NEOBRUFEN WITH CODEINE 400 mg/30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Neobrufen with Codeine 400 mg/30 mg Film-Coated Tablets

ibuprofen/codeine, phosphate hemihydrate

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

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

Package Leaflet Contents:

1. What Neobrufen with Codeine is and what it is used for.
2. What you need to know before taking Neobrufen with Codeine.
3. How to take Neobrufen with Codeine.
4. Possible side effects.
5. Storage of Neobrufen with Codeine.
6. Package Contents and Additional Information

1. What Neobrufen with Codeine is and what it is used for

Neobrufen with Codeine contains the active ingredients ibuprofen and codeine phosphate. Ibuprofen belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs) and acts against pain.

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

Neobrufen with Codeine is used in adults 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 starting to take Neobrufen with Codeine

Do not take Neobrufen with Codeine:

• if you are allergic to ibuprofen, codeine, or any of the other components of this medication (including those listed in section 6).
• if, when taking anti-inflammatory medications, acetylsalicylic acid, or other analgesics, you have experienced allergic reactions such as asthma, rhinitis, urticaria, angioedema, or have nasal polyps or have had gastrointestinal bleeding or stomach perforation,
• if you have had or have a stomach or duodenal ulcer or have suffered a perforation of the digestive tract,
• if you have severe liver or kidney disease,
• if you vomit blood, have black stools, or have bloody diarrhea,
• if you have bleeding disorders or coagulation disorders,
• if you have severe asthma or chronic obstructive pulmonary disease,
• if you have severe heart failure,
• if you have respiratory failure or chronic constipation,
• if you have severe dehydration caused by vomiting, diarrhea, or insufficient fluid intake
• to relieve pain in children and adolescents (0 to 18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome,
• if you know you metabolize codeine to morphine very quickly,
• if you are in the third trimester of pregnancy,
• if you are breastfeeding

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Neobrufen with Codeine.

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

Be careful with Neobrufen with Codeine:

Due to ibuprofen:

• 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 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 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, since medications containing ibuprofen can worsen these conditions;

• If gastrointestinal bleeding or an ulcer occurs, treatment should be stopped immediately, so inform your doctor of any unusual abdominal symptoms during treatment and especially during the early stages of treatment;
  • Anti-inflammatory/analgesic medications like ibuprofen can 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.

Due to codeine:

• Codeine should be used with caution in patients with biliary tract disease, including acute pancreatitis, as codeine can cause spasms of the Oddi sphincter and decrease bile and pancreatic secretions.
• It should be used with caution in patients with bronchial asthma or chronic rhinitis

Contact your doctor if you have severe abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these can be symptoms of pancreatitis and biliary system inflammation.

You should especially discuss treatment with your doctor or pharmacist before taking Neobrufen with Codeine if:

• you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. In combined treatment with anticoagulants, your doctor should monitor prothrombin time (a way to measure blood coagulation) during the first few days. You should also discuss the use of other medications that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants;
• you have an infection: ibuprofen can hide the signs of an infection, such as fever and pain. Consequently, Neobrufen with Codeine may delay 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 medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay;

• you are taking other NSAIDs (including Coxib medications), due to the increased risk of ulcers or bleeding;
• 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"). High doses of ibuprofen or prolonged use have been associated with an increased risk of these adverse events;
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;
• similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension);
• you are over 65 years old, as the tendency to experience adverse reactions increases;
• ibuprofen belongs to a group of medications that can decrease female fertility. This effect is reversible when the medication is stopped;
• you have eye disorders, you should stop taking the medication and, as a precaution, an ophthalmological examination should be performed;
• after administering the medication, you observe symptoms of aseptic meningitis (inflammation of the meninges not caused by bacteria), consult your doctor;
• you have had kidney or liver disease. In these cases, you should use the smallest possible dose and for the shortest time. And monitor renal function;
• in case of dehydration, you should ensure sufficient fluid intake;
• you have acute intermittent porphyria (a rare disorder in which large amounts of porphyrin are excreted in urine and feces);
• you have chickenpox (a common childhood infectious disease), you should not take ibuprofen;
• you have chronic constipation;
• you have a disease that affects your ability to breathe or have a history of bronchial asthma, chronic rhinitis, or allergic diseases such as bronchospasm (contraction of the bronchi that makes breathing difficult), urticaria, or angioedema, after using other medications;
• you have a history of hypotension (low blood pressure), hypothyroidism (decreased thyroid hormones in the blood that cause alterations in the body), seizures, increased intracranial pressure (increased pressure inside the skull), or head injury;
• the pain or fever persists for more than 3 days, worsens, or other symptoms appear, your doctor should evaluate the clinical situation;
• physical dependence (appearance of physical symptoms when a substance to which the body is accustomed is withdrawn) and tolerance (need to increase the dose to achieve the effect that was previously achieved with a lower dose) may occur with repeated administration of Neobrufen with Codeine due to its codeine content. Caution should be exercised in patients with chemical dependence (patients who are unable to stop using drugs or alcohol);
  • codeine is converted to morphine in the liver by an enzyme. Morphine is the substance that provides pain relief. Some people have a variation of this enzyme, which can affect people in different ways. In some people, morphine is not produced or is produced in very low quantities and will not provide sufficient pain relief. Others are more likely to experience severe adverse reactions because they produce a very high amount of morphine. If you notice any of the following adverse effects, you should stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite;

• due to its dosage and pharmaceutical form, this medication is only for administration to adults;
• with prolonged use, headaches may appear that should not be treated with an increase in dose;
• adverse reactions due to ibuprofen, especially gastrointestinal ones, can increase with alcohol consumption;
• serious skin reactions have been reported with Neobrufen with Codeine treatment. Stop taking Neobrufen with Codeine and consult your doctor immediately if you experience any skin rash, lesions on 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;
• special monitoring is required in patients undergoing major surgery;
• it can cause allergic reactions without prior exposure to the medication.
• pain or increased sensitivity to pain (hyperalgesia) appears that does not respond to an increase in the medication dose.

With the use of ibuprofen, signs of an allergic reaction to the medication have been reported, including respiratory problems, swelling of the face and neck (angioedema), and chest pain. If you notice any of these signs, stop taking Neobrufen with Codeine immediately and contact your doctor or emergency services.

Sleep-related respiratory disorders

Neobrufen with Codeine can cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Consult your doctor, even if any of the above circumstances have occurred to you at some point.

Children and adolescents

Use in children and adolescents after surgery

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

Use in children with respiratory problems

Codeine is not recommended in children with respiratory problems, as it can worsen symptoms of morphine toxicity in these children.

Other medications and Neobrufen with Codeine

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription, homeopathic products, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

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

Medications that interfere with ibuprofen:

• Do not use with other analgesic and anti-inflammatory medications (NSAIDs), including anti-inflammatory Coxib medications.
• Anticoagulants/antiplatelet agents (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)
• Hydantoins (for seizures) and sulfonamides (antibiotics for infections).
• Lithium (medication used for manic-depressive disorders).
• Digoxin and cardiac glycosides (used for the heart).
• Methotrexate (used in cancer treatment and rheumatoid arthritis).
• Pentoxifylline (used in circulatory disorders).
• Probenecid and sulfinpyrazone (used in patients with gout or with penicillin in infections).
• Quinolones (antibiotics used in infections).
• Thiazides (diuretics used to increase urine production).
• Sulfonylureas (used to decrease blood glucose levels).
• Cyclosporine, tacrolimus (used to prevent rejection after a transplant).
• Thrombolytics (medications that dissolve or break down blood clots).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).
• Corticosteroids (have many applications because they act against inflammation, as immunosuppressants in autoimmune diseases and organ transplants, and in diseases that affect metabolism).-
• MAOI antidepressants (for depression).
• Mifepristone (abortifacient medication).
• Selective serotonin reuptake inhibitors (used in depression).
• Colestyramine (to reduce cholesterol).
• Aminoglycosides (antibiotics).
• Medications like voriconazole or fluconazole (for fungal infections).
• Herbal extracts: Ginkgo biloba tree.
• Other medications may also affect or be affected by treatment with Neobrufen with Codeine. Therefore, you should always consult your doctor or pharmacist before using Neobrufen with Codeine with other medications.

Medications that interfere with codeine:

• Central nervous system depressants (medications that act on the central nervous system (CNS), used, for example, to decrease intense pain, in cases of mental illnesses, such as neuromuscular blockers, etc., and when taken with Neobrufen with Codeine, may increase the CNS depressant effect).
• Do not administer this medication with alcohol to avoid damaging the stomach and possible potentiation of the codeine depressant effect.
• CYP2C9 inhibitors such as quinidine (for heart arrhythmias) or fluoxetine may decrease the effect of codeine.
• Concomitant use of Neobrufen with Codeine with sedative medications, such as benzodiazepines or related substances, increases the risk of somnolence, breathing difficulties (respiratory depression), and coma and could be potentially fatal. Due to this, concomitant use should only be considered when other options are not possible.

However, if your doctor prescribes Neobrufen with Codeine along with sedative medications, the dose and duration of concomitant treatment will be limited by your doctor.

• Gabapentin or pregabalin to treat epilepsy or pain caused by nerve damage (neuropathic pain)

Inform your doctor about all sedative medications you are taking and take exactly the dose your doctor recommends. It is helpful that you inform your friends or family to be alert to the appearance of the signs and symptoms explained above. Contact your doctor if you experience these symptoms.

Interference with diagnostic tests:

If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are being treated with Neobrufen with Codeine, as it may alter the results.

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

3. How to take Neobrufen with Codeine

If you have been prescribed Neobrufen with Codeine, before starting treatment and regularly during this time, your doctor will explain what you can expect from the use of Neobrufen with Codeine, when and for how long you should use it, when you should contact your doctor, and when you should stop treatment (see also If you stop treatment with Neobrufen with Codeine).

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

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

Adults

The recommended dose is 1 tablet (400 mg of ibuprofen, 30 mg of codeine phosphate hemihydrate) every 4-6 hours as needed for pain relief. Do not take more than 6 tablets (2,400 mg of ibuprofen, 180 mg of codeine phosphate hemihydrate) within 24 hours.

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

This medication is administered orally.

It is advisable to take the medication with food or some food. Any patient who experiences digestive discomfort before taking the medication should consult a doctor.

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

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

Use in children and adolescents

Do not administer to children under 18 years of age.

Use in people over 65 years of age

Elderly people are often more prone to adverse effects, so it may be necessary to reduce the dose. Consult your doctor.

Patient 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.

If you take more Neobrufen with Codeine than you should

If you have taken more Neobrufen with Codeine 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 sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of 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.

Metabolic acidosis (a disorder that produces an increase in blood acidity) has been rarely reported, hypothermia (body temperature below 35°C), renal effects, gastrointestinal bleeding, coma, apnea (cessation of respiratory signal for at least 10 seconds), and depression of the central nervous system and respiratory system. Cardiovascular toxicity, including hypotension (lower than usual blood pressure), bradycardia (decrease in heart rate), and tachycardia (increase in heart rate to more than 100 per minute), has been reported. In cases of significant overdose, kidney failure and liver damage are possible.

Symptoms reported with codeine overdose include drowsiness, skin rash, pupil contraction, vomiting, tingling, ataxia (decreased ability to coordinate body movements), and skin swelling. Respiratory failure and some deaths have also been reported. Other symptoms observed are initial excitement, anxiety, insomnia, and later, in certain cases, headache, changes in blood pressure, arrhythmias (changes in heart rhythm), dry mouth, hypersensitivity reactions (allergy), tachycardia (increase in heart rate to more than 100 per minute), convulsions, gastrointestinal disorders, and nausea.

If a severe poisoning has occurred, the doctor will take the necessary measures. There is no specific antidote for ibuprofen with codeine overdose.

In case of ingestion of significant amounts, activated charcoal should be administered. If there is central nervous system depression, artificial respiration, oxygen administration, and naloxone are necessary.

If you forget to take Neobrufen with Codeine

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 stop treatment with Neobrufen with Codeine

Due to the codeine content, there is a risk of possible effects derived from withdrawal when stopping treatment (appearance of physical symptoms when removing a substance to which the body is accustomed).

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse reactions can be minimized by using the lowest effective dose for the shortest possible time to control symptoms.

The assessment of the frequency of adverse reactions is based on the following criteria: Very frequent: may affect more than 1 in 10 people; Frequent: may affect up to 1 in 10 people; Infrequent: may affect up to 1 in 100 people; Rare: may affect up to 1 in 1,000 people; Very rare: may affect up to 1 in 10,000 people; Frequency not known: cannot be estimated from available data.

The adverse effects that may appear due to the ibuprofen content are:

• Gastrointestinal disorders

The most frequent adverse effects that occur with medicines like Neobrufen with Codeine are gastrointestinal:

Frequent: nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, vomiting blood, gastrointestinal bleeding.

Infrequent: gastritis, duodenal ulcer, stomach ulcer, mouth ulcers (oral aphthae), gastrointestinal perforation.

Very rare: pancreatitis.

Frequency not known: ulcerative colitis, Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea).

Peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients, may occur.

• Immune system disorders

Rare: anaphylactic reaction (allergic reaction to a substance whose first administration did not cause any disorder)

Hypersensitivity reactions have been observed after treatment with NSAIDs. This can consist of (a) a non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity such as asthma, exacerbated asthma, bronchospasm, or dyspnea, or (c) various skin disorders, including eruptions of various types, pruritus, urticaria, purpura, and angioedema.

• Skin and subcutaneous tissue disorders

Frequent: skin rash.

Infrequent: itching, urticaria, purpura (purple spots on the skin), angioedema (transient edema in areas of the skin, mucous membranes, or sometimes in viscera), photosensitivity reaction (abnormal skin response to light exposure).

Very rare: different forms of severe skin reactions, such as bullous dermatosis (including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple-colored lesions, preferably on the trunk)), toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and skin detachment), and erythema multiforme (allergic reaction with general discomfort, fever, joint pain, and skin lesions).

Frequency not known: a severe skin reaction known as DRESS syndrome (by its English acronym) may occur. 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 localized blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Neobrufen with Codeine if you experience these symptoms and seek immediate medical attention. See also section 2.

• Infections and infestations:

Infrequent: rhinitis (inflammation of the nasal mucosa).

Rare: aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).

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 the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Blood and lymphatic system disorders:

Rare: leukopenia (decrease in white blood cells, may manifest as frequent infections with fever, chills, or sore throat), thrombocytopenia (decrease in blood platelets), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), neutropenia (decrease in granulocytes that predisposes to infections), agranulocytosis (severe decrease in granulocytes), hemolytic anemia (premature destruction of red blood cells).

• Psychiatric disorders:

Infrequent: insomnia, anxiety

Rare: depression, confusion.

• Nervous system disorders:

Frequent: headache, dizziness.

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

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

• Eye disorders:

Infrequent: visual impairment, blurred vision, decreased visual acuity, or changes in color perception that resolve spontaneously.

Rare: toxic optic neuropathy (retinal degeneration).

• Ear and labyrinth disorders:

Infrequent: hearing impairment, vertigo, and tinnitus.

• Hepatobiliary disorders:

Infrequent: hepatitis (inflammation of the liver), jaundice (yellowing of the skin and eyes), abnormal liver function.

Very rare: liver failure (severe liver damage).

• Renal and urinary disorders:

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

• Respiratory, thoracic, and mediastinal disorders:

Infrequent: asthma, bronchospasm (bronchial constriction), dyspnea (difficulty breathing).

• Musculoskeletal and connective tissue disorders:

Rare: neck stiffness.

• General disorders and administration site conditions:

Frequent: fatigue.

Rare: edema (fluid retention).

• Cardiac disorders:

Infrequent: heart failure, myocardial infarction.

Frequency not known: chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

• Vascular disorders:

Infrequent: hypertension.

Medicines like Neobrufen with Codeine may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke at high doses (2,400 mg daily) and in prolonged treatments. On the other hand, low doses (less than or equal to 1,200 mg daily of ibuprofen) are not associated with an increased risk of myocardial infarction.

The following adverse effects have been reported in the treatment with NSAIDs: edema (fluid retention), hypertension (high blood pressure), and coronary insufficiency (inability of the heart to pump blood in adequate volumes for normal functioning).

The adverse effects that may appear due to the codeine content are the characteristic effects of opioids

The frequency and severity of these effects are determined by the dose, duration of treatment, and individual sensitivity. These include:

• Respiratory, thoracic, and mediastinal disorders

Bronchospasm, respiratory depression.

• Psychiatric disorders:

Confusion, agitation.

Dependence may occur, especially with high doses of codeine for a prolonged period.

• Nervous system disorders:

Dizziness and somnolence.

• Cardiac disorders

Palpitations

• Gastrointestinal and hepatobiliary disorders:

Constipation, nausea, vomiting.

Frequency not known: symptoms related to pancreatitis (inflammation of the pancreas) and biliary system disorders (a problem affecting a valve in the intestines, called Oddi sphincter dysfunction), e.g., severe abdominal pain and possibly radiating to the back, nausea, vomiting, or fever

• Immune system disorders:

Rash, urticaria, allergic reactions.

• Skin and subcutaneous tissue disorders

Itching, excessive sweating.

• Renal and urinary disorders:

Urinary retention.

• General disorders and administration site conditions:

Tolerance to the drug (need to increase the dose to achieve the effect that was previously achieved with a lower dose) may occur, especially with high doses of codeine for a prolonged period.

Neobrufen with Codeine, especially when taken in doses higher than recommended or for a prolonged period, may cause kidney damage, which becomes 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.

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. Storage of Neobrufen with Codeine

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Store this medicine in a safe location that is inaccessible to other people. It can cause serious harm and be fatal to people for whom it has not been prescribed.

Do not use this medicine after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Neobrufen with Codeine

The active ingredients are ibuprofen and codeine phosphate hemihydrate.

Each tablet contains 400 mg of ibuprofen and 30 mg of codeine phosphate hemihydrate.

The other components (excipients) are: potato starch, sodium glycolate, microcrystalline cellulose, anhydrous colloidal silica, pregelatinized corn starch, L-leucine, talc, 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1) (Eudragit L30 D55), titanium dioxide, Macrogol 6000, simethicone emulsion, and sodium carboxymethylcellulose.

Product Appearance and Package Contents

This medicine is presented in the form of film-coated tablets with a notch on one side to make them easier to swallow. Each package contains 30 or 500 film-coated tablets packaged in Al/PVDC-PVC/PVDC blisters.

Marketing Authorization Holder and Manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Farmasierra Manufacturing S.L.

Carretera de Irún km 26,200

San Sebastián de los Reyes

28700 - Madrid

Spain

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the last revision of this prospectus:December 2024.

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