PASSIO

PASSIO Balance coated tablets

Important notes (mandatory information)

PassioBalance coated tablets. Active ingredient: Passion flower herb dry extract. Areas of application: for nervous restlessness.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

PassioBalance coated tablets for use in adults and adolescents aged 12 years and over
Active ingredient: Passion flower herb dry extract

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you do not feel better or even worse after 2 weeks, contact your doctor.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

1. WHAT IS PASSIOBALANCE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PASSIOBALANCE?
3. HOW TO TAKE PASSIOBALANCE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE PASSIOBALANCE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PASSIOBALANCE AND WHAT IS IT USED FOR?

PassioBalance is a herbal medicine for calming. PassioBalance is used for nervous restlessness.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING PASSIOBALANCE?

PassioBalance must not be taken if you are allergic to passion flower herb dry extract or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If your symptoms persist for more than 2 weeks or worsen, you must see a doctor in any case.

Children under 12 years of age

There are no adequate studies on the use of PassioBalance in children. PassioBalance should therefore not be used in children under 12 years of age.

Taking PassioBalance with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. No interactions with other medicines have been reported to date.

Taking PassioBalance with food, drink and alcohol

The consumption of alcohol and alcoholic beverages is not recommended during treatment with PassioBalance, as there is no knowledge to date about the timely and simultaneous intake of passion flower herb and alcohol (see also section 2: Driving and operating machinery).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Safety during pregnancy and breast-feeding has not been adequately studied. PassioBalance is not recommended for pregnant and breast-feeding women.

Driving and operating machinery

Medicines with a sedative effect can generally alter reactions to such an extent that the ability to actively participate in road traffic or to operate machinery is impaired. This also applies if you take the medicine as intended (i.e. use as recommended under 3.: How to take PassioBalance?). This applies to an even greater extent in conjunction with alcohol.

PassioBalance contains glucose and sucrose

Therefore, please only take PassioBalance after consulting your doctor if you are known to suffer from an intolerance to certain sugars.

3. HOW TO TAKE PASSIOBALANCE?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is

Adolescents aged 12 years and over and adults take 1 tablet 2 to 3 times a day.

Method of administration

For oral use. Take the tablet with sufficient liquid (preferably 1 glass of drinking water) and without chewing. The tablets should be taken evenly distributed throughout the day.

Duration of use

The duration of use of PassioBalance is not limited in principle. However, please always observe the information in section 2: Warnings and precautions and section 4: What side effects are possible? If your symptoms persist for more than 2 weeks or worsen, you must see a doctor in any case.

If you have taken more PassioBalance than you should

In case of suspected overdose, contact a doctor so that he/she can decide on the further course of action. In the treatment of an overdose, he/she will be guided by the clinical picture and take appropriate countermeasures. An accidental, minor overdose (taking 2 - 3 tablets of this medicine) usually has no adverse effects. However, please inform a doctor about the overdose.

If you forget to take PassioBalance

Do not take twice the amount if you have forgotten to take the previous dose. Continue taking the next regular dose or as prescribed by your doctor.

If you have any further questions about taking this medicine, ask your doctor and pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. After taking PassioBalance, allergic skin reactions, nausea and increased pulse may occur. The frequency is not known. In these cases, you should stop taking the medicine and see your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE PASSIOBALANCE?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack. Do not store above +30°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What PassioBalance contains

The active ingredient is: Passion flower herb dry extract. 1 coated tablet contains 425 mg dry extract of passion flower herb (5-7:1), extraction solvent ethanol 50% (V/V). The other ingredients are gum arabic, calcium carbonate, carnauba wax, cellulose powder, croscarmellose sodium, spray-dried glucose syrup, hypromellose, magnesium stearate (Ph. Eur.) [vegetable], maltodextrin, shellac (dewaxed and bleached), stearic acid, sucrose, talc, tragacanth, bleached wax, highly dispersed silicon dioxide, iron(III)hydroxide-oxide (E 172), titanium dioxide (E 171).

What PassioBalance looks like and contents of the pack

Light yellow, round, biconvex coated tablet. PassioBalance is available in packs of 30 and 60 coated tablets.

Pharmaceutical entrepreneur

STADA Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in September 2019.

Source: Package leaflet information
Status: 10/2020
Active ingredient: Passion flower herb dry extract. Areas of application: for nervous restlessness.