Astefor 400/30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Astefor 400 mg / 30 mg film-coated tablets

Ibuprofen / codeine phosphate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the 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. How to store Astefor.
6. Contents of the pack and other 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, which work by relieving pain. It may 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 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 to any of the components of this medicine (listed in section 6).
• If you have previously experienced allergic reactions such as asthma, rhinitis, or urticaria when taking anti-inflammatory medicines, acetylsalicylic acid, or other painkillers, or if you have had gastrointestinal bleeding or stomach perforation.
• If you have severe liver or kidney disease.
• If you have had or currently have a stomach or duodenal ulcer, or have experienced a perforation of the digestive tract.
• If you are vomiting blood, have black stools, or have bloody diarrhoea.
• If you have bleeding or coagulation 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 of age) after removal of tonsils or adenoids due to obstructive sleep apnoea syndrome.
• If you know you are a rapid metabolizer of codeine 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.

It is important that you use the lowest dose that relieves/controls your pain.

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

Be cautious with Astefor:

• Allergic reactions to ibuprofen have been reported, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Stop using this medicine immediately and contact your doctor or emergency medical services right away if you notice any of these signs.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. The risk is higher when high doses are used, with prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
• If you have Crohn’s disease or ulcerative colitis, as medicines like Astefor may worsen these conditions.
• Inform your doctor if you are simultaneously taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid.

You should also inform your doctor about using other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

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

• Contact your doctor if you experience severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever, as these may be symptoms of inflammation of the pancreas (pancreatitis) or of the biliary system.

Discuss your treatment with your doctor or pharmacist before taking this medicine if:

• You have heart problems, including heart failure, angina (chest pain), a history of heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.
• Serious skin reactions have been reported with Astefor, 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). Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.
• Medicines of this type may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).
• If you are dehydrated, e.g., due to severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately.
• If you are over 65 years of age, as the risk of adverse reactions increases.
• Ibuprofen belongs to a group of medicines that may reduce female fertility. This effect is reversible upon discontinuation of the medicine.
• If you experience eye disturbances, stop taking the medicine and, as a precaution, have an ophthalmological examination.
• If you experience symptoms of aseptic meningitis (inflammation of the meninges not caused by bacteria) after taking the medicine, consult your doctor.
• If you have had kidney or liver disease.
• If you have acute intermittent porphyria (a rare disorder characterized by excessive excretion of porphyrins in urine and faeces).
• If you have chickenpox (a childhood infectious disease), you should not take ibuprofen.
• If you suffer from chronic constipation.
• If you have a disease affecting 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 increasing the dose of the medicine.

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

Special caution is recommended with Astefor.

Infections:

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor without delay.

Skin reactions

Serious skin reactions have been reported with Astefor treatment. Stop taking Astefor and seek immediate medical attention if you develop any skin rash, lesions of mucous membranes, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

Codeine

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for pain relief. Some people have a variation in this enzyme, which may affect individuals differently. In some people, little or no morphine is produced, resulting in inadequate pain relief. In others, a very high amount of morphine may be produced, increasing the risk of serious adverse reactions.

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

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

Tolerance, dependence and addiction This medicine contains codeine, which is an opioid. Repeated use of this medicine may lead to becoming accustomed to it (i.e., needing higher doses). Repeated use of this medicine may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. If you take this medicine for longer than recommended or at higher doses than recommended, you are at risk of serious harm. These serious effects may affect the stomach, intestines, and kidneys, and blood potassium levels may drop to dangerously low levels. These effects can be fatal (see section 4). Dependence or addiction may make you feel that you have lost control over how much medicine you need to take or how often you need to take it. The risk of developing dependence or addiction varies from person to person. Your risk of dependence or addiction to Astefor may be higher if: You or a member of your family has abused or been dependent on alcohol, prescription medicines, or drugs ("addiction"). You smoke. You have had mood-related problems (depression, anxiety, or personality disorders) or a psychiatrist has treated you for other psychiatric disorders. If you notice any of the following signs while taking Astefor, it could indicate that you have developed dependence or addiction: You need to take the medicine for longer than recommended by your doctor. You need to take a higher dose than recommended. You feel you need to keep taking the medicine, even though it does not help relieve your pain. You take the medicine for reasons other than the one for which it was prescribed, for example, to "feel calm" or "help you sleep". You have tried several times to stop taking the medicine or control its use, but without success. You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal effects"). If you notice any of these signs, speak with your doctor to determine the best course of treatment for you, when to stop treatment, and how to do so (see section 3, If you stop taking Astefor).

Sleep-related respiratory disorders

Astefor may cause sleep-related breathing 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 maintaining sleep, or excessive daytime sleepiness.

If you or another person notice these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Use in individuals over 65 years of age

Elderly individuals are often more susceptible to its effects, so the dose may sometimes need to be reduced. Consult your doctor.

Use in athletes

Athletes are advised that this medication contains codeine, which is a narcotic detectable 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 tonsil or adenoid removal 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 symptoms of morphine toxicity may be worse in these children.

Other medicines and Astefor

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

Astefor may affect or be affected by other medicines:

• Anticoagulant medicines (e.g., used to treat or prevent blood clotting problems, such as acetylsalicylic acid, warfarin, ticlopidine),
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan).
• Hydantoins and sulfonamides.
• Lithium (a medicine used for depression).
• Digoxin and cardiac glycosides (used for heart conditions).
• Methotrexate (used in the treatment of cancer and rheumatoid arthritis).
• Pentoxifylline (used for circulatory disorders).
• Phenytoin (used in the treatment of epilepsy).
• Probenecid and sulfinpyrazone (used in patients with gout or together with penicillin in infections).
• Quinolones (used for infections).
• Thiazides (diuretics).
• Sulfonylureas (used to reduce blood glucose levels).
• Cyclosporine, tacrolimus (used to prevent transplant rejection).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV).
• Corticosteroids.
• Antihypertensives.
• Antidepressants.
• Central nervous system depressants.
• This medicine should not be taken with alcohol to avoid stomach damage and the potential enhancement of codeine's depressant effect.
  • Gabapentin or pregabalin for treating epilepsy or pain caused by nerve system injury (neuropathic pain).

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

Interference with diagnostic tests

If you are due to have any diagnostic tests (including blood and urine tests, etc.), inform your doctor that you are being treated with this medicine, as it may alter test results.

Taking Astefor with food, drinks, and alcohol

It is recommended to take this medicine during or immediately after meals. Administration of ibuprofen with food delays its absorption. The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic drinks – beer, wine, liquor, etc. – per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

This medicine must not be taken during the third trimester of pregnancy, as it may harm the fetus or cause complications during childbirth. It may cause kidney and heart problems in your unborn baby. It may also affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond the expected duration.

Because the use of medicines of this type has been associated with an increased risk of congenital abnormalities and miscarriage, you should not take this medicine during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or while trying to conceive, the lowest effective dose for the shortest possible duration should be used.

From week 20 of pregnancy onwards, this medicine may cause kidney problems in the fetus if taken for more than a few days, potentially leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing potential, it should be noted that medicines of the type Astefor have been associated with a reversible reduction in fertility.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Women who are breastfeeding should consult their doctor before taking this medicine, as ibuprofen passes into breast milk.

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

Driving and use of machines

Do not drive or operate tools or machinery, as this medicine contains codeine, which may impair the mental and/or physical abilities required to perform potentially dangerous activities.

If you take only a single dose of Astefor or use it for a short period, special precautions are not usually necessary.

Information about excipients

Astefor contains sodium carmellose and sodium starch glycolate

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

3. How to take Astefor

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

Follow exactly the instructions given by your doctor regarding administration of the medicine. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment, and when and how you should stop it. Do not discontinue treatment prematurely, as you will not achieve the expected effect.

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

This medicine must not be taken for longer than 3 days. If pain does not improve after 3 days, seek advice from your doctor.

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

Adults:

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

Use in children

Children under 12 years of age must not take this medicine due to the risk of serious breathing problems.

Before starting treatment and regularly during treatment, 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 discontinue treatment (see also If you stop taking Astefor).

Instructions for correct administration of the preparation

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

If you take more Astefor than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to find out about the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal bleeding (see also section 4), diarrhea, headache, tinnitus, confusion, and tremulous eye movements. Agitation, drowsiness, disorientation, or coma may also occur.

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

Acute renal failure and liver damage may occur. Asthma may be exacerbated in asthmatic patients. In addition, hypotension and decreased respiration may occur.

If you forget to take Astefor

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

If you stop taking Astefor

There is a risk of possible withdrawal-related effects upon discontinuation of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will 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 less than 1 in 10 patients),
Uncommon (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 (in less than 1 in 10,000 patients).

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

• Reddish, non-elevated, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized rash, high body temperature, and enlarged 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 exanthematous pustulosis).

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

The adverse effects related to ibuprofen content are:

Gastrointestinal disorders

• Frequent: Diarrhea, nausea, vomiting.
• Uncommon: Bleeding, gastric or duodenal ulcer, onset of gastritis.
• Rare: Perforation of the stomach (in some cases fatal) or intestine, especially in elderly patients. Flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, worsening of ulcerative colitis and Crohn's disease.

Blood disorders

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

Psychiatric disorders

• Uncommon: Sleep disturbances and mild restlessness.
• Rare: Mental disturbances and depression.

Nervous system disorders

• Frequent: Headache, fatigue, dizziness, vertigo.
• Uncommon: Insomnia, restlessness.
• Rare: Nervousness, irritability, depression, confusion, reversible decrease in visual acuity, auditory disturbances.
• Very rare: Aseptic meningitis (inflammation of the meninges not caused by bacteria).

Eye disorders

• Uncommon: Blurred vision, decreased visual acuity, or changes in color perception that resolve spontaneously.
• Rare: Visual obscuration.

Ear and labyrinth disorders

• Frequent: Tinnitus (ringing in the ears).
• Uncommon: Hearing disturbances.

Vascular disorders

• Medicines like Astefor may be associated with a moderately increased risk of heart attack ("myocardial infarction") or stroke.
• Frequency not known (cannot be estimated from available data):
• Chest pain, which may 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 treatment using medicines of the type Astefor.

Liver disorders

• Rare: liver disturbances including jaundice (yellowing of the skin). Medications such as Astefor may rarely be associated with liver damage.

• Kidney disorders

• Rare: acute interstitial nephritis with hematuria (blood in urine), proteinuria (excretion of protein 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 beginning of treatment (acute generalized exanthematous pustulosis). Discontinue taking Astefor if you experience these symptoms and seek immediate medical attention. See also section 2.

Skin becomes sensitive to light.

Other disorders:

• Rare: neck stiffness.

General or administration-related reactions:

• Hypersensitivity reactions usually occur in patients with a history of allergy to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. These reactions may also occur in patients who have not previously shown hypersensitivity to these drugs, and include the following symptoms:
• Frequent: skin rashes and itching.
• Uncommon: asthma, rhinitis, urticaria, and allergic reactions.
• Rare: bronchospasm (sudden sensation of suffocation), dyspnea (difficulty breathing), and angioedema (a circulatory reaction affecting the deeper layers of the skin, causing inflammation and swelling).
• Very rare: Medications such as Astefor may very rarely be associated with severe blistering reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Adverse effects that may occur 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 inflammation of the pancreas (pancreatitis) and of the biliary tract system (a problem affecting a valve in the intestines, known as Oddi sphincter dysfunction), e.g., severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever.

Reporting of adverse reactions

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

5. Storage of Astefor

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

No special storage conditions are required.

Store this medicine in a secure place inaccessible to other people. It may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

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

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Astefor:

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

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

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

Appearance of Astefor and contents of the pack:

White, oblong, film-coated tablets with a notch on one side, allowing them to be divided and making them easier to swallow.

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

Manufacturer

Farmasierra Manufacturing S. L.

Carretera de Irún km 26,200

28709, San Sebastián de los Reyes

Madrid

Spain

Date of the most recent revision of this leaflet: November 2024

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