Velamox - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Amoxicillin

Velamox 1 g dispersible tablets
Velamox 500 mg hard capsules
Velamox 250 mg / 7 ml powder for oral suspension

Why is Velamox used? What is it for?

Pharmacotherapeutic group

Antibiotic.

Therapeutic indications

Infections from germs sensitive to amoxicillin affecting different organs or systems:

  • upper respiratory tract infections (tonsillitis, pharyngitis, laryngitis, sinusitis);
  • lower respiratory tract infections (tracheobronchitis, acute and chronic bronchitis, bronchopneumonia, pneumonia, bronchiectasis, lung abscesses);
  • otomastoid infections;
  • infections of the uro-genital tract and venereological infections;
  • enteric and hepato-biliary infections, salmonellosis;
  • other infections, including endocarditis, sepsis, surgical infections, dermatological infections.

Contraindications When Velamox should not be used

Known hypersensitivity to the active substance, to other beta-lactam antibiotics (e.g. penicillins, cephalosporins) or to any of the excipients.

Infections sustained by penicillinase-producing microorganisms.

Precautions for use What you need to know before taking Velamox

It does not offer particular advantages in infections with penicillin G-sensitive germs, nor is it active on penicillinase-producing staphylococci and therefore poorly sensitive to penicillin G. Before initiating therapy with Velamox, a thorough investigation of previous hypersensitivity reactions to penicillins or to cephalosporins.

Cross-sensitivity between penicillins and cephalosporins has been documented.

Severe and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics.

These reactions have mostly been reported following parenteral use of penicillins, very rarely following oral use.

The onset of such reactions is, however, more frequent in subjects with a history of hypersensitivity to penicillins.

In the event of an allergic reaction, treatment should be discontinued and suitable alternative therapy instituted or, in the presence of severe anaphylactic reactions, immediate treatment with epinephrine and other appropriate emergency measures may be required (treatment with oxygen, steroids for intravenously; make sure that the airways are open, even resorting, when necessary, to intubation).

The administration of Velamox should be avoided if infectious mononucleosis is suspected since, in this condition, the use of amoxicillin has been associated with the onset of morbilliform rash.

Prolonged use of penicillins, as well as other antibiotics, can favor the development of non-sensitive microorganisms and / or fungal infections. In this case, the adoption of adequate therapeutic measures is required.

Although amoxicillin has the low toxicity characteristic of antibiotics of the penicillin group, periodic checks of blood counts and liver and kidney function are recommended in prolonged treatments.

Precautions should be taken for premature babies and during the neonatal period: renal, hepatic and haematological functions should be monitored.

Prolongation of prothrombin time has been reported rarely in patients receiving Velamox. Therefore, in case of concomitant administration of anticoagulants, adequate monitoring of this parameter should be carried out. In patients with renal insufficiency, the dosage should be adjusted according to the degree of renal impairment (see "Dose, method and time of administration").

Velamox tablets contain aspartame and should be used with caution in patients with phenylketonuria. Velamox powder for pediatric suspension is contraindicated in patients with hereditary fructose intolerances, glucose / galactose malabsorption syndrome, sucrose isomaltase deficiency.

Velamox powder for pediatric suspension contains sodium benzoate, a mild irritant to the skin, eyes and mucous membranes, which may increase the risk of jaundice in neonates.

Interactions Which drugs or foods can change the effect of Velamox

Cross allergy with penicillin G and cephalosporins is possible.

Probenecid decreases renal tubular secretion of amoxicillin. The concomitant administration of probenecid and Velamox may result in an increase and prolongation of the blood levels of amoxicillin over time. The concomitant use of allopurinol and amoxicillin can increase the likelihood of allergic skin reactions.

A synergistic therapeutic effect is known between semi-synthetic penicillins and aminoglycosides. Acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs in large doses, administered concomitantly with penicillins, increase their plasma levels and their half-life.

Tetracyclines and other bacteriostatic drugs can interfere with the bactericidal effects of amoxicillin.

In patients being treated with amoxicillin, when testing for the presence of glucose in the urine, it is recommended to resort to enzymatic methods that use glucose oxidase. With chemical methods, due to the high urinary concentrations of amoxicillin, false positive readings can occur.

Like other broad spectrum antibiotics, Velamox can reduce the effectiveness of oral contraceptives and patients should be advised of this.

Warnings It is important to know that:

Pregnancy and breastfeeding

Pregnancy

The safety of this medicine for use in pregnancy has not been established in accurate studies in pregnant women. Amoxicillin can be used in pregnancy if the potential benefits of treatment to the mother outweigh any possible risk to the fetus.

Feeding time

Velamox can be administered during breastfeeding.

Except for the risk of sensitization associated with the excretion of traces of amoxicillin in breast milk, there are no known adverse effects for the newborn.

Effects on ability to drive and use machines

Velamox does not interfere with the ability to drive and use machines.

Dosage and method of use How to use Velamox: Dosage

Adults and children weighing 40 kg or more

1 tablet of 1 g every 12 hours or every 8 hours, or 1 capsule of 500 mg every 8 hours. The tablets can also be taken after dissolving in water.

Children weighing less than 40 kg

The daily dose for children is 40-90 mg / kg / day to be divided into 2-3 administrations * (not exceeding 3 g / day) depending on the indication, the severity of the disease and the susceptibility of the pathogen (see "Special Dose Recommendations" and "Usage Precautions").

* Pharmacokinetic / pharmacodynamic data indicate that three times a day dosing is associated with increased efficacy, therefore twice dosing is only recommended when the daily dose is at the upper end of the above range.

Special dose recommendations

Tonsillitis: 50 mg / kg / day divided into two doses.

Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosing regimens should be indicated by national / local recommendations.

Early Lyme disease (isolated erythema migrans): 50 mg / kg / day in three divided doses, for 14-21 days.

Endocarditis prophylaxis: 50 mg amoxicillin / kg body weight given as a single dose one hour before surgery.

Each ml of Velamox suspension contains 37.5 mg of amoxicillin.

The following table shows the volume of suspension (in ml) corresponding to the minimum and maximum daily doses and the special dose of 50 mg / kg / day. The volume can be measured using the enclosed calibrated measuring cup in milliliters (ml):


Example posology table Weight in kg Dose / day To be divided into 2 or 3 administrations 40 mg / kg / day 50 mg / kg / day 90 mg / kg / day 4 to 5 5 ml 6 ml 11 ml > 5 to 7 6 ml 8 ml 14 ml > 7 to 9 9 ml 11 ml 19 ml > 9 to 12 11 ml 14 ml 25 ml > 12 to 15 14 ml 18 ml 32 ml > 15 to 18 18 ml 22 ml 40 ml > 18 to 22 21 ml 27 ml 48 ml > 22 to 26 26 ml 32 ml 58 ml > 26 to 30 30 ml 37 ml 67 ml > 30 to 35 35 ml 43 ml 78 ml > 35 to 39 40 ml 50 ml 80ml **

** Dose of 80 ml = 3 g (maximum recommended dose)

Senior citizens

As for adults, except in cases of severe renal impairment (see below).

Dosage in renal insufficiency

The dose should be reduced in patients with severe renal insufficiency.

Adults and children over 40 kg

  • Glomerular filtrate 30-10 ml / min: 500 mg (maximum) 2 times a day
  • Glomerular filtrate <10 mL / min: 500 mg (maximum) 1 time per day Peritoneal dialysis patients: 500 mg (maximum) 1 time per day

Children under 40 kg

A reduction in the total daily dose and an increase in the dose interval is recommended in patients with a creatinine clearance below 30 ml / min (see sections 4.4 and 5.2).


Creatinine clearance ml / min Dose Interval between administrations > 30 Usual dose No adjustments are needed 10 -30 Usual dose 12 hours (corresponding to 2/3 of the dose) < 10 Usual dose 24 hours (corresponding to 1/3 of the dose)

Children on hemodialysis: 15 mg / kg (equal to 0.4 ml / kg), once a day.

Before dialysis, an additional dose of 15 mg / kg (equal to 0.4 ml / kg) should be administered. To restore circulating drug levels, another dose of 15 mg / kg (equal to 0.4 ml / kg) should be administered after dialysis.

Amoxicillin can be removed from the circulation by hemodialysis.

Method of administration

Treatment should be continued for 48-72 hours after clinical response.

The duration of treatment must be established in relation to the evolution of the infectious form. It is advisable to treat any infection caused by beta-haemolytic streptococci for at least 10 days, to eradicate the infectious agent and, therefore, prevent the onset of rheumatic fever acute or glomerulonephritis.

Dispersible tablets.

The tablets can be taken in the following ways:

  • Direct swallowing of tablets
  • Swallowing of the suspension obtained by first dispersing the tablets in water

Pediatric discontinuation

Before administration, prepare the suspension by adding water to the contents of the bottle up to the level mark. Shake well and leave to rest for a few minutes. Therefore, since the preparation of the suspension involves a reduction in volume, bring it back to volume by further addition of water up to the level mark.

The suspension thus obtained must be stored in the refrigerator (between 2 ° and 10 ° C) and used within 10 days of preparation.

The bottle should be shaken vigorously before each administration.

Instructions for Use

See Dose, method and time of administration.

Overdose What to do if you have taken too much Velamox

Gastrointestinal effects such as nausea, vomiting and diarrhea may occur and symptoms of disturbed water and electrolyte balance should be treated symptomatically.

When administering high doses of amoxicillin, adequate water supply should be ensured and sufficient urine volume should be ensured to minimize the possibility of amoxicillin crystalluria.

Amoxicillin can be removed from the circulation by hemodialysis.

Side Effects What are the side effects of Velamox

The following convention has been used to classify undesirable effects: very common (> 1/10), common (> 1/100, 1 / 1,000, 1 / 10,000, <1 / 1,000), very rare (<1 / 10,000) .

Most of the undesirable effects described below are not only characteristic of amoxicillin but can also occur with other penicillins.

The frequency of undesirable effects, unless otherwise specified, derives from more than 30 years of post-marketing family surveillance studies.

Haematological and lymphatic system disorders

Very rare: reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anemia, purpura, eosinophilia.

Prolonged bleeding time and prothrombin time have been reported (see Precautions for use).

Disorders of the immune system

Very rare: As with other antibiotics, severe allergic reactions have been reported such as: angioneurotic edema, anaphylaxis (see Precautions for use), serum sickness, hypersensitivity vasculitis

In the event of a hypersensitivity reaction, treatment should be discontinued (see also dermatological and subcutaneous tissue disorders).

Disorders of the nervous system

Very rare: hyperkinesia, dizziness and convulsions. Seizures can occur in patients with impaired renal function or in patients treated with high doses of the drug.

Gastrointestinal disorders

Data from clinical studies.

Common: glossitis, stomatitis, diarrhea and nausea.

Uncommon: vomiting.

Post-marketing data

Very rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis).

Change in the superficial coloring of the teeth in children. Usually this effect can be eliminated (or even prevented) with normal oral hygiene operations.

Hepato-biliary disorders

Very rare: hepatitis and cholestatic jaundice. A moderate increase in transaminase levels (AST and / or ALT).

The increase in AST and / or ALT is of uncertain significance.

Dermatological and subcutaneous tissue disorders

Data from clinical studies

Common: skin rash

Uncommon: hives and itching.

Post-marketing data

Very rare: allergic reactions, erythema multiforme and maculopapular, Stevens Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalized exanthematous pustulosis.

In the event of any hypersensitivity reaction, treatment should be discontinued (see also immune system disorders).

Kidney and urinary tract disorders

Very rare: interstitial nephritis, crystalluria.

The incidence of these side effects is derived from clinical trials involving a total of approximately 6,000 adult and pediatric patients administered amoxicillin.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.

Expiry and Retention

Special precautions for storage

Velamox 1 g dispersible tablets and Velamox 500 mg hard capsules: none, under normal storage conditions.

Velamox 250 mg / 7 ml powder for oral suspension: the oral suspension obtained must be stored in the refrigerator (between 2 ° and 10 ° C) and used within 10 days of preparation.

Expiry: see the expiry date printed on the package.

The expiry date indicated refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after the expiry date shown on the package. Keep this medicine out of the reach of children.

Composition and pharmaceutical form

Composition

Velamox 1 g dispersible tablets

Each dispersible tablet contains:

Active ingredient: amoxicillin trihydrate corresponding to amoxicillin 1 g.

Excipients: polyplasdon XL; peppermint flavoring; aspartame; magnesium stearate.

Velamox 500 mg hard capsules

Each hard capsule contains:

Active ingredient: amoxicillin trihydrate corresponding to amoxicillin 500 mg.

Excipients: magnesium stearate; erythrosine (E 127); indigo carmine (E132); titanium dioxide (E 171); yellow iron oxide (E 172); jelly.

Velamox 250 mg / 7 ml powder for oral suspension

100 g of powder for oral suspension contains:

Active ingredient: amoxicillin trihydrate corresponding to amoxicillin 7.62 g.

Excipients: anhydrous sodium citrate; anhydrous citric acid; sodium edetate; sodium benzoate; peach aroma; strawberry flavor; lemon flavor; sucrose.

Pharmaceutical forms and content

Dispersible tablets, hard capsules and powder for oral suspension for pediatric use.

Velamox 1 g dispersible tablets - 12 tablets.

Velamox 500 mg hard capsules - 12 hard capsules.

Velamox 250 mg / 7 ml powder for oral suspension - 1 bottle of 100 ml with measuring cup with notches at volumes 3 ml, 4 ml, 5 ml, 7 ml, 9 ml, 10 ml, 11 ml, 13 ml, 15 ml .

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Velamox can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VELAMOX

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

VELAMOX 1 g dispersible tablets

Each tablet contains:

Active principle:

amoxicillin trihydrate corresponding to amoxicillin 1 g.

VELAMOX 500 mg hard capsules

Each hard capsule contains:

Active principle:

amoxicillin trihydrate corresponding to amoxicillin 500 mg.

VELAMOX 250 mg / 7 ml powder for oral suspension

100 g of powder for oral suspension contains:

Active principle:

amoxicillin trihydrate corresponding to amoxicillin 7.62 g.

For excipients see 6.1.

03.0 PHARMACEUTICAL FORM

Tablets, hard capsules and powder for oral suspension for pediatric use.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Infections from germs sensitive to amoxicillin affecting different organs or systems:

- upper respiratory tract infections (tonsillitis, pharyngitis, laryngitis, sinusitis);

- infections of the lower respiratory tract (tracheobronchitis, acute and chronic bronchitis, bronchopneumonia, pneumonia, bronchiectasis, lung abscesses);

- otomastoid infections;

- infections of the uro-genital system and venereological infections;

- enteric and hepato-biliary infections, salmonellosis;

- other infections, including endocarditis, sepsis, surgical infections, dermatological infections.

04.2 Posology and method of administration

Adults and children weighing 40 kg or more

1 tablet of 1 g every 12 hours or every 8 hours, or 1 capsule of 500 mg every 8 hours.

The tablets can also be taken after dissolving in water.

Children weighing less than 40 kg

The daily dose for children is 40-90 mg / kg / day to be divided into 2-3

doses * (not exceeding 3 g / day) depending on indication, disease severity and pathogen susceptibility (see "Special dose recommendations" and sections 4.4, 5.1 and 5.2).

* Pharmacokinetic / pharmacodynamic data indicate that three times daily dosing is associated with increased efficacy, therefore twice daily dosing is only recommended when the daily dose is at the upper end of the above range.

Special dose recommendations

Tonsillitis: 50 mg / kg / day divided into two doses.

Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dose regimens should be indicated by national / local recommendations.

Early Lyme disease (isolated erythema migrans): 50 mg / kg / day in three divided doses, for 14-21 days.

Endocarditis prophylaxis: 50 mg amoxicillin / kg body weight given as a single dose one hour before surgery.

Each ml of Velamox suspension contains 37.5 mg of amoxicillin. The following table shows the volume of suspension (in ml) corresponding to the minimum and maximum daily doses and the special dose of 50 mg / kg / day. The volume can be measured using the enclosed calibrated measuring cup in milliliters (ml):


Example posology table Weight in kg Dose / day To be divided into 2 or 3 administrations 40 mg / kg / day 50 mg / kg / day 90 mg / kg / day 4 to 5 5 ml 6 ml 11 ml > 5 to 7 6 ml 8 ml 14 ml > 7 to 9 9 ml 11 ml 19 ml > 9 to 12 11 ml 14 ml 25 ml > 12 to 15 14 ml 18 ml 32 ml > 15 to 18 18 ml 22 ml 40 ml > 18 to 22 21 ml 27 ml 48 ml > 22 to 26 26 ml 32 ml 58 ml > 26 to 30 30 ml 37 ml 67 ml > 30 to 35 35 ml 43 ml 78 ml > 35 to 39 40 ml 50 ml 80ml **

** Dose of 80 ml = 3 g (maximum recommended dose)

Senior citizens

As for adults, except in cases of severe renal impairment (see below).

Dosage in renal insufficiency

The dose should be reduced in patients with severe renal insufficiency.

Adults and children over 40 kg

• Glomerular filtrate 30-10 ml / min: 500 mg (maximum) 2 times a day.

• Glomerular filtrate

Peritoneal dialysis patients: 500 mg (maximum) once daily.

Children under 40 kg

In patients with creatinine clearance below 30 ml / min, an increase in the interval between dosing and a reduction in the total daily dose is recommended (see sections 4.4 and 5.2).


Creatinine clearance ml / min Dose Interval between administrations > 30 Usual dose No adjustments are needed 10 -30 Usual dose 12 hours (corresponding to 2/3 of the dose) Usual dose 24 hours (corresponding to 1/3 of the dose)

Children on hemodialysis: 15 mg / kg (equivalent to 0.4 ml / kg) once a day.

Before dialysis, an additional dose of 15 mg / kg (equal to 0.4 ml / kg) should be administered. To restore circulating drug levels, another dose of 15 mg / kg (equal to 0.4 ml / kg) should be administered after dialysis.

Amoxicillin can be removed from the circulation by hemodialysis.

Method of administration

Treatment should be continued for 48-72 hours after clinical response.

It is recommended that any infection caused by beta-haemolytic streptococci be treated for at least 10 days to eradicate the infectious agent and thereby prevent the onset of acute rheumatic fever or glomerulonephritis.

Oral administration

Absorption of amoxicillin is not significantly affected when the drug is taken with food.

Pediatric oral suspension

Before administration, prepare the suspension by adding water to the contents of the bottle up to the level mark. Shake well and leave to rest for a few minutes. Therefore, since the preparation of the suspension involves a reduction in volume, bring it back to volume by further addition of water up to the level mark.

The suspension thus obtained must be stored in the refrigerator (between 2 ° and 10 ° C) and used within 10 days of preparation.

The bottle should be shaken vigorously before each administration.

In very early childhood, the product should be administered in cases of real need under the direct supervision of the doctor.

04.3 Contraindications

Known hypersensitivity to the active substance, to other beta-lactam antibiotics (e.g. penicillins, cephalosporins) or to any of the excipients. Infections sustained by penicillinase-producing microorganisms.

04.4 Special warnings and appropriate precautions for use

It does not offer particular advantages in infections by germs sensitive to penicillin G, nor is it active on penicillinase-producing staphylococci and therefore scarcely sensitive to penicillin G.

Before initiating therapy with VELAMOX, a thorough investigation of previous hypersensitivity reactions to penicillins or cephalosporins should be conducted.

Cross-sensitivity between penicillins and cephalosporins has been documented.

Severe and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics.

These reactions have mostly been reported following parenteral use of penicillins, very rarely following oral use.

The onset of such reactions is, however, more frequent in subjects with a history of hypersensitivity to penicillins.

In the event of an allergic reaction, treatment should be discontinued and suitable alternative therapy instituted or, in the presence of severe anaphylactic reactions, immediate treatment with epinephrine and other appropriate emergency measures may be required (treatment with oxygen, steroids for intravenously; make sure that the airways are open, even resorting, when necessary, to intubation).

The administration of VELAMOX should be avoided if infectious mononucleosis is suspected since, in this condition, the use of amoxicillin has been associated with the onset of morbilliform rash.

Precautions should be taken for premature babies and during the neonatal period: renal, hepatic and haematological functions should be monitored.

Prolonged use of penicillins, as well as other antibiotics, can favor the development of non-sensitive microorganisms and / or fungal infections. In this case, the adoption of adequate therapeutic measures is required.

Although amoxicillin has the low toxicity characteristic of antibiotics of the penicillin group, periodic checks of blood counts and liver and kidney function are recommended in prolonged treatments.

Prolongation of prothrombin time has been reported rarely in patients receiving VELAMOX. Therefore, in case of concomitant administration of anticoagulants, adequate monitoring of this parameter should be carried out.

In patients with renal insufficiency, the posology should be adjusted according to the degree of renal impairment (see Section 4.2).

VELAMOX tablets contain aspartame and should be used with caution in patients with phenylketonuria.

VELAMOX powder for oral suspension for pediatric use is contraindicated in patients with hereditary fructose intolerances, glucose / galactose malabsorption syndrome, sucrose isomaltase deficiency.

VELAMOX powder for oral suspension for pediatric use contains sodium benzoate, which is mildly irritating to the skin, eyes and mucous membranes, which may increase the risk of jaundice in neonates.

Keep this medicine out of the reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

Cross allergy with penicillin G and cephalosporins is possible.

Probenecid decreases renal tubular secretion of amoxicillin. The concomitant administration of probenecid and VELAMOX may result in an increase and prolongation of the blood levels of amoxicillin over time.

The concomitant use of allopurinol and amoxicillin can increase the likelihood of allergic skin reactions.

A synergistic therapeutic effect is known between semi-synthetic penicillins and aminoglycosides.

Acetylsalicylic acid, phenylbutazone or other anti-inflammatory drugs in large doses, administered concomitantly with penicillins, increase their plasma levels and their half-life.

Tetracyclines and other bacteriostatic drugs can interfere with the bactericidal effects of amoxicillin.

In patients being treated with amoxicillin, when testing for the presence of glucose in the urine, it is recommended to resort to enzymatic methods that use glucose oxidase. With chemical methods, due to the high urinary concentrations of amoxicillin, false positive readings can occur.

Like other broad spectrum antibiotics, VELAMOX may reduce the efficacy of oral contraceptives and patients should be advised of this.

04.6 Pregnancy and breastfeeding

Pregnancy

The safety of this medicine for use in pregnancy has not been established in accurate studies in pregnant women. Amoxicillin can be used in pregnancy if the potential benefits of treatment for the mother outweigh any possible risk to the fetus ( see Section 5.3).

Feeding time

VELAMOX can be administered during lactation.

Except for the risk of sensitization associated with the excretion of traces of amoxicillin in breast milk, there are no known adverse effects for the newborn.

04.7 Effects on ability to drive and use machines

No adverse effects on the ability to drive and use machines have been observed.

04.8 Undesirable effects

The following convention was used to classify undesirable effects:

very common (> 1/10), common (> 1/100, 1 / 1,000, 1 / 10,000,

Most of the undesirable effects described below are not only characteristic of amoxicillin but can also occur with other penicillins.

The frequency of undesirable effects, unless otherwise specified, is derived from more than 30 years of post-marketing pharmacovigilance studies.

Haematological and lymphatic system disorders

Very rare: reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anemia, purpura, eosinophilia.

Prolonged bleeding time and prothrombin time have been reported (see Section 4.4).

Disorders of the immune system

Very rare: As with other antibiotics, severe allergic reactions such as: angioneurotic edema, anaphylaxis (see Section 4.4), serum sickness, hypersensitivity vasculitis have been reported.

In the event of a hypersensitivity reaction, treatment should be discontinued (see also dermatological and subcutaneous tissue disorders).

Disorders of the nervous system

Very rare: hyperkinesia, dizziness and convulsions. Seizures can occur in patients with impaired renal function or in patients treated with high doses of the drug.

Gastrointestinal disorders

Data from clinical studies

Common: glossitis, stomatitis, diarrhea and nausea.

Uncommon: vomiting.

Post-marketing data

Very rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis).

Change in the superficial coloring of the teeth in children. Usually this effect can be eliminated (or even prevented) with normal oral hygiene operations.

Hepato-biliary disorders

Very rare: hepatitis and cholestatic jaundice. A moderate increase in transaminase levels (AST and / or ALT). The increase in AST and / or ALT is of uncertain significance.

Dermatological and subcutaneous tissue disorders

Data from clinical studies

Common: skin rash

Uncommon: hives and itching

Post-marketing data

Very rare: allergic reactions, erythema multiforme or maculopapular, Stevens Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalized exanthematous pustulosis.

In the event of any hypersensitivity reaction, treatment should be discontinued (see also immune system disorders).

Kidney and urinary tract disorders

Very rare: interstitial nephritis, crystalluria.

The incidence of these side effects is derived from clinical trials involving a total of approximately 6,000 adult and pediatric patients administered amoxicillin.

04.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhea may occur and symptoms of disturbed water and electrolyte balance should be treated symptomatically.

When administering high doses of amoxicillin, adequate water supply should be ensured and sufficient urine volume should be ensured to minimize the possibility of amoxicillin crystalluria.

Amoxicillin can be removed from the circulation by hemodialysis.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: beta-lactam antibacterials, broad spectrum penicillins.

ATC code: J01CA04.

Amoxicillin is a semi-synthetic aminopenicillin belonging to the group of beta-lactam antibiotics. It has a broad spectrum of antibacterial activity against many Gram-positive and Gram-negative microorganisms, acting by inhibiting the biosynthesis of the cell wall mucopeptide.

However, amoxicillin is sensitive to degradation by beta-lactamases and therefore the spectrum of activity of amoxicillin alone does not include organisms producing these enzymes including resistant staphylococci and all strains of Pseudomonas, Klebsiella and Enterobacter.

Strains of the following organisms are generally sensitive to the bactericidal action of amoxicillin in vitro:

Gram positive

Streptococcus faecalis

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococcus viridans

Staphylococcus aureus (sensitive to penicillins)

Clostridium spp

Corynebacterium spp

Bacillus anthracis

Listeria monocytogenes

Gram negative

Haemophilus influenzae

Escherichia coli

Proteus mirabilis

Salmonella spp

Shigella spp

Bordetella pertussis

Brucella spp

Neisseria gonorrhoeae

Neisseria meningitidis

Pasteurella septica

Helicobacter pylori

Leptospira spp

Fusobacterium spp

Vibrio cholerae

Others

Borrelia burgdorferi

05.2 Pharmacokinetic properties

Absorption

Amoxicillin is rapidly absorbed from the intestine in quantities ranging from 72 to 93%.

Absorption does not depend on food intake.

Distribution

The blood peak is reached 1-2 hours after administration. Following administration of doses of 250 and 500 mg amoxicillin, respectively, the mean peak serum concentrations reported are 5.2 mcg / mL and 8.3 mcg / mL, respectively.

Amoxicillin is not highly bound to plasma proteins, approximately 18% of the total drug content in plasma is bound to proteins. Amoxicillin rapidly diffuses into most tissues and body fluids, except the brain and cerebral fluid. -spinal.

Inflammation generally increases the permeability of the meninges to penicillins and therefore to amoxicillin.

Excretion

The major route of elimination of amoxicillin is via the kidney. Approximately 60-70% of amoxicillin is excreted unchanged in the urine during the first 6 hours after administration of a standard dose.

The elimination half-life is approximately one hour.

In premature infants with gestational age of 26-33 weeks, the total clearance after intravenous administration of amoxicillin, on day 3 of life, ranges from 0.75 to 2 ml / min, very similar to the clearance of inulin (glomerular filtrate) in this population. Following oral administration, the absorption and bioavailability of amoxicillin in young children may be different than in adults. Consequently, the exposure to amoxicillin expected in this patient group is high due to low clearance; however, the increase in exposure may be partially diminished by the reduced bioavailability after oral administration.

Some of the amoxicillin is also excreted in the urine as inactive penicilloic acid in amounts equivalent to 10-25% of the initial dose.

Concomitant administration of probenecid delays the excretion of amoxicillin.

Small amounts of the drug are also excreted in the faeces and bile.

05.3 Preclinical safety data

Reproduction studies have been performed in mice and rats with doses up to ten times higher than those used in humans and these studies did not reveal any reduction in fertility or harm to the fetus following the use of amoxicillin.

There is no relevant information to add.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

VELAMOX 1 g dispersible tablets

Each dispersible tablet contains:

polyplasdone XL, peppermint flavor, aspartame, magnesium stearate.

VELAMOX 500 mg hard capsules

Each hard capsule contains:

magnesium stearate, erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), gelatin, yellow iron oxide (E172).

VELAMOX 250 mg / 7 ml powder for oral suspension

100 g of powder for oral suspension contains:

anhydrous sodium citrate, anhydrous citric acid, sodium edetate, sodium benzoate, peach flavor, strawberry flavor, lemon flavor, sucrose.

06.2 Incompatibility

In solution, amoxicillin is incompatible with: cimetidine, aminophylline, ACTH, noradrenaline, CAF, tetracycline, erythromycin, vitamin B and K.

06.3 Period of validity

With intact packaging:

VELAMOX 1 g dispersible tablets: 3 years.

VELAMOX 500 mg hard capsules: 3 years.

VELAMOX 250 mg / 7 ml powder for oral suspension: 3 years.

Shelf life after reconstitution of the product:

VELAMOX 250 mg / 7 ml powder for oral suspension: after shaking, a suspension is obtained which, stored in a refrigerator (between 2 ° and 10 ° C), remains stable for a period of 10 days.

06.4 Special precautions for storage

VELAMOX 1 g dispersible tablets and VELAMOX 500 mg hard capsules: none, under normal storage conditions.

VELAMOX 250 mg / 7 ml powder for oral suspension: the suspension obtained should be stored in the refrigerator (between 2 ° and 10 ° C), where it remains stable for a period of 10 days.

06.5 Nature of the immediate packaging and contents of the package

VELAMOX 1 g dispersible tablets - 12 tablets.

VELAMOX 500 mg hard capsules - 12 hard capsules.

VELAMOX 250 mg / 7 ml powder for oral suspension - 1 bottle of 100 ml with measuring cup with notches at volumes 3 ml, 4 ml, 5 ml, 7 ml, 9 ml, 10 ml, 11 ml, 13 ml, 15 ml .

06.6 Instructions for use and handling

See Section 4.2.

07.0 MARKETING AUTHORIZATION HOLDER

MEDIOLANUM pharmaceuticals S.p.A.

Via San Giuseppe Cottolengo, 15 - 20143 Milan.

08.0 MARKETING AUTHORIZATION NUMBER

VELAMOX 1 g dispersible tablets A.I.C. n. 023097102

VELAMOX 500 mg hard capsules A.I.C. n. 023097013

VELAMOX 250 mg / 7 ml powder for oral suspension A.I.C. n. 023097037

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

June 2010.

10.0 DATE OF REVISION OF THE TEXT

August 2012.

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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