Ask a doctor about a prescription for AGIOLAX GRANULADO
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.
Package Leaflet Contents
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:
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.
Do not take Agiolax granules
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.
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.
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.
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.
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):
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.
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.
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.
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.
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/
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for AGIOLAX GRANULADO – subject to medical assessment and local rules.