Package leaflet: Information for the user

Tractana coated tablets

Passiflora extract
Please read 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 advised.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 2 weeks.

Contents of this leaflet:

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

1. What Tractana is and what it is used for

Tractana is a traditional herbal medicinal product containing passionflower extract.
Tractana is used in adults and adolescents over 12 years of age to relieve mild symptoms of mental stress, such as nervousness, anxiety, or irritability, and to aid sleep.
This product is a traditional herbal medicinal product intended for specific indications based exclusively on long-standing use.

2. What you need to know before taking Tractana

Do not take Tractana

if you are allergic to passionflower 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 Tractana.

Due to the lack of adequate data, the use of Tractana in children under 12 years of age is not recommended unless advised by a doctor.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Other medicines and Tractana
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of sedative medicines (such as benzodiazepines) is not recommended unless advised by a doctor or pharmacist.
Tractana with food and beverages
Not applicable.
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.
In the absence of sufficient data to exclude harmful effects during pregnancy or breastfeeding, the use of this medicine in these cases is not recommended.
Driving and using machines
This medicine may impair your ability to drive or operate machinery. If this effect occurs, do not drive or operate machinery.
Tractana contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Tractana

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults and children over 12 years of age is:

For relief of temporary mental stress: 1-2 tablets in the morning and 1-2 tablets in the evening. The dosage may be increased according to the advice of your doctor or pharmacist (up to a maximum of 8 tablets per day).
To aid sleep: 1-2 tablets in the evening, half an hour before going to bed.

Take the tablets with plenty of water.
If symptoms worsen or do not improve after 2 weeks, contact a doctor or pharmacist.
If you take more Tractana than you should
If you (or someone else) have taken a large number of tablets at the same time, or if you suspect that a child has taken a tablet, contact a doctor or pharmacist.
No cases of overdose have been reported.
If you forget to take Tractana
Do not take a double dose to make up for the forgotten dose.
If you stop taking Tractana
No adverse effects occur if you stop taking Tractana.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No adverse reactions have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tractana

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines 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 Tractana contains
The active substance is passionflower aerial extract (Passiflora incarnata L.).
Each coated tablet contains 200 mg of dry extract of Passiflora incarnata L., herba
(equivalent to 700 mg – 1000 mg of passionflower).
Extraction solvent: Ethanol 60% V/V.
The other components are:

Tablet core: microcrystalline cellulose, povidone, sodium starch glycolate (type A), hydrogenated cottonseed oil, colloidal anhydrous silica, tricalcium phosphate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172).
Excipient in the extract: maltodextrin.

Description of the appearance of Tractana and the contents of the pack
Tractana tablets are pink, oblong, biconvex.
Tractana is available in packs of 28, 42, 98 or 98x1 tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Tilman SA, Z.I. Sud 15, 5377 Baillonville, Belgium
Marketing Authorization Holder for Italy:
LABORATORI BALDACCI S.p.A.
Via San Michele degli Scalzi, 73 - PISA
This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium, Luxembourg: Sedistress 200
Finland, Norway, Sweden: Sedix
France, Slovenia: Anxemil
Netherlands: Sofytol
Austria: PhytoCalm
Cyprus, Greece, Spain, Poland: Sedistress