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KALMS LAVENDER ONE-A-DAY CAPSULES

Active substance(s): LAVENDER OIL

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Kalms Lavender One-a-Day capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains:
80 mg of oil from flowering tops of Lavender (Lavandula angustifolia Miller,
aetheroleum).
Each soft capsule also contains: up to 13 mg of sorbitol (see ‘Section 4.4 Special
warnings and precautions for use’.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Soft capsule, oval shaped, violet colour

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of the symptoms
of mild anxiety such as stress and nervousness based on traditional use only.

4.2

Posology and method of administration
For oral use only. The capsules should be swallowed with a full glass of water. The
capsules should not be chewed.
Adults and the elderly. Take one soft capsule once daily.
The use of this product in children and adolescents under 18 years of age is not
recommended (see Section 4.4. Special warnings and precautions for use. ').
If the symptoms worsen, or do not improve after 2 weeks, a doctor or qualified
healthcare practitioner should be consulted.

4.3

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section
6.1

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
Contains sorbitol. Patients with rare hereditary problems of fructose intolerance
should not take this medicine.
The use of this product in children and adolescents under 18 years of age is not
recommended and medical advice should be sought.
If the symptoms worsen, or do not improve after 2 weeks, a doctor or qualified
healthcare practitioner should be consulted.
Should not be taken with other medicines for sleep or anxiety.
This product is intended for the relief of symptoms of mild anxiety such as stress and
nervousness. Patients with signs and symptoms of depression should seek medical
advice for appropriate treatment.

4.5

Interaction with other medicinal products and other forms of interaction
None reported.

4.6

Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of
sufficient data, the use during pregnancy and lactation is not recommended.
No impairment of fertility with Lavender oil was shown in reproductive toxicity
studies in rats and rabbits (see section 5.3).

4.7

Effects on ability to drive and use machines
May impair ability to drive and use machines. Affected patients should not drive or
operate machinery.
No studies on the effect on the ability to drive and use machines have been
performed.

4.8

Undesirable effects
The evaluation of adverse reactions is based on the following information on
frequency:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
not known (cannot be estimated from the available data)
Gastrointestinal disorders
Common: eructation

Skin and subcutaneous tissue disorders / Immune system disorders
Common: allergic skin reactions (urticaria, pruritus, exanthema)
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 case of overdose has been reported.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Not required as per Article 16c(1)8a)(iii) of Directive 2001/83/EC as amended.

5.2

Pharmacokinetic properties
Not required as per Article 16c(1)8a)(iii) of Directive 2001/83/EC as amended.

5.3

Preclinical safety data
In the mouse, no symptoms of systemic toxicity were found after oral administration
of Lavender oil at single doses of up to 2000 mg/kg. The administration of doses of
2700 mg/kg up to 4000 mg/kg of Lavender oil by oral route led in a dose-dependent
manner to a mild to moderate inhibition of motility, ataxia and dyspnoea.
In safety-pharmacological investigations, no effect of Lavender oil on cardiovascular
para¬meters (NOEL* ≥ 450 mg/kg orally, dog), behaviour and body temperature
(NOEL* ≥ 450 mg/kg orally, rat) was observed; in the rat, a dose of 450 mg/kg orally
led to a short-term respiration-stimulating effect (NOEL* 150 mg/kg orally).
Chronic toxicity was investigated in the rat and dog (30, 100 or 300 mg/kg Lavender
oil by oral route) for a duration of 26 weeks (rat) and 39 weeks (dog). In both studies,
the NOAEL** was 300 mg/kg BW.
Studies on reproductive toxicity were carried out in the rat (combined segment I and
segment II study, segment III study) and in the rabbit (segment II study) with doses
ranging from 30 to 300 mg/kg Lavender oil by oral route. No effect on fertility,
embryo-fetal as well as peri- and postnatal development was observed.
No mutagenicity was observed in tests (AMES test, test with cultivated human
lymphocytes, micronucleus test) conducted with Lavender oil.
Studies on carcinogenicity have not been performed.
* NOEL = No observed effect level
** NOAEL = No observed adverse effect level

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Gelatin succinylated
Glycerol 85%
Refined rapeseed oil
Sorbitol (E 420)
Carmine lacquer (E 120)
Patent blue V aluminium lacquer (E131)
Titanium dioxide (E171)

6.2

Incompatibilities
None known

6.3

Shelf life
5 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 14, 28 and 56 soft capsules.
The soft capsules are packed in PVC/PVDC blisters and inserted into a carton
together with the package leaflet.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Germany

8

MARKETING AUTHORISATION NUMBER(S)
THR 05332/0008

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/11/2015

10

DATE OF REVISION OF THE TEXT
30/11/2015

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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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