Package leaflet: Information for the user

Baldivian Noc, 441.35 mg, coated tablets
Valerianae extractum hydroalcoholicum siccum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please 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 14 days of treatment, or if your condition worsens, consult your doctor.

Table of contents

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

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

Baldivian Noc is a herbal medicinal product containing dried hydroalcoholic extract of valerian root.
This medicine is used to alleviate mild sleep disturbances. It is intended for adults and adolescents
above the age of 12 years.
If there is no improvement after 14 days of use, or if the patient feels worse, medical advice should be sought.

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 lack of data, the medicine should not be used in children under 12 years of age.
Baldivian Noc and other medicines
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use with synthetic sedatives requires medical diagnosis and supervision.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Use of Baldivian Noc is not recommended during pregnancy and breastfeeding due to lack of data.
Driving and operating machinery
Baldivian Noc may affect the ability to drive and operate machinery.
Patients should not drive, operate machinery, or engage in or participate in hazardous activities.
Baldivian Noc contains sucrose
This medicine contains sucrose. If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine.

3. How to use Baldivian Noc

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.

Adults, elderly, adolescents aged over 12 years
The recommended dose is 1 effervescent tablet taken 30 minutes to one hour before bedtime. If necessary, the same dose (1 tablet) may additionally be taken in the evening hours.

Use in children
Due to 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 with an adequate amount of liquid, preferably a glass of water.
The medicine may be taken with or without food.

Due to the gradual action of valerian root, this medicine is not indicated for the treatment of severe sleep disorders caused by nervous tension.
For optimal therapeutic effect, treatment should be continued for 2–4 weeks.

If there is no improvement after 14 days of use, or if the patient feels worse, consult a doctor.

Taking more Baldivian Noc than recommended
If a patient accidentally takes one tablet more than the recommended dose, this usually does not cause any adverse effects. Continue taking Baldivian Noc as described in this leaflet or as directed by your doctor.

If a patient takes a significantly higher dose (6 or more tablets), consult a doctor or pharmacist immediately.
Symptoms of overdose include: fatigue, abdominal cramps, breathing difficulties, dizziness, hand tremors, and pupil dilation.

If you forget to take Baldivian Noc
Do not take a double dose to make up for the missed tablet. Continue taking Baldivian Noc as described in this leaflet or as directed by your doctor.

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

4. Possible side effects

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

Gastrointestinal symptoms (e.g. nausea, abdominal cramps).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Al. 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 enables further information on the safety of the medicine to be collected.

5. How to store Baldivian Noc

Keep this medicine out of sight and reach of children. Store at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the pack after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Baldivian Noc contains
The active substance in Baldivian Noc is dried hydroalcoholic extract of valerian root (Valerianae extractum hydroalcoholicum siccum).

Each coated tablet contains 441.35 mg of extract (as dry extract) from Valeriana officinalis L., s.l., root (equivalent to 2.65 g – 3.27 g of valerian root). Extraction solvent: ethanol 70% (V/V).
Other ingredients are:
Tablet core: Maltodextrin, Colloidal anhydrous silica, Microcrystalline cellulose, Magnesium stearate.
Sugar coating: Sucrose, Talc, Calcium carbonate, Titanium dioxide (E 171), Spray-dried gum arabic, 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 pack
Baldivian Noc is a light blue, round, biconvex coated tablet.
The tablet diameter is approximately 12.4 mm, height approximately 7.5 mm.
Packs: PVC/PVDC/Aluminium blisters in a cardboard box. Available pack sizes contain 15, 30, 60, 90 and 120 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
PharmaSGP GmbH
Am Haag 14
82166 Gräfelfing
Germany
e-mail: [email protected]

Manufacturer
Haleon Italy Manufacturing S.R.L.
via Nettunense 90
04011 Aprilia
Italy

Wiewelhove GmbH
Dörnebrink 19
49479 Ibbenbüren
Germany

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Austria: Baldriparan für die Nacht
Poland: Baldivian Noc
Hungary: Baldivian Night