PATIENT INFORMATION LEAFLET

Pasang 425 mg coated tablets

Dried extract of Passiflora

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

-You should consult a doctor if you get worse or do not improve after 2 weeks.

1.What is Pasang and what it is used for

2.What you need to know before taking Pasang

3.How to take Pasang

4.Possible side effects

5.Storage of Pasang

6.Contents of the pack and additional information

Pasangare oral tablets.

It is traditionally indicated for the symptomatic and transient treatment of states of restlessness, stress, and irritability with difficulty falling asleep.

Do not take Pasang :

- if you are allergic (hypersensitive) to passionflower or to any of the other components of Pasang.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pasang.

If symptoms continue or worsen after 2 weeks of treatment, consult your doctor.

Taking Pasang with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Although no interactions with Pasang have been described so far, it is recommended not to take this medication simultaneously with others with sedative activity, nor consume alcoholic beverages during treatment with Pasang .

Taking Pasang with food and drinks

It is not recommended to consume alcohol or alcoholic beverages during treatment with Pasang .

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

The safety of this medication during pregnancy and during breastfeeding has not been established.

Driving and operating machines

Pasang is a medication that can cause drowsiness. Do not drive or operate machines if you feel drowsiness or notice that your attention and reaction time are reduced.

Pasang contains glucose and sucrose

This product contains glucose and sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Pasang is a medication administered orally.

The recommended dose is:

Adults and children over 12 years old: 1 tablet 2 or 3 times a day, taken with main meals, accompanied by a liquid.

Use in children

Pasang should not be administered to children under 12 years old.

If you estimate that the action of Pasang is too strong or too weak, inform your doctor or pharmacist.

If you take morePasangthan you should

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20,indicating the product and the amount ingested.

If you forgot to take Pasang

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medicationmay produce adverse effects, although not all people may experience them.

After taking medications that contain Passiflora, such as Pasang, skin allergic reactions (for example, exanthema, urticaria, pruritus) may occur, as well as an acceleration of heart rate and gastrointestinal discomfort (for example, nausea, stomach pain, diarrhea). The frequency with which the mentioned adverse effects may appear is unknown.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above30°C.

Store in the original packaging.

Do not use Pasangafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pasang

Each Pasang tablet contains as active ingredient 425.00 mg of Dried Extract ofPassiflora incarnata,equivalent to approximately 2,550 g of plant.

The other components are: Maltodextrin, Anhydrous Colloidal Silica, Powdered Cellulose, Sodium Croscarmellose, Magnesium Stearate, Stearic Acid, Talc, Sucrose, Calcium Carbonate E170, Acacia, Tragacanth, Spray Dried Glucose, Hypromellose, Capol 600 T.S. (Beeswax, Carnauba Wax, Shellac), Iron Oxide/Hydroxide E172.

Appearance of the product and content of the container

PVC/PVDC-aluminum blister of 15 tablets, in packs of 30, 60, or 90 tablets, depending on the presentation.

Not all container sizes may be marketed.

Holder of the marketing authorization

Pascoe pharmazeutische Präparate GmbH

Schiffenberger Weg 55

D-35394 Giessen (Germany)

[email protected]

Responsible for manufacturing

Pascoe pharmazeutische Präparate GmbH

Europastrasse 2

D-35394 Giessen (Germany)

This leaflet was approved in October 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/