Document: leaflet HERBAL STORE_THR 20894-0064 change

• leaflet GERARD HOUSE_THR 20894-0064
• leaflet HEALTHAID_THR 20894-0064
• leaflet HERBAL STORE_THR 20894-0064

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Patient Information Leaflet

St John’s Wort Tablets

St John's Wort extract 161 mg

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

This product is available without prescription; however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your doctor, pharmacist or qualified healthcare practitioner if you need more information or advice. You must contact a doctor or qualified healthcare practitioner if your symptoms feel worse, or do not improve after 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.

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

4.    Possible side effects

5.    How to store this product

6.    Further information

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

This product contains:

St John's Wort extract

These tablets are a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only.

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 concentrating.

If your doctor has told you that you are suffering from depression do not use this product. If you think you are depressed you should tell your doctor before taking this product.

2.    Before you take this product

Do not take this product if you:

•    are under 18 years old

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

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 (an 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 anti-diabetic medicine).

Pregnancy and breast feeding:

Do not take this product if you are pregnant or breastfeeding, because there is no evidence that it is safe to do so.

While you are taking this product:

Avoid prolonged sunbathing or the use of sun beds or solariums. Stop taking this product 10 days before having an operation.

Driving and using machinery:

No studies on the effect on the ability to drive and use machinery have been performed. In rare cases St. John's Wort may make you feel dizzy or sleepy. If affected do not drive or operate machinery.

3. How to take this product

Swallow the tablets whole with water.

Do not chew.

Adults and the elderly: Take one to two tablets a day.

Do not give to children or adolescents under 18 years old. Do not exceed the stated dose.

If your symptoms worsen, or persist after 6 weeks, consult your doctor or qualified healthcare practitioner.

What to do if too many tablets are taken.

If you take too many tablets by mistake contact your doctor or pharmacist straight away and take this leaflet with you.

What to do if you miss a dose.

If you miss a dose continue to take your usual dose when it is due, do not take a double dose.

If you are unsure about anything, ask your doctor, pharmacist or qualified healthcare practitioner for advice.

4. Possible side effects

Most people do not have any side effects while taking this product but the following side effects have been reported:

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

•    Allergic skin reactions such as rash, hives and itching of the skin. Stop taking the product if an allergic skin reaction occurs.

•    Fatigue, restlessness.

•    Also sunburn-like reactions on skin exposed to strong sunlight or strong ultraviolet (UV) irradiation e.g. solarium have been reported, particularly in fair skinned individuals.

Other side effects:

•    headaches

•    nerve pain or tingling (neuropathy)

•    anxiety

•    mania

•    dizziness.

These are usually mild and disappear after a few days. The frequency of these occurring is not known. However, if any side effect persists for more than a few days or anything else unusual happens, stop taking the product immediately and see 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.