Leaflet: information for the user
Amoxicilina Almus 500 mg hard capsules EFG
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
1. What Amoxicilina Almus is and what it is used for
2. What you need to know before you start taking Amoxicilina Almus
3. How to take Amoxicilina Almus
4. Possible side effects
5. Storage of Amoxicilina Almus
6. Contents of the pack and additional information
What is Amoxicilina Almus
Amoxicilina Almus is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called “penicillins”.
Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold. It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash. |
What is Amoxicilina Almus used for
Amoxicilina Almus is used to treat infections caused by bacteria in different parts of the body. Amoxicilina Almus may also be used in combination with other medications to treat stomach ulcers.
Do not take Amoxicilina Almus:
Do not take amoxicillin if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking amoxicillin.
Warnings and precautions
Consult your doctor or pharmacist before taking Amoxicilina Almus if:
If you are unsure whether any of the above situations apply to you, inform your doctor or pharmacist before taking Amoxicilina Almus.
Blood and urine tests
If you are having:
Inform your doctor or pharmacist that you are taking Amoxicilina Almus. This is because this medication may affect the results of these types of tests.
Use of Amoxicilina Almus with other medications
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and operating machinery
Amoxicilina Almus may have adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may make it unsafe to drive.
Do not drive or operate machinery unless you are feeling well.
Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The usual dose is:
Children under 40 kg of weight
All doses are based on the child's body weight in kilograms.
Adults, elderly patients, and children 40 kg of weight or more
The usual dose of Amoxicilina Almus is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.
Renal problems
If you have renal problems, the dose may be lower than the usual dose.
If you take more Amoxicilina Almus than you should
If you have taken more Amoxicilina than you should, the signs may be stomach discomfort (nausea, vomiting, or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show them.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Amoxicilina Almus
How long should you take Amoxicilina Almus
You may develop candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) if you take amoxicilina for a prolonged period. If this happens, consult your doctor.
If you take amoxicilina for a prolonged period, your doctor may perform additional tests to check that your kidneys, liver, and blood are functioning normally.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Amoxicilina Almus and see a doctor immediately if you experience any of the following severe side effects – you may need urgent medical treatment:
The following side effects are very rare (they may affect up to 1 in 10,000 people)
orsevere diarrhea with bleeding
orblisters, redness, or bruises on the skin
ordark urine or pale stools
oryellowing of the skin and the white of the eyes (jaundice). See anemia below, which may cause jaundice.
These may occur during treatment or several weeks after.
If any of the above symptoms appear, stop taking the medicine and see your doctor immediately.
Occasionally, you may experience milder skin reactions such as:
If you experience any of them, talk to your doctor as you will need to interrupt your treatment with Amoxicilina Almus.
Other possible side effects are:
Frequent(they may affect up to 1 in 10 people)
Rare(they may affect up to 1 in 100 people)
Very rare(they may affect up to 1 in 10,000 people)
Chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome).
Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children receiving amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
Crystals in the urine that cause acute kidney injury.
Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist,even if it is a possibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: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.
Do not store at a temperature above 25°C.
Do not use this medication after the expiration date that appears 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, 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 ofAmoxicilina Almus
The active ingredient is amoxicilina.
Each capsule contains amoxicilina trihydrate equivalent to 500 mg amoxicilina.
The other components are:
Capule content: magnesium stearate (E 572).
Capule coating: gelatine, titanium dioxide (E 171), iron oxide red (E 172), quinoline yellow (E 104).
Printing ink: shellac, propylene glycol, iron oxide black (E 172), potassium hydroxide.
Appearance of the product and contents of the package
Amoxicilina Almus 500 mg capsules are brown and yellow capsules with a circular impression “AMOXY 500” in black printing ink both on the body and the cap. Capsule size 0el (approximately 23.2 mm).
The capsules are packaged in Alu-PVC/PVDC and Alu/PVC blisters.
Amoxicilina Almus 500 mg hard capsules are available in packs of 12, 20 and 30 capsules.
Only some pack sizes may be marketed.
Marketing authorization holder and responsible person for manufacturing
Marketing authorization holder
Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email:[email protected]
Responsible person for manufacturing
Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park, Paola, PLA 3000, Malta
This medicinal product is authorized in the Member States of the EEA with the following names:
Spain - Amoxicilina Almus 500 mg hard capsules EFG
France - Amoxicilline Almus Pharma 500 mg gélule
Last review date of this leaflet: January 2023
The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
General advice on the use of antibiotics Antibiotics are used for the treatment of bacterial infections. They are not effective against viral infections. Occasionally, a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the likelihood of bacteria becoming resistant to them. When your doctor prescribes an antibiotic, it is only for your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that may make the antibiotic ineffective:
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Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.