NEURAPAS Coated Tablets

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

NEURAPAS coated tablets

Dry extract of St. John's Wort, Valerian and Passionflower

Follow the instructions for administration of the medicine contained in this leaflet or as indicated 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 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 your symptoms worsen or do not improve after 4 weeks.

Contents of the package leaflet:

1. What is NEURAPAS and what is it used for
2. What you need to know before taking NEURAPAS
3. How to take NEURAPAS
4. Possible side effects
5. Storage of NEURAPAS
6. Contents of the pack and further information

1. What is NEURAPAS and what is it used for

NEURAPAS is presented in the form of coated tablets, for oral administration.

NEURAPAS is a herbal medicine, traditionally used for the relief of states of exhaustion that occur with loss of interest and sleep disturbances.

2. What you need to know before taking NEURAPAS

Do not take NEURAPAS

• if you are already taking certain medicines (see Taking other medicines)
• if you are allergic (hypersensitive) to the active ingredients or to any of the other components of this medicine (listed in section 6).
• if you have hypersensitivity to light
• if you are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take NEURAPAS

If you are being treated with other medicines, consult your doctor or pharmacist before taking this St. John's Wort preparation (see Use of NEURAPAS with other medicines)

If you are already taking NEURAPAS at the same time as other medicines, do not stop taking NEURAPAS without consulting your doctor first. If you stop taking the St. John's Wort preparation, some adverse reactions to the other medicines may occur, especially in the case of ciclosporin, theophylline, digoxin, or oral anticoagulants (warfarin, acenocoumarol) (see Use of NEURAPAS with other medicines).

If you are taking NEURAPAS, avoid intense exposure to UV rays (long exposures to the sun, UVA ray baths).

If your symptoms worsen or persist after 4 weeks, despite taking the recommended dose regularly, you should consult your doctor. On the other hand, improvement usually does not occur until 10 to 14 days after starting treatment.

Use of NEURAPAS with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Patients who are taking the following medicines:

• for AIDS (antiretrovirals)
• for cancer (irinotecan)
• for transplant rejection (ciclosporin, tacrolimus)
• for epilepsy
• for the heart (digoxin)
• for cholesterol (simvastatin)
• for the treatment of asthma or chronic bronchitis (theophylline)
• for migraine
• for chronic idiopathic urticaria (fexofenadine)
• for benign prostatic hyperplasia (finasteride)
• for anxiety (buspirone)
• for depression
• to treat addiction to drugs such as morphine or heroin, opioids (methadone)
• oral anticoagulants
• oral contraceptives

should not start using St. John's Wort preparations without consulting their doctor or pharmacist first (see Warnings and precautions).

Also, inform your doctor or pharmacist of any suspected change in the effects of the medicines you are taking at the same time as NEURAPAS.

Pregnancy and breastfeeding

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

Do not take this medicine during pregnancy.

Driving and using machines

This medicine may cause drowsiness. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction capacity are reduced.

NEURAPAS contains lactose, glucose, and glycerol

• This medicine contains lactose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• This medicine may cause headache, stomach upset, and diarrhea because it contains glycerol.

3. How to take NEURAPAS

NEURAPAS is a medicine that is taken orally.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is

Adults and children over 18 years:

Administer a dose of 2 tablets three times a day.

The normal duration of treatment is 3 to 4 weeks. If improvement occurs, treatment can be continued for up to 8 weeks, always under medical advice.

It is advisable to take the doses at the same time every day.

It is recommended to drink a glass of water with each dose.

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

If you take more NEURAPAS than you should

The adverse effects of this medicine may be intensified. If the following symptoms appear: redness, itching, and rash on the skin, you should avoid exposure of the skin to UV rays (long exposures to the sun, UVA ray baths), even for a week after.

In cases of overdose or accidental ingestion of large quantities of NEURAPAS, go immediately to a medical center or call the Toxicology Information Service, phone: 915.620.420, indicating the medicine and the amount ingested.

If you forget to take NEURAPAS

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

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

4. Possible side effects

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

NEURAPAS may cause, in people with fair skin, reactions similar to sunburn in areas of the body exposed to intense sunlight. In these cases, you should avoid intense exposure to UV rays (long exposures to the sun, UVA ray baths), even for a week after.

Rarely, gastrointestinal disorders, allergic reactions (redness, itching, and rash on the skin), and agitation may occur.

Reporting of side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of NEURAPAS

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of NEURAPAS

Each coated tablet contains, as active ingredients:

• 60 mg of dry extract of flowering tops of Hypericum perforatum (St. John's Wort), equivalent to 276-390 mg of flowering tops, and with a content of 0.08 mg of total hypericins.
• 28 mg of dry extract of root of Valeriana officinalis (Valerian), equivalent to 106-156 mg of root.
• 32 mg of dry extract of flowering tops of Passiflora incarnata (Passionflower), equivalent to 200-227 mg of flowering tops.

Solvent used for extraction: ethanol

The other ingredients are:

povidone K30, lactose, glycerol, spray-dried glucose syrup, colloidal anhydrous silica, croscarmellose, maltodextrin, talc, sodium croscarmellose, magnesium stearate, Eudragit E, Macrogol 6000, indigo carmine (E132).

Appearance and packaging of the product

This medicine is presented in packs containing 60 or 100 tablets, in blister packs of aluminum/PVC/Aclar, 20 tablets per blister.

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 leaflet was approved in

July 2017

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