ASTEFOR 400mg/30 mg ORAL SUSPENSION GRANULES

Introduction

Patient Information Leaflet

Astefor 400 mg / 30 mg Oral Suspension Granules

Ibuprofen / Codeine, phosphate

Contents of the pack:

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

1. What Astefor is and what it is used for

This medicine contains ibuprofen and codeine as active substances. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Codeine belongs to a group of medicines called opioid analgesics that act by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol or ibuprofen.

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

2. What you need to know before you take Astefor

Do not take Astefor

• If you are allergic (hypersensitive) to ibuprofen, codeine, or any of the other ingredients of this medicine (listed in section 6).
• If you have had allergic reactions of the asthma type, rhinitis, or urticaria when taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics, or if you 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 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 old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you know you metabolize codeine very quickly into morphine.
• If you are in the third trimester of pregnancy.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor before starting to take this medicine.

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

It is important that you use the smallest dose that relieves-controls the pain.

Be careful with Astefor:

• Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using this medicine immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

• If you have had or develop 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 the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you have Crohn's disease or ulcerative colitis, as medications of the Astefor type may worsen these conditions.
• Tell 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 comment on 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 may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

• Contact your doctor if you have intense abdominal pain and possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of pancreatitis and biliary system inflammation.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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. There have been reports of serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), in association with Astefor treatment. Stop treatment with this medicine and seek immediate medical attention if you notice any of the symptoms related to these serious 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 suffer from 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 precautionary measure, an ophthalmological examination should be performed.
• 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, 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 below.

Special caution is recommended with Astefor.

Infections:

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, this medication may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

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

Codeine

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from serious adverse reactions because they produce a very high amount of morphine.

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

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 shortness 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

Elderly people are more likely to be affected by 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

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medications.

Astefor may affect or be affected by other medications. For example:

• 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 (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 taken 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 Astefor. 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.), tell your doctor that you are being treated with this medication, as it may alter the 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) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected.

Because the administration of this type of medication has been associated with an increased risk of congenital anomalies/abortions, you should not take it during the first 6 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 may cause 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 for more than a few days, your doctor may recommend additional checks.

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

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Women who are breastfeeding 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

This medication contains lactose: if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication

This medication contains 30 mg of aspartame in each dose unit. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it

correctly.

This medication contains 33.54 mg of sodium (main component of table/cooking salt) in each dose unit. This is equivalent to 1.67% of the maximum daily sodium intake recommended for an adult.

3. How to take Astefor

Follow your doctor's administration instructions for this medication exactly.

This medication is administered orally. Remember to take your medication

Your doctor will indicate the duration of treatment with this medication, and when and how it should be interrupted. Do not suspend treatment beforehand, as the expected results will not be obtained.

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 effective lowest 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).

Adults and adolescents from 12 to 18 years

In adults, the daily dose is 1 sachet (400 mg of ibuprofen/30 mg of codeine) every 4-6 hours, according to the intensity of the pain and response to treatment. In some processes, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 6 sachets (2,400 mg of ibuprofen/180 mg of codeine).

In adolescents 12 years of age or older, the daily dose is 1 sachet every 6 hours, as needed. Do not take more than 4 sachets in 24 hours.

Use in children

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

Children under 40 kg in weight or under 12 years of age should not take this medication because the dose of ibuprofen it contains is not suitable for the recommended dosage in these children.

Before starting treatment and regularly during it, 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.

Use in elderly patients

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has checked that you tolerate the medication well.

Use in patients with kidney and/or liver disease

If you have mild or moderate kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose that they have prescribed.

Instructions for the correct administration of the preparation

Pour the contents of the sachet into a glass. Add a small amount of water and mix well. Take immediately.

Patients with stomach upset should take this medication with milk and/or during meals.

If you take more Astefor than you should

If you have taken more of the medication than you should, or if a child has taken the medication by accident, always contact a doctor or the nearest hospital for advice on the risk and measures to take.

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 tremulous 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 cold, 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 respiration may occur.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the medication packaging and leaflet to the healthcare professional.

In case of overdose, mild symptoms due to ibuprofen are: abdominal pain, nausea, vomiting, indifference, sleep, headache, rapid involuntary eye movements, ringing in the ears, and lack of muscle coordination. It is rare for more serious symptoms such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, seizures, kidney function alterations, coma, dyspnea/acute adult respiratory distress syndrome, and transient respiratory arrest in children (after ingesting large quantities) to appear.

The symptoms due to codeine are: initial excitement, anxiety, insomnia, and later in certain cases drowsiness, headache, changes in blood pressure, arrhythmias, dry mouth, hypersensitivity reactions, tachycardia, seizures, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

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

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

If you forget to take Astefor

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

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

If you interrupt treatment with Astefor

There is a risk of possible effects derived from abstaining from treatment with this medication.

If you have any other doubts about the use of this medication, 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).

Interrupt treatment with Astefor and seek immediate medical attention if you notice any of the following symptoms:

• Reddish, non-raised, target-like or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. 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, and 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 eliminate blood acids through urine effectively (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.

The adverse effects that may appear due to the content of ibuprofen 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 stools, mouth 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.
• Neurological 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), high blood pressure, 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 (protein elimination through 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.

The 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 drugs 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.

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

nausea, vomiting, constipation, dizziness, sleep, 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.

The adverse effects that may appear due to the content of codeine are: nausea, vomiting, constipation, dizziness, sleep, palpitations, itching, and excessive sweating.

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 leaflet. 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 sight and reach of children. It does not require special storage conditions.

Keep this medication in a safe location that other people cannot access. It can cause serious harm and be fatal for people it has not been prescribed for.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection 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, anhydrous lactose, sodium saccharin, sodium lauryl sulfate, polyvinylpyrrolidone K30, orange flavor (flavoring substances, corn maltodextrin, alpha-tocopherol (E-307), aspartame (E-951), sodium cyclamate, neo-hesperidin, titanium dioxide, isomalt (E-953), xylitol (E-967).

Astefor appearance and package contents:

White granules for oral suspension, packaged in single-dose sachets.

Each package contains 30 sachets.

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 leaflet:November 2024

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