IBUPROFEN (ARGININE) TARBIS 600 mg ORAL SOLUTION GRANULES

2. Before taking Ibuprofen (arginine) Tarbis 600 mg granules for oral solution

Do not take Ibuprofeno (arginina) Tarbis 600 mg granulado para solución oral

• If you are allergic to Ibuprofen or other medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Such reactions could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you have severe heart failure
• You are in the third trimester of pregnancy
• If you have a serious liver or kidney disease.

Be careful with Ibuprofeno (arginina) Tarbis 600 mg granulado para solución oral:

• 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 high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you take 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 inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications of the type of Ibuprofeno (arginina) Tarbis 600 mg may worsen these conditions.
• If you have had kidney or liver disease.
• If you have edema (fluid retention)
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment for an infection, as Ibuprofeno (arginina) Tarbis 600 mg may mask the fever, which is an important sign of infection.
• If you have heart, kidney, or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.

Warnings and 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 Ibuprofeno (arginina) Tarbis 600 mg granulado para solución oral EFG 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 are a smoker.
• If you have an infection; see the "Infections" section below.

Similarly, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension)

Skin reactions

Severe skin reactions have been reported with Ibuprofeno (arginina) treatment. Stop taking Ibuprofeno (arginina) and consult your doctor immediately if you present any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections: Ibuprofeno may hide the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay adequate 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.

Taking Ibuprofeno (arginina) with other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, even those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Ibuprofeno (arginina) Tarbis 600 mg may affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory drugs
  • 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)

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

• Methotrexate. Your doctor may adjust the dose of this antimetabolite medication (slows down the growth of certain cells produced by the body).
• 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 elimination).
• Fluconazole (for the treatment of fungal infections).
• 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).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).

Other medications may also affect or be affected by treatment with Ibuprofeno (arginina) Tarbis 600 mg. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno (arginina) Tarbis 600 mg with other medications.

Taking Ibuprofeno (arginina) Tarbis 600 mg with food and drinks:

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility of stomach discomfort.

Pregnancy:

Precautions during pregnancy and in women of childbearing age

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 delivery more than expected. Because the administration of medications of the type ibuprofen has been associated with an increased risk of congenital anomalies/abortions, you should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible.

From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause 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 a period longer than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that medications of the type Ibuprofeno (arginina) Tarbis 600 mg have been associated with a decrease in fertility.

Breastfeeding:

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 or pharmacist before using any medication.

Use in children

Do not administer to children under 14 years old

Driving and using machines:

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

Important information about some of the components of Ibuprofeno (arginina) Tarbis 600 mg granules for oral solution:

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

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

3. How to take Ibuprofeno (arginina) Tarbis 600 mg granules for oral solution

Ibuprofeno (arginina) Tarbis 600 mg is administered orally.

It is important that you use the smallest dose that relieves/controls the pain and do not take Ibuprofeno (arginina) Tarbis 600 mg for longer than necessary to control your symptoms.

The recommended average dosage is 1 sachet of Ibuprofeno (arginina) Tarbis 600 mg every 12 hours. If stomach discomfort occurs after taking the medication, it should be administered with milk or during meals. In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed the daily dose of 2,400 mg of ibuprofen (4 sachets), taking into account that the effective dose should be administered.

In elderly patients, the dosage should be established by the doctor, as it may be necessary to reduce the usual dose. In case of kidney disorders, the doses should be adjusted since the medication is eliminated mainly through this route.

The use of this medication is not recommended in children under 14 years old, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these children.

The effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

If you take more Ibuprofeno (arginina) Tarbis 600 mg granules for oral solution than you should:

If you have taken more Ibuprofeno (arginina) Tarbis 600 mg than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

If you have taken more Ibuprofeno (arginina) Tarbis 600 mg than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone 91 5620420, indicating the medication and the amount ingested.

If you forget to take Ibuprofeno (arginina) Tarbis 600 mg granules for oral solution:

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

4. Possible Adverse Effects

Like all medicines, Ibuprofen (arginine) Tarbis 600 mg can have adverse effects.

The observed adverse effects are described below according to their frequency of presentation:

Very frequent (at least 1 in 10 patients); Frequent (at least 1 in 100 patients); Infrequent (at least 1 in 1000 patients); Rare (at least 1 in 10,000 patients); Very rare (less than 1 in 10,000 patients).

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medicines like Ibuprofen (arginine) Tarbis 600 mg are gastrointestinal: peptic ulcers, digestive hemorrhages, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral aphthae, worsening of ulcerative colitis, and Crohn's disease have also been observed.

Less frequently, the appearance of gastritis has been observed.

Skin and allergic reactions:

Frequent: skin rash.

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

Rare: severe allergic reactions (anaphylactic shock).

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

Frequency not known: generalized red scaly rash, with bumps under the skin and localized blisters mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen (arginine) if you experience these symptoms and seek immediate medical attention. See also section 2.

Medicines like Ibuprofen (arginine) Tarbis 600 mg may be associated, in very rare cases, 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), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

Severe allergic reaction that can manifest with nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

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

Central nervous system:

Frequent: headache, feeling of instability, and nervousness.

Infrequent: fatigue or drowsiness, insomnia, anxiety, vision changes, ringing or buzzing in the ears.

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

Very rare: aseptic meningitis.

Blood:

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

Cardiovascular:

Medicines like Ibuprofen (arginine) Tarbis 600 mg may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medicines of the type Ibuprofen (arginine) Tarbis 600 mg.

Kidney:

Kidney disease.

Liver:

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). Medicines like Ibuprofen (arginine) Tarbis 600 mg may be associated, in rare cases, with liver damage.

Others:

Frequency not known: the skin becomes sensitive to light.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ibuprofen (arginine) Tarbis

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

No special storage conditions are required. Keep in the original packaging to protect from light and moisture.

Expiration Date:

This medicine should not be used after the expiration date indicated on the packaging.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of ibuprofen (arginine) 600 mg granulate for oral solution.

The active ingredient is Ibuprofen. Each sachet contains 600 mg of Ibuprofen.

The other components (excipients) are: Arginine, Aspartame (E-951), Compression sugar (sucrose), sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, menthol flavor (10.86.4580), peppermint flavor (506041 TP0504) contains gluten-free cornstarch, purified water.

Appearance of the Product and Packaging Content

Sachets with granulate for oral solution. It is presented in the form of a white granulate with a characteristic mint odor.

It is presented in packaging with 20 or 40 sachets.

Marketing Authorization Holder and Manufacturer

Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Toll Manufacturing Services S.L.,

C/Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

or

LAMP S. PROSPERO S.p.A.

Via della Pace, 25

41030 San Prospero (MO) - Italy

Date of the Last Revision of this Prospectus: February 2023

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