PATIENT INFORMATION LEAFLET

Plantaben3,5 geffervescent powder

seed coat ofPlantago ovata(ispaghula husk)

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

- Ifyou experience any side effects, consult your doctor, pharmacist or nurse,even if they are not listed in this leaflet. See section 4.

• You must consult a doctor if you get worse or do not improveafter 3 days

Contents of the pack and additional information

Plantabenbelongs to a group of medications called:volume-forming laxatives. The active ingredient is the cuticles of the seeds of a plant called Plantago Ovata. These cuticles have a great capacity to retain liquid, increasing the volume of the fecal mass and giving it an adequate consistency to regulate intestinal transit.

Plantabenis used:

• For symptomatic treatment of constipation.
• In situations where it would be desirable to facilitate the deposition of feces, for example in cases of painful defecation after rectal or anal surgery, anal fissures, and hemorrhoids.

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

Do not takePlantaben

• If you are allergic to Plantago ovata seeds or any of the other components of this medication, as listed in section 6 (see section “Warnings and precautions”).
• If you have intestinal obstruction, intestinal stenosis (narrowing), fecal impaction (accumulation of hardened feces), colon atony (lack of tone and weakness), or ileus (colon paralysis).
• If you experience abdominal pain, nausea, or vomiting.
• If you have difficulty swallowing.
• If you have uncontrolled diabetes mellitus.
• If you have undiagnosed rectal bleeding.
• If you have difficulty defecating after using a laxative.
• If you have esophageal and cardia diseases (the junction of the esophagus and stomach).
• If you have intestinal paralysis or megacolon.

Warnings and precautions

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

If you are a healthcare professional or caregiver who has handled products with Plantago ovata powder for a prolonged period, you may have become allergic to these products due to continuous inhalation. If symptoms (listed in section 4) are confirmed to be due to an allergic reaction, do not use this product (see section “Do not take Plantaben”).

During treatment, you should drink 1-2 liters of water per day. Ingestion of this product without adequate liquid may cause a blockage in the throat or esophagus.

This preparation should not be taken and then immediately laid down.

If abdominal pain, nausea, or vomiting occur, treatment will be interrupted and a doctor will be consulted.

Children and adolescents

It is not recommended for use in children under 6 years old.

Other medications and Plantaben

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

• If you are taking other medications, such as minerals (calcium, iron, lithium, zinc), vitamins (vitamin B12), blood-thinning medications (cumarinic derivatives), or heart disease medications (digitalis), take Plantaben 1 hour before or after taking your medication, as the fiber may hinder its absorption.
• Do not take Plantaben if you are taking diarrhea medications or medications that prevent intestinal motility (such as difenoxilato, loperamida, opiates), as it may cause intestinal obstruction.
• In diabetic patients treated with insulin, it may be necessary to reduce the insulin dose when this medication is taken with meals.
• Concomitant use with thyroid hormones requires medical supervision, as it may be necessary to adjust the dose of these hormones.

TakingPlantabenwith food and drinks and alcohol

The fiber can be taken before or after meals. If taken 30 minutes before meals, it may reduce appetite.

Pregnancy and lactation and fertility

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

The soluble fiber absorbs organic, inorganic, and mineral substances, so to avoid the risk of excessive elimination of these substances during pregnancy, it is recommended not to exceed the recommended doses in this prospectus or prescribed by your doctor.

Driving and operating machinery

No effects have been described that would affect the ability to drive or use hazardous machinery.

Plantaben contains sodium saccharin, sodium bicarbonate, and yellow-orange S (E-110) dye

This medication contains 178.36 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 26.7% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need Plantaben daily or for a prolonged period, especially if you have been advised to follow a low-sodium diet.

This medication may cause allergic reactions because it contains yellow-orange S (E-110) dye. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions of themedication contained in this leaflet or thoseindicated by your doctor or pharmacist or nurse.In case of doubt, ask your doctor or pharmacist or nurse..

Plantaben is administered orally.

The recommended dose is:

Use in adults, elderly patients, and children over 12 years old:

2 to 3 sachets per day (equivalent to 7 –11 gof Ispaghula husk per day), as needed and response.

Use in children from6 to 12 years old:

1 to 2 sachets per day (equivalent to 3 –8 gof Ispaghula husk per day), as needed and response.

To ensure correct administration, it is recommended to empty the contents of the sachet into a glass of cold water or any other liquid (200 cc), shake the mixture until it is uniform, and drink immediately. It is recommended to drink another glass of liquid afterwards. Additionally, it is recommended to drinkfrom1 to 2 litersof water per day during treatment.

It should be taken in an upright position.

Do not take the preparation and lie down immediately afterwards

During the preparation of the product for administration, try to avoid inhaling the powder.

Remember to take your medicine.

Use in children and adolescents

It is not recommended for use in children under 6 years old.

If you take morePlantabenthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20indicating the medication and the amount ingested.

No symptoms of intoxication by overdose have been described, since the active components of this preparation are not absorbed.

However, in case of massive ingestion, symptomatic treatment will be performed. Overdose with Ispaghula may cause abdominal discomfort and flatulence and even intestinal obstruction. Adequate liquid intake should be maintained.

If you forgot to takePlantaben

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

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

Like all medications, Plantaben may cause adverse effects, although not everyone will experience them.

The seeds of Plantago ovata contain substances that may cause allergic reactions after taking the medication orally, after contact with the skin, or, in the case of powder formulations, after inhalation.

Allergic symptoms may include nasal congestion, eye redness, difficulty breathing, skin reactions, itching, and in some cases, anaphylaxis (sudden and generalized allergic reaction that can cause life-threatening shock). People who frequently handle the powder formulations of the product are more prone to experiencing these reactions (See Section 2).

At the beginning of treatment and, depending on the dose, some discomforts such as flatulence (gas) and a feeling of fullness may appear, which disappear in a few days without the need to discontinue the medication.

In some cases, abdominal distension may appear.

If ingested without sufficient liquid, there may be a risk of intestinal or esophageal obstruction or fecal impaction (accumulation of hardened feces).

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 Medicines 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 usethis medicationafter the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicinesshould not be thrownaway through the drains or in the trash. Dispose of thepackagingand themedicinesthat you no longer need at the SIGRE Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of thepackagingand themedicinesthat you no longer need. In this way, you will help to protect the environment.environment.

Composition ofPlantaben

The active principle is the seed coat ofPlantago ovata.Each sachet contains3.5 gof seed coat ofPlantago ovata.

The other components are: sodium saccharin, sodium bicarbonate, tartaric acid powder, orange essence, yellow-orange S (E-110) dye.

Appearance of the product and contents of the packaging

Plantaben is presented in boxes containing 30 sachets with5 gof effervescent powder, beige in color and orange-scented, for oral administration, once dispersed in water.

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer responsible for the medicinal product

Rottapharm Ltd.

Damastown, Ind. Park, Mulhuddart, Dublin 15, Ireland.

You can request more information about this medicinal product 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 leaflet: April 2023

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