Prospect: information for the patient

Astefor 400 mg / 30 mg granulated for oral suspension

Ibuprofen / Codeine, phosphate

1.What is Astefor and for what it is used.

2.What you need to know before starting to take Astefor.

3.How to take Astefor.

4.Possible adverse effects.

5.Storage of Astefor.

6.Contents of the package and additional information

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

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

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 you have had allergic reactions to anti-inflammatory drugs, aspirin, or other analgesics, such as asthma-like reactions, 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 bleeding, or have had a perforation of the digestive tract.
• If you vomit blood, have black stools, or have bloody diarrhea.
• If you have bleeding or clotting disorders.
• If you have severe heart failure.
• If you have asthma or chronic obstructive pulmonary disease (COPD).
• 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 quickly to morphine.
• If you are in the third trimester of pregnancy.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor before starting this medication.

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

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

Be careful with Astefor:

• Signs of allergic reaction to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using this medication immediately and contact your doctor or emergency medical services if you observe any of these signs.

-If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in the elderly. In these cases, your doctor may consider adding a stomach protector medication.

-If you have Crohn's disease or ulcerative colitis, as Astefor-type medications may worsen these conditions.

-Inform your doctor if you are taking anticoagulant medications, such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

-Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may increase the risk of 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 and possibly radiating to the back, nausea, vomiting, or fever, which may be symptoms of pancreatitis and biliary tract inflammation.

You should inform your doctor or pharmacist before taking this medication if:

-You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GAP), have been reported in association with Astefor treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any of these symptoms.

-Fluid retention may occur, especially in patients with heart failure and/or high blood pressure.

-In case of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately.

-Be cautious with Astefor if you are over 65 years old, as you may be more prone to adverse reactions.

-Ibuprofen may decrease female fertility. This effect is reversible when the medication is discontinued.

-If you have eye problems, discontinue the medication and consider an eye examination as a precautionary measure.

-Seek medical attention if you experience symptoms of aseptic meningitis (inflammation of the meninges not caused by bacteria) after taking the medication.

-If you have kidney or liver disease.

-If you have porphyria, a rare disorder in which large amounts of porphyrin are eliminated in urine and feces.

-Do not take ibuprofen if you have chickenpox, as it may worsen the condition.

-If you have chronic constipation.

-If you have a respiratory disease that affects your ability to breathe.

-If you have an infection, see the "Infections" section below.

Be cautious with Astefor.

Infections:

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

Severe skin reactions:

Severe skin reactions have been reported in association with Astefor treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any of these symptoms.

Codeine:

Codeine is metabolized 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 may affect individuals differently. In some people, morphine is not produced or is produced in very small amounts, and it will not provide sufficient pain relief. In others, it is more likely to cause severe adverse reactions because a large amount of morphine is produced.

If you experience any of the following adverse effects, discontinue treatment with this medication and seek medical attention immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea, or vomiting, constipation, loss of appetite.

You may develop physical dependence and tolerance with repeated administration of this medication due to the codeine content.

Respiratory problems related to sleep:

Astefor may cause respiratory problems related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to lack of breath, difficulty maintaining sleep, or excessive daytime drowsiness.

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

Use in people over 65 years old:

Older people are more prone to these effects, so you may need to reduce the dose. Consult your doctor.

Use in athletes:

Inform athletes that this medication contains codeine, a detectable narcotic in doping tests.

Children and adolescents:

Do not administer to children under 12 years old.

Use in children and adolescents after surgery:Do not use codeine for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems:Do not recommend the use of codeine in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Other medications and Astefor:

Inform your doctor or pharmacist if you are taking or have taken, are currently taking, or may need to take any other medication.

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

-Anticoagulant medications (e.g., for blood clotting problems, e.g., aspirin, warfarin, ticlopidine),

-Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

-Hidantoins and sulfamides.

-Lithium (a medication used for depression).

-Digoxin and cardiac glycosides (used for the heart).

-Methotrexate (used in cancer treatment and rheumatoid arthritis).

-Pentoxifylline (used in circulatory disorders).

-Phenytoin (used in epilepsy treatment).

-Probenecid and sulfinpyrazone (used in patients with gout or with penicillin in infections).

-Quinolones (used in infections).

-Thiazides (diuretics).

-Sulfonylureas (used to lower blood glucose levels).

-Ciclosporin, tacrolimus (used to prevent rejection after a transplant)

-Trombolytics (medications that dissolve or break down blood clots).

-Zidovudine (used in HIV-infected patients, the cause of AIDS).

-Corticosteroids.

-Antihypertensives.

-Antidepressants

-Central nervous system depressants.

-Do not take this medication with alcohol to avoid damaging the stomach and potential potentiation of codeine's depressive effect.

• Gabapentin or pregabalin for epilepsy or neuropathic pain caused by nerve damage.

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

Interference with diagnostic tests:

If you are undergoing any diagnostic tests (including blood and urine analyses, etc.), inform your doctor that you are taking 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. Ibuprofen absorption is delayed when taken with food. Using ibuprofen in patients who regularly consume alcohol (three or more alcoholic beverages – beer, wine, or liquor per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

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

Pregnancy:

Do not take this medication 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 and your baby's tendency to bleed and delay or prolong delivery.

Due to the association of administering this type of medication with an increased risk of congenital anomalies/abortions, do not take it during the first six months of pregnancy unless absolutely necessary and advised by your doctor.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 week 20 of pregnancy onwards,this medicationmay cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

For fertile women, consider that medications like Astefor have been associated with a decrease in the ability to conceive.

Breastfeeding:

Consult your doctor or pharmacist before using any medication.

Women in a breastfeeding period 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 operating machinery:

Do not drive or operate tools or machines, as this medication contains codeine, which may impair your mental and/or physical abilities required for potentially hazardous activities.

If you only take a single dose of Astefor or take it for a short period, no special precautions are necessary.

Information about excipients:

This medication contains lactose: If your doctor has indicated that you have a lactose intolerance, consult before taking this medication

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor.

This medication is administered orally. Remember to take your medication

Your doctor will inform you of the duration of treatment with this medication, and when and how to interrupt it. Do not suspend treatment beforehand, as this will not yield the expected results.

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

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

The most effective dose should be used for the shortest duration necessary to relieve symptoms.

If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents aged 12 to 18 years

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

In adolescents aged 12 years or older, the daily dose is 1 tablet every 6 hours, as needed. Do not take more than 4 tablets in 24 hours.

Use in children

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

Children weighing less than 40 kg or under 12 years of age should not take this medication, as 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 the use of [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 confirmed 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 prescribed by your doctor.

Instructions for correct administration of the preparation

Empty the contents of the tablet into a glass. Add a small amount of water and mix well. Swallow immediately.

Patients with stomach discomfort 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 to obtain an opinion on the risk and advise on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal hemorrhage (see also section 4), diarrhea, headache, ringing in the ears, confusion, and tremors of the eyes. It may also cause agitation, drowsiness, disorientation, or coma.

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

Acute renal failure and liver damage may occur. Asthma exacerbation may occur in asthmatics. Hypotension and decreased respiration may also 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 bring the packaging and the medication leaflet to the healthcare professional.

In case of overdose, mild symptoms due to ibuprofen are: abdominal pain, nausea, vomiting, indifference, sleepiness, headache, involuntary rapid eye movements, ringing in the ears, and muscle coordination disorders. It is rare for more severe symptoms such as intestinal hemorrhage, hypotension, hypothermia, metabolic acidosis, seizures, kidney function disorders, coma, dyspnea/adult respiratory distress syndrome, and transient respiratory arrest in children (after ingesting large amounts) to occur.

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

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

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

If you forget to take Astefor

Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Astefor

There is a risk of possible withdrawal effects from suspending treatment with this medication.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Inform your doctor or pharmacist if you experience any of the following side effects:

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

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

• Flat, red spots, often with blisters in the center, that may peel or form ulcers on the trunk, mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

This medicine, especially when taken in doses higher than recommended or for a prolonged period, may cause kidney damage, making it difficult for the kidneys to effectively remove acidic substances from the blood (tubular acidosis). It may also significantly reduce potassium levels in the blood (see section 2). This is a very serious condition that requires immediate treatment. Signs and symptoms include muscle weakness and dizziness.

The side effects that may occur due to the presence 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), especially in the elderly. Flatulence, constipation, stomach pain, abdominal pain, bloody stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease.

Blood disorders

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

Mental disorders

• Infrequent: sleep disturbances and mild restlessness.
• Rare: mental disturbances and depression.
• Nervous system disorders.
• Frequent: headache, fatigue, dizziness, vertigo.
• Infrequent: insomnia, restlessness.
• Rare: nervousness, irritability, depression, confusion, reversible visual impairment, 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: loss of vision.
• Ear and labyrinth disorders

• Frequent: tinnitus.
• Infrequent: hearing disturbances

Vascular disorders

• Medicines like Astefor may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.
• Unknown frequency (cannot be estimated from available data):
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

• Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medicines like Astefor.

Liver disorders

• Rare: liver damage, including jaundice (yellow discoloration of the skin). Medicines like Astefor may be associated with rare cases of 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 "unknown" Generalized, red, scaly rash with bumps under the skin and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Astefor if you experience these symptoms and seek immediate medical attention. See section 2.

The skin becomes sensitive to light.

Other disorders:

• Rare: neck stiffness.

General or administration reactions:

• Reactions of hypersensitivity occur normally in patients with a history of allergy to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. This may also occur in patients who have not previously shown hypersensitivity to these drugs and includes the following symptoms:
• Frequent: skin rashes and itching.
• Infrequent: asthma, rhinitis, urticaria, and allergic reactions.
• Rare: bronchospasm (sudden sensation of choking), dyspnea (difficulty breathing), and angioedema (circulatory reaction affecting the deeper layers of the skin with inflammation and swelling).
• Very rare: Medicines like Astefor may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The side effects that may occur due to the presence of codeine are:

nausea, vomiting, constipation, dizziness, sleepiness, palpitations, itching, and excessive sweating.

Other possible side effects:

Unknown frequency (cannot be estimated from available data): symptoms related to inflammation of the pancreas (pancreatitis) and the biliary system (a problem affecting a valve in the intestines, called Oddi's sphincter dysfunction), e.g., intense abdominal pain and possibly radiating to the back, nausea, vomiting, or fever.

The side effects that may occur due to the presence of codeine are: nausea, vomiting, constipation, dizziness, sleepiness, palpitations, itching, and excessive sweating.

Reporting of side effects

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

Keep this medication out of the sight and reach of children. No special storage conditions are required.

Store this medication in a secure location that is inaccessible to others. It may cause severe injuries and be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date appearing on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Astefor:

The active principles 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 (aroma substances, corn maltodextrin, alpha-tocopherol (E-307), aspartate (E-951), sodium cyclamate, neo-hesperidin, titanium dioxide, isomalta (E-953), xylitol (E-967).

Appearance of Astefor and contents of the packaging:

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

Each package contains 30 sachets.

Holder of the marketing authorization:

Farmasierra Laboratorios S. L.

Carretera de Irún km 26,200.

28709, San Sebastián de los Reyes.

Madrid

Spain

Tel.: 91-657 06 59

Fax: 91-657 08 20

Responsible for manufacturing:

Farmasierra Manufacturing S. L.

Carretera de Irún km 26,200.

28709, San Sebastián de los Reyes.

Madrid.

Spain

Last review date of this leaflet:November 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/