DIACIMI TABLETS - summary of medicine characteristics

DiaCimi Tablets film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

6.5 mg 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.’Special warnings and precautions for use.’

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.

4.1 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 day if possible (morning or evening) and swallowed whole with plenty of liquid. Do not chew the tablets.

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 patients who have active liver disease or a history of liver damage.

– In patients who have been treated or who are undergoing treatment for breast cancer or other hormone dependent tumours.

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 DiaCimi 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).

Patients who have been treated or who are undergoing treatment for breast cancer or other hormone-dependant tumours should not use Black Cohosh preparations without medical advice (see section 5.3 Preclinical Safety data)

Estrogens may only be taken simultaneously with DiaCimi Tablets 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 rare hereditary problems of galactose intolerance, the Lapp 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

Very rarely (less than 1 in 1000, but more than 1 in 10000 treated patients), there may be gastrointestinal symptoms (dyspeptic symptoms, diarrhoea), allergic skin reactions (nettle rash, itching of the skin, skin rash), facial oedema and peripheral oedema, and weight gain.

In rare cases, Black cohosh may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests).

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 large 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

The preclinical toxicology data available are limited.

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 glycolate (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, 60, 90 or 100 film-coated tablets

DiaCimi Tablets film-coated tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton.

6.6 Special precautions for disposal

No special requirements