Package leaflet: Information for the patient

Ketoprofen-SF, 50 mg/ml, solution for injection
For use in adults only
Ketoprofenum
Please read all of this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again. If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

What Ketoprofen-SF is and what it is used for
Important information before using Ketoprofen-SF
How to use Ketoprofen-SF
Possible side effects
How to store Ketoprofen-SF
Contents of the pack and other information

1. What Ketoprofen-SF is and what it is used for

Ketoprofen-SF is used for symptomatic treatment of acute severe pain in the following conditions:

Acute arthritis,
Chronic arthritis, especially rheumatoid arthritis (chronic polyarthritis),
Ankylosing spondylitis (Bechterew's disease) and other rheumatic inflammatory conditions of the spine,
Exacerbation of degenerative joint and spinal disease (osteoarthritis).

2. Important information before using Ketoprofen-SF

When not to use Ketoprofen-SF:

if the patient is allergic to ketoprofen, benzyl alcohol, or any of the other ingredients of this medicine (listed in section 6),
if the patient has ever experienced bronchospasm, bronchial asthma attack, nasal mucosal swelling (rhinitis), skin reactions (urticaria), or other allergic reactions after taking ketoprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs),
if the patient has ever experienced skin hypersensitivity reactions to light (photoallergic or phototoxic reactions) while taking ketoprofen or fibrates (lipid-lowering drugs),
if the patient has unexplained disorders of the blood-forming system (responsible for blood component production),
if the patient has active gastrointestinal ulcer (peptic ulcer disease of the stomach and/or duodenum) or a history of gastrointestinal bleeding, ulcers, or gastrointestinal perforation,
if the patient has a bleeding tendency,
coagulation disorders or treatment with anticoagulant drugs,
if the patient has cerebral hemorrhage (bleeding from cerebral vessels) or other active bleeding,
if the patient has severe heart failure,
if the patient has severe liver or kidney function disorders,
in children and adolescents under 18 years of age,
during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with Ketoprofen-SF, discuss this with your doctor or pharmacist.
Inform your pharmacist or doctor if the patient has an infection – see below, the section titled “Infections”.
The section “Warnings and precautions” contains information about when the patient may use Ketoprofen-SF only under certain conditions (i.e., with longer intervals between doses or at lower doses, with simultaneous monitoring of body functions). However, even in such cases, special caution is required. For further information, contact your doctor.
This section also applies to patients who have previously experienced the situations described below.
The injection solution is indicated only when a rapid onset of action is required or when oral or rectal administration of drugs is impossible. In such cases, treatment is usually given as a single initial injection.
Using the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Effect on the gastrointestinal tract (stomach and intestines)
Avoid concomitant use of Ketoprofen-SF with other drugs from the NSAID group (non-steroidal anti-inflammatory drugs), including so-called selective cyclooxygenase-2 inhibitors.
Elderly patients
When using NSAIDs, the risk of adverse effects, especially gastrointestinal bleeding or perforation, which may be fatal, is higher in elderly patients. For this reason, elderly patients require special medical care.
Gastrointestinal bleeding, ulcers, and perforations
Gastrointestinal bleeding, ulcers, or perforations, which may be fatal, have been reported for all NSAIDs, at any time during treatment, with or without warning symptoms or serious gastrointestinal events in the patient's history.
Epidemiological data indicate that the use of ketoprofen may be associated with increased gastrointestinal toxicity compared to other NSAIDs, especially when higher doses are used.
The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses in patients with a history of peptic ulcer disease, particularly if complicated by bleeding or perforation (see section 2 “When not to use Ketoprofen-SF”), and in elderly patients. Therefore, treatment in elderly patients should be initiated with the lowest available dose.
Consideration should be given to combined therapy with protective agents (e.g., misoprostol or proton pump inhibitors) in these patients, as well as in patients requiring concomitant treatment with low-dose acetylsalicylic acid and other drugs increasing the risk of gastrointestinal adverse effects.
Patients, especially elderly ones, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Caution is advised in patients taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) like warfarin, selective serotonin reuptake inhibitors (used, among others, in depression treatment), or antiplatelet drugs such as acetylsalicylic acid (see section 2 “Ketoprofen-SF and other medicines”).
The relative risk of gastrointestinal bleeding is higher in patients with low body weight. If gastrointestinal ulceration or bleeding occurs, Ketoprofen-SF should be discontinued immediately.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as these drugs may exacerbate these conditions (see section 4 “Possible side effects”).
Effect on the circulatory system
Taking medicines such as Ketoprofen-SF may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher with long-term use of high doses. Do not use higher doses or longer treatment durations than recommended.
If the patient has heart problems, a history of stroke, or suspected risk of these conditions (e.g., high blood pressure, diabetes, elevated cholesterol levels, smoking), discuss the treatment approach with a doctor or pharmacist.
Caution is recommended in patients with hypertension and/or mild to moderate heart failure in their history, as fluid retention and edema have been reported with NSAID treatment.
Skin reactions
Very rare cases of serious and sometimes fatal skin reactions – with redness, blisters – have been reported during NSAID treatment (including, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell’s syndrome); see section 4 “Possible side effects”). The risk of these reactions is probably higher at the beginning of treatment, as most cases occurred within the first month of treatment. At the first signs of skin rash, mucosal changes, or other symptoms of hypersensitivity reactions, Ketoprofen-SF should be discontinued immediately and medical advice sought.
Photoallergic reactions caused by NSAIDs are well-known adverse effects of this drug group and are most commonly attributed to UV radiation. Ketoprofen causes an increased risk of photoallergic contact dermatitis. Symptoms may sometimes appear after a latency period of hypersensitivity. Skin symptoms may persist for several months after discontinuation of the drug. If a photoallergic reaction occurs in patients taking Ketoprofen-SF, treatment should be discontinued and medical advice sought.
Infections
Ketoprofen-SF may mask objective signs of infection, such as fever and pain. Therefore, Ketoprofen-SF may delay appropriate treatment of infection and consequently 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 during an ongoing infection and infection symptoms persist or worsen, medical advice should be sought immediately.
Other information
Ketoprofen-SF should be used only after careful consideration of the benefit-risk ratio in patients with specific congenital blood production disorders (porphyria).
Close medical supervision is required in the following cases:

in patients with pre-existing kidney damage,
in patients with liver function disorders,
in patients immediately after major surgery,
in patients with allergies (e.g., skin reactions to other drugs, asthma, hay fever), chronic rhinitis, chronic respiratory diseases with airway constriction,
in patients taking potent diuretics,
in patients taking NSAIDs or other painkillers,
in patients with blood clotting disorders and those taking anticoagulants.

Acute hypersensitivity reactions (e.g., anaphylactic shock) are very rarely observed.
If the first symptoms of severe hypersensitivity reactions occur after taking Ketoprofen-SF, the medicine should be discontinued. Depending on symptoms, any medical intervention must be performed by a specialist.
If visual disturbances occur, such as blurred vision, treatment should be discontinued.
Ketoprofen, the active substance in Ketoprofen-SF, may temporarily inhibit platelet aggregation. Patients with blood clotting disorders should be closely monitored.
If anticoagulants (blood-thinning drugs) or blood glucose-lowering drugs are used during ketoprofen treatment, blood glucose and coagulation should be carefully monitored.
Diabetes or concomitant use of potassium-sparing drugs may lead to hyperkalemia (see section 2 “Ketoprofen-SF and other medicines”). In such cases, potassium levels in the blood should be regularly monitored.
Like other NSAIDs, ketoprofen may mask symptoms of infectious diseases.
In patients with abnormal liver function test results or a history of liver disease, aminotransferase levels should be periodically checked, especially during long-term treatment.
During prolonged use of Ketoprofen-SF, regular monitoring of liver enzyme activity, kidney function, and blood morphology is required.
Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to acetylsalicylic acid or NSAIDs than the general population. Taking this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs (see section 2 “When not to use Ketoprofen-SF”).
Inform your doctor or dentist about taking Ketoprofen-SF before any surgical procedure.
Prolonged use of painkillers may cause headache, which should not be treated by increasing the dose of the medicine. If frequent headaches occur despite treatment with Ketoprofen-SF, consult a doctor.
Chronic use of painkillers, especially when multiple painkillers are taken simultaneously, may lead to permanent kidney damage, including kidney failure (analgesic nephropathy).
Ketoprofen-SF and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Concomitant use of Ketoprofen-SF and digoxin (used to strengthen heart muscle) may worsen heart failure and lead to increased digoxin serum concentration. Monitoring of digoxin serum levels is recommended.
Concomitant use of Ketoprofen-SF with drugs containing phenytoin (used in epilepsy treatment) or lithium (used in psychiatric disorders) may increase their serum concentrations, sometimes leading to toxic lithium levels in serum due to reduced renal lithium excretion. Serum lithium concentrations should be carefully monitored, and monitoring of phenytoin serum concentration is recommended.
Ketoprofen-SF may reduce the effectiveness of diuretics (fluid-reducing drugs), beta-blockers, and drugs used to treat hypertension.
Ketoprofen-SF may reduce the effectiveness of angiotensin-converting enzyme inhibitors (drugs used in heart failure and hypertension treatment). Additionally, concomitant use of these drugs may increase the risk of kidney function disorders.
Concomitant use of Ketoprofen-SF and potassium-sparing diuretics (a group of fluid-reducing drugs) may lead to increased blood potassium concentration. Blood potassium levels should be monitored.
Concomitant use of Ketoprofen-SF with other NSAIDs (including selective cyclooxygenase-2 inhibitors) or glucocorticoids increases the risk of gastrointestinal ulcers or bleeding.
Antiplatelet drugs (inhibiting or reducing blood clotting) such as acetylsalicylic acid, tirofiban, eptifibatide, abciximab, iloprost, and certain antidepressants (selective serotonin reuptake inhibitors - SSRIs) may increase the risk of gastrointestinal bleeding.
Administration of Ketoprofen-SF within 24 hours before or after methotrexate (a drug used in cancer and autoimmune disease treatment) may lead to increased methotrexate concentration and increase its adverse effects.
Concomitant use of Ketoprofen-SF with cyclosporine or tacrolimus carries a risk of additive kidney toxicity, especially in elderly patients.
Drugs containing probenecid and sulfinpyrazone (used in gout treatment) may delay ketoprofen excretion. This may lead to excessive accumulation of Ketoprofen-SF in the body and increase the frequency and severity of adverse effects.
NSAIDs may enhance the effect of anticoagulants (blood thinners) such as warfarin.
To date, clinical studies have not shown interactions between ketoprofen and oral antidiabetic drugs (used in diabetes treatment). Nevertheless, preventive monitoring of blood glucose levels during concomitant treatment is recommended.
Concomitant use of loop diuretics (used in hypertension treatment) may increase the frequency of kidney function disorders.
Drugs neutralizing gastric juice may reduce ketoprofen absorption in the intestine.
Concomitant use of pentoxifylline (a drug used in intermittent claudication treatment) with Ketoprofen-SF may increase the risk of bleeding.
Administration of antibiotics (drugs used to combat bacterial infectious diseases) such as quinolone derivatives may increase the risk of seizures.
Ketoprofen-SF enhances the effect of thrombolytic drugs (drugs preventing blood clot formation).
Certain medicinal products or therapeutic groups of drugs may lead to hyperkalemia, e.g., potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim. The occurrence of hyperkalemia may depend on several concurrent risk factors. This risk is greater when the mentioned drugs are used simultaneously.
Ketoprofen-SF and alcohol
Do not consume alcohol while taking Ketoprofen-SF.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Ketoprofen-SF if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart disorders in the unborn child. It may increase the tendency to bleeding in the mother and child and may cause delay or prolongation of delivery.
During the first 6 months of pregnancy, Ketoprofen-SF should not be used unless the doctor considers its use absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ketoprofen-SF may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
There are no data on ketoprofen passage into breast milk. Use of Ketoprofen-SF is not recommended in breastfeeding women.
Ketoprofen-SF may impair fertility. Inform the doctor if the patient plans to conceive or has problems conceiving.
Driving and operating machinery
Since adverse effects on the central nervous system (e.g., fatigue, dizziness) may occur during use of higher doses of Ketoprofen-SF, reaction ability may be delayed in individual cases, and the ability to drive and operate machinery may be impaired. This is particularly applicable when alcohol is consumed simultaneously.
Patients should be informed about the possibility of drowsiness, dizziness, or seizures and advised not to drive or operate machinery if such symptoms occur.
Patients should be informed about the possibility of visual disturbances. If such symptoms occur, the patient should not drive or operate machinery.
Ketoprofen-SF contains benzyl alcohol
This medicine contains 50 mg of benzyl alcohol in each ampoule, equivalent to 25 mg/ml of injection solution.
Pregnant or breastfeeding women and patients with liver or kidney diseases should contact a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to use Ketoprofen-SF

This medicine should always be used exactly as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If signs of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Ketoprofen-SF is particularly suitable for the treatment of acute pain. Dosage should be individually adjusted according to observed symptoms.
Treatment with Ketoprofen-SF solution for injection should consist of a single injection. In severe cases, Ketoprofen-SF may be administered twice daily.
In such cases, the injection site must be changed each time.
Do not exceed the daily dose of 200 mg.
If further treatment is required, ketoprofen in tablet, capsule, or suppository form should be used.

Use in children and adolescents
Ketoprofen-SF must not be used in children and adolescents under 18 years of age (see also section 2, "When not to use Ketoprofen-SF").

Route of administration
Ketoprofen-SF solution for injection is usually administered by a physician or nurse. Due to the route of administration of Ketoprofen-SF, consult your doctor or pharmacist in case of doubt.
Ketoprofen-SF is injected slowly and deeply into the buttock. As with other non-steroidal anti-inflammatory drugs, the patient should be observed for at least one hour after administration of Ketoprofen-SF due to the risk of anaphylactic (allergic) reactions.
Medicinal products intended for parenteral administration should be inspected visually before use. Only clear solutions without visible particles should be used.

Use of a higher than recommended dose of Ketoprofen-SF
Inform your doctor immediately if an overdose of Ketoprofen-SF is suspected. The physician will decide on appropriate preventive measures based on the severity of intoxication.
Symptoms of overdose may include central nervous system disturbances such as headache, dizziness, drowsiness, mental confusion, and loss of consciousness, as well as abdominal pain, diarrhoea, nausea, and vomiting. Additionally, arterial hypotension, respiratory depression (decreased respiratory rate), gastrointestinal bleeding, and skin and mucous membrane cyanosis (purpura) may occur.
There is no specific antidote.

Missed dose of Ketoprofen-SF
Do not use a double dose to make up for a missed dose. Continue using Ketoprofen-SF as recommended.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When considering the adverse effects listed below, it should be remembered that they are mainly dose-dependent and may vary between individual patients.
Adverse effects most commonly affect the gastrointestinal tract. Gastrointestinal ulceration (peptic ulcer), perforation, or bleeding – sometimes with fatal outcome – may occur, particularly in elderly patients (see section 2 "Warnings and precautions"). After administration of Ketoprofen-SF, nausea, vomiting, diarrhoea, flatulence (passing gas), constipation, indigestion, abdominal pain, melaena (black, tarry stools), haematemesis (vomiting blood), ulcerative stomatitis (small ulcers or painful swellings of the oral mucosa and tongue), and worsening of symptoms of colitis and Crohn's disease have been reported (see section 2 "Warnings and precautions"). Gastritis (inflammation of the gastric mucosa) has been observed less frequently. The risk of gastrointestinal bleeding particularly depends on the dose and duration of treatment.
Oedema, high blood pressure, and heart failure have been reported in association with treatment with NSAIDs.
Use of medicines such as Ketoprofen-SF may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
The following adverse effects have been reported with ketoprofen use in adults:

Very common (may affect more than 1 in 10 people)
Gastrointestinal disturbances such as nausea, vomiting, heartburn, stomach pain, flatulence, constipation or diarrhoea, and minor gastrointestinal bleeding, which in isolated cases may lead to anaemia.

Common (may affect up to 1 in 10 people)
Hypersensitivity reactions such as skin rash and itching, insomnia, restlessness, irritability, headache, dizziness, fatigue, gastrointestinal ulceration with bleeding and perforation in some cases, fluid accumulation in the upper or lower limbs (peripheral oedema), particularly in patients with high blood pressure.
After intramuscular administration, adverse effects at the injection site (pain and burning sensation) or tissue damage (formation of sterile abscess, destruction of fatty tissue) may occur.

Uncommon (may affect up to 1 in 100 people)
Somnolence, visual disturbances (see section 2 "Warnings and precautions"), tinnitus (ringing in the ears), haematemesis (vomiting blood), black, tarry stools (melaena), stomatitis (inflammation of the oral mucosa), gastritis.
If moderate to severe epigastric pain, haematemesis, blood in stools and/or black discoloration of stools occurs, treatment with Ketoprofen-SF should be discontinued immediately and medical advice sought without delay.
Liver function disorders, photosensitivity, rash, itching, oedema, fluid retention in the body (oedema), excessive loss of protein in urine (nephrotic syndrome), inflammatory changes in kidney tissue (interstitial nephritis), kidney function disorders.
Reduced urine output, fluid accumulation in the body (oedema), and general malaise may be symptoms of kidney dysfunction, even leading to kidney failure.

Rare (may affect up to 1 in 1,000 people)
Haemorrhagic anaemia, leukopenia, asthma, hepatitis, increased aminotransferase activity, increased serum bilirubin levels due to liver disorders, hyperkalaemia (see section 2 "Ketoprofen-SF and other medicines"), colitis.

Very rare (may affect up to 1 in 10,000 people)
Cases of worsening of inflammatory conditions associated with infection (e.g. development of necrotizing fasciitis) have been described in connection with the use of NSAIDs, including Ketoprofen-SF.
Therefore, immediate medical advice should be sought if signs or symptoms of infection appear or worsen (e.g. redness, swelling, warmth, pain, fever) during treatment with Ketoprofen-SF.
Haemolytic anaemia (caused by accelerated breakdown of red blood cells), blood disorders (aplastic anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms may include: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, nosebleeds, and bleeding under the skin. In such cases, Ketoprofen-SF should be discontinued immediately and a doctor consulted. The above symptoms should not be treated with analgesics or antipyretics.
Blood morphology should be monitored regularly during long-term treatment.
Acute hypersensitivity reactions. Symptoms include: facial swelling, tongue swelling, internal laryngeal oedema with narrowing of the airways, shortness of breath, palpitations, decreased blood pressure, and even life-threatening anaphylactic shock.
Immediate medical advice should be sought if early signs of these symptoms occur, which may appear even after the first dose of Ketoprofen-SF.
Heart failure, myocardial infarction, arterial hypertension, pancreatitis, liver damage (particularly during long-term treatment), hair loss (alopecia), serious skin reactions such as skin rash with redness and blisters (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis – Lyell's syndrome), kidney damage (papillary necrosis), particularly during prolonged treatment, as well as increased uric acid levels, acute tubular necrosis.
Kidney function should be monitored regularly.
After several months of uneventful use, the skin may become photosensitive, showing signs of erythema, itching, blistering, and nodules in areas of skin exposed to sunlight or artificial UV light (e.g. solarium).

Frequency not known (frequency cannot be estimated from available data)
Mood changes, seizures, bronchospasm (particularly in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, urticaria, worsening of symptoms of chronic urticaria, angioedema, confusion, aseptic meningitis.
Benzyl alcohol may cause allergic reactions.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ketoprofen-SF

Keep this medicine out of sight and reach of children.
Do not use Ketoprofen-SF after the expiry date stated on the ampoule and carton after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
The medicine should be used immediately after opening.
This medicine is for single use only.
Do not use Ketoprofen-SF if signs of deterioration are observed.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ketoprofen-SF contains
The active substance is ketoprofen.
1 ml of injection solution contains 50 mg of ketoprofen.
One 2 ml ampoule of injection solution contains 100 mg of ketoprofen (Ketoprofenum).
Excipients: benzyl alcohol, arginine, citric acid monohydrate, water for injections.

What Ketoprofen-SF looks like and contents of the pack
Ketoprofen-SF 50 mg/ml is a clear, colourless to slightly yellow injection solution.
One pack contains 1 amber glass ampoule with 2 ml of injection solution.
Ketoprofen-SF is available in packs containing 1, 5, 10, 20, 30 or 50 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna, Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Gabrilen N i.m.
Poland: Ketoprofen-SF

Ketoprofen-sf