Package leaflet: Information for the user

DORMIPLANT 160 mg + 80 mg coated tablets

Valeriana officinalis L. s.l. root dry extract, Melissa officinalis L. leaf dry extract
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Talk to your doctor if you do not notice any improvement or if your symptoms worsen after two weeks of treatment.

Contents of this leaflet:

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

1. What DORMIPLANT is and what it is used for

DORMIPLANT is a herbal medicinal product containing the dry extract of valerian root and the dry extract of lemon balm leaf.
DORMIPLANT is a mild sedative, also used to promote night-time rest.

2. What you need to know before taking DORMIPLANT

Do not take DORMIPLANT

if you are allergic to the dry extract of valerian root, the dry extract of lemon balm leaf, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking DORMIPLANT.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Consult your doctor if symptoms persist for more than 2 weeks or worsen during treatment.

Children
Use in children under 12 years of age is not recommended, as there are no data available on the efficacy and safety of the medicine in pediatric patients.

Other medicines and DORMIPLANT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Only limited data are available on pharmacological interactions with other medicines.
DORMIPLANT may enhance the effects of synthetic sedatives when used concomitantly. Concurrent use with synthetic sedatives requires medical diagnosis and supervision.

DORMIPLANT and alcohol
Concomitant intake of DORMIPLANT and alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Due to lack of data on the safety profile of the combination of valerian and lemon balm during pregnancy, administration of DORMIPLANT is not recommended in pregnant women or during breastfeeding.

Driving and using machines
DORMIPLANT may impair your ability to drive or operate machinery.

DORMIPLANT contains sucrose and hydrogenated castor oil
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Hydrogenated castor oil may cause gastrointestinal disturbances and diarrhea.

3. How to take DORMIPLANT

Take this medicine exactly as stated in this leaflet or as directed by your pharmacist. If you have any doubts, consult your pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age:
1-2 coated tablets to be taken twice daily.
Do not exceed the recommended doses.

Use in children
Use is not recommended in children under 12 years of age.

Method of administration
The tablet should be swallowed whole with water.
It is recommended to take DORMIPLANT after main meals and in the evening before going to bed.

If you take more DORMIPLANT than you should
If you take an excessive dose of DORMIPLANT, contact your doctor immediately.

If you forget to take DORMIPLANT
Do not take a double dose to make up for the forgotten dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody experiences them.
Gastrointestinal disorders such as nausea and abdominal cramps (frequency not known) have been reported during the use of preparations containing valerian root and lemon balm leaf.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How to store DORMIPLANT

Do not store above 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the product in its original, unopened packaging, correctly stored.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DORMIPLANT contains

The active substances are: Dry extract of the root of Valeriana officinalis, 160 mg; Dry extract of the leaves of Melissa officinalis, 80 mg.
The other components are: microcrystalline cellulose, hydrogenated castor oil, hypromellose, crospovidone, anhydrous colloidal silica, stearic acid, sucrose, titanium dioxide (E171), indigo carmine (E132), magnesium stearate, talc, vanillin, sodium saccharin, anti-foaming emulsifier.

Description of the appearance of DORMIPLANT and contents of the pack
DORMIPLANT tablets are film-coated tablets. DORMIPLANT is available in packs containing 10, 14, 15, 20, 25, 30, 40, 45, 50, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4, 76227 Karlsruhe – Germany

Marketing Authorization Holder (Responsible for Release)
LOACKER REMEDIA S.r.l.
Egna (BZ), Italy