Diltix 400 mg comprimidos recubiertos con pelicula efg

Leaflet: information for the user

Diltix 400 mg film-coated tabletsEFG

Ibuprofen

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 3 days if you have a fever or 4 days for pain treatment in adults.
• You should consult a doctor if you get worse or do not improve after 3 days in case of being an adolescent.

1. What Diltix is and what it is 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. Contents of the pack and additional information

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

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

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 (tightening of the muscles in the lungs that can cause shortness of breath), asthma (nasal secretion, itching, and inflammation of the nasal passages with sneezing), urticaria (a type of skin rash), or angioedema (swelling under the skin) after taking ibuprofen, aspirin, or other similar pain-relieving medications (NSAIDs).
• You have bleeding disorders or blood clotting problems.
• You have an active ulcer or a history of recurrent stomach or duodenal ulcers (peptic ulcers) or bleeding (two or more episodes of ulceration or bleeding).
• You have a history of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs.
• You have a current or recent history of cerebral or other active bleeding.
• You have severe liver, kidney, or heart disease.
• You have severe dehydration (caused by vomiting, diarrhea, or inadequate 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 duration.

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 the connective tissue).

• You have or have had intestinal disease (ulcerative colitis or Crohn's disease)as your condition may worsen.
• You have hereditary disorders in blood formation (e.g., intermittent acute porphyria).
• You have reduced liver or kidney function.
• You have undergone major surgery.
• You are sensitive (allergic) to other substances.
• You have hay fever (allergy to pollen), nasal polyps, or chronic obstructive respiratory diseases, there is an increased risk of allergic reactions. These allergic reactions may present as asthma attacks (known as analgesic asthma). Quincke's edema or urticaria.
• You are dehydrated.
• You have an infection; see the "Infections" heading below.

Effects on the gastrointestinal tract
The combined use of ibuprofen with other anti-inflammatory non-steroidal drugs (NSAIDs), including those called COX-2 inhibitors (COX-2 inhibitors), should be avoided.

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

The risk of experiencing gastrointestinal bleeding, ulcers, and perforation is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2 "Do not take Diltix if") 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 aspirin or other medications that may increase the risk of gastrointestinal problems,your doctor may consider associating a stomach-protecting medication (such as misoprostol or proton pump inhibitors).

If you have a history of adverse reactions affecting 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 should be exercised if you are also taking other medications that may increase the risk of ulcers or bleeding, e.g., oral corticosteroids, anticoagulants (anticoagulants) such as warfarin, selective serotonin reuptake inhibitors (used to treat psychiatric disorders, including depression) or platelet aggregation inhibitors such as aspirin (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

Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the 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, coronary bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or if you are a smoker.

Cases of an allergic reaction to ibuprofen have been reported, which include problems breathing, swelling of the face and neck region (angioedema), and chest pain. Discontinue treatment with ibuprofen immediately and contact your doctor or seek emergency care if you notice any of these signs.

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

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

Infections

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

Other warnings
In rare cases, severe hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If you experience the first signs of a hypersensitivity reaction after taking ibuprofen, discontinue treatment and consult your doctor. The necessary medical measures, in line with the symptoms, should be initiated by specialized personnel.

Ibuprofen may inhibit the aggregation and function of platelets (platelet aggregation) in a reversible manner. Therefore, patients with bleeding disorders should be carefully monitored.

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

The prolonged use of any type of analgesic for headache may exacerbate it. If you observe or suspect this situation, consult a doctor and discontinue treatment.

Generally, the habitual use of different types of analgesics may lead to the development of severe kidney problemswith a risk of renal insufficiency (analgesic nephropathy). This risk can be increased in conditions of physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

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

If you experience vision problems, please consult your doctor.

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

Adolescents
There is a risk of renal insufficiency in dehydrated adolescents.

Other medications and Diltix

Inform your doctor or pharmacist that you are using or have used recently 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 (usedfor 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. Serum levels of lithium require monitoring. Generally, serum levels of digoxin and phenytoin do not require monitoring when used as directed (3 or 4 days at most).
• Anticoagulants (to thin the blood/prevent blood clots, e.g., aspirin, warfarin, ticlopidine). NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and blood pressure medications:
  Ibuprofen may reduce the effect of medications used to increase urine production (diuretics) and lower blood pressure (blood pressure medications, e.g., ACE inhibitors and beta-blockers). The combined administration of ibuprofen and potassium-sparing diuretics (medications used to increase urine production) may lead to an increase in potassium levels in the blood.
• Blood pressure medications (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as 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 higher risk of renal dysfunction.
• Colestiramine (a medication used to reduce cholesterol) in combination with ibuprofen may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.
• Other analgesics: The combined use of ibuprofen with other anti-inflammatory and analgesic medications in 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.
• Metotrexate: The administration of ibuprofen within 24 hours before or after the administration of metotrexate (usedto treat certain types of cancer and rheumatism) may cause an increase in metotrexate concentrations and an increase in its side effects.
• Ciclosporin and tacrolimus: There is a higher risk of kidney damage from immunosuppressive medications such as ciclosporin and tacrolimus.
• Probenecid or sulfinpirazona: Medications containing probenecid or sulfinpirazona (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.
• Sulfonilureas: During the combined use of ibuprofen and sulfonilureas (medications used to treat diabetes), it is recommended to monitor blood sugar levels.
• Zidovudine: There is evidence that suggests a higher risk of hemarthrosis (accumulation of blood in the joints) and bruising (hematomas) in HIV-positive patients with hemophilia who use zidovudine (antiretroviral medication) in combination with ibuprofen.
• Quinolone antibiotics: The risk of seizures (attacks) may increase when quinolone antibiotics, such as ciprofloxacin, are taken with ibuprofen at the same time.
• Aminoglucosides: The combined use of ibuprofen with aminoglucosides (a type of antibiotic) with NSAIDs may decrease the elimination of aminoglucosides.
• Voriconazol and fluconazol (CYP2C9 inhibitors) used for fungal infections, as the effect of ibuprofen may increase. Consider reducing the dose of ibuprofen, particularly when administering a high dose of ibuprofen with voriconazol or fluconazol.
• 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 in the NSAID group (e.g., ibuprofen) may reduce the effect of mifepristone.
• Ritonavir: The combined use with ritonavir (an antiviral medication used to treat HIV) may increase the plasma concentrations of analgesics in the NSAID group.
• Alcohol, bisphosphonates, and oxpentifilina (pentoxifilina): The combined use of ibuprofen with alcohol, bisphosphonates (used for osteoporosis) or pentoxifilina (for peripheral artery disease) may increase the gastrointestinal side effects and the risk of bleeding and ulcers.
• Baclofeno (a muscle relaxant) due to the high toxicity of baclofeno.
• Corticosteroids (used to treat inflammation) 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

Reactions to ibuprofen may be increased by taking alcohol, especially those affecting the central nervous system and the gastrointestinal tract. Do 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 tendency and that of your baby to bleed and delay or prolong delivery. Do not take ibuprofen during the first 6 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, you should take the minimum dose for the shortest duration possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic 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 adverse effects have been reported so far, it is usually not necessary to interrupt breastfeeding during a short period of ibuprofen use at the recommended dose for fever and pain.

Fertility

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

Driving and operating machinery

Ibuprofen generally has a negligible or insignificant influenceon the ability to drive and operate machinery. However, at higher doses, adverse effects such as fatigue and dizziness may appear, affecting reaction time when driving and operating machinery. This is especially important when 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".

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

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

The recommended dose is:

Adults and adolescents over 40 kg of weight (12 years or older)

A single dose of half a tablet (200 mg) or a whole tablet (400 mg). If necessary, take an additional dose of half or a whole tablet.

The dosing interval should be chosen according to the observed symptoms and the recommended daily maximum dose.The interval between doses should not be less than 6 hours.Do not take more than 3 tablets (1,200 mg) of ibuprofen in a 24-hour period.

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

Adverse reactions can be minimized by using the 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, which will be the lowest possible dose.

Administration form

Oral route.

Take the tablet with a glass of water.

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

Patients with sensitive stomachs are recommended to 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 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, you 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood) 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, seizures (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, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, decreased body temperature, and respiratory problems.

If you forgot to take Diltix

Do not take a double dose to compensate for the missed doses.

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

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

The most common side effects observed affect the digestive tract. They may occur ulcers in the stomach/duodenum (peptic ulcers), perforation or bleeding, sometimes fatal, 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, mouth and throat ulcers (stomatitis ulcerosa),exacerbation of colitis and Crohn's disease(see section 2: "Warnings and precautions") have been reported after use. Less frequently, gastritishas been observed. In particular, the risk of developing gastrointestinal bleeding depends on the level of the dose and the duration of treatment.

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

More serious side effects

• Stop treatment and seek immediate medical attentionif you develop severe allergic reactions (hypersensitivity), a very rare side effect (may affect up to 1 in 10,000 people):
• These may manifest as:

• inflammation in the face(facial edema), tongue or throat (laryngeal edema with respiratory tract constriction)
• difficulty breathing
• rapid heartbeats
• falling blood pressure to fatal shock.
• chest pain, which may be a sign of a possible severe allergic reaction called Kounis syndrome [unknown frequency (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 local infection symptoms, such as throat/pharyngeal/mouth pain or urinary problems. Ibuprofen can cause adecrease 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 immediately if you notice any of the following symptoms:
• • flat, red, 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 [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome] [very rare side effect (may affect up to 1 in 10,000 people)].
  • a severe skin reaction known as DRESS (by its English acronym) may occur. The symptoms of DRESS include: skin rash, fever, lymph node inflammation, and elevated eosinophils (a type of white blood cell)[unknown frequency (frequency cannot be estimated from available data)].
  • skin rash or lesions on 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 (skin erosions and painful lesions with necrosis andskin detachment). [very rare side effect (may affect up to 1 in 10,000 people)].
  • a red, scaly rash that spreads with swelling under the skin and blisters, accompanied by fever. Symptoms appear normally at the beginning of treatment (generalized acute pustular exanthema). [unknown frequency (frequency cannot be estimated from available data)].
• Stop taking ibuprofenif you experience relatively intense pain in the upper abdomen, vomit with blood, present black stools or bloody diarrheaand inform your doctor immediately.
• If you have edema (fluid retention), especially in patients with high blood pressure (hypertension) or kidney problems, nephrotic syndrome,renal tubular nephritis (kidney disorder)that may be associated with acute kidney failure (kidney insufficiency) [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 (usually feeling sick) may be signs of kidney insufficiency.

If you experience any of the side effects or if they worsen, stop treatment and seek immediate medical attention.

Other side effects

Frequent (may affect more than 1 in 10 people)

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

Rare (may affect up to 1 in 100 people)

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

Stop taking ibuprofen and inform your doctor immediately.

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

• Tinnitus (ringing in the ears).
• Loss of hearing.
• Renal papillary necrosis,high blood urea levels,high uric acid 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 (leucopenia) or platelet levels (thrombocytopenia); and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anemia, or hemolytic anemia).The first symptoms are: fever, throat pain, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nasal and skin bleeding.
• Worsening of inflammation associated with infection (e.g. necrotizing fasciitis) related to the use of certain analgesics (NSAIDs). If during ibuprofen administration, symptoms of an infection or it worsens (e.g. redness, swelling, heat, pain, fever) seek medical attention immediately. It should be determined if antibiotic therapy is indicated.
• Asymptomatic meningitis (inflammation of the brain and its covering not caused by infection) has been observed during ibuprofen use, such as acute headache, nausea, vomiting, fever, neck stiffness, or transient loss of consciousness with ibuprofen use. Patients with autoimmune disorders (Lupus, mixed connective tissue disease) appear to be predisposed.
• Low blood sugar (hypoglycemia).
• Low sodium levels in the blood (hyponatremia).
• Palpitations, heart failure, heart attack.
• High blood pressure (hypertension).
• Vascular inflammation (vasculitis).
• Inflammation of the esophagus or pancreas (pancreatitis),intestinal narrowing or constriction (intestinal stenosis type diaphragm).
• Psychotic reactions, hallucinations, confusion, depression, and anxiety.
• Asthma, difficulty breathing (dyspnea), bronchospasm.
• Yellow discoloration of the eyes and/or skin (jaundice),liver dysfunction, liver damage, especially with prolonged treatment, liver insufficiency, acute hepatitis.
• Hair loss (alopecia),red or purple discoloration patches on the skin (purpura) or photosensitivity reactions (triggered by sunlight).
• Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur.

Unknown frequency (cannot be estimated from available data)

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

Medicines like ibuprofen may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Reporting of side effects

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

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

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

Do not store at a temperature above 25°C.

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

Diltix Composition

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

The other components are:

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

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

Product appearance and container content

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

The tablet can be divided into equal doses.

They are presented in containers with blisters of 10, 12, 20, 24, 30, 50, or 60 film-coated tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Aristo Pharma GmbH

Wallenroder Strasse 8-10,

Berlin - 13435 – Germany

For more information about this medication, please contact 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 with the following names:

Germany:IbuARISTO akut 400 mg

Italy:Ibuprofene Aristo

Poland:Axoprofen Forte

Spain:Diltix 400 mg film-coated tablets EFG

Last review date of this leaflet:09/2024

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/