When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
1. TRADE NAME OF THE MEDICINAL PRODUCT
Amoxil 3g Powder for Oral Suspension Sachets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains Amoxicillin Trihydrate equivalent to 3.0g amoxicillin.
Each sachet also contains sorbitol (E420)
For a full list of excipients see section 6.1
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Saccharin sodium (dried),
Xanthan gum (E415),
Peach dry flavour,
Strawberry dry flavour
Lemon dry flavour,
Sorbitol (E420).
6.2 Incompatibilities Not applicable. 6.3 Shelf-life Powder: 3 years Use immediately following reconstitution. 6.4 Special Precautions for Storage Do not store above 250C. Store in a dry place. Store in the original package in order to protect from moisture. 6.5 Nature and Contents of Container Paper/aluminium foil/polythene/laminate single dose sachet. Paper/aluminium foil/Copolymer film laminate The copolymer consists of ethylene and acrylic acid. Pack size: 2 sachets 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product. Instructions for Use/Handling 1. Cut sachet along dotted line; 2. Empty contents into a glass; 3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
Not applicable.
6.3 Shelf-life Powder: 3 years Use immediately following reconstitution. 6.4 Special Precautions for Storage Do not store above 250C. Store in a dry place. Store in the original package in order to protect from moisture. 6.5 Nature and Contents of Container Paper/aluminium foil/polythene/laminate single dose sachet. Paper/aluminium foil/Copolymer film laminate The copolymer consists of ethylene and acrylic acid. Pack size: 2 sachets 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product. Instructions for Use/Handling 1. Cut sachet along dotted line; 2. Empty contents into a glass; 3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
Powder: 3 years
Use immediately following reconstitution.
6.4 Special Precautions for Storage
Do not store above 250C. Store in a dry place.
Store in the original package in order to protect from moisture.
6.5 Nature and Contents of Container Paper/aluminium foil/polythene/laminate single dose sachet. Paper/aluminium foil/Copolymer film laminate The copolymer consists of ethylene and acrylic acid. Pack size: 2 sachets 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product. Instructions for Use/Handling 1. Cut sachet along dotted line; 2. Empty contents into a glass; 3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
Paper/aluminium foil/polythene/laminate single dose sachet.
Paper/aluminium foil/Copolymer film laminate
The copolymer consists of ethylene and acrylic acid.
Pack size: 2 sachets
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product. Instructions for Use/Handling 1. Cut sachet along dotted line; 2. Empty contents into a glass; 3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
1. Cut sachet along dotted line; 2. Empty contents into a glass; 3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
2. Empty contents into a glass; 3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
3. Half fill sachet with water; 4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
4. Pour into glass, stir well and drink immediately. A white to off-white coloured suspension is formed on reconstitution with water.
A white to off-white coloured suspension is formed on reconstitution with water.
4.4 Special Warnings and Special Precautions for Use
……..
Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. ………… 4.5 Interaction with Other Medicaments and Other Forms of Interaction ……….additional paragraph In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. 4.8 Undesirable Effects ……………….. Blood and lymphatic system disorders Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (See Warnings and Precautions). ……………….
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
…………
4.5 Interaction with Other Medicaments and Other Forms of Interaction
……….additional paragraph In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. 4.8 Undesirable Effects ……………….. Blood and lymphatic system disorders Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (See Warnings and Precautions). ……………….
In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin. 4.8 Undesirable Effects ……………….. Blood and lymphatic system disorders Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (See Warnings and Precautions). ……………….
In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
4.8 Undesirable Effects
………………..
Blood and lymphatic system disorders
Very rare:
Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and prothrombin time (See Warnings and Precautions).
……………….
old wording
new wording
Children under 40Kg#
Glomerular filtration rate
Oral treatment
< 30
No adjustment necessary
10-30 ml/min
15mg/kg given twice daily
< 10ml / min
15mg/kg given as as single daily dose
(maximum 500mg/twice daily)
15mg/kg given as as single daily dose (maximum 500mg)
4.5 Interaction with other medicinal products and other forms of interaction
Probenecid decreases the renal tubular excretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives
4.8: Undesirable effects
Infections and Infestations
Very rare:Mucocutaneous candidiasis
Gastrointestinal disorders
#Common: Diarrhoea and nausea.
#Uncommon: Vomiting.
Black hairy tongue