Package leaflet: Information for the user

BOTANOVA®

Film-coated tablets Traditional Herbal Medicinal Product

In this leaflet:

1.    What BOTANOVA® is and what it is used for    4. Possible side effects

2.    Before you take BOTANOVA®    5. How to store BOTANOVA®

3. How to take BOTANOVA®    6. Further information

1. WHAT BOTANOVA® IS AND WHAT IT IS USED FOR

BOTANOVA® is a traditional herbal medicinal product used to releave

•    slightly low mood and mild anxiety

•    sleep disturbances due to symptoms of mild anxiety based on traditional use only

2. BEFORE YOU TAKE BOTANOVA®

Do not use BOTANOVA®:

•    if you know you are allergic (hypersensitive) to St John's Wort, Passion flower or Valerian or to any of the other ingredients

•    in children or adolescents under 18 years old

•    if you are pregnant or breastfeeding

•    if you have been diagnosed with depression or you think you may be depressed

•    if you are about to undergo surgery

•    if you are taking any of the medicines mentioned under taking BOTANOVA® with other medicines below without prior consultation with your doctor

•    if you know your skin is hypersensitive to light or if you are undergoing a phototherapy or any photodiagnostic procedures

Take special care with BOTANOVA®:

Do not exceed the stated dose.

If the condition worsens, or if symptoms persist for more than six weeks medical advice should be sought.

The dosing and safety of St. John's Wort have not been studied in children/adolescents below 18 years and safety is not established. This product is intended for relief of slightly low mood and mild anxiety and of sleep disturbances due to symptoms of mild anxiety. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.

In very rare cases, particularly in light-skinned persons, sun burn type reactions on skin areas exposed to strong sunlight may occur due to photosensitisation by St John's Wort. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums.

This product should be discontinued at least 10 days prior to elective surgery due to the potential for interactions with medicines used during general and regional anaesthesia.

Taking BOTANOVA® 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 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 following table.

Do not take BOTANOVA® if you are taking any of the following medicines:
All hormonal contraceptives	The birth control 'Pill', emergency contraception (known as "the morning after pill"), hormonal implants, creams, patches, intra-uterine devices with hormones
All medicines amend to 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	Cyclosporin, tacrolimus
All medicines for HIV infections	Aprenavir, 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

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Taking BOTANOVA® with food and drink: BOTANOVA® can be taken with or without food and drink.

Pregnancy and Breastfeeding: BOTANOVA® should not be used by pregnant or breastfeeding women since no appropriate studies have been performed.

Driving and using machines: BOTANOVA® may cause tiredness; if affected do not drive or operate machinery.

Important information about some of the ingredients: Each film-coated tablet contains lactose monohydrate (90.5 mg) and glucose (10.4 mg). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this product.

3. HOW TO TAKE BOTANOVA®

Unless prescribed otherwise:

For the relief of slightly low mood and mild anxiety

adults and the elderly should take 2 film-coated tablets one to three times daily

For the relief of sleep disturbances due to symptoms of mild anxiety

adults and the elderly should take 2 film-coated tablets before going to sleep.

The maximum daily dose is 6 tablets.

The tablets should be swallowed whole with some liquid.

If you take more BOTANOVA® than you should: No symptoms of overdose with BOTANOVA® have been reported. If you forget to take BOTANOVA®: Don't worry. Leave out that dose and take the next dose at the right time.

If you want to stop taking BOTANOVA®: No adverse reactions to stopping BOTANOVA® have been reported.

If your symptoms worsen or if they do not improve after six weeks speak to your doctor.

4. POSSIBLE SIDE EFFECTS

What adverse experiences may you have when taking BOTANOVA®?

Like all medicines, BOTANOVA® can cause side effects, although not everybody gets them. The frequency of the following effects is not known.

There have been reports of gastrointestinal symptoms (dyspepsia, anorexia, nausea, diarrhoea and constipation), fatigue or restlessness. Other side effects include headaches, neuropathy, anxiety, dizziness, abdominal pain, mania and allergic reactions.

Use of high-dose St John's Wort extract especially in fair-skinned individuals, can lead to increased sensitivity to sunlight (photo -sensitization) and therefore produce sunburn-like reactions of skin areas exposed to intense sunlight.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

5.    HOW TO STORE BOTANOVA®

Keep out of the reach and sight of children. Do not use after the expiration date stated on the blister pack and carton. The expiry date refers to the last day of the month. Do not store above 30°C. Keep the blisters in the outer carton in order to protect from light.

6.    FURTHER INFORMATION What BOTANOVA® contains

•    Each film-coated tablet contains: Active ingredients: 60 mg of extract (as dry extract) from St John's Wort Herb (Hypericum perforatum L.) (4.6-6.5:1), extraction solvent: ethanol 38% (m/m); 28 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.) (3.8-5.6:1), extraction solvent: ethanol 40% (m/m); 32 mg of extract (as dry extract) from Passion Flower Herb (Passiflora incarnata L.) (6.25-7.1:1), extraction solvent: ethanol 60% (m/m).

•    The other ingredients are:

Excipients of the herbal preparation: Lactose monohydrate; glucose, liquid, spray-dried; maltodextrin; silica, colloidal anhydrous. Excipients of the tablet: Lactose monohydrate; silica, colloidal anhydrous; talc; magnesium stearate; povidone K30; glycerol (85 per cent); croscarmellose sodium.

Excipients of the film coating: Basic butylated methacrylate copolymer; talc; titanium dioxide (E 171); indigo carmine laquer (E 132); macrogol 6000; magnesium stearate.

What BOTANOVA® looks like and contents of the pack:

Light blue, biconvex, round film-coated tablets in blister pack containing 20 film-coated tablets per blister.

Original packs of 20, 60, and 100 film-coated tablets. Not every pack sizes may be marketed.

Registration Holder and Manufacturer:

PASCOE Pharmazeutische Praparate GmbH ■ Schiffenberger Weg 55

D-35394 Giessen ■ Germany

This leaflet was last revised in 07/2016.

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