SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Padma Circosan capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains:

40 mg costus root (Saussurea costus (Falc.) Lipsch., radix )

40 mg Iceland moss (Cetraria islandica (L.) Ach. s.l., thallus)

35 mg neem fruit (Azadirachta indica A. Juss., fructus)

30 mg cardamom fruit (Elettaria cardamomum (Roxb.) Maton var. minuscula Burk., fructus)

30 mg myrobalan fruit (Terminalia chebula Retz, fructus)

30 mg red sanderswood (Pterocarpus santalinus L.f., lignum)

25 mg allspice (Pimenta dioica (L.) Merr., fructus)

20 mg Bengal quince (Aegle marmelos (L.) Correa, fructus)

15 mg European columbine (Aquilegia vulgaris L., herba)

15 mg liquorice root (Glycyrrhiza glabra L., radix)

15 mg ribwort plantain (Plantago lanceolata L. s.l., folium)

15 mg knotgrass (Polygonum aviculare L. s.l., herba)

15 mg golden cinquefoil (Potentilla aurea L., herba)

12 mg clove (Syzygium aromaticum (L.) Merr. et L. M. Perry, flos)

10 mg kaempferia galanga rhizome (Kaempferia galanga L., rhizoma)

10 mg heart leaf sida (Sida cordifolia L., herba)

10 mg valerian root (Valeriana officinalis L. s.l., radix)

6 mg lettuce leaf (Lactuca sativa var. capitata L., folium)

5 mg calendula flower head (Calendula officinalis L., flos cum calyce)

4 mg D-camphor (D-Camphora)

Ancillary mineral

20 mg calcium sulphate hemihydrate (Calcii sulfas hemihydricus).

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsules, hard.

Two piece clear hard capsules with brown powder.

CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of Raynaud's syndrome and for the relief of symptoms associated with minor venous circulatory disturbances such as tired heavy legs, pain, swelling, and for calf cramps, based on traditional use only.

Padma Circosan is derived from a formula of Tibetan Medicine.

4.2 Posology and method of administration

For oral use only.

The capsules should be swallowed whole on an empty stomach with a glass of water.

If gastrointestinal symptoms occur, the capsules should be taken with meals and with plenty of fluids (preferably lukewarm water).

Persons who have difficulty swallowing may suspend the contents of the capsules in a glass of lukewarm water.

Patients should wait at least one and a half to two hours before taking any other medicinal products after taking Padma Circosan capsules.

Adults and the Elderly:

Two capsules 3 times a day.

The dosage can be reduced to 1 to 2 capsules per day if symptom relief is obtained. Children and Adolescents:

This medicine is not recommended for children and adolescents under 18 years of age (see section 4.4 “Special warnings and precautions for use”).

Duration of use:

If the symptoms worsen or do not improve after 4 weeks of taking the product, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active substances, plants of the Asteraceae (Compositae) family or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age is not recommended because of the need for medical supervision.

If there is inflammation of the skin or subcutaneous induration, ulcers, sudden swelling of one or both legs particularly associated with redness and heat, cardiac or renal insufficiency, or a sudden sharp pain in the leg when at rest a doctor should be consulted.

If the symptoms worsen or do not improve after 4 weeks of taking the product, a doctor or qualified healthcare practitioner should be consulted.

Patients should stop taking the product immediately and consult their doctor if they develop any 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.)

Each capsule contains 15 mg liquorice root. This amount is such that further warnings are not required whilst taking Padma Circosan.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with this product.

Each capsule contains a small amount of liquorice root and valerian root, such that any characteristic interactions of these individual herbs are not expected to occur whilst taking Padma Circosan.

4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established.

In the absence of sufficient data the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

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 performed.

Each capsule contains a small amount of valerian root, such that any characteristic effects of this individual herb are not expected to occur whilst taking Padma Circosan.

4.8    Undesirable effects

The following adverse reactions have been reported:

The frequency is not known: dyspepsia, nausea, heartburn, diarrhoea, rash and itching.

Single cases of disturbances of liver function have been reported after intake of Padma Circosan (jaundice and disturbances in liver function tests), the causal relationship between this effect and the use of the product has not been demonstrated.

If other adverse reactions not mentioned above occur, a doctor or 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    Overdose

No cases of overdose have been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Pharmacokinetic properties

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

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on the conventional studies of single-dose and repeat-dose toxicity and genotoxicity. Tests on reproductive toxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Colloidal anhydrous silica.

Capsule shell: gelatin

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 original package.

6.5 Nature and contents of container

Either aluminium-PVC/PE/PVdC blister packs or aluminium-PVC/PVdC blister packs.

Packs contain 60, 120 or 200 capsules. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

PADMA EUROPE GmbH Hietzinger Hauptstr. 37/2 AT-1130 Vienna Austria.

8    MARKETING AUTHORISATION NUMBER(S)

THR 39568/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/02/2013

10    DATE OF REVISION OF THE TEXT

14/07/2015