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DIAFEMIN TABLETS

Active substance(s): CIMICIFUGA RHIZOME / ST JOHNS WORT DRY EXTRACT

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
DiaFemin Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
300 mg of extract (as dry extract) from St. John’s Wort aerial parts (Hypericum
perforatum L.) (3.5-6:1) (equivalent to 1050 – 1800 mg of St. John’s Wort).
Extraction solvent: Ethanol 60% m/m
and
6.4 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga
racemosa (L.) Nutt.) (4.5-8.5:1) (equivalent to 28.80-54.40 mg of Black Cohosh
rhizome).
Extraction solvent: Ethanol 60% v/v
Each coated tablet contains 19 mg of lactose monohydrate, 234 mg of sucrose and 6
mg of glucose.
For full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Coated tablet.
Light yellow, shape like lenses, smooth glossy surface.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional herbal medicinal product used for the relief of symptoms of the
menopause, including hot flushes, night sweats, slightly low mood and mild anxiety
based on traditional use only.

4.2

Posology and method of administration
For oral use only.
For women experiencing menopausal symptoms, take 1 tablet daily. Tablets should
be taken at the same time of day if possible (morning or evening) and swallowed
whole with plenty of liquid. Do not chew the tablets.
If symptoms worsen or do not improve after 6 weeks a doctor or qualified healthcare
practitioner should be consulted.
The use in children or adolescents under 18 years of age is not recommended (see
Section 4.4 special warnings and precautions for use).

4.3

Contraindications
Hypersensitivity to the active ingredient(s) or any of the excipients.
Patients with known dermal photosensitivity or patients undergoing phototherapy or
any photodiagnostic procedures.
This product should not be taken concomitantly with the medicines included in
Section 4.5. This is because St John’s Wort (Hypericum perforatum) has been shown
to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19 and
CYP3A4 as well as transport protein P-glycoprotein. This results in pharmacokinetic
interactions with a large number of medicines including leading to a possible decrease
in the effectiveness of those medicines.
In addition, pharmacodynamic interactions have also been identified with
antidepressants, particularly the SSRI antidepressants and with the triptan group of
medicine.
Patients who have hepatic and/or renal impairment since the safety of Black cohosh
extract has not been studied in patients with hepatic and/or renal impairment.
In patients who have active liver disease or a history of liver damage.

In patients currently receiving treatment for or has had a history of an oestrogen
dependent tumour.
As there is evidence that Black cohosh may have hormone-like actions, it should only
be used by women of childbearing potential if contraception is used.

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than six weeks a doctor or
qualified healthcare practitioner should be consulted.
The use of this product in children and adolescents under 18 years of age is not
recommended since there is no relevant use.
This product is intended for relief of menopausal symptoms including slightly low
mood and mild anxiety. Patients with signs and symptoms of depression should
consult a doctor for appropriate treatment.
In very rare cases, particularly in light-skinned persons, sun burn type reactions on
skin areas exposed to strong sunlight may occur due to photosensitisation by St
John’s Wort. Persons using this product should avoid excessive sunbathing or the use
of sunbeds or solariums.
This product should be discontinued at least 10 days prior to elective surgery due to
the potential for interactions with medicinal products used during general and
regional anaesthesia (see Section 4.5).
There have been rare cases of hepatic reactions associated with the use of Black
Cohosh. Patients taking DiaFemin Tablets should be informed to immediately stop
the use of the product and consult their doctor if they develop signs and symptoms
suggestive of liver dysfunction. (Fatigue, anorexia, yellowing of the skin and eyes or
severe upper stomach pain with nausea and vomiting or dark urine).
Advice should be sought from a doctor if the patient has a family history of an
oestrogen dependent tumour.
Oestrogens may only be taken simultaneously with DiaFemin Tablets under
supervision of a doctor, as their effect may be intensified by Black Cohosh.
If menstrual disorders occur or menstruation re-appears and if the symptoms are
persistent, of unknown origin, or have recently occurred, a doctor should be consulted

as this may indicate the presence of other conditions which need to be medically
diagnosed.
Patients with rare hereditary problems of galactose intolerance and/or fructose
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
This product contains sucrose, lactose and glucose.

4.5

Interaction with other medicinal products and other forms of interaction
Substances in St John’s Wort (Hypericum perforatum) have been shown to induce the
cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19 and CYP3A4 as well as
the transport protein P-glycoprotein. This results in pharmacokinetic interactions with
a large number of medicines leading to a potential decrease in the effectiveness of
those medicines.
The concomitant use of ciclosporin, tacrolimus for systemic use, amprenavir,
indinavir and other protease inhibitors, irinotecan and warfarin is contraindicated.
Special care should be taken in the case of concomitant use of all drug substances the
metabolism of which is influenced by CYP1A2, CYP3A4, CYP2C9, CYP2C19 or Pglycoprotein (e.g. amitriptyline, fexofenadine, benzodiazepines, methadone,
simvastatin, digoxin, finasteride) because a reduction of plasma concentration is
possible.
Users of oral contraceptives taking St John’s Wort (Hypericum perforatum) may
experience intracyclic menstrual bleeding and risk of contraception failure is
increased.
Clinically significant pharmacodynamic interactions have also been identified with
the SSRI antidepressants, and the triptan group of medicines used to treat migraines.
Due to the increased risk of undesirable effects associated with these interactions this
product should not be used concomitantly with these types of medicines.
Therefore this product should not be taken concomitantly with the medicines included
in Table below.

Coadministered
drug

Interaction

Recommendations concerning
co-administration

Anaesthetics /pre-operative medicines
Fentanyl,
propofol,
sevoflurane,
midazolam

Reduced blood levels with
risk of therapeutic failure.

Based on the elimination halflives of hypericin and hyperforin
this product should be
discontinued at least 10 days
prior to elective surgery.

Analgesics
Tramadol

Reduced blood levels with
risk of therapeutic failure.

Do not take with this product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this product.

Antianginals
Ivabradine

Anti-arrhythmics
Amiodarone

Antibacterials
Erythromycin,
clarithromycin,
telithromycin

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced anticoagulant
effect and need for increased
dose

Do not take with this
product.

Increased serotonergic
effects with increased
incidence of adverse
reactions.

Do not take with this
product.

Reduced blood levels with
increased risk of frequency
and severity of seizures.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Anticoagulants
warfarin,
acenocoumarol

Antidepressants
Tricyclics eg.
amitriptyline,
clomipramine
MAOIs eg.
moclobemide

SSRIs eg.
citalopram,
escitalopram,
fluoxetine,
fluvoxamine,
paroxetine, sertraline,

Others eg.
duloxetine,
venlafaxine

Antiepileptics
All drugs in this class
including:
carbamazepine
phenobarbitone
phenytoin
primidone
sodium valproate

Antifungals
itraconazole,
voriconazole

Antimalarials
artemether

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
possible loss of HIV
suppression.

Do not take with this
product.

Reduced blood levels with
possible loss of HIV
suppression

Do not take with this
product.

buspirone

Increased serotonergic
effects with increased
incidence of adverse
reactions.

Do not take with this
product.

Aprepitant

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

lumefantrine
Anti-parkinsons
rasagiline

Antipsychotics
aripiprazole

Antivirals
HIV protease
inhibitors:
amprenavir,
atazanavir, darunavir,
fosamprenavir,
indinavir, lopinavir,
nelfinavir, ritonavir,
saquinavir, tipranavir

HIV non-nucleoside
reverse
transcriptase
inhibitors: efavirenz,
nevirapine,
delavirdine

Anxiolytics

Barbiturates
butobarbital,
phenobarbital

Calcium channel blockers

amlodipine,nifedipine Reduced blood levels with
risk of therapeutic failure.
verapamil, felodipine

Do not take with this
product.

Cardiac glycosides
digoxin

Reduced blood levels and
loss of control of heart
rhythm or heart failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

CNS Stimulants
methyl phenidate
Cytotoxics
irinotecan, dasatinib,
erlotinib, imatinib,
sorafenib, sunitinib,
etoposide, mitotane

Hormonal contraceptives
Oral contraceptives
Emergency Hormonal
Contraception

Reduced blood levels with
risk of unintended
pregnancy and breakthrough
bleeding.

Do not take with this
product.

Hormonal implants,
injections
Transdermal patches,
creams etc.
Intra-uterine devices
with hormones
Hormone Replacement Therapy
Hormone
Replacement
Therapy:

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Increased serotonergic
effects with increased
incidence of adverse
reactions.

Do not take with this
product.

Reduced blood levels with
risk of transplant rejection.

Do not take with this
product.

simvastatin,
atorvastatin

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Lithium

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Oral
Trandermal patches,
gels
Vaginal rings
Hormone antagonists
exemestane
Diuretics
eplerenone
5HT agonists
almotriptan,eletriptan,
frovatriptan,
naratriptan,
rizatriptan,
sumatriptan and
zolmitriptan

Immunosuppressants
ciclosporin,
tacrolimus
Lipid regulating drugs

Proton pump inhibitors
lansoprazole,
omeprazole
Theophylline

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Reduced blood levels and
loss of control of asthma or
chronic airflow limitation.

Do not take with this
product.

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Thyroid hormones
thyroxine

Oral hypoglycaemic drugs
gliclazide

4.6

Reduced blood levels with
risk of therapeutic failure.

Do not take with this
product.

Fertility, Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established.
Therefore it should be avoided during pregnancy or lactation.
Additionally because of the potential for Black cohosh to have hormone-like actions,
the use by women who could become pregnant is not recommended unless
contraception is used.

4.7

Effects on ability to drive and use machines
May impair the ability to drive and use machines. If affected, do not drive or operate
machines.

4.8

Undesirable effects
Gastrointestinal disorder (e.g. dyspepsia, anorexia, nausea, diarrhoea, constipation);
allergic skin reaction (e.g. rash, urticaria, pruritis); fatigue and restlessness may occur.
The frequency is not known.
Fair-skinned individuals may react with intensified sunburn-like symptoms under
intense sunlight or strong ultra-violet (UV) irradiation.
Other ADRs reported in the literature with products containing Black cohosh include
facial oedema, peripheral oedema and weight gain.
Other ADRs reported in the literature with products containing St. John’s wort
include headaches, neuropathy, anxiety, dizziness and mania.
In rare cases, Black cohosh containing products may cause liver reactions (including
hepatitis, jaundice and disturbances in liver function tests).

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare
practitioner should be consulted.

4.9

Overdose
There are no data on human overdose with St John’s Wort.
After intake of up to 4.5 g dry extract per day for 2 weeks and additionally 15 g dry
extract just before hospitalization, seizures and confusion have been reported.
Where a large overdose has occurred, phototoxic reactions may occur. The skin of the
patient should be protected for one to two weeks from UV irradiation and sunlight.
Outdoor activities should be restricted and clothes and/or sun block preparations used
to protect the skin from sunlight. Symptomatic and supportive measures should be
taken as appropriate.
Older herbal texts state that doses of over 5 g of unprocessed Black Cohosh daily may
produce symptoms of nausea, vomiting, dizziness, visual and nervous disturbances,
reduced pulse rate and increased perspiration.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2

Pharmacokinetic properties
Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3

Preclinical safety data
The preclinical toxicology data available are limited. Tests on reproductive toxicity,
genotoxicity and carcinogenicity have not been performed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Extract excipients:

Maltodextrin
Silica, colloidal anhydrous
Cellulose, powdered
Lactose monohydrate
Tablet core:
Silica, colloidal anhydrous
Croscarmellose sodium
Cellulose, microcrystalline
Sodium starch glycollate (type A)
Magnesium stearate
Excipients of the coating:
Hypromellose
Sucrose
Talcum
Calcium carbonate E 170
Tragacanth
Acacia
Liquid glucose (dry substance)
Titanium dioxide E 171
Iron oxide hydrate E 172
Vanillin
Beeswax, white
Carnauba wax
Shellac

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
3 years

6.4

Special precautions for storage
Do not store above 25° C. Store in the original package.

6.5

Nature and contents of container
Original packages contain 30, 60, 90 or 100 coated tablets
DiaFemin Tablets are packed in PVC/ PVDC- aluminium blisters and inserted into a
carton.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
Diapharm GmbH & Co. KG
Hafenweg 18-20
48155 Münster
Germany

8

MARKETING AUTHORISATION NUMBER(S)
THR 42340/0015

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12/04/2011

10

DATE OF REVISION OF THE TEXT
07/08/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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