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UCALM ST JOHNS WORT TABLETS

Active substance(s): ST JOHNS WORT EXTRACT / ST JOHNS WORT EXTRACT / ST JOHNS WORT EXTRACT

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Ucalm - PIL25804 (updated 12.08.15).pdf

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12/08/2015

13:09

Ucalm®

St John’s Wort tablets

PIL25804

St John’s Wort extract 300mg

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Ucalm® carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your doctor, pharmacist, or qualified healthcare practitioner if you need more information or advice.
See your doctor or healthcare practitioner if symptoms worsen or persist for more than 6 weeks.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What the product is, and what it is used for
2. Before you take this product
3. How to take this product

1.

4. Possible side effects
5. How to store this product
6. Further information

WHAT THE PRODUCT IS AND WHAT IT IS USED FOR
This product is a traditional herbal medicinal product containing St. John’s Wort. Each Ucalm® coated tablet
contains 300mg of extract (as dry extract)from St John’s Wort aerial parts (Hypericum perforatum L)(5-7:1)
(equivalent to 1500 – 2100mg of St John’s Wort herb). Extraction solvent: Ethanol 60%v/v.
Ucalm® is a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety,
based on traditional use only.

2.

BEFORE YOU TAKE THIS PRODUCT
Do not take this product:




if you know you are allergic to St John’s Wort or any
of the other ingredients, (see section 6)
if you are under 18 years of age
if you have been diagnosed with depression, or think
you may be depressed, (see below)





if you are pregnant or breastfeeding
if you are about to undergo surgery
If your skin is exceptionally sensitive to light
(photosensitive) and if you are having light
treatment (phototherapy) for any condition

Suffering from depression? Symptoms of depression include feelings of helplessness and hopelessness, loss of
interest in daily activities, appetite or weight changes, sleep changes, loss of energy and difficulty in concentrating.
If your doctor has told you that you are suffering from depression do not use this product. If you think you are
suffering from depression, you should tell your doctor.
Taking other medicines: St John’s Wort can affect the way some medicines work and reduce their effectiveness.
Medicines that can be affected by St John’s Wort include prescription medicines and those that you may have bought
yourself without a prescription.
Therefore it is important that you do not take St John’s Wort if you are using any of the medicines listed in the table below:

DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES
All hormonal contraceptives

All medicines for depression/
anxiety
All hormonal replacement
therapy (HRT) treatments
All medicines for thinning
the blood
All medicines for epilepsy
All immunosuppressant medicines
All medicines for HIV infections
Some
Some
Some
Some

medicines
medicines
medicines
medicines

for
for
for
for

cholesterol
cancer
heart disease
migraines

Some medicines for high
blood pressure
A medicine for regulating mood
A thyroid hormone

The birth control “Pill”, emergency contraception (also known as the 'morning
after' pill), hormonal implants, creams, patches, intra-uterine devices with hormones.
Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine,
fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine.
HRT tablets, patches, gels, vaginal rings.
Warfarin, acenocoumarol.
Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate.
Ciclosporin, tacrolimus.
Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir,
ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine.
Simvastatin, atorvastatin.
Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane.
Digoxin, ivabradine, amiodarone.
Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,
sumatriptan, zolmitriptan.
Amlodipine, nifedipine, felodipine, verapamil.
Lithium.
Thyroxine.

Ucalm - PIL25804 (updated 12.08.15).pdf

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12/08/2015

13:09

Avoid excessive sunbathing or the use of sunbeds/solariums.
Stop using it at least 10 days prior to undergoing any surgery.
Driving and operating machinery: In rare cases St John’s Wort may make you feel dizzy or sleepy. If affected do not
drive or use machines.
St John’s Wort may also affect the following medicines. Therefore do not take Ucalm® with these medicines unless
a doctor has said it is safe to do so:
• fentanyl, propofol, sevoflurane, and midazolam
• aprepitant(used to treat post-operative vomiting)
(anaesthetics/pre-operative medicines)
• butobarbital and Phenobarbital (barbiturates)
• tramadol (an analgesic)
• methyl phenidate (a central nervous system or
• erythromycin, clarithromycin, & telithromycin (antibiotics)
CNS stimulant)
• itroconazole and voriconazole (antifungals)
• exemestane (a hormone antagonist)
• artemether and lumfantrine (antimalarials)
• eplerenone (a diuretic)
• rasagiline (an anti-Parkinsons medicine)
• lansoprazole and omeprazole (proton pump inhibitors)
• aripiprazole (an antipsychotic medicine)
• theophylline (a bronchodilator)
• buspirone (an anxiolytic)
• gliclazide (an antidiabetic medicine)
Take special care with the product: This product contains glucose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this product.

3.

HOW TO TAKE THIS PRODUCT
Adults and the elderly: Take 2 tablets once a day. The tablets should be swallowed whole with a little water or
other liquid. The tablets should not be chewed.
Do not exceed stated dose.
See your doctor or qualified healthcare practitioner if symptoms worsen, or persist for more than 6 weeks.
Not suitable for children or adolescents under the age of 18 years.
If you take more than the recommended dose: Speak to a doctor, pharmacist or qualified healthcare practitioner
and take this leaflet with you.
If you forget to take this product: Continue to take your usual dose at the usual time, it does not matter if you
have missed a dose.
If you are unsure about anything or have any questions about this product, consult your doctor, pharmacist or
qualified healthcare practitioner.

4.

POSSIBLE SIDE EFFECTS
Like all medicines, this product can have side effects. The following side effects have been reported:
- gastrointestinal disorders such as indigestion, loss of appetite, nausea, diarrhoea, constipation; fatigue
and restlessness.
- allergic skin reactions such as rash, hives or itching of the skin. If you experience allergic skin reactions, stop
taking the product and consult your doctor.
Also sunburn-like reactions on skin exposed to strong sunlight or strong ultra-violet (UV) irradiation e.g. solarium
have been reported, particularly in fair skinned individuals. Other side effects that have been reported include
headaches, nerve pain or tingling, anxiety, dizziness and mania.
If any of the above side effects becomes serious or if other side effects not mentioned above occur,
a doctor or pharmacist should be consulted.
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
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.

HOW TO STORE THIS PRODUCT
Do not store above 25°C. Store in the original packaging in order to protect from light and moisture.
Keep out of the reach and sight of children.
Do not use this product after the expiry date which is stated on the base of the bottle after EXP. The expiry date
refers to the last day of that month.
Do not use this product if you notice any unusual discolouring or softening of the tablets as this may mean that they
have deteriorated.
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.

6.

FURTHER INFORMATION
Each film-coated tablet contains 300mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum
perforatum L.) (5-7:1) (equivalent to 1500 – 2100mg St. John’s Wort) Extraction solvent 60%v/v. This product also
contains the following ingredients: (herbal extract) maltodextrin, silica colloidal anhydrous; (tablet core) calcium
hydrogen phosphate dihydrate, cellulose microcrystalline, hydroxypropylmethyl cellulose, croscarmellose sodium,
silica colloidal hydrated, magnesium stearate; (tablet coating) sodium carboxymethylcellulose, lecithin, dextrose
monohydrate, sodium citrate, dextrin.
Each bottle contains 30, 60, 90 and 120 tablets. Not all pack sizes may be marketed.
Registration number: THR 33336/0003
Traditional Herbal Registration Holder and Manufacturer:
Natures Aid Ltd, St Georges Park, Preston, Lancs. PR4 2DQ
Tel: 01772 686231; Fax: 01772 671688; e mail: sales@naturesaid.co.uk
This leaflet was last approved in 02/2014.

For a large print, braille or audio version of this leaflet please call 01772 686231

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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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