Package Insert: Information for the User

Fastum 50 mg Hard Capsules

ketoprofen

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

Fastum contains ketoprofen, apain reliever that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Fastum is indicated for the treatment of:

• Rheumatoid arthritis (a disease that produces inflammation of the joints)
• Osteoarthritis(a degenerative joint disease)
• Ankylosing spondylitis (a chronic form of arthritis that causes pain and stiffness in the vertebrae and joints of the base of the spine)
• Acute gout episodes
• Mild to moderate acute pain, such as muscle or joint pain, dental pain, and menstrual pain.

Do not take Fastum

-If you are allergic to ketoprofen or any of the other components of this medication (listed in section 6).

-If you are allergic to acetylsalicylic acid or another nonsteroidal anti-inflammatory drug.

-If you have asthma or have had asthma attacks after taking acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs.

-If you have or have had a stomach or duodenal ulcer or hemorrhage, or suffer or have suffered a perforation of the digestive tract.

-If you have a severe heart condition called congestive heart failure.

-If you have severe liver dysfunction.

-If you have moderate to severe kidney dysfunction.

-If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

• Use the smallest dose possible to alleviate or control your symptoms and for the shortest time possible to minimize the risk of adverse effects.

Consult your doctor or pharmacist:

• If you have allergies.
• If you are being treated with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
• If you have an infection; see the "Infections" section below.
• If you have had or develop a stomach or intestinal ulcer, hemorrhage, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms. Discontinue ketoprofen treatment immediately if gastrointestinal bleeding occurs, a stomach or intestinal ulcer develops, or a perforation occurs in the stomach or duodenum.

The risk of developing a stomach or intestinal ulcer, hemorrhage, or perforation is higher when using high doses and prolonged treatment, especially in patients with a history of ulcers, particularly complicated ulcers with hemorrhage or perforation, and in elderly patients. In these cases, start treatment with the lowest possible dose, and your doctor may consider associating a stomach protector (e.g., misoprostol or other acid-blocking medications).

• Patients over 65 years old are at a higher risk of adverse reactions to NSAIDs, and specifically may suffer from gastrointestinal hemorrhages and perforations, which can be fatal. If you are over 65 years old, you may be at a higher risk of adverse effects (see section 4). If these occur, consult your doctor immediately.
• If you have kidney, liver, or heart diseases (elevated blood pressure and/or congestive heart failure).

Monitor kidney function in patients with heart, liver, kidney, or diuretic treatment, particularly in elderly patients, as they are more prone to renal dysfunction.

Periodically monitor liver enzyme levels (transaminases) in patients with liver dysfunction or a history of liver problems.

Hyperkalemia (elevated potassium levels in the blood) may occur, especially in patients with diabetes, kidney dysfunction, or concomitant treatment with potassium-promoting agents. In these cases, monitor potassium levels.

• If you have a blood disorder or systemic lupus erythematosus or mixed connective tissue disease (autoimmune diseases affecting connective tissue).
• If you have asthma. Administration of this medication may cause asthma attacks or bronchospasm (sudden feeling of suffocation), particularly in individuals with aspirin or NSAID allergies.

• If visual disturbances, such as blurred vision, occur, discontinue treatment.
• If you are a fertile woman, be aware that Fastum may reduce your ability to conceive. If you have fertility problems and are planning to become pregnant or undergoing fertility studies, do not take this medication.

Inform your doctor:

• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants like warfarin or antiplatelet agents like acetylsalicylic acid (aspirin). Also, inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and antidepressants, selective serotonin reuptake inhibitors.

• If you have Crohn's disease or ulcerative colitis (inflammatory bowel diseases), as Fastum 50 mg capsules may exacerbate these conditions.

Cardiovascular precautions

NSAIDs like Fastum may be associated with a small increased risk of thrombotic arterial events, such as heart attacks or strokes, especially when used at high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), consult your doctor or pharmacist about this treatment.

Additionally, this type of medication may cause fluid retention, especially in patients with congestive heart failure and/or high blood pressure.

NSAIDs like Fastum may increase the risk of atrial fibrillation (irregular and often rapid heart rhythm) that can cause blood clots in the heart.

Risk of severe skin reactions

Very rarely, severe skin reactions, some of which can be fatal, have been reported in association with NSAID use, including dermatitis exfoliativa (skin scaling), Stevens-Johnson syndrome (skin and mucous membrane lesions), and toxic epidermal necrolysis (skin vesicles and peeling). It appears that patients are at a higher risk of these reactions at the beginning of treatment: the onset of these adverse reactions usually occurs within the first month of treatment. Discontinue Fastum administration immediately if you experience the first symptoms of skin erythema (skin redness), lesions, or other signs of hypersensitivity.

Infections

Fastum may mask the signs of an infection, such as fever and pain. Consequently, Fastum may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to varicella. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Children and adolescents

Do not use Fastum in children and adolescents, as there are no available safety and efficacy data.

Other medications and Fastum

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• Other nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, as they may increase the risk of ulcers and gastrointestinal bleeding.

• Anticoagulants (blood thinners) such as heparin, oral anticoagulants like warfarin, antiplatelet agents like ticlopidine and clopidogrel, thrombin inhibitors like dabigatran, and direct factor Xa inhibitors like apixaban, rivaroxaban, and edoxaban, as they may increase the risk of bleeding: heparin, antagonists of vitamin K like warfarin, antiplatelet agents like ticlopidine and clopidogrel, thrombin inhibitors like dabigatran, and direct factor Xa inhibitors like apixaban, rivaroxaban, and edoxaban.

Medications containing lithium (used to treat bipolar disorder and major depressive disorder), as they may cause an increase in lithium plasma levels (decreased renal excretion of lithium) that may reach toxic levels. Monitor lithium levels during ketoprofen treatment.

• Methotrexate (used to treat cancer and rheumatoid arthritis), as it increases the hematologic toxicity of methotrexate due to decreased renal clearance.

Hydantoins and phenytoin (used to treat epilepsy), as their toxic effects may be increased.

• Diuretics (medications that increase urine flow). Monitor renal function.

• Inhibitors of the enzyme cyclooxygenase and angiotensin II antagonists (used to treat high blood pressure). In patients with kidney problems, there may be a greater deterioration, even leading to acute kidney failure.

• Medications that may promote hyperkalemia (such as potassium salts, potassium-sparing diuretics, inhibitors of the enzyme cyclooxygenase, heparins (low molecular weight or unfractionated), ciclosporin, tacrolimus, and trimethoprim): the risk of hyperkalemia may increase when administered concomitantly (see section “Warnings and precautions”).

• Corticosteroids (used to treat a wide range of diseases, including allergies, hormonal imbalances, and inflammatory diseases): they increase the risk of stomach or intestinal ulcers and bleeding.

Pentoxifylline (used to treat chronic venous ulcers) may increase the risk of bleeding.

• Sulfonilureas: NSAIDs may increase the hypoglycemic effect of sulfonilureas.

• Tenofovir (used to treat HIV/AIDS): may increase the risk of kidney failure.

Taking Fastum with food and drinks

Take the capsules with liquids. It is recommended to take with food, as this helps to reduce the risk of gastrointestinal side effects.

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient, especially those affecting the gastrointestinal tract or the central nervous system.

Pregnancy, breastfeeding, and fertility

Do not take Fastum during the last three months of pregnancy or while breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Fastum during the first six months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, take the minimum dose for the shortest time possible.

Ketoprofen may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and may delay or prolong labor more than expected.

From week 20 of pregnancy, Fastum may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

During the third trimester of pregnancy, ketoprofen administration is contraindicated.

Breastfeeding

Ketoprofen is excreted in breast milk. Therefore, the use of Fastum in women during lactation is contraindicated.

Fertility

Fastum use may alter female fertility and is not recommended in women trying to conceive. In women with fertility problems or undergoing fertility studies, consider suspending this medication.

Driving and operating machinery

Fastum may affect your ability to drive and operate machinery, as it may cause drowsiness, dizziness, seizures, and/or visual disturbances and visual disturbances as adverse effects. If you experience these effects, do not drive or operate machinery until these symptoms disappear.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

If you estimate that the effect of Fastum is too strong or too weak, inform your doctor or pharmacist.

The most effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

Your doctor will indicate the duration of your treatment with Fastum. Do not discontinue treatment before, as this will not yield the expected results. Similarly, do not take this medication for a longer period than indicated by your doctor.

Adults

The recommended dose is 1 capsule 3 times a day (3 capsules a day, which is equivalent to 150 mg of ketoprofen per day). The maximum recommended dose is 200 mg per day (4 capsules a day).

Method of Administration

The capsule should be taken with liquids. It is recommended to take it with food, as this helps to reduce the risk of experiencing adverse effects in the stomach or intestines(see section 2 "Taking Fastum with food and drinks").

Use in Children and Adolescents

Fastum is not recommended for use in children and adolescents, as there are not enough safety and efficacy data available.

Patients with Renal Insufficiency (Kidney Dysfunction) and Elderly Patients

Your doctor may consider reducing the initial dose. Once individual tolerance has been verified, the dose may be adjusted.

Patients with Liver Insufficiency

Your doctor will prescribe the minimum effective dose.

If You Take More Fastum Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Remember to always carry the medication packaging or this leaflet with you when consulting a healthcare professional.

If You Forget to Take Fastum

Do not take a double dose to compensate for the missed doses. Take the next dose when due (see section 3 “How to Take Fastum”).

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The possible side effects have been grouped according to organ system and frequency.

The following table indicates how many patients may experience these side effects:

Nervous system disorders

• Uncommon: drowsiness or insomnia, headache, dizziness.
• Rare: paresthesia (tingling or numbness).
• Frequency not known:aseptic meningitis (a benign process characterized by inflammation of the meninges that cover the brain, headache, and stiffness), dysgeusia (alteration of taste), vertigo, convulsions.

Vestibular disorders

• Rare: tinnitus (ringing in the ears).

Psychiatric disorders

• Frequency not known: depression, hallucinations, confusion, mood changes.

Gastrointestinal disorders

• Common: dyspepsia (digestive disorders), nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence.
• Uncommon: gastritis (inflammation of the stomach lining), rectal bleeding, gastrointestinal bleeding, intestinal ulceration.
• Rare: stomatitis (mouth infection), peptic ulcer.
• Frequency not known: melena (blood in the stool), hematemesis (vomiting blood), Crohn's disease, worsening of ulcerative colitis (chronic inflammatory diseases of the intestine), pancreatitis, gastrointestinal perforation.

Respiratory, thoracic, and mediastinal disorders

• Rare: asthma.
• Frequency not known: bronchospasm, particularly in patients with hypersensitivity to acetylsalicylic acid (aspirin) and other nonsteroidal anti-inflammatory drugs, rhinitis.

CARDIOVASCULAR DISORDERS

• Uncommon: exacerbation of heart failure.
• Frequency not known: atrial fibrillation (rapid and irregular heartbeats), vasculitis (inflammation of blood vessels), hypertension (high blood pressure).

HEPATOBIILARY DISORDERS

• Rare: liver damage, hepatitis, elevated transaminases, elevated bilirubin levels in blood due to liver disorders.

Skin and subcutaneous tissue disorders

• Common: maculopapular rash, urticaria.
• Very rare: bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin reactions that mimic burns).
• Frequency not known: acute generalized exanthematous pustulosis (skin eruption characterized by the formation of pustules), purpura (skin discoloration due to small hemorrhages), vesicular rash, angioedema (swelling of the face, lips, or throat), exfoliative dermatitis (skin peeling), photosensitivity, alopecia.

Haematologic and lymphatic system disorders

• Rare: haemorrhagic anaemia.
• Frequency not known: thrombocytopenia (low platelet count), haemolytic anaemia, leucopenia (low white blood cell count).

Metabolic and nutritional disorders

• Frequency not known: hyponatremia (low sodium levels in blood), hyperkalemia (high potassium levels in blood).

Renal and urinary disorders

• Frequency not known: acute renal failure, tubulointerstitial nephritis (kidney inflammation), nephrotic syndrome (abnormal protein excretion in urine), renal function test abnormalities.

Immune system disorders

• Frequency not known: anaphylactic reactions (including shock).

General disorders and administration site conditions

• Uncommon: edema, fatigue.

Visual disorders

• Rare: blurred vision (see section 2).

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fastum

• The active principle is ketoprofen. Each capsule contains 50 mg.
• The other components are:
• capsule content: cornstarch, microcrystalline cellulose, talc, magnesium stearate
• components of the gelatin capsule: gelatin, water, titanium dioxide (E-171) and printing ink (which contains shellac (E-904),anhydrous ethanol (E-1510), isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), purified water, concentrated ammonia solution (E-527), potassium hydroxide, and iron oxide black (E-172)).

Appearance of the product and content of the packaging

White capsules, printed with the name “Fastum” and the Menarini logo “M”.

Each package contains 40 capsules in PVC-Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing

Menarini Laboratories, S.A.

Alfons XII, 587 - Badalona (Barcelona) - Spain

For further information about this medication, please contact the local representative of the marketing authorization holder

Guidotti Farma, S.L.

Alfons XII, 587 - Badalona (Barcelona) - Spain

Last review date of this prospectus:December 2023.

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/