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BOTANOVA FILM-COATED TABLETS

Active substance(s): PASSION FLOWER EXTRACT / ST JOHNS WORT EXTRACT / VALERIAN ROOT DRY EXTRACT / PASSION FLOWER EXTRACT / ST JOHNS WORT EXTRACT / VALERIAN ROOT DRY EXTRACT / PASSION FLOWER EXTRACT / ST JOHNS WORT EXTRACT / VALERIAN ROOT DRY EXTRACT

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Package leaflet: Information for the user
BOTANOVA®
Film-coated tablets
Traditional Herbal Medicinal Product

Read all of this leaflet carefully because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 You must contact a doctor if your symptoms worsen or do not improve after 6 weeks.
 If any of the side effects become serious or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What BOTANOVA® is and what it is used for
2.
Before you take BOTANOVA®
3.
How to take BOTANOVA®
4.
Possible side effects
5.
How to store BOTANOVA®
6.
Further information

Film-coated tablet contains:
St. John´s Wort extract 60 mg
Passion flower extract
32 mg
Valerian extract
28 mg

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

All medicines amend to 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

The birth control ‘Pill’, emergency
contraception (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
Cyclosporin, tacrolimus
Aprenavir, atazanavir, darunavir,
fosamprenavir, indinavir, lopinavir, nelfinavir,
ritonavir, saquinavir, tipranavir, efavirenz,
nevirapine, delavirdine

Some medicines for cholesterol
Some medicines for cancer

Simvastatin, atorvastatin
Irinotecan, dasatinib, erlotinib, imatinib,
sorafenib, sunitinib, etoposide, mitotane

Some medicines for heart disease
Some medicines for migraines

Digoxin, ivabradine, amiodarone
Almotriptan, eletriptan, frovatriptan,
naratriptan, rizatriptan, sumatriptan,
zolmitriptan
Amlodipine, nifedipine, felodipine, verapamil

Some medicines for high blood pressure

A medicine for regulating mood

Lithium

A thyroid hormone

Thyroxine

St. John´s Wort may also affect the following medicines. Therefore do not take BOTANOVA ® with
these medicines unless a doctor or pharmacist 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)
itroconazole 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 antidiabetic medicine)

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 (photosensitization) 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 Präparate GmbH
Schiffenberger Weg 55
D-35394 Giessen
Germany
This leaflet was last revised in 07/2016.

Expand Transcript

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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