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Zipvit St. Johns Wort Mood Relief Tablets

Document: leaflet ZIPVIT_THR 32087-0002 change



PATIENT

INFORMATION LEAFLET

zipvit

St John's Wort Mood Relief Tablet

St John's Wort Extract 317mg

Certification Mark


Please read this entire leaflet carefully before you take this product as it contains important information for you. Keep this leaflet, you may need to read it again.

This medicine is available without prescription. However, you still need to use this product carefully to get the best results from it.

If you have any further questions ask your doctor, pharmacist or qualified healthcare practitioner.

If symptoms worsen or persist after 6 weeks, or if any side effects listed in this leaflet become serious or if any other side effects are experienced, consult a doctor or a qualified healthcare practitioner.

In This Leaflet

1.    What this product is and what it is used for.

2.    Before you take this product.

3.    How to take this product.

4.    Possible side effects.

5.    How to store this product.

6.    Further information.

1.    What are St John's Wort Tablets and what are they used for?

This is a traditional herbal medicinal product containing St John's Wort Extract. It is used to relieve the symptoms of slightly low mood and mild anxiety. This is based on traditional use only.

2.    Before You Take This Product

DO NOT take this product if:

•    Your skin is exceptionally sensitive to sunlight (photosensitive).

•    You are having light treatment (phototherapy) for any condition.

•    You are suffering from depression (see below).

•    You are pregnant or breast-feeding.

•    You are allergic to any of the ingredients (see section 6).

•    You are under the age of 18 years.

Suffering from depression?

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, appetite or weight changes, changes in sleep pattern, loss of energy and difficulty concentrating. If you think you may be suffering from depression, you should tell your doctor before taking this product. If your doctor has told you that you are suffering from depression do not use this product.

While you are taking this product:

•    Avoid excessive sunbathing or the use of sunbeds/solariums.

•    Stop using it at least 10 days prior to undergoing any surgery.

Driving or operating machines:

In rare cases St John's Wort may make you feel dizzy or sleepy.

If affected do not drive or use machinery.

Taking this product with 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 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 below.

All hormonal contraceptives: The birth control 'Pill', emergency contraception (also known as the 'morning after pill'), hormonal implants, cream, patches or 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 (anticoagualants): 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, sumatripan, zolmitriptan.

THR

Taking the product with other medicines (continued)

Some medicines for high blood pressure: amlodipine, nifedipine, felodipine, verapamil.

A medicine for regulating mood: Lithium.

A thyroid hormone:- Thyroxine.

St John's Wort may also affect the following medicines, therefore do not take this product with these medicines unless a doctor has said it is safe to do so:

•    fentanyl, propofol, sevoflurane and midazolam (anaesthetics/pre-operative medicines).

•    tramadol (an analgesic).

•    erythromycin, clarithromycin and telithromycin (antibiotics).

•    itraconazole and voriconazole (antifungals).

•    artemether and lumefantrine (antimalarials).

•    rasagiline (anti-Parkinson's medicine).

•    aripiprazole (an antipsychotic medicine).

•    buspirone (an anxiolytic).

•    aprepitant (used to treat post-operative vomiting).

•    butobarbital and phenobarbital (barbiturates).

•    methyl phenidate (a central nervous system or CNS stimulant).

•    exemestane (a hormone antagonist).

•    eplerenone (a diuretic).

•    lansoprazole and omeprazole (proton pump inhibitors).

•    theophylline (a bronchodilator).

•    gliclazide (an antidiabetic medicine).

3.    How To Take This Product

Adults and the elderly: Take 1 tablet daily. Swallow the tablet whole with some water or other liquid. Do not chew.

Do not exceed the stated dose.

If you take too much of this product (overdose)

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 symptoms worsen or do not improve after 6 weeks consult your doctor or qualified healthcare practitioner or pharmacist.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4.    Possible Side Effects

Like all medicines, this product can cause side effects.

The following side effects have been reported:

•    Gastrointestinal disorders such as indigestion, loss of appetite, nausea, diarrhoea and constipation.

•    Fatigue and restlessness.

•    Allergic reactions such as a rash, hives or itching of the skin. If you experience allergic reaction, 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 side effects become serious or if you notice a side effect not listed in this leaflet, please tell your doctor, pharmacist or qualified healthcare practitioner.

You can help to make medicines safer by reporting any side effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP's surgery or pharmacy, or call free phone 0808 100 3352 (available 10am-2pm Monday - Friday)

5.    How to Store St John's Wort Tablets

Keep out of the reach and sight of children.

Do not store above 25 °C.

Store in original packaging.

Do not use your tablets after the expiry date which is stated on the box and the blister pack. The expiry date refers to the last day of that month.

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 317mg of extract (as dry extract) from 5t John's Wort aerial parts (Hypericum perforatum L.).(5-7:1)(equivalent to 1583mg to 2216mg of St John's Wort).

Extraction Solvent: Ethanol 60% v/v

It also contains other ingredients.

Extract :- Maltodextrin, Colloidal Anhydrous Silica.

Tablet Core :- Calcium hydrogen phosphate, Cellulose Microcrystalline,

Sodium Starch Glycolate, Magnesium Stearate, Colloidal Anhydrous Silica, Table Coating:- Hypromellose, Glycerol, Talc.

Healthsense St John's Wort Tablets are available in packs of 30, 60 and 90 tablets

Not all packs sizes may be marketed.

The tablets are a clear coated brown speckled oval tablet.

Registration number: THR 32087/0002

Traditional herbal registration holder and manufacturer:

RPL (UK) LTD,

3 Kincraig Court, Kincraig Road, Bispham,

Blackpool, FY2 0FY, UK Tel: 01253 501520

Distributed By

Zipvit

The Towers Business Park Rugeley, Staffordshire, WS15 1UZ

For Large Print, Braille or audio Formats Please Contact 01253 501 520 This Leaflet was revised in August 2013