Active substance(s): PASSIFLORA INCARNATA AERIAL PARTS POWDERED
What PHYTOCALM looks like and contents of the pack
Each pack contains 45 hard capsules.
Not all pack sizes may be marketed.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Passion flower herb
Read all of this leaflet carefully before you start taking this medicine.
It contains important information for your treatment.
This medicine is available without prescription. However, you still need to use
PHYTOCALM carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Traditional Herbal Registration Holder and Manufacturer
LID de Carros Le Broc – 1er avenue, 2709 m
06510 CARROS - France
Tel.: (+33) (0) 4 93 29 11 28 - Fax: (+33) (0) 4 93 29 11 62
Distributed in UK by
IN THIS LEAFLET:
1. What PHYTOCALM is and what it is used for
2. Before you take PHYTOCALM
3. How to take PHYTOCALM
4. Possible side effects
5. How to store PHYTOCALM
6. Further information
Unit 7 Decade Close
High Carr Business Park
Newcastle under Lyme
ST5 7UH - Tel: +44 (0) 1782 564512
This leaflet was last revised in June 2016.
Traditional Herbal Registration Number
For a large print, call +44 (0)1782 564512 or email to email@example.com
1 - WHAT PHYTOCALM IS AND WHAT IT IS USED FOR
PHYTOCALM is a traditional herbal medicinal product used:
• for the temporary relief of symptoms associated with stress, such as
• to aid sleep
This is based on traditional use only.
2 - BEFORE YOU TAKE PHYTOCALM
DO NOT TAKE PHYTOCALM IF
- You are allergic (hypersensitive) to the active substance or to any of the other
ingredients of PHYTOCALM (see Section 6 Further Information).
- You are under 18 years old.
TAKE SPECIAL CARE WITH PHYTOCALM
- Do not take more than the recommended dose.
- Tell your doctor or a healthcare practitioner :
• If your symptoms worsen or persist after 4 weeks
• If side-effects not mentioned in this leaflet occur
TAKING OTHER MEDICINES
Phytocalm should not be taken in combination with other medicines for anxiety
or to help you sleep (such as benzodiazepines).
PREGNANCY & BREAST FEEDING:
Do not use if you are pregnant or breast-feeding.
DRIVING AND USING MACHINES
Passion flower may cause drowsiness. If you are affected, do not drive or use
3 - HOW TO TAKE PHYTOCALM
Adults and the elderly:
Take 2 capsules after evening meal and 2 capsules before going to sleep,
with a large glass of water.
You can take up to 6 capsules daily if necessary.
The use in children and adolescents under 18 years of age is not recommended.
For oral use only.
If your symptoms worsen or do not improve after 4 weeks, consult your
doctor or a qualified health care practitioner.
Don’t take more than the recommended dose.
IF YOU TAKE MORE PHYTOCALM THAN YOU SHOULD
If you take too much and feel ill, talk to your doctor.
IF YOU FORGET TO TAKE PHYTOCALM
Do not take a double dose to make up for a forgotten dose.
IF YOU STOP TAKING PHYTOCALM
You can stop taking Phytocalm at any time.
4 - POSSIBLE SIDE EFFECTS
Like all medicines, Phytocalm can have side effects, althought not
everybody gets them.
There has been one report of nausea and tachycardia (increased heart beat),
and one report of hypersensitivity (vasculitis) in patients using Passion
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 the package leaflet. You can
also report side effects directly via the Yellow Card Scheme at www.mhra.gov.
By reporting side effects you can help provide more information on the safety
of this medicine.
5 - HOW TO STORE PHYTOCALM
Keep out of the reach and sight of children.
Do not use PHYTOCALM after the expiry date which is stated on the bottle
after “Exp”. The expiry date refers to the last day of that month.
Store in the original package. Store below 30°C.
6 - FURTHER INFORMATION
What PHYTOCALM contains
- Each hard capsule contains 300 mg of Passion Flower herb (Passiflora
incarnata L., herba).
- The other ingredient is hypromellose (capsule shell).
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.