Altargo

1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Altargo 10 mg/g ointment 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each gram of ointment contains 10 mg retapamulin (1% w/w). 
 

 
Excipient(s) with known effect: 

Each gram of ointment contains up to 20 micrograms of butylated hydroxytoluene (E321). 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Ointment. 
 
Smooth, off-white ointment. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Short term treatment of the following superficial skin infections in adults, adolescents, infants and 
children (aged from nine months) (see section 5.1): 
 

• Impetigo. 
 

• Infected small lacerations, abrasions, or sutured wounds.  
 
See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin 
against different types of Staphylococcus aureus. 
 
Consideration should be given to official guidance on the appropriate use of antibacterial medicinal 
products. 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine 
months to 11 years) 
 
A thin layer of ointment should be applied to the affected area twice daily for five days.  
The area treated may be covered with sterile bandage or gauze dressing. 
 
Safety and efficacy have not been established in the following: 
 
• Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area. 

 
• Infected lesions that exceed 10 cm in length or a total surface area >100 cm2.  

 

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In patients aged less than 18 years the total surface area treated should be no more than 2% of the body 
surface area. 
 
Patients not showing a clinical response within two to three days should be re-evaluated and 
alternative therapy should be considered (see section 4.4). 
 
Special populations 
 
Elderly (aged 65 and older) 
 
No dosage adjustment is necessary. 
 

 
Renal impairment 

No dosage adjustment is necessary.  See section 5.3.  
 

 
Hepatic impairment 

No dosage adjustment is necessary.  See section 5.3.  
 
Paediatric population 
 
The safety and efficacy of retapamulin ointment in infants less than nine months of age has not been 
established. Currently available data are described in section 5.2, but no recommendation on a 
posology can be made. 
 
Method of administration 
 
Retapamulin is for cutaneous use only. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Sensitisation or severe local irritation  
 
In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment 
should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the 
infection instituted. 
 
Eyes and mucous membranes 
 
Retapamulin ointment must be kept away from the eyes and mucous membranes. Epistaxis has been 
reported with use of Altargo on nasal mucosa.   
 
Ingestion 
 
Care must be taken to avoid ingestion. 
 
Re-evaluation of treatment 
 
Alternative therapy should be considered if there is no improvement or a worsening in the infected 
area after 2-3 days of treatment. 
 
 

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Prolonged use and overgrowth of non-susceptible micro-organisms 
 
Prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including 
fungi.  If super-infection with a non-susceptible organism is suspected, treatment should be guided by 
clinical and microbiological assessments. 
 
Abscesses 
 
Retapamulin should not be used to treat abscesses. 
 
Methicillin-resistant Staphylococcus aureus (MRSA) 
 
Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see 
section 5.1). 
In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in 
patients with infections caused by MRSA.  The reason for the reduced clinical efficacy observed in 
these patients is unknown. 
 
Butylated hydroxytoluene 
 
Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e.g. 
contact dermatitis), or irritation to the eyes and mucous membranes. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
The effect of concurrent application of retapamulin and other topical medicinal products to the same 
area of skin has not been studied, and is not recommended. 
 
In human liver microsomes, retapamulin was shown to be a strong inhibitor of CYP3A4. However, 
since plasma concentrations of retapamulin during topical application have been low (see section 5.2), 
it is not expected that concurrent systemic administration of CYP3A4 substrates will result in 
clinically important inhibition of their metabolism by retapamulin.  
 
Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and 
Cmax by 81% after topical application of retapamulin 10 mg/g ointment on the abraded skin of healthy 
adult males.  Nevertheless, the highest plasma concentrations recorded were low (< 10.5 ng/ml in the 
absence of ketoconazole and < 17 ng/ml in the presence of ketoconazole. 
 
Systemic exposure to retapamulin has been low following topical application of 10 mg/g ointment in 
adult and paediatric patients aged 2 years and older (maximum plasma concentration < 20 ng/mL). 
Therefore it is not expected that clinically important increases in plasma concentrations of retapamulin 
will occur in patients aged 2 years and older who are also receiving CYP3A4 inhibitors. 
 
Paediatric population 
 
In children aged from 9 months to 2 years it is possible that higher plasma concentrations may 
occasionally occur during treatment with retapamulin 10 mg/g ointment compared to older children 
and adults. Therefore caution is advised if retapamulin 10 mg/g ointment is administered to children in 
this age group who are also receiving CYP3A4 inhibitors, as further increase in systemic exposure to 
retapamulin may occur upon CYP3A4 inhibition.  
 
See section 5.2 regarding plasma concentrations of retapamulin observed in patients in different age 
groups. 
 
 
 
 

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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
No clinical data on exposed pregnancies are available.  Animal studies have shown reproductive 
toxicity after oral administration and are insufficient with respect to effects on parturition and 
fetal/postnatal development (see section 5.3).  
 
Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly 
indicated and the use of retapamulin is considered to be preferable to administration of a systemic 
antibacterial medicinal product. 
 
Breast-feeding 
 
It is unknown whether retapamulin is excreted in human breast milk.  Minimal systemic exposure is 
observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible. The 
excretion of retapamulin in milk has not been studied in animals.  A decision on whether to 
continue/discontinue breast-feeding or to continue/discontinue therapy with Altargo should be made 
taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the 
woman. 
 
Fertility 
 
There are no data on the effects of retapamulin on human fertility.  No treatment-related effects on 
male or female fertility have been shown in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Altargo has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most 
commonly reported adverse reaction was application site irritation, which affected approximately 1% 
of patients. 
 
Tabulated list of adverse reactions 
 
The following convention has been used for the classification of frequency: 
very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), 
rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available 
data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 
Organ systems Common  Uncommon 

 
Not known 
 

Immune system 
disorders 

  Hypersensitivity, 
including angioedema 
 

Skin and subcutaneous 
tissue disorders 
 
 

 Contact dermatitis  

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General disorders and 
administration site 
conditions 

Application 
site reactions 
 
Irritation 

Application site 
reactions 
 
Pain 
Pruritus 
Erythema 

Application site 
irritation (including 
burning sensation) 

 
Paediatric population 
 
Frequency, type and severity of adverse reactions in the paediatric population are the same as in 
adults. 
 
Reporting of suspected adverse reactions  
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V.  
 
 
4.9 Overdose 
 
Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated 
symptomatically. 
No specific antidote is known.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, Antibiotics for 
topical use. ATC code: D06AX13 
 
Mechanism of action 
 
Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated through 
fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus). 
 
Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S 
subunit of the bacterial ribosome that is distinct from the binding sites of other non-pleuromutilin 
antibacterial agents that interact with the ribosome. 
 
Data indicate that the binding site involves ribosomal protein L3 and is in the region of the ribosomal 
P site and peptidyl transferase centre.  By virtue of binding to this site, pleuromutilins inhibit peptidyl 
transfer, partially block P-site interactions, and prevent normal formation of active 50S ribosomal 
subunits. Therefore the pleuromutilins appear to inhibit bacterial protein synthesis by multiple 
mechanisms.  
 
Retapamulin is predominantly bacteriostatic against S. aureus and S. pyogenes.  
 

 
Mechanism of resistance  

Due to its distinct mode of action, target specific cross-resistance with other classes of antibacterial 
agents is rare. 
 

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In vitro, three mechanisms have been identified which reduce susceptibility to retapamulin. One 
involves mutations in ribosomal protein L3, the second is a non-specific efflux mechanism (ABC 
transporter vgaAv). This non-target specific efflux mechanism has also been demonstrated to reduce 
the in vitro activity of streptogramin A. 
 
Susceptibility to pleuromutilins can also be affected by the Cfr rRNA methyltransferase, which 
confers cross-resistance to phenicols, lincosamides and streptogramin A in staphylococci.   
 
Retapamulin MICs of 2-64 µg/ml have been reported for clinical isolates of S. aureus possessing 
either the efflux or cfr resistance mechanisms described above. For S. aureus isolates with laboratory-
generated mutations in ribosomal protein L3, retapamulin MICs were 0.25-4 µg/ml. While the S. 
aureus epidemiological cut off value for retapamulin is 0.5 µg/ml, the clinical significance of isolates 
with elevated retapamulin MICs is unknown due to the potential for high local concentrations 
(20,000 µg/ml) of retapamulin on the skin. 
 
No development of resistance was observed during treatment with retapamulin in the clinical study 
programme and all clinical isolates were inhibited by retapamulin concentrations of <2 µg/ml. 
 
Antibacterial spectrum 
 
The prevalence of acquired resistance may vary geographically and with time for selected species, and 
local information on resistance is desirable, particularly when treating severe infections. As necessary, 
expert advice should be sought when the local prevalence of resistance is such that the utility of the 
agent in at least some types of infection is questionable. 
 

Commonly susceptible species 
 
Staphylococcus aureus* $ 
 
Streptococcus pyogenes* 
 
Streptococcus agalactiae 
 
Inherently resistant organisms 
 
Enterobacteriaceae 
 
Pseudomonas aeruginosa 
 
Enterococcus faecalis 
 

 

$ In vitro, retapamulin was equally active against methicillin-susceptible and methicillin-resistant 
strains of S. aureus.  However, see section 4.4 and below regarding clinical efficacy against MRSA. 
Retapamulin should not be used to treat infections known or thought likely to be due to MRSA. 
 
* Activity has been satisfactorily demonstrated in clinical studies 
 
Clinical efficacy and safety 
 
Very few MRSA were isolated in studies in impetigo and all were clinical successes (100%: 8/8).  
In studies in impetigo and in two studies of secondarily infected open wounds (SIOW), clinical 
success rates were high for retapamulin in patients with mupirocin-resistant S. aureus (100%: 11/11) 
or fusidic acid-resistant S. aureus (96.7%: 29/30).  However, in the two studies that enrolled patients 
with SIOW the efficacy of retapamulin in infections due to MRSA was inadequate (75.7%). No 

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differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates 
were susceptible or resistant to methicillin. 
 
The explanation for lower clinical efficacy against MRSA in SIOW is unclear and it may have been 
influenced by the presence of a particular MRSA clone.  In the case of treatment failure associated 
with S. aureus, the presence of strains possessing additional virulence factors (such as Panton-
Valentine Leukocidin) should be considered.  
 

Clinical Success Rates at Follow up for SIOW patients with S. aureus 
Phenotype/PFGE 
type 

RETAPAMULIN Cephalexin 
n/N Success 

Rate (%) 
95% Exact 

CI 
n/N Success 

Rate (%) 
S. aureus (all) 337/379 88.9 (85.3,91.9) 155/186 83.3 
   MRSA $ 28/37 75.7 (58.8,88.2) 21/26 80.8 
   MSSA 309/342 90.4 (86.7,93.3) 133/159 83.6 

CI: confidence interval. Exact CI is calculated using the F-distribution method. 
$: the response rate for MRSA due to PVL+ MRSA was 8/13 (62%) 

 
A multicentre, randomised, double-blind, study compared the efficacy of retapamulin ointment to 
placebo ointment for the treatment of SIOW. The study failed to meet the primary end point which 
was the clinical success rate at follow-up (day 12 – 14) for subjects in the Intent to Treat Clinical 
population (see Table below).  
 

Clinical Response at Follow-up (day 12-14), by Analysis population 
 Retapamulin Placebo Difference 

in success 
rates (%) 

95% CI (%) 
Analysis 
population 

n/N Success 
rate 

n/N Success 
rate 

ITTC 184/246 74.8 75/113 66.4 8.4 (-1.6, 18.4) 
PPC 170/215 79.1 72/97 74.2 4.8 (-5.2, 14.8) 
ITTB 139/182 76.4 54/84 64.3 12.1 (0.6, 23.6) 
PPB 128/158 81.0 51/69 73.9 7.1 (-4.4, 18.6) 
CI: confidence interval. Confidence interval was not adjusted for multiplicity. 
ITTC- Intent to Treat Clinical Primary Efficacy Population; PPC –Per Protocol Clinical Primary 
Efficacy population;  ITTB- Intent to Treat Bacteriological evaluable, Primary Efficacy Population; 
PPB – Per Protocol Bacteriologically evaluable, Primary Efficacy Population. 
 
However, when adjusted for baseline wound characteristics including pathogen, wound size and 
severity, the clinical success rate of retapamulin was superior to placebo for the primary efficacy 
endpoint (p=0.0336). Lesions of subjects treated with retapamulin healed more quickly by the End of 
therapy visit (day 7-9), with a reduction in size of the lesions by 77.3% compared to 43.5% for 
placebo treated subjects. However by the Follow-up visit this difference was less pronounced, (88.6% 
vs, 81% for retapamulin and placebo treated subjects respectively). 
 
In the Intent to Treat Bacteriological evaluable population, the clinical success rate of retapamulin 
(76.4%: 139/182) was statistically superior to that of placebo (64.3%; 54/84). This difference was 
primarily due to the higher success rate observed in retapamulin-treated subjects with infections 
caused by S. aureus in comparison to placebo treated subjects (see Table below).  However, 
retapamulin showed no advantage over placebo in subjects with SIOW due to S. pyogenes. 
 
Clinical Success rates at Follow-up for Intent to Treat Bacteriological Evaluable SIOW subjects 

with S. aureus and S. pyogenes 
Pathogen Retapamulin Placebo 
 n/N Success 

rate (%) 
95% Exact CI n/N Success 

rate (%) 
S. aureus (all) 117/147 79.6 72.2,85.8 43/65 66.2 
MRSA 15/24 62.5 40.6,81.2 2/8 25.0 

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MSSA 102/123 82.9 75.1,89.1 41/57 71.9 
S. pyogenes 29/36 80.6 64.0,91.8 12/15 80.0 
CI: confidence interval. Exact CI is calculated using the F-distribution method 
 
 
 
 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Healthy adults 
 
In a study conducted in healthy adult subjects, 10 mg/g retapamulin ointment was applied daily to 
intact and to abraded skin under occlusion for up to 7 days. Systemic exposure following topical 
application of retapamulin through intact skin was very low. The geometric mean Cmax value in plasma 
after application to 200 cm2 of abraded skin was 9.75 ng/ml on day 1 and 8.79 ng/ml on day 7, and the 
maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ml. 
 
Patients from the age of 2 years 
 
Single plasma samples were obtained from 516 adult and paediatric patients who received topical 
treatment with retapamulin 10 mg/g ointment twice daily for 5 days for the treatment of secondarily 
infected traumatic lesions.  Sampling occurred pre-dose for adult subjects on days 3 or 4, and between 
0-12 hours after the last application for paediatric subjects on days 3 or 4.  The majority of samples 
(89%) were below the lower limit of quantitation (0.5 ng/ml). Of the samples that had measurable 
concentrations 90% had retapamulin concentrations less than 2.5 ng/ml.  The maximum measured 
plasma concentration of retapamulin was 10.7 ng/ml in adults and 18.5 ng/ml in paediatric patients 
(aged 2-17 years). 
 
Patients aged from 2 months to 24 months 
 
Single plasma samples were obtained approximately 4-8 hours after the first application on days 3 or 4 
from patients aged from 2 months to 2 years with impetigo or with secondarily infected traumatic 
lesions or dermatoses (note that retapamulin is not indicated for use in secondarily infected 
dermatoses). Retapamulin concentrations were measurable in 46% (36/79) of samples (range 0.52 to 
177.3 ng/ml) but the majority of these samples (27/36; 75%) contained < 5.0 ng/ml. 
 
Among the children aged from 9 months to 2 years plasma concentrations of retapamulin were 
measurable in 32% (16/50) of samples. A single retapamulin concentration (95.1 ng/ml) exceeded the 
highest concentration observed in patients aged 2-17 years (18.5 ng/ml). This plasma concentration 
was observed in a child with a secondary infected dermatosis, for which retapamulin is not indicated 
for use. 
 
Retapamulin is not recommended for use in children aged less than 9 months. In children aged from 2 
months to 9 months plasma concentrations of retapamulin were measurable in 69% (20/29) of 
samples. Four plasma retapamulin concentrations (26.9, 80.3, 174.3, and 177.3 ng/ml) exceeded the 
highest concentration observed in patients aged 2-17 years (18.5 ng/ml).  
 
Distribution 
 
Due to the very low systemic exposures, tissue distribution of retapamulin has not been investigated in 
humans.   
 
In vitro, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor. 

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However, the maximum individual systemic exposure in humans following topical application of 
10 mg/g ointment on 200 cm2 of abraded skin (Cmax= 22 ng/ml; AUC(0-24) = 238 ng.h/ml) was 660-fold 
lower than the retapamulin IC50  for Pgp inhibition.  
 
Retapamulin is approximately 94% bound to human plasma proteins.  
 
 
 
 
Biotransformation 
 
The in vitro oxidative metabolism of retapamulin in human liver microsomes was primarily mediated 
by CYP3A4 with minor contributions from CYP2C8 and CYP2D6 (see section 4.5).  
 
Elimination 
 
Retapamulin elimination in humans has not been investigated.  
 
Special populations 
 
No pharmacokinetic data are available in patients with renal or hepatic impairment.  However, due to 
the low systemic plasma levels that have been observed, no safety problems are foreseen. 
 
5.3 Preclinical safety data 
 
Repeated-dose toxicity 
 
In 14-day (50, 150 or 450 mg/kg) oral toxicity studies in rats there was evidence of adaptive hepatic 
and thyroid changes.  Neither of these findings is of clinical relevance. 
 
In monkeys dosed orally (50, 150 or 450 mg/kg) for 14 days there was dose-related emesis. 
 
Carcinogenesis, mutagenesis, reproductive toxicity 
Long-term studies in animals to evaluate carcinogenic potential have not been conducted with 
retapamulin. 
 
There was no evidence of genotoxicity when evaluated in vitro for gene mutation and/or chromosomal 
effects in the mouse lymphoma cell assay, in cultured human peripheral blood lymphocytes, or when 
evaluated in vivo for chromosomal effects in a rat micronucleus test.  
 
There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 
450 mg/kg/day, resulting in exposure margins of up to 5-times the highest human estimated exposure 
(topical application to 200 cm2 abraded skin: AUC 238 ng.h/ml). 
 
In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed 
skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/kg/day 
(corresponding to ≥ 3 times the human estimated exposure (see above).  There were no treatment-
related malformations in rats. 
 
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 
of gestation. Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/kg/day corresponding to ≥ 8 
times the estimated human exposure (see above). There was no treatment-related effect on embryo-
fetal development.  
 
No studies to evaluate effects of retapamulin on pre-/postnatal development were performed.  
However, there were no systemic effects on juvenile rats with topical application of retapamulin 
ointment. 

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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
White soft paraffin 
Butylated hydroxytoluene (E321) 
 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Unopened tube and sachet: 2 years. 
 
In-use tube: 7 days. 
 
6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container  
 
0.5 g aluminium foil sachet. Carton of 12 sachets. 
 
5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
Any remaining ointment at the end of treatment should be discarded. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
980 Great West Road 
BrentfordMiddlesex TW8 9GS 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S ) 
 
EU/1/07/390/001 
EU/1/07/390/002 
EU/1/07/390/003 
EU/1/07/390/004 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

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Date of first authorisation: 24 May 2007 
Date of latest renewal: 20 April 2012 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of  the European Medicines 
Agency: http://www.ema.europa.eu/. 

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13 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A.  MANUFACTURER(S) RESPONSIBLE FOR BATCH 
RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE   
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 

  
 
 

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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Glaxo Operations UK Ltd. (trdg as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
Durham, DL12 8DT   
United Kingdom  
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

• Periodic Safety Update Reports 
 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
  
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
 EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 

• Risk Management Plan (RMP) 
 
The MAH shall perform  the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or within 60 days 
of an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 
 
 
 
 
 

 
 
 
 
 
 
 
 

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15 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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A. LABELLING 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON FOR 5 g, 10 g, 15 g TUBE 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Altargo 10 mg/g ointment 
Retapamulin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each gram contains 10 mg retapamulin (1% w/w) 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: 
White soft paraffin 
Butylated hydroxytoluene (E321) 
See package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Ointment 
5 g x 1 tube 
10 g x 1 tube 
15 g x 1 tube 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Do not swallow. 
Apply to the affected area as directed by your doctor. 
Read the package leaflet before use. 
Cutaneous use only. 
 

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
Do not use in the eyes or on mucous membranes 
 
 
8. EXPIRY DATE 
 

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18 
 

EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
980 Great West Road 
Brentford 
Middlesex TW8 9GS 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/390/002    5 g 
EU/1/07/390/003  10 g 
EU/1/07/390/004  15 g 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Altargo 
 
 
 
 
 
 

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19 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON FOR 0.5 g SACHET  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Altargo 10 mg/g ointment 
Retapamulin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each gram contains 10 mg retapamulin (1% w/w) 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: 
White soft paraffin 
Butylated hydroxytoluene (E321) 
See package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Ointment 
0.5 g x 12 sachets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Do not swallow 
Apply to the affected area as directed by your doctor 
Read the package leaflet before use 
Cutaneous use only 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not use in the eyes or on mucous membranes. 
 
 
8. EXPIRY DATE 
 
EXP  
 

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20 
 

 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd  
980 Great West Road  
Brentford 
Middlesex TW8 9GS 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/07/390/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Altargo  
 
 
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21 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
5 g, 10 g 15 g TUBE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Altargo 10 mg/g ointment 
Retapamulin 
Cutaneous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 g 
 
10 g 
 
15 g 
 
 
6. OTHER 
 
Do not use in the eyes or on mucous membranes. 
 
 
 
 

 
 
 
 
 
 
 
 
 

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22 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
0.5 g SACHET  
 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Altargo 10 mg/g ointment 
Retapamulin 
Cutaneous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 g 
 
 
6. OTHER 
 
Do not use in the eyes or on mucous membranes. 
 
Do not store above 25°C. 
 
Read the package leaflet before use. 
 
 

 
 
 
 
 
 
 
 
 
 
 

 

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23 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 

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24 
 

 
 

 
Package leaflet: Information for the patient 

 
Altargo 10 mg/g ointment 

 
Retapamulin 

 
 
Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 
 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor or pharmacist 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness seem the same as yours. 
- If  you get any side effects talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Altargo is and what it is used for 
2. What you need to know before you use Altargo   
3. How to use Altargo 
4. Possible side effects 
5. How to store Altargo  
6.    Contents of the pack and other information 
 
1. What Altargo is and what it is used for 
 
Altargo ointment contains an antibiotic called retapamulin, which is used on the skin. 
Altargo is used to treat bacterial infections affecting small areas of skin.  Infections that may be treated 
include impetigo (which causes crusting scabs on infected areas), cuts, grazes and stitched wounds.   
 
Altargo is for adults and children aged nine months and older. 
 
 
2. What you need to know before you use Altargo 
 
Do not use Altargo 
 
If you are allergic to retapamulin or any of the other ingredients of this medicine (listed in section 6).  
 
Warnings and precautions 
 
Talk to your doctor or pharmacist before using Altargo. 
 
If you notice any worsening of the infection or develop increased redness, irritation or other signs and 
symptoms at the site of application you should stop using Altargo and tell your doctor.  See also 
section 4 of this leaflet. 
 
If there is no improvement in your infection after two to three days of treatment contact your doctor. 
 
Children 
 
Altargo should not be used on children who are less than nine months old. 

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25 
 

 
 
 
Other medicines and Altargo 
 
Do not apply other ointments, creams or lotions to the area being treated with Altargo unless 
specifically instructed to do so by your doctor. 
 
Tell your doctor if you are using, have recently used or might use any other medicines. If the patient is 
a child less than two years old it is especially important that you tell your doctor about any other 
medicines that the child is being given, including medicines bought without a prescription. It is 
possible that using Altargo in children who are taking certain medicines (such as some medicines used 
to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual.  
This might lead to side effects. Your doctor will decide if Altargo can be used for a child aged less 
than 2 years old who is taking other medicines. 
 
Pregnancy and breast-feeding  
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before using this medicine.  Your doctor will decide if this 
treatment is right for you. 
 
Driving and using machines 
 
Altargo is not expected to affect your ability to drive or use machines. 
 
Altargo contains butylated hydroxytoluene (E321)   
It may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous 
membranes. 
 
 
3. How to use Altargo 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 
you are not sure.  
 
How to apply Altargo 
 
A thin layer of ointment is usually put on the infected skin twice a day for five days. 
After applying your ointment, you may cover the treated area with a sterile bandage or gauze dressing, 
unless your doctor has told you to leave it uncovered. 
Keep using Altargo for as long as your doctor advises.   
 
Altargo is for use on the skin only.  It must not be put in the eyes, on the mouth or lips, inside the nose 
or inside the female genital area.  If the ointment accidentally gets on to these areas, wash the area 
with water and consult your doctor if you experience discomfort.  If you accidentally use Altargo 
inside your nose you could have a nose bleed. 
 
Wash your hands before and after applying the ointment. 
 
If you use more Altargo than you should 
 
Carefully wipe off the extra ointment. 
 
If you forget to use Altargo 
 
Apply the ointment as soon as you remember, and apply the next dose at the usual time. 

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26 
 

 
 
 
If you accidentally swallow Altargo 
 
Contact your doctor or pharmacist for advice. 
 
If you stop using Altargo 
 
If you stop using Altargo too soon, the bacteria may start to grow again and your infection may come 
back. Do not stop using this medicine before talking to your doctor or pharmacist. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Conditions to look out for 
 
Severe skin reactions or allergies (frequency not known) 
If you develop a severe skin reaction or an allergy: (e.g. severe itching or severe rash, swelling of the 
face, lips, or tongue):  

• stop using Altargo 
• carefully wipe off the ointment 
• contact your doctor or pharmacist immediately. 

 
The following side effects have occurred on the skin where Altargo has been applied: 
 
Common side effects (may affect up to 1 in 10 people): 
 
- skin irritation 
  
Uncommon side effects (may affect up to 1 in 100 people):  
 
- pain, itching, redness or rash (contact dermatitis)  
 
Other side effects (frequency not known, cannot be estimated from the available data): 
 
- a burning sensation  
 
Reporting of side effects 
If you get any side effects, talk to your doctor, nurse or pharmacist.  This includes any possible side 
effects not listed in this leaflet.  You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Altargo 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’.  
The expiry date refers to the last day of that month. 
 

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27 
 

Do not store above 25°C.  
 
Discard open tubes 7 days after opening, even if they are not empty. They should not be kept for 
future use. 
Do not throw away any medicines via household waste.  Ask your pharmacist how to throw away 
medicines you no longer use. These measures will help protect the environment. 
 
 
 
6. Contents of the pack and other information 
 
What Altargo contains 
 
- The active substance is retapamulin. Each gram of ointment contains 10 milligrams of 

retapamulin. 
- The other ingredients are white soft paraffin and butylated hydroxytoluene (E321), a 

preservative. 
 
What Altargo looks like and contents of the pack 
 
Altargo is a smooth, off-white ointment. 
It is supplied in an aluminium tube with a plastic cap, containing either 5, 10 or 15 grams of ointment, 
or in an aluminium foil sachet containing 0.5 g of ointment. 
 
Pack of 1 tube. 
Pack of 12 sachets. 
 
Not all pack sizes may be marketed in your country. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder Manufacturer 
 
Glaxo Group Ltd   
980 Great West Road  
Brentford 
Middlesex TW8 9GS, 
United Kingdom 
 

 
Glaxo Operations UK, Ltd,  (trading as Glaxo 
Wellcome Operations) 
Harmire Road 
Barnard Castle 
County Durham 
DL12 8DT 
 

 

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28 
 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 (0)10 85 52 00 

Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)10 85 52 00 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
cz.info@gsk.com 

Malta 
GlaxoSmithKline  (Malta) Limited 
Tel: + 356 21 238131 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
estonia@gsk.com 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (0)22 576 9000 

España 
Stiefel Farma, S.A.  
Tel: + 34 902 202 700 
es-ci@gsk.com 
 

Portugal 
GlaxoSmithKline – Produtos Farmacêuticos, Lda  
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 

France 
Laboratoire GlaxoSmithKline 
Tél.: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Hrvatska 
GlaxoSmithKline d.o.o. 
Tel: + 385 1  6051 999 
 
Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 
 

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29 
 

Ísland 
Vistor hf. 
Simi: + 354 535 7000 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com  
 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com   

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

 

 
This leaflet was last revised in  
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
____________________________________________________________________________ 
 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET