IBUPROFEN CLOVER 600 mg SOFT GEL CAPSULES

Introduction

Leaflet: information for the patient

Ibuprofen Clover 600 mg soft capsules

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

• Keep this leaflet, as you may need to read it again.
• 1. 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Ibuprofen Clover and what is it used for
2. What you need to know before taking Ibuprofen Clover
3. How to take Ibuprofen Clover
4. Possible side effects

5 Conservation of Ibuprofeno Clover

1. Package contents and additional information

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

Ibuprofen Clover belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). This medication is used for the treatment of fever, treatment of pain of mild or moderate intensity including migraine, treatment of arthritis (inflammation of the joints, including usually those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking

Ibuprofen Clover belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs). This medication is indicated for the treatment of fever and pain of mild or moderate intensity, including migraine, treatment of arthritis (inflammation of the joints, including usually those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

What you need to know before taking Ibuprofen Clover

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 Ibuprofen Clover immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Do not take Ibuprofen Clover

• If you are allergic to the active ingredient, to other medications of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other components of this medication (listed in section 6). The reactions that indicate allergy could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions - Be especially careful with Ibuprofen Clover:

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 Clover and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Tell your doctor

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving ibuprofen treatment, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have 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 experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a consequence of dehydration.
• 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 previous warning symptoms. This risk is higher when using high doses and prolonged treatments, 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 type of acetylsalicylic acid. You should also discuss 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 (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" section below.

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

Skin reactions

Severe skin reactions have been reported in association with ibuprofen Clover treatment. Stop taking Ibuprofeno Clover and seek medical attention immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a 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 Clover 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).

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

Since the administration of ibuprofen-like medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated.

For women of childbearing age, it should be taken into account that ibuprofen-like medications have been associated with a decrease in fertility.

Infections

Ibuprofen Clover may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen Clover may delay the 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.

The intake of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood concentrations of urea nitrogen and serum creatinine and potassium (may increase)
• Liver function tests: increased transaminase values

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc...), inform your doctor that you are taking this medication, as it may alter the results.

Other medications and Ibuprofen Clover

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The following medications may interfere and should not be taken with Ibuprofen Clover without consulting your doctor first:

• Other non-steroidal anti-inflammatory drugs, such as aspirin, as the risk of stomach ulcers and gastrointestinal bleeding may increase.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin.
• Colestyramine (medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• 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 production), as they may increase the risk of kidney toxicity.
• 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), as they may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Antihypertensives: to decrease high blood pressure.
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

The intake of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood concentrations of urea nitrogen and serum creatinine and potassium (may increase)
• Liver function tests: increased transaminase values

Taking Ibuprofen Clover with food, drinks, and alcohol:

You can take it alone or with food. In general, it is recommended to take it before meals or with milk to reduce the possibility of stomach upset. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

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 baby. It may increase the risk of bleeding for you and your baby during delivery, delay delivery, or prolong it more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest time possible. If you take it for more than a few days from the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus, 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 you need treatment for more than a few days, your doctor may recommend additional monitoring.

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

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines:

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take one dose of ibuprofen or for a short period, you do not need to take special precautions.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

Ibuprofen Clover contains potassium, sorbitol (E 426), and the colorant Red allura (E-129).Patients with kidney failure or on low-potassium diets should note that this medication contains 0.91 mmol (35.96 mg) of potassium per soft capsule.

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

This medication may cause allergic reactions because it contains Red allura (E129). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to Take Ibuprofen Clover

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

Your doctor will indicate the duration of treatment with Ibuprofen Clover. Do not stop treatment before, as the expected results will not be obtained. Similarly, do not use this medication for longer than indicated by your doctor.

The lowest 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).

Adults and Adolescents:

The recommended dose in adults and adolescents from 14 to 18 years is one capsule (600 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of the condition and response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents from 12 to 18 years.

Use in Children and Adolescents:

The use of this medication is not recommended in children or adolescents with less than 40 kg of weight or under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

Adolescents over 14 years will follow the adult dosage recommendations, but the maximum recommended daily dose in these patients is 1600 mg.

Elderly Patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has checked that you tolerate the medication well.

Patients with Kidney and/or Liver Disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose that your doctor has prescribed.

Method of Administration

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food.

Take ibuprofen with enough water. The tablets should be swallowed whole, without chewing, breaking, crushing, or sucking to avoid discomfort in the mouth and throat irritation.

If you think the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If You Take More Ibuprofen Clover Than You Should

If you have taken more Ibuprofen Clover than you should or if a child has accidentally ingested the medication, consult your doctor or pharmacist or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the prospectus of the medication to the healthcare professional.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. In rare cases, there have been cases of rapid involuntary eye movements, increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, transient loss of breathing (apnea), central nervous system depression, and respiratory system. It can also present agitation, drowsiness, disorientation, or coma, and there have been cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate). Occasionally, patients suffer from seizures.

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported. In these cases, the doctor will take the necessary measures.

Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney failure and liver damage may occur. It is possible that there may be an exacerbation of asthma in asthmatics. Additionally, there may be low blood pressure and reduced respiratory capacity.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if more than 400 mg/kg has been ingested and within 60 minutes following ingestion.

If You Missed a Dose of Ibuprofen Clover

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the missed dose and take the next dose at its usual time.

4. Possible Adverse Effects

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

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

Adverse effects of medications like ibuprofen are more common in people over 65 years old.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

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

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

• Reddish patches, not raised, in the shape of a target or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can 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, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and Infestations

Uncommon: inflammation of the nasal mucosa.

Very rare: aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis) has been described coinciding with the use of NSAIDs. If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to go to the doctor immediately.

Blood and Lymphatic System Disorders

Rare: decreased platelet count, decreased white blood cell count (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cell count (may manifest as difficulty breathing and pale skin), decreased granulocyte count (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white, and platelet blood cells), agranulocytosis (significant decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Immune System Disorders

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), bronchospasm (spasm of the bronchi that prevents air from passing to the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may appear.

Very rare: joint pain and fever (systemic lupus erythematosus).

Psychiatric Disorders

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Nervous System Disorders

Frequent: headache and dizziness or feeling of instability.

Uncommon: paresthesia (sensation of numbness, tingling, burning, etc., more frequent in hands, feet, arms, or legs), drowsiness or somnolence.

Rare: optic neuritis (inflammation of the optic nerve).

Eye Disorders

Uncommon: vision disturbances.

Rare: retinal degeneration.

Ear and Labyrinth Disorders

Uncommon: ringing or buzzing in the ears, vertigo, hearing difficulty.

Cardiovascular Disorders

Very rare: heart failure, myocardial infarction, and hypertension.

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

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

Gastrointestinal Disorders

Frequent: digestive disorders such as heartburn (dyspepsia), diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, bloody stools (melena), vomiting blood (hematemesis), gastrointestinal bleeding.

Uncommon: gastritis, duodenal ulcer, gastric ulcer, inflammation of the oral mucosa with ulcer formation, gastrointestinal perforation.

Very rare: pancreatitis.

Unknown frequency: colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea).

Hepatobiliary Disorders

Rare: liver damage, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Unknown frequency: liver failure (severe liver deterioration).

Skin and Subcutaneous Tissue Disorders

Frequent: skin rash.

Uncommon: skin redness, itching or skin swelling, purpura (purple spots on the skin).

Very rare: severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), hair loss, erythema multiforme (skin lesion), and inflammation of the skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Unknown frequency: the skin becomes sensitive to light. A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). 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 start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen Clover if you present these symptoms and seek immediate medical attention. See also section 2.

Renal and Urinary Disorders

Uncommon: interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and renal failure (sudden loss of kidney function).

General Disorders and Administration Site Conditions

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with Ibuprofen Clover, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

Frequent: fatigue.

If any of the following adverse effects occur, interrupt treatment and go to your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Blood vomiting or coffee grounds-like vomiting.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofen Clover

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Keep in the original packaging.

Do not use this medication after the expiration date that appears on the box after "CAD". 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 packages and medications you no longer need at the pharmacy's collection point. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofen Clover

• The active ingredient is Ibuprofen. Each capsule contains 600 mg of ibuprofen.
• The other components (excipients) are Macrogol 600, Potassium Hydroxide, Allura Red (E-129), Purified Water, Capsule shell excipients, Gelatin, Sorbitol (E-420), Purified Water

Appearance of the Product and Package Contents

They are soft gelatin capsules, red in color, oval in shape, and smooth in appearance.

It is presented in a package that contains 30 soft capsules packaged in aluminum/PVC+PVDC blisters

Marketing Authorization Holder and Manufacturer

HC CLOVER PS SL

Alicante Street, 8.

28500 – Arganda del Rey

Madrid

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

HC CLOVER PS SL

Alicante Street, 8.

28500 – Arganda del Rey

Madrid

Spain

Date of the last revision of this prospectus: November 2024

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines, http://www.aemps.gob.es/.