Hova

Package Leaflet: Information for the Patient

Hova, 200.2 mg + 45.5 mg, coated tablets
Valerianae radicis extractum siccum+ Lupuli floris extractum siccum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

Table of Contents of the Leaflet:

• 1. What is Hova and what is it used for
• 2. Important information before taking Hova
• 3. How to take Hova
• 4. Possible side effects
• 5. How to store Hova
• 6. Contents of the pack and other information

1. What is Hova and what is it used for

Hova contains plant-based ingredients that improve sleep and have a mildly sedative effect.
They induce or prolong the active sleep phase.

Indications for use of Hova:

• sleep disorders (and falling asleep)
• mild nervous tension states

If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

2. Important information before taking Hova

Hova should not be taken in case of intolerance or hypersensitivity to any component of the preparation.

When not to take Hova

• if the patient is allergic to valerian root extract (Valerianae radicisextractum siccum) and hop flower extract (Lupuli floris extractum siccum) or any other component of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Hova, the doctor or pharmacist should be consulted.

Hova and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Interactions are not known. However, it is not justified to take Hova tablets and other sedative and sleep-inducing preparations at the same time.

Taking Hova with food, drink, and alcohol

During treatment with Hova, it is recommended to avoid consuming alcoholic beverages.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Due to the lack of data on safety, it is not recommended to take the medicine during pregnancy and breastfeeding.

Driving and using machines

Due to increased drowsiness, it is not recommended to take the medicine in the evening for people driving vehicles.
During treatment with Hova, in states of anxiety, at the recommended dose of 1 tablet, no negative effect on the ability to drive vehicles and mechanical devices has been found.
Taking the tablets as prescribed does not pose a risk of dependence on the medicine or reduce fitness the next day.

Hova contains maltodextrin, glucose, and lactose

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

3. How to take Hova

This medicine should always be taken exactly as described in the package leaflet for the patient, or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Hova is intended for adults and adolescents over 12 years of age.
The recommended dose is:
In sleep disorders of neurovegetative origin, 2 tablets are taken 30 minutes before sleep.
In states of tension and anxiety, 1 tablet is recommended 1 to 3 times a day.
Hova tablets should be swallowed whole with a small amount of liquid.
Duration of treatment
Since the effectiveness of valerian and hop extracts develops gradually, the medicine is not indicated for acute treatment of mild nervous tension and sleep disorders. To achieve the optimal therapeutic effect, it is recommended to take the medicine for more than 4 weeks.

Taking a higher dose of Hova than recommended

Taking a larger number of Hova tablets at one time reduces psychophysical fitness, and it is not recommended to drive vehicles in such cases.

Missing a dose of Hova

Treatment with the medicine should be continued, following the recommended dosage regimen of Hova. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Hova

No adverse effects have been reported due to withdrawal of the medicine.
In case of any further doubts regarding the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Hova can cause side effects, although not everybody gets them.
After taking valerian root extract preparations, gastrointestinal symptoms (such as nausea and abdominal cramps) may occur. The frequency of these effects is not known.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Hova

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after {Expiry date:}. The expiry date refers to the last day of the given month.
Store in the original package, at a temperature not exceeding 25°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hova contains

The active substances of the medicine are:

• 220 mg of extract (as dry extract) (4-7:1) from Valeriana officinalisL., radix(valerian root), including:
• native extract - 200.2 mg
• maltodextrin - 8% and silicon dioxide - 1% together 19.8 mg. Extractant - 70% ethanol (V/V)
• 65 mg of extract (as dry extract) (4-8:1) from Humulus lupulusL., flos(hop flower), including:
• native extract - 45.5 mg
• liquid glucose - 30%, i.e. 19.5 mg. Extractant - 40% methanol (V/V)

Other ingredients are: maltodextrin, silicon dioxide, liquid glucose, microcrystalline cellulose, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000, macrogol 6000, quinoline yellow lake (E104), indigo carmine lake (E132).

What Hova looks like and contents of the pack

Coated tablets, light green in color, round, biconvex, without spots and cracks, with permissible minor irregularities resulting from the graininess of the coating.
A cardboard box containing 10, 20, or 30 tablets in a blister pack.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
To obtain more detailed information, please contact the representative of the marketing authorization holder:

Poland

Biofarm Sp. z o.o.
Ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. 061 66 51 500

Date of approval of the leaflet: