Patient Information Leaflet

Hova, 200.2 mg + 45.5 mg, coated tablets
Valerianae radicis extractum siccum + Lupuli floris extractum siccum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents:

What Hova is and what it is used for
What you need to know before taking Hova
How to take Hova
Possible side effects
How to store Hova
Contents of the package and other information

1. What Hova is and what it is used for

Hova contains herbal ingredients with sleep-promoting and mild sedative properties.
They induce or prolong the active sleep phase.
Indications for Hova:

Sleep disorders (including difficulty falling asleep)
Mild states of nervous tension

If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using Hova medicine

Do not use Hova medicine if there is intolerance or hypersensitivity to any component of the preparation.
When not to use Hova medicine

if the patient is allergic to dry extract of valerian root ( Valerianae radicis extractum siccum ) and dry extract of hops ( Lupuli floris extractum siccum ) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Hova medicine, consult a doctor or pharmacist.
Hova medicine and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to use.
Interactions are not known. However, simultaneous use of Hova tablets and other sedative or sleep-inducing preparations is not justified.
Use of Hova medicine with food, drink and alcohol
During treatment with Hova tablets, consumption of alcoholic beverages should be avoided.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to lack of safety data, use of this medicine is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Because of increased tendency to drowsiness, use of this medicine in the evening is not recommended for drivers.
When used as recommended (1 tablet) for anxiety, Hova has not been shown to negatively affect the ability to drive or operate machinery.
Use of the tablets according to instructions does not create risk of drug dependence and does not reduce performance the following day.
Hova contains maltodextrin, glucose and lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Hova medicine

This medicine should always be taken exactly as described in the patient leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Hova is intended for adults and adolescents over 12 years of age.
Recommended dose:
For sleep disorders of neurovegetative origin, take 2 tablets half an hour before bedtime.
For states of tension and anxiety, it is recommended to take 1 tablet 1 to 3 times daily.
Hova tablets should be swallowed whole with a small amount of liquid.

Duration of use
Since the therapeutic effect of extracts from valerian root and hops develops gradually, this medicine is not indicated for the acute treatment of mild nervous tension and sleep disorders. To achieve optimal therapeutic effect, it is recommended to use the medicine for longer than 4 weeks.

Use of a higher than recommended dose of Hova
Taking more tablets than recommended reduces psycho-physical performance; driving or operating machinery is not advised in such cases.

Missed dose of Hova
Continue taking the medicine as directed, following the recommended dosing schedule of Hova. Do not take a double dose to make up for a missed dose.

Stopping Hova
No adverse symptoms occur when discontinuing the medicine.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
After using preparations containing valerian root, gastrointestinal symptoms (such as nausea and abdominal cramps) may occur. The frequency of these reactions is unknown.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, faks: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Hova

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after {Expiry date:}. The expiry date refers to the last day of the specified month.
Store in the original packaging, at a temperature not exceeding 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What the medicine Hova contains
The active substances are:

220 mg of extract (as dry extract) (4-7:1) from Valeriana officinalis L., radix (valerian root), including:
- native extract - 200.2 mg
- maltodextrin - 8% and colloidal anhydrous silicon dioxide - 1%, together 19.8 mg. Extraction solvent - ethanol 70% (V/V)
65 mg of extract (as dry extract) (4-8:1) from Humulus lupulus L., flos (hops flower), including:
- native extract - 45.5 mg
- liquid glucose - 30%, i.e. 19.5 mg. Extraction solvent - methanol 40% (V/V)

The other ingredients are: maltodextrin, colloidal anhydrous silicon dioxide, liquid glucose,
microcrystalline cellulose, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide
(E171), macrogol 4000, macrogol 6000, quinoline yellow lake (E 104), indigo carmine lake (E132).
What Hova looks like and contents of the pack
Film-coated tablets, light green in colour, round, biconvex, without spots or crumbling,
with minor surface irregularities acceptable due to the granular nature of the coating.
Cardboard box containing 10, 20 or 30 tablets in a blister pack.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
Poland
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. 061 66 51 500