Neobrufen with Codeine 400 mg/30 mg film-coated tablets

Spain
Brand name Neobrufen with Codeine 400 mg/30 mg film-coated tablets
Form tablets, film-coated
Active substance / Dosage
IBUPROFEN · 400 mg
CODEINE PHOSPHATE HEMIHYDRATE · 30 mg
Prescription type Prescription Only Medicine
ATC code
N02A N02AJ N02AJ08
Registration number 70441
Manufacturer Viatris Healthcare Limited

Table of Contents

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Neobrufen with Codeine 400 mg/30 mg film-coated tablets

ibuprofen/codeine hemihydrate phosphate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the package leaflet:

  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. How to store Neobrufen with Codeine.
  6. Contents of the pack and other information.

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

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

This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics, which act by relieving pain. It may 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 pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

2. What you need to know before starting Neobrufen with Codeine

Do not take Neobrufen with Codeine:

  • if you are allergic to ibuprofen, codeine, or any of the other ingredients of this medicine (listed in section 6);
  • if you have experienced allergic reactions such as asthma, rhinitis, urticaria, angioedema, nasal polyps, gastrointestinal bleeding, or stomach perforation after taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics;
  • if you have had or currently have a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract;
  • if you have severe liver or kidney disease;
  • if you vomit blood, have black stools, or experience diarrhea with blood;
  • if you have bleeding disorders or coagulation problems;
  • if you have severe asthma or chronic obstructive pulmonary disease (COPD);
  • 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 of age) after tonsil or adenoid removal due to obstructive sleep apnea syndrome;
  • if you know that you metabolize codeine to morphine very rapidly;
  • if you are in the third trimester of pregnancy;
  • if you are breastfeeding.

Warnings and precautions:

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

It is important to use the lowest dose that relieves/controls your pain. You should not take this medicine for longer than necessary to control your symptoms.

Tolerance, dependence, and addiction

This medicine contains codeine, which is an opioid. It may cause dependence and/or addiction.

Repeated use of opioids may lead to reduced effectiveness of the medication (becoming accustomed to it, known as tolerance). Repeated use of Neobrufen with Codeine may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use, and

there is also a risk of serious stomach/intestinal and kidney injuries, and blood potassium levels may decrease to very low levels. These conditions can be life-threatening (see section 4).

Dependence or addiction may cause a feeling of lack of control over the amount of medication used or how frequently it is taken.

The risk of dependence or addiction varies from person to person. You may have a higher risk of dependence or addiction to Neobrufen with Codeine if:

  • You or a family member have abused alcohol or have experienced dependence on alcohol, prescription medications, or illegal drugs ("addiction").
  • You smoke.
  • You have ever had mood disorders (depression, anxiety, or personality disorders) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking Neobrufen with Codeine, it could be a sign of dependence or addiction:

  • You need to take the medication for longer than recommended by your doctor.
  • You need to take a higher dose than recommended.
    • You may feel a need to continue taking the medication, even when it no longer helps relieve pain.
  • You are using this medication for reasons other than those prescribed, for example, “to stay calm” or “to help sleep”.
  • You have made repeated unsuccessful attempts to stop using the medication or control its use.
  • You feel unwell when you stop using the medication and feel better once you resume taking it ("withdrawal effects").

If you notice any of these symptoms, consult your doctor to determine the best course of treatment for your case, when it is appropriate to stop treatment, and how to do so safely (see section 3, “If you stop treatment with Neobrufen with Codeine”).

Be cautious with Neobrufen with Codeine:

Due to ibuprofen:

  • If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior 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 such cases, your doctor may consider adding a stomach-protective medication;

  • If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as medications containing ibuprofen may worsen these conditions;

  • If gastrointestinal bleeding or an ulcer occurs, treatment must be stopped immediately; therefore, inform your doctor of any unusual abdominal symptoms during treatment, especially in the early stages;

    • Anti-inflammatory/analgesic medications such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Due to codeine:

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

Contact your doctor if you experience severe upper abdominal pain that may radiate to the back, nausea, vomiting, or fever, as these could be symptoms associated with inflammation of the pancreas (pancreatitis) and bile ducts.

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

  • You are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. When used in combination with anticoagulants, your doctor should monitor your prothrombin time (a way of measuring your blood clotting) during the first few days. You should also inform them about using other medications that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants;

  • You have an infection: ibuprofen may mask signs of infection, such as fever and pain. Therefore, Neobrufen with Codeine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin bacterial infections related to chickenpox. If you take this medication while having an infection and infection symptoms persist or worsen, consult your doctor without delay;

  • You are taking other NSAIDs (including Coxib-type medications), due to the increased risk of ulcers or bleeding;

  • You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 such adverse events;

  • You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker;

  • These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension);

  • You are over 65 years old, as the risk of adverse reactions increases with age;

  • Ibuprofen belongs to a group of medications that may reduce female fertility. This effect is reversible upon discontinuation of the medication;

  • You have eye disorders; you should stop taking the medication and, as a precaution, undergo an ophthalmological examination;

  • After taking the medication, you experience 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, use the lowest possible dose for the shortest possible time and monitor kidney function;

  • In case of dehydration, ensure adequate 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 childhood infectious disease), you should not take ibuprofen;

  • You have chronic constipation;

  • You have a disease affecting your ability to breathe or have a history of bronchial asthma, chronic rhinitis, or allergic diseases such as bronchospasm (bronchial constriction making breathing difficult), urticaria, or angioedema, after using other medications;

  • You have a history of hypotension (lower than normal blood pressure), hypothyroidism (low thyroid hormone levels in the blood causing bodily disturbances), seizures, increased intracranial pressure (increased pressure inside the skull), or head injury;

  • Pain or fever persists for more than 3 days, worsens, or new symptoms appear; your doctor should evaluate your clinical condition;

  • Physical dependence (appearance of physical symptoms upon withdrawal of a substance the body is accustomed to) and tolerance (need to increase the dose to achieve the effect previously obtained with a lower dose) may occur with repeated administration of Neobrufen with Codeine due to its codeine content. Caution is required in patients with chemical dependence (patients 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 in this enzyme, which may affect individuals differently. In some people, morphine is not produced or is produced in very low amounts, providing insufficient pain relief. In others, a very high amount of morphine may be produced, increasing the risk of serious adverse reactions. If you notice any of the following adverse effects, stop taking this medication and seek immediate medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite;

  • Due to its dosage and pharmaceutical form, this medication is intended for adult use only;

  • With prolonged use, headaches may appear that should not be treated by increasing the dose;

  • Adverse reactions due to ibuprofen, especially gastrointestinal, may increase with alcohol consumption;

  • Serious skin reactions have been reported with Neobrufen with Codeine treatment. Stop taking Neobrufen with Codeine and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4;

  • Special monitoring is required in patients undergoing major surgery;

  • It may cause allergic reactions even without prior exposure to the drug.

  • You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of your medication.

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

Sleep-related breathing disorders

Neobrufen with Codeine may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include breathing pauses 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 occurred in the past.

Children and adolescents

Use in children and adolescents after surgery

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

Use in children with respiratory problems

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

Other medicines and Neobrufen with Codeine

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including over-the-counter, homeopathic, herbal medicines, 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, dose adjustment or treatment interruption may be necessary:

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

Medications that interfere with ibuprofen:

  • Should not be used with other analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), including Coxib anti-inflammatory drugs.
  • Anticoagulants/antiplatelet agents (e.g., to treat or prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
  • Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing drugs, and angiotensin-II receptor antagonists such as losartan)
  • Hydantoins (for seizures) and sulfonamides (antibiotics for infections).
  • Lithium (used for manic-depressive disorders).
  • Digoxin and cardiac glycosides (used for heart conditions).
  • Methotrexate (used in cancer and rheumatoid arthritis treatment).
  • Pentoxifylline (used for circulatory disorders).
  • Probenecid and sulfinpyrazone (used in gout patients or with penicillin in infections).
  • Quinolones (antibiotics used for infections).
  • Thiazides (diuretics used to increase urine elimination).
  • Sulfonylureas (used to lower blood glucose levels).
  • Cyclosporine, tacrolimus (used to prevent transplant rejection).
  • Thrombolytics (medications that dissolve or break down blood clots).
  • Zidovudine (used in treating patients infected with the human immunodeficiency virus causing AIDS).
  • Corticosteroids (have many applications due to their anti-inflammatory action, as immunosuppressants in autoimmune diseases and organ transplants, and in diseases affecting metabolism).
  • MAOI antidepressants (used to treat depression).
  • Mifepristone (abortifacient medication).
  • Selective serotonin reuptake inhibitors (used in depression).
  • Cholestyramine (used to reduce cholesterol).
  • Aminoglycosides (antibiotics).
  • Drugs such as voriconazole or fluconazole (used for fungal infections).
  • Herbal extracts: Ginkgo biloba tree extract.
  • Other medications may also affect or be affected by treatment with Neobrufen with Codeine. Therefore, always consult your doctor or pharmacist before using Neobrufen with Codeine with other medications.

Medications that interfere with codeine:

  • Central nervous system (CNS) depressants (drugs acting on the CNS, used, for example, to reduce severe pain, in mental illnesses, as neuromuscular blockers, etc.); taking them with Neobrufen with Codeine may increase CNS depressant effects.
  • This medication should not be taken with alcohol to avoid stomach damage and possible potentiation of codeine's depressant effects.
  • CYP2C9 inhibitors such as quinidine (for heart arrhythmias) or fluoxetine may reduce the effect of codeine.
  • Concomitant use of Neobrufen with Codeine with sedative medications, such as benzodiazepines or related substances, increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and could be potentially fatal. Therefore, concomitant use should only be considered when no other options are available.

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

  • Gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain).

Inform your doctor about all sedative medications you are taking and take exactly the dose recommended by your doctor. It may help to inform your friends or family to be alert for the signs and symptoms described above. Contact your doctor if you experience these symptoms.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood or urine tests), inform your doctor that you are being treated with Neobrufen with Codeine, as it may alter test results.

Taking ibuprofen may 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 urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
  • Liver function tests: increased transaminase values

Taking Neobrufen with Codeine with food, drinks, and alcohol

It is recommended to take Neobrufen with Codeine during or immediately after meals. Taking ibuprofen with food delays its absorption.

Do not consume alcohol during treatment with this medication due to the increased risk of adverse reactions related to codeine.

Using ibuprofen in patients who habitually consume alcohol (three or more alcoholic drinks—beer, wine, liquor—per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

In the third trimester, administration of Neobrufen with Codeine is contraindicated, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor beyond expected duration.

Since administration of medications like Neobrufen with Codeine has been associated with an increased risk of congenital abnormalities/abortion, you should not take it during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, use the lowest dose for the shortest time necessary. From week 20 of pregnancy onward, Neobrufen with Codeine may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Fertility

For women of childbearing age, it should be noted that medications like Neobrufen with Codeine have been associated with reduced fertility.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Labor

Administration of Neobrufen with Codeine during labor is not recommended.

Codeine may prolong labor. High-dose codeine close to delivery may cause neonatal respiratory depression. Its use during labor is not recommended if the baby is premature. Opioid analgesics cross the placenta. Administration of medications containing codeine in the days before delivery may cause neonatal abstinence syndrome. It is recommended to monitor newborns whose mothers took opioids during labor (FDA Category C). If respiratory depression is severe, naloxone may be required.

Driving and using machines

Due to ibuprofen: patients experiencing dizziness, vertigo, visual disturbances, or other central nervous system disorders while taking this medication should refrain from driving or operating machinery. If a single dose of ibuprofen is taken or treatment is short-term, no special precautions are necessary.

Due to codeine: Neobrufen with Codeine may cause drowsiness, impairing mental and/or physical abilities. If you experience these effects, avoid driving vehicles or operating machinery.

Use in athletes

It is reported that this medication contains a component that is metabolized to morphine, which may lead to a positive result in doping control tests.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take Neobrufen with Codeine

If your doctor has prescribed Neobrufen with Codeine, before starting treatment and regularly during treatment, your doctor will explain what you can expect from using 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 section "If you stop taking Neobrufen with Codeine").

Always follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will explain what you can expect from using Neobrufen with Codeine, when and for how long you need to take it, when to contact your doctor, and when you should discontinue treatment (see also section "If you stop taking Neobrufen with Codeine").

Neobrufen with Codeine should be used at the lowest effective dose 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

The recommended dose is 1 tablet (400 mg ibuprofen, 30 mg codeine phosphate hemihydrate) every 4–6 hours depending on the intensity of pain. Do not take more than 6 tablets (2,400 mg ibuprofen, 180 mg 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 mouth discomfort and throat irritation.

This medicine is administered orally.

It is advisable to take the medicine with food or meals. Any patient who experiences gastrointestinal discomfort before taking the medicine should consult a doctor.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

This medicine should not be taken for longer than 3 days. If pain does not improve after 3 days, consult your doctor.

Use in children and adolescents

Do not administer to individuals under 18 years of age.

Use in patients aged 65 years and older

Elderly individuals are more likely to experience adverse effects, so a lower dose may be necessary. Consult your doctor.

Patients with kidney and/or liver disease

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

If you take more Neobrufen with Codeine than you should

If you have taken more Neobrufen with Codeine than prescribed, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and amount ingested, or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, ringing in the ears, confusion, involuntary eye movements, and lack of muscle coordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, chills, and breathing difficulties have been reported.

Metabolic acidosis (a disorder causing increased acidity in blood plasma), 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 and respiratory systems have been rarely reported. Cardiovascular toxicity has also been reported, including hypotension (lower than normal blood pressure), bradycardia (reduced heart rate), and tachycardia (increased heart rate above 100 beats per minute). In cases of significant overdose, renal failure and liver damage are possible.

Symptoms reported with codeine overdose include drowsiness, skin rash, pupil constriction, vomiting, tingling, ataxia (reduced ability to coordinate body movements), and skin swelling (edema). Respiratory failure and some deaths have also been reported. Other observed symptoms include initial excitement, anxiety, insomnia, followed in some cases by headache, blood pressure disturbances, arrhythmias (abnormal heart rhythms), dry mouth, hypersensitivity reactions (allergy), tachycardia (increased heart rate above 100 beats per minute), seizures, 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 cases of ingestion of large amounts, activated charcoal should be administered. If central nervous system (CNS) depression occurs, artificial ventilation, oxygen, and naloxone administration are required.

If you forget to take Neobrufen with Codeine

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

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

If you stop taking Neobrufen with Codeine

Due to its codeine content, there is a risk of possible withdrawal-related effects upon discontinuation of treatment (onset of physical symptoms when stopping a substance to which the body has become accustomed).

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

The assessment of the frequency of adverse reactions is based on the following criteria: Very common: may affect more than 1 in 10 people; Common: may affect up to 1 in 10 people; Uncommon: 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.

Adverse effects that may occur due to the ibuprofen content are:

-Gastrointestinal disorders

The most common adverse effects associated with medicines such as Neobrufen with Codeine are gastrointestinal:

Common: nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, blood in stools, vomiting blood, gastrointestinal bleeding.

Uncommon: gastritis, duodenal ulcer, gastric ulcer, mouth ulcers (aphthous stomatitis), gastrointestinal perforation.

Very rare: pancreatitis.

Ulcers, gastrointestinal bleeding, and perforations (in some cases fatal) may occur, particularly in elderly patients.

-Immune system disorders

Rare: anaphylactic reaction (an allergic reaction to a substance that did not cause any disorder upon first administration).

Hypersensitivity reactions have been observed following treatment with NSAIDs. These may include: (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity such as asthma, worsening of asthma, bronchospasm, or dyspnoea, or (c) various skin disorders including rashes of different types, pruritus, urticaria, purpura, and angioedema.

-Skin and subcutaneous tissue disorders

Common: skin rash.

Uncommon: itching, urticaria, purpura (purple spots on the skin), angioedema (transient swelling of skin, mucous membranes, or sometimes internal organs), photosensitivity reaction (abnormal skin response to light exposure).

Very rare: severe skin reactions such as bullous dermatoses (including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purpuric lesions, mainly on the trunk)), toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with skin necrosis and peeling), and erythema multiforme (an allergic reaction with general malaise, fever, joint pain, and skin lesions).

Frequency not known: a serious skin reaction known as DRESS syndrome (an acronym in English). Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash with nodules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

Skin reactions that typically appear in the same body area after repeated intake of the medicine.

Stop taking Neobrufen with Codeine if you experience these symptoms and seek immediate medical attention. See also section 2.

-Infections and infestations:

Uncommon: rhinitis (inflammation of the nasal mucosa).

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

Exacerbation of inflammation related to infections (e.g., development of necrotizing fasciitis) has been reported in association with NSAID use. If signs of infection appear or worsen during ibuprofen use, prompt medical consultation is recommended.

-Blood and lymphatic system disorders:

Rare: leucopenia (reduced white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), thrombocytopenia (reduced platelets in blood), aplastic anaemia (bone marrow failure to produce various blood cells), neutropenia (reduced granulocytes, predisposing to infections), agranulocytosis (severe reduction in granulocytes), haemolytic anaemia (premature destruction of red blood cells).

  • Psychiatric disorders:

Uncommon: insomnia, anxiety.

Rare: depression, confusion.

-Nervous system disorders:

Common: headache, dizziness.

Uncommon: paraesthesia (numbness, tingling, "pins and needles" sensations, more frequent in hands, feet, arms, or legs), somnolence.

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

-Eye disorders:

Uncommon: visual disturbances, blurred vision, reduced visual acuity, or changes in colour perception, which resolve spontaneously.

Rare: toxic optic neuropathy (degeneration of the retina).

-Ear and labyrinth disorders:

Uncommon: hearing impairment, vertigo, tinnitus.

-Hepatobiliary disorders:

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

Very rare: liver failure (severe deterioration of liver function).

-Renal and urinary disorders:

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

-Respiratory, thoracic and mediastinal disorders:

Uncommon: asthma, bronchospasm (narrowing of the bronchi), dyspnoea (difficulty breathing).

-Musculoskeletal and connective tissue disorders:

Rare: neck stiffness.

-General disorders and administration site conditions:

Common: fatigue.

Rare: oedema (fluid retention).

  • Cardiac disorders:

Uncommon: 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:

Uncommon: hypertension.

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

In NSAID treatment, the following adverse effects have been reported: oedema (fluid retention), hypertension (high blood pressure), and coronary insufficiency (inability of the heart to pump blood in adequate volumes for normal function).

Adverse effects that may occur 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 prolonged use of high doses of codeine.

-Nervous system disorders:

Dizziness and somnolence.

-Cardiac disorders

Palpitations.

-Gastrointestinal and hepatobiliary disorders:

Constipation, nausea, vomiting.

Frequency not known: symptoms associated with inflammation of the pancreas (pancreatitis) and of the biliary tract system (a disorder affecting a valve in the digestive tract, known as Oddi sphincter dysfunction), for example, severe upper abdominal pain that may radiate 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:

Drug tolerance may develop (need to increase the dose to achieve the effect previously obtained with a lower dose), especially with prolonged use of high doses of codeine.

Neobrufen with codeine, especially when taken at doses higher than recommended or for prolonged periods, may cause kidney damage, rendering the kidneys unable to effectively eliminate acids from the blood into the urine (renal tubular acidosis). It may also greatly reduce blood potassium levels (see section 2). This is a very serious disorder requiring immediate treatment. Signs and symptoms include muscle weakness and dizziness.

Reporting of adverse effects

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

5. Storage of Neobrufen with Codeine

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

No special storage conditions are required.

Store this medicine in a secure and protected place, inaccessible to others. This medicine may cause serious harm or be fatal to individuals who take it without having been prescribed it.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Neobrufen with Codeine

The active substances 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: sodium starch glycolate, microcrystalline cellulose, anhydrous colloidal silica, pregelatinized maize 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.

Appearance of the medicine and contents of the pack

This medicine is presented as film-coated tablets with a score line on one side to facilitate swallowing. Each pack contains 30 or 500 film-coated tablets, packed in Al/PVDC-PVC/PVDC blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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
28706 - Madrid
Spain

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of the most recent review of this leaflet: January 2026.

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