Leaflet: information for the user

Ibuprofen (arginine) STADA 600 mg powder for oral solution EFG

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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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.

Ibuprofeno (arginina) Stada belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of pain: headache pain, dental pain, post-operative pain, menstrual pain, symptomatic treatment of headache and febrile states. Ibuprofeno (arginina) Stada is also indicated in rheumatoid arthritis (including juvenile rheumatoid arthritis) ankylosing spondylitis, osteoarthritis and other acute or chronic rheumatic processes, as well as in other muscle (sprains and strains) and bone pathologies where pain and inflammation occur.

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 nonsteroidal anti-inflammatory drugs. Such reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach ulcer or bleeding, 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 serious liver or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno (arginina) Stada.

• If you have had or develop a stomach ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

• If you take simultaneously medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you have 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 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" heading later.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using this medication immediately and contact your doctor or emergency medical services 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 syndrome), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno (arginina) Stada if:

-You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (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.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Children and adolescents

Do not administer to children under 14 years old.

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 having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Other medications and Ibuprofeno (arginina) Stada

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

Ibuprofeno (arginina) Stada may affect or be affected by other medications. For example:

• Other nonsteroidal 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.
• Metotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).
• Mifepristone (inducer of abortion).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hidantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfamides 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 (used in the treatment of fungal infections).
• Pentoxifylline (used in the treatment of intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used in gout).
• Sulfonilureas such as tolbutamide (used in diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV).
• 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 the treatment with Ibuprofeno (arginina) Stada. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno (arginina) Stada with other medications.

Taking Ibuprofeno (arginina) Stada with food and drinks

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 discomfort.

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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected. 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 a period longer than a few days, your doctor may recommend additional checks.

Fertility

For fertile women, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

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 operating machines

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

Ibuprofeno (arginina) Stada contains aspartame, saccharose, and sodium

This medication contains 30 mg of aspartame in each packet.

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

This medication contains saccharose. 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 packet; that is, 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.

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

The 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 average dose is 1 sachet of Ibuprofen (arginina) every 12 hours. If gastrointestinal discomfort is detected after taking the medication, it will be administered with milk or during meals. In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed the daily dose of 2,400 mg of ibuprofen (4 sachets), taking into account that the lower dose considered effective should be administered.

In elderly patients, the dose should be established by the doctor, as it is possible that a reduction in the usual dose may be needed. In cases of kidney disorders, the doses should be adjusted since the medication is eliminated mainly through this route.

Children and adolescents

This medication is not recommended for use in children or adolescents under 14 years old, as the dose of ibuprofen contained in this medication is not suitable for the recommended dose in this patient group.

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

If you have taken more Ibuprofen (arginina) Stada than you should, or if a child has accidentally ingested the medication, consult a doctor, pharmacist, or the Toxicological Information Service immediately, 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-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have also been reported.

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

If you forgot to take Ibuprofen (arginina) Stada

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 observed side effects are described below according to their frequency of presentation: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (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); unknown frequency (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with Ibuprofeno (arginina) Stada medications are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients.

Also observed were nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease. Less frequently, gastritis has been observed.

Dermatological and subcutaneous tissue disorders

Common:skin rash.

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

Rare:severe allergic reactions (anaphylactic shock).

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

Unknown frequency: Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See section 2.

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

Asymptomatic 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 may manifest with nausea, vomiting, facial swelling, tongue and throat swelling, breathing difficulty, asthma, palpitations, hypotension, or shock.

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

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

• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may 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 swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Nervous system disorders

Common:headache, feeling of instability, and nervousness.

Uncommon:fatigue or somnolence, insomnia, anxiety, visual disturbances, tinnitus or buzzing in the ears.

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

Very rare:asymptomatic meningitis.

Blood and lymphatic system disorders

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

Cardiac and vascular disorders

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

Also observed were edema (fluid retention), hypertension, and heart failure in association with treatments with medications of the type Ibuprofeno (arginina) Stada.

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

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare:hepatitis (liver inflammation) and jaundice (yellow skin discoloration). Medications like Ibuprofeno (arginina) Stada may be associated, in rare cases, with liver damage.

Reporting of side effects

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

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

This medication does not requirespecial 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 “CAD.:”. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno (arginina) 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 aroma (contains cornstarch) and purified water.

Appearance of the product and content of the packaging

Ibuprofeno (arginina) Stada 600 mg granulated for oral solution is presented in sachets with white granulated powder and a peppermint odor.

Ibuprofeno (arginina) Stada 600 mg granulated for oral solution is presented in packs with 20, 40 and 500 (clinical pack) sachets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

Last review date of this leaflet: October 2024

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