IBUPROFEN AUROVITAS 400 mg SOFT GEL CAPSULES

Introduction

Prospect: information for the user

Ibuprofen Aurovitas 400 mg soft capsules EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

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

Contents of the prospectus

1. What is Ibuprofen Aurovitas and what is it used for
2. What you need to know before taking Ibuprofen Aurovitas
3. How to take Ibuprofen Aurovitas
4. Possible adverse effects
5. Storage of Ibuprofen Aurovitas
6. Package contents and additional information

1. What is Ibuprofen Aurovitas and what is it used for

Ibuprofen Aurovitas contains the active ingredient ibuprofen. It belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs produce relief by modifying the body's response to pain and fever.

Ibuprofen is indicated in adults and adolescents with a weight over 40 kg (over 12 years), for the short-term symptomatic treatment of mild to moderate pain, such as headaches, flu-like illness, toothache, muscle pain, menstrual pain, and fever.

Ibuprofen is also indicated in adults for the treatment of mild to moderate pain during migraine with or without aura.

You should consult a doctor if you do not improve or if you get worse after 3 days in adolescents, or after 3 days in case of fever or migraine and 5 days in case of pain in adults.

2. What you need to know before taking Ibuprofen Aurovitas

Do not take Ibuprofen Aurovitas:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6)
• If you have ever had an allergic reaction to acetylsalicylic acid (ASA) or other NSAIDs such as asthma, difficulty breathing, swelling of the face, tongue, or throat, hives, itching, and nasal discharge
• If you have (or have had two or more episodes of) stomach or duodenal ulcer or bleeding
• If you have had gastrointestinal perforation or hemorrhage while taking NSAIDs
• If you have had a cerebrovascular hemorrhage or other active bleeding
• If you have unclear blood clotting disorders
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake)
• If you have severe liver, kidney, or heart problems
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofen Aurovitas:

• If you have recently undergone major surgery.
• If you have asthma or an allergic disorder, as you may have difficulty breathing.
• If you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, there is an increased risk of allergic reactions. These allergic reactions can appear as asthma attacks (called analgesic asthma), Quincke's edema, or hives.
• If you have ever had a gastrointestinal ulcer (see also the section "Do not take Ibuprofeno Aurovitas").
• If you have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease).
• If you have systemic lupus erythematosus or mixed connective tissue disease (a disease that affects the skin, joints, and kidneys).
• If you have hereditary disorders of blood cell formation (e.g., acute intermittent porphyria).
• If you have blood coagulation disorders.
• If you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclooxygenase-2 inhibitors, should be avoided due to the increased risk of adverse effects (see the section "Other medications and Ibuprofeno Aurovitas" below).
• If you have chickenpox, it is recommended to avoid using this medication.
• If you are an elderly person.
• If you have liver or kidney problems.
• If you have an infection: see the heading "Infections" below.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain due to ibuprofen, have been reported. Stop using this medication immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.
• Severe skin reactions, such as 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), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 your doctor without delay.

Start treatment with the lowest available dose if you have ever had gastrointestinal ulcers, are an elderly person, or need to take low-dose acetylsalicylic acid or other medications that may increase the gastrointestinal risk (see "Other medications and Ibuprofeno Aurovitas" below). Your doctor may also add treatment with medications that protect the gastric mucosa (e.g., misoprostol or proton pump inhibitors). Inform your doctor if you experience any unusual symptoms in the stomach, especially signs of bleeding such as vomiting blood or black, tarry stools (see also section 4, "Possible adverse effects").

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment (see section 3).

You should discuss your treatment with your doctor or pharmacist before taking this medication 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, have a family history of heart disease or stroke, or if you are a smoker. Very rare cases of potentially fatal skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of ibuprofen. Patients are at higher risk of experiencing these reactions during the first month of treatment. Stop taking this medication and consult your doctor or pharmacist if you notice a skin rash, mucosal lesions, or any other sign of allergic reaction (see section 4).

Adverse effects can be minimized by using the minimum effective dose for the shortest possible time. Elderly people are at higher risk of experiencing side effects.

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment. Stop taking this medication and consult your doctor immediately if you experience any skin rash, mucosal lesions, blisters, or other signs of allergy, as these can be the first signs of a severe skin reaction. See section 4.

Regular use of (various types of) pain relievers can lead to long-term, serious kidney problems. This risk can be increased by physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.

Prolonged use of any type of pain reliever for headache can worsen it. If this situation is observed or suspected, consult a doctor and discontinue treatment. The diagnosis of medication-overuse headache (MOH) can be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medications.

During long-term treatment with ibuprofen, liver parameters, kidney function, and blood count should be regularly monitored. Your doctor may request a blood test during treatment.

Children and adolescents

There is a risk of kidney failure in dehydrated children and adolescents.

Ibuprofen is contraindicated in adolescents who weigh less than 40 kg and children under 12 years.

Other medications and Ibuprofen Aurovitas

This medication may affect or be affected by other medications. For example:

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• 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 ibuprofen treatment. Therefore, always consult a doctor or pharmacist before taking this medication with other medications.

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication. In particular, inform them if you are taking:

• Acetylsalicylic acid or other NSAIDs (anti-inflammatory and analgesic): as it may increase the risk of bleeding or gastrointestinal ulcers.
• Digoxin (used to treat heart failure): as it may increase the effect of digoxin.
• Glucocorticoids (medications containing cortisone or similar substances): as it may increase the risk of bleeding or gastrointestinal ulcers.
• Phenytoin (for epilepsy): as it may increase the effect of phenytoin.
• Selective serotonin reuptake inhibitors (medications for depression): as it may increase the risk of gastrointestinal bleeding.
• Lithium (a medication for manic-depressive illness and depression): as it may increase the effect of lithium.
• Probenecid and sulfinpyrazone (medications for gout): as it may delay the excretion of ibuprofen.
• Moclobemide (used to treat depression).
• Potassium-sparing diuretics: as it may lead to hyperkalemia (high potassium levels in the blood).
• Methotrexate (a medication for cancer or rheumatism): as it may increase the effect of methotrexate.
• Tacrolimus and cyclosporin (immunosuppressive medications): as it may cause kidney damage.
• Zidovudine (a medication for HIV/AIDS): as ibuprofen use may increase the risk of bleeding in a joint or bleeding that leads to swelling in HIV-positive hemophiliacs.
• Zidovudine or ritonavir (used to treat HIV-positive patients).
• Sulfonylureas (antidiabetic medications): as interactions may occur.
• Quinolone antibiotics: as it may increase the risk of seizures.
• Mifepristone (a medication prescribed for abortion): as ibuprofen may reduce the effect of this medication.
• Bisphosphonates (medications prescribed for osteoporosis): as they may increase the risk of bleeding and gastrointestinal ulcers.
• Oxpentifylline (pentoxifylline) (medications prescribed to increase blood flow to arms and legs): as it may increase the risk of gastrointestinal bleeding.
• Baclofen, a muscle relaxant: as it may increase the toxicity of baclofen.
• Ginkgo biloba herbal medicine (there is a possibility that it may bleed more easily if taken with ibuprofen).
• Voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections): as the effect of ibuprofen may increase. A dose reduction of ibuprofen should be considered, especially when ibuprofen is used in high doses with voriconazole or fluconazole.
• Colestyramine (used in the treatment of high cholesterol).

Taking Ibuprofen Aurovitas with alcohol:

Alcohol consumption should be avoided while taking this medication, as it may intensify adverse effects.

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 labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should take the lowest 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts. However, as no harmful effects have been reported in breastfed infants to date, it is not usually necessary to interrupt breastfeeding during short-term use of ibuprofen at the recommended dose for fever and pain.

Fertility

This product belongs to a group of medications (NSAIDs) that may affect female fertility. This effect is reversible when the medication is stopped. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines:

The influence of this medication on the ability to drive and use machines is zero or insignificant when used in short treatments and normal doses. If you experience fatigue, dizziness, vertigo, and vision disturbances, do not drive or use machines. Alcohol consumption increases the risk of these adverse effects.

Ibuprofen Aurovitas contains sorbitol

This medication contains 79.20 mg of sorbitol in each capsule.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

3. How to take Ibuprofeno Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The lowest 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).

Dosage

Mild to moderate pain and/or fever

Adults and adolescents over 40 kg in weight (over 12 years old)

The recommended single dose is 1 capsule of 400 mg, which can be taken, if necessary, up to 3 times a day every 6 to 8 hours. Do not take more than 3 capsules (1200 mg ibuprofen) in 24 hours.

For elderly people with a higher risk of side effects, use the lowest possible dose for the shortest time necessary to relieve symptoms.

Do not exceed the recommended doses or treatment duration (3 days in adolescents and 3 days in case of fever and 5 days in case of pain in adults).

Ibuprofeno Aurovitas is not intended for use in adolescents under 40 kg in weight and children under 12 years old.

In case of migraine attack

Adults

Take one 400 mg capsule as soon as possible from the start of the attack.

If you do not feel relief after the first dose, do not take a second dose during the same attack. However, the attack can be treated with another treatment that is not a non-steroidal anti-inflammatory or acetylsalicylic acid.

If the pain recurs, a second dose can be taken, provided that there is an interval of 8 hours between the two doses. Do not take more than 3 capsules (1200 mg of ibuprofen) in a 24-hour period.

You should consult a doctor if you do not feel better or if you worsen after 3 days.

Method of administration

Ibuprofen capsules are swallowed whole with plenty of water. Do not chew the capsules.

If you take more Ibuprofeno Aurovitas 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 Toxicology Information Service, phone: 91 562 04 20, 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 bloody spit), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, and blood in the stool. Disorientation or coma may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, excitement, blue discoloration of the skin and mucous membranes (cyanosis), chills, and breathing difficulties have been reported. Additionally, in case of severe poisoning, the bleeding time is prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma is possible in asthmatic patients. Additionally, there may be low blood pressure and reduced breathing (respiratory depression).

In case of overdose, go to the doctor immediately, even if you feel well.

If you forget to take Ibuprofeno Aurovitas

Consult the previous sections on how to take this medication and do not take more than you should.

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

If you have doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects can be minimized if the lowest dose is taken for the shortest time necessary to relieve symptoms. Elderly people who use this medication have an increased risk of developing problems associated with side effects.

Medications like Ibuprofeno Aurovitas may be associated with a small risk of increased heart attacks ("myocardial infarction") or stroke (see section 2 "Warnings and precautions").

If you think you have any of the following side effects or symptoms, stop treatment and seek immediate help:

• stomach and intestinal ulcers, sometimes accompanied by bleeding and perforation, vomiting blood or black stools (frequent: may affect up to 1 in 10 people),
• kidney disease with blood in the urine that may be associated with kidney failure (uncommon: may affect up to 1 in 100 people),
• severe allergic reactions (very rare: may affect up to 1 in 10,000 people) such as:
• unexplained breathing difficulties or wheezing,
• dizziness or rapid heartbeat,
• drop in blood pressure that causes shock,
• swelling of the face, tongue, or throat,
• skin rash that can be fatal with severe blisters and bleeding on the lips, eyes, mouth, throat, nose, and genitals or severe skin reactions that start with painful red areas, later large blisters, and finally peeling of the skin layers. This is accompanied by fever and chills, muscle pain, and general malaise (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000 people),
• generalized red and scaly rash with bumps under the skin and blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). See also section 2 (frequency not known: frequency cannot be estimated from available data)
• a serious skin condition that can affect the mouth and other parts of the body with symptoms that include: red spots, often with itching, similar to measles rash, starting on the limbs and sometimes on the face and the rest of the body. The spots can become blisters or turn into red marks with clear centers. Those affected may experience fever, sore throat, headache, and/or diarrhea (very rare: may affect up to 1 in 10,000 people),
• severe skin peeling (very rare: may affect up to 1 in 10,000 people),
• pancreatitis with severe pain in the upper part of the stomach, sometimes with nausea and vomiting (very rare: may affect up to 1 in 10,000 people),
• nausea, vomiting, loss of appetite, feeling of general malaise, fever, itching, yellowing of the skin and eyes, light-colored stools, dark-colored urine that can be a symptom of hepatitis or liver failure (very rare: may affect up to 1 in 10,000 people),
• heart disease with shortness of breath and inflammation of the legs or feet due to fluid accumulation (heart failure) (very rare: may affect up to 1 in 10,000 people),
• meningitis (infection around the brain or spinal cord with symptoms that include fever, nausea, vomiting, headache, stiff neck, drowsy state, and loss of contact with the environment) (very rare: may affect up to 1 in 10,000 people),
• heart attack ("myocardial infarction", very rare: may affect up to 1 in 10,000 people) or stroke (frequency not known: cannot be estimated from available data),
• severe kidney damage (papillary necrosis), particularly with long-term treatment (rare: may affect up to 1 in 1,000 people),
• worsening of inflammation associated with infections (e.g., development of necrotizing fasciitis syndrome) related to the use of other NSAIDs (very rare: may affect up to 1 in 10,000 people),
• problems with blood cell production; the first signs are: fever, sore throat, superficial mouth ulcers, symptoms similar to the flu, intense exhaustion, nosebleeds, and skin bleeding (very rare: may affect up to 1 in 10,000 people)
• a severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and elevated eosinophils (a type of white blood cell) (frequency not known: frequency cannot be estimated from available data).

Other side effects:

Very common (may affect more than 1 in 10 people):

• nausea, heartburn, flatulence, diarrhea, constipation, vomiting, abdominal pain.

Common (may affect up to 1 in 10 people):

• headache, drowsiness, dizziness, feeling of spinning, fatigue, agitation, difficulty sleeping, irritability,
• hidden blood loss that can cause a situation where there is a decrease in the number of red blood cells (symptoms that include fatigue, headache, shortness of breath when exercising, dizziness, and pale appearance), mouth ulcers, and cold sores, colon inflammation (symptoms that include diarrhea, usually with mucus and blood, stomach pain, fever), worsening of inflammatory bowel disease, intestinal wall inflammation.

Uncommon (may affect up to 1 in 100 people):

• hives, itching, unusual bleeding or bruising under the skin, skin rash, asthma attacks (sometimes accompanied by low blood pressure),
• stuffy or runny nose, sneezing, facial pain or pressure, difficulty breathing,
• stomach inflammation (symptoms that include pain, nausea, vomiting, vomiting blood, blood in the intestine),
• fluid accumulation in the body's tissues, especially in patients with high blood pressure or kidney problems,
• visual disturbances.

Rare (may affect up to 1 in 1,000 people):

• a disease that affects the skin, joints, and kidneys (lupus erythematosus syndrome),
• depression, confusion, hallucinations, mental illness with strange or disturbing thoughts or moods,
• ringing, whistling, or other persistent noises in the ears,
• increased urea nitrogen in the blood, serum transaminases, and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid, all seen in a blood test,
• vision loss.

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

• rapid or irregular heartbeat (palpitations),
• fluid accumulation in the body's tissues,
• high blood pressure,
• esophageal inflammation, intestinal narrowing,
• unusual hair loss or baldness,
• severe skin infections with soft tissue complications if you have chickenpox,
• menstrual disorders,

Frequency not known (frequency cannot be estimated from available data):

• the skin becomes sensitive to light,
• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibuprofeno Aurovitas

Keep this medication out of sight and reach of children.

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

Do not store above 30 °C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Aurovitas:

• The active ingredient is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• The other ingredients (excipients) are:

Core of the capsule:Macrogol 600, potassium hydroxide

Capsule shell:Gelatin, liquid sorbitol

Printing ink:Components of the printing ink (black):

Black iron oxide (E172)

Propylene glycol (E1520)

Hypromellose 2910 (6 cP)

Appearance of the product and package contents

Soft gelatin capsules, transparent, colorless, oval-shaped, size '12', printed as "I400" with edible black ink, containing a clear viscous liquid from colorless to pale yellow.

This medication is available in PVC/PVdC-Aluminum blister packs of 10, 12, 14, 20, 30, 36, and 50 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

This medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Ibuprofen AB 400 mg soft capsules/capsules molles/Weichkapseln

France: IBUPROFENE ARROW CONSEIL 400 mg, soft capsule

Italy: Ibuprofene Aurobindo Pharma

Netherlands: Ibuprofen Liquid Caps Auro 400 mg, soft capsules

Poland: Ibuprofen MAX Aurovitas

Portugal: Ibuprofeno Generis

Spain: Ibuprofeno Aurovitas 400 mg soft capsules EFG

Date of the last revision of this leaflet:May 2025

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