AMOXICILLINA 1 G Coated tablet

Зміст інструкції

1. AMOXICILLINA ALMUS 1 g tablets
   1. Possible side effects
   2. How to store AMOXICILLINA ALMUS
   3. Contents of the pack and other information

AMOXICILLINA ALMUS 1 g tablets

Amoxicillina

Equivalent medicinal product

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is AMOXICILLINA ALMUS and what it is used for
• 2. What you need to know before you take AMOXICILLINA ALMUS
• 3. How to take AMOXICILLINA ALMUS
• 4. Possible side effects
• 5. How to store AMOXICILLINA ALMUS
• 6. Contents of the pack and other information
• 1. What is AMOXICILLINA ALMUS and what it is used forAMOXICILLINA ALMUS contains the active ingredient amoxicillin, which belongs to a group of medicines called penicillins.

AMOXICILLINA ALMUS is an antibiotic used against infections caused by bacteria.
AMOXICILLINA ALMUS is indicated for infections caused by bacteria sensitive to amoxicillin:

• acute and chronic respiratory tract infections;
• ear, nose, throat, larynx and mouth infections;
• urinary tract and genital infections;
• infections of the intestine and biliary tract;
• skin and soft tissue infections;
• infections requiring surgical intervention.
• 2. What you need to know before you take AMOXICILLINA ALMUSDo not take AMOXICILLINA ALMUS
• If you are allergic to amoxicillin, penicillin or 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 also a skin rash or the development of swelling of the face or throat;
• if you have or suspect you have infectious mononucleosis.

Do not take AMOXICILLINA ALMUS if you recognize yourself in any of the situations above.
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If you have any doubts, ask your doctor or pharmacist before taking AMOXICILLINA ALMUS.
AMOX is not indicated for the treatment of infections sustained by microorganisms producing
penicillinases.
Contraindicated in pediatric 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 fatigue)
you have kidney problems
you do not urinate regularly.
If you are unsure whether any of the above points apply to you, ask 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 estriol (used in pregnancy to check the normal development of the fetus) tell 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.
Tell 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 for the treatment of gout), your doctor may decide to adjust the dose of Amoxicillina Almus;
• medicines to reduce blood clotting (e.g. warfarin) you may need to undergo additional blood tests;
• other antibiotics (e.g. tetracyclines) the effectiveness of Amoxicillina Almus may be reduced;
• if you are taking aminoglycoside drugs;
• if you are taking acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs at high doses;
• amoxicillin may decrease the effect of heparin;
• methotrexate (used for the treatment of cancer and severe psoriasis), penicillins can reduce the excretion of methotrexate causing a potential increase in side effects; probenecid (used for the treatment of gout), the concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
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Pregnancy
If you are pregnant you can take AMOXICILLINA ALMUS only if necessary, under the
direct supervision of your doctor.

Driving and using machines
This medicine can cause side effects whose symptoms (such as allergic reactions, dizziness and
convulsions) may interfere with the ability to drive vehicles. Do not drive vehicles and do not 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, that is to say essentially ‘sodium-free’.

• 3. How to take AMOXICILLINA ALMUS

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts ask your doctor or pharmacist.
The recommended dose is 1 tablet 2 times a day, every 12 hours.
The doctor may decide to change the dose and duration of treatment depending on the type of infection, body
weight and the patient's conditions, and at the doctor's discretion

Use in patients with kidney problems
The dose must be reduced in patients with severe kidney problems. The doctor will establish the dose based on
the condition of your kidneys.

If you take more AMOXICILLINA ALMUS than you should
If you take an excessive amount of Amoxicillina Almus, symptoms such as
gastrointestinal disorders (nausea, vomiting or diarrhea) or the presence of crystals in the urine, with possible
clouding of the urine, or problems with urination may appear. Seek medical attention as soon as possible,
bringing the medicine with you to show it.

If you forget to take AMOXICILLINA ALMUS

• If you forget a dose, take it as soon as you remember.
• Do not take the next dose too soon, wait about 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 to take Amoxicillina Almus for the time indicated by your doctor, even if you feel better. To fight the infection it is necessary to take all the prescribed doses. The infection could return if some bacteria survive.
• If, once the treatment is finished, you still do not feel well, see your doctor again.

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The use of Amoxicillina Almus for long periods may lead to the development of candidiasis
(an infection caused by a yeast that affects the moist areas of the body, causing irritation,
itching and whitish discharge). If this happens, see your doctor.
If you take Amoxicillina Almus for long periods, your doctor may subject you to additional tests
to verify that everything is normal at the level of kidneys, liver and blood.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Amoxicillina Almus and consult your doctor immediately if you experience any of the
following serious side effects, as medical treatment may be urgently needed.
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 difficulty breathing.

These effects can be severe and, in some cases, have been fatal:

• skin rash or the appearance of small, pinpoint, round and flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls caused by an allergic reaction.

It may be accompanied by joint pain (arthritis) and kidney problems:

• a delayed allergic reaction may occur, typically 7-12 days after taking Amoxicillina Almus, accompanied by signs such as skin rash, fever, joint pain and swollen lymph nodes, especially those under the arm;
• a skin reaction defined as “erythema multiforme”, with itchy, reddish-purple patches on the skin, especially 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. It may be accompanied by fever and a feeling of extreme fatigue;
• other serious skin reactions may include changes in skin color, the formation of bumps under the skin, the appearance of blisters, pustules, peeling, redness, pain, itching and scaling, 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 problem;
• the Jarisch-Herxheimer reaction, which may occur during the treatment of Lyme disease with AMOXICILLINA ALMUS causing fever, chills, headache, muscle pain and rash;
• inflammation of the large intestine (colon) with diarrhea (sometimes containing blood), pain and fever;
• serious liver effects may occur, observed mainly in subjects treated for long periods, in men and in the elderly. Inform your doctor urgently if you notice the appearance of: severe diarrhea with bleeding or blisters, redness or bruising of the skin or dark urine or pale stools or yellowing of the skin or whites of the eyes (jaundice). See also

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the section on anemia, below, as a possible cause of jaundice;

• chest pain in the context of allergic reactions, which may be a symptom of a 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 certain type of allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the drug). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure;
• rash with blisters arranged in a circle with a central crust or like 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 effects occur, stop taking the medicine and
seek immediate medical attention.
Sometimes less serious skin reactions may occur, such as:

• a slightly itchy rash (pinkish-reddish round patches), localized swelling similar to hives on 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 Amoxicillina Almus.
Other possible side effects are:

Common(may affect up to 1 in 10 people):

• rash
• nausea
• diarrhea.

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 with kidney problems
• dizziness
• hyperactivity
• the presence of crystals in the urine leading to acute kidney damage, with possible clouding of the urine, difficulty urinating or discomfort during urination. Make sure to drink plenty of fluids to reduce the risk of developing these symptoms
• teeth may appear stained, but generally return to their normal appearance with brushing (this effect has been documented in children)
• the tongue may become yellowish, brownish or black and have a hairy appearance
• excessive destruction of red blood cells, responsible for causing a type of anemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness and yellowing of the skin and whites of the eyes

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• reduction in the number of white blood cells
• reduction in the number of cells involved in blood clotting
• increased time required for blood to clot compared to normal. This effect may be noticed in case of nosebleeds or if you get a cut.

Other possible, although rare, side effects: glossitis, stomatitis, alteration of platelet aggregation,
eosinophilia, vertigo, headache, anorexia, epigastric pain, gastritis, glossitis, stomatitis, drug-induced
enterocolitis syndrome, mixed liver damage, hepatocellular damage, alteration of liver function, drug
eruption 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, anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura,
eosinophilia, leukopenia, neutropenia, agranulocytosis are usually reversible with
discontinuation of therapy.
In prolonged treatments, with high doses, periodic checks of blood counts and
liver and kidney function are recommended.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AMOXICILLINA ALMUS contains

• The active ingredient is amoxicillin. Each tablet contains 1.148 g of amoxicillin trihydrate equivalent to 1 g of amoxicillin.
• The other ingredients are: microcrystalline cellulose, crème caramel flavour, magnesium stearate, sodium carboxymethylamide, Peg 4000.

Description of the appearance of AMOXICILLINA ALMUS and contents of the pack
Blisters of 12 tablets of 1 g.
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Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder
Pharmacare S.r.l. Via Marghera, 29 - 20149 Milan, Italy

(logo ALMUS)

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 of the time this is due to the fact that the bacteria responsible for the infection are resistant to the antibiotic administered and are therefore able to survive and proliferate despite treatment.
There are various reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the chances that bacteria develop resistance.
The prescription of a course of antibiotics is intended to treat only the current illness.
By following the advice below, you will help prevent the development of resistant bacteria that could invalidate the effectiveness of antibiotic therapy.

• 1. It is very important that antibiotics are taken at the correct dose, at the correct times and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if difficult to understand, ask for explanations from your doctor or pharmacist.
• 2. Antibiotics should not be taken if they have not been specifically prescribed for you and should be used only to treat the infection for which they have been prescribed.
• 3. You should not take antibiotics prescribed to other people, even if the infection seems similar.
• 4. You should not give antibiotics prescribed to you to other people.
• 5. If, once the treatment cycle has been completed according to the doctor's instructions, there is any unused antibiotic remaining, this must be taken to the pharmacy for correct disposal.

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