PROSPECTO: INFORMATION FOR THE USER

Plantago Ovata Madaus3.5 geffervescent powder

seed coat ofPlantago ovata(Ispaghula husk)

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the package and additional information

Plantago Ovatabelongs to the group of medications known asVolume-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.

Plantago Ovatais used:

• For the treatment of habitual or chronic 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.

• In patients where it is advisable to increase daily fiber intake, for example, as an adjunct in constipation associated with irritable bowel syndrome and as an adjunct to the diet in hypercholesterolemia.

Do not takePlantago Ovata

• 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), or colon atony (lack of tone and weakness).
• If you experience abdominal pain, nausea, or vomiting.
• If you have difficulty swallowing.
• If you have intestinal paralysis or megacolon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Plantago Ovata.

If you are a healthcare professional or caregiver who has handled products with Plantago ovata seed 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 Plantago Ovata”).

It is recommended to take it with an abundant amount of water.

The ingestion of this product without the adequate amount of liquid may cause a blockage in the throat or esophagus.

Children and adolescents

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

Other medications and Plantago Ovata:

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), medications to prevent blood clotting (cumarinic derivatives), or heart disease medications (digitalis), take Plantago Ovata 2 hours before or 2 hours after taking your medication, as the fiber may hinder its absorption.

- Do not take Plantago Ovata if you are taking medications for diarrhea 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.

- Concomitant use with thyroid hormones requires medical supervision, as it may be necessary to adjust the dose of these hormones.

Plantago Ovata intake with food and beverages:

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

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 taking 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 prescribed doses by your doctor.

Driving and operating machinery:

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

Plantago Ovata contains sodium and yellow-orange colorant S (E-110)

This medication contains 178.36 mg of sodium (main component of table salt/for cooking) in each packet. This is equivalent to 8.9% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need Plantago Ovata daily or for a prolonged period of time, especially if you have been recommended a low-sodium diet.

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

Follow exactly the administration instructions of Plantago ovata indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Plantago Ovata is administered orally at a dose of 3.5 g.

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

• The recommended dose for indications related to constipation is 2 to 3 packets per day (equivalent to 7 – 11 g of Ispaghula husk per day), as needed and in response.
• As a daily fiber supplement: the recommended dose is 2 to 6 packets per day (equivalent to 7 – 20 g of Ispaghula husk per day), as needed and in response.

Use in children and adolescents

It is not recommended for use in children under 12 years old as a daily fiber supplement.

Children aged 6 to 12 years:

• For indications related to constipation: 1 to 2 packets per day (equivalent to 3 – 8 g of Ispaghula husk per day), as needed and in response.

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

To ensure proper administration, it is recommended to empty the contents of the packet into a glass of cold water or any other liquid (200 cc), stir the mixture until it is uniform, and drink immediately.

It is recommended to drink another glass of liquid afterwards. Additionally, it is recommended to drink 1 to 2 liters of water per day during treatment.

When preparing the product for administration, avoid inhaling the powder.

It should be taken in an upright position.

Do not lie down immediately after taking the preparation.

Remember to take your medication.

If you take more thanPlantago Ovatathan you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

No adverse effects have been described due to overdose, as the active components of this preparation are not absorbed.

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

If you forgot to takePlantago Ovata

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

If you interrupt the treatment withPlantago Ovata

Your doctor will indicate the duration of treatment with Plantago Ovata. Do not discontinue treatment prematurely, as the effect may not occur.

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

Like all medications, Plantago Ovata may produce 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 may cause life-threatening shock). People who frequently handle the powder formulations of the product are more likely to experience 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 within a few days without the need to discontinue medication.

In some cases, abdominal pain or diarrhea may appear.

If ingested without sufficient liquid, there may be a risk of intestinal or esophageal obstruction or fecal impaction (accumulation of hardened feces). Ispaghula husk contains substances that may cause allergic reactions orally or through contact.

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 about the safety of this medication.

KeepPlantago Ovataout of sight and reach of children.

Do not use this medication after the expiration date that appears on the box after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Plantago Ovata Madaus

The active principle is the cuticle of the seeds ofPlantago ovata.Each sachet contains3.5 gof cuticle of seeds ofPlantago ovata.

The other components are sodium acarina, sodium bicarbonate, tartaric acid sand, orange essence, and yellow-orange S (E-110) dye.

Appearance of the product and contents of the packaging

Plantago ovata Madaus 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 and responsible for manufacturing

Holder

Meda Pharma SL

C/General Aranaz, 86

28027 Madrid

Spain

Responsible for manufacturing

ROTTAPHARM Ltd.

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

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this prospectus:November 2023

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