Baldivian Noc

Package Leaflet: Information for the User

Baldivian Noc, 441.35 mg, Effervescent Tablets

Valerianae extractum hydroalcoholicum siccum

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

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

• This package 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 this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 14 days, they should contact their doctor.

Package Leaflet Contents

• 1. What is Baldivian Noc and what is it used for
• 2. Important information before using Baldivian Noc
• 3. How to use Baldivian Noc
• 4. Possible side effects
• 5. How to store Baldivian Noc
• 6. Package contents and other information

1. What is Baldivian Noc and what is it used for

Baldivian Noc is a herbal medicine containing dry extract of valerian root.
This medicine is used for the relief of sleep disturbances. It is intended for adults and adolescents over 12 years of age.
If there is no improvement or the patient feels worse after 14 days, they should consult their doctor.

2. Important information before using Baldivian Noc

When not to use Baldivian Noc:

• if the patient is allergic to dry extract of valerian root or any of the other ingredients of this medicine (listed in section 6).

Children

Due to the lack of data, this medicine should not be used in children under 12 years of age.

Baldivian Noc and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use with synthetic sedatives requires diagnosis and medical supervision.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The use of Baldivian Noc is not recommended during pregnancy and breastfeeding due to the lack of data.

Driving and using machines

Baldivian Noc may affect the ability to drive and use machines.
Patients should not drive, operate machinery, perform, or participate in hazardous activities.

Baldivian Noc contains sucrose

This medicine contains sucrose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before using this medicine.

3. How to use Baldivian Noc

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Adults, elderly, and adolescents over 12 years of age
The recommended dose is 1 effervescent tablet 30 minutes to 1 hour before bedtime, if necessary, an additional dose (1 tablet) in the evening.

Use in children

Due to the lack of data, Baldivian Noc should not be used in children under 12 years of age.
Method of administration
The tablet should be swallowed whole, washed down with a sufficient amount of liquid, preferably a glass of water.
The medicine can be taken with or without food.
Due to the gradual effect of valerian root, the medicine is not indicated for the treatment of severe sleep disturbances due to nervous tension. To achieve the best treatment effects, it is recommended to continue treatment for 2-4 weeks.
If there is no improvement or the patient feels worse after 14 days, they should consult their doctor.

Overdose of Baldivian Noc

If the patient accidentally takes one more tablet than the recommended dose, it usually does not cause any adverse effects. The patient should continue to take Baldivian Noc as described in this package leaflet or as directed by their doctor.
If the patient has taken a significantly larger dose of the medicine (6 or more tablets), they should consult their doctor or pharmacist.
Overdose symptoms include: fatigue, abdominal cramps, breathing difficulties, dizziness, hand tremors, and pupil dilation.

Missed dose of Baldivian Noc

The patient should not take a double dose to make up for a missed tablet. They should continue to take Baldivian Noc as described in this package leaflet or as directed by their doctor.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequency not known (frequency cannot be estimated from the available data)

• gastrointestinal symptoms (e.g., nausea, abdominal cramps).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products;
Aleje Jerozolimskie 181C; PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Baldivian Noc

The medicine should be stored out of sight and reach of children. Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Baldivian Noc contains

The active substance of the medicine is dry extract of valerian root (Valerianae extractum hydroalcoholicum siccum).

• Each effervescent tablet contains 441.35 mg of extract (as dry extract) from Valeriana officinalisL., s.l., root (corresponding to 2.65 g - 3.27 g of valerian root). Extraction solvent: ethanol 70% (V/V).
• Other ingredients are: Tablet core: Maltodextrin Silica, colloidal anhydrous Microcrystalline cellulose Magnesium stearate. Sugar coating: sucrose, talc, calcium carbonate, titanium dioxide (E 171), dried spray arabic gum, shellac, Macrogol 6000, Capol 600 Pharma (white wax, carnauba wax, shellac, ethanol), Povidone K 25, purified castor oil, potassium dihydrogen phosphate, Indigo carmine (E 132).

What Baldivian Noc looks like and contents of the package

Baldivian Noc is a light blue, round, biconvex effervescent tablet.
Tablet diameter approximately 12.4 mm, height approximately 7.5 mm.
PVC/PVDC/Aluminum blisters in a cardboard box. The package contains 15, 30, 60, 90, and 120 effervescent tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

PharmaSGP GmbH
Am Haag 14
82166 Gräfelfing
Germany
e-mail: info@pharmasgp.com

Manufacturer

Haleon Italy Manufacturing S.R.L.
via Nettunense 90
04011 Aprilia
Italy
Wiewelhove GmbH
Dörnebrink 19
49479 Ibbenbüren
Germany

This medicine is authorized in the Member States of the European

Economic Area under the following names:

Austria
Baldriparan für die Nacht
Poland
Baldivian Noc
Hungary
Baldivian Night
Date of last revision of the package leaflet:03/2024