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LACTIC ACID 5% PESSARIES BP

Active substance(s): LACTIC ACID

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Product Summary
1.

Trade Name of the Medicinal Product
Lactic Acid 5% Pessaries BP

2.

Qualitative and Quantitative Composition
Lactic Acid BP 5% w/w

3.

Pharmaceutical Form
Pessaries

Clinical Particulars
4.1

Therapeutic Indications
For the treatment of leucorrhoea.

4.2

Posology and Method of Administration
To be inserted high into the vagina.
Adults
One pessary to be inserted once or twice daily or as recommended by the physician.
Children
The product is not recommended for use in children.

4.3

Contra-indications
None known.

4.4

Special Warnings and Precautions for Use
If symptoms persist consult your doctor.

4.5

Interaction with other Medicaments and other forms of Interaction
None known.

4.6

Pregnancy and Lactation
No evidence of harmful effect is known.

4.7

Effects on Ability to Drive and Use Machines
Not applicable.

4.8

Undesirable Effects
None known.

4.9

Overdose
Not applicable.

Pharmacological Properties
5.1

Pharmacodynamic Properties
Lactic Acid 5% Pessaries is a well established preparation reference to them has been
available in the BPC, BP Martindale and BNF for a number of years.
They modify vaginal acidity helping to maintain or re-establish the normal vaginal flora and
in doing so may bring relief to the condition of leucorrhoea.

5.2

Pharmacokinetic Properties
None know.
Lactic Acid is a natural secretion of the vagina.

5.3

Preclinical Safety Data
There are no additional preclinical data of relevance to the prescriber other than those stated
elsewhere in the document.

Pharmaceutical Particulars
6.1

List of Excipients
Gelatin, Glycerol and Purified Water.

6.2

Incompatibilities

None known.

6.3

Shelf-life
24 months unopened.

6.4

Special Precautions for Storage
Store below 25°C in a dry place.

6.5

Nature and Contents of Container
Hydrophobic paper lined cardboard box containing 12, 36, 50, 100, 144 or 150 pessaries.

6.6

Instruction for Use/Handling
None stated.

Administration Details
7.

Marketing Authorization Holder
Martindale Pharmaceuticals Ltd.
Bampton Road,
Harold Hill,
Romford,
RM3 8UG

8.

Marketing Authorization Number
PL 00156/0070

9.

Date of First Authorization/Renewal of Authorization
First authorised: 6 June 1997
Renewal date: 29 August 1999

10.

Date of (Partial) Revision of the Text
Not applicable

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