Amoxicillin Almus
Italy
Table of Contents
Package leaflet: information for the patient
AMOXICILLINA ALMUS 1 g tablets
Amoxicillin
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
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What AMOXICILLINA ALMUS is and what it is used for
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What you need to know before taking AMOXICILLINA ALMUS
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How to take AMOXICILLINA ALMUS
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Possible side effects
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How to store AMOXICILLINA ALMUS
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Contents of the pack and other information
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What AMOXICILLINA ALMUS is and what it is used for
AMOXICILLINA ALMUS contains the active substance amoxicillin, which belongs to a group of medicines called penicillins.
AMOXICILLINA ALMUS is an antibiotic used to treat bacterial infections.
AMOXICILLINA ALMUS is indicated for infections caused by bacteria sensitive to amoxicillin:
- acute and chronic respiratory tract infections;
- infections of the ear, nose, throat, larynx and mouth;
- urinary and genital tract infections;
- intestinal and biliary tract infections;
- skin and soft tissue infections;
- infections requiring surgical intervention.
- What you need to know before taking AMOXICILLINA ALMUS
Do not take AMOXICILLINA ALMUS
- if you are allergic to amoxicillin, penicillin, or to any of the other ingredients of this medicine (listed in section 6);
- if you have previously had an allergic reaction to any antibiotic. This includes skin rash or development of swelling of the face or throat;
- if you have or suspect you have infectious mononucleosis.
Do not take AMOXICILLINA ALMUS if any of the above situations apply to you.
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If you are in any doubt, consult your doctor or pharmacist before taking AMOXICILLINA ALMUS.
AMOX is not indicated for the treatment of infections caused by penicillinase-producing microorganisms.
Contraindicated in paediatric age.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMOXICILLINA ALMUS if:
- you have glandular fever (fever, sore throat, swollen glands and extreme tiredness);
- you have kidney problems;
- you do not urinate regularly.
If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking AMOXICILLINA ALMUS.
Blood and urine tests
If you are undergoing:
- urine tests (for glucose) or blood tests for liver function;
- tests for oestriol (used during pregnancy to monitor normal fetal development),
inform your doctor or pharmacist that you are taking AMOXICILLINA ALMUS, as this medicine may alter the results of these tests.
Other medicines and AMOXICILLINA ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:
- allopurinol, used to treat gout, together with Amoxicillina Almus. In this case, there is an increased risk of allergic skin rash;
- probenecid (used to treat gout), your doctor may decide to adjust the dose of Amoxicillina Almus;
- medicines to reduce blood clotting (e.g. warfarin), you may need additional blood tests;
- other antibiotics (e.g. tetracyclines), the effectiveness of Amoxicillina Almus may be reduced;
- if you are taking aminoglycoside antibiotics;
- if you are taking acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs at high doses;
- amoxicillin may reduce the effect of heparin;
- methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion, potentially increasing side effects;
- probenecid (used to treat gout), concomitant use of probenecid may reduce amoxicillin excretion and is not recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
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Pregnancy
You may take AMOXICILLINA ALMUS during pregnancy only if clearly needed and under direct medical supervision.
Driving and using machines
This medicine may cause side effects such as allergic reactions, dizziness or convulsions, which may affect your ability to drive or operate machinery. Do not drive or use machines if you do not feel well.
AMOXICILLINA ALMUS contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
- How to take AMOXICILLINA ALMUS
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is 1 tablet twice daily, every 12 hours.
Your doctor may decide to adjust the dose and duration of treatment depending on the type of infection, body weight, patient condition, and medical judgment.
Use in patients with kidney problems
The dose should be reduced in patients with severe kidney problems. Your doctor will determine the appropriate dose based on your kidney function.
If you take more AMOXICILLINA ALMUS than you should
If you take an excessive amount of Amoxicillina Almus, symptoms such as gastrointestinal disturbances (nausea, vomiting or diarrhoea), presence of crystals in the urine (possibly causing cloudy urine), or difficulty urinating may occur. Contact your doctor as soon as possible, and take the medicine with you so you can show it to them.
If you forget to take AMOXICILLINA ALMUS
- If you miss a dose, take it as soon as you remember.
- Do not take the next dose too soon; wait approximately 4 hours before taking the next dose.
- Do not take a double dose to make up for a missed dose.
How long should you take Amoxicillina Almus?
- Continue taking Amoxicillina Almus for the length of time prescribed by your doctor, even if you feel better. It is important to take all prescribed doses to fully treat the infection, as the infection may return if some bacteria survive.
- If you still do not feel well after completing the treatment, contact your doctor again.
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Prolonged use of Amoxicillina Almus may lead to candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching and white discharge). If this occurs, consult your doctor.
If you take Amoxicillina Almus for a long time, your doctor may carry out additional tests to monitor your kidney, liver and blood function.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Amoxicillin Almus and consult a doctor immediately if you experience any of the following serious side effects, as urgent medical treatment may be required.
The following side effects are very rare (may affect up to 1 in 10,000 people):
- allergic reactions, accompanied by signs such as skin itching or rash, swelling of the face, lips, tongue or body, or breathing difficulties.
These side effects can be serious and, in some cases, have been fatal:
- skin rash or appearance of small, round, flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels caused by an allergic reaction.
It may be associated with joint pain (arthritis) and kidney problems:
- a delayed allergic reaction, usually occurring 7–12 days after taking Amoxicillin Almus, accompanied by signs such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those under the arm;
- a skin reaction known as "erythema multiforme", with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme fatigue;
- other severe skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching and shedding, and may be associated with fever, headache and widespread pain;
- fever, chills, sore throat or other signs of infection, or a tendency to bruise. These may be signs of a blood cell disorder;
- the Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with AMOXICILLIN ALMUS, causing fever, chills, headache, muscle pain and skin rash;
- inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain and fever;
- severe side effects affecting the liver may occur, observed mainly in patients treated for long periods, in men and in elderly people. Inform your doctor urgently if you notice: severe diarrhoea with bleeding or blisters, skin redness or bruising, dark urine, pale stools, or yellowing of the skin or the white part of the eye (jaundice). See also
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the section on anaemia below as a possible cause of jaundice;
- chest pain occurring in the context of allergic reactions, which may be a symptom of heart attack triggered by allergy (Kounis syndrome);
- Drug-Induced Enterocolitis Syndrome (DIES). DIES has been reported mainly in children treated with amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure;
- skin rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease);
- inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
These effects may occur during treatment with the medicine or even several weeks later.
If any of the above-mentioned effects occur, stop taking the medicine and consult a doctor immediately.
Sometimes less severe skin reactions may occur, such as:
- a slightly itchy skin rash (roundish pink-red patches), localized swelling similar to hives on the forearms, legs, palms of the hands, hands or feet. This is an uncommon effect (may affect up to 1 in 100 people).
If any of these side effects occur, consult your doctor, as it will be necessary to stop treatment with Amoxicillin Almus.
Other possible side effects are:
Common (may affect up to 1 in 10 people):
- skin rash
- nausea
- diarrhoea.
Uncommon (may affect up to 1 in 100 people):
- vomiting.
Very rare (may affect up to 1 in 10,000 people):
- candidiasis (vaginal, oral or skin fold infection caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment
- kidney problems
- seizures, observed in patients treated with high doses or who have kidney problems
- dizziness
- hyperactivity
- presence of crystals in the urine leading to acute kidney injury, possibly causing cloudy urine, difficulty urinating or discomfort during urination. Make sure you drink plenty of fluids to reduce the risk of developing these symptoms
- teeth may appear stained, but usually return to their normal appearance with brushing (this effect has been reported in children)
- the tongue may become yellowish, brownish or blackish in colour and have a hairy appearance
- excessive destruction of red blood cells, causing a type of anaemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and the white part of the eye
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- decreased number of white blood cells
- decreased number of cells involved in blood clotting
- prolonged blood clotting time compared to normal. This effect may become apparent with nosebleeds or when sustaining a cut.
Other possible, although rare, side effects: glossitis, stomatitis, altered platelet aggregation,
eosinophilia, vertigo, headache, anorexia, epigastric pain, gastritis, glossitis, stomatitis,
drug-induced enterocolitis syndrome, mixed liver damage, hepatocellular liver damage, altered liver function,
drug rash with eosinophilia and systemic symptoms (DRESS), angioedema, skin rashes (maculopapular rash, erythematous rash, morbilliform rash), superinfections, positive direct Coombs test, prolonged bleeding time, prolonged activated partial thromboplastin time.
Changes in transaminase levels, anaemia, haemolytic anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia, neutropenia, agranulocytosis are usually reversible upon discontinuation of therapy.
In prolonged treatments with high doses, periodic monitoring of blood counts and liver and kidney function is recommended.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store AMOXICILLINA ALMUS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store this medicine at room temperature and in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What AMOXICILLINA ALMUS contains
- The active substance is amoxicillin. Each tablet contains 1.148 g of amoxicillin trihydrate equivalent to 1 g of amoxicillin.
- The other components are: microcrystalline cellulose, caramel cream flavour, magnesium stearate, sodium carboxymethylcellulose, Peg 4000.
Description of the appearance of AMOXICILLINA ALMUS and package contents
Blister pack containing 12 tablets of 1 g.
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Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l., Via Marghera, 29 - 20149 Milan, Italy
(ALMUS logo)
Manufacturer
LA.FA.RE. S.r.l., Via Sacerdote Benedetto Cozzolino, 77, 80056, Ercolano (Naples) - Italy
General recommendation on the use of antibiotics
Antibiotics are used to treat bacterial infections and have no effect against infections caused by viruses.
It may happen that a bacterial infection does not respond to a course of antibiotic therapy. Most often, this is due to the fact that the bacteria causing the infection are resistant to the administered antibiotic and are therefore able to survive and multiply despite treatment.
There are several reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
The prescription of an antibiotic course is intended solely to treat the current illness.
By following the recommendations below, you can help prevent the development of resistant bacteria, which could undermine the effectiveness of antibiotic therapy.
- It is very important that antibiotics are taken at the correct dose, at the right times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine, and, if they are difficult to understand, to ask your doctor or pharmacist for clarification.
- Antibiotics must not be taken if they have not been specifically prescribed for you, and must be used only to treat the infection for which they were prescribed.
- Do not take antibiotics prescribed for other people, even if the infection appears similar.
- Do not give your prescribed antibiotics to other people.
- If, after completing the treatment course as directed by your doctor, you have leftover antibiotic, it should be returned to a pharmacy for proper disposal.
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