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KALMS TABLETS

Active substance(s): GENTIAN EXTRACT / HOPS POWDER / VALERIAN EXTRACT

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5. How to store Kalms tablets
Keep out of the reach and sight of children.
Do not take Kalms tablets after the expiry date which is stated
on the packaging. Do not store above 25ºC. Store in the
original package.
6. Further Information
What Kalms Tablets contain:
The active substance per coated tablet is:
• 45mg of Hop Strobiles (Humulus lupulus L.)
• 3.75mg of extract (as dry extract) from Valerian root
3
(Valeriana officinalis L.) (equivalent to 135 to 167mg of Valerian
root) Extraction solvent: Ethanol 60%v/v
• 
22.5mg of extract (as dry extract) from Gentian root
(Gentiana lutea L.) (equivalent to 90mg of Gentian root)
Extraction solvent: Ethanol 50% v/v
Each coated tablet contains 247mg sucrose.
The other ingredients are:
•  xtract: Maltodextrin, Silicon Dioxide
E
• Core: Acacia (Spray-dried), Icing Sugar, Magnesium Stearate,
Maize Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic
Acid.
• oating: Acacia (Spray-dried), Calcium Carbonate (Light),
C
Carnauba Wax, Mastercote White SP0950G, Talc, Shellac
Varnish, Sucrose, Titanium Dioxide E171, Yellow Beeswax.
What Kalms tablets look like and contents of the pack
Kalms tablets are white, circular, sugar coated tablets. They are
available in amber glass bottles containing 100 or 200 tablets.
Kalms tablets are also available in blister packs containing
84 tablets. Not all pack sizes may be marketed.
Traditional Herbal Registration holder & manufacturer
G. R. Lane Health Products Limited,
Sisson Road, Gloucester, GL2 0GR, United Kingdom
Tel: +44 (0)1452 524012
Email: info@laneshealth.com
This leaflet was last revised 04/2015
For a large print, Braille or audio versions of this leaflet please
telephone: 01452 524012.

Tablets
Hop Strobiles and extracts of Valerian and Gentian
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription. However you
still need to take Kalms tablets carefully to get the best results
from them.
• Keep this leaflet. You may need to read it again.
• sk your pharmacist if you need more information
A
or advice.
•  ou must contact a doctor or qualified healthcare practitioner
Y
if your symptoms worsen, or do not improve after 4 weeks.
• f any of the side effects become serious, or if you notice any
I
side effect not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Kalms tablets are and what they are used for
2. Before you take Kalms tablets
3. How to take Kalms tablets
4. Possible side effects
5. How to store Kalms tablets
6. Further information

Certification Mark

613032
613032 Kalms Leaflet THR V10.indd 1-2

THR 01074/0235
27/04/2015 13:27

Job Name: 613032 Kalms
Leaflet THR V10
Date: 27/4/15
Amends author: NK
Brief Description:
MHRA amends
Size: 163mm x 140mm
Colours:
K

Pantone 2748

1. What Kalms tablets are and what they are used for
Hop Strobiles and extracts of Valerian root and Gentian root.
A traditional herbal medicinal product used for the temporary
relief of;
• Symptoms associated with stress such as mild anxiety
and irritability
•  ymptoms associated with menopause such as flushings and
S
cold sweats
• Sleep disturbances
Based on traditional use only.
2. Before you take Kalms tablets
Do not take Kalms tablets if you:
• re allergic to any of the ingredients (see Section 6 for a
a
complete list of ingredients).
• are pregnant or breastfeeding
• are under 18 years old
• are already taking a medicine for sleep or anxiety
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including:
• medicines obtained without a prescription.
Important information about some of the ingredients:
•  his medicine contains sucrose. If you have been told by your
T
doctor that you have an intolerance to some sugars, consult
your doctor before taking this product.
•  riving and using machines: If you feel sleepy, do not drive or
D
operate machines.
Additional information:
The effects of this medicine may be increased by alcohol.
Therefore alcohol should be avoided whist taking this medicine.
3. How to take Kalms tablets
For the temporary relief of:
• ymptoms associated with stress such as mild anxiety and
s
irritability or symptoms associated with menopause such as
flushings and cold sweats;
Adults and the elderly: Take 2 tablets three times per day
with water after meals.
For temporary relief of sleep disturbances;
Adults and the elderly: 2 tablets 30 to 60 minutes before
bedtime. One additional tablet can be taken earlier during the
evening if necessary.
613032 Kalms Leaflet THR V10.indd 3-4

•  or oral short term use only.
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•  he tablets should be swallowed whole with some water or
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other liquid.
•  he use of this product in children or adolescents under 18
T
years of age is not recommended because data is not sufficient
and medical advice should be sought.
•  s treatment effects may not be apparent immediately, this
A
medicine should be taken for 2-4 weeks continuously
•  he maximum daily dose is 6 tablets.
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•  o not exceed the stated dose.
D
Duration of use
If symptoms worsen, or do not improve after 4 weeks, a doctor
or a qualified healthcare practitioner should be consulted.
If you take more Kalms tablets than you should
If you take too many tablets, consult your doctor or qualified
healthcare practitioner as soon as possible. Take this leaflet to
show them.
If you forget to take Kalms tablets
Do not take a double dose to make up for a missed dose.
If you are unsure about anything, consult your doctor or
qualified healthcare practitioner for advice.
4. Possible side effects
L
 ike all medicines, Kalms tablets can cause side effects, although
not everybody gets them.
•  astrointestinal effects such as nausea, and stomach cramps
G
have been reported with Valerian root preparations. The
frequency is not known.
•  astrointestinal disorders have been observed with Gentian
G
root. The frequency was uncommon. In rare cases, tachycardia
and pruritis have been reported. Headache may occur. The
frequency is unknown.
• f any of the side effects become serious, or if you notice any
I
side effect not listed in this leaflet, please tell your doctor or
pharmacist.
Reporting of side effects.
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

27/04/2015 13:27

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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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