Leaflet: information for the user

Agiolax granulated

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

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for 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, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Agiolax granulated belongs to a group of medications called laxatives.

These medications act by facilitating the absorption of water by the intestinal mass, forming a gel that increases the volume and fluidity of the feces. Agiolax granulated acts as an intestinal regulator, increasing the volume of the feces and stimulating evacuation.

Agiolax granulated is used for:

• Short-term treatment of occasional constipation.

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

Do not use it for more than 1 week. Generally, it is enough to take this medication 2 or 3 times during a week.

Do not take Agiolax granulated

• 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 acute intestinal paralysis or megacolon.
• If you have inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis).
• If you have appendicitis.
• If you have any unexplained abdominal symptoms, acute or persistent, including rectal bleeding.
• If you have sudden changes in bowel habits that persist for more than 2 weeks.
• If you are unable to defecate after using a laxative.
• If you have esophageal or cardia diseases (the part of the stomach that connects to the esophagus).
• If you have difficulty swallowing or any 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 granulated.

Do not use it daily for a prolonged period of time. Avoid using it for more than 1 week.

• Abuse may cause diarrhea, leading to fluid and electrolyte loss (mainly a decrease in potassium).
• Prolonged abuse may worsen constipation.
• Chronic use may cause colon pigmentation (pseudomelanosis colonica), which is harmless and will disappear when treatment is stopped.
• If 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 old.

Other medications and Agiolax granulated

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

It is not recommended to administer it to patients taking cardiac glycosides (medications that regulate heart activity) and antiarrhythmic medications (e.g. quinidine).

Do not administer it together with other medications that induce hypopotasemia (e.g. thiazide diuretics, corticosteroids and licorice root), as it may favor electrolyte imbalance.

The absorption of other medications taken together, 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 medication before taking Agiolax. Similarly, Agiolax should not be administered 30 minutes to 1 hour before taking other medications.

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

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

Taking Agiolax granulated with food, drinks and alcohol

Do not take Agiolax immediately after a meal.

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

Pregnancy, breastfeeding and fertility

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

Use during pregnancy is contraindicated

This preparation is eliminated in small amounts through breast milk. Its use is contraindicated during breastfeeding.

Driving and operating machinery

No effects on driving and operating machinery have been described.

Agiolax granulated contains saccharose

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

Follow exactly 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 taken without dissolving or chewing, in an upright position, and with the help of abundant liquid (1 or 2 glasses), regardless of the type chosen (water, milk, orange juice, etc.).

Maintain a gap of half to one hour between taking any other medication or food.

Take Agiolax preferably at night, but not immediately before going to bed.

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

The treatment duration should not exceed 7 days.

The recommended dose is:

Adults and adolescents over 12 years:It is recommended to take one tablespoon of Agiolax in the morning and another at night, although it can be taken in a single dose as long as the dose does not exceed 2 tablespoons per day.

Senior 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.

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 the consequent loss of fluid and electrolytes, which should be replenished.

The treatment should be maintenance, with abundant amounts of liquid. 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 forgot to take Agiolax granules

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

If you interrupt the 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 may produce adverse effects, although not all people may experience them:

Severe adverse effects that are very rare (may affect up to 1 in 10,000 people):

• After oral administration or skin contact, it may cause hypersensitivity reactions up to anaphylactic reactions.

Unknown frequency (cannot be estimated from available data):

At the beginning of treatment and depending on the dose, some discomforts such as flatulence (gas) and/or feeling of fullness, characteristic of dietary fiber, may appear, which disappear within a few days without the need to suspend treatment.

• Yellow-brown (according to pH) urine discoloration due to metabolites, which is of no importance.
• Dermatological symptoms such as exanthema and/or itching.
• Nausea and vomiting.
• Long-term use may lead to disturbances in water balance and electrolyte metabolism and may result in albuminuria and hematuria.
• Abdominal pain, spasms, and diarrhea, particularly in patients with irritable colon. However, these symptoms may also occur as a result of an individual overdose. In such cases, dose reduction is necessary.
• Intestinal mucosa pigmentation (pseudomelanosis coli), which generally reverses after suspending the medication.
• Intestinal or esophageal obstruction, mainly if ingested with little liquid.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse 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 that appears 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 above25?°C

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofAgiolax granulated

The active principles are:

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

Cuticles of plantago ovata seeds (Ispaghula husk)………. 0,110 g

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

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

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

Appearance of the product and content of the packaging

Agiolax granulated is presented in bottles containing 100 or 250 g of granulated for oral administration.

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

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 review of this prospectus:September 2023

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