Ibuprofen (arginine) Stada 600 mg granules for oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

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

Leaflet Contents

1. What Ibuprofen (arginine) STADA is and what it is used for
2. What you need to know before taking Ibuprofen (arginine) STADA
3. How to take Ibuprofen (arginine) STADA
4. Possible side effects
5. How to store Ibuprofen (arginine) STADA
6. Contents of the pack and other information

1. What Ibuprofeno (arginina) Stada is and what it is used for

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: headaches, dental pain, postoperative pain, menstrual pain, symptomatic treatment of headache and febrile conditions. Ibuprofeno (arginina) Stada is also indicated in rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, and other acute or chronic rheumatic conditions, as well as in other muscular (sprains and strains) and bone disorders where pain and inflammation occur.

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

Do not take Ibuprofeno (arginine) Stada:

• If you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Such reactions may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you suffer from severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have severe liver or kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ibuprofeno (arginine) Stada.

• If you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even occur without prior warning symptoms.

This risk is higher when high doses are used, with prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protecting medicine.

• If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines like Ibuprofeno (arginine) may worsen these conditions.
• If you have previously had kidney or liver disease.
• If you have edema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you are being treated for an infection, as Ibuprofeno (arginine) may mask fever, an important sign of infection.
• If you have heart, kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular check-ups. Your doctor will advise you on how often these checks should be done.
• If you have an infection; see the section “Infections” below.
• Allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using this medicine immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Special caution is advised with ibuprofen:

Skin reactions

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

Cardiovascular precautions

Medicines such as ibuprofen (non-steroidal anti-inflammatory/analgesic drugs) may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno (arginine) Stada if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 smoke.

Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

Do not give to children under 14 years of age.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Other medicines and Ibuprofeno (arginine) Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ibuprofeno (arginine) Stada may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs.
• Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (which slows the growth of certain body cells).
• Mifepristone (used to induce abortion).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output).
• Fluconazole (used to treat fungal infections).
• Pentoxifylline (used for intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).

Other medicines may also interact with or be affected by treatment with Ibuprofeno (arginine) Stada. Therefore, always consult your doctor or pharmacist before using Ibuprofeno (arginine) Stada with other medicines.

Taking Ibuprofeno (arginine) Stada with food and drink

You may take it alone or with food. It is generally recommended to take it during or immediately after meals to reduce the possibility of stomach discomfort.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take ibuprofen during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor more than expected. You should not take ibuprofen during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Fertility

For women of childbearing age, it should be noted that medicines such as Ibuprofeno (arginine) have been associated with a reversible reduction in fertility.

Breastfeeding

Although only small amounts of the medicine 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 medicine should be used with caution in patients whose activities require alertness and who experience drowsiness, dizziness or depression during treatment.

Ibuprofeno (arginine) Stada contains aspartame, sucrose and sodium

This medicine contains 30 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; hence, it is essentially “sodium-free”.

3. How to take Ibuprofen (arginine) Stada

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The lowest effective dose should be used for the shortest duration 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 (arginine) every 12 hours. If gastric discomfort occurs after taking the medicine, it should be taken 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), keeping in mind that the lowest effective dose should be used.

In elderly patients, the dose should be determined by the doctor, as a reduction of the usual dose may be necessary. In case of kidney disorders, doses should be adjusted, since the medicine is primarily eliminated through this route.

Children and adolescents

The use of this medicine is not recommended in children or adolescents under 14 years of age, as the dose of ibuprofen contained in this medicine 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 medicine, contact a doctor, pharmacist, or the Toxicology Information Service immediately, telephone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to find out about the risk and seek advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

If a severe poisoning 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 missed doses.

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

4. Possible adverse effects

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

The adverse effects observed are described below according to their frequency of occurrence: 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); frequency not known (cannot be estimated from the available data).

The following adverse effects have been observed:

Gastrointestinal disorders

The most common adverse effects with medicines such as Ibuprofen (arginine) Stada are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

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

Skin and subcutaneous tissue disorders

Common: skin rash.

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

Rare: severe allergic reactions (anaphylactic shock).

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

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

Medicines such as ibuprofen (arginine) may, very rarely, be associated 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), mostly occurring in patients with autoimmune disorders such as systemic lupus erythematosus.

Severe allergic reaction that may present with nausea, vomiting, swelling of the face, tongue and throat, breathing difficulties, asthma, palpitations, hypotension or shock.

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell).

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

• Flat, non-elevated reddish spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Nervous system disorders

Common: headache, dizziness, nervousness.

Uncommon: fatigue or drowsiness, insomnia, anxiety, visual disturbances, tinnitus (ringing or buzzing in the ears).

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

Very rare: aseptic meningitis.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, blood cell abnormalities (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds and skin bleeding).

Cardiac and vascular disorders

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using medicines of the type Ibuprofen (arginine) Stada.

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

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin). Medicines such as Ibuprofen (arginine) Stada may, in rare cases, be associated with liver injury.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen (Arginine) Stada

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno (arginina) Stada

• The active substance is ibuprofen. Each sachet contains 600 mg of ibuprofen (as 1,110 mg of ibuprofen arginate).
• The other components (excipients) are: arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, menthol flavour, mint flavour (contains maize starch), and purified water.

Appearance of the product and contents of the pack

Ibuprofeno (arginina) Stada 600 mg granules for oral solution is presented in sachets containing white granules with a mint odour.

Ibuprofeno (arginina) Stada 600 mg granules for oral solution is available in packs containing 20, 40 and 500 (clinical pack) sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio 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 most recent review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.