IBUPROFEN (ARGININE) STADA 600 mg ORAL SOLUTION GRANULES

2. What you need to know before taking Ibuprofen (arginine) Stada

Do not take Ibuprofeno (arginina) Stada:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have an allergy to other medications such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Such reactions could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have a severe liver or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen (arginine) Stada.

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications of the ibuprofen type may worsen these conditions.
• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment for an infection, as Ibuprofen (arginine) may mask fever, which is an important sign of infection.
• If you have heart, kidney, or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have an infection; see the "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using this medication immediately and contact your doctor or the medical emergency service if you observe any of these signs.

Special caution is recommended with ibuprofen:

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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of 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 (arginine) Stada 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, a family history of heart disease or stroke, or if you are a smoker.

Similarly, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

Do not administer to children under 14 years of age.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, 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 medications and Ibuprofen (arginine) Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Ibuprofen (arginine) Stada may affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory drugs.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medication (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine elimination).
• Fluconazole (for the treatment of fungal infections).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan)

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

Taking Ibuprofen (arginine) Stada with food and beverages

You can take it alone or with food. In general, it is recommended to take it during meals or immediately after eating to reduce the possibility of stomach upset.

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 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 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 amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Fertility

For patients of childbearing age, it should be noted that medications of the ibuprofen type have been associated with a decrease in fertility.

Breastfeeding

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and using machines

Although this effect is rare, this medication should be used with caution in patients whose activity requires attention and who have observed drowsiness, dizziness, or depression during treatment.

Ibuprofen (arginine) Stada contains aspartame, sucrose, and sodium

This medication contains 30 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

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

3. How to take Ibuprofen (arginine) Stada

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

Ibuprofen (arginine) Stada is administered orally. Pour the contents of one sachet into a half glass of water and stir.

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

The recommended average dose is 1 sachet of Ibuprofen (arginine) every 12 hours. If stomach upset occurs after taking the medication, it should be administered with milk or during meals. In rheumatoid arthritis, higher doses may be required, but in any case, the daily dose of 2,400 mg of ibuprofen (4 sachets) should not be exceeded, taking into account that the lowest effective dose should be administered.

In elderly patients, the dose should be established by the doctor, as it may be necessary to reduce the usual dose. In case of kidney disorders, the doses should be adjusted, as the medication is eliminated mainly through this route.

Children and adolescents

The use of this medication is not recommended in children or adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dose in this patient group.

If you take more Ibuprofen (arginine) Stada than you should

If you have taken more Ibuprofen (arginine) Stada than you should, or if a child has accidentally ingested the medication, consult a doctor, pharmacist, or the Toxicology Information Service (telephone: 91 562 04 20) immediately, 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 blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If a severe overdose has occurred, the doctor will take the necessary measures.

If you forget to take Ibuprofen (arginine) Stada

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

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

The observed adverse effects are described below according to their frequency of presentation: very frequent (may affect more than 1 in 10 people); frequent (may affect up to 1 in 10 people); infrequent (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).

The following adverse effects have been observed:

Gastrointestinal Disorders

The most frequent adverse effects that occur with medications like Ibuprofen (arginine) Stada are gastrointestinal: peptic ulcers, digestive hemorrhages, perforations (in some cases fatal), especially in elderly patients.

Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, the appearance of gastritis has been observed.

Disorders of the Skin and Subcutaneous Tissue

Frequent: skin rash.

Infrequent: skin redness, itching or swelling of the skin, swelling of the lips, face, or tongue, increased nasal secretion, and difficulty breathing.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: intense itching of the skin with sudden onset or blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions due to light influence.

Frequency not known: Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you present these symptoms and seek immediate medical attention. See also section 2.

Medications like ibuprofen (arginine) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

Severe allergic reaction that can manifest with nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, inflammation of the lymph nodes, and elevated eosinophils (a type of white blood cell).

Interrupt treatment with this medication and seek immediate medical attention if you notice any of the following symptoms:

• Reddish, non-elevated spots, target-like or circular on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Disorders of the Nervous System

Frequent: headache, feeling of instability, and nervousness.

Infrequent: fatigue or drowsiness, insomnia, anxiety, vision changes, ringing or buzzing in the ears.

Rare: disorientation or confusion, depression, abnormal or blurred vision, and hearing difficulty.

Very rare: aseptic meningitis.

Disorders of the Blood and Lymphatic System

Very rare: prolonged bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding).

Cardiac and Vascular Disorders

Medications like Ibuprofen (arginine) Stada may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of the type Ibuprofen (arginine) Stada.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Renal and Urinary Disorders

Kidney disease.

Hepatobiliary Disorders

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). Medications like Ibuprofen (arginine) Stada may be associated, in rare cases, with liver damage.

Reporting of Adverse Effects

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

5. Conservation of Ibuprofen (arginine) Stada

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions. Keep in its original packaging to protect from light and moisture.

Do not use this medication after the expiration date that appears on the packaging after "EXP.:". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Ibuprofen (arginine) Stada

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen (as 1.110 mg of ibuprofen arginine).
• The other components (excipients) are: arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, peppermint flavor, spearmint flavor (contains cornstarch), and purified water.

Appearance of the Product and Packaging Content

Ibuprofen (arginine) Stada 600 mg granules for oral solution are presented in sachets with white granules and a minty smell.

Ibuprofen (arginine) Stada 600 mg granules for oral solution are presented in packages with 20, 40, and 500 (clinical package) sachets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Toll Manufacturing Services S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

or

BIOCENTURY, S.L.

Ctra. N-II Km 714

17242 Quart (Girona)

Spain

or

LAMP S. Prospero S.P.A.

Via Della Pace, 25

41030 San Prospero (MO)

Italy

Date of the Last Revision of this Prospectus: October 2024

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