JARABE DEL DR MANCEAU Syrup

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DR. MANCEAU SYRUP

Contents of the package leaflet:

1. What DR. MANCEAU SYRUP is and what it is used for
2. Before taking DR. MANCEAU SYRUP
3. How to take DR. MANCEAU SYRUP
4. Possible side effects
5. Storage of DR. MANCEAU SYRUP
6. Additional information

1. What is Dr. Manceau Syrup and what is it used for

DR. MANCEAU SYRUP is a laxative that is administered orally.

DR. MANCEAU SYRUP is indicated for the short-term treatment of occasional constipation in adults, adolescents, and children over 12 years of age.

2. Before taking Dr. Manceau Syrup

Do not take DR. MANCEAU SYRUP:

• If you are allergic (hypersensitive) to senna or any of the other components.
• If you have:
• • Undiagnosed abdominal pain
  • Colic
  • Nausea
  • Other symptoms that may suggest the presence of appendicitis
  • Intestinal obstruction and stenosis
  • Intestinal atony
  • Organic inflammatory colopathies (ulcerative rectocolitis, Crohn's disease)
  • Abdominal pain syndromes of undetermined cause
  • Hydric and electrolytic metabolic disorders
• Do not use in patients with:
• • Fructose intolerance
  • Glucose/galactose malabsorption syndrome
  • Sucrose-isomaltase deficiency
• Children under 12 years of age.

Be careful with Dr. Manceau Syrup:

This medication contains sucrose, patients with hereditary fructose intolerance, glucose or galactose malabsorption, or sucrose-isomaltase insufficiency should not take this medication.

This product contains 768mg of sucrose per ml of syrup, which should be taken into account by diabetic patients.

Patients who are taking cardiac glycosides, antiarrhythmic medications, medications that prolong the QT interval, diuretics, adrenocorticoids, or licorice root should consult their doctor before taking this medication concomitantly.

Intake of stimulant laxatives for a period longer than the intended application may cause worsening of constipation. This preparation should only be used when a therapeutic effect has not been achieved with a change in dietary habits or with bulk-forming laxatives.

Use in elderly patients with incontinence

It is recommended to frequently change the diaper to avoid prolonged contact of the skin with feces in elderly patients with incontinence who take the medication.

Use of other medications

Cardiac glycosides may potentiate their effect.

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication - including those purchased without a medical prescription.

Pregnancy

Consult your doctor or pharmacist before using any medication.

As a general precaution, and due to the lack of data on its use during pregnancy and lactation, its use is not recommended in these situations.

Breastfeeding

Women during the breastfeeding period should consult with their doctor or pharmacist before taking this medication, as sennosides pass into breast milk, although in reduced proportions.

Driving and using machines

No effects have been described that affect the ability to drive vehicles or operate machinery.

Important information about some components of Dr. Manceau Syrup

This medication contains 768mg of sucrose per ml of syrup. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Dr. Manceau Syrup

Follow these instructions unless your doctor has given you different instructions.

Consult your doctor or pharmacist if you have doubts.

The medication is taken orally.

The normal dose is:

Adults, adolescents, and children over 12 years of age: 5ml, 1 to 3 times a day, as needed. The dose should be individualized and the minimum sufficient to achieve an evacuation.

The recommended treatment duration will be 6 days at most. In general, it is sufficient to take it two or three times a week during treatment.

The maximum recommended daily dose of hydroxyanthracene derivatives is 30 mg. A 5ml measure of the dosing spoon corresponds to 10mg of hydroxyanthracene heterosides expressed as sennosides B.

It is advisable to take the medication at night, before bedtime. The laxative effect occurs after 8-12 hours.

In the case of elderly patients, a lower dose may be necessary due to the greater sensitivity of these patients to the effects of the medication.

Use in children: The use of this medication is not recommended in children under 12 years of age, except under medical prescription.

If you take more DR. MANCEAU SYRUP than you should:

If you have taken more DR. MANCEAU SYRUP than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

In case of accidental overdose, diarrhea with electrolyte loss, as well as cramps and general weakness, may occur. The patient should contact their doctor.

If you forget to take DR. MANCEAU SYRUP:

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

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

4. Possible side effects

Like all medications, DR. MANCEAU SYRUP can have side effects, although not all people will experience them.

Very rarely (in less than 1 case per 10,000 patients treated), intestinal discomfort such as cramps may occur, in which case it is necessary to reduce the dose. Also, very rarely, allergic reactions (pruritus, urticaria, or localized or generalized exanthema) may appear.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Dr. Manceau Syrup

Keep out of the reach and sight of children.

No special storage conditions are required. Store in the original container.

Do not use DR. MANCEAU SYRUP after the expiration date indicated on the container, after the word EXP.

"Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.”

6. Additional information

Composition of DR. MANCEAU SYRUP

The active ingredients per 5ml of syrup are:

• Aqueous extract of Pyrus Malus L (reineta apple) fruits …………… 0.5g
• Aqueous extract of Cassia angustifolia Vahl (senna) leaves ……. 0.4g
• Aqueous extract of Coriandrum sativum L (coriander) fruits …… 0.05g

The other components (excipients) are: Sucrose (768mg) per ml of syrup, Purified Water.

Appearance of the product and container contents

Dr. Manceau Syrup is presented in 60ml and 120ml bottles, packaged in cardboard boxes that include a dosing spoon.

Marketing authorization holder and manufacturer:

Laboratorios ALCOR, S.L.

Polígono Industrial del Henares, C/ Juan de Austria, 142

19004 GUADALAJARA

This leaflet was approved in September 2011

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