Ibufast Forte

Leaflet attached to the packaging: information for the user

IBUFAST Forte, 400 mg, coated tablets

Ibuprofen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days (in case of fever) or 5 days (in case of pain) there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet

• 1. What is Forte and what is it used for
• 2. Important information before taking Forte
• 3. How to take Forte
• 4. Possible side effects
• 5. How to store Forte
• 6. Contents of the packaging and other information

1. What is Forte and what is it used for

The medicine is intended for short-term symptomatic treatment of:

• mild to moderate pain, such as: rheumatic and muscular pain, back pain, neuralgia, primary dysmenorrhea, toothache, migraine, headache,
• flu and cold symptoms,
• fever lasting less than 3 days.

If in adult patients after 3 days (in case of fever) or 5 days (in case of pain) there is no improvement or the patient feels worse, you should consult a doctor. If there is a need to administer this medicine to adolescents for more than 3 days or if symptoms worsen, you should consult a doctor.

2. Important information before taking Forte

When not to take Forte

Forte should not be taken:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• in patients with hypersensitivity (allergy) to other non-steroidal anti-inflammatory drugs (NSAIDs),
• in patients currently or in the past suffering from:
• asthma, urticaria or allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• increased bleeding tendency or active bleeding,
• gastrointestinal bleeding or perforation related to previous NSAID treatment,
• ulcerative colitis, Crohn's disease, peptic ulcer, or recurrent gastrointestinal bleeding (defined as two or more distinct episodes of confirmed ulceration or bleeding),
• severe heart, kidney, and liver failure,
• inborn errors of porphyrin metabolism (e.g. acute intermittent porphyria),
• chronic alcoholism (14 to 20 drinks per week or more),
• blood cell production disorders of unknown etiology.

Taking ibuprofen is contraindicated in the third trimester of pregnancy (last 3 months of pregnancy). It is not recommended to take ibuprofen during breastfeeding. In the first and second trimester of pregnancy (first 6 months of pregnancy), this medicine should not be taken unless clearly indicated by a doctor.

Warnings and precautions

Forte should not be taken in the following situations, unless clearly indicated by a doctor:

• with uncontrolled hypertension,
• with congestive heart failure,
• with diagnosed ischemic heart disease,
• with peripheral artery disease and (or) cerebrovascular disease,
• with significant dehydration (caused by vomiting, diarrhea, or inadequate fluid intake),
• with systemic lupus erythematosus or other autoimmune diseases,
• in children.

Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to relieve symptoms (see "How to take Forte"). Like other NSAIDs, ibuprofen may mask infection symptoms. With long-term use of any pain medication, headache may occur, which should not be treated with higher doses of the medication. When consuming alcohol and taking NSAIDs, side effects related to the active substance, especially those related to the gastrointestinal tract or central nervous system, may be exacerbated. Cardiovascular and cerebrovascular effects You should be cautious (consult a doctor or pharmacist) before starting treatment if the patient has a history of hypertension or heart failure, e.g. fluid retention and edema associated with NSAID treatment. Before taking Forte, you should discuss treatment with your doctor or pharmacist if you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor blood circulation in the legs or feet due to narrow or blocked arteries), or any other stroke (including mini-stroke or transient ischemic attack "TIA").

• if the patient has heart problems, including heart failure, angina (chest pain), or if the patient has had a heart attack, bypass surgery, peripheral artery disease (poor blood circulation in the legs or feet due to narrow or blocked arteries), or any other stroke (including mini-stroke or transient ischemic attack "TIA").
• if the patient has high blood pressure, diabetes, high cholesterol, or if there is a history of heart disease or stroke in the family, or if the patient smokes.

Respiratory disorders You should exercise special caution in patients with asthma or asthma-like conditions, chronic rhinitis, or respiratory diseases in their medical history, as ibuprofen may cause bronchospasm, urticaria, or angioedema in these patients. Allergic reactions Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are rare. Forte treatment should be discontinued immediately after the first symptoms of hypersensitivity reaction appear. Medical personnel must initiate appropriate procedures, depending on the symptoms. You should be cautious in patients who have experienced allergic reactions or hypersensitivity to other substances, as they may have an increased risk of hypersensitivity to ibuprofen. It is recommended to be cautious in patients suffering from hay fever, nasal polyps, or chronic obstructive pulmonary disease, as they have an increased risk of allergic reactions. They may develop as asthma attacks (so-called analgesic asthma), angioedema, or urticaria. During ibuprofen treatment, symptoms of allergic reaction to this medicine have been reported, including difficulty breathing, swelling in the face and neck (angioedema), chest pain. If any of these symptoms are noticed, Forte should be discontinued immediately and medical help or emergency services should be sought. Heart, kidney, or liver disorders It is recommended to be cautious in patients with kidney, liver, or heart disorders, as NSAID use may worsen kidney function. Concurrent regular use of several pain medications further increases this risk. In this case, the dose should be as small as possible and used for the shortest possible time (see "When not to take Forte"). Renal effects At the start of ibuprofen treatment, as with other NSAIDs, caution should be exercised in patients with significant dehydration. There is a risk of kidney function disorders, especially in children, adolescents, and dehydrated elderly patients. Like other NSAIDs, prolonged use of ibuprofen has caused renal papillary necrosis and other kidney pathology. Cases of toxic kidney effects have also been observed in patients in whom prostaglandins have a compensatory function in maintaining renal perfusion. In these patients, NSAID administration may cause dose-dependent reduction of prostaglandin production and, consequently, renal blood flow, which may lead to significant kidney decompensation. Patients at increased risk of this reaction are those with kidney function disorders, heart failure, liver function disorders, patients treated with diuretics and ACE inhibitors, and elderly patients. After discontinuation of NSAID treatment, kidney function usually returns to pre-treatment state. Aseptic meningitis In rare cases, patients treated with ibuprofen have developed aseptic meningitis. Although it is more likely to occur in patients with systemic lupus erythematosus and connective tissue diseases, aseptic meningitis has been reported in patients without underlying chronic disease. Hematologic effects Ibuprofen, like other NSAIDs, may inhibit platelet aggregation and may prolong bleeding time in healthy patients. Skin reactions Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, Forte should be discontinued immediately and medical help should be sought. In exceptional cases, chickenpox may be the cause of severe skin and soft tissue infections. Currently, it is not possible to rule out the involvement of NSAIDs in exacerbating these infections. Therefore, it is recommended to avoid taking Forte in case of chickenpox. Elderly patients In elderly patients, the frequency of side effects after NSAID use is higher, especially gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration, and perforation Ibuprofen should be used with caution in patients with a history of ulcer disease or other gastrointestinal disorders, as these conditions may worsen. Cases of gastrointestinal bleeding, ulceration, and perforation of the gastrointestinal tract, including fatal cases, have been reported with all NSAIDs, at any time during their use, with or without warning symptoms, or with a history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration, or perforation of the gastrointestinal tract is higher with higher doses of ibuprofen in patients with a history of ulcer disease, especially if accompanied by bleeding or perforation, and in elderly patients. In these patients, treatment should be started with the smallest effective dose. In these patients, as well as in those who must take low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal complications, concomitant administration of protective medications (e.g. misoprostol or proton pump inhibitors) should be considered. You should be cautious in patients who must take other medications that increase the risk of gastrointestinal ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents, such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs in patients treated with Forte, treatment should be discontinued immediately. You should avoid concomitant administration of Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of gastrointestinal ulceration or bleeding. Patients with a history of gastrointestinal diseases, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in treatment.

Children and adolescents

Forte should not be taken by children under 12 years of age.

Forte and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should be cautious in patients treated with any of the following medicines, due to reported interactions: Lithium NSAIDs may decrease lithium excretion. Methotrexate NSAIDs may decrease methotrexate excretion, and consequently increase its plasma concentration. Cardiac glycosides NSAIDs may exacerbate heart failure, decrease glomerular filtration rate, and increase cardiac glycoside plasma concentration. Cholestyramine Concomitant administration of ibuprofen and cholestyramine may decrease ibuprofen absorption in the gastrointestinal tract. However, the clinical significance of this interaction is unknown. Cyclosporin Concomitant administration of NSAIDs and cyclosporin increases the risk of nephrotoxicity. Antihypertensive agents, beta-blockers, and diuretics NSAIDs may decrease the effect of these medications. Diuretics may increase the risk of NSAID nephrotoxicity. In some patients with kidney function disorders (e.g. dehydrated patients or elderly patients with kidney function disorders), concomitant administration of an ACE inhibitor, beta-blocker, or angiotensin II antagonist and cyclooxygenase inhibitors may lead to further worsening of kidney function, including acute kidney failure, which is usually reversible. This combination of medications should be used with caution, especially in the elderly. Patients should maintain adequate hydration and consider periodic monitoring of kidney function after starting combination treatment. Other NSAIDs, including selective cyclooxygenase-2 inhibitors You should avoid concomitant administration of Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the possibility of their additive effect. Corticosteroids Concomitant use with NSAIDs increases the risk of gastrointestinal ulceration or bleeding. Anticoagulants NSAIDs may enhance the effect of anticoagulants, such as warfarin. Acetylsalicylic acid Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the possibility of exacerbating side effects. Antiplatelet agents (e.g. clopidogrel and ticlopidine), selective serotonin reuptake inhibitors (SSRIs) There is an increased risk of gastrointestinal bleeding when used concomitantly with NSAIDs. Aminoglycosides NSAIDs may decrease aminoglycoside excretion. Ginkgo biloba It may increase the risk of bleeding in combination with NSAIDs. Mifepristone NSAIDs may reduce the effect of mifepristone. Quinolone antibiotics Patients taking NSAIDs and quinolones may exhibit an increased risk of seizures. Tacrolimus There is an increased risk of nephrotoxicity when NSAIDs are used concomitantly with tacrolimus. Zidovudine There is an increased risk of hematologic toxicity when NSAIDs are used concomitantly with zidovudine. Sulfonylurea derivatives NSAIDs may enhance the effect of sulfonylurea-containing medications (rare cases of hypoglycemia have been reported in patients taking sulfonylurea derivatives and ibuprofen concomitantly). CYP2C9 inhibitors Concomitant administration of ibuprofen with CYP2C9 inhibitors may lead to increased exposure to ibuprofen (CYP2C9 substrate). You should consider reducing the ibuprofen dose, especially when administering high doses of ibuprofen concomitantly with voriconazole or fluconazole. Probenecid and sulfinpyrazone Medications containing probenecid or sulfinpyrazone may delay ibuprofen excretion. Phenytoin Concomitant use of Forte with phenytoin may increase the plasma concentration of these medications.

Forte with food, drink, and alcohol

To achieve a faster maximum effect, Forte should be taken on an empty stomach. In patients with sensitive stomachs, it is recommended to take Forte with food. During treatment, you should not consume alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking Forte. Pregnancy You should not take Forte if you are in the last 3 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 risk of bleeding in the mother and child and cause prolonged or delayed delivery. During the first 6 months of pregnancy, you should not take Forte unless clearly indicated by a doctor. If treatment is necessary during this period or when trying to conceive, you should use the smallest possible dose for the shortest possible time. From the 20th week of pregnancy, Forte may cause the unborn child to have a narrowed blood vessel (ductus arteriosus) in the heart or kidney problems, which may lead to low amniotic fluid levels around the baby (oligohydramnios). If treatment is necessary for a longer period than a few days, the doctor may recommend additional monitoring. Breastfeeding You should not take Forte while breastfeeding. Fertility There is evidence that prostaglandin synthesis/cyclooxygenase inhibitors may reduce female fertility by affecting ovulation. This effect is reversible after treatment discontinuation.

Driving and using machines

IBUFAST Forte has a minor influence on the ability to drive and use machines. Therefore, you should be more cautious when driving vehicles or operating machines. This is especially true when taking ibuprofen in combination with alcohol.

Forte contains lactose monohydrate and sodium

Lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult a doctor before taking Forte.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 coated tablet, which means the medicine is considered "sodium-free".

3. How to take Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.

Adults and adolescents over 12 years of age (with body weight ≥40 kg)

This medicine is intended for oral use only and short-term use. The dose of ibuprofen depends on the patient's age and body weight. In adults and adolescents, you should not exceed the maximum single dose of 400 mg of ibuprofen. Taking more than 400 mg of ibuprofen in a single dose does not provide better pain relief. The interval between consecutive doses should be at least 4 hours. You should not exceed the total dose of 1200 mg of ibuprofen in 24 hours. The recommended dose is 400 mg of ibuprofen (1 tablet) up to 3 times a day at 4-6 hour intervals. You should not exceed the dose of 1200 mg of ibuprofen (3 tablets) per day.

Adult patients should consult a doctor if symptoms persist or worsen, or if it is necessary to use this medicine for more than 3 days in case of fever or 5 days in case of pain. If adolescents need to take this medicine for more than 3 days or if symptoms worsen, you should consult a doctor.

Children

Forte is contraindicated in children under 12 years of age.

Elderly patients

In elderly patients, there is no need to modify the dose, unless they have severe kidney or liver failure. In such cases, the dose should be adjusted according to individual needs. In this group, you should exercise greater caution. Renal impairment There is no need to reduce the dose in patients with mild or moderate kidney function disorders (patients with severe kidney failure, see section 2). Hepatic impairment There is no need to reduce the dose in patients with mild or moderate liver function disorders (patients with severe liver function disorders, see section 2). Method of administration The medicine should be taken orally. The ibuprofen tablet should be taken with a large amount of fluid. The tablet should be swallowed whole. You should not chew, break, crush, or suck the tablet to avoid discomfort in the mouth or throat irritation. Average treatment duration The average treatment duration depends on the patient's clinical condition. You should use the smallest effective dose for the shortest possible time necessary to relieve symptoms. You should not take higher doses of the medicine than recommended. You should not take the medicine for more than 3 days in case of fever, unless advised by a doctor. In case of pain, you should not take the medicine for more than 5 days in adults, unless advised by a doctor, as intense and prolonged pain may require medical evaluation and treatment.

Taking a higher dose of Forte than recommended

If you have taken a higher dose of Forte than recommended or if a child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to your health and advice on what actions to take. Symptoms may include nausea, abdominal pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and respiratory disorders have been reported. In case of overdose, gastric lavage should be performed, followed by supportive measures. There is no specific antidote for ibuprofen.

Missing a dose of Forte

If you miss one or more doses, you should continue taking the next dose as usual. You should not take a double dose to make up for the missed tablet. If you have any further doubts about taking this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Forte can cause side effects, although not everybody gets them. If you experience any of the following symptoms, you should stop taking ibuprofen and seek medical help:

• Red, non-raised, target-like or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Red, peeling rash with bumps under the skin and blisters, with concurrent fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Side effects observed with ibuprofen are similar to those of other NSAIDs: Gastrointestinal disorders The most commonly observed side effects are gastrointestinal. After taking these medications, nausea, indigestion, vomiting, bloody vomiting, bloating, abdominal pain, diarrhea, constipation, black stools, and gastrointestinal bleeding have been reported. Less frequently, cases of gastritis, duodenal ulcers, and gastric ulcers, as well as perforation of the gastrointestinal tract, have been observed. Immune system disorders After ibuprofen treatment, hypersensitivity reactions have been reported. These may be non-specific allergic reactions and anaphylaxis, respiratory reactions, including asthma, worsened asthma, bronchospasm, or shortness of breath, or skin diseases, including various skin rashes, itching, urticaria, purpura, angioedema, and very rarely exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Infections and infestations Worsening of infectious conditions, such as skin infections (e.g. development of necrotizing fasciitis), has been reported with NSAID use. If infection symptoms occur or worsen during ibuprofen treatment, you should consult a doctor immediately. Skin and subcutaneous tissue disorders In rare cases, during chickenpox, severe skin and soft tissue infections, including necrotizing fasciitis, have been reported (see also "Infections and infestations"). Cardiovascular disorders Clinical studies indicate that ibuprofen use, especially in high doses (2400 mg per day) and for a longer period, may be associated with a slight increase in the risk of arterial thrombotic events (e.g. heart attack or stroke) (see section 2). The following side effects are probably related to ibuprofen use and are listed in decreasing order of frequency. Frequency is defined as: very common (more than 1 in 10 people), common (not more than 1 in 10 people), uncommon (not more than 1 in 100 people), rare (not more than 1 in 1,000 people), very rare (not more than 1 in 10,000 people), and frequency not known (frequency cannot be estimated from available data). Common:

• indigestion, diarrhea, nausea, vomiting, abdominal pain, bloating, constipation, black stools, and gastrointestinal bleeding;
• headache and dizziness;
• skin rash;
• fatigue.

Uncommon:

• gastritis, duodenal ulcers, gastric ulcers, and perforation of the gastrointestinal tract;
• nephrotoxicity, including interstitial nephritis, nephrotic syndrome, and kidney failure;
• asthma, bronchospasm, and shortness of breath;
• hepatitis, jaundice, and liver function disorders;
• hypersensitivity reactions;
• urticaria, itching, purpura, angioedema, and photosensitivity reaction;
• insomnia, anxiety, and depression;
• impaired hearing, dizziness, and tinnitus;
• paresthesia and somnolence;
• visual disturbances;
• rhinitis.

Rare:

• anaphylactic reactions; Symptoms may include: facial swelling, tongue and laryngeal edema, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock);
• aseptic meningitis;
• leukopenia, thrombocytopenia, aplastic anemia, neutropenia, agranulocytosis, and hemolytic anemia; The first symptoms are: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding and bruising;
• toxic optic neuropathy;
• optic neuritis;
• edema;
• disorientation.

Very rare:

• heart failure and myocardial infarction;
• red, non-raised, target-like or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• liver failure;
• pancreatitis;
• hypertension.

Frequency not known:

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• red, peeling rash with bumps under the skin and blisters, with concurrent fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis);
• worsening of ulcerative colitis and Crohn's disease.

A severe skin reaction known as DRESS (drug reaction with eosinophilia and systemic symptoms) may occur. DRESS symptoms include widespread rash, high body temperature, and swollen lymph nodes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Forte

Do not store above 30°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Forte contains

• The active substance of Forte is ibuprofen - 1 coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: tablet core: hypromellose (2910), corn starch, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, colloidal anhydrous silica, magnesium stearate; coating: hypromellose (2910), propylene glycol (E 1520), talc, titanium dioxide (E 171).

What Forte looks like and contents of the pack

White, elongated, biconvex coated tablets. Forte is available in PVC/PVDC/Aluminum blisters containing 20 or 50 coated tablets, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fortis Pharmaceuticals Sp. z o.o. ul. Mickiewicza 29 40-085 Katowice e-mail: [email protected] tel.: +48 32 726 66 67

Manufacturer:

PHARMEX ADVANCED LABORATORIES, S.L. Ctra. A-431 Km.19 14720 Almodóvar del Río (Córdoba) Spain

Date of last revision of the leaflet: