Product Information for the Patient

Astefor 400 mg / 30 mg Film-Coated Tablets

Ibuprofen / Codeine Phosphate

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

-Keep this product information as you may need to refer to 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 adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this product information, inform your doctor or pharmacist. See section 4.

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 aged 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 painkillers, 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 system.
• 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).
• For pain relief in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you know that 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.

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

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

Be careful with Astefor:

• Signs of an allergic reaction to ibuprofen, such as respiratory problems, swelling of the face and neck (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 medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin.

You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.

• Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

• Seek medical attention if you experience severe 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 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 if you 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 and seek medical attention immediately if you notice any of these symptoms.
• This type of medication may cause fluid retention, 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.
• If you are over 65 years old, as you may be more prone to adverse reactions.
• Ibuprofen belongs to a group of medications that 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 precaution.
• If you experience symptoms of aseptic meningitis (inflammation of the meninges not caused by bacteria) after taking the medication, consult your doctor.
• If you have kidney or liver disease.
• If you have intermittent acute porphyria (a rare disorder in which large amounts of porphyrin are eliminated in urine and feces).
• If you have chickenpox (a childhood infection), do not take ibuprofen.
• 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.
• Pain or increased sensitivity to pain (hyperalgesia) that does not respond to an increase in 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. Therefore, it is possible that this medication may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Severe skin reactions

Severe skin reactions associated with Astefor treatment have been reported. Stop taking Astefor and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Codeine

Codeine is converted to morphine in the liver by an enzyme. Morphine is the substance that provides pain relief. Some people have a variation of this enzyme 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. Others are more likely to experience severe adverse reactions because they produce a large amount of morphine.

If you experience any of the following adverse effects, discontinue 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 its effects, so you may need to reduce the dose. Consult your doctor.

Use in athletes

Inform athletes that this medication contains codeine, which is 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, or may need to take or use any other medication.

Astefor may affect or be affected by other medications:

-Anticoagulant medications (e.g., for blood clotting problems or to prevent clotting, 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).

-Hidantoínas and sulfamidas.

-Lithium (a medication used for depression).

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

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

-Pentoxifilina (used in circulatory disorders).

-Fenitoína (used in epilepsy treatment).

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

-Quinolonas (used in infections).

-Tiazidas (diuretics).

-Sulfonilureas (used to lower blood glucose levels).

-Ciclosporina, tacrolimus (used to prevent rejection after transplantation)

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

-Zidovudina (used in HIV-infected patients, causing AIDS).

-Corticosteroids.

-Anti-hypertensives.

-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.

• Gabapentina or pregabalina for epilepsy or pain caused by nervous system damage (neuropathic pain)

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

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, 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. The administration of ibuprofen with food delays its absorption. The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic beverages per day) may 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

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 tendency and that of your baby to bleed and delay or prolong delivery.

Due to the association of administering medications of this type 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, it is essential to consider that medications of the type Astefor have been associated with a decrease in the ability to conceive.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women 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 operating machinery

Do not drive or operate tools or machines, as this medication contains codeine, which may impair 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

Astefor contains sodium carmelose and sodium glycolate starchor

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

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

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

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

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, ask your doctor for advice.

The most effective dose should be used for the shortest duration necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2)

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

Adults:

The usual dose is 1 tablet (400 mg of ibuprofen, 30 mg of codeine) every 4-6 hours according to the intensity of the pain. No more than 6 tablets (2,400 mg of ibuprofen, 180 mg of codeine) should be taken within 24 hours.

Use in children

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

Before starting treatment and regularly during this, 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.

Instructions for correct administration of the preparation

It is advisable to take the medication with meals or with some food. Any patient who notes 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself 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. It may also cause agitation, drowsiness, disorientation, or coma.

Occasionally, patients develop seizures. At high doses, somnolence, 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. It is possible to exacerbate asthma in asthmatics. Additionally, hypotension and decreased respiration may occur.

If you forgot to take Astefor

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

If you interrupt treatment with Astefor

There is a risk of possible effects due to withdrawal from suspending treatment.

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

Like all medicines, this medicine can 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 taking this medicine and seek medical attention immediately if you notice any of the following symptoms:

• flat red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and symptoms similar to the flu (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin eruption, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized red and scaly eruption, 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, which becomes unable to effectively remove acids from the blood through urine (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 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) or, especially in the elderly. Flatulence, constipation, stomach burning, abdominal pain, blood in stool, 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 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: 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 Astefor-like medicines.

Liver disorders

• Rare: liver damage, including jaundice (yellow discoloration of the skin). Medicines 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

• Unknown frequency: generalized red scaly eruption, 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 medical attention immediately. See section 2.

The skin becomes sensitive to light.

Other disorders:

• Rare: neck stiffness.

General or administration reactions:

• Hypersensitivity reactions 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 feeling 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 codeine content 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., severe abdominal pain and possibly radiating to the back, nausea, vomiting, or feverReporting 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 reach and sight 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 indicated on the packaging, the expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Astefor:

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

Each blister pack 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 cornstarch, L-Leucine, Eudragit L30 D55, titanium dioxide, Macrogol 6000, simethicone emulsion, and sodium carboxymethylcellulose.

Appearance of Astefor and contents of the packaging:

White, oblong, film-coated tablets with an incision on one face that allows them to be broken and swallowed more easily.

Each pack 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

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