PASANG 425 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pasang 425 mg coated tablets

Dry extract of Passiflora

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 weeks.

Contents of the package leaflet:

1. What is Pasang and what is it 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. Package contents and additional information

1. What is Pasang and what is it used for

Pasang is an oral tablet.

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

2. Before taking Pasang

Do not takePasang if:

• you are allergic (hypersensitive) to passiflora or any of the other components of Pasang.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pasang.

If symptoms persist or worsen after 2 weeks of treatment, you should consult a doctor.

Taking Pasang with other medications

Tell 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 to date, it is recommended not to take this medication simultaneously with other medications with sedative activity, nor to consume alcoholic beverages during treatment with Pasang.

Taking Pasang with food and beverages

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

Pregnancy and lactation

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

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

Driving and using machines

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

Pasang contains glucose and sucrose

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

3. How to take Pasang

Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Pasang is a medication administered orally.

The recommended dose is:

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

Use in children

Pasang should not be administered to children under 12 years.

If you think the effect of Pasang is too strong or too weak, tell your doctor or pharmacist.

If you take more Pasang than 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 forget to take Pasang

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

After taking medications containing Passiflora, such as Pasang, allergic skin reactions (e.g., exanthema, urticaria, pruritus) may occur, as well as increased heart rate and gastrointestinal disorders (e.g., nausea, stomach pain, diarrhea). The frequency with which these side effects may appear is not known.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pasang

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

Do not store above 30°C.

Keep in the original packaging.

Do not use Pasang after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Pasang

Each Pasang tablet contains as an active ingredient 425.00 mg of dry extract of Passiflora 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, Liquid glucose (spray dried), Hypromellose, Capol 600 T.S. (Beeswax, Carnauba wax, Shellac), Iron hydroxide/oxide E172.

Appearance of the product and package contents

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

Not all pack sizes may be marketed.

Marketing authorization holder

Pascoe pharmazeutische Präparate GmbH

Schiffenberger Weg 55

D-35394 Giessen (Germany)

pharmakovigilanz@pascoe.de

Manufacturer

Pascoe pharmazeutische Präparate GmbH

Europastrasse 2

D-35394 Giessen (Germany)

This package leaflet was approved in October 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/