ALBOTHYL VAGINAL SUPPOSITORY 90 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

POLICRESULEN

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

G01AX03

Dosage:

90 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

POLICRESULEN 90 mg

Administration route:

VAGINAL

Prescription type:

Pharmacy Only

Manufactured by:

Takeda GmbH

Authorization status:

ACTIVE

Authorization date:

1989-06-30

Patient Information leaflet

Composition
1 vaginal suppository contains:

Active Ingredient
Policresulen 90mg

Excipients
Macrogol 1500 and 4000; water

Pharmaceutical form and contents
Vaginal suppositories
Packs with 6 vaginal suppositories

Pharmacotherapeutic/ Indication group/action mechanism
Antiseptic/ Gynaecological agent

Manufacturer
Takeda GmbH
Robert-Bosch-Str. 8
78224 Singen
Germany
Marketing Authorization Holder
Takeda Pharmaceuticals (Asia Pacific) Pte. Ltd
21 Biopolis Road
Nucleos North Tower, Level 4
Singapore 138567

Indications
Local treatment of inflammation or infection andtissue damage of
vagina and cervix 
(e.g. dischargedue to bacterial, trichomonal and fungal
infections,pressure sores from 
pessaries), condylomataacuminata, etc.
Protuberance of cervical mucosa (cervical ectopia).

Contraindications
Albothyl vaginal suppositories must not be administeredin cases of
hypersensitivity 
to any of theconstituents.

Pregnancy and lactation
Albothyl vaginal suppositories may be usedduring pregnancy and
breastfeeding 
only whereit is strictly indicated, after due consideration ofthe
risks to the mother 
and child. There havenot been any studies of the risks associated
withuse during 
pregnancy in humans, but animal studieshave not yielded any evidence
of fetal 
malformation.It is not known whether the active substancepasses into
milk.

Cauterization of the cervix should be avoided in pregnant
women, particularly in the 
later stages of pregnancy, since it may cause labour to begin. The
cervical portio and 
the parts of the vagina adjacent to the portio should be cauterized
with appropriate 
care, and only in certain strictly defined indications.

Special warnings and precautions for use
- To avoid erosion of the oesophagus, care must be taken not to
swallow the 
suppositories.If Albothyl vaginal suppositories havebeen swallowed
inadvertently, 

Summary of Product characteristics

Composition
1 vaginal suppository contains:
Active Ingredient
Policresulen 90mg
Excipients
Macrogol 1500 and 4000; water
Pharmaceutical form and contents
Vaginal suppositories
Packs with 6 vaginal suppositories
Pharmacotherapeutic/ Indication group/action mechanism
Antiseptic/ Gynaecological agent
Manufacturer
Takeda GmbH
Robert-Bosch-Str. 8
78224 Singen
Germany
Marketing Authorization Holder
Takeda Pharmaceuticals (Asia Pacific) Pte. Ltd
21 Biopolis Road
Nucleos North Tower, Level 4
Singapore 138567
Indications
Local treatment of inflammation or infection andtissue damage of
vagina and cervix
(e.g. dischargedue to bacterial, trichomonal and fungal
infections,pressure sores from
pessaries), condylomataacuminata, etc.
Protuberance of cervical mucosa (cervical ectopia).
Contraindications
Albothyl vaginal suppositories must not be administeredin cases of
hypersensitivity
to any of theconstituents.
Pregnancy and lactation
Albothyl vaginal suppositories may be usedduring pregnancy and
breastfeeding
only whereit is strictly indicated, after due consideration ofthe
risks to the mother
and child. There havenot been any studies of the risks associated
withuse during
pregnancy in humans, but animal studieshave not yielded any evidence
of fetal
malformation.It is not known whether the active substancepasses into
milk.
Cauterization of the cervix should be avoided in pregnant women,
particularly in the
later stages of pregnancy, since it may cause labour to begin. The
cervical portio and
the parts of the vagina adjacent to the portio should be cauterized
with appropriate
care, and only in certain strictly defined indications.
Special warnings and precautions for use
- To avoid erosion of the oesophagus, care must be taken not to
swallow the
suppositories.If Albothyl vaginal suppositories havebeen swallowed
inadvertently,