AGIOLAX GRANULATED 250G

VER PROSPECTO

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse, including side effects not listed in this leaflet. See section 4.
• You should see a doctor if it worsens or if it does not improve after 3 days.

Leaflet content:

1. What is Agiolax granules and what is it used for?
2. What you need to know before you take Agiolax granules
3. How to take Agiolax granules
4. Possible adverse effects
5. How to store Agiolax granules
6. Contents of the pack and additional information

1. What Agiolax granules is and what it is used for

Agiolax granules belongs to a group of medicines called laxatives.

These drugs act by facilitating the absorption of water by the intestinal bolus, forming a gel that increases the volume and fluidity of the stool. Agiolax granules acts as an intestinal regulator, increasing the volume of stool and stimulating evacuation.

Agiolax granules is used for :

• Short-term treatment of occasional constipation.

You should see a doctor if it worsens or does not improve after 3 days.

It should not be used for more than 1 week. It is usually enough to take this medicine up to 2 or 3 times during a week.

2. Before taking Agiolax granules

Do not take Agiolax granules

• If you are allergic to Plantago ovata, Cassia angustifolia or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from obstruction and stenosis (narrowing) of the intestine.
• If you have paralytic ileus (acute blockage of the intestine due to paralysis of bowel movements).
• If you suffer from inflammatory diseases of the colon (eg Crohn's disease, ulcerative colitis).
• If you have appendicitis.
• If there are any undiagnosed acute or persistent abdominal symptoms, including rectal bleeding.
• If you suffer from sudden changes in bowel habits that persist for more than 2 weeks.
• If you are unable to have a bowel movement after using a laxative.
• If you suffer from diseases of the esophagus or cardia (end of the stomach that joins the esophagus).
• If you have diabetes mellitus that is difficult to control.
• If you have difficulty swallowing or a throat problem.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Agiolax granules.

It should not be used daily for a long period of time. Its use should be avoided for more than 1 week.

• Abuse can cause diarrhea, with consequent loss of fluid and electrolytes (mainly a decrease in potassium).
• Long-term abuse can also aggravate constipation.
• Chronic use can cause pigmentation of the colon (colonic pseudomelanosis), which is harmless and will disappear when treatment is withdrawn.
• If symptoms worsen or do not improve after 3 days of treatment, see your doctor.

children and adolescents

Do not administer to children under 12 years of age.

Other medicines and Agiolax granules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Its administration is not recommended in patients receiving treatment based on cardiac glycosides (drugs that regulate cardiac activity) and antiarrhythmic drugs (eg, quinidine).

It should not be co-administered with other hypokalemia-inducing drugs (eg, thiazide diuretics, adrenocorticosteroids, and licorice root) as it may promote electrolyte imbalance.

The absorption of other co-administered drugs, such as minerals, vitamins (B12), cardiac glycosides, coumarin derivatives (anticoagulants), carbamazepine (antiepileptic) and lithium (used in the treatment of bipolar disorder), may be delayed.

Wait 30 minutes to 1 hour after taking any other medicine before taking Agiolax. Similarly, Agiolax should not be administered from 30 minutes to 1 hour before the intake of other medications.

If you are an insulin-dependent diabetic and take Agiolax with food, your insulin dose may need to be reduced.

The use of Plantago ovata seeds in conjunction with thyroid hormones requires medical supervision as the dosage of these hormones may need to be adjusted.

Taking Agiolax granules with food, drink and alcohol

Do not take Agiolax immediately after food.

Wait 30 minutes to 1 hour after eating food before taking Agiolax.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before using this medicine.

This preparation is eliminated in small quantities through breast milk, its use is contraindicated during lactation.

Driving and using machines

No effects on driving and using machines have been described.

Agiolax granules contain sucrose

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Agiolax granules

Follow exactly the directions for administration of this medication given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Agiolax granules are administered orally.

The granules must be ingested without dissolving or chewing, with the help of plenty of liquid (1 or 2 glasses), regardless of the type you choose (water, milk, orangeade, etc.).

Maintain an interval of half an hour to an hour apart after taking any other medicine or food.

Do not take Agiolax granules immediately before going to bed.

Agiolax granules usually cause bowel movements within 12-24 hours. If symptoms worsen or do not improve after 3 days of treatment, check with your doctor.

The duration of treatment should not be more than 7 days.

The recommended dose is:

Adults and adolescents over 12 years of age: It is recommended, preferably, to take a dessert spoonful of Agiolax in the morning and another at night, although it can be taken in a single dose as long as the dose of 2 teaspoons per day is not exceeded.

Elderly patients : The same dose as adults.

Pregnant women:

Do not use in pregnant

Use in children and adolescents

Not recommended for children under 12 years of age

If you take more Agiolax granules than you should

If you have taken more Agiolax granules than you should, talk to your doctor or pharmacist.

The main symptoms are colic and severe diarrhoea, with the consequent loss of fluid and electrolytes, which should be replenished.

Treatment should be maintenance, with copious amounts of fluids. Electrolytes, especially potassium, should be monitored.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, telephone 915 62 04 20, indicating the medication and the amount ingested.

If you forget to take Agiolax granules

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

If you stop taking Agiolax granules

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

4. Possible adverse effects

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

Not known (frequency cannot be estimated from the available data):

• At the start of treatment and depending on the dose, some discomfort may appear such as flatulence (gas) and/or a feeling of fullness, characteristic of dietary fiber, which disappear after a few days without the need to suspend treatment.
• Abdominal spasms and pain.
• Red-brown coloration (depending on the pH) of the urine by the metabolites, which is unimportant.
• Hypersensitivity reactions (allergy).
• Intestinal or esophageal obstruction, especially if it is ingested with little liquid.

Communication of adverse effects

If you get any side effects, talk to your doctor, pharmacist and nurse, including possible side effects not listed in this leaflet.

You can also notify them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Agiolax granules

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 pack after EXP. The expiration date is the last day of the month indicated.

Keep the original package.

Keep the container perfectly closed.

Do not store at temperatures above 25?C

Medications should not be thrown down the drain or in the trash. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines that you do not need. This way you will help to protect the environment.

6. Contents of the pack and other information

What Agiolax granules contain

The active ingredients are: Plantago ovata seeds powder ………………………………. 2,600g

Seed cuticles of Plantago ovata (Ispaghula husk)………. 0.110g

Fruits of Cassia angustifolia (Sennae fructus)…. ………………0.337-0.658g

(with a content of sennosides expressed as sennosides B…… 0.015 g

• The other ingredients are sucrose, Carum carvi essential oil, Salvia officinalis essential oil, Peppermint essential oil, gum arabic, talc, iron oxide red (E172), iron oxide yellow (E172), iron oxide black ( E172), solid paraffin, liquid paraffin.

Appearance of the product and contents of the container

Agiolax granules are presented in bottles containing 100 or 250 g of granules for oral administration.

Marketing Authorization Holder

Meda Pharma SL

C/ General Aranaz 86. 28027 Madrid.

Spain

Responsible for manufacturing

MADAUS GmbH

Lutticher Strasse, 5

53842 Troisdorf Germany

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Mylan Pharmaceuticals, SL

C/ Plom, 2-4, 5th floor

08038 - Barcelona, ​​Spain

This leaflet has been revised in November 2021

La información detallada y actualizada de este medicamento está disponible en la página Web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) http://www.aemps.gob.es/