VELAMOX 500 mg Hard Capsules

Зміст інструкції

1. Velamox 1 g dispersible tablets
   1. What is Velamox and what is it used for
   2. How to take Velamox
   3. Possible side effects
   4. How to store Velamox
   5. Contents of the pack and other information
2. Velamox 500 mg hard capsules
   1. What is Velamox and what is it used for
   2. How to take Velamox
   3. Possible side effects
   4. How to store Velamox
   5. Contents of the pack and other information
3. Velamox 37,5 mg/ml powder for oral suspension
   1. What is Velamox and what is it used for
   2. How to take Velamox
   3. Possible side effects
   4. How to store Velamox
   5. Contents of the pack and other information

Velamox 1 g dispersible tablets

Amoxicillin

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 Velamox is and what it is used for
• 2. What you need to know before you take Velamox
• 3. How to take Velamox
• 4. Possible side effects
• 5. How to store Velamox
• 6. Contents of the pack and other information

1. What is Velamox and what is it used for

Velamox is an antibiotic whose active ingredient, amoxicillin, belongs to a group of
medicinal substances known as “penicillins”.
Velamox is used to treat infections caused by bacteria in different parts of the body, such as:

• infections of the upper respiratory tract such as tonsillitis, pharyngitis, laryngitis, sinusitis;
• infections of the lower respiratory tract such as tracheobronchitis, bronchitis, pneumonia, bronchopneumonia, dilation of some airways (bronchiectasis), inflammation with localized pus production in the lungs (pulmonary abscesses);
• otitis media (ear infections);
• infections of the urinary and genital tract and sexually transmitted infections;
• intestinal infections, of the liver and biliary tract, infection of the digestive tract caused by bacteria of the genus Salmonella (salmonellosis);
• other infections, including endocarditis (inflammation of the tissue lining the inside of the heart); inflammation resulting from an acute bacterial infection that spreads throughout the body (sepsis), infections following surgical procedures, bacterial skin infections.

2. What you need to know before taking Velamox
Do not take Velamox if:
you are allergic to the active ingredient or to any of the other ingredients of this
medicinal product (listed in section 6);
you are allergic to any other antibiotic of the same family (e.g. other penicillins
or cephalosporins);
you have infections caused by bacteria that are not sensitive to this medicinal product.

Warnings and precautions
Talk to your doctor or pharmacist before taking Velamox if:

• you have had an allergic reaction to penicillins or cephalosporins in the past, as serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported with the use of antibiotics such as Velamox, which occur mostly following administration of the medicinal product by parenteral route (i.e. by routes other than intestinal absorption) and very rarely by oral route;
• you suffer from a viral infection called mononucleosis, as the use of amoxicillin has been associated with the appearance of a morbilliform rash;
• you experience severe and persistent diarrhea during or after treatment, this may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhea can occur with the use of almost all antibiotics, including Velamox, and is due to the alteration of the normal bacterial flora of the intestine, which allows the excessive growth of a bacterium called Clostridium difficile. If you experience diarrhea, your doctor will subject you or your child to careful monitoring;
• you are taking medicines to reduce blood clot formation (anticoagulants), in which case your doctor will subject you to blood tests to monitor your coagulation (see section “Other medicines and Velamox”);
• you suffer from kidney problems (renal insufficiency), in which case your doctor may need to adjust the dose (see section 3 “How to take Velamox”);
• you suffer or have suffered from convulsions or diseases of the nervous system involving the meninges.

Stop taking Velamox and tell your doctor if you experience:
symptoms of an allergic reaction that may include skin rash or difficulty in
breathing, even accompanied by swelling of the face, lips, tongue and/or throat.

Blood and urine tests
If your doctor has prescribed a prolonged treatment, they will advise you to undergo periodic
blood tests or tests to monitor liver and kidney function.
If you are undergoing urine tests (for glucose), tell your doctor or pharmacist that
you are taking Velamox, as this medicinal product may alter the test results.

Other medicines and Velamox
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines.
Pay particular attention and tell your doctor if you are taking:

• penicillin G and cephalosporins, due to the possibility of developing an allergy even to these antibiotics;
• probenecid (used for the treatment of gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended;
• allopurinol (a medicine used to treat gout), as you may be more likely to develop an allergic skin reaction;
• aminoglycosides, a category of antibiotics, as taking it with Velamox may determine a potentiated therapeutic effect;
• medicines to reduce blood clot formation, in which case you must undergo additional blood tests;
• acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs at high doses;
• tetracyclines and other bacteriostatic antibiotics, they may interfere with the effect of Velamox;
• oral contraceptives, Velamox may reduce their effectiveness;
• methotrexate (used for the treatment of cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.

Velamox with food and drink
Velamox can be taken with or without food.

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 using this medicine.

Pregnancy
If you are pregnant, take this medicine under strict medical supervision, the
doctor will assess whether the potential benefits for you outweigh the possible risks to the baby.

Breastfeeding
Velamox can be taken during breastfeeding. With the exception of the risk of
sensitization associated with the passage of traces of amoxicillin into breast milk, no
negative effects on the newborn are known.

Driving and operating machinery
Velamox does not impair the ability to drive vehicles or operate machinery.

Velamox dispersible tablets contains aspartame
This medicine contains 20 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful to you if you suffer from phenylketonuria, a
rare genetic disease that causes a build-up of phenylalanine because the body is unable to
dispose of it properly.

3. How to take Velamox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Take the tablet by adding it to a glass of water and stirring until completely dissolved, or by swallowing it whole.

Adults, elderly patients and children weighing 40 kg or more
The recommended dose is 1 g tablet every 8 or 12 hours.

Children weighing less than 40 kg
The usual dose is from 40 mg to 90 mg per kilogram of body weight per day, to be administered in two or three separate doses (not exceeding 3 g per day) depending on the type of
infection. Your doctor will tell you how much, how often a day, and for how long to administer
Velamox to your child.
For children weighing less than 40 kg, a powder for oral suspension formulation is also available.

Recommendations for special doses

Tonsillitis: the daily dose is 50 mg per kilogram of body weight divided into two
administrations.

Acute otitis media: the doctor will establish the correct dose based on local recommendations.

Early Lyme disease(infection caused by a parasite called a tick) isolated erythema migrans
(early stage – circular reddish or rosy skin rash): the daily dose is 50 mg per kilogram of body weight divided into three separate doses, for
14-21 days.

Prevention of heart infections (endocarditis) during surgical procedures: 50 mg
of amoxicillin per kilogram of body weight, administered as a single dose one hour before
surgery.

Kidney problems
If you or your child have kidney problems or are undergoing dialysis, your doctor will tell you to take a lower dose than usual and less frequently.
Follow your doctor's instructions carefully.

Duration of treatment
The doctor will establish the duration of treatment depending on the evolution of your illness.
Continue taking Velamox for at least 48-72 hours from when you start to feel better.
In case of particular infections (caused by beta-hemolytic streptococci), your doctor will indicate
that you continue the treatment for at least 10 days .
If you take more Velamox than you should
In case of accidental ingestion/taking of an excessive dose of Velamox, immediately inform your doctor or go to the nearest hospital.
The signs of overdose are: nausea, vomiting and diarrhea.
Make sure to drink plenty of fluids during the administration of high doses of amoxicillin, to
reduce the risk of developing crystal formation in the urine.

If you forget to take Velamox
If you forget a dose, take it as soon as you remember. Do not take a double dose to
compensate for the missed dose.

If you stop taking Velamox
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.
Most of the side effects described below can occur with penicillins, including Velamox.

Stop taking Velamox and consult your doctor immediately if you experience any of the
following serious side effects, as urgent medical treatment may be needed.

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)
• Drug-induced enterocolitic 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 medicine). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.

The following serious side effects are very rare (may affect up to 1 in

• 10,000):
• severe allergic reaction (anaphylactic shock) with characteristic symptoms (see section 2 “Warnings and precautions”) such as: severe and sudden drop in blood pressure (hypotension), acceleration or slowing of the heartbeat, unusual tiredness or weakness, anxiety, agitation, 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, redness of the skin especially around the ears, bluish discoloration of the skin, mucous membranes and nails (cyanosis), profuse sweating, nausea, vomiting, abdominal cramps, diarrhea;
• severe allergic reaction, accompanied by symptoms such as skin itching or rash, swelling of the face, lips, tongue or body, or difficulty breathing (such as angioedema, anaphylaxis);
• allergic reaction accompanied by symptoms such as skin rash, fever, joint pain and swollen lymph nodes, especially those under the arm (serum sickness);
• skin rash or appearance of small, flat, round, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls due to an allergic reaction (hypersensitivity vasculitis). It may be accompanied by joint pain (arthritis) and kidney problems;
• skin reaction defined as erythema multiforme or maculopapular rash, with itchy, reddish-purple patches on the skin, especially on the palm of the hands or the sole 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 great fatigue;
• severe skin rashes with blisters, detachment of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• other severe skin reactions with blisters, pustules containing pus, crusts and swellings under the skin (bullous exfoliative dermatitis, acute generalized exanthematous pustulosis);
• 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);
• inflammation of the colon, the second part of the large intestine, causing watery diarrhea generally with blood and mucus, stomach pain and/or fever (pseudomembranous colitis and hemorrhagic colitis);
• inflammation of the liver (hepatitis), yellowing of the skin and whites of the eyes (cholestatic jaundice).

Other possible side effects are:
Common (may affect up to 1 in 10 people):

• inflammation of the tongue which makes it red, swollen and painful (glossitis), acute and painful inflammation of the oral mucosa involving the gums, the inside of the cheeks, the palate, the inside of the lips and the tongue (stomatitis), diarrhea, nausea;
• skin rash.

Uncommon (may affect up to 1 in 100 people):

• vomiting;
• hives, itching.

Very rare (may affect up to 1 in 10,000 people):

• infection of the vagina, mouth or skin folds caused by a yeast (mucocutaneous candidiasis), colitis associated with antibiotic use;
• change in the superficial color of the teeth in children. This effect can usually be eliminated (or even prevented) by following normal oral hygiene operations;
• excessive destruction of red blood cells and reduction of hemoglobin levels (hemolytic anemia) which can cause fatigue, headache, shortness of breath, dizziness, paleness;
• reduction in the number of white blood cells (reversible leukopenia, including severe neutropenia or agranulocytosis), low number of cells involved in blood clotting (platelets) (reversible thrombocytopenia), red spots as a result of the rupture of capillaries under the skin surface (purpura), increase in some white blood cells (eosinophilia), increase in the time it takes for blood to clot compared to normal (prolongation of bleeding and prothrombin time);
• hyperactivity (hyperkinesis), dizziness, seizures (observed in patients treated with high doses or with kidney problems);
• moderate increase in some liver enzymes (AST, ALT);
• inflammation of the kidneys (interstitial nephritis), presence of crystals in the urine (crystalluria), leading to acute kidney damage;
• the tongue may take on a yellowish, brownish or black color and a hairy appearance.

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

• pain in the upper abdomen, at the level of the stomach (epigastric pain);
• inflammation of the stomach (gastritis);
• skin 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).

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 Velamox

Keep this medicine out of the 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.
The expiry date refers to the product in intact packaging, correctly
stored.
This medicine does not require any particular storage conditions.
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 Velamox contains
The active ingredient is amoxicillin trihydrate. Each dispersible tablet contains amoxicillin
trihydrate corresponding to 1 g of amoxicillin;
The other ingredients are: polyplasdone XL; peppermint aroma; aspartame; magnesium
stearate.

Description of the appearance of Velamox and contents of the pack
Velamox is available in the form of dispersible tablets in packs of 12 tablets.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via S.G. Cottolengo, 15
20143 Milano

Manufacturer
Mitim S.r.l.
Via Cacciamali, 34/36/38
Brescia

Velamox 500 mg hard capsules

Amoxicillin

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 Velamox is and what it is used for
• 2. What you need to know before you take Velamox
• 3. How to take Velamox
• 4. Possible side effects
• 5. How to store Velamox
• 6. Contents of the pack and other information

1. What is Velamox and what is it used for

Velamox is an antibiotic whose active ingredient, amoxicillin, belongs to a group of
medicinal substances known as “penicillins”.
Velamox is used to treat infections caused by bacteria, in different parts of the body, such as:

• infections of the upper respiratory tract such as tonsillitis, pharyngitis, laryngitis, sinusitis;
• infections of the lower respiratory tract such as tracheobronchitis, bronchitis, pneumonia, bronchopneumonia, dilation of some airways (bronchiectasis), inflammation with localized pus production in the lungs (pulmonary abscesses);
• inflammations of otitis media (affecting the middle ear);
• infections of the urinary and genital tract and sexually transmitted infections;
• intestinal infections, of the liver and biliary tract, infection of the digestive tract caused by bacteria of the genus Salmonella (salmonellosis);
• other infections, including endocarditis (inflammation of the tissue lining the inside of the heart); inflammation, which results from an acute bacterial infection, that spreads throughout the body (sepsis), infections following surgical procedures, bacterial infections of the skin.

2. What you need to know before you take Velamox
Do not take Velamox if:
you are allergic to the active ingredient or to any of the other ingredients of this
medicinal product (listed in section 6);
you are allergic to any other antibiotic of the same family (for example other penicillins
or cephalosporins);
you have infections caused by bacteria that are not sensitive to this medicinal product.

Warnings and precautions
Talk to your doctor or pharmacist before taking Velamox if:

• you have had an allergic reaction to penicillins or cephalosporins in the past, as severe and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported with the use of antibiotics such as Velamox, which occur mostly following administration of the medicinal product by the parenteral route (i.e. by routes other than intestinal absorption) and very rarely by the oral route;
• you have an infection caused by a virus, called mononucleosis, as the use of amoxicillin has been associated with the appearance of a morbilliform rash;
• you experience severe and persistent diarrhea during or after treatment, this may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhea can occur with the use of almost all antibiotics, including Velamox, and is due to the alteration of the normal bacterial flora of the intestine which thus allows the excessive growth of a bacterium called Clostridium difficile. If you experience diarrhea, your doctor will subject you or your child to careful monitoring;
• you are taking medicines to reduce blood clot formation (anticoagulants), in which case your doctor will subject you to blood tests to monitor your coagulation (see section “Other medicines and Velamox”);
• you suffer from kidney problems (renal insufficiency), in which case your doctor may consider it necessary to adjust the dose (see section 3 “How to take Velamox”);
• you suffer from or have suffered from convulsions or diseases of the nervous system involving the meninges.

Stop taking Velamox and tell your doctor if you experience:
symptoms of an allergic reaction that may include skin rash or difficulty breathing, even accompanied by swelling of the face, lips, tongue and/or throat.

Blood and urine tests
If your doctor has prescribed a prolonged treatment, they will advise you to undergo periodic
blood tests or tests to monitor liver and kidney function.
If you are undergoing urine tests (for glucose), tell your doctor or pharmacist that
you are taking Velamox, as this medicinal product may alter the test results.

Other medicines and Velamox
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Pay particular attention and tell your doctor if you are taking:

• penicillin G and cephalosporins, due to the possibility of developing an allergy even towards these antibiotics;
• probenecid (used for the treatment of gout), the concomitant use of probenecid may

reduce the excretion of amoxicillin and is not recommended;

• allopurinol (a medicine used to treat gout), as you may be more likely to develop an allergic skin reaction;
• aminoglycosides, a category of antibiotics, as taking it with Velamox may determine a potentiated therapeutic effect;
• medicines to reduce blood clot formation, in which case you must undergo additional blood tests;
• acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs at high doses;
• tetracyclines and other bacteriostatic antibiotics, they may interfere with the effect of Velamox;
• oral contraceptives, Velamox may reduce their effectiveness;
• methotrexate (used for the treatment of cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.

Velamox with food and drink
Velamox can be taken with or without food.

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 using this medicine.

Pregnancy
If you are pregnant, take this medicine under strict medical supervision, the
doctor will assess whether the potential benefits for you outweigh the possible risks to the baby.

Breastfeeding
Velamox can be taken during breastfeeding. With the exception of the risk of
sensitization associated with the passage of traces of amoxicillin into breast milk, no
negative effects on the newborn are known.

Driving and using machines
Velamox does not impair the ability to drive vehicles or operate machinery.

3. How to take Velamox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults, elderly patients and children weighing 40 kg or more
The recommended dose is 1 capsule of 500 mg every 8 hours.

Children weighing less than 40 kg
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, to be administered in two or three separate doses (not exceeding 3 g per day) depending on the type of
infection. Your doctor will tell you how much, how often a day and for how long to administer
Velamox to your child.
For children weighing less than 40 kg, a powder for oral suspension formulation is also available.

Recommendations for special doses

Tonsillitis: the daily dose is 50 mg per kilogram of body weight divided into two
administrations.

Acute otitis media: the doctor will establish the correct dose based on local recommendations.

Early Lyme disease(infection caused by a parasite called a tick) isolated erythema migrans
(early stage - circular reddish or rosy skin rash): the daily dose is 50 mg per kilogram of body weight divided into three separate doses, for
14-21 days.

Prevention of heart infections (endocarditis) during surgical procedures: 50 mg
of amoxicillin per kilogram of body weight, administered in a single dose one hour before
surgery.

Kidney problems
If you or your child have kidney problems or are undergoing dialysis, your doctor will
advise you to take a lower dose than usual and less frequently.
Follow your doctor's instructions carefully.

Duration of treatment
Your doctor will determine the duration of treatment depending on the course of your illness.
Continue to take Velamox for at least 48-72 hours after you start to feel better.
In case of particular infections (caused by beta-hemolytic streptococci), your doctor will advise
you to continue treatment for at least 10 days.

If you take more Velamox than you should
In case of accidental ingestion/administration of an excessive dose of Velamox, immediately inform
your doctor or go to the nearest hospital. Signs of overdose are:
nausea, vomiting and diarrhea.
Make sure to drink plenty of fluids during the administration of high doses of amoxicillin, to
reduce the risk of developing crystal formation in the urine.

If you forget to take Velamox
If you forget a dose, take it as soon as you remember. Do not take a double dose to
make up for the missed dose.

If you stop taking Velamox
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 everyone will experience them.
Most of the side effects described below can occur with penicillins, including Velamox.

Stop taking Velamox and consult your doctor immediately if you observe any of the
following serious side effects, as urgent medical treatment may be necessary.

• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)
• Drug-induced enterocolitic 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 medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure. The following serious side effects are very rare (may affect up to 1 in
• 10,000):
• severe allergic reaction (anaphylactic shock) with characteristic symptoms (see paragraph 2 “Warnings and precautions”) such as: severe and sudden decrease in blood pressure (hypotension), acceleration or slowing of the heartbeat, unusual fatigue or weakness, anxiety, agitation, 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, redness of the skin especially around the ears, bluish discoloration of the skin, mucous membranes and nails (cyanosis), profuse sweating, nausea, vomiting, abdominal cramps, diarrhea;
• severe allergic reaction, accompanied by symptoms such as, for example, skin itching or rash, swelling of the face, lips, tongue or body, or difficulty breathing (such as angioedema, anaphylaxis);
• allergic reaction accompanied by symptoms such as, for example, skin rash, fever, joint pain and swollen lymph nodes, especially those under the arm (serum sickness);
• skin rash or appearance of small, flat, round spots, reddish in color under the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls due to an allergic reaction (hypersensitivity vasculitis). It may be accompanied by joint pain (arthritis) and kidney problems;
• skin reaction defined as erythema multiforme or maculopapulous, with itchy, reddish-purple patches on the skin, especially on the palm of the hands or the sole 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 great fatigue;
• severe skin rashes with blisters, detachment of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• other severe skin reactions with blisters, pustules containing pus, scabs and swellings under the skin (bullous exfoliative dermatitis, acute generalized exanthematous pustulosis);
• 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);
• inflammation of the colon, the second part of the large intestine, causing watery diarrhea generally with blood and mucus, stomach pain and/or fever (pseudomembranous colitis and hemorrhagic colitis);
• inflammation of the liver (hepatitis), yellowing of the skin and whites of the eyes (cholestatic jaundice).

Other possible side effects are:
Common (may affect up to 1 in 10 people):

• inflammation of the tongue which makes it red, swollen and painful (glossitis), acute and painful inflammation of the oral mucosa involving the gums, the inside of the cheeks, the palate, the inside of the lips and the tongue (stomatitis), diarrhea, nausea;
• skin rash.

Uncommon (may affect up to 1 in 100 people):

• vomiting;
• hives, itching.

Very rare (may affect up to 1 in 10,000 people):

• yeast infection of the vagina, mouth or skin folds (mucocutaneous candidiasis), colitis associated with antibiotic use;
• change in the superficial coloration of teeth in children. Usually this effect can be eliminated (or even prevented) by following normal oral hygiene operations;
• excessive destruction of red blood cells and reduction of hemoglobin levels (hemolytic anemia) which can cause fatigue, headache, shortness of breath, dizziness, pallor;
• reduction in the number of white blood cells (reversible leukopenia, including severe neutropenia or agranulocytosis), low number of cells involved in blood coagulation (platelets) (reversible thrombocytopenia), red spots as a result of the rupture of capillaries under the skin surface (purpura), increase in some white blood cells (eosinophilia), increase in the time required for blood to clot compared to normal (prolongation of bleeding and prothrombin time);
• hyperactivity (hyperkinesis), dizziness, seizures (observed in patients treated with high doses or with kidney problems);
• moderate increase in some liver enzymes (AST, ALT);
• inflammation of the kidneys (interstitial nephritis), presence of crystals in the urine (crystalluria), leading to acute kidney damage;
• the tongue may assume a yellowish, brownish or blackish color and a villous appearance.

Not known (frequency cannot be estimated based on available data):

• pain in the upper part of the abdomen, at the level of the stomach (epigastric pain);
• inflammation of the stomach (gastritis);
• skin 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).

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 Velamox

Keep this medicine out of the 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.
The expiry date refers to the product in intact packaging, correctly
stored.
This medicine does not require any particular storage conditions.
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 Velamox contains
The active ingredient is amoxicillin trihydrate. Each hard capsule contains amoxicillin trihydrate
corresponding to 500 mg of amoxicillin;
The other ingredients are: magnesium stearate, erythrosine (E 127), indigotine (E132), titanium dioxide
(E 171), yellow iron oxide (E 172) and gelatin.

Description of the appearance of Velamox and contents of the pack
Velamox is presented in the form of hard capsules in packs of 12 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via S.G. Cottolengo, 15
20143 Milano

Manufacturer
Mitim S.r.l.
Via Cacciamali, 34/36/38
Brescia

Velamox 37,5 mg/ml powder for oral suspension

Amoxicillin

Read this leaflet carefully before you start 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 Velamox is and what it is used for
• 2. What you need to know before you take Velamox
• 3. How to take Velamox
• 4. Possible side effects
• 5. How to store Velamox
• 6. Contents of the pack and other information

1. What is Velamox and what is it used for

Velamox is an antibiotic whose active ingredient, amoxicillin, belongs to a group of
medicinal substances known as “penicillins”.
Velamox is used to treat infections caused by bacteria, in different parts of the body, such as:

• infections of the upper respiratory tract such as tonsillitis, pharyngitis, laryngitis, sinusitis;
• infections of the lower respiratory tract such as tracheobronchitis, bronchitis, pneumonia, bronchopneumonia, dilation of some airways (bronchiectasis), inflammation with localized pus production in the lungs (pulmonary abscesses);
• otitis media (affecting the middle ear);
• infections of the urinary and genital tract and sexually transmitted infections;
• intestinal infections, of the liver and biliary tract, infection of the digestive tract caused by bacteria of the genus Salmonella (salmonellosis);
• other infections, including endocarditis (inflammation of the tissue lining the inside of the heart); inflammation, which results from an acute bacterial infection, that spreads throughout the body (sepsis), infections following surgical procedures, bacterial infections of the skin.

2. What you need to know before you take Velamox
Do not take Velamox if:
you are allergic to the active ingredient or to any of the other ingredients of this
medicinal product (listed in section 6);
you are allergic to any other antibiotic of the same family (e.g. other penicillins
or cephalosporins);
you have infections caused by bacteria that are not sensitive to this medicinal product.

Warnings and precautions
Talk to your doctor or pharmacist before taking Velamox if:

• you have had an allergic reaction to penicillins or cephalosporins in the past, as serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported with the use of antibiotics such as Velamox, which occur mostly following administration of the medicinal product by the parenteral route (i.e. by routes other than intestinal absorption) and very rarely by oral route;
• you suffer from an infection caused by a virus, called mononucleosis, as the use of amoxicillin has been associated with the appearance of a morbilliform rash;
• you experience severe and persistent diarrhea during or after treatment, this may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhea can occur with the use of almost all antibiotics, including Velamox, and is due to the alteration of the normal bacterial flora of the intestine, which allows the excessive growth of a bacterium called Clostridium difficile. If you experience diarrhea, your doctor will subject you or your child to careful monitoring;
• you are taking medicines to reduce blood clotting (anticoagulants), in which case your doctor may subject you to blood tests to monitor your coagulation (see section “Other medicines and Velamox”);
• you suffer from kidney problems (renal insufficiency), in which case your doctor may need to adjust the dose (see section 3 “How to take Velamox”);
• you suffer from or have suffered from convulsions or diseases of the nervous system involving the meninges.

Stop taking Velamox and tell your doctor if you experience:
symptoms of an allergic reaction that may include skin rash or difficulty in
breathing, even accompanied by swelling of the face, lips, tongue and/or throat.

Blood and urine tests
If your doctor has prescribed a prolonged treatment, he/she will indicate that you undergo periodic
blood tests or tests to monitor the function of the liver and kidneys.
If you undergo urine tests (for glucose), inform your doctor or pharmacist that
you are taking Velamox, as this medicinal product may alter the test results.

Paediatric population
In premature babies and during the neonatal period, the doctor will indicate that blood tests and
tests to monitor the function of the liver and kidneys are carried out.

Other medicines and Velamox
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Pay particular attention and inform your doctor if you are taking:

• penicillin G and cephalosporins, for the possibility of developing an allergy even to these antibiotics;
• probenecid (used for the treatment of gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended;
• allopurinol (a medicine used to treat gout), as you may be more likely to develop an allergic skin reaction;
• aminoglycosides, a category of antibiotics, as taking them with Velamox may determine an enhanced therapeutic effect;
• medicines to reduce blood clotting, in which case you must undergo additional blood tests;
• acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs at high doses;
• tetracyclines and other bacteriostatic antibiotics may interfere with the effect of Velamox;
• oral contraceptives, Velamox may reduce their effectiveness;
• methotrexate (used for the treatment of cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.

Velamox with food and drink
Velamox can be taken with or without food.

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 using this medicine.

Pregnancy
If you are pregnant, take this medicine under strict medical supervision, the
doctor will assess whether the potential benefits for you outweigh the possible risks to the baby.

Breastfeeding
Velamox can be taken during breastfeeding. Except for the risk of
sensitization associated with the passage of traces of amoxicillin into breast milk, no
negative effects on the newborn are known.

Driving and using machines
Velamox does not impair the ability to drive vehicles or operate machinery.

Velamox oral suspension contains the following excipients with known effects:
Sucrose
This medicine contains 0.427 g of sucrose (sugar) in 1 ml and maltodextrin
(glucose). This should be taken into consideration in people affected by diabetes mellitus. If your
doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
It may be harmful to teeth.

Sodium
This medicine contains 0.92 mg of sodium (the main component of table salt) in 1
ml. This is equivalent to 0.046 % of the recommended maximum daily intake with
the diet of an adult.

Sodium benzoate
This medicine contains 0.74 mg of sodium benzoate in 1 ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns
up to 4 weeks of age.

3. How to take Velamox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before administration, prepare the suspension by adding water to the contents of the bottle, up to reaching the level mark. Shake the suspension well and let it rest for a few minutes. Then, since the preparation of the suspension involves a reduction in volume, add water again until reaching the level mark.
Store the resulting suspension in the refrigerator (between 2° and 10° C). Once prepared, the suspension must be used within 10 days.
Shake the bottle vigorously before each administration.
The doses to be administered are calculated based on the child's body weight expressed in kilograms.

Adults, elderly patients and children with a weight equal to or greater than 40 kg
The suspension is generally not prescribed to adults and children with a weight greater than 40 kg. Ask your doctor or pharmacist for advice.

Children with a weight less than 40 kg
The daily dose for children is 40-90 mg per kilogram of body weight per day, to be administered in 2-3 separate doses (not exceeding 3 g per day), depending on the severity and type of infection. The doctor will tell you how much, how many times a day and for how long to administer Velamox to your child. Velamox should be administered in early infancy only when absolutely necessary under the direct control of the doctor.

Recommendations for special doses

Tonsillitis: the daily dose is 50 mg per kilogram of body weight divided into two administrations.

Acute otitis media: the doctor will establish the correct dose based on local recommendations.

Early Lyme disease(infection caused by a parasite called a tick) isolated erythema migrans (early stage - circular reddish or rosy skin rash): the daily dose is 50 mg per kilogram of body weight divided into three separate doses, for 14-21 days.

Prevention of heart infections (endocarditis) during surgical procedures: 50 mg of amoxicillin per kilogram of body weight, administered in a single dose one hour before the surgical procedure.
To identify the correct amount of oral suspension to administer, refer to the following table which shows the volume of suspension (in ml) corresponding to the minimum (40 mg), maximum (90 mg) daily doses and the special dose of 50 mg per kilogram of body weight. The volume can be measured using the enclosed measuring cup calibrated in milliliters (ml).
Each ml of Velamox oral suspension contains 37.5 mg of amoxicillin.

**Dose of 80 ml corresponding to 3 g (maximum recommended dose).

Kidney problems
If your child suffers from kidney problems or is undergoing dialysis, the doctor will advise you to administer a lower total daily dose than usual, observing a wider time interval between doses. Carefully follow the doctor's instructions.

Duration of treatment
The doctor will establish the duration of treatment depending on the evolution of your illness.
Continue to take Velamox for at least 48-72 hours from when you begin to feel better.
In case of particular infections (caused by beta-hemolytic streptococci), the doctor will advise you to continue the treatment for at least 10 days .
If you take more Velamox than you should
In case of accidental ingestion/intake of an excessive dose of Velamox, immediately inform your doctor or go to the nearest hospital. The signs of overdose are: nausea, vomiting and diarrhea.
Make sure to drink plenty of fluids during the administration of high doses of amoxicillin, to reduce the risk of developing crystal formation in the urine.

If you forget to take Velamox
If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop the treatment with Velamox
If you have any doubts 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 everyone will experience them.
Most of the side effects described below can occur with penicillins, including Velamox.

Stop taking Velamox and consult your doctor immediately if you experience any of the following serious side effects, as urgent medical treatment may be necessary:

• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome);
• drug-induced enterocolitic 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 medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

The following serious side effects are very rare (may affect up to 1 in

• 10,000):
• severe allergic reaction (anaphylactic shock) with characteristic symptoms (see section 2 “Warnings and precautions”) such as: severe and sudden drop in blood pressure (hypotension), acceleration or slowing of the heartbeat, unusual fatigue or weakness, anxiety, agitation, 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, redness of the skin especially around the ears, bluish discoloration of the skin, mucous membranes, and nails (cyanosis), profuse sweating, nausea, vomiting, abdominal cramps, diarrhea;
• severe allergic reaction, accompanied by symptoms such as skin itching or rash, swelling of the face, lips, tongue or body, or difficulty breathing (such as angioedema, anaphylaxis);
• allergic reaction accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, especially those under the arm (serum sickness);
• skin rash or the appearance of small, flat, round, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls due to an allergic reaction (hypersensitivity vasculitis). It may be accompanied by joint pain (arthritis) and kidney problems;
• skin reaction defined as erythema multiforme or maculopapular rash, with itchy, reddish-purple patches on the skin, especially on the palm of the hands or the sole 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 great fatigue;
• severe skin rashes with blisters, detachment of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• other skin reactions with blisters containing pus, crusts, and swellings under the skin (bullous exfoliative dermatitis, acute generalized exanthematous pustulosis);
• flu-like symptoms with 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);
• inflammation of the colon, the second part of the large intestine, causing watery diarrhea generally with blood and mucus, stomach pain and/or fever (pseudomembranous colitis and hemorrhagic colitis);
• inflammation of the liver (hepatitis), yellowing of the skin and whites of the eyes (cholestatic jaundice).

Other possible side effects are:
Common (may affect up to 1 in 10 people):

• inflammation of the tongue, making it red, swollen, and painful (glossitis), acute and painful inflammation of the oral mucosa involving the gums, the inside of the cheeks, the palate, the inside of the lips, and the tongue (stomatitis), diarrhea, nausea;
• skin rash.

Uncommon (may affect up to 1 in 100 people):

• vomiting;
• hives, itching.

Very rare (may affect up to 1 in 10,000 people):

• vaginal, oral, or skin fold infection caused by a yeast (mucocutaneous candidiasis), colitis associated with antibiotic use;
• alteration of the superficial coloration of the teeth in children. This effect can usually be eliminated (or even prevented) by following normal oral hygiene operations;
• excessive destruction of red blood cells and reduction of hemoglobin levels (hemolytic anemia) which can cause fatigue, headache, shortness of breath, dizziness, paleness;
• reduction in the number of white blood cells (reversible leukopenia, including severe neutropenia or agranulocytosis), low number of cells involved in blood clotting (platelets) (reversible thrombocytopenia), red spots as a result of the rupture of capillaries under the skin surface (purpura), increase in some white blood cells (eosinophilia), increase in the time it takes for blood to clot compared to normal (prolongation of bleeding and prothrombin time);
• hyperactivity (hyperkinesis), dizziness, seizures (observed in patients treated with high doses or with kidney problems);
• moderate increase in some liver enzymes (AST, ALT);
• inflammation of the kidneys (interstitial nephritis), presence of crystals in the urine (crystalluria), leading to acute kidney damage;
• the tongue may become yellowish, brownish, or black and have a hairy appearance.

Not known (frequency cannot be estimated based on available data):

• pain in the upper abdomen, at the level of the stomach (epigastric pain);
• inflammation of the stomach (gastritis);
• skin 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).

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 Velamox

Keep this medicine out of the 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.
The expiry date refers to the product in intact packaging, correctly
stored.
Once prepared, the suspension must be stored in a refrigerator (between 2° and 10° C) and
used within 10 days of preparation.
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 Velamox contains
The active ingredient is amoxicillin trihydrate. Each ml of suspension contains 37.5 mg of
amoxicillin.
The other ingredients are: anhydrous sodium citrate, anhydrous citric acid, sodium edetate, sodium
benzoate, peach flavour, strawberry flavour, lemon flavour, maltodextrin (contained in the flavours) and
sucrose.

Description of the appearance of Velamox and contents of the pack
Velamox is presented in the form of an oral suspension powder contained in a 100
ml bottle equipped with a level marking.
Each pack is equipped with a measuring cup which provides markings corresponding to 3 ml,
4 ml, 5 ml, 7 ml, 9 ml, 10 ml, 11 ml, 13 ml and 15 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via S.G. Cottolengo, 15
20143 Milano

Manufacturer
Mitim S.r.l.
Via Cacciamali, 34/36/38
Brescia