Package leaflet: Information for the user

Amoxicillin Mylan Generics 1 g tablets

amoxicillin
Generic medicine
Read this entire leaflet carefully before using 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 (or your child) only. Do not give it to other people, even if their symptoms appear similar to yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amoxicillin Mylan Generics is and what it is used for
What you need to know before taking Amoxicillin Mylan Generics
How to take Amoxicillin Mylan Generics
Possible side effects
How to store Amoxicillin Mylan Generics
Contents of the pack and other information

1. What Amoxicillin Mylan Generics is and what it is used for

What Amoxicillin Mylan Generics is
Amoxicillin Mylan Generics is an antibiotic. Its active substance, called amoxicillin, belongs to a group of medicines known as "penicillins".
What Amoxicillin Mylan Generics is used for
Amoxicillin Mylan Generics is used to treat bacterial infections in various parts of the body.
Amoxicillin Mylan Generics may also be used in combination with other medicines for the treatment of gastric ulcers.

2. What you need to know before using Amoxicillin Mylan Generics

Do not use Amoxicillin Mylan Generics:

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 skin rash or development of swelling of the face or throat.

Do not use Amoxicillin Mylan Generics if any of the above situations apply to you. If you have any doubts, consult your doctor or pharmacist before using Amoxicillin Mylan Generics.

Warnings and precautions
Talk to your doctor or pharmacist before using Amoxicillin Mylan Generics if:

you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness)
you have kidney problems
you do not urinate regularly
you have a viral infection called “infectious mononucleosis” or other viral infections caused by viruses known as herpes simplex, cytomegalovirus, or HIV (the AIDS virus), as you are very likely to develop a rash with small raised spots and reddish patches (maculopapular eruptions). If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before using Amoxicillin Mylan Generics.

Blood and urine tests
If you are undergoing:

urine tests (for glucose) or blood tests for liver function
tests for estriol (used during pregnancy to monitor normal fetal development), inform your doctor or pharmacist that you are being treated with Amoxicillin Mylan Generics, as this medicine may alter the results of these tests.

Other medicines and Amoxicillin Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking penicillin G and cephalosporins, due to the possibility of developing an allergic reaction also to these antibiotics.
If you are taking allopurinol (a medicine used to treat gout) together with Amoxicillin Mylan Generics, you may have a higher chance of developing an allergic skin reaction.
If you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking aminoglycosides (antibiotics), the effectiveness of Amoxicillin Mylan Generics may be enhanced, and the effectiveness of these antibiotics may also increase if administered simultaneously.
If you are taking medicines to prevent blood clots (e.g. warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g. tetracyclines), the effectiveness of Amoxicillin Mylan Generics may be reduced.
If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, potentially increasing its side effects.
Acetylsalicylic acid, phenylbutazone (anti-inflammatory medicines), and other anti-inflammatory medicines may increase the effectiveness and/or toxic effects of Amoxicillin Mylan Generics.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will evaluate the benefits of treatment with this medicine against the possible risks.

Driving and using machines
Amoxicillin Mylan Generics may cause side effects whose symptoms (such as allergic reactions, dizziness, and seizures) may impair your ability to drive.
Do not drive or operate machinery if you do not feel well.

Amoxicillin Mylan Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to use Amoxicillina Mylan Generics

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the doses at regular intervals throughout the day, at least 4 hours apart.
Amoxicillina Mylan Generics is taken by mouth.
Depending on the severity of the infection, your doctor may increase the dosage of this medicine and determine the most appropriate treatment duration for you or your child.

Recommended dose:
Children weighing less than 40 kg
All doses are calculated according to the child's body weight in kilograms.

Your doctor will tell you how much Amoxicillina Mylan Generics to give your child.
The recommended dose is 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
The maximum dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more
The recommended dose is 250–500 mg three times a day or 750 mg–1 g every 12 hours, depending on the severity and type of infection.

Severe infections: 750 mg to 1 g three times a day.
Urinary tract infections: 3 g twice a day for one day.
Lyme disease (an infection caused by a parasite called a tick):
- Isolated erythema migrans (early stage – circular reddish or rosy skin rash): 4 g per day,
- Systemic manifestations (late stage – more severe symptoms or when the disease spreads to other parts of the body): up to 6 g per day.
Gastric ulcers: 750 mg or 1 g twice a day for 7 days, in combination with other antibiotics and medications for gastric ulcer treatment.
Prevention of heart infections during surgical procedures: The dose will vary depending on the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist, or nurse will provide more detailed information.
The maximum recommended dose is 6 g per day.

Renal impairment and patients undergoing dialysis (blood filtration using machines)
A reduction in the recommended doses may be necessary.

If you use more Amoxicillina Mylan Generics than you should
If you take too much Amoxicillina Mylan Generics, 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 bring the medicine with you.

If you forget to use Amoxicillina Mylan Generics

If you miss a dose, take it as soon as you remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for a forgotten dose.

How long should you use Amoxicillina Mylan Generics

Continue using Amoxicillina Mylan Generics for the length of time prescribed by your doctor, even if you start feeling better. It is essential to take all prescribed doses to fully eliminate the infection. The infection may return if some bacteria survive.
If you still do not feel well after completing the treatment, consult your doctor again. Prolonged use of Amoxicillina Mylan Generics may lead to the development of candidiasis (a yeast infection affecting moist areas of the body, causing irritation, itching, and whitish discharge). If this occurs, consult your doctor. If you are taking Amoxicillina Mylan Generics for a long time, your doctor may carry out additional tests to monitor your kidneys, liver, and blood.

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 everyone will experience them.
Stop using Amoxicillina Mylan Generics and consult a doctor immediately if you notice any of the
following serious side effects, as urgent medical treatment may be required:
The following side effects have a frequency not known (cannot be estimated from the available data):

Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillina Mylan Generics, causing fever, chills, headache, muscle pain, and skin rash.
Chest pain occurring in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (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 recurrent vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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 effects can be severe and, in some cases, fatal.
Allergic reaction such as: sudden drop in blood pressure (hypotension), rapid or slow heartbeat, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, generalized itching especially on the soles of the feet and palms of the hands, hives with or without angioedema (swollen, itchy areas of skin most frequently affecting extremities, external genital organs, and face, particularly around the eyes and lips), skin redness especially around the ears, bluish discoloration of the skin, mucous membranes, and nails (cyanosis), excessive sweating, nausea, vomiting, abdominal cramps, diarrhea.
Skin rash or appearance of small, round, flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of blood vessel walls caused by an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems.
A delayed allergic reaction may occur, usually 7–12 days after taking Amoxicillina Mylan Generics, 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 hive-like swelling, 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 serious skin reactions may include changes in skin color, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching, and flaking, and may be associated with fever, headache, and widespread body aches.
Flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms).
Fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder.
Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis), with symptoms such as severe headache, high temperature, chills, neck stiffness, or sensitivity to bright light.
Inflammation of the large intestine (colon) with diarrhea (sometimes containing blood), abdominal pain, and fever.
Serious 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 diarrhea with bleeding or blisters, skin redness or bruising, dark urine, pale stools, or yellowing of the skin or whites of the eyes (jaundice). See also the entry on anemia below as a possible cause of jaundice. 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 contact your doctor immediately.
Less severe skin reactions may sometimes occur, such as:

A slightly itchy rash (roundish pink-red patches), localized swelling resembling hives on the forearms, legs, palms, 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 treatment with Amoxicillina Mylan Generics may need to be discontinued.
Other possible side effects include:
Common (may affect up to 1 in 10 people)

Skin rash
Nausea
Diarrhea
Hives

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 yeast); your doctor or pharmacist will prescribe appropriate treatment
Kidney problems
Seizures, observed in patients receiving high doses or with existing kidney problems
Dizziness
Hyperactivity
Presence of crystals in the urine (which may lead to acute kidney injury), possibly causing cloudy 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 usually return to normal appearance with brushing (this effect has been documented in children)
The tongue may become yellowish, brownish, or blackish and have a hairy appearance
Excessive destruction of red blood cells, leading to a type of anemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and whites of the eyes
Decreased number of white blood cells
Decreased number of cells involved in blood clotting
Prolonged blood clotting time compared to normal. This may be noticed in cases of nosebleeds or cuts

Not known (frequency cannot be estimated from the available data)

Serum sickness-like reactions (involving signs such as hives or allergic-type skin rashes accompanied by fever, muscle pain, joint pain, and joint inflammation).
Skin rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease).

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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Amoxicillin Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amoxicillina Mylan Generics contains

Each tablet contains as the active substance 750 mg or 1 g of amoxicillin (equivalent to 1.148 g of amoxicillin trihydrate).
The other components are: microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose. See section 2 “Amoxicillina Mylan Generics contains sodium”.

Description of the appearance of Amoxicillina Mylan Generics and package contents
The tablets are packaged in blisters enclosed in a box. Available in packs of 12 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
Mitim S.r.l., Via Cacciamali 34-36-38, Brescia
LA.FA.RE. S.r.l.
Via Sacerdote Benedetto Cozzolino, 77, 80056 – Ercolano (NA), 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 that bacteria will develop resistance.
The prescription of an antibiotic course is intended to treat only the current illness. By following the advice 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 correct 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 should not be taken unless they have been specifically prescribed for you and should be used solely 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 to other people antibiotics that have been prescribed for you.
If, after completing the treatment course as directed by your doctor, there is any unused antibiotic remaining, it should be returned to a pharmacy for proper disposal.

Package leaflet: information for the user

Amoxicillin Mylan Generics 250 mg/5 ml powder for oral suspension

amoxicillin
Generic Medicine
Please read this leaflet carefully before using 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 (or your child) only. Do not give it to others, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amoxicillin Mylan Generics is and what it is used for
What you need to know before using Amoxicillin Mylan Generics
How to use Amoxicillin Mylan Generics
Possible side effects
How to store Amoxicillin Mylan Generics
Contents of the pack and other information

1. What Amoxicillina Mylan Generics is and what it is used for

What Amoxicillina Mylan Generics is
Amoxicillina Mylan Generics is an antibiotic. Its active substance, called amoxicillin,
belongs to a group of medicines known as "penicillins".
What Amoxicillina Mylan Generics is used for
Amoxicillina Mylan Generics is used to treat bacterial infections in various parts of the
body. Amoxicillina Mylan Generics may also be used in combination with other medicines
for the treatment of gastric ulcers.

2. What you need to know before using Amoxicillin Mylan Generics

Do not use Amoxicillin Mylan Generics:

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 skin rash or development of swelling of the face or throat. Do not use Amoxicillin Mylan Generics if any of the above situations apply to you. If you are in doubt, consult your doctor or pharmacist before using Amoxicillin Mylan Generics.

Warnings and precautions
Talk to your doctor or pharmacist before using Amoxicillin Mylan Generics if:

you have glandular fever (fever, sore throat, swollen glands, and extreme tiredness)
you have kidney problems
you do not urinate regularly
you have a viral infection called “infectious mononucleosis” or other viral infections caused by viruses known as herpes simplex, cytomegalovirus, or HIV (the AIDS virus), as you are very likely to develop a rash with small raised spots and reddish patches (maculopapular eruptions).

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before using Amoxicillin Mylan Generics.
Blood and urine tests
If you are undergoing:

urine tests (for glucose) or blood tests for liver function
tests for estriol (used during pregnancy to monitor normal fetal development), inform your doctor or pharmacist that you are being treated with Amoxicillin Mylan Generics, as this medicine may alter the results of these tests.

Other medicines and Amoxicillin Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking penicillin G and cephalosporins, due to the possibility of developing an allergy also to these antibiotics.
If you are taking allopurinol (a medicine used to treat gout), taking it together with Amoxicillin Mylan Generics may increase the likelihood of developing an allergic skin reaction.
If you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking aminoglycosides (antibiotics), the effectiveness of Amoxicillin Mylan Generics may be enhanced, and the effect of these antibiotics may also increase when administered simultaneously.
If you are taking medicines to reduce blood clotting (e.g. warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g. tetracyclines), the effectiveness of Amoxicillin Mylan Generics may be reduced.
If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, potentially increasing its adverse effects.
Acetylsalicylic acid, phenylbutazone (anti-inflammatory medicines), and other anti-inflammatory medicines may increase the effectiveness and/or toxic effects of Amoxicillin Mylan Generics.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will assess the benefits of treatment with this medicine against the possible risks.
Driving and using machines
Amoxicillin Mylan Generics may cause adverse effects whose symptoms (such as allergic reactions, dizziness, and seizures) may interfere with your ability to drive or operate machinery.
Do not drive or operate machinery if you do not feel well.
Amoxicillin Mylan Generics 250 mg/5 ml powder for oral suspension contains sucrose,
benzoic acid sodium salt (E211) and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before using this medicine.
This medicine contains 200 mg of sodium (a main component of table salt) per dose.
This corresponds to 10% of the maximum daily recommended dietary intake for an adult.
This medicine contains 200 mg of sodium benzoate per bottle, equivalent to 2 mg/ml of solution.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to use Amoxicillina Mylan Generics

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Shake the bottle well before taking a dose.
Take the doses at regular intervals throughout the day, spaced at least 4 hours apart. Amoxicillina Mylan Generics is taken orally. Depending on the severity of the infection, your doctor may increase the dosage of this medicine and determine the most appropriate treatment duration for you or your child. The recommended dose is: Children weighing less than 40 kg All doses are calculated according to the child's body weight in kilograms.
Your doctor will tell you how much Amoxicillina Mylan Generics to give your child.
The recommended dose ranges from 40 mg to 90 mg per kilogram of body weight per day, divided into two or three separate doses.
The maximum recommended dose is 100 mg per kilogram of body weight per day. Adults, elderly patients, and children weighing 40 kg or more

This suspension is generally not prescribed for adults and children weighing more than 40 kg. Please consult your doctor or pharmacist.

Renal impairment and dialysis (blood filtration using machines)
A reduction in the recommended dose may be necessary.

Instructions for administration
Add water to the bottle up to the level indicated by the mark on the bottle's neck and shake well; after shaking, if the suspension level is below the mark, add more water until the indicated level is reached.
Before each use, shake the reconstituted suspension well.
Administer the reconstituted suspension to your child using the provided calibrated oral syringe.

If you use more Amoxicillina Mylan Generics than you should
If you take too much Amoxicillina Mylan Generics, symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or the presence of crystals in the urine, possibly causing cloudy urine or difficulty urinating, may occur. Contact your doctor as soon as possible, and bring the medicine with you for identification.

If you forget to use Amoxicillina Mylan Generics

If you forget a dose, take it as soon as you remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for the missed dose.

How long should you use Amoxicillina Mylan Generics

Continue using Amoxicillina Mylan Generics for the length of time prescribed by your doctor, even if you start feeling better. It is important to take all prescribed doses to fully eliminate the infection. The infection may return if some bacteria survive.
If you still do not feel well after completing the treatment, contact your doctor again. Prolonged use of Amoxicillina Mylan Generics 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 are taking Amoxicillina Mylan Generics for a prolonged period, your doctor may perform additional tests to monitor kidney, liver, and blood function.

If you have any questions about the use of 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 using Amoxicillin Mylan Generics 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 have a frequency not known (cannot be estimated from the available data):

Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillin Mylan Generics, causing fever, chills, headache, muscle pain and skin rash.
Chest pain as part of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).
Drug-induced enterocolitis syndrome (DIES): DIES has been mainly reported in children treated with amoxicillin. It is a certain type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

The following side effects are very rare (may affect up to 1 in 10,000 people):

Allergic reactions, accompanied by signs such as itching or skin rash, swelling of the face, lips, tongue or body, or breathing difficulties. These effects can be serious and, in some cases, have been fatal.
Allergic reaction such as: sudden drop in blood pressure (hypotension), rapid or slow heartbeat, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, generalized itching especially on the soles of the feet and palms of the hands, urticaria with or without angioedema (swollen and itchy skin areas, most frequently affecting the extremities, external genital organs and face, particularly around the eyes and lips), skin redness especially around the ears, bluish discoloration of the skin, mucous membranes and nails (cyanosis), excessive sweating, nausea, vomiting, abdominal cramps, diarrhoea.
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 accompanied by joint pain (arthritis) and kidney problems.
A delayed allergic reaction may occur, usually 7-12 days after taking Amoxicillin Mylan Generics, accompanied by signs such as skin rash, fever, joint pain and swollen lymph nodes, particularly those under the arm.
A skin reaction called "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. It may be accompanied by fever and a feeling of extreme fatigue.
Other serious 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 body aches.
Flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms).
Fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder.
Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis) with symptoms such as severe headache, high temperature, chills, neck stiffness or sensitivity to bright light.
Inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), 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 the entry on anaemia below as a possible cause of jaundice. 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 contact your 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, contact your doctor, as it will be necessary
to stop treatment with Amoxicillin Mylan Generics.
Other possible side effects are:
Common (may affect up to 1 in 10 people)

Skin rash
Nausea
Diarrhoea
Urticaria

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 pre-existing kidney problems
Dizziness
Hyperactivity
Presence of crystals in the urine (which may lead 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 documented in children)
The tongue may become yellowish, brownish or blackish in colour and have a hairy appearance
Excessive destruction of red blood cells, leading to 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.
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 become apparent with nosebleeds or when getting a cut

Not known (frequency cannot be estimated from the available data):

Serum sickness-like reactions (involving signs such as urticaria or allergic-type skin rashes accompanied by fever, muscle pain, joint pain and joint inflammation).
Skin rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease).

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 Amoxicillin Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Liquid suspension
Do not store this medicine above 25°C.
Once prepared, the suspension must be used within 7 days.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Amoxicillina Mylan Generics contains

Each dose of the suspension contains 250 mg of amoxicillin as the active substance.
The other components are: precipitated silica (aerosil), sodium carboxymethylcellulose, sodium benzoate, tutti-frutti flavour, sucrose. See section 2 “Amoxicillina Mylan Generics 250 mg/5 ml powder for oral suspension contains sucrose, sodium benzoate (E211) and sodium”.

Description of the appearance of Amoxicillina Mylan Generics and contents of the pack
Bottle with dosing cap. Each carton contains 40 g of powder for the extemporaneous preparation of 100 ml of 5% suspension.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Mitim S.r.l., Via Cacciamali 34-36-38, Brescia
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. The 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 advice below, you can help prevent the development of resistant bacteria, which could render antibiotic therapy ineffective.

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 they are difficult to understand, to ask your doctor or pharmacist for clarification.
Antibiotics should not be taken unless they have been specifically prescribed for you, and should only be used 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 any unused antibiotic left, it should be taken to a pharmacy for proper disposal.

Instructions for reconstitution
Turn the bottle upside down and shake to loosen the powder.
Add water to the bottle up to the level indicated by the mark on the bottle’s groove and shake well; if, after shaking, the suspension level is below the mark, add more water until the indicated level is reached. Turn and shake again.
Shake well before taking each dose.