Bearberry Elusanes 200mg 30 capsules urinary disorders
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  • Bearberry Elusanes 200mg 30 capsules urinary disorders

Naturactive PHYTO Bearberry 200mg 30 capsules

€4.99

Indications : Traditionally used to promote renal water elimination. Traditionally used as an adjuvant of diuresis cures in benign urinary disorders.

48 hours
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SUMMARY OF PRODUCT FEATURES

1. NAME OF THE MEDICINAL PRODUCT

ELUSANES BUSSEROLE, capsule

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Bearberry (aqueous dry extract of leaf)................................................................................200 mg

on maltodextrin

For one capsule.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsule.

4. CLINICAL DATA

4.1. therapeutic indications

Herbal medicine.

Traditionally used to promote renal elimination of water.

Traditionally used as an adjuvant to diuresis cures in benign urinary disorders.

4.2. Dosage and method of administration

Oral use. For adults only.

1 capsule morning and evening, to be taken with a large glass of water.

4.3. Contraindications

Not applicable.

4.Special warnings and precautions for use

Special warnings

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable.

4.6. Pregnancy and lactation

There are no reliable data on teratogenesis in animals.

Clinically, no specific malformative or fetotoxic effects have been observed to date.

However, the follow-up of exposed pregnancies is insufficient to exclude any risk.

Therefore, as a precautionary measure, this drug should not be used during pregnancy.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Not applicable.

4.9. Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Not applicable.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients

Lactose monohydrate, colloidal anhydrous silica, magnesium stearate.

Composition of the capsule shell: gelatin, yellow iron oxide, titanium dioxide.

6.Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

No special storage precautions.

6.5. Nature and contents of the outer packaging

20 or 30 capsules in a white high density polyethylene bottle with a white polypropylene cap.

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

8. MARKETING AUTHORIZATION NUMBER(S)

● 345 794-1: 20 capsules in bottle (PE/PP).

● 335 842-3: 30 capsules in a bottle (PE/PP).

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25 November 1992 - 25 November 2007

10. DATE OF UPDATE OF THE TEXT

19 August 2010

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND SUPPLY

Not subject to medical prescription.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Name of the medicinal product

ELUSANES BUSSEROLE, capsule

Box

Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist for more information.

  • Keep this leaflet as you may need to read it again.
  • If you need more information and advice, ask your pharmacist.
  • If symptoms worsen or persist, consult a doctor
  • If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Summary of leaflet

In this leaflet :

1. WHAT IS ELUSANES BUSSEROLE, capsule AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING ELUSANES BUSSEROLE, capsule?

3. HOW DO I TAKE ELUSANES BUSSEROLE, capsule?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO CONSERVE ELUSANES BUSSEROLE, capsule?

6. ADDITIONAL INFORMATION

1. WHAT IS ELUSANES BUSSEROLE, capsule and WHAT IS IT USED FOR?

Pharmacotherapeutic class

Medicinal product BASED ON PLANTS.

Therapeutic indications

Traditionally used to promote renal elimination of water.

Traditionally used as an adjuvant treatment for benign urinary disorders.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING ELUSANES BUSSEROLE, capsule?

List of information necessary before taking the medicine

If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.

Contraindications

Not applicable.

Precautions for use; special warnings

Take care with ELUSANES BUSSEROLE, capsule:

Special warnings

The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare metabolic diseases).

Precautions for use

If urinary problems persist for more than three days, consult a doctor.

Interactions with other drugs

Taking or using other medicines

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and lactation

It is preferable not to use this medicine during pregnancy.

If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether you should continue the treatment.

Ask your doctor or pharmacist for advice before taking any medication.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

List of excipients with a notable effect: lactose

3. HOW TO TAKE ELUSANES BUSSEROLE, capsule?

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage

For adults only.

1 capsule morning and evening, to be taken with a large glass of water.

Method of administration

Take by mouth.

Symptoms and instructions in case of overdose

Not applicable.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, ELUSANES BUSSEROLE, capsule is likely to have undesirable effects, although not everyone is subject to them.

If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO USE ELUSANES BUSSEROLE, capsule?

Keep out of the reach and sight of children.

Expiry date

Do not use ELUSANES BUSSEROLE, capsule after the expiry date stated on the box.

Storage conditions

No particular precautions for storage.

If necessary, warnings against certain visible signs of deterioration

Do not dispose of the medicine in the sewage system or in your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What does ELUSANES BUSSEROLE, capsule contain?

The active substance is :

Bearberry (aqueous dry extract of leaf) ..............................................................................200 mg

on maltodextrin

For one capsule.

The other components are:

Lactose monohydrate, maltodextrin, colloidal anhydrous silica, magnesium stearate, gelatine, yellow iron oxide, titanium dioxide.

Pharmaceutical form and contents

What is ELUSANES BUSSEROLE, capsule and what does it contain?

This medicine comes in capsule form. Box of 20 or 30.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Operator

PIERRE FABRE MEDICAMENT

45, PLACE ABEL GANCE

92100 BOULOGNE

Manufacturer

PIERRE FABRE MEDICAMENT PRODUCTION

45, PLACE ABEL GANCE

92100 BOULOGNE

Names of the medicinal product in the member states of the European Economic Area

Not applicable.

Date of approval of the package leaflet

The last date on which this leaflet was approved was 19 August 2010.

MA under exceptional circumstances

Not applicable.

Internet information

Detailed information on this medicinal product is available on the Afssaps website (France).

Information reserved for health professionals

Not applicable.

Other

Not applicable.

3400933584238

Specific References

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