Diltix 600 mg comprimidos recubiertos con pelicula efg

Leaflet: information for thepatient

Diltix 600 mg film-coated tablets EFG

Ibuprofen

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

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

1. What Diltix is and for what it is used

2. What you need to know before starting to take 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 belongs

to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the treatment of pain and has an anti-inflammatory effect.

Ibuprofen is indicated for adults and adolescents weighing 50 kg or more (15 years or older) and is used for symptomatic treatment of pain and inflammation in arthritic diseases (e.g. rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis) and in non-rheumatic inflammation and painful inflammation after soft tissue injuries.

Do not take Diltix

• If you are allergic to ibuprofen or any of the other ingredients in this medicine (listed in section 6). Allergic reactions may include: swelling of the eyelids, lips, tongue, or throat.
• If you have ever had an allergic reaction (such as bronchospasm (tightening of the muscles in the lungs that can cause asthma and shortness of breath), asthma attacks, nasal discharge, nasal inflammation, skin reactions, or sudden swelling) after taking aspirin or other similar pain-relieving medicines (NSAIDs).
• If you have bleeding or blood clotting disorders.
• If you have an active or recurrent stomach or duodenal ulcer (peptic ulcer) or bleeding (two or more episodes of ulceration proven or bleeding).
• If you have a history of gastrointestinal bleeding or perforation associated with previous treatment with NSAIDs.
• If you have a current or past history of cerebral or other active bleeding.
• If you have severe liver, kidney, or heart failure.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen.

Adverse reactions are minimized by using the lowest effective dose for the shortest period of 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 the connective tissue).

• You have or have had gastrointestinal 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.
• After undergoing major surgery.
• There may be allergic reactions with this medicine.
• If you have hay fever, 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.
• If you have an infection:see the heading "Infections" later.

Effects on the gastrointestinal tract
The combined use of ibuprofen with other non-steroidal anti-inflammatory 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 may 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") 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).

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially bleeding and perforation of the gastrointestinal tract and shouldconsult with your doctor, particularly at the beginning of therapy.

Caution should be exercised if also taking other medications that may increase the risk of ulcers or bleeding, for example, 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 medicines 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) such as 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.

Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you observe any of these signs.

Skin reactions
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular psoriasis, have been reported in association with ibuprofen treatment. Discontinue treatment with 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 advisable to avoid using ibuprofen.

Infections

Ibuprofenmay mask the signs of an infection, such as fever and pain. Therefore, it is possible thatibuprofenmay delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine 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, kidney function, and blood counts is required.

If you take ibuprofen before surgery, you should consult your doctor or dentist.

The long-term use of any type of analgesic for headache may exacerbate it. If you observe or suspect this situation, you should consult a doctor and discontinue treatment.
In general, 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 may 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

Patients who experience eye problems during treatment with ibuprofen should discontinue therapy and undergo eye examinations.

Elderly patients
Elderly patients have a higher risk of experiencing adverse effects after using non-steroidal anti-inflammatory drugs (NSAIDs), especially bleeding and perforation of the gastrointestinal tract, which may be potentially fatal in some cases. For this reason, close medical supervision is required in elderly patients.

Children and adolescents
There is a risk of renal insufficiency in dehydrated adolescents.

Other medicines 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. Monitoring of serum levels of lithium is required. Monitoring of serum levels of digoxin and phenytoin is recommended.
• Anticoagulants (to dilute the blood/prevent blood clots, for example, aspirin, warfarin, ticlopidine). NSAIDs may increase the effects of anticoagulants such as warfarin.
• Diuretics and blood pressure medications:
  for example, ACE inhibitors, beta-blockers, and angiotensin II receptor antagonists. The combined administration of ibuprofen and diuretics that save potassium (medicines used to increase urine elimination) may lead to an increase in potassium levels in the blood. Therefore, monitoring of these levels is recommended.
• Medications that lower high blood pressure(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 hypertension) on 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 NSAIDs, including COX-2 inhibitors (for example, 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: Administration of ibuprofen within 24 hours before or after administration of metotrexate (usedto treat cancer and inflammatory diseases) may cause an increase in metotrexate concentrations and an increase in its side effects.
• Ciclosporin and tacrolimus may damage the kidneys.
  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 combined use of ibuprofen and sulfonilureas (medications used to treat diabetes), monitoring of blood sugar levels is recommended.
• Zidovudine: There is evidence of a higher risk of hemarthrosis (accumulation of blood in the joints) and bruising (hematomas) in HIV-positive patients with hemophilia who use zidovudine (antiviral medication) 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 NSAIDs (i.e. ibuprofen) may reduce the effect of mifepristone.
• Ritonavir: Combined use with ritonavir (an antiviral medication used to treat HIV) may increase the plasma concentrations of analgesic NSAIDs.
• Alcohol, bisphosphonates, and oxpentifilina (pentoxifilina): The combined use of ibuprofen with alcohol, bisphosphonates (used for osteoporosis) or pentoxifilina (for peripheral arterial circulatory problems) may increase 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

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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you become pregnant while taking ibuprofen.

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

Breastfeeding

Only small amounts of ibuprofen pass into breast milk, and, in general, it is not necessary to stop breastfeedingif used at the recommended dose and for the shortest possible time for fever and pain. However, if you need longer treatment or higher doses, you should consider stopping breastfeeding.

Fertility
Ibuprofenmay affect fertility in women. You should inform 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, if you experience adverse effects such as fatigue and dizziness, your reaction time may be affected, so do not drive or operate machinery. Alcohol consumption increases the risk of these adverse effects.

Diltix contains lactose

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

Diltix contains sodium

This medicine contains less than 1 mmolof sodium (23 mg) 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:

Rheumatic diseases, inflammatory processes, and painful inflammation in soft tissue injuries

Adults
The usual single dose is 300-600 mg of ibuprofen. The recommended daily dose is 1,200-1,800 mg divided into doses.The interval between doses should not be less than 6 hours.Some patients may remain with 600-1,200 mg daily. In severe or acute conditions, the dose may be increased until the acute phase is controlled, provided the daily dose does not exceed 2,400 mg in divided doses.

Adolescents 15 years and older (≥50 kg body weight):
The recommended dose should be adjusted by weight: 20-40 mg/kg/day (max. 2,400 mg/day) in 3-4 divided doses.

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

Children and adolescents
This medication is not recommended for use in children weighing less than 50 kg or under 15 years of age.

Administration form

Oral route.

Take the tablet with a glass of water.

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

Patients with sensitive stomachs are recommended to take ibuprofen with food.

Treatment duration

Your doctor will decide on the treatment duration.
In rheumatic diseases, it may be necessary to use ibuprofen for a longer period of time.

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), or less frequently diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, involuntary eye movement, and worsening of asthma in asthmatics. At high doses, symptoms of drowsiness, disorientation, chest pain, palpitations, loss of consciousness, coma, seizures (mainly in children), vertigo, weakness, and dizziness, blood in the urine, decreased potassium levels in the blood, low blood pressure, increased potassium levels in the blood, increased prothrombin time, 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 doubts 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.

Regarding the following side effects, it should be remembered that these depend mainly on the dose and vary from person to person.

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, ulcers (wounds) in the mouth and throat region (stomatitis ulcerosa), exacerbation of colitis and Crohn's disease (see section 2: "Warnings and precautions") have been reported after use.

Less frequently, the appearance of gastritis has 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 a potentially fatal shock.
• chest pain, which may be a sign of a possible severe allergic reaction called Kounis syndrome [frequency unknown (the frequency cannot be estimated from available data)]

• 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.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. 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, or purple spots on the trunk, often with central blisters, peeling of the skin, 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. Symptoms of DRESS syndrome include: skin rash, fever, lymph node inflammation, and elevated eosinophils (a type of white blood cell)[frequency unknown (the 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 (erosions on mucous membranes and painful lesions with necrosis and skin detachment)[a very rare side effect (may affect up to 1 in 10,000 people)]may also occur. There may also be severe infection with skin destruction (necrosis), subcutaneous tissue, and muscle.
• red, scaly, and generalized rash, with swelling under the skin and localized blisters, mainly on skin folds, the trunk, and upper limbs, accompanied by fever, usually at the beginning of treatment (acute generalized pustular psoriasis).

• Stop taking ibuprofenif you experience relatively intense pain in the upper abdomen, vomit with blood, present black stools, or have 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) [infrequent side effects (may affect up to 1 in 100 people)]. Decreased urine production,swelling caused by fluid accumulation in tissues (edema),and discomfort (usually feeling unwell) may be signs of kidney insufficiency.

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

Other side effects

Very common (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.

Common (may affect up to 1 in 10 people)

• Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, or fatigue.
• Especially in elderly patients, gastrointestinal ulcers, sometimes with bleeding and perforation, inflammation of the mucous membrane of the mouth with ulceration (stomatitis ulcerosa), inflammation of the stomach (gastritis), exacerbation of colitis and Crohn's disease, which may be fatal.

Infrequent (may affect up to 1 in 100 people)

• Vision disturbances. In this case, stop using ibuprofen and inform your doctor.
• Inflammation of the stomach (gastritis).
• Allergic reactions, such as skin rashes, itching, and asthma attacks (possibly with falling blood pressure).

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 damage (necrosis papilar), high blood urea levels, and high uric acid levels in the blood.

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

• Blood 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, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nasal bleeding, and skin bleeding.
• Worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) related to the use of certain analgesics (NSAIDs).
• If during ibuprofen administration, signs of infection(e.g. redness, swelling, overheating, pain, fever)appear or worsen, seek immediate medical attention. Antibiotic therapy should be determined.
• Symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, or disorientation, have been observed with ibuprofen use. Patients with autoimmune disorders (LES, mixed connective tissue disease) appear to be predisposed.
• Low blood sugar (hypoglycemia).
• Low sodium levels in the blood (hyponatremia).
• Palpitations, heart failure, myocardial infarction
• High blood pressure (hypertension)
• Vascular inflammation (vasculitis)
• Inflammation of the esophagus or pancreas (pancreatitis), narrowing of the large or small intestine (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.
• Loss of hair (alopecia), red or purple discoloration of the skin (purpura), or photosensitivity reactions (triggered by sunlight).
• Exceptionally, severe skin infections and complications in soft tissue may occur during chickenpox.

Frequency unknown (cannot be estimated from available data)

• Chronic rhinitis.
• Paresthesia (numbness, tingling, or prickling sensation) and inflammation of the optic nerve (neuritis optica).
• Sudden loss of kidney function (kidney insufficiency).

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 a possible side effect that does not appear in this leaflet. 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 and the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Diltix Composition

The active ingredient is ibuprofen.

Each tablet contains 600 mg of ibuprofen.

The other components are:

Tablet core:hypromellose, croscarmellose sodium, 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 packaging contents

Coated, oblong tablets, white or off-white, with a breaking line on both sides and dimensions of 17.5 mm in length and 9 mm in width.

The tablet can be divided into equal doses.

Diltix 600 mg is packaged in blisters in quantities of 10, 20, 30, 40, 50, 60, 84, 100, 250, or 500 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH

Wallenroder Strasse 8-10,

Berlin - 13435 – Germany

For further 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 European Economic Area member states with the following names:

Germany:IbuARISTO 600 mg

Denmark:Ibuprofen „Aristo“

Italy:Ibuprofene Aristo Pharma

Poland:Axoprofen Max

Spain:Diltix 600 mg coated tablets EFG

Portugal:Ibuprofeno Aristo

Sweden:Ibuprofen Aristo

Last review date of this prospectus:September 2024

Further 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/