Passipas

Document: Passipas Coated tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Passipas, coated tablets

Extract from Passion Flower

Read all of this leaflet carefully before you start 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.

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You should talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is in this leaflet:

1. What Passipas is and what it is used for

2. What you need to know before you take Passipas

3. How to take Passipas

4. Possible side effects

5. How to store Passipas

6. Contents of the pack and other information

1. WHAT PASSIPAS IS AND WHAT IT IS USED FOR

Passipas is a traditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep.

The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

You should talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PASSIPAS

Do not take Passipas

if you are allergic to Passion Flower or any of the other ingredients of this medicine (listed in section 6).

Children:

Passipas is not recommended for use in children under 12 years of age because no adequate data are available.

Other medicines and Passipas

There are no reports of interactions between Passipas and other medicines.

If you see a doctor, remember to tell him/her that you are taking or have recently taken this OTC medicine.

Pregnancy, breast-feeding and fertility

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

No studies of possible effects on fertility are available.

Driving and using machines

This medicinal product may impair ability to drive and use machines. You should not drive or use machines, if you feel affected.

Passipas contains glucose and sucrose. Therefore, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Passipas.

3. HOW TO TAKE PASSIPAS

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

The recommended dose for adults, elderly and adolescents from 12 years of age is:

For the relief of mild symptoms of mental stress:

2-3 tablets daily, taken evenly spread over the day.

To aid sleep:

1-2 tablets taken half an hour before bedtime.

The maximum dose is 3 tablets daily.

Passipas should be swallowed whole with sufficient liquid (preferably a glass of drinking water).

You should talk to a doctor if your symptoms get worse or if you do not feel better after 14 days.

Use in children:

PASSIPAS is not recommended for use in children under 12 years of age because no adequate data are available.

If you take more Passipas than you should

If you or someone else have taken more Passipas tablets than recommended, or if you think a child have swallowed the medicine by accident, please contact your doctor or pharmacist.

There have been no reports of overdose.

If you forget to take Passipas

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

There are no known side effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system:

[Contact details for national reporting system acc. to appendix 5 to QRD template]

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PASSIPAS

Do not store above 30°C.

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 the blister below “EXP”.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Passipas contains:

The active substance in each tablet is: 425 mg of dry extract from Passion Flower Herb (Passiflora incarnata), corresponding to approximately 2-3 g dried herb of Passion flower.
The other ingredients are: sucrose; maltodextrin; talc; calcium carbonate; croscarmellose sodium; silica, colloidal anhydrous; cellulose, powdered; stearic acid; hypromellose; acacia; magnesium stearate; titanium dioxide E171; liquid glucose, spray dried; tragacanth; shellac; beeswax, white; carnauba wax; yellow iron oxide E172.

What Passipas looks like and contents of the pack

Pale yellow, round, coated tablets in blister packs (PVC/PVDC/Aluminium)

Pack sizes: 10, 30, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Registration Holder

Manufacturer

PASCOE pharmazeutische Präparate GmbH

Schiffenberger Weg 55, 35394 Giessen, Germany

Tel: +49 641 7960 0, fax: +49 641 7960 109

This medicinal product is authorised in the Member States of the EEA under the following names:

DK: Pascoflair

NO: Pascoflair

SE: Passipas

This leaflet was last revised in 14 April 2016.

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