Cimirelief Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cimirelief Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
2.5 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt) (6 - 11: 1).
Extraction solvent: isopropyl alcohol 40 % v/v.
Each tablet contains 197 mg lactose monohydrate, corresponding to 187 mg lactose. For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to beige, round tablets
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, sweating, sleep disturbances, restlessness, nervous irritability or temporary mood changes 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.
One tablet twice a day, morning and evening.
The tablets should be swallowed whole with a glass of water. Do not chew the tablets.
Children and adolescents under 18 years
There is no relevant indication for use in children or adolescents.
Duration of use
If symptoms persist, worsen or do not improve after 12 weeks a doctor should be consulted.
Hepatic and renal impairment
The safety of Black Cohosh 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 Black Cohosh or to any of the excipients.
Patients who have active liver disease or a history of liver damage.
Women who are pregnant or breast feeding or in women who could become pregnant (unless contraception is used).
In patients currently receiving treatment for or has had a history of an estrogen dependent tumour.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
There have been rare cases of hepatic reactions associated with the use of Black Cohosh. Patients taking the product should immediately stop the use of the product and consult their doctor if they develop signs and symptoms suggestive of liver dysfunction (fatigue, loss of appetite, 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. Please see section 5.3 “Preclinical safety data”.
Oestrogens may only be taken concurrently with the product 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.
The tablets contain lactose monohydrate: 197 mg per tablet, corresponding to 187 mg lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
There is no relevant indication in children or adolescents under 18 years of age.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been conducted to determine if drug interactions occur with the product.
4.6 Fertility, Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. Therefore it should be avoided during pregnancy or lactation.
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 conducted
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been conducted.
4.8 Undesirable effects
Gastrointestinal disorders (dyspepsia, diarrhoea), allergic skin reactions (urticaria, pruritus, skin rash), facial oedema and peripheral oedema, increase in liver enzymes (transaminases), weight gain. The frequency is not known.
In rare cases, Black Cohosh may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests).
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
No case of overdose has been reported.
In the event of overdose the undesirable effects listed in section 4.8 may worsen. The patient should stop taking the medicine and consult a doctor.
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
No genotoxic or mutagenic effect was reported in either bacterial test systems or an in vivo mice micronucleus test performed with an isopropanolic/aqueous Cimicifuga rhizome extract.
A reproduction toxicology study on the embryo-foetal development of Wistar rats during Cimicifuga treatment did not reveal any damage to the offspring. The highest dose tested was equivalent to 250 times the daily therapeutic dose in humans.
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 carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cellulose powder
Lactose monohydrate Magnesium stearate Potato starch.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4
Special precautions for storage
6.5 Nature and contents of container
PVC/PVDC-Al blister strips in cardboard carton.
Packs of 60, 100 and 200 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7
MARKETING AUTHORISATION HOLDER
Schaper & Brummer GmbH & Co. KG,
Bahnhofstr.
35,38259 Salzgitter, Germany
8 MARKETING AUTHORISATION NUMBER(S)
THR 26548/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/06/2011
10 DATE OF REVISION OF THE TEXT
06/08/2015