IBUCOD 200 mg/mL + 10 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Ibucod 200 mg/ml+10 mg/ml Oral Solution

Ibuprofen (arginine) / codeine, phosphate hemihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ibucod and what is it used for
2. What you need to know before you take Ibucod
3. How to take Ibucod
4. Possible side effects
5. Storage of Ibucod
6. Contents of the pack and other information

1. What is Ibucod and what is it used for

This medicine contains ibuprofen and codeine as active substances. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs)

Codeine belongs to a group of medicines called opioid analgesics that act by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol or ibuprofen.

This medicine is used in adults and adolescents from 12 years of age for the short-term treatment of moderate intensity pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

2. What you need to know before you take Ibucod

Do not take Ibucod

• If you are allergic to ibuprofen, codeine, other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: 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 or have 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 (medicines 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.
• If you are breastfeeding.
• If you have asthma or chronic obstructive pulmonary disease.
• If you have respiratory depression or chronic constipation.
• To relieve pain in children and adolescents (0-18 years of age) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you know you metabolize codeine very quickly into morphine

Warnings and precautions

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 treatment with Ibucod as it may mask fever, which is an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine 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, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this case could cause kidney failure due to 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 high doses are used and treatments are prolonged, 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 medicine.
• If you are taking medicines that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• 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 medicines of the Ibucod type may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production) because your doctor needs to 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 treatment with ibuprofen.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter controls if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• In cases of intracranial injuries, codeine can cause respiratory depression. Also, codeine's adverse reactions can mask the clinical course of patients with head trauma.
• Due to its content of codeine, in prolonged treatments, as well as in cases of potential abuse of the medicine, tolerance and dependence, both psychological and physical, may occur.
• Codeine can also cause chronic constipation, as although some tolerance to the effects of opioids on gastrointestinal motility develops, patients who take opioids chronically continue to suffer from constipation.

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from serious adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, you must stop taking this medicine and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.

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

Infections: Ibucod may hide the signs of an infection, such as fever and pain. Therefore, it is possible that Ibucod may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines like ibuprofen can be associated with a small increased risk of 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 Ibucod 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.

Also, this type of medicine 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 Ibucod treatment. Stop taking Ibucod and go to the doctor immediately if you present any skin rash, lesions in the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very serious skin reaction. See section 4.

Precautions during pregnancy and in women of childbearing age

Because the administration of medicines of the Ibucod type 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 Ibucod is contraindicated.

For women of childbearing age, it should be taken into account that medicines of the Ibucod type have been associated with a decrease in fertility.

Interference with diagnostic tests

Taking ibuprofen can alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping 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)
• With liver function tests: increased transaminase values

If you are going to have any diagnostic test, tell your doctor that you are being treated with Ibucod, as it may alter the results.

Consult your doctor or pharmacist before starting to take Ibucod.

Children and adolescents

This medicine is only for administration to adults and children over 12 years of age.

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

The use of codeine is not recommended in children with respiratory problems, as the symptoms of morphine toxicity can be worse in these children.

Use of Ibucod with other medicines

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

Ibucod can affect or be affected by other medicines. For example:

Related to ibuprofen

• Other non-steroidal anti-inflammatory drugs like aspirin.
• Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine. Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Lithium (medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• 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.
• Selective serotonin reuptake inhibitor antidepressants.
• Diuretics (medicines used to increase urine production).
• Pentoxifylline (to treat 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 or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (medicine against the AIDS virus).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan). Thrombolytics (medicines that dissolve clots).
• • Aminoglycoside antibiotics such as neomycin.
  • Herbal extracts: Ginkgo biloba tree.

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

Related to codeine

• Morphine-derived medicines such as nalbuphine, buprenorphine, or pentazocine (used to treat moderate or severe pain).

• Central nervous system depressants (antidepressants, sedatives, antihistamines H1, anxiolytics, and hypnotics, neuroleptics, barbiturates, benzodiazepines, clonidine, and related, thalidomide).

Tell your doctor if you are going to have a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibucod with food, drinks, and alcohol

In general, it is recommended to take the medicine with meals to reduce the possibility of stomach upset.

Alcohol enhances the sedative effect of this medicine, so you should avoid taking alcoholic beverages and medicines that contain alcohol.

Pregnancy, breastfeeding, and fertility

Do not take Ibucod if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take this medicine 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 possible time. From the 20th week of pregnancy, Ibucod can cause kidney problems in your fetus if taken for more than a few days, which can 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 more than a few days, your doctor may recommend additional checks.

Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines

If you experience drowsiness, dizziness, vertigo, vision changes, or other symptoms while taking this medicine, you should not drive or use hazardous machinery.

Ibucod contains maltitol liquid and sucrose

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

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

3. How to take Ibucod

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 Ibucod. Do not suspend treatment beforehand, as this will not achieve the expected results. Similarly, do not use Ibucod for longer than indicated by your doctor.

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

This medication should not be taken for more than 3 days. If the pain does not improve after 3 days, consult your doctor.

The effective lowest dose should be used for the shortest necessary time to relieve symptoms. If you have an infection, consult a doctor if symptoms (such as fever or pain) persist or worsen (see section 2).

Use in adults

Take 2-3 ml every 6 to 8 hours (1,200/60 mg - 1,800/90 mg per day), depending on the intensity of the condition and response to treatment.

In some cases, higher doses may be required, but in any case, do not exceed the maximum daily dose of 12 ml (2,400/120 mg per day).

Use in children over 12 years old

Children 12 to 15 years old, weighing over 40 kg

Take 2 ml every 8 hours (1,200/60 mg per day)

Children 16 to 18 years old

Take 2 ml every 6 to 8 hours (1,200/60 mg - 1,600/80 mg per day), depending on the intensity of the condition and response to treatment.

Do not exceed the maximum daily dose of 8 ml (1,600/80 mg per day).

Use in children under 12 years old

Children under 12 years old should not take Ibucod due to the risk of severe respiratory problems.

Children weighing less than 40 kg should not take this medication due to the lack of safety and efficacy data for the combination.

Use in 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.

Use in 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 prescribed by your doctor.

Do not take this medication if you have severe kidney and/or liver disease.

Method of administration

This medication is administered orally.

The dose will be administered after diluting the solution in water. Take the medication with meals or with some food. If you experience digestive discomfort, consult your doctor before taking the medication.

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

If you take more Ibucod than you should

If you have taken more medication than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the medication leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. 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, chills, and breathing difficulties have been reported.

Symptoms reported with codeine overdose include drowsiness, skin rash, pinpoint pupils (miosis), vomiting, tingling, lack of muscle coordination, and skin swelling. Cases of respiratory failure and some deaths have also been reported.

Other observed symptoms are initial excitement, anxiety, insomnia, and later, in certain cases, headache, changes in blood pressure, changes in heart rhythm, dry mouth, allergic reactions, increased heart rate, convulsions, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

If severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Stomach emptying will be considered if significant amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Ibucod

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

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

If you interrupt treatment with Ibucod

There is a risk of possible withdrawal effects when stopping treatment with this medication.

4. Possible side effects

Like all medications, Ibucod can cause side effects, although not everyone will experience them. Inform your doctor or pharmacist if you experience any of the following side effects.

The side effects of medications like Ibucod are more common in people over 65 years old.

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

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); uncommon (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).

Ibucod, especially when taken in doses higher than recommended or for a prolonged period, may cause kidney damage, making them unable to eliminate acids from the blood through urine effectively (renal tubular acidosis). It may also significantly reduce potassium levels in the blood (see section 2). This is a very serious disorder that requires immediate treatment. The signs and symptoms include muscle weakness and dizziness.

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

The following side effects have been observed:

Related to ibuprofen

Gastrointestinal:

The most frequent side effects that occur with medications like Ibucod are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, vomiting blood, oral thrush, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other side effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of diverticular disease, hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with medications like Ibucod.

Skin:

Medications like Ibucod may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis). Other side effects are: Frequent: skin rash. Uncommon: skin redness, itching or skin swelling, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the blood vessels in the skin. Unknown frequency: a severe skin reaction known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red 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). Stop taking Ibucod if you experience these symptoms and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

Immune system:

Uncommon: transient edema in skin areas, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing into the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of generalized severe hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

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

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or instability. Rare: paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had 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.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

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

Ocular:

Uncommon: vision changes. Rare: abnormal or blurred vision.

Blood:

Rare: decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very 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 ulcers in the mouth, pseudo-flu symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Kidney:

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and kidney failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

Medications like Ibucod may be associated, in rare cases, with liver damage.

Other rare side effects are: hepatitis (liver inflammation), abnormal liver function, and jaundice (yellowing of the skin and eyes). Unknown frequency: liver failure (severe liver deterioration).

General:

Very rare: worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with Ibucod, 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.

If any of the following side effects occur, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• 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.

Related to codeine

Gastrointestinal:

Rare: constipation, nausea. Very rare: jaundice (yellowing of the skin and eyes).

Blood:

Very rare: decreased platelets, agranulocytosis (very significant decrease in granulocytes, a type of white blood cell), decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased neutrophils (a type of white blood cell that may predispose to infections), hemolytic anemia (premature destruction of red blood cells).

General:

Rare: discomfort, drowsiness. Very rare: fever, allergic reactions ranging from a simple skin rash or urticaria to severe allergic reactions like anaphylactic shock.

Reporting side effects

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

5. Conservation of Ibucod

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 shown on the package 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 SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibucod

The active ingredients are ibuprofen (arginine) and codeine phosphate hemihydrate. Each ml of solution contains 200 mg of ibuprofen, provided by 370 mg of ibuprofen arginine, and 7.4 mg of codeine equivalent to 10 mg of codeine phosphate hemihydrate.

The other components are: L-arginine, domiphen bromide, liquid maltitol (E-965), sodium saccharin, caramel flavor composed of (natural identical flavoring substances, natural flavoring substances, flavoring preparations, maltodextrin, sucrose, vegetable oil, silicon dioxide (E-551), and lecithin (E-322)), peppermint flavor (composed of natural flavoring preparations, natural flavoring substances, natural identical flavoring substances, maltodextrin, modified corn starch (E-1450), glycerol triacetate (E-1518), and pulegone), thaumatin (E-957), purified water.

Appearance of Ibucod and package contents

Transparent solution, brown in color, free of foreign substances, and with a marked mint odor, in a topaz glass bottle containing 30 and 60 ml of solution, along with a graduated measuring cup marked at ½, 1, 2, 3, and 4 ml.

Marketing authorization holder:

Farmalider S.A.

C/ Aragoneses, 15

28108 Alcobendas (Madrid)

Spain

Manufacturer:

FARMASIERRA MANUFACTURING S.L.

Ctra. de Irún, km 26,200

28709 San Sebastián de los Reyes (Madrid)

Spain

“or”

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191

Spain

“or”

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this leaflet:September 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/