Summary of Product Characteristics (SmPC) - Kira Menopause Relief film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Kira Menopause relief film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
6.5mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5 – 8.5: 1) (equivalent to 29.25 -55.25 mg of Black Cohosh).
Extraction Solvent:
Ethanol 60% (v/v).
One film-coated tablet contains 142 mg lactose monohydrate (See Section 4.4).
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, convex curved and with a score mark on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of symptoms of the menopause, such as hot flushes, night sweats, and temporary changes in mood (such as nervous irritability and restlessness) based on traditional use only.
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.
4.2 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 the day if possible (morning or evening) and swallowed whole with plenty of liquid. Do not chew the tablets.
Black Cohosh should not be taken for more than 6 months without medical advice.
Children and adolescents less than 18 years old
This product is not indicated in patients less than 18 years.
Hepatic and renal impairment
The safety of cimicifuga rhizome extract has not been studied in patients with hepatic and/or renal impairment. This product should not be taken by patients who have hepatic impairment or renal impairment.
4.3 Contraindications
Hypersensitivity to the active ingredient or to any of the excipients In patients under 18 years old.
Women who are pregnant or breast feeding or in women who could become pregnant (unless contraception is used).
In patient 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.
4.4 Special warnings and precautions for use
There have been rare cases of hepatic reactions associated with the use of Black Cohosh. Patients taking Kira Menopause relief 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).
Patients who have been treated or who are undergoing treatment for breast cancer or other hormone-dependent tumours should not use Cimicifuga preparations without medical advice (see section 5.3).
Advice should be sought from a physician if the patient has a family history of an oestrogen dependent tumour.
Oestrogens may only be taken simultaneously with Kira Menopause relief under medical supervision, 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 a history of liver disorder should take Kira Menopause relief with caution (see section 4.8).
Patients should stop taking Kira® Menopause relief and consult their doctor immediately if they develop signs and symptoms suggestive of liver injury (tiredness, loss of appetite, yellowing of skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine).
If vaginal bleeding occurs or other symptoms occur, a doctor should be consulted.
If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist should be consulted.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy or lactation is not recommended.
Additionally, because of the potential for the product to have hormone-like actions the product should also be avoided by women who could become pregnant unless contraception is used.
No studies on the effects on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed.
4.8 Undesirable effects
Hepatobiliary disorders
Liver toxicity (including hepatitis, jaundice, disturbances in the liver function tests) is associated with the use of Cimicifugae rhizoma containing products. The frequency is not known.
Skin and subcutaneous tissue disorders
Allergic skin reactions (urticaria, itching, exanthema), facial oedema and peripheral oedema have been reported. The frequency is not known.
Gastrointestinal disorders
Gastrointestinal symptoms (i.e. dyspeptic disorders, diarrhoea) have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted.
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 Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
In the event of an overdose, patients are advised to contact a doctor, pharmacist or qualified healthcare professional. A small overdose (up to 4 tablets) is unlikely to cause any symptoms. In the event of a larger overdose (more than 4 tablets), advice should be sought from a doctor. Management of a larger overdose should be symptomatic and supportive in nature.
Older herbal texts state that doses of over 5 g unprocessed drug 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 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.
In a six-month study in rats the no-observed- effect-level (NOEL) for the isopropanolic extract (Granulate) was defined with 21.06 mg native extract/kg bodyweight.
Evidence from in-vitro and in-vivo pharmacological studies suggests that Cimicifuga extracts do not influence the latency or development of breast cancer. However, contradictory results have been obtained in other in-vitro experiments.
In Cimicifuga-treated (isopropanolic black cohosh extract equivalent to 40 mg of root and rhizome), tumour-bearing, female transgenic mice, the percentage of mice with detectable metastatic lung tumours at necropsy was increased compared to those on the control diet. However, in the same experimental model, no increase in primary breast tumour was seen. Influence on breast cancer or other hormone-depending tumours cannot be completely excluded.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate
Cellulose powdered
Silica, colloidal anhydrous
Excipients of the tablet:
Silica, colloidal anhydrous
Magnesium stearate
Maize starch
Cellulose, microcrystalline
Sodium starch glycollate (type A)
Excipients of the film-coating:
Hypromellose
Macrogol 4000
Titanium dioxide E 171
6.2 Incompatibilities
Not applicable
6.3 Shelf life
4 years.
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original packaging.
6.5 Nature and contents of container
Original packages containing 30 film-coated tablets.
Kira® Menopause relief film-coated 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
Bayer plc
400 South Oak Way
Reading
RG2 6AD
8 MARKETING AUTHORISATION NUMBER(S)
THR 00010/0087
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/09/2017
10 DATE OF REVISION OF THE TEXT
11/12/2025