Septrin Paediatric 40mg/200mg per 5ml Oral Suspension.

  • Name:

    Septrin Paediatric 40mg/200mg per 5ml Oral Suspension.

  • Company:
    info
  • Active Ingredients:

    Sulfamethoxazole, Trimethoprim

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/04/20

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Summary of Product Characteristics last updated on medicines.ie: 27/4/2020

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When a pharmaceutical company changes any document, 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.

Updated on 27 April 2020 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 April 2020 PIL

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  • XPIL Updated

Updated on 27 April 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 25 January 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 25 January 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 January 2019 SmPC

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  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 January 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 January 2019 PIL

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  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 June 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 June 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 15 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 15 November 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains 40 mg Trimethoprim and 200 mg Sulfamethoxazole.

Excipients with known effect:

Contains 3.25 g sorbitol per 5 ml, less than 100 mg of ethanol per 5 ml, 5 mg sodium benzoate per 5 ml and vanilla flavour with 0.00015 µL sulphur dioxide per 5 ml.

4.4 Special warnings and precautions for use

Fatalities, although very rare, have occurred due to severe reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias and hypersensitivity of the respiratory tract.

Life threatening adverse reaction

• Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of Septrin.
• Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment.
• If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, Septrin treatment should be discontinued (see section 4.8).
• The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.
• If the patient has developed SJS or TEN with the use of Septrin, Septrin must not be re started in this patient at any time.

Elderly patients

Particular care is always advisable when treating elderly patients because, as a group, they are more susceptible to adverse reactions and more likely to suffer serious effects as a result particularly when complicating conditions exist, e.g. impaired kidney and/or liver function and/or concomitant use of other drugs.

Patients with renal impairment

For patients with known renal impairment special measures should be adopted (see section 4.2). An adequate urinary output should be maintained at all times.

Evidence of crystalluria in vivo is rare, although sulphonamide crystals have been noted in cooled urine from treated patients. In patients suffering from hypoalbuminaemia the risk may be increased.

Folate

Regular monthly blood counts are advisable when Septrin is given for long periods, or to folate deficient patients or to the elderly; since there exists a possibility of asymptomatic changes in haematological laboratory indices due to lack of available folate. Supplementation with folinic acid may be considered during treatment but this should be initiated with caution due to possible interference with antimicrobial efficacy (see section 4.5).

Patients with glucose-6-phosphate dehydrogenase deficiency

In glucose 6 phosphate dehydrogenase (G 6 PD) deficient patients, haemolysis may occur.

Patients with severe atopy or bronchial asthma

Septrin should be given with caution to patients with severe atopy or bronchial asthma.

Treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci

Septrin should not be used in the treatment of streptococcal pharyngitis due to Group A β haemolytic streptococci; eradication of these organisms from the oropharynx is less effective than with penicillin.


Phenylalanine metabolism

Trimethoprim has been noted to impair phenylalanine metabolism but this is of no significance in phenylketonuric patients on appropriate dietary restriction.

Patients with or at risk of porphyria
The administration of Septrin to patients known or suspected to be at risk of porphyria should be avoided. Both trimethoprim and sulphonamides (although not specifically sulfamethoxazole) have been associated with clinical exacerbation of porphyria.


Patients with hyperkalaemia and hyponatraemia
Close monitoring of serum potassium is warranted in patients at risk of hyperkalaemia and hyponatraemia.


Patients with serious haematological disorders
Except under careful supervision Septrin should not be given to patients with serious haematological disorders (see section 4.8). Septrin has been given to patients receiving cytotoxic therapy with little or no additional effect on the bone marrow or peripheral blood.

Patients with rare hereditary problems of fructose intolerance should not take this medicine (see section 2).

Septrin contains methyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).

Septrin contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.

Septrin contains sulphur dioxide, which may rarely cause severe hypersensitivity reactions and bronchospasm.

Septrin contains sodium benzoate, which may increase the risk of jaundice in newborns babies.


4.5 Interaction with other medicinal products and other forms of interaction

Diuretics (thiazides): in elderly patients concurrently receiving diuretics, mainly thiazides, there appears to be an increased risk of thrombocytopenia with or without purpura.

Pyrimethamine: occasional reports suggest that patients receiving pyrimethamine at doses in excess of 25 mg weekly may develop megaloblastic anaemia should co-trimoxazole be prescribed concurrently.

Zidovudine: in some situations, concomitant treatment with zidovudine may increase the risk of haematological adverse reactions to co-trimoxazole. If concomitant treatment is necessary, consideration should be given to monitoring of haematological parameters.

Lamivudine: administration of trimethoprim/sulfamethoxazole 160 mg/800 mg (co-trimoxazole) causes a 40% increase in lamivudine exposure because of the trimethoprim component. Lamivudine has no effect on the pharmacokinetics of trimethoprim or sulfamethoxazole.

Warfarin: co-trimoxazole has been shown to potentiate the anticoagulant activity of warfarin via stereo-selective inhibition of its metabolism. Sulfamethoxazole may displace warfarin from plasma-albumin protein-binding sites in vitro. Careful control of the anticoagulant therapy during treatment with Septrin is advisable.

Phenytoin: co-trimoxazole prolongs the half-life of phenytoin and if co-administered excessive phenytoin effect. Close monitoring of the patient's condition and serum phenytoin levels are advisable.

Interaction with sulphonylurea hypoglycaemic agents is uncommon but potentiation has been reported.

Rifampicin: concurrent use of rifampicin and Septrin results in a shortening of the plasma half-life of trimethoprim after a period of about one week. This is not thought to be of clinical significance.

Cyclosporin: reversible deterioration in renal function has been observed in patients treated with co-trimoxazole and cyclosporin following renal transplantation.

When trimethoprim is administered simultaneously with drugs that form cations at physiological pH, and are also partly excreted by active renal secretion (e.g. procainamide, amantadine), there is the possibility of competitive inhibition of this process which may lead to an increase in plasma concentration of one or both of the drugs.

Digoxin: concomitant use of trimethoprim with digoxin has been shown to increase plasma digoxin levels in a proportion of elderly patients.

Hyperkalaemia: caution should be exercised in patients taking any other drugs that can cause hyperkalaemia. Trimethoprim contributes to decreased renal clearance of ACE inhibitors and potassium sparing diuretics, giving increased risk of hyperkalaemia.

Azathioprine: There are conflicting clinical reports of interactions, resulting in serious haematological abnormalities, between azathioprine and co-trimoxazole.

Methotrexate: co-trimoxazole may increase the free plasma levels of methotrexate. If Septrin is considered appropriate therapy in patients receiving other anti-folate drugs such as methotrexate, a folate supplement should be considered. (see section 4.4)

Repaglinide: trimethoprim may increase the exposure of repaglinide which may result in hypoglycaemia.

Folinic acid: folinic acid supplementation has been shown to interfere with the antimicrobial efficacy of trimethoprim-sulfamethoxazole. This has been observed in Pneumocystis jiroveci pneumonia prophylaxis and treatment.

Contraceptives: oral contraceptive failures have been reported with antibiotics. The mechanism of this effect has not been elucidated. Women on treatment with antibiotics should temporarily use a barrier method in addition to the oral contraceptive, or choose another method of contraception.

Interaction with laboratory tests:

Trimethoprim interferes with assays for serum methotrexate when dihydrofolate reductase from Lactobacillus casei is used in the assay. No interference occurs if methotrexate is measured by radio-immune assay.

Trimethoprim may interfere with the estimation of serum/plasma creatinine when the alkaline picrate reaction is used. This may result in overestimation of serum/plasma creatinine of the order of 10%.
Functional inhibitation of the renal tubular secretion of creatinine may produce a spurious fall in the estimated rate of creatinine clearance.



4.6 Fertility, pregnancy and lactation


5.1 Pharmacodynamic properties

Pharmacotherapeutic group: ANTIBACTERIALS FOR SYSTEMIC USE – SULFONAMIDES AND TRIMETHOPRIM Combinations of sulfonamides and trimethoprim, incl. derivatives;ATC code: J01EE01

Mechanism of action

Sulfamethoxazole competitively inhibits the utilisation of para-aminobenzoic acid in the synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis. Trimethoprim reversibly inhibits bacterial dihydrofolate reductase (DHFR), an enzyme active in the folate metabolic pathway converting dihydrofolate to tetrahydrofolate. Depending on the conditions the effect may be bactericidal. Thus trimethoprim and sulfamethoxazole block two consecutive steps in the biosynthesis of purines and therefore nucleic acids essential to many bacteria. This action produces marked potentiation of activity in vitro between the two agents.
Trimethoprim binds to plasmodial DHFR but less tightly than to the bacterial enzyme. The affinity of trimethoprim for mammalian DHFR is some 50,000 times less than for the corresponding bacterial enzyme.

Resistance

In vitro studies have shown that bacterial resistance can develop more slowly with both sulfamethoxazole and trimethoprim in combination that with either sulfamethoxazole or trimethoprim alone.

Resistance to sulfamethoxazole may occur by different mechanisms. Bacterial mutations cause an increase the concentration of PABA and thereby out-compete with sulfamethoxazole resulting in a reduction of the inhibitory effect on dihydropteroate synthetase enzyme. Another resistance mechanism is plasmid-mediated and results from production of an altered dihydropteroate synthetase enzyme, with reduced affinity for sulfamethoxazole compared to the wild-type enzyme.

Resistance to trimethoprim occurs through a plasmid-mediated mutation which results in production of an altered dihydrofolate reductase enzyme having a reduced affinity for trimethoprim compared to the wild-type enzyme.

Susceptibility testing breakpoints

Testing of trimethoprim sulfamethoxazole was performed using the common dilution series to assess the Minimum Inhibitory Concentration (MIC). The MIC breakpoints for resistance are those recommended by CLSI (Clinical and Laboratory Standards Institute – formerly the National Committee for Clinical Laboratory Standards (NCCLS) and EUCAST guidelines.

Pharmacodynamic effects


5.2 Pharmacokinetic properties

Absorption:

After oral administration trimethoprim and sulfamethoxazole are rapidly and nearly completely absorbed. The presence of food does not appear to delay absorption. Peak levels in the blood occur between one and four hours after ingestion and the level attained is dose related. Effective levels persist in the blood for up to 24 hours after a therapeutic dose. Steady state levels in adults are reached after dosing for 2-3 days. Neither component has an appreciable effect on the concentrations achieved in the blood by the other.

Distribution:

Approximately 50% of trimethoprim in the plasma is protein bound
Tissue levels of trimethoprim are generally higher than corresponding plasma levels, the lungs and kidneys showing especially high concentrations. Trimethoprim concentrations exceed those in plasma in the case of bile, prostatic fluid and tissue, saliva, sputum and vaginal secretions. Levels in the aqueous humor, breast milk, cerebrospinal fluid, middle ear fluid, synovial fluid and tissue (intestinal) fluid are adequate for antibacterial activity. Trimethoprim passes into amniotic fluid and foetal tissues reaching concentrations approximating those of maternal serum.
Approximately 66% of sulfamethoxazole in the plasma is protein bound.
The concentration of active sulfamethoxazole in amniotic fluid, aqueous humour, bile, cerebrospinal fluid, middle ear fluid, sputum, synovial fluid and tissue (interstitial) fluid is of the order of 20-50% of the plasma concentration.

Biotransformation

Renal excretion of intact sulfamethoxazole accounts for 15-30% of the dose. This drug is more extensively metabolised than trimethoprim, via acetylation, oxidation or glucuronidation. Over a 72 hour period, approximately 85% of the dose can be accounted for in the urine as unchanged drug plus the major (N4-acetylated) metabolite.

Elimination

The half-life of trimethoprim in man is in the range 8.6 to 17 hours in the presence of normal renal function. There appears to be no significant difference in the elderly compared with young patients.

The principle route of excretion of trimethoprim is renal and approximately 50% of the dose is excreted in the urine within 24 hours as unchanged drug. Several metabolites have been identified in the urine. Urinary concentration of trimethoprim varies widely.

The half-life of sulfamethoxazole in man is approximately 9-11 hours in the presence of normal renal function. There is no change in the half-life of active sulfamethoxazole with a reduction in renal function but there is prolongation of the half-life of the major, acetylated metabolite when the creatinine clearance is below 25 ml/minute.

The principle route of excretion of sulfamethoxazole is renal; between 15% and 30% of the dose recovered in the urine is in the active form. In elderly patients there is a reduced renal clearance of sulfamethoxazole.

Special patient populations

Renal impairment
The elimination half-life of trimethoprim is increased by a factor of 1.5-3.0 when the creatinine clearance is less than 10 mL/minute. When the creatinine clearance falls below 30 mL/min the dosage of Septrin should be reduced (see section 4.2).
Hepatic impairment
Caution should be exercised when treating patients with severe hepatic impairment as there may be changes in the absorption and biotransformation of trimethoprim and sulfamethoxazole

Older patients
In older patients, a slight reduction in renal clearance of sulfamethoxazole but not trimethoprim has been observed.

Paediatric population
See special dosage regimen (see section 4.2).


6.6 Special precautions for disposal and other handling



10 DATE OF REVISION OF THE TEXT

October 2017



 

Updated on 14 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 November 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 17 November 2016 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 15 November 2016 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 10 April 2014 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

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7 MARKETING AUTHORISATION HOLDER

12/13 Exchange Place

I.F.S.C Dublin 1

3016 Lake Drive,

Citywest Business Campus

Dublin 24

10 DATE OF REVISION OF THE TEXT

July April 20143

Updated on 8 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 24 July 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

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Text in blue: Added
Text striked through: deleted


Spelling error corrected throughout the document for sulfamethoxazole and Trimethoprim
 

4.4 Special warnings and  precautions for  use

 

Fatalities, although very rare, have occurred due to severe reactions including Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood dyscrasias and hypersensitivity of the respiratory tract.

 

Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of Septrin. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, Septrin treatment should be discontinued (see 4.8 Undesirable Effects).

The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of Septrin, Septrin must not be re-started in this patient at any time.

 

 

Septrin should be discontinued at the first appearance of skin rash (see section 4.8, Undesirable effects)

Particular care is always advisable when treating elderly patients because, as a group, they are more susceptible to adverse reactions and more likely to suffer serious effects as a result particularly when complicating conditions exist, eg. impaired kidney and/or liver function and/or concomitant use of other drugs.



4.8 Undesirable effects



Skin and subcutaneous tissue disorders

Common:          Skin rashes

Very rare:          Photosensitivity, exfoliative dermatitis, fixed drug eruption, erythema multiforme, , Stevens-Johnson syndrome, Lyell's  syndrome (toxic epidermal necrolysis)

 

Lyell's syndrome carries a high mortality.

Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported (see section 4.4).

10 DATE OF REVISION OF THE TEXT

 

February 2011July 2013


Updated on 23 July 2013 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change to side-effects
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Updated on 21 June 2013 SmPC

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  • Change to section 3 - Pharmaceutical form
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3 Oral suspension.

Off-white, banana and vanilla Pink aniseed flavored oral syrup.


10 DATE OF REVISION OF THE TEXT

 

June 2013 February2013

Updated on 14 June 2013 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 11 January 2013 SmPC

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Improved electronic presentation

Updated on 21 November 2012 PIL

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  • Improved electronic presentation

Updated on 24 October 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 May 2011 PIL

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  • Change to marketing authorisation holder

Updated on 5 May 2011 SmPC

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  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • SPC retired pending re-submission

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Product ownership changed from GSK to Aspen

Updated on 29 October 2008 SmPC

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  • Correction of spelling/typing errors

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Updated on 28 October 2008 SmPC

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Updated on 12 September 2008 PIL

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  • Change to side-effects

Updated on 11 September 2008 SmPC

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  • Change to section 4.8 - Undesirable effects

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The following text has been added to section 4.8 of the SPC’s:

 

Eye disorders:

Very rare: Uveitis

Updated on 4 April 2008 SmPC

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  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

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4.5       Interaction with other medicaments and other forms of interaction

5.1       Pharmacodynamic Properties

Updated on 12 June 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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4.3       Contraindications

 

Septrin presentations should not be given to patients with a history of hypersensitivity to sulphonamides, trimethoprim or co-trimoxazole or any excipients of the presentations.
 
4.4       Special Warnings and Special Precautions for Use

Regular monthly blood counts are advisable when Septrin is given for long periods, or to folate deficient patients or to the elderly, since there exists a possibility of asymptomatic changes in haematological laboratory indices due to lack of available folate. These changes may be reversed by administration of folinic acid (5 to 10 mg/day) without interfering with the antibacterial activity.

 

In glucose-6-phosphate dehydrogenase deficient (G-6-PD) patients haemolysis may occur.

Septrin should be given with caution to patients with severe allergy or bronchial asthma.

Septrin should not be used in the treatment of streptococcal pharyngitis due to Group A beta-haemolytic streptococci; eradication of these organisms from the oropharynx is less effective than with penicillin.

 

Trimethoprim has been noted to impair phenylalanine metabolism but this is of no significance in phenylketonuric patients on appropriate dietary restriction.

The administration of Septrin to patients known or suspected to be at risk of acute porphyria should be avoided. Both trimethoprim and sulphonamides (although not specifically sulfamethoxazole) have been associated with clinical exacerbation of porphyria.

Close monitoring of serum potassium and sodium is warranted in patients at risk of hyperkalaemia.  and hyponatraemia.

 

Except under careful supervision Septrin should not be given to patients with serious haematological disorders (see Adverse Reactions).   Septrin has been given to patients receiving cytotoxic therapy with little or no additional effect on the bone marrow or peripheral blood.

 

4.8       Undesirable Effects

 

As Septrin contains trimethoprim and a sulphonamide the type and frequency of adverse reactions associated with such compounds are expected to be consistent with extensive historical experience.

 

Data from large published clinical trials were used to determine the frequency of very common to rare adverse events.  Very rare adverse events were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than a "true" frequency. In addition, adverse events may vary in their incidence depending on the indication.

 

The following convention has been used for the classification of adverse events in terms of frequency:

Very common 1/10, 

common 1/100 and <1/10, 

uncommon 1/1000 and <1/100, 

rare 1/10,000 and <1/1000, 

very rare <1/10,000.

Infections and Infestations

Common:

Monilial overgrowth.

 

Blood and lymphatic system disorders

Very rare:

Leucopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anaemia, aplastic anaemia, haemolytic anaemia, methaemoglobinaemia, eosinophilia, purpura, haemolysis in certain susceptible G-6-PD deficient patients.

 

Immune system disorders

Very rare: 

Serum sickness, anaphylaxis, allergic myocarditis, angioedema, drug fever, allergic vasculitis resembling Henoch-Schoenlein purpura, periarteritis nodosa, systemic lupus erythematosus.

 

Metabolism and nutrition disorders

Very common:

Hyperkalaemia

Very rare:

Hypoglycaemia, hyponatraemia, anorexia

 

Psychiatric disorders

Very rare:

Depression, hallucinations

Nervous system disorders

Common:

Headache

Very rare:

Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, dizziness

Aseptic meningitis was rapidly reversible on withdrawal of the drug, but recurred in a number of cases on re-exposure to either Septrin or to trimethoprim alone.

 

Respiratory, thoracic and mediastinal disorders

Very rare:

Cough, shortness of breath, pulmonary infiltrates

Cough, shortness of breath and pulmonary infiltrates may be early indicators of respiratory hypersensitivity which, while very rare, has been fatal.

 

Gastrointestinal disorders

Common:

Nausea, diarrhoea

Uncommon:

Vomiting

Very rare:

Glossitis, stomatitis, pseudomembranous colitis, pancreatitis

 

Hepatobiliary disorders

Very rare:

Cholestatic jaundice, hepatic necrosis

Cholestatic jaundice and hepatic necrosis may be fatal.

Oral:

Very rare: 

Elevation of serum transaminases, elevation of bilirubin levels

 

Skin and subcutaneous tissue disorders

Common: 

Skin rashes

Very rare:

Photosensitivity, exfoliative dermatitis, fixed drug eruption, erythema multiforme, Stevens-Johnson syndrome, Lyells syndrome (toxic epidermal necrolysis)

Lyells syndrome carries a high mortality.

 

Musculoskeletal and connective tissue disorders

Very rare:

Arthralgia, myalgia

 

Renal and urinary disorders

Very rare:

Impaired renal function (sometimes reported as renal failure), interstitial nephritis

 

Effects associated with Pneumocystis jiroveci (carinii) pneumonitis (PJP) management

Very rare:

Severe hypersensitivity reactions, rash, fever, neutropenia, thrombocytopenia, raised liver enzymes, rhabdomyolysis

 

At the high dosages used for PJP management severe hypersensitivity reactions have been reported, necessitating cessation of therapy. If signs of bone marrow depression occur, the patient should be given calcium folinate supplementation (5 to 10 mg/day). Severe hypersensitivity reactions have been reported in PJP patients on re-exposure to trimethoprim-sulfamethoxazole, sometimes after a dosage interval of a few days. Rhabdomyolysis has been reported in HIV positive patients receiving Septrinfor prophylaxis or treatment of PJP.

 

Very rare:

Hyperkalaemia, hyponatraemia

Updated on 23 May 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 23 May 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 October 2003 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 2 - Qualitative and quantitative composition

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)