Velamox

Package leaflet: Information for the user

Velamox 1 g dispersible tablets

Amoxicillin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Velamox is and what it is used for
2. What you need to know before taking 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 Velamox is and what it is used for

Velamox is an antibiotic whose active substance, amoxicillin, belongs to a group of medicinal substances known as "penicillins".
Velamox is used to treat bacterial infections in various parts of the body, such as:

• upper respiratory tract infections such as tonsillitis, pharyngitis, laryngitis, sinusitis;
• lower respiratory tract infections such as tracheobronchitis, bronchitis, pneumonia, bronchopneumonia, dilation of certain airways (bronchiectasis), inflammation with pus formation localized in the lungs (lung abscesses);
• otomastoiditis (inflammation affecting the middle ear);
• urinary and genital tract infections and sexually transmitted infections;
• intestinal, liver and biliary tract infections, gastrointestinal infection 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 spreading throughout the body (sepsis), post-surgical infections, bacterial skin infections.

2. What you need to know before taking Velamox
Do not take Velamox if:
you are allergic to the active substance 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 medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Velamox if:

• you have previously experienced an allergic reaction to penicillins or cephalosporins, as severe and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported with antibiotics such as Velamox, occurring mostly after parenteral administration (i.e. by routes other than intestinal absorption) and very rarely after oral administration;
• you have a viral infection called mononucleosis, as the use of amoxicillin has been associated with the appearance of a morbilliform skin rash;
• you develop severe and persistent diarrhoea during or after treatment, as this may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhoea may occur with the use of almost all antibiotics, including Velamox, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If you experience diarrhoea, your doctor will carefully monitor you or your child;
• you are taking medicines to reduce blood clot formation (anticoagulants); in this case, your doctor will perform blood tests to monitor your coagulation (see section “Other medicines and Velamox”);
• you have kidney problems (renal impairment); in this case, your doctor may consider it necessary to adjust the dose (see section 3 “How to take Velamox”);
• you suffer from or have previously suffered from seizures or neurological disorders involving the meninges.

Stop treatment with Velamox and inform your doctor if you experience:
symptoms of an allergic reaction, which 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, he/she will recommend periodic blood tests or examinations to monitor liver and kidney function.
If you undergo urine tests (for glucose), inform your doctor or pharmacist that you are taking Velamox, as this medicine may alter test results.
Other medicines and Velamox
Inform 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, due to the possibility of developing allergy also to these antibiotics;
• probenecid (used for the treatment of gout); concomitant use of probenecid may reduce amoxicillin excretion and is not recommended;
• allopurinol (a medicine used to treat gout), as you may have a higher chance of developing an allergic skin reaction;
• aminoglycosides, a class of antibiotics; taking them with Velamox may result in enhanced therapeutic effect;
• medicines to reduce blood clot formation; in this case, you should undergo additional blood tests;
• acetylsalicylic acid, phenylbutazone or other anti-inflammatory medicines at high doses;
• tetracyclines and other bacteriostatic antibiotics, which 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 methotrexate excretion, causing a potential increase in side effects.

Velamox with food and drink
Velamox may be taken with or without food.
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.
Pregnancy
If you are pregnant, take this medicine only under close medical supervision; your doctor will assess whether the potential benefits to you outweigh any possible risks to the unborn child.
Breastfeeding
Velamox may be taken during breastfeeding. Except for the risk of sensitization associated with trace amounts of amoxicillin passing into breast milk, no adverse effects on the newborn are known.
Driving and using machines
Velamox does not affect the ability to drive or use machinery.
Velamox dispersible tablets contain aspartame
This medicine contains 20 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Velamox

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablet by adding it to a glass of water and stirring until completely dissolved, or swallow the tablet whole.

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

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

Dosage recommendations for special indications
Tonsillitis: the daily dose is 50 mg per kilogram of body weight, divided into two doses.
Acute otitis media: your doctor will determine the appropriate dose according to local guidelines.
Early Lyme disease (infection caused by a parasite called tick), isolated erythema migrans (early stage – circular rash with reddish or rosy discoloration): 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.

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

Duration of treatment
Your doctor will determine the duration of treatment based on the progression of your illness.
Continue taking Velamox for at least 48–72 hours after you start feeling better.
In the case of certain infections (caused by beta-haemolytic streptococci), your doctor will instruct you to continue treatment for at least 10 days.

If you take more Velamox than you should
If you or your child accidentally take too much Velamox, contact your doctor immediately or go to the nearest hospital.
Signs of overdose include: nausea, vomiting, and diarrhoea.
Make sure to drink plenty of fluids when taking high doses of amoxicillin, to reduce the risk of forming crystals in the urine.

If you forget to take Velamox
If you miss 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 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 everyone experiences them.
Most of the side effects described below may occur with penicillins, including Velamox.
Stop taking Velamox and consult a doctor immediately if you notice any of the following
serious side effects, as urgent medical treatment may be required.

• Chest pain occurring 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 mainly reported 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, diarrhoea, and low blood pressure.

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

• severe allergic reaction (anaphylactic shock) with characteristic symptoms (see section 2 “Warnings and precautions”) such as: severe and sudden drop in blood pressure (hypotension), rapid or slowed heartbeat, unusual tiredness 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, skin redness especially around the ears, bluish discoloration of the skin, mucous membranes, and nails (cyanosis), excessive sweating, nausea, vomiting, abdominal pain with cramps, diarrhoea;
• severe allergic reaction, accompanied by symptoms such as skin itching or rash, swelling of the face, lips, tongue or body, or breathing difficulties (e.g. angioneurotic oedema, anaphylaxis);
• allergic reaction accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, particularly 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 walls of blood vessels caused by an allergic reaction (hypersensitivity vasculitis). It may be associated with joint pain (arthritis) and kidney problems;
• skin reaction known as erythema multiforme or maculopapular rash, with itchy reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme fatigue;
• severe skin rashes with blisters, peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• other severe skin reactions with blisters, pus-filled pustules, crusts, and swellings under the skin (exfoliative bullous dermatitis, acute generalized exanthematous pustulosis);
• 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);
• inflammation of the colon, the second part of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever (pseudomembranous colitis and haemorrhagic 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 causing it to become red, swollen, and painful (glossitis), acute and painful inflammation of the mucous membranes of the mouth affecting the gums, inside of the cheeks, palate, inner lips, and tongue (stomatitis), diarrhoea, 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 yeast (mucocutaneous candidiasis), antibiotic-associated colitis;
• changes in surface tooth discoloration in children. This effect can usually be removed (or even prevented) by following normal oral hygiene practices;
• excessive destruction of red blood cells and reduced haemoglobin levels (haemolytic anaemia), which may cause fatigue, headache, shortness of breath, dizziness, pallor;
• reduced number of white blood cells (reversible leucopenia, including severe neutropenia or agranulocytosis), low number of blood cells involved in blood clotting (platelets) (reversible thrombocytopenia), red spots due to rupture of capillaries under the skin surface (purpura), increased levels of certain white blood cells (eosinophilia), prolonged blood clotting time compared to normal (prolonged bleeding and prothrombin time);
• hyperactivity (hyperkinesia), dizziness, seizures (observed in patients treated with high doses or with kidney problems);
• moderate increase in certain liver enzymes (AST, ALT);
• inflammation of the kidneys (interstitial nephritis), presence of crystals in the urine (crystalluria), leading to acute kidney injury;
• the tongue may become yellowish, brownish, or blackish in colour and have 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 ring with a central crust or resembling a string of pearls (linear IgA disease);
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

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 the following website:
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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original packaging, stored correctly.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Velamox contains
The active substance is amoxicillin trihydrate. Each dispersible tablet contains amoxicillin trihydrate equivalent to 1 g of amoxicillin.
The other components are: polyclad XL; peppermint flavour; aspartame; magnesium stearate.

Description of the appearance of Velamox and package contents
Velamox is available as 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 Milan

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

Package leaflet: information for the user

Velamox 500 mg hard capsules

Amoxicillin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Velamox is and what it is used for

Velamox is an antibiotic whose active substance, amoxicillin, belongs to a group of medicinal substances known as "penicillins".
Velamox is used to treat bacterial infections in different parts of the body, such as:

• infections of the upper respiratory tract, such as tonsillitis, pharyngitis, laryngitis, and sinusitis;
• infections of the lower respiratory tract, such as tracheobronchitis, bronchitis, pneumonia, bronchopneumonia, dilation of certain airways (bronchiectasis), and localized lung inflammation with pus formation (lung abscesses);
• inflammation of the middle ear (otomastoiditis);
• urinary and genital tract infections, and sexually transmitted infections;
• intestinal infections, liver and biliary tract infections, and gastrointestinal infections caused by bacteria of the genus Salmonella (salmonellosis);
• other infections, including endocarditis (inflammation of the tissue lining the inside of the heart); systemic inflammation due to acute bacterial infection spreading throughout the body (sepsis), post-surgical infections, and bacterial skin infections.

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

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

• you have previously had an allergic reaction to penicillins or cephalosporins, as severe and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported with antibiotics like Velamox, mostly after parenteral administration (i.e. by routes other than intestinal absorption) and very rarely after oral use;
• you have a viral infection called mononucleosis, as the use of amoxicillin has been associated with the appearance of a measles-like skin rash;
• you develop severe and persistent diarrhoea during or after treatment, as this may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhoea can occur with the use of almost all antibiotics, including Velamox, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If you experience diarrhoea, your doctor will closely monitor you or your child;
• you are taking medicines to reduce blood clotting (anticoagulants); in this case, your doctor will perform blood tests to monitor your coagulation (see section “Other medicines and Velamox”);
• you have kidney problems (renal impairment); in this case, your doctor may consider it necessary to adjust the dose (see section 3 “How to take Velamox”);
• you suffer or have suffered from seizures or neurological disorders involving the meninges.

Stop treatment with Velamox and inform your doctor if you experience:
symptoms of an allergic reaction, which 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 course of treatment, you will be advised to undergo periodic blood tests or examinations to monitor liver and kidney function.
If you are undergoing urine tests (for glucose), inform your doctor or pharmacist that you are taking Velamox, as this medicine may alter test results.

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

• penicillin G and cephalosporins, due to the possibility of developing an allergic reaction to these antibiotics;
• probenecid (used to treat 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 have a higher chance of developing an allergic skin reaction;
• aminoglycosides, a class of antibiotics; taking them with Velamox may result in enhanced therapeutic effect;
• medicines to reduce blood clotting; in this case, additional blood tests are required;
• acetylsalicylic acid, phenylbutazone, or other anti-inflammatory medicines at high doses;
• tetracyclines and other bacteriostatic antibiotics; these may interfere with the effect of Velamox;
• oral contraceptives; Velamox may reduce their effectiveness;
• methotrexate (used to treat cancer and severe psoriasis); penicillins may reduce methotrexate excretion, potentially increasing its side effects.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you are pregnant, take this medicine only under strict medical supervision. Your doctor will assess whether the potential benefits to you outweigh any possible risks to the unborn child.

Breastfeeding
Velamox can be taken during breastfeeding. Except for the risk of sensitization due to traces of amoxicillin passing into breast milk, no adverse 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult 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 divided doses (without exceeding 3 g per day), depending on the type of infection. Your doctor will tell you how much, how many times a day, and for how long to administer Velamox to your child.
For children weighing less than 40 kg, an oral suspension powder formulation is also available.
Special dose recommendations
Tonsillitis: the daily dose is 50 mg per kilogram of body weight, divided into two doses.
Acute otitis media: your doctor will determine the appropriate dose based on local guidelines.
Early Lyme disease (infection caused by a parasite called 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 the surgical procedure.
Renal problems
If you or your child have kidney problems or are undergoing dialysis, your doctor will instruct you to take a lower than usual dose and less frequently. Follow your doctor's instructions carefully.
Duration of treatment
Your doctor will determine the duration of treatment depending on the progression of your illness.
Continue taking Velamox for at least 48–72 hours after you start feeling better.
In case of specific infections (caused by beta-hemolytic streptococci), your doctor will instruct you to continue treatment for at least 10 days.
If you take more Velamox than you should
If an excessive dose of Velamox has been accidentally ingested or taken, contact your doctor immediately or go to the nearest hospital. Signs of overdose include: nausea, vomiting, and diarrhea.
Make sure you drink plenty of fluids when receiving high doses of amoxicillin, to reduce the risk of developing crystals in the urine.
If you forget to take Velamox
If you forget a dose, take it as soon as you remember. Do not use a double dose to make up for the forgotten dose.
If you stop taking Velamox
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 everyone gets them.
Most of the side effects described below may occur with penicillins, including Velamox.
Stop taking Velamox and contact a doctor immediately if you experience any of the
following serious side effects, as urgent medical treatment may be required.

• Chest pain in the context of allergic reactions, which may be a symptom of myocardial infarction triggered by allergy (Kounis syndrome)
• Drug-induced enterocolitis syndrome (DIES): DIES has been mainly reported 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). Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

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

• Severe allergic reaction (anaphylactic shock) with characteristic symptoms (see section 2 “Warnings and precautions”) such as: severe and sudden drop in blood pressure (hypotension), rapid or slow heartbeat, unusual tiredness 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, skin redness especially around the ears, bluish discoloration of the skin, mucous membranes, and nails (cyanosis), excessive sweating, nausea, vomiting, abdominal pain with cramps, diarrhoea;
• Severe allergic reaction, accompanied by symptoms such as skin itching or rash, swelling of the face, lips, tongue or body, or breathing difficulties (e.g. angioedema, anaphylaxis);
• Allergic reaction accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those under the arm (serum sickness);
• 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 (hypersensitivity vasculitis). It may be associated with joint pain (arthritis) and kidney problems;
• Skin reaction known as erythema multiforme or maculopapular rash, with itchy reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme fatigue;
• Severe skin eruptions with blisters, skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Other severe skin reactions with blisters, pus-filled pustules, crusts, and swellings under the skin (exfoliative bullous dermatitis, acute generalized exanthematous pustulosis);
• Influenza-like symptoms with skin 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 diarrhoea usually with blood and mucus, stomach pain and/or fever (pseudomembranous colitis and haemorrhagic 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 causing it to become red, swollen and painful (glossitis), acute and painful inflammation of the mucous membranes of the mouth affecting the gums, inner cheeks, palate, inner lips, and tongue (stomatitis), diarrhoea, 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 yeast (mucocutaneous candidiasis), antibiotic-associated colitis;
• Changes in surface tooth discoloration in children. This effect can usually be removed (or even prevented) by following normal oral hygiene practices;
• Excessive destruction of red blood cells and reduction in haemoglobin levels (haemolytic anaemia), which may cause fatigue, headache, shortness of breath, dizziness, pallor;
• Decreased number of white blood cells (reversible leucopenia, including severe neutropenia or agranulocytosis), low number of blood clotting cells (platelets) (reversible thrombocytopenia), red spots due to rupture of capillaries under the skin surface (purpura), increase in certain white blood cells (eosinophilia), prolonged blood clotting time compared to normal (prolonged bleeding and prothrombin time);
• Hyperactivity (hyperkinesia), dizziness, seizures (observed in patients treated with high doses or with kidney problems);
• Moderate increase in certain liver enzymes (AST, ALT);
• Inflammation of the kidneys (interstitial nephritis), presence of crystals in the urine (crystalluria), leading to acute kidney injury;
• The tongue may become yellowish, brownish, or blackish in color and have a hairy appearance.

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

• Pain in the upper abdomen, at stomach level (epigastric pain);
• Inflammation of the stomach (gastritis);
• Skin rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease);
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original intact packaging, stored correctly.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Velamox contains
The active substance is amoxicillin trihydrate. Each hard capsule contains amoxicillin trihydrate
equivalent to 500 mg of amoxicillin.
The other ingredients are: magnesium stearate, erythrosine (E 127), indigo carmine (E 132), titanium
dioxide (E 171), yellow iron oxide (E 172) and gelatin.
Description of the appearance of Velamox and pack contents
Velamox is available as hard capsules in packs containing 12 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via S.G. Cottolengo, 15
20143 Milan
Manufacturer
Mitim S.r.l.
Via Cacciamali, 34/36/38
Brescia

Instructions for the user: package leaflet

Velamox 37.5 mg/ml oral suspension powder

Amoxicillin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could 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:

1. What Velamox is and what it is used for
2. What you need to know before taking Velamox
3. How to take Velamox
4. Possible side effects
5. How to store Velamox
6. Package contents and other information

1. What Velamox is and what it is used for

Velamox is an antibiotic whose active substance, amoxicillin, belongs to a group of medicinal substances known as "penicillins".
Velamox is used to treat bacterial infections in various 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 certain airways (bronchiectasis), localized lung inflammation with pus formation (lung abscesses);
• ear infections (otitis and mastoiditis) affecting the middle ear;
• urinary and genital tract infections and sexually transmitted infections;
• intestinal infections, liver and biliary tract infections, gastrointestinal infections caused by bacteria of the genus Salmonella (salmonellosis);
• other infections, including endocarditis (inflammation affecting the tissue lining the inside of the heart); inflammation resulting from acute bacterial infection spreading 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 substance or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to any other antibiotic in the same family (e.g. other penicillins or cephalosporins);
you have infections caused by bacteria that are not sensitive to this medicine.

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

• you have previously had an allergic reaction to penicillins or cephalosporins, as severe and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported with antibiotics like Velamox, mostly after parenteral administration (i.e. via routes other than intestinal absorption) and very rarely after oral administration;
• you have a viral infection called mononucleosis, as the use of amoxicillin has been associated with the appearance of a morbilliform skin rash;
• you develop severe and persistent diarrhoea during or after treatment, which may be a sign of a serious intestinal inflammation (pseudomembranous colitis). Diarrhoea may occur with the use of almost all antibiotics, including Velamox, and is due to disruption of the normal intestinal bacterial flora, allowing excessive growth of a bacterium called Clostridium difficile. If you experience diarrhoea, your doctor will closely monitor you or your child;
• you are taking medicines to reduce blood clotting (anticoagulants); in this case, your doctor will perform blood tests to monitor your coagulation (see section “Other medicines and Velamox”);
• you have kidney problems (renal impairment); in this 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 seizures or nervous system disorders involving the meninges.

Stop treatment with Velamox and inform your doctor if you experience:
symptoms of an allergic reaction, which may include skin rash or difficulty breathing, possibly accompanied by swelling of the face, lips, tongue and/or throat.

Blood and urine tests
If your doctor has prescribed a prolonged treatment, you will be advised to undergo periodic blood tests and examinations to monitor liver and kidney function.
If you are undergoing urine tests (for glucose), inform your doctor or pharmacist that you are taking Velamox, as this medicine may alter test results.

Paediatric population
In premature infants and during the neonatal period, your doctor will advise periodic blood tests and examinations to monitor liver and kidney function.

Other medicines and Velamox
Inform 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, due to the possibility of developing an allergic reaction to these antibiotics;
• probenecid (used to treat gout); concomitant use of probenecid may reduce amoxicillin excretion and is not recommended;
• allopurinol (a medicine used to treat gout), as you may have a higher risk of developing an allergic skin reaction;
• aminoglycosides, a class of antibiotics; taking them with Velamox may result in enhanced therapeutic effect;
• medicines to reduce blood clotting; in this case, additional blood tests are required;
• high-dose acetylsalicylic acid, phenylbutazone or other anti-inflammatory medicines;
• tetracyclines and other bacteriostatic antibiotics, which may interfere with the effect of Velamox;
• oral contraceptives; Velamox may reduce their effectiveness;
• methotrexate (used to treat cancer and severe psoriasis); penicillins may reduce methotrexate excretion, potentially increasing side effects.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you are pregnant, take this medicine only under strict medical supervision. Your doctor will assess whether the potential benefits to you outweigh any possible risks to the unborn child.

Breastfeeding
Velamox can be taken during breastfeeding. Except for the risk of sensitization associated with trace amounts of amoxicillin passing into breast milk, no adverse effects on the newborn are known.

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

Velamox oral suspension contains the following excipients with known effects:

Sucrose
This medicine contains 0.427 g of sucrose (sugar) per 1 ml and maltodextrin (glucose). This should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
May be harmful to teeth.

Sodium
This medicine contains 0.92 mg of sodium (the main component of table salt) per 1 ml. This corresponds to 0.046% of the maximum daily dietary intake recommended for an adult.

Sodium benzoate
This medicine contains 0.74 mg of sodium benzoate per 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 exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Before administration, prepare the suspension by adding water to the contents of the bottle up to the marked level. Shake well and let it stand for a few minutes. Then, since preparing the suspension results in a reduction of volume, add water again up to the marked level.
Store the prepared 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 according to the child's body weight expressed in kilograms.

Adults, elderly patients, and children weighing 40 kg or more
The suspension is generally not prescribed for adults and children weighing 40 kg or more. Please consult your doctor or pharmacist.

Children weighing less than 40 kg
The daily dose for children is 40–90 mg per kilogram of body weight per day, given in 2–3 divided doses (without exceeding 3 g per day), depending on the severity and type of infection. Your doctor will tell you how much, how many times a day, and for how long to administer Velamox to your child. Velamox should be used in very young infants only when strictly necessary and under direct medical supervision.

Dosage recommendations for specific indications
Tonsillitis: The daily dose is 50 mg per kilogram of body weight, divided into two doses.
Acute otitis media: Your doctor will determine the appropriate dose based on local guidelines.
Early Lyme disease (infection caused by a parasite called a tick), isolated erythema migrans (early stage – circular reddish or pinkish skin rash): The daily dose is 50 mg per kilogram of body weight, divided into three doses, for 14–21 days.
Prevention of heart infections (endocarditis) during surgical procedures: 50 mg of amoxicillin per kilogram of body weight, given as a single dose one hour before surgery.

To determine the correct volume of oral suspension to administer, refer to the following table, which indicates the volume of suspension (in ml) corresponding to the minimum daily dose (40 mg), maximum daily dose (90 mg), and the special dose of 50 mg per kilogram of body weight. The volume can be measured using the provided calibrated dosing cup marked in millilitres (ml).
Each ml of Velamox oral suspension contains 37.5 mg of amoxicillin.

Dose of 80 ml corresponding to 3 g (maximum recommended dose).
Renal problems
If your child has kidney problems or is undergoing dialysis, the doctor will instruct you to
administer a lower total daily dose than usual, with a longer interval between doses.
Follow the doctor's instructions carefully.
Duration of treatment
The doctor will determine the duration of treatment depending on the progression of the illness.
Continue taking Velamox for at least 48–72 hours after you start feeling better.
In case of specific infections (caused by beta-haemolytic streptococci), the doctor will instruct you
to continue treatment for at least 10 days.
If you take more Velamox than you should
In case of accidental ingestion/overdose of Velamox, contact your doctor immediately or go to the nearest hospital.
Signs of overdose include: nausea, vomiting, and diarrhoea.
Make sure you drink plenty of fluids when taking high doses of amoxicillin, to reduce the risk of 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 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 gets them.
Most of the side effects described below may occur with penicillins, including Velamox.
Stop taking Velamox and consult a doctor immediately if you experience any of the
following serious side effects, as urgent medical treatment may be required:

• chest pain occurring in the context of allergic reactions, which may be a symptom of allergic-triggered heart attack (Kounis syndrome);
• drug-induced enterocolitis syndrome (DIES): DIES has been mainly reported 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, diarrhoea, and low blood pressure.

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

• severe allergic reaction (anaphylactic shock) with characteristic symptoms (see section 2 “Warnings and precautions”) such as: severe and sudden drop in blood pressure (hypotension), rapid or slow heartbeat, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, widespread itching especially on the soles of the feet and palms of the hands, hives with or without angioedema, skin redness especially around the ears, bluish discoloration of the skin, mucous membranes, and nails (cyanosis), excessive sweating, nausea, vomiting, abdominal pain with cramps, diarrhoea;
• severe allergic reaction, accompanied by symptoms such as skin itching or rash, swelling of the face, lips, tongue or body, or breathing difficulties (e.g. angioneurotic oedema, anaphylaxis);
• allergic reaction accompanied by symptoms such as skin rash, fever, joint pain, and swollen lymph nodes, particularly those under the arm (serum sickness);
• skin rash or appearance of small, round, flat, reddish spots beneath the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls caused by an allergic reaction (hypersensitivity vasculitis). It may be accompanied by joint pain (arthritis) and kidney problems;
• skin reaction known as erythema multiforme or maculopapular rash, with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of hive-like skin 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;
• severe skin eruptions with blisters, skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• other skin reactions with pus-filled blisters, crusts, and swellings under the skin (bullous exfoliative dermatitis, acute generalized exanthematous pustulosis);
• 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);
• inflammation of the colon, the second part of the large intestine, causing watery diarrhoea usually containing blood and mucus, stomach pain and/or fever (pseudomembranous colitis and haemorrhagic 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 causing it to become red, swollen, and painful (glossitis), acute and painful inflammation of the mucous membranes of the mouth affecting the gums, inner cheeks, palate, inner lips, and tongue (stomatitis), diarrhoea, nausea;
• skin rash.

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

• vomiting;
• urticaria, itching.

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

• vaginal, oral, or skin fold infection caused by yeast (mucocutaneous candidiasis), antibiotic-associated colitis;
• changes in tooth surface colouration in children. This effect can usually be removed (or even prevented) by following normal oral hygiene practices;
• excessive destruction of red blood cells and reduced haemoglobin levels (haemolytic anaemia), which may cause fatigue, headache, shortness of breath, dizziness, pallor;
• reduced number of white blood cells (reversible leucopenia, including severe neutropenia or agranulocytosis), low levels of blood clotting cells (platelets) (reversible thrombocytopenia), red spots due to rupture of capillaries under the skin surface (purpura), increased number of certain white blood cells (eosinophilia), prolonged blood clotting time compared to normal (prolonged bleeding time and prothrombin time);
• hyperactivity (hyperkinesia), dizziness, seizures (observed in patients receiving high doses or with kidney problems);
• mild increase in certain liver enzymes (AST, ALT);
• inflammation of the kidneys (interstitial nephritis), presence of crystals in the urine (crystalluria), leading to acute kidney injury;
• the tongue may develop a yellowish, brownish, or blackish discolouration 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 blistering arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease);
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

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 the website
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 stated on the packaging after
"Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging,
correctly stored.
Once reconstituted, the suspension must be stored in the refrigerator (between 2° and 10° C) and
used within 10 days of reconstitution.
Do not dispose of 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 Velamox contains
The active substance is amoxicillin trihydrate. Each ml of suspension contains 37.5 mg of
amoxicillin.
The other components 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 a powder for oral suspension contained in a 100 ml bottle with a level mark.
Each pack includes a dosing cup with markings at 3 ml, 4 ml, 5 ml, 7 ml, 9 ml, 10 ml, 11 ml, 13 ml and 15 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A.
Via S.G. Cottolengo, 15
20143 Milan, Italy

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