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POTTERS CALM & RELAX

Active substance(s): HOPS / SCULLCAP POWDER / VALERIAN ROOT AQUEOUS DRY EXTRACT 4:1 / VERVAIN HERB AQUEOUS DRY EXTRACT 3:1

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Potter’s Calm & Relax

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains: 75 mg Hop strobile (Humulus lupulus L.)
45 mg Scullcap (Scutellaria lateriflora L.)
30 mg of extract (as dry extract) from Vervain Herb (Verbena officinalis L.)
(3:1) (equivalent to 90 mg Vervain herb) Extraction solvent: Water
25 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.)
(4:1) (Equivalent to100 mg Valarian root) Extraction solvent: Water.
Excipient of known effect:
Each tablet contains 46.5 mg of sucrose. (See Section 4.4 “Special warnings
and precautions for use”.)
For full list of excipients see Section 6.1.

3

PHARMACEUTICAL FORM
Tablet.
A peach coloured, round, biconvex sugar-coated tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional herbal medicinal product used for the short term relief of symptoms
associated with stress such as mild anxiety, tenseness or irritability, based on
traditional use only.

4.2

Posology and method of administration
For oral use only.
Adults and the elderly: Take two tablets three times a day.

Not recommended for children and adolescents under 18 years of age. (See
section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified health
care practitioner should be consulted.

As treatment effects may not be apparent immediately, the product should be
taken for 2-4 weeks continuously.

4.3

Contraindications
Hypersensitivity to the active ingredients or any of the excipients.

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
The use of this product is not recommended in children and adolescents under 18
years of age because data are not sufficient and medical advice should be sought.

If symptoms worsen or persist for more than 4 weeks, a doctor or a qualified
health care practitioner should be consulted.
This medicinal product contains sucrose.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Valerian extract: Only limited data on pharmacological interactions with other
medicinal products are available. Clinically relevant interactions with drugs,
metabolized by the CYP2D6, CYP3A4/5, CYP1A2 or CYP2E1 pathway has
not been
observed.
Combination with synthetic sedatives is not recommended.
The effects of valerian may be potentiated by alcohol. Excessive concomitant
consumption of alcohol should therefore be avoided.

4.6

Fertility, Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been
established, therefore the use of this product during pregnancy and lactation is
not recommended.
Studies on fertility have not been carried out.

4.7

Effects on ability to drive and use machines
May impair ability to drive and use machines. If affected, patients should not drive or
operate machinery.

4.8

Undesirable effects
Gastrointestinal symptoms such as nausea, abdominal cramps may occur after
ingestion of valerian root preparations. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health
care 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
Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue,
abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which
disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily
consumption corresponding to approximately 30g of the drug) withdrawal
symptoms (delirium) have been reported.
Symptomatic and supportive measures should be taken as appropriate.

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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been
performed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Extract excipients
Maltodextrin
Colloidal anhydrous silica
Tablet
Sucrose
Acacia
Talc
Magnesium Stearate
Sodium Starch Glycolate
Kaolin Light
Yellow Iron Oxide (E172)
Red Iron Oxide (E 172)
Titanium Dioxide (E171)
Shellac

6.2

Incompatibilities
None known.

6.3

Shelf life
Three years.

6.4

Special precautions for storage
Do not store above 25˚C. Store in the original container.

6.5

Nature and contents of container
Tamper evident polyethylene/polypropylene pot packed in a cardboard box:
30, 50, 60, 84, 100, 126 and 168 tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
There are no special precautions for disposal.

7

MARKETING AUTHORISATION HOLDER
Soho Flordis UK Limited
1 Botanic Court,
Martland Park,
Wigan,
WN5 0JZ,
UK.
Trading as: Potters, Wigan WN5 0JZ

8

MARKETING AUTHORISATION NUMBER(S)
THR 44893/ 0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/02/2013

10

DATE OF REVISION OF THE TEXT
19/10/2015

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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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