Fastum 50 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fastum 50 mg hard capsules

ketoprofen

Read the entire patient information leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fastum is and what it is used for
2. What you need to know before taking Fastum
3. How to take Fastum
4. Possible side effects
5. How to store Fastum
6. Contents of the pack and other information

1. What Fastum is and what it is used for

Fastum contains ketoprofen, an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Fastum is indicated for the treatment of:

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

2. What you need to know before taking Fastum

Do not take Fastum

• If you are allergic to ketoprofen or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to acetylsalicylic acid (aspirin) or to any other non-steroidal anti-inflammatory drug (NSAID).
• If you have asthma or have had asthma attacks after taking acetylsalicylic acid (aspirin) or other NSAIDs.
• If you have or have had a stomach or duodenal ulcer (a part of the intestine), or if you suffer or have suffered a perforation of the digestive tract.
• If you have a heart condition called severe heart failure.
• If you have severe liver dysfunction (impaired liver function).
• If you have moderate to severe kidney dysfunction (impaired kidney function).
• If you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

• Use the lowest effective dose that relieves/controls your symptoms for the shortest possible duration to minimize the risk of adverse effects.

Consult your doctor or pharmacist:

• If you suffer from allergic diseases.
• If you are being treated with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors.
• If you have an infection; see the section titled «Infections» below.
• If you have had or develop a stomach or intestinal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. Treatment with ketoprofen must be stopped immediately if gastrointestinal bleeding, ulceration, or perforation of the stomach or duodenum occurs.

The risk of developing a stomach or intestinal ulcer, bleeding, or perforation is higher when high doses are used or treatment is prolonged, in patients with a history of ulcers—especially ulcers complicated by bleeding or perforation—and in elderly patients. In these cases, treatment should be initiated with the lowest possible dose, and your doctor may consider adding a stomach-protective agent (e.g., misoprostol or other drugs that reduce gastric acid production).

• Elderly patients are more likely to experience adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal. If you are elderly, you may be at higher risk of adverse effects (see section 4). If these occur, consult your doctor immediately.
• If you have kidney, liver, or heart disease (high blood pressure and/or heart failure).

Kidney function should be monitored in patients with heart, liver, or kidney disorders, in those taking diuretics, and particularly in elderly patients, who are more prone to kidney function impairment.

Liver enzyme levels (transaminases) should be periodically monitored in patients with impaired liver function or a history of liver problems.

Hyperkalemia (increased blood potassium levels) may occur, especially in patients with diabetes, kidney impairment, or those receiving concomitant treatment with agents that promote hyperkalemia. In such cases, potassium levels should be monitored.

• If you have a blood cell production disorder, systemic lupus erythematosus, or mixed connective tissue disease (immune system disorders affecting connective tissue).

• If you suffer from asthma. Administration of this medicine may trigger asthma attacks or bronchospasm (sudden sensation of suffocation), particularly in individuals allergic to aspirin or NSAIDs.

• If visual disturbances occur, such as blurred vision, treatment should be discontinued.

• If you are a woman of childbearing age, you should be aware that Fastum may reduce fertility. If you have fertility problems and are planning to become pregnant or undergoing fertility investigations, you should not take this medicine.

Inform your doctor:

• If you are taking medications that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants like warfarin or antiplatelet agents such as acetylsalicylic acid (aspirin). You should also mention the use of other medications that could increase the risk of such bleeding, such as oral corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

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

Cardiovascular precautions

Medicines like Fastum may be associated with a small increased risk of arterial thrombotic events, such as heart attacks ("myocardial infarction") or strokes (cerebrovascular accidents), especially when used at high doses or for prolonged periods. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or believe you may be at risk of these conditions (for example, if you have high blood pressure, diabetes [high blood sugar], elevated cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

Additionally, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

The use of NSAIDs such as Fastum may increase the risk of atrial fibrillation (an irregular and often very rapid heart rhythm [arrhythmia] that can lead to blood clots in the heart).

Risk of serious skin reactions

Very rarely, serious and sometimes fatal skin reactions have been reported with the use of NSAIDs, including exfoliative dermatitis (skin scaling), Stevens-Johnson syndrome (skin and mucosal lesions), and toxic epidermal necrolysis (blistering and peeling of the skin) (see section 4). The risk appears to be higher at the beginning of treatment: most such adverse reactions occur within the first month of treatment. Fastum must be discontinued immediately at the first signs of skin erythema (redness), lesions, or other signs of hypersensitivity.

Infections

Fastum may mask signs of infection, such as fever and pain. Therefore, Fastum may delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.

Children and adolescents

The use of Fastum is not recommended in children and adolescents, as there are no available data on safety and efficacy.

Other medicines and Fastum

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Other non-salicylate anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors (medicines for pain and inflammation), as they may increase the risk of gastrointestinal ulcers and bleeding.

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

• Medicines containing lithium (used in the treatment of bipolar disorder and recurrent major depression), as they may cause an increase in plasma lithium concentration (reduced renal excretion of lithium), potentially reaching toxic levels. Lithium levels should be monitored during treatment with ketoprofen.

• Methotrexate (used in the treatment of cancer and rheumatoid arthritis), as it may increase methotrexate hematological (blood-related) toxicity due to reduced renal clearance.

• Hydantoins and phenytoin, used for epilepsy, as their toxic effects may be enhanced.

• Diuretics (medicines that increase urine flow). Kidney function should be monitored.

• ACE inhibitors and angiotensin II receptor antagonists (used to treat high blood pressure). In patients with impaired kidney function, further deterioration may occur, potentially leading to acute kidney failure.

• Medicines that may promote hyperkalemia (such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins [low molecular weight or unfractionated], cyclosporine, tacrolimus, and trimethoprim): the risk of hyperkalemia (increased blood potassium levels) may increase when these are used concomitantly (see section *“Warnings and precautions”).

• Corticosteroids (used to treat various conditions such as allergies, hormonal disorders, and inflammatory diseases): they increase the risk of gastrointestinal ulcer or bleeding.

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

• Sulfonylureas: NSAIDs may enhance the hypoglycemic effect of sulfonylureas.

• Tenofovir (used in the treatment of AIDS [HIV]): may increase the risk of kidney failure.

• Nicorandil (used for heart conditions), as the combined use of nicorandil and NSAIDs increases the risk of serious complications such as gastrointestinal ulceration, perforation, and bleeding (see section *“Warnings and precautions”).

• Cyclosporine or tacrolimus (used in organ transplantation), as they increase the risk of nephrotoxicity (kidney toxicity).

• Cardiac glycosides (used in heart conditions), as NSAIDs may increase plasma levels of cardiac glycosides.

• Antihypertensives (beta-blockers, ACE inhibitors, diuretics): medicines used to treat high blood pressure, as they may reduce antihypertensive efficacy.

• Thrombolytics (dissolve blood clots), as they increase the risk of bleeding.

• Antiplatelet agents used to reduce platelet aggregation and clot formation, as they increase the risk of gastrointestinal bleeding.

• Selective serotonin reuptake inhibitors (SSRIs, antidepressants): they increase the risk of gastrointestinal bleeding.

• Probenecid (used in patients with gout): may increase ketoprofen blood concentrations, requiring dose adjustment.

Taking Fastum with food and drink

Take the capsules with liquid. It is recommended to take them with food, as this helps reduce the risk of adverse effects on the stomach or intestine.

The use of NSAIDs in combination with alcohol may worsen adverse reactions caused by the active ingredient, especially if they affect the gastrointestinal tract or 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not take Fastum during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time.

Ketoprofen may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond expected duration.

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

In the third trimester of pregnancy, the use of ketoprofen is contraindicated.

Breastfeeding

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

Fertility

The use of Fastum may impair female fertility and is not recommended in women attempting to conceive. In women with difficulty conceiving or undergoing fertility investigations, discontinuation of this medicine should be considered.

Driving and using machines

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

3. How to take Fastum

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

Your doctor will determine the duration of your treatment with Fastum. Do not stop treatment prematurely, as otherwise the expected results may not be achieved. Likewise, do not take this medicine longer than indicated by your doctor.

Adults

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

Method of administration

The capsule should be taken with liquid. It is recommended to take it with food, as this helps reduce the risk of adverse effects on the stomach or intestine (see section 2 "Taking Fastum with food and drink").

Use in children and adolescents

Use of Fastum is not recommended in children and adolescents, as there is insufficient safety and efficacy data available.

Patients with renal impairment (poor kidney function) and elderly patients

Your doctor may consider reducing the initial dose. Once individual tolerance has been confirmed, dose adjustment may be considered.

Patients with hepatic impairment

Your doctor will prescribe the lowest 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Always remember to carry the medicine package or this leaflet with you when consulting a healthcare professional.

If you forget to take Fastum

Do not take a double dose to make up for missed doses. Take the next dose at the scheduled time (see section 3 "How to take Fastum").

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

Disorders of the nervous system

• Uncommon: somnolence or insomnia, headache, dizziness.
• Rare: paresthesia (tingling or numbness sensation).
• Frequency not known: aseptic meningitis (a benign condition characterized by inflammation of the meninges covering the brain, headache, and stiffness), dysgeusia (taste disturbance), vertigo, seizures.

Disorders of the ear and labyrinth

• Rare: tinnitus (ringing in the ears).

Psychiatric disorders

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

Gastrointestinal disorders

• Frequent: dyspepsia (digestive disturbances), nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence.
• Uncommon: gastritis (inflammation of the stomach mucosa), rectal bleeding, gastrointestinal bleeding, intestinal ulceration.
• Rare: stomatitis (mouth infection), peptic ulcer.
• Frequency not known: melena (blood in stools), hematemesis (vomiting blood), Crohn's disease, worsening of ulcerative colitis (chronic inflammatory bowel diseases), 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 non-steroidal anti-inflammatory drugs, rhinitis.

Cardiovascular disorders

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

Hepatobiliary disorders

• Rare: hepatic injury, hepatitis, increased transaminase levels, increased blood bilirubin levels due to hepatic disorders.

Skin and subcutaneous tissue disorders

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

Blood and lymphatic system disorders

• Rare: hemorrhagic anemia.
• Frequency not known: thrombocytopenia (decreased platelet count), hemolytic anemia, leucopenia (decreased white blood cell count).

Metabolism and nutrition disorders

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

Renal and urinary disorders

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

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 adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Fastum

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Fastum

• The active substance is ketoprofen. Each capsule contains 50 mg.
• The other components are:
  • capsule contents: maize starch, microcrystalline cellulose, talc, magnesium stearate
  • components of the gelatin capsule: gelatin, water, titanium dioxide (E-171), and printing ink (containing shellac (E-904), dehydrated alcohol (E-1510), isopropyl alcohol, butyl alcohol, propylene glycol (E-1520), purified water, concentrated ammonium solution (E-527), potassium hydroxide, and black iron oxide (E-172)).

Appearance of the product and contents of the pack

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

Each pack contains 40 capsules in PVC-aluminum blisters.

Marketing Authorization Holder and Manufacturer

Laboratorios Menarini, S.A.

Alfons XII, 587 - Badalona (Barcelona) - Spain

Further information about this medicinal product is available upon request to the local representative of the Marketing Authorization Holder

Guidotti Farma, S.L.

Alfons XII, 587 - Badalona (Barcelona) - Spain

Date of the most recent revision of this leaflet: December 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/