Astefor 400 mg/30 mg granules for oral suspension

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Astefor 400 mg / 30 mg granules for oral suspension

Ibuprofen / Codeine phosphate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you. Keep this leaflet as you may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, as it may harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. 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. Storage of 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 any of the components of this medicine (listed in section 6).
• If you have experienced allergic reactions such as asthma, rhinitis, or urticaria after taking anti-inflammatory drugs, 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 gastrointestinal tract perforation.
• If you are vomiting blood, have black stools, or have bloody diarrhoea.
• If you have bleeding disorders or coagulation problems.
• 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 of age) after tonsil or adenoid removal due to obstructive sleep apnoea syndrome.
• If you are known to metabolize codeine rapidly 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 intended only for adults and children over 12 years of age.

It is important to use the lowest effective dose that relieves or controls your pain.

Be cautious with Astefor:

• Allergic reactions to ibuprofen, such as breathing difficulties, facial or neck swelling (angioedema), and chest pain, have been reported. 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 with high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protecting medicine.

• If you have Crohn’s disease or ulcerative colitis, as medicines like Astefor may worsen these conditions.

• Inform your doctor if you are taking medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention if you are taking other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• Anti-inflammatory/pain 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 pancreatitis or biliary tract system inflammation.

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 artery 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 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) have been reported in association with treatment with Astefor. 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.

• Also, this type of medicine 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 stopping the medicine.

• If you experience eye disturbances, stop taking the medicine and, as a precaution, have an ophthalmological examination.

• If you notice 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 involving 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 section “Infections” below.

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 an 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 this medicine. Stop taking this medicine and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a serious 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, constricted pupils, nausea or vomiting, constipation, or 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 medicine. Repeated use of opioids may reduce the effectiveness of the medicine (the body becomes accustomed to it; this is called tolerance). Repeated use of [product name] may also lead to dependence, abuse and addiction, which in turn may lead to potentially fatal overdose. If you take <product name> for longer than recommended or at higher doses than recommended, your risk of these adverse effects increases and you may also be at risk of serious injuries. These include serious stomach/intestinal and kidney injuries, and very low levels of potassium in the blood. These conditions 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 family member have abused or been dependent on alcohol, prescription medicines or drugs ("addiction"). You smoke. You have had problems related to mood (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 be a sign 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 may feel that 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 start taking 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 you should 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 someone else notices 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 following tonsillectomy or adenoidectomy due to the risk of obstructive sleep apnea syndrome.

Use in children with respiratory problems: The use of codeine is not recommended in children with respiratory disorders, as symptoms of morphine toxicity may be more severe 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. For example:

• Anticoagulant medicines (e.g. for treating or preventing blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine),
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, 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 organ transplant rejection).
• Thrombolytics (medicines that dissolve or break down blood clots).
• Zidovudine (used in the treatment of patients infected with human immunodeficiency virus, the cause of AIDS).
• Corticosteroids.
• Antihypertensives.
• Antidepressants.
• Central nervous system depressants.
• This medicine should not be taken with alcohol, to avoid stomach damage and the possible enhancement of codeine's depressant effect.
  • Gabapentin or pregabalin for treating epilepsy or pain caused by nerve system damage (neuropathic pain).

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

Interference with diagnostic tests

If you are due to have any diagnostic tests (including blood and urine tests), 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 habitually consume alcohol (three or more alcoholic drinks—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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

This medicine should 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 fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond the expected duration.

Because administration of drugs of this type has been associated with an increased risk of congenital abnormalities and miscarriage, you should not take it 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 become pregnant, you should use the lowest dose for the shortest time possible. From week 20 of pregnancy onward, this medicine may cause kidney problems in your fetus if taken for more than a few days, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing 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 age, it should be noted that medicines like 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 hazardous activities.

If you take only a single dose of Astefor or use it for a short period, you may not need to take special precautions.

Information about excipients

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

This medicine contains 30 mg of aspartame per dose unit. Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains 33.54 mg of sodium (main component of table/cooking salt) per dose unit. This corresponds to 1.67% of the maximum daily recommended sodium intake for an adult.

3. How to take Astefor

Follow exactly the instructions for using this medicine as given by your doctor.

This medicine is taken orally. Remember to take your medicine as directed.

Your doctor will tell you how long to take this medicine, and when and how to stop it. Do not stop treatment earlier, as otherwise the expected results will not be achieved.

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

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

The lowest effective dose should be used for the shortest time necessary to relieve symptoms.

If you have an infection, consult a doctor 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 sachet (400 mg ibuprofen / 30 mg codeine) every 4–6 hours, depending on the intensity of pain and response to treatment. In some conditions, 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 ibuprofen / 180 mg codeine).

In adolescents aged 12 years 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 must not take this medicine due to the risk of serious breathing problems.

Children weighing less than 40 kg or under 12 years of age must not take this medicine, as the dose of ibuprofen it contains is not suitable for the recommended dosing in these children.

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 stop treatment (see also If you stop taking Astefor).

Use in elderly patients

If you are over 60 years old, your doctor may prescribe a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine 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 than usual dose. If so, take exactly the dose prescribed by your doctor.

Instructions for 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 experiencing stomach discomfort should take this medicine with milk and/or during meals.

If you take more Astefor than you should

If you have taken more of the medicine than you should have, or if a child has accidentally taken the medicine, always contact a doctor or the nearest hospital for advice on the risks and the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may be bloody), gastrointestinal bleeding (see also section 4), diarrhoea, 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, and breathing problems may occur. 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 reduced breathing may occur.

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

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

In cases of overdose, mild symptoms due to ibuprofen include: abdominal pain, nausea, vomiting, indifference, drowsiness, headache, rapid involuntary eye movements, tinnitus, and lack of muscle coordination. More severe symptoms such as intestinal bleeding, low blood pressure, lowered body temperature, metabolic acidosis, seizures, impaired kidney function, coma, dyspnoea/acute respiratory distress syndrome in adults, and transient respiratory arrest in children (after ingestion of large amounts) are rare.

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

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

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

If you forget to take Astefor

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

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

If you stop taking Astefor

There is a risk of possible withdrawal effects when stopping treatment with this medicine.

If you have any further questions about the use of this medicine, 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 Astefor and seek immediate medical attention if you notice any of the following symptoms:

• Reddish, non-elevated spots, target-shaped or circular rashes 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).
• Widespread, 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 prolonged periods, may cause kidney damage, rendering the kidneys unable to effectively eliminate acids from the blood via urine (renal tubular acidosis). It may also greatly reduce blood potassium levels (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 the ibuprofen content are:

Gastrointestinal disorders

• Frequent: Diarrhea, nausea, vomiting.
• Uncommon: Bleeding, gastric or duodenal ulcer, development of gastritis.
• Rare: Stomach (in some cases fatal) or intestinal perforation, especially in elderly patients. 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 blood platelets (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 darkening.

Ear and labyrinth disorders

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

Vascular disorders

• Medicines such as 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), high blood pressure, and heart failure have also been observed in association with treatment using medicines like Astefor.

Liver disorders

• Rare: Liver abnormalities including jaundice (yellowing of the skin). Medicines 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 affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Astefor if you experience these symptoms and seek immediate medical attention. See also section 2.

The 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 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 deep layers of the skin, causing inflammation and swelling).
• Very rare: Medicines such as Astefor may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The adverse effects related 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 an intestinal valve, known as Oddi sphincter dysfunction), e.g., severe abdominal pain possibly radiating to the back, nausea, vomiting, or fever.

The adverse effects related to the codeine content are: nausea, vomiting, constipation, dizziness, drowsiness, palpitations, itching, and excessive sweating.

Reporting of adverse effects

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

5. Storage of Astefor

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

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

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

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

6. Contents of the pack and other information

Composition of Astefor:

The active substances 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: croscarmellose sodium, anhydrous lactose, sodium saccharin, sodium lauryl sulfate, polyvinylpyrrolidone K30, orange flavour (flavouring substances, corn maltodextrin, alpha-tocopherol (E-307), aspartame (E-951), sodium cyclamate, neo-hesperidin, titanium dioxide, isomalt (E-953), xylitol (E-967).

Appearance of Astefor and contents of the pack:

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

Each pack contains 30 sachets.

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 package leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/