PROSPECTO: INFORMATION FOR THE USER

DR. MANCEAU SYRUP

Dr. Manceau's Syrup is a laxative administered orally

Dr. Manceau's Syrup is indicated for the short-term treatment of occasional constipation in adults, adolescents, and children over 12 years old.

Do not take DR. MANCEAU SYRUP:

• If you are allergic (hypersensitive) to the product or any of its components.
• If you have:
• • Undiagnosed abdominal pain
  • Colics
  • Nausea
  • Other symptoms that may suggest the presence of appendicitis
  • Intestinal obstruction and stenosis
  • Intestinal atony
  • Inflammatory organic colopathies (ulcerative colitis, Crohn's disease)
  • Abdominal pain syndromes of unknown cause
  • Metabolic and electrolyte disturbances
• Do not use in patients with:
• • Fructose intolerance
  • Syndrome of poor glucose/galactose absorption
  • Saccharose-isomaltose deficiency
• Children under 12 years old.

Be especially careful with Dr. Manceau Syrup:

This medication contains saccharose. Patients with hereditary fructose intolerance, poor glucose or galactose absorption, or saccharose-isomaltose insufficiency should not take this medication.

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

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

A prolonged intake of laxative stimulants may cause worsening of constipation. This preparation should only be used when a therapeutic effect has not been achieved with a change in eating habits or with bulk-forming laxatives.

Use in elderly patients with incontinence:

Frequent changing of diapers is recommended to avoid prolonged skin contact with feces in elderly patients with incontinence who take the medication.

Use of other medications:

Cardiac glycosides may potentiate its effect.

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

Lactation:

Women during lactation should consult their doctor or pharmacist before taking this medication, as sennosides pass into breast milk in reduced proportions.

Driving and operating machinery:

No adverse 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 saccharose per ml of syrup. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Consult your doctor or pharmacist if you have any doubts.

The medication is taken orally.

The usual dose is:

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

The recommended treatment duration will be a maximum of 6 days. In general, it is sufficient to take it 2 or 3 times a week during treatment.

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

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

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

Use in children: This medication is not recommended for use in children under 12 years old, except on doctor's prescription.

If you take more Dr. Manceau's Syrup than you should:

If you have taken more Dr. Manceau's Syrup than you should, consult your doctor, pharmacist, or call the Toxicological 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 forgot to take Dr. Manceau's Syrup:

Do not take a double dose to compensate for the missed doses.

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

Like all medications, DR. MANCEAU SYRUP may have adverse effects, although not everyone will experience them.

Very rarely (in less than 1 case per 10,000 treated patients) intestinal discomfort such as cramps may occur, in which case the dose should be reduced. Very rarely, allergic reactions (pruritus, urticaria, or localized or generalized exanthema) may also appear.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 CAD.

“Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.”

Composition of DR. MANCEAU SYRUP

The active principles for each 5ml of syrup are:

• Water extract of Pyrus Malus L (Red Delicious apple) fruit………… 0.5g
• Water extract of Cassia angustifolia Vahl (senna) leaves………………. 0.4g
• Water extract of Coriandrum sativum L (coriander) fruit…………... 0.05g

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

Appearance of the Product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios ALCOR, S.L.

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

19004 GUADALAJARA

This leaflet was approved in September 2011

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.