Ibuprofen STADA 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Stada 400 mg film-coated tablets EFG

Read the entire 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 you should not give it to others, even if they have the same symptoms as you, because it could harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

• What Ibuprofeno Stada is and what it is used for
• What you need to know before taking Ibuprofeno Stada

1. How to take Ibuprofeno Stada
2. Possible side effects
3. Storage of Ibuprofeno Stada
4. Contents of the pack and other information

1. What Ibuprofeno Stada is and what it is used for

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

Ibuprofen is indicated for the treatment of symptoms of:

• Rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, and other acute or chronic rheumatic conditions.
• Soft tissue injuries such as sprains and strains.
• Mild to moderate pain conditions such as dental pain, postoperative pain, headache, and menstrual pain.
• Fever of various causes.

2. What you need to know before taking Ibuprofeno Stada

It is important that you use the smallest dose that relieves/controls your pain and that you do not take this medicine for longer than necessary to control your symptoms.

Do not take Ibuprofeno Stada:

• if you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6). Reactions may include: itchy rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• if you have previously had a stomach or duodenal bleed or have suffered a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug (NSAID).
• if you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• if you are vomiting blood.
• if you have black stools or diarrhoea with blood.
• if you have ulcerative colitis or active Crohn’s disease.
• if you have severe liver or kidney disease.
• if you have severe heart failure.
• if you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants at the same time, your doctor will perform blood coagulation tests.
• if you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno 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 without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective 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 inhibitors (SSRIs).
• If you have Crohn’s disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you have had kidney or liver disease. If you experience oedema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you visit your doctor, inform them that you are being treated with ibuprofen, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have an infection; see the “Infections” section below.
• Signs of allergic reaction to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking this medicine immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Special caution is recommended 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), during treatment with ibuprofen. Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen 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 Stada if:

• you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary 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 ischaemic attack “TIA”).
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

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

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of an 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 without delay.

Use of Ibuprofeno Stada with other medicines

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

Ibuprofen may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs)

• Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.

• Methotrexate. Your doctor may need to adjust the dose of this medicine.

• Mifepristone.

• Digoxin and cardiac glycosides (used in the treatment of heart failure).

• Hydantoins such as phenytoin (used in the treatment of epilepsy).

• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).

• Corticosteroids such as cortisone and prednisolone.

• Diuretics.

• Fluconazole.

• Pentoxifylline.

• Probenecid.

• Quinolone antibiotics such as norfloxacin.

• Sulfinpyrazone.

• Sulfonylureas such as tolbutamide.

• Tacrolimus.

• Zidovudine.

• Anticoagulant medicines (e.g. to treat coagulation problems/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).

• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).

Other medicines may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medicines.

Other interactions requiring caution:

• Corticosteroids such as cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, cyclosporine, zidovudine, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding and fertility

If you are pregnant or 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 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in your baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labour more than expected. You should not take ibuprofen during the first 6 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 possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby 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 like ibuprofen have been associated with a reduced ability to conceive.

Breastfeeding

Although drug levels in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

If you take only a single dose of ibuprofen, or take it for a short period, no special precautions are necessary.

Ibuprofeno Stada contains lactose and sodium

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

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

3. How to take Ibuprofeno Stada

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how long your treatment with ibuprofen should last. Do not stop the treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use ibuprofen for longer than indicated by your doctor.

Ibuprofeno consists of tablets for oral administration. Swallow the tablet whole with a little water.

If you have a sensitive stomach, take the medicine with food.

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).

Adults

The dosage should be adjusted according to the severity of the condition and the patient's discomfort. In general, the recommended daily dose is 1,200 mg of ibuprofen (3 tablets), divided into 3 doses.

In some conditions, higher doses may be required; however, in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg of ibuprofen (6 tablets).

Children and adolescents

Adolescents weighing more than 40 kg: the recommended daily dose is 1,200 mg of ibuprofen (3 tablets); one tablet every 6–8 hours. It is recommended not to exceed the maximum daily dose of 1,600 mg of ibuprofen (4 tablets).

This medicine is not recommended for use in children and adolescents weighing less than 40 kg, as the ibuprofen dose it contains is not suitable for the recommended dosing in these patients.

Elderly patients

If you are over 60 years old, your doctor may prescribe a lower than usual dose. In such case, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose. In such case, take exactly the dose prescribed by your doctor.

If you think that the effect of ibuprofen is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Stada than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, consult immediately a doctor, pharmacist, or the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to learn about the risk and receive 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 and 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 Ibuprofeno Stada

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

If you forget to take your scheduled dose, take it as soon as you remember. However, if the time for your next dose is approaching, skip the missed dose and take the next dose at the usual time.

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.

Adverse effects with medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: 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 available data).

The following adverse effects have been observed:

Gastrointestinal disorders

The most common adverse effects associated with medicines such as ibuprofen 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, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Very common: diarrhoea, indigestion.

Common: nausea, vomiting, abdominal pain.

Uncommon: gastrointestinal bleeding, stomach or duodenal ulcers, mouth ulcers.

Rare: gastric or intestinal perforation, flatulence, constipation, inflammation of the oesophagus, ulcers or inflammation of the intestine.

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 skin itching or skin blisters, joint pain and fever (lupus erythematosus), hair loss, skin reactions due to light exposure, serious skin reactions such as allergic vasculitis, Lyell's syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Frequency not known: Widespread red scaly rash with bumps 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 immediately if you experience these symptoms and seek medical attention immediately. See also section 2.

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).

Central nervous system disorders

Common: fatigue or drowsiness, headache, dizziness or unsteadiness.

Uncommon: insomnia, anxiety, restlessness, visual disturbances, ringing or buzzing in the ears.

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

Very rare: aseptic meningitis.

Blood and lymphatic system disorders

Very rare: prolonged bleeding time, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin).

Cardiovascular disorders

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

Oedema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using ibuprofen-type medicines. Swelling of the limbs or fluid accumulation in the arms or legs (more likely in individuals with high blood pressure or kidney disorders). Heart failure or high blood pressure (hypertension), especially in elderly patients. Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Renal and urinary disorders

Kidney impairment or renal failure.

Hepatobiliary disorders

Medicines such as ibuprofen may rarely be associated with liver damage.

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin).

Other

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue and throat, breathing difficulty, asthma, palpitations, hypotension, or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, facial swelling, chest wheezing, or breathing difficulty.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhoea.
• Severe stomach pain.
• Blisters or extensive skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in arms or legs.
• Flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, elevated body temperature, and swollen 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).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Stada

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

Do not store above 30°C.

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 point located at the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Stada

• The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are:

Core

Sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, purified water and magnesium stearate.

Coating

Titanium dioxide (E-171), hypromellose, talc, purified water and propylene glycol.

Appearance of the product and contents of the pack

Ibuprofeno Stada is presented as film-coated oval, biconvex tablets, scored on both sides, white in colour.

Each pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

FARMALIDER, S.A.

Aragoneses, 2

28108 Alcobendas

Madrid, Spain

or

FROSST IBERICA, S.A.

Vía Complutense, 140

Alcalá de Henares

Madrid, Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid), Spain

Date of the most recent revision of this leaflet: October 2024

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