PLANTAGO OVATA VIATRIS 3.5 g EFFERVSCENT POWDER

Introduction

Prospect: Information for the User

Plantago Ovata Viatris 3.5 g Effervescent Powder

husk of Plantago ovataseeds

Read the entire 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 to you only, and you should not give it to others, even if they 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 Prospectus:

1. What is Plantago Ovata and what is it used for
2. What you need to know before taking Plantago Ovata
3. How to take Plantago Ovata
4. Possible adverse effects
5. Storage of Plantago Ovata
6. Package contents and additional information

1. What is Plantago Ovata and what is it used for

Plantago Ovata belongs to the group of medications called Bulk-Forming Laxatives. The active principle is the husk of the seeds of a plant called Plantago ovata. These husks have a high capacity to retain liquid, increasing the volume of the fecal mass and giving it a suitable consistency to regulate intestinal transit.

Plantago Ovata is 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 to the treatment of constipation associated with irritable bowel syndrome and as an adjunct to the diet in hypercholesterolemia.

2. What you need to know before taking Plantago Ovata

Do not takePlantago Ovata

• If you are allergic to Plantago ovata seeds or any of the other components of this medication, including those listed in section 6 (see section "Warnings and Precautions").
• If you have intestinal obstruction, stenosis (narrowing) of the digestive tract, fecal impaction (accumulation of hardened feces), or atony (lack of tone and weakness) of the colon.
• If you have 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 it is confirmed that the symptoms (listed in section 4) are due to an allergic reaction, do not use this product (see section "Do not take Plantago Ovata").

It is recommended to take it with a large amount of water.

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

Children and Adolescents

Its use is not recommended in children under 6 years of age.

Other Medications and Plantago Ovata

Tell your doctor or pharmacist that you are using, have recently used, 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), you should take Plantago Ovata 2 hours before or 2 hours after taking your medication, as fiber may interfere with its absorption.
• Do not take Plantago Ovata if you are taking medications for diarrhea or medications that inhibit intestinal motility (such as difenoxylate, loperamide, opioids), as intestinal obstruction may occur.
• 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.

TakingPlantago Ovatawith Food and Drinks

Fiber can be administered before or after meals. If taken 30 minutes before meals, it may decrease 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.

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 Using Machines

No effects have been described that affect the ability to drive or operate 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/cooking salt) per sachet. This is equivalent to 8.9% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need to take Plantago Ovata 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 colorant S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Plantago Ovata

Follow the administration instructions of Plantago Ovata indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Plantago Ovata Viatris 3.5 g is administered orally.

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

• In indications related to constipation: the recommended dose is 2 to 3 sachets per day (equivalent to 7-11 g of Ispaghula husk per day), as needed and according to response.
• As a complement to daily fiber intake: the recommended dose is 2 to 6 sachets per day (equivalent to 7-20 g of Ispaghula husk per day), as needed and according to response.

Use in Children and Adolescents

Its use is not recommended in children under 12 years of age as a complement to daily fiber intake.

Children from 6 to 12 years:

• In indications related to constipation: 1 to 2 sachets per day (equivalent to 3-8 g of Ispaghula husk per day), as needed and according to response.

Its use is not recommended in children under 6 years of age.

For 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 drink 1 to 2 liters of water per day during treatment.

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

It should be taken in an upright position.

Do not take the preparation and lie down immediately afterwards.

Remember to take your medication.

If you take morePlantago Ovatathan you should

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

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

However, in case of massive ingestion, symptomatic treatment will be carried out. Overdose with Ispaghula can cause abdominal discomfort and flatulence and even intestinal obstruction. Adequate fluid intake should be maintained.

If you forget to takePlantago Ovata

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

If you interrupt treatment withPlantago Ovata

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

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

4. Possible Adverse Effects

Like all medications, Plantago Ovata can cause adverse effects, although not everyone will experience them.

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

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

At the start of treatment and, depending on the dose, some discomfort such as flatulence (gas) and feeling of fullness may appear, which disappear in a few days without needing to stop the medication.

In some cases, abdominal pain or diarrhea may appear.

If ingested without sufficient liquid, there is a risk of intestinal or esophageal obstruction or fecal impaction (accumulation of hardened feces). Ispaghula husk contains substances that can cause allergic reactions orally or by 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 not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Plantago Ovata

Keep Plantago Ovata out of sight and reach of children.

Do not use this medication after the expiration date shown on the box after "CAD" or "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Plantago Ovata Viatris

The active principle is the husk of Plantago ovataseeds. Each sachet contains 3.5 g of husk of Plantago ovataseeds.

The other components are sodium saccharin, sodium bicarbonate, tartaric acid, orange flavor, and yellow-orange colorant S (E-110).

Appearance of the Product and Package Contents

Plantago Ovata Viatris is presented in boxes containing 30 sachets with 5 g of effervescent powder, beige in color and orange in flavor, for oral administration, once dispersed in water.

Marketing Authorization Holder and Manufacturer

Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

ROTTAPHARM Ltd.

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

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this prospectus:November 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/