AGIOLAX GRANULADO

Introduction

Package Leaflet: Information for the User

Agiolax Granules

Plantago ovata seeds / Plantago ovata seed husks (Ispaghula husk) / Cassia angustifolia fruits (Sennae fructus)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Package Leaflet Contents

1. What Agiolax granules are and what they are used for
2. What you need to know before taking Agiolax granules
3. How to take Agiolax granules
4. Possible side effects
5. Storage of Agiolax granules
6. Package contents and additional information

1. What Agiolax granules are and what they are used for

Agiolax granules belong to a group of medications called laxatives.

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

Agiolax granules are used for:

• Short-term treatment of occasional constipation.

You should consult a doctor if your symptoms worsen or do not improve after 3 days.

It should not be used for more than 1 week. Generally, it is sufficient to take this medication up to 2 or 3 times during a week.

2. What you need to know before taking Agiolax granules

Do not take Agiolax granules

• If you are allergic to Plantago ovata, Cassia angustifolia, or any of the other components of this medication (listed in section 6).
• If you have intestinal obstruction and stenosis (narrowing).
• If you have paralytic ileus (acute intestinal obstruction due to paralysis of intestinal movements) or megacolon.
• If you have inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis).
• If you have appendicitis.
• If there are any abdominal symptoms, acute or persistent, that have not been diagnosed, including rectal bleeding.
• If you have sudden changes in bowel habits that persist for more than 2 weeks.
• If you have difficulty defecating after using a laxative.
• If you have esophageal or cardia (stomach) diseases.
• If you have difficulty swallowing or throat problems.
• If you are pregnant or breastfeeding.
• If you have severe dehydration.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Agiolax granules.

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

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

Children and adolescents

Do not administer to children under 12 years of age.

Other medications and Agiolax granules

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

It is not recommended to administer to patients being treated with cardiac glycosides (medications that regulate heart activity) and antiarrhythmic medications (e.g., quinidine).

It should not be administered in conjunction with other medications that induce hypokalemia (e.g., thiazide diuretics, adrenocorticosteroids, and licorice root), as it may favor electrolyte imbalance.

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

After taking any other medication, wait 30 minutes to 1 hour before taking Agiolax. Similarly, Agiolax should not be administered 30 minutes to 1 hour before taking other medications.

If you are an insulin-dependent diabetic and take Agiolax with meals, you may need to reduce your insulin dose.

The use of Plantago ovata seeds along with thyroid hormones requires medical supervision, as it may be necessary to adjust the dose of these hormones.

Taking Agiolax granules with food, drinks, and alcohol

Do not take Agiolax immediately after a meal.

After eating, wait 30 minutes to 1 hour before taking Agiolax.

Pregnancy, breastfeeding, and fertility

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

Use during pregnancy is contraindicated.

This preparation is excreted in small amounts in breast milk; its use is contraindicated during breastfeeding.

Driving and using machines

No effects on driving or using machines have been reported.

Agiolax granules contain sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Agiolax granules

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Agiolax granules are administered orally.

The granules should be ingested without dissolving or chewing, in an upright position, and with the help of plenty of liquid (1 or 2 glasses), regardless of the type chosen (water, milk, orangeade, etc.).

Maintain an interval of half an hour to one hour after taking any other medication or food.

Take Agiolax preferably at night, but not immediately before bedtime.

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

The duration of treatment should not exceed 7 days.

The recommended dose is:

Adults and adolescents over 12 years: It is recommended to take one dessert spoon of Agiolax in the morning and one 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 women.

Use in children and adolescents:

Not recommended in 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, consult your doctor or pharmacist.

The main symptoms are colic and severe diarrhea, with consequent loss of fluid and electrolytes, which should be replaced.

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 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 forgotten doses.

If you interrupt treatment with Agiolax granules

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them:

Very rare serious side effects (may affect up to 1 in 10,000 people):

• After oral administration or skin contact, it can cause hypersensitivity reactions, including anaphylactic reactions.

Frequency not known (cannot be estimated from available data):

At the start of treatment and depending on the dose, some discomfort such as flatulence and/or a feeling of fullness may appear, characteristic of dietary fiber, which disappears after a few days without the need to discontinue treatment.

• Reddish-brown discoloration (depending on pH) of the urine due to metabolites, which is of no importance.
• Skin symptoms such as exanthema and/or itching.
• Nausea and vomiting.
• Chronic use can lead to disorders in water and electrolyte balance and may cause albuminuria and hematuria.
• Abdominal pain, spasms, and diarrhea, particularly in patients with irritable colon. However, these symptoms can also occur as a consequence of individual overdose. In such cases, dose reduction is necessary.
• Pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually reverses after the medication is discontinued.
• Intestinal or esophageal obstruction, mainly if ingested with little liquid.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Agiolax granules

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging.

Keep the container perfectly closed.

Do not store at a temperature above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Agiolax granules

The active ingredients are:

Plantago ovata seed powder ………………………………. 2,600 g

Plantago ovata seed husks (Ispaghula husk)………. 0,110 g

Cassia angustifolia fruits (Sennae fructus)…. ………………0,337-0,658 g

(with a content of sennosides expressed as sennoside B…… 0,015 g

The other components are sucrose, Carum carvi essential oil, Salvia officinalis essential oil, Mentha piperita essential oil, gum arabic, talc, red iron oxide (E-172), yellow iron oxide (E-172), black iron oxide (E-172), solid paraffin, liquid paraffin.

Appearance of the product and package contents

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

Marketing authorization holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

MADAUS GmbH

Lutticher Strasse, 5

53842 Troisdorf Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Date of the last revision of this package leaflet:September 2023

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