Ucalm - PIL25805 (updated 18.07.16).pdf 18/07/2016 16.34

(natures aid)

PATIENT INFORMATION LEAFLET

Ucalm®

St John’s Wort tablets St John’s Wort extract 300mg

In this leaflet:

1.    What the product is, and what it is used for    4. Possible side effects

2. Before you take this product    5. How to store this product

3. How to take this product    6. Further information

1. 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)

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	The birth control “Pill”, emergency contraception (also known as the 'morning after' pill), hormonal implants, creams, patches, intra-uterine devices with hormones.
All medicines for depression/ anxiety	Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine.
All hormonal replacement therapy (HRT) treatments	HRT tablets, patches, gels, vaginal rings.
All medicines for thinning the blood	Warfarin, acenocoumarol.
All medicines for epilepsy	Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate.
All Immunosuppressant medicines	Ciclosporin, tacrolimus.
All medicines for HIV Infections	Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine.
Some medicines for cholesterol	Simvastatin, atorvastatin.
Some medicines for cancer	Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane.
Some medicines for heart disease	Digoxin, ivabradine, amiodarone.
Some medicines for migraines	Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan.
Some medicines for high blood pressure	Amlodipine, nifedipine, felodipine, verapamil.
A medicine for regulating mood	Lithium.
A thyroid hormone	Thyroxine.

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: St John’s Wort may make you feel dizzy or sleepy. If affected do not drive or use machines.

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.

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 07/2016.

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