Agiolax granules

Package leaflet: Information for the user

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

Contents of the leaflet

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

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

Agiolax granules belong to a group of medicines called laxatives.

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

Agiolax granules are used for:

• Short-term treatment of occasional constipation.

You should consult a doctor if 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 medicine 2 or 3 times within 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 ingredients of this medicine (listed in section 6).
• If you have intestinal obstruction or stenosis (narrowing of the intestine).
• If you have paralytic ileus (acute intestinal blockage 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 you have any acute or persistent undiagnosed abdominal symptoms, including rectal bleeding.
• If you experience sudden changes in bowel habits lasting more than 2 weeks.
• If you are unable to defecate after using a laxative.
• If you have diseases of the esophagus or cardia (the part of the stomach connecting to the esophagus).
• If you have difficulty swallowing or any throat problems.
• If you are pregnant or breastfeeding.
• If you are severely dehydrated.

Warnings and precautions

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

This medicine should not be used daily for prolonged periods. Its use should be avoided for longer than 1 week.

• Abuse may cause diarrhea, resulting in loss of fluids and electrolytes (mainly a decrease in potassium).
• Long-term abuse may worsen constipation.
• Chronic use may lead to pigmentation of the colon (pseudomelanosis coli), which is harmless and resolves upon discontinuation of treatment.
• If symptoms worsen or do not improve within 3 days of treatment, consult your doctor.

Children and adolescents

Do not administer to children under 12 years of age.

Other medicines and Agiolax granules

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

Administration is not recommended in patients taking cardiac glycosides (medicines that regulate heart function) or antiarrhythmic drugs (e.g., quinidine).

Concomitant use with other drugs that induce hypokalemia (e.g., thiazide diuretics, adrenocorticosteroids, and licorice root) is not recommended, as it may promote electrolyte imbalance.

The absorption of other concomitantly 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 to 60 minutes after taking any other medicine before taking Agiolax. Likewise, Agiolax should not be taken 30 to 60 minutes before taking other medicines.

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

The use of plantago ovata seeds together 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 meals.

Wait 30 to 60 minutes after eating before taking Agiolax.

Pregnancy, breastfeeding, and fertility

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

Use during pregnancy is contraindicated.

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

Driving and using machines

No effects on driving or using machines have been reported.

Agiolax granules contains sucrose

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Agiolax granules

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Agiolax granules are administered orally.

The granules must be swallowed without dissolving or chewing, in an upright position and with plenty of liquid (1 or 2 glasses), regardless of the type you choose (water, milk, orange juice, etc.).

Maintain a time interval of half to one hour between the intake of any other medicine or food.

Take Agiolax preferably at night, but not 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, consult your doctor.

The duration of treatment should not exceed 7 days.

Recommended dose:

Adults and adolescents over 12 years of age: It is recommended to take, preferably, one dessertspoonful of Agiolax in the morning and another in the evening. However, it may be taken as a single dose, provided that the total daily dose does not exceed 2 teaspoonfuls.

Elderly patients: Same dose as for adults.

Pregnant women:

Do not use during pregnancy.

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, 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 supportive, with abundant fluid intake. Electrolytes, especially potassium, should be monitored.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 915 62 04 20, indicating the medicine and the amount ingested.

If you forget to take Agiolax granules

Do not take a double dose to make up for missed doses.

If you stop treatment with Agiolax granules

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them:

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

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

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

At the beginning of treatment and depending on the dose, some discomforts such as flatulence and/or a sensation of fullness—typical of dietary fiber—may occur, which disappear within a few days without the need to discontinue treatment.

• Reddish-brown discoloration (depending on pH) of urine due to metabolites, which is not clinically significant.
• Skin symptoms such as rash and/or itching.
• Nausea and vomiting.
• Chronic use may lead to disturbances in fluid balance and electrolyte metabolism and may result in albuminuria and hematuria.
• Abdominal pain, spasms, and diarrhea, particularly in patients with irritable bowel syndrome. However, these symptoms may also occur as a consequence of individual overdose. In such cases, dose reduction is necessary.
• Pigmentation of the intestinal mucosa (pseudomelanosis coli), which generally resolves after discontinuation of the medicine.
• Intestinal or esophageal obstruction, mainly if taken with insufficient liquid.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Agiolax granules

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

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Keep the container tightly closed.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Agiolax granules

The active substances are:

Plantago ovata seeds powder …………………………………… 2.600 g
Plantago ovata seed husks (Ispaghula husk) …………………… 0.110 g
Cassia angustifolia fruit (Sennae fructus) ……………………… 0.337–0.658 g
(containing sennosides expressed as sennoside B ……………… 0.015 g)

The other components are sucrose, caraway essential oil (Carum carvi), sage essential oil (Salvia officinalis), peppermint essential oil (Mentha piperita), 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 contents of the container

Agiolax granules are available 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,

The Netherlands

Manufacturer responsible

MADAUS GmbH

Lutticher Strasse, 5

53842 Troisdorf, Germany

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Date of the most recent review of this leaflet: September 2023

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