ASTEFOR 400/30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Astefor 400 mg / 30 mg Film-Coated Tablets

Ibuprofen / Codeine, Phosphate

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 or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. See section 4.

Contents of the package leaflet:

1. What Astefor is and what it is used for.
2. What you need to know before taking Astefor.
3. How to take Astefor.
4. Possible side effects.
5. Storage of Astefor.
6. Package contents and additional information

1. What Astefor is and what it is used for

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

This medication 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 taking Astefor

Do not take Astefor

• If you are allergic (hypersensitive) to ibuprofen, codeine, or any of the components of this medication (listed in section 6).
• If, when taking anti-inflammatory medications, acetylsalicylic acid, or other analgesics, you have experienced allergic reactions such as asthma, rhinitis, or urticaria, or have had gastrointestinal bleeding or stomach perforation.
• If you have 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, have black stools, or have bloody diarrhea.
• If you have bleeding disorders or coagulation disorders.
• If you have severe heart failure.
• If you have asthma or chronic obstructive pulmonary disease.
• 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 to morphine very quickly.
• If you are in the third trimester of pregnancy.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor before starting to take this medication.

It is essential to use the smallest dose that relieves/controls the pain.

This medication is only for adults and children over 12 years of age.

Be careful with Astefor:

• Ibuprofen has been reported to cause signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using this medication immediately and contact your doctor or medical emergency services immediately if you observe any of these signs.
• 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 prior warning symptoms. This risk is higher when using high doses and prolonged treatments, 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-protecting medication.
• If you have Crohn's disease or ulcerative colitis, as medications of the Astefor type can worsen these conditions.
• Inform your doctor if you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type.

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.

• 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.

• Contact your doctor if you experience 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 discuss your treatment with your doctor or pharmacist before taking this medication 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.
• Severe skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), in association with Astefor treatment. Discontinue treatment with this medication and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.
• Similarly, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
• In case of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately.
• If 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.
• If you have eye disorders, you should stop taking the medication and, as a precaution, undergo an ophthalmological examination.
• If, after administering the medication, you observe symptoms of aseptic meningitis (inflammation of the meninges not caused by bacteria), consult your doctor.
• If you have had kidney or liver disease.
• If you have acute intermittent porphyria (a rare disorder in which large amounts of porphyrin are eliminated in urine and feces).
• If you have chickenpox (a common childhood infectious disease), you should not take ibuprofen.
• If you have chronic constipation.
• If you have any disease that affects your ability to breathe.
• If you have an infection, see the "Infections" heading later.
• Pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increase in the medication dose.

Consult your doctor if you experience any of the following symptoms while taking Astefor.

Special caution is recommended with Astefor.

Infections:

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 a doctor without delay.

Skin reactions

Severe skin reactions have been reported in association with Astefor treatment. Stop taking Astefor and seek medical attention immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very severe skin reaction. See section 4.

Codeine

Codeine is converted to 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 experience serious adverse reactions because they produce a very high amount of morphine.

If you experience any of the following side effects, you must stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, or loss of appetite.

Physical dependence and tolerance can occur with repeated administration of this medication due to its codeine content.

Sleep-related respiratory disorders

Astefor may 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 lack of breath, difficulty staying asleep, or excessive daytime sleepiness.

If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Use in people over 65 years of age

Older people are usually more prone to its effects, so the dose may need to be reduced sometimes. Consult your doctor.

Use in athletes

Athletes are informed that this medication contains codeine, which is a detectable narcotic in doping tests.

Children and adolescents

Do not administer to children under 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.

Other medications and Astefor

Inform your doctor or pharmacist if you are taking or using, have recently taken or used, or might take or use any other medication.

Astefor may affect or be affected by other medications:

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Hydantoins and sulfonamides.
• Lithium (medication used for depression).
• Digoxin and cardiac glycosides (used for the heart).
• Methotrexate (used in the treatment of cancer and rheumatoid arthritis).
• Pentoxifylline (used in circulatory disorders).
• Phenytoin (used in the treatment of epilepsy).
• Probenecid and sulfinpyrazone (used in patients with gout or with penicillin in infections).
• Quinolones (used in infections).
• Thiazides (diuretics).
• 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.
• Antihypertensives.
• Antidepressants
• Central nervous system depressants.
• This medication should not be administered with alcohol to avoid damaging the stomach and the possible potentiation of the depressant effect of codeine.
• Gabapentin or pregabalin to treat epilepsy or pain caused by nerve system damage (neuropathic pain)

Other medications may also affect or be affected by treatment with this medication. Therefore, you should always consult your doctor or pharmacist before using Astefor with other medications.

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 this medication, as it may alter the test results.

Taking Astefor with food, drinks, and alcohol

It is recommended to take this medication during or immediately after meals. The administration of ibuprofen with food delays its absorption. The use of ibuprofen in patients who habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor... - per day) can cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medication should not be taken during the third trimester 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 labor more than expected.

Because the administration of medications of this type has been associated with an increased risk of congenital anomalies/abortions, you should not take it during the first six months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest time necessary.

From the 20th week of pregnancy onwards, this medication may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment during a period longer than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medications of the Astefor type have been associated with a decrease in fertility.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Breastfeeding women should consult their doctor before taking this medication, as ibuprofen passes into breast milk.

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

Driving and using machines

Do not drive or operate tools or machines, as this medication contains codeine, which can impair the mental and/or physical ability required for the performance of potentially hazardous activities.

If you only take one dose of Astefor or take it for a short period, it is not necessary to take special precautions.

Information about excipients

Astefor contains sodium carmellose and sodium starch glycolate

This medication contains less than 1 mmol of sodium (23 mg) per unit dose; that is, it is essentially "sodium-free".

3. How to take Astefor

This medication is administered orally. Remember to take your medication.

Follow the administration instructions of the medication indicated by your doctor exactly. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of the treatment, and when and how you should interrupt it. Do not suspend treatment beforehand, as you will not achieve the expected effect.

If you estimate that the action of this medication is too strong or 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.

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

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

Adults:

The normal dose is 1 tablet (400 mg of ibuprofen, 30 mg of codeine) every 4-6 hours according to the intensity of the pain. Do not take more than 6 tablets (2,400 mg of ibuprofen, 180 mg of codeine) within 24 hours.

Use in children

Children under 12 years of age should not take this medication due to the risk of serious respiratory problems.

Before starting treatment and regularly during this time, your doctor will explain what you can expect from using [product name], when and for how long you should use it, when you should contact your doctor, and when you should interrupt treatment (see also If you interrupt treatment with Astefor).

Instructions for the correct administration of the preparation

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

If you take more Astefor than you should

If you have taken more medication 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.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and trembling eye movements. Agitation, drowsiness, disorientation, or coma may also occur.

Occasionally, patients develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, feeling of cold in the body, and respiratory problems. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors.

Acute kidney failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, hypotension and decreased breathing may occur.

If you forget to take Astefor

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

If you interrupt treatment with Astefor

There is a risk of possible withdrawal effects when treatment is stopped.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them. Inform your doctor or pharmacist if you experience any of the following adverse effects:

The assessment of the frequency of adverse reactions is based on the following criteria: Frequent (in more than 1 in 100 patients, but in less than 1 in 10 patients), infrequent (in more than 1 in 1,000 patients, but in less than 1 in 100 patients), rare (in more than 1 in 10,000 patients, but in less than 1 in 1,000 patients), very rare (in less than 1 in 10,000 patients).

Stop treatment with this medication and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-raised, target-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

This medication, especially when taken in doses higher than recommended or for a prolonged period, can cause kidney damage, making them unable to effectively eliminate acids from the blood through urine (renal tubular acidosis). It can 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.

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

Gastrointestinal disorders

• Frequent: diarrhea, nausea, vomiting.
• Infrequent: bleeding, gastric or duodenal ulcers, gastritis.
• Rare: stomach or intestinal perforation (in some cases fatal), flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, worsening of ulcerative colitis and Crohn's disease.

Blood disorders

• Rare: reduction in the number of white blood cells (leukopenia).
• Very rare: decrease in the number of platelets (thrombocytopenia), decrease in the number of red blood cells (aplastic anemia and hemolytic anemia).

Psychiatric disorders

• Infrequent: sleep disturbances and mild restlessness.
• Rare: mental disorders and depression.
• Nervous system disorders.
• Frequent: headache, fatigue, dizziness, vertigo.
• Infrequent: insomnia, restlessness.
• Rare: nervousness, irritability, depression, confusion, reversible decrease in visual acuity, hearing disturbances.
• Very rare: aseptic meningitis (inflammation of the meninges not caused by bacteria).

Eye disorders

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

• Ear and labyrinth disorders.

• Frequent: ringing in the ears.

• Infrequent: hearing disturbances.

Vascular disorders

• Medications like Astefor may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.
• Frequency not known (cannot be estimated from available data):
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medications like Astefor.

Liver disorders

• Rare: liver disorders, including jaundice (yellowing of the skin). Medications like Astefor may be associated, in rare cases, with liver damage.

• Kidney disorders.

• Rare: acute interstitial nephritis with hematuria (blood in urine), proteinuria (elimination of proteins in urine), and occasionally nephrotic syndrome.

Skin disorders

• Frequency "not known" Widespread red, scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Astefor if you experience these symptoms and seek medical attention immediately. See also section 2.

Skin becomes sensitive to light.

Other disorders:

• Rare: neck stiffness.

General or administration reactions:

• Hypersensitivity reactions usually occur in patients with a history of allergy to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. This can also happen in patients who have not previously shown hypersensitivity to these medications and includes the following symptoms:
• Frequent: skin patches and itching.
• Infrequent: asthma, rhinitis, urticaria, and allergic reactions.
• Rare: bronchospasm (sudden feeling of suffocation), dyspnea (difficulty breathing), and angioedema (reaction of the blood circulation that affects the deep layers of the skin with inflammation and swelling).
• Very rare: Medications like Astefor may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Adverse effects that may appear due to the codeine content are:

Nausea, vomiting, constipation, dizziness, drowsiness, palpitations, itching, and excessive sweating.

Other possible adverse effects:

Frequency not known (cannot be estimated from available data): symptoms related to pancreatitis (inflammation of the pancreas) and bile duct disorders (a problem affecting a valve in the intestines, called dysfunction of the Oddi sphincter), e.g., severe abdominal pain and possibly radiating to the back, nausea, vomiting, or fever Reporting 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 medication.

5. Conservation of Astefor

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

No special storage conditions are required.

Keep this medication in a secure location that is inaccessible to others. It can cause serious harm and be fatal to people for whom it has not been prescribed.

Do not use this medication after the expiration date indicated on the packaging. 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 packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Astefor composition:

The active ingredients are ibuprofen and codeine (as hemihydrate phosphate).

Each sachet contains 400 mg of ibuprofen and 30 mg of codeine (as hemihydrate phosphate).

The other components are: sodium croscarmellose, microcrystalline cellulose, talc, anhydrous colloidal silica, pregelatinized corn starch, L-leucine, Eudragit L30 D55, titanium dioxide, Macrogol 6000, simethicone emulsion, and sodium carboxymethylcellulose.

Astefor appearance and package contents:

White, oblong, film-coated tablets with a notch on one side that allows them to be split and makes them easier to swallow.

Each package contains 30 film-coated tablets.

Marketing authorization holder

Farmasierra Laboratorios S.L.

Carretera de Irún km 26,200.

28709, San Sebastián de los Reyes.

Madrid.

Spain.

Phone: 91-657 06 59.

Fax: 91-657 08 20.

Manufacturer

Farmasierra Manufacturing S.L.

Carretera de Irún km 26,200.

28709, San Sebastián de los Reyes.

Madrid.

Spain.

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

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