Menoforce Sage tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Dry extract salvia officinalis l.

Available from:

Bioforce (UK) Ltd

INN (International Name):

Dry extract salvia officinalis l.

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

2013-05-03

Patient Information leaflet

                                Bioforce UK
Salvia tablets
GB – Irvine, Ayrshire
CTD Module 1
May 2018
___________________________________________________________________________________
PACKAGE LEAFLET
Page 1 of 4
Salvia off. Tabl (2)
Art. no. 01103800
PACKAGE LEAFLET: INFORMATION FOR THE USER
MENOFORCE
Sage tablets
Sage dry extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
PRODUCT BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this product exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 12 weeks.
WHAT IS IN THIS LEAFLET:
1.
What Menoforce is and what it is used for
2.
What you need to know before you take Menoforce
3.
How to take Menoforce
4.
Possible side effects
5.
How to store Menoforce
6.
Contents of the pack and other information
1.
WHAT MENOFORCE IS AND WHAT IT IS USED FOR
Menoforce is a traditional herbal medicinal product containing the
extract of fresh Sage
leaves.
It is used to relieve:
•
Menopausal hot flushes
•
Excessive sweating
This is based exclusively on long-standing use.
Menoforce is for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MENOFORCE
DO NOT TAKE MENOFORCE
•
If you are allergic to Sage or any of the other ingredients in this
product (listed in
section 6).
•
If you are pregnant or breast-feeding.
Bioforce UK
Salvia tablets
GB – Irvine, Ayrshire
CTD Module 1
May 2018
___________________________________________________________________________________
PACKAGE LEAFLET
Page 2 of 4
Salvia off. Tabl (2)
Art. no. 01103800
WARNINGS AND PRECAUTIONS
•
Talk to your doctor if your symptoms worsen or do not improve within
12 weeks.
•
Excessive sweating can sometimes be a sign
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Menoforce Sage tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 51 mg of dry extract from fresh Sage (Salvia
officinalis L.) leaves (equivalent to 795 - 1370 mg of
fresh herb). Extraction solvent: ethanol 68% v/v.
Excipients with known effect:
One tablet contains 10.2 mg sucrose laurate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
It is an olive green to yellowish-brown, slightly dotted, oblong,
biconvex, bevelled tablet with a slightly aromatic
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of
menopausal hot flushes and excessive perspiration,
exclusively based on long-standing use.
This product is indicated for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (18 years and over): 1 tablet daily.
This product is not indicated in patients less than 18 years.
If the symptoms worsen during the use of Menoforce or do not improve
after 12 weeks a qualified healthcare
professional e.g. a doctor or pharmacist should be consulted.
Due to a lack of data the safety of this product for long term use has
not been established.
Method of Administration
For oral use only.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to Sage preparations or
to any of the excipients listed in section 6.1.
Do not use if pregnant or breast-feeding.
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                                Read the complete document