DILTIX 400 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Diltix 400 mg Film-Coated TabletsEFG

Ibuprofen

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days if you have a fever or 4 days for pain treatment in case you are an adult.
• You should consult a doctor if your condition worsens or does not improve after 3 days in case you are an adolescent.

Package Leaflet Contents

1. What is Diltix and what is it used for
2. What you need to know before taking Diltix
3. How to take Diltix
4. Possible side effects
5. Storage of Diltix
6. Package Contents and Additional Information

1. What is Diltix and what is it used for

Diltix contains the active ingredient ibuprofen. Ibuprofen is a medication that reduces fever and relieves pain (non-steroidal anti-inflammatory medication (NSAID)).

In adults and adolescents weighing 40 kg or more (12 years or older), it is used for the short-term symptomatic treatment of mild or moderate pain and/or fever.

2. What you need to know before taking Diltix

Do not take Diltix if

• you are allergic to ibuprofen or any of the other components of this medication (listed in section 6). Allergic reactions may include: swelling of the eyelids, lips, tongue, or throat.
• you have ever had an allergic reaction such as bronchospasm (tension of the lung muscles that can cause shortness of breath), asthma (nasal secretion, itching, and inflammation of the nasal passages with sneezing), hives (a type of skin rash), or angioedema (swelling under the skin) after taking ibuprofen, acetylsalicylic acid, or other similar analgesics (NSAIDs).
• you have bleeding disorders or blood coagulation disorders.
• you have an active stomach ulcer or a history of recurrent stomach ulcers/duodenal ulcers (peptic ulcers) or bleeding (two or more episodes of proven ulceration or bleeding).
• you have a history of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs.
• you have had a cerebrovascular hemorrhage or other active bleeding.
• you have severe liver, kidney, or heart failure.
• you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• you are in the third trimester of pregnancy.

Warnings and Precautions

Adverse reactions are minimized by using the lowest effective dose for the shortest possible time.

You should consult your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases that affect connective tissue).

• after undergoing major surgery.

Effects on the Gastrointestinal Tract

The use of ibuprofen in combination with other non-steroidal anti-inflammatory medications (NSAIDs), including so-called COX-2 inhibitors (inhibitors of cyclooxygenase-2), should be avoided.

Gastrointestinal Tract Bleeding, Ulcers, and Perforation

Cases of gastrointestinal tract bleeding, ulcers, and perforation (which can be fatal) have been reported during treatment with NSAIDs. At any time during treatment, with or without previous warning symptoms, and with or without a history of previous serious gastrointestinal events.

The risk of experiencing gastrointestinal bleeding, ulcers, and perforation is greater with increased NSAID doses and is greater in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Diltix") and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as for patients who require additional treatment with low doses of acetylsalicylic acid or other medications that may increase the risk of gastrointestinal disorders, your doctor will consider the possibility of associating a stomach-protecting medication (e.g., misoprostol or proton pump inhibitors).

If you have a history of adverse reactions that affect the gastrointestinal tract - especially in elderly patients - consult your doctor in case of unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the start of therapy.

Caution is recommended if you are also taking other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression), or platelet aggregation inhibitors like acetylsalicylic acid (see section 2 "Other Medications and Diltix").

You should discontinue treatment and consult a doctor if you develop gastrointestinal bleeding or ulcers during treatment with ibuprofen.

Effects on the Cardiovascular System

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medication, including breathing problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Discontinue treatment with ibuprofen immediately and contact your doctor as soon as possible if you notice any of these signs.

Skin Reactions

Severe skin reactions, including exfoliative dermatitis, multiforme exanthema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in relation to ibuprofen treatment. Stop taking ibuprofeno and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

If you have chickenpox, it is advisable to avoid using ibuprofen.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, it is possible that ibuprofen may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other Warnings

In very rare cases, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. At the first signs of a hypersensitivity reaction after taking ibuprofen, treatment should be discontinued and a doctor consulted. Medically required measures, in line with the symptoms, should be initiated by specialized personnel.

Ibuprofen may reversibly inhibit platelet aggregation and function (platelet aggregation). Therefore, patients with coagulation disorders should be carefully monitored.

During prolonged use of ibuprofen, regular monitoring of liver function tests, kidney function, and blood counts is required.

Prolonged use of any type of analgesic for headache may worsen it. If this situation is observed or suspected, consult a doctor and discontinue treatment.

In general, habitual use of different types of analgesics can lead to the appearance of serious kidney problems with a risk of renal failure (analgesic nephropathy). This risk can be increased in conditions of physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.

The risk of renal failure increases in dehydrated patients, elderly patients, and those taking diuretics and ACE inhibitors.

In case of vision problems, please consult your doctor.

Elderly Patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal (see also the warning about bleeding at the beginning of section 2).

Adolescents

There is a risk of renal failure in dehydrated adolescents.

Other Medications and Diltix

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

Ibuprofen may affect or be affected by other medications. For example:

• Digoxin, phenytoin, and lithium: the combined use of ibuprofen and digoxin (used for heart failure), phenytoin (used to treat seizures/epilepsy), or lithium (used to treat, for example, depression) may increase the concentration of these medications in the blood. Monitoring of lithium serum levels is necessary. Generally, monitoring of digoxin and phenytoin serum levels is not required when used as indicated (3 or 4 days at most).
• Anticoagulants (to dilute blood/prevent blood clots, e.g., acetylsalicylic acid, warfarin, ticlopidine). NSAIDs may increase the effects of anticoagulants like warfarin.
• Diuretics and medications for high blood pressure: Ibuprofen may reduce the effect of medications used to increase urine production (diuretics) and decrease blood pressure (antihypertensive medications, e.g., ACE inhibitors, beta blockers, and angiotensin II receptor antagonists). The combined administration of ibuprofen and potassium-sparing diuretics (medications used to increase urine elimination) may lead to an increase in potassium levels in the blood.
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta blockers like atenolol, and angiotensin II receptor antagonists like losartan): ibuprofen may reduce the effect of ACE inhibitors (used to treat heart failure and high blood pressure). Additionally, during combined use, there is a greater risk of renal dysfunction.
• Colestyramine (a medication used to reduce cholesterol) in combination with ibuprofen may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical importance is unknown.
• Other analgesics: the combined use of ibuprofen with other anti-inflammatory and analgesic medications of the NSAID group, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
• Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) may increase the risk of gastrointestinal bleeding.
• Methotrexate: the administration of ibuprofen within 24 hours before or after the administration of methotrexate (used to treat certain types of cancer and rheumatism) may cause an increase in methotrexate concentrations and an increase in its side effects.
• Cyclosporine and tacrolimus: there is a greater risk that immunosuppressive medications like cyclosporine and tacrolimus may damage the kidneys.
• Probenecid or sulfinpyrazone: medications containing probenecid or sulfinpyrazone (used in patients with gout) may delay the excretion of ibuprofen. This may cause ibuprofen to accumulate in the body, with an increase in its side effects.
• Sulfonylureas: during the combined use of ibuprofen and sulfonylureas (medications used to treat diabetes), it is recommended to monitor blood sugar levels.
• Zidovudine: there is evidence suggesting a greater risk of hemarthrosis (blood accumulation in the joints) and bruising (hematomas) in HIV-positive hemophilic patients who use zidovudine (an anti-AIDS medication) along with ibuprofen.
• Quinolone antibiotics: the risk of seizures (attacks) may increase when quinolone antibiotics, such as ciprofloxacin, and ibuprofen are taken at the same time.
• Aminoglycosides: the combined use of ibuprofen with aminoglycosides (a type of antibiotic) with NSAIDs may decrease the elimination of aminoglycosides.
• Voriconazole and fluconazole (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may increase. The reduction of the ibuprofen dose should be considered, particularly when a high dose of ibuprofen is administered with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medication) may increase the risk of bleeding with NSAIDs.
• Mifepristone: the combined use of mifepristone with other anti-inflammatory and analgesic medications of the NSAID group (i.e., ibuprofen) may decrease the effect of mifepristone.
• Ritonavir: combined use with ritonavir (an antiviral medication used to treat HIV infections) may increase the plasma concentrations of NSAIDs.
• Alcohol, bisphosphonates, and oxpentifylline (pentoxifylline): the combined use of ibuprofen with alcohol, bisphosphonates (used for osteoporosis), or pentoxifylline (for treating peripheral arterial circulatory problems) may increase gastrointestinal side effects and the risk of bleeding and ulcers.
• Baclofen (a muscle relaxant) due to the high toxicity of baclofen.
• Medications for treating inflammation (corticosteroids) due to the increased risk of gastrointestinal ulcers or bleeding.

Other medications may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medications.

Taking Diltix with Alcohol

The adverse reactions of ibuprofen may be increased with the consumption of alcohol, especially those affecting the central nervous system and the gastrointestinal tract. You should not drink alcohol while taking ibuprofen.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of the fluid 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.

Breastfeeding

Small amounts of ibuprofen pass into breast milk. However, as no harmful effects have been reported in children to date, it is not usually necessary to interrupt breastfeeding during short-term use of ibuprofen at the recommended dose for fever and pain.

Fertility

This product belongs to the group of NSAIDs that may affect fertility in women. This effect is reversible upon discontinuation of the medication. You should consult your doctor if you plan to become pregnant or if you have difficulty becoming pregnant.

Driving and Using Machines

Ibuprofen generally has a negligible influence on the ability to drive and use machines. However, at higher doses, adverse effects such as fatigue and dizziness may occur, and reaction capacity may be affected while driving and operating machines. This is especially important when the medication is combined with alcohol.

Diltix Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Diltix Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Diltix

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

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2). The recommended dose is:

Adults and adolescents from 40 kg in weight (from 12 years or older)

Half a tablet (200 mg) or one whole tablet (400 mg) as a single dose. If necessary, take an additional half or one tablet.

The dosing interval should be chosen according to the observed symptoms and the recommended maximum daily dose. The interval between doses should not be less than 6 hours. Do not take more than 3 tablets (1200 mg) of ibuprofen in a 24-hour period.

Ibuprofen 400 mg is not recommended for use in adolescents with less than 40 kg in weight or children under 12 years of age.

Adverse reactions can be minimized by using the lowest effective dose for the shortest time possible to control symptoms.

If you have severe liver or kidney disease or are an elderly patient, your doctor will indicate the correct dose for you to take, which will be the lowest possible dose.

Method of administration

Oral.

Take the tablet with a glass of water.

Ibuprofen tablets should not be crushed, chewed, or sucked to avoid discomfort in the mouth or throat irritation. The tablets can be divided into equal doses.

It is recommended that patients with sensitive stomachs take ibuprofen with food.

Ibuprofen is intended for short-term use only.

For adults

If you need this medication for more than 3 days to treat fever or for more than 4 days to treat pain, or if symptoms worsen, you should consult a doctor.

For adolescents

If adolescents need this medication for more than 3 days, or if symptoms worsen, they should consult a doctor.

If you take more Diltix than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), and rarely diarrhea. Additionally, it may cause headache, gastrointestinal bleeding, blurred vision, ringing in the ears, confusion, involuntary eye movement, and worsening of asthma in asthmatics. At high doses, symptoms of drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, coma, convulsions (mainly in children), dizziness, weakness, and dizziness, blood in the urine, low potassium levels in the blood, low blood pressure, high potassium levels in the blood, increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, decreased body temperature, and respiratory problems have been reported.

If you forget to take Diltix

Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most common side effects observed affect the digestive tract. Stomach/duodenal ulcers (peptic ulcers), perforation, or bleeding may occur, sometimes fatally, especially in elderly patients (see section 2: "Warnings and precautions"). Nausea, vomiting, diarrhea, flatulence, constipation, digestive problems, abdominal pain, blood in stool, vomiting with blood, sores (ulcers) in the mouth and throat area (stomatitis ulcerosa), exacerbation of colitis and Crohn's disease (see section 2: "Warnings and precautions") have been reported after its use. Gastritis has been observed less frequently. In particular, the risk of developing gastrointestinal bleeding depends on the dose level and treatment duration.

Inflammation (edema), high blood pressure (hypertension), and heart failure have been observed in association with NSAID treatments.

More serious side effects

• Stop treatment and go to your doctor immediatelyif you develop severe allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people):
• These may manifest as:

• facial inflammation (facial edema), tongue, or throat (laryngeal edema with constriction of the airways)
• difficulty breathing
• rapid heartbeat
• drop in blood pressure to mortal shock.
• chest pain, which may be a sign of a severe allergic reaction called Kounis syndrome [frequency not known (frequency cannot be estimated from available data)].

• You should consult your doctor immediatelyif you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection, such as sore throat/pharynx/mouth or urinary problems. Ibuprofen may cause a decrease in white blood cells (agranulocytosis, a very rare side effect [may affect up to 1 in 10,000 people]) with a decrease in resistance to infection. It is essential to inform your doctor about your medication.
• Stop taking ibuprofen and seek medical attention immediatelyif you notice any of the following symptoms:
• red, target-like, or circular patches on the trunk, often with central blisters, 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] [a very rare side effect (may affect up to 1 in 10,000 people)].
• a severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node inflammation, and elevated eosinophils (a type of white blood cell) [frequency not known (frequency cannot be estimated from available data)].
• skin rash or lesions on the mucous membranes. Severe rashes may include blisters on the skin, especially on the legs, arms, hands, and feet, and may include the face and lips. A more severe skin reaction, toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), may occur. [a very rare side effect (may affect up to 1 in 10,000 people)].
• a widespread red and scaly rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). [frequency not known (frequency cannot be estimated from available data)].

• Stop taking ibuprofenif you experience relatively severe pain in the upper abdomen, vomit blood, have black stools, or bloody diarrhea, and inform your doctor immediately.
• If you have edema (fluid retention), especially in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome, tubulointerstitial nephritis (kidney disorder) that may be associated with acute renal failure (renal failure) [very rare side effects (may affect up to 1 in 10,000 people)]. Decreased urine production, swelling caused by fluid accumulation in tissues (edema), and discomfort (generally feeling unwell) may be signs of renal failure.

If you experience any of these side effects or if they worsen, stop treatment and go to your doctor immediately.

Other side effects

Frequent (may affect more than 1 in 10 people)

• Gastrointestinal disorders, e.g., heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, digestive problems, and mild gastrointestinal bleeding, which may cause anemia in exceptional cases.

Uncommon (may affect up to 1 in 100 people)

• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, or fatigue.
• Visual disturbances. In this case, you should discontinue treatment with ibuprofen and consult your doctor.
• Especially in elderly patients, gastrointestinal ulcers, sometimes with bleeding and perforation (hole in the intestinal walls), stomatitis ulcerosa (inflammation of the mouth mucosa with ulceration), gastritis (inflammation of the stomach), worsening of colitis and Crohn's disease, which may be fatal.
• Gastritis (inflammation of the stomach).
• Hypersensitivity reactions such as skin rash and itching, as well as asthma attacks (with possible drop in blood pressure).

Stop taking ibuprofen and inform your doctor immediately.

Rare (may affect up to 1 in 1,000 people)

• Ringing in the ears (tinnitus).
• Hearing loss.
• Kidney damage (papillary necrosis), high uric acid levels in the blood, high urea levels in the blood.

Very rare (may affect up to 1 in 10,000 people)

• Blood cell formation disorders, such as decreased red blood cells or hemoglobin (anemia), white blood cells (leukopenia), or platelet count (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia, or hemolytic anemia). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.
• Worsening of inflammation associated with infection (e.g., necrotizing fasciitis) related to the use of certain analgesics (NSAIDs) has been described. If symptoms of an infection or worsening of an infection (e.g., redness, swelling, heat, pain, fever) appear during the administration of ibuprofen, you should consult your doctor immediately. It will be determined whether anti-infective/antibiotic therapy is indicated.
• Symptoms of aseptic meningitis (inflammation of the brain and its lining not caused by infection) have been observed during ibuprofen intake, such as severe headache, nausea, vomiting, fever, neck stiffness, or transient loss of consciousness with the use of ibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) seem to be predisposed.
• Low blood sugar levels (hypoglycemia).
• Low sodium levels in the blood (hyponatremia).
• Palpitations, heart failure, heart attack.
• High blood pressure (hypertension).
• Vasculitis (inflammation of blood vessels).
• Inflammation of the esophagus or pancreas (pancreatitis), narrowing of the large or small intestine (intestinal stenosis).
• Psychotic reactions, hallucinations, confusion, depression, and anxiety.
• Asthma, difficulty breathing (dyspnea), bronchospasm.
• Yellowing of the eyes and/or skin (jaundice), liver dysfunction, liver damage, especially with prolonged treatment, liver failure, acute hepatitis.
• Hair loss (alopecia), discolored red or purple spots on the skin (purpura), or photosensitivity reactions (triggered by sunlight).
• Severe skin infections and soft tissue complications may exceptionally occur during chickenpox.

Frequency not known (cannot be estimated from available data)

• Nasal mucosa inflammation (rhinitis).
• Numbness and tingling sensation (paresthesia) and optic nerve inflammation (neuritis optica).
• Sudden loss of kidney function.

Medications like ibuprofen may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or stroke.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Diltix

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Diltix composition

The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other ingredients are:

Tablet core:hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate.

Coating:hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Product appearance and package contents

White or off-white, round, scored, film-coated tablets with a diameter of approximately 12 mm.

The tablet can be divided into equal doses.

They are available in blister packs of 10, 12, 20, 24, 30, 50, or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH

Wallenroder Strasse 8-10,

Berlin - 13435 - Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: IbuARISTO akut 400 mg

Italy: Ibuprofene Aristo

Poland: Axoprofen Forte

Spain: Diltix 400 mg film-coated tablets EFG

Date of the last revision of this leaflet:09/2024

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