or thrombocytopenia), bleeding, or a tendency to bleed during treatment with medicines that help prevent blood clots (anticoagulants);
• if the patient is undergoing intensive diuretic treatment (to reduce the amount of fluid in the blood vessels);
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Ketoprofen Dompé, the patient should discuss it with their doctor or pharmacist.
The risk of side effects can be minimized by using the smallest effective dose for the shortest possible period necessary to control the symptoms.
The patient should avoid taking Ketoprofen Dompé at the same time as other NSAIDs (including selective cyclooxygenase-2 inhibitors).
Taking anti-inflammatory (pain-relieving) medicines like ketoprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses and for a long time. Do not exceed the recommended dose or treatment duration.
The patient should stop taking ketoprofen if:

• if the patient notices symptoms of bleeding into the stomach or intestines (e.g. bright red stools, black, tarry stools, vomiting blood or dark particles that look like coffee grounds), they should stop taking the medicine and immediately consult their doctor. The risk of bleeding is higher when taking high doses, in elderly patients, and in patients with a history of ulcers.
• 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 immediately consult their doctor.
• If the patient notices any symptoms of rash, red, painful skin around body openings (mucous membranes) or allergic reactions after taking Ketoprofen Dompé, they should stop taking the medicine and immediately consult their doctor.
• if the patient experiences vision disturbances, including blurred vision.
• if the patient has abnormal liver function test results.

Before starting treatment with Ketoprofen Dompé, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney disease (e.g. nephrotic syndrome, chronic kidney failure) or is taking diuretics (medicines used to increase urine production).
• if the patient has heart disorders, such as high blood pressure, heart failure, arterial disease, and (or) disorders of the blood vessels supplying the brain, diabetes, high cholesterol, a positive family history of heart disease or stroke, or if the patient smokes.
• if the patient has liver disease (e.g. cirrhosis) or abnormal liver function test results.

if the patient has any allergy (e.g. hay fever)

• if the patient has asthma or other respiratory disease, as the medicine may cause asthma attacks or anaphylaxis.
• if the patient has an immune system disease that causes joint pain, skin changes, and disorders of other organs (systemic lupus erythematosus).
• if the patient has an infection - see "Infections" below.
• if the patient is pregnant, trying to become pregnant, or breastfeeding (see section 2).

Infections

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

Children and adolescents

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

Elderly

This medicine should be used with caution in the elderly, as they may experience more gastrointestinal side effects, which can be fatal. Treatment should be started with the lowest possible dose, and any unusual symptoms, especially at the beginning of treatment, should be reported.

Patients with a history of gastrointestinal disorders

Ketoprofen should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as it may exacerbate the disease. Treatment should be started with the lowest possible dose, and any unusual symptoms, especially at the beginning of treatment, should be reported.

Ketoprofen Dompé and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• other NSAIDs (e.g. aspirin, ibuprofen) or paracetamol, as this may increase the risk of stomach and intestinal bleeding.
• blood-thinning medicines, such as anticoagulants (aspirin, warfarin, heparin, ticlopidine, or clopidogrel), thrombolytics (reteplase, streptokinase);
• medicines used in certain mental disorders and depression (e.g. lithium and selective serotonin reuptake inhibitors (SSRIs));
• medicines used in cancer treatment (e.g. erlotinib, methotrexate);
• medicines used in epilepsy treatment (e.g. hydantoin, diphenylhydantoin);
• certain antibiotics (e.g. quinolones, sulfonamides);
• medicines that may increase potassium levels in the blood (e.g. potassium chloride);
• medicines used to prevent organ rejection after transplantation (e.g. cyclosporine, tacrolimus);
• antiretroviral medicines used to treat HIV infection (e.g. ritonavir, zidovudine);
• diuretics, such as bendroflumethiazide, as there is a higher risk of kidney failure and the effect of diuretics may be reduced;
• medicines used to treat high blood pressure (e.g. ACE inhibitors and angiotensin II antagonists, beta-blockers);
• corticosteroids (steroid hormones, such as hydrocortisone or prednisolone);
• muscle relaxants, such as baclofen;
• medicines used to treat heart failure and to regulate heart rhythm (e.g. digoxin, digitoxin);
• medicines used to treat diabetes (e.g. gliclazide);
• medicines used to treat gout (e.g. probenecid);
• pentoxifylline - a medicine used to treat muscle pain;
• penicillamine - a medicine used to treat rheumatoid arthritis;
• medicines used to terminate pregnancy (e.g. gemeprost, mifepristone) or if the patient uses intrauterine devices, as their effectiveness may be reduced.

Taking Ketoprofen Dompé with alcohol

The patient should avoid drinking alcohol while being treated with ketoprofen lysinate.

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.
Ketoprofen 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 affect the patient's and their baby's tendency to bleed and may cause delayed or prolonged labor. Ketoprofen should not be taken during the first six months of pregnancy, unless it is absolutely necessary and the doctor recommends it. If treatment is necessary during this time or when the patient is trying to become pregnant, the lowest possible dose should be used for the shortest possible time. If the patient takes this medicine for more than a few days starting from the 20th week of pregnancy, ketoprofen may cause kidney problems in the unborn baby, which may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.
The patient should not breastfeed while taking Ketoprofen Dompé, as it is not known whether ketoprofen passes into breast milk.
Taking Ketoprofen Dompé may reduce fertility in women and is not recommended in women who are planning to become pregnant.

Driving and using machines

Ketoprofen Dompé does not affect the ability to drive or use machines. However, if the patient experiences side effects such as dizziness, drowsiness, seizures, or vision disturbances, they should not drive or use machines.

Ketoprofen Dompé contains sodium

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

Ketoprofen Dompé contains sucrose (in the peppermint flavor)

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

3. How to take Ketoprofen Dompé

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest possible period necessary to relieve the symptoms.
The recommended dose is:
Adults and adolescents from 16 years of age:
One whole double sachet, equivalent to 50 mg of ketoprofen (which corresponds to 80 mg of ketoprofen lysinate), three times a day, preferably with meals.
The maximum daily dose of ketoprofen is 200 mg, which corresponds to 320 mg of ketoprofen lysinate.
Before starting treatment with a dose of 200 mg of ketoprofen per day, the patient should carefully weigh the benefits and risks, and taking a higher dose is not recommended.
Elderly patients:
The doctor should exercise caution when determining the dose and consider the possibility of reducing the dose.
Patients with liver failure:
The initial dose should be reduced, and maintenance treatment should be started with the smallest effective dose. Individual dose adjustment should be considered only after the patient has shown good tolerance to the medicinal product.

How to take Ketoprofen Dompé

After opening the sachet along the line marked "whole dose", the patient will obtain a dose of 50 mg of ketoprofen lysinate (which corresponds to 80 mg of ketoprofen lysinate).
The contents of the sachet should be poured into a glass filled with about half a glass of water and mixed for one minute. The solution should be taken immediately. It is best to take it with a meal.

Taking a higher dose of Ketoprofen Dompé than recommended

If the patient takes a higher dose of Ketoprofen Dompé than recommended, they may experience dizziness, nausea, stomach pain, or headache. They should seek medical attention immediately, even if they feel well.

Missing a dose of Ketoprofen Dompé

If the patient forgets to take a dose of Ketoprofen Dompé, they should take it as soon as possible.
If it is almost time for the next dose, they should not take the missed dose; they should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ketoprofen Dompé

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

4. Possible side effects

Like all medicines, Ketoprofen Dompé can cause side effects, although not everybody gets them.

The patient should stop taking Ketoprofen Dompé and seek medical attention immediately

if they experience any of the following symptoms at any time during treatment with Ketoprofen Dompé:

• symptoms of bleeding into the intestines, such as: bright red stools, black, tarry stools, vomiting blood or dark particles that look like coffee grounds;
• symptoms of rash, severe skin reactions, and blisters on the skin, mouth, and eyes;
• symptoms of a severe allergic reaction, such as:
• difficulty breathing or unexplained wheezing;
• dizziness or rapid heartbeat;
• swelling of the lips, face, throat, or tongue.

The patient should inform their doctor if they experience:

• fever, sore throat, mouth ulcers, headache, vomiting, unexplained bleeding, and fatigue;
• indigestion, stomach pain or abdominal pain, constipation, diarrhea, bloating, or nausea, chest pain or rapid, irregular heartbeat;
• liver or kidney disorders with swelling in the hands and feet.

The following side effects may occur:

Frequently(may occur in up to 1 in 10 people):

• gastrointestinal disorders (indigestion), nausea, abdominal pain, vomiting.

Less frequently(may occur in up to 1 in 100 people):

• headache, dizziness, drowsiness, sleep disturbances;
• constipation, diarrhea, bloating (gas in the intestines), inflammation of the stomach lining, discomfort in the stomach;
• skin rash, itching;
• swelling due to fluid retention;
• fatigue, chills.

Rarely(may occur in up to 1 in 1,000 people):

• iron deficiency due to bleeding;
• numbness, tingling;
• blurred vision (see section 2);
• ringing in the ears (tinnitus);
• asthma;
• mouth ulcers (stomatitis), stomach or duodenal ulcers (peptic ulcers), inflammation of the colon (colitis);
• liver inflammation, increased liver enzyme activity, high bilirubin levels due to liver disorders, yellowing of the skin or whites of the eyes (jaundice);
• weight gain.

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

• movement disorders (dyskinesia), loss of consciousness (fainting);
• low blood pressure (hypotension);
• swelling of the larynx;
• blood in the urine (hematuria);
• weakness (asthenia), facial swelling.

Frequency not known(frequency cannot be estimated from the available data):

• inflammation of the membranes surrounding the brain, inflammation of the lymphatic vessels;
• changes in blood cell and platelet counts;
• allergic reactions;
• changes in potassium levels in the blood;
• depression, hallucinations, disorientation, mood changes, restlessness, drowsiness;
• uncontrolled muscle contractions (seizures), tremors, excessive restlessness (hyperkinesia);
• taste disturbances; swelling around the eyes;
• heart failure, heart rhythm disorders, or rapid heartbeat;
• high blood pressure, hot flashes (flushing), inflammation of the blood vessels;
• respiratory failure due to bronchospasm or acute respiratory distress;
• nasal congestion and runny nose (rhinitis);
• stomach pain, worsening of gastrointestinal diseases, heartburn;
• bleeding into the stomach; symptoms may include severe stomach pain, chills, nausea, vomiting, heartburn;
• perforation of the intestine, stomach ulcers;
• pancreatitis; vomiting blood or black stools (presence of digested blood in the stool), hyperchlorhydria (excessive production of stomach acid);
• sensitivity to sunlight or UV lamps;
• hair loss;
• severe skin reactions, itchy rash, redness, changes, skin irritation, blistering;
• swelling of the deep layers of the skin (e.g. face, hands), caused by excess fluid;
• kidney failure, kidney inflammation, abnormal kidney function test results;
• fluid retention, reduced urine production.

Medicines like Ketoprofen Dompé may be associated (especially when used in high doses and for a long time) with an increased risk of arterial thrombotic events (blood clots in blood vessels), such as heart attack (myocardial infarction) or stroke (cerebrovascular event) (see section 2).
Following the instructions in this leaflet may reduce the risk of side effects.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, 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
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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The expiry date applies to products that have been stored correctly in their original, unopened packaging.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 in the form of ketoprofen lysinate. One double sachet contains 50 mg of ketoprofen, which corresponds to 80 mg of ketoprofen lysinate.
• The other ingredients are: mannitol (E 421), sodium chloride, colloidal anhydrous silica, ammonium glycyrrhizinate, povidone K25, sodium saccharin (E 954), peppermint flavor (contains: natural flavoring substances, flavoring preparations, gum arabic (E 414), sucrose, calcium phosphate (E 341))

What Ketoprofen Dompé looks like and contents of the pack

Ketoprofen Dompé is a granule with an ivory color and a mild minty smell. Ketoprofen Dompé is available in packs of 10, 20, or 30 double sachets.

Marketing authorization holder

Dompé farmaceutici S.p.A
Via San Martino 12
20122 Milano
Italy

Manufacturer

Dompé farmaceutici S.p.A.
Via Campo di Pile
67100 L’Aquila
Italy
Date of last revision of the leaflet:February 2024