PLANTAGO OVATA CINFA 3.5 g POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

plantago ovata cinfa 3.5 g oral powder for suspension

Plantago Ovata

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is plantago ovata cinfa and what is it used for

plantago ovata cinfa belongs to the group of medications called bulk-forming laxatives. The active ingredient is the cuticle of the seeds of a plant called Plantago Ovata. These cuticles 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 cinfa is used:

• For the symptomatic treatment of constipation.
• In situations where it would be desirable to facilitate the passage of stools, 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.

2. What you need to know before taking plantago ovata cinfa

Do not take plantago ovata cinfa:

• 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), atony (lack of tone and weakness) of the colon, or ileus (paralysis of the colon).
• If you have abdominal pain, nausea, or vomiting.
• If you have difficulty swallowing.
• If you have uncontrolled diabetes mellitus.
• If you have undiagnosed rectal bleeding.
• If you are unable to defecate after using a laxative.
• If you have esophageal or cardia (esophagus-stomach junction) diseases.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take plantago ovata cinfa.

If you are a healthcare professional or caregiver who has handled products containing Plantago Ovata seed powder for an extended 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 cinfa").

During treatment, you should drink 1 or 2 liters of water per day.

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

Do not take this preparation and lie down immediately after.

If abdominal pain, nausea, or vomiting occur, treatment should be discontinued and a doctor consulted.

Children and Adolescents

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

Taking plantago ovata cinfa with other medications

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

• If you are taking other medications, such as minerals (calcium, iron, lithium, zinc), vitamins (vitamin B12), medications to prevent blood clotting (cumarin derivatives), or medications for heart conditions (digitalis), you should take plantago ovata 1 hour before or after ingestion of your medication, as the 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, or opiates), as intestinal obstruction may occur.

• 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.

Taking plantago ovata cinfa with food and drinks

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

Pregnancy and Breastfeeding

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

Pregnancy:

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.

Breastfeeding:

Consult your doctor or pharmacist before taking the medication.

Driving and Using Machines

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

plantago ovata cinfa contains aspartame (E-951)

This medication contains 90 mg of aspartame (E-951) per sachet.

Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

plantago ovata cinfa contains yellow-orange colorant S (E-110)

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 cinfa

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults, elderly, adolescents, and children over 12 years:

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

It is not recommended for use in the pediatric population under 12 years of age as a supplement to daily fiber intake.

Children from 6 to 12 years of age:

• For 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.

It is not recommended for use in children under 6 years of age for indications related to constipation.

Method of administration:

plantago ovata cinfa is administered orally.

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), 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.

Do not take the preparation and lie down immediately after.

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

Remember to take your medication.

If you take more plantago ovata cinfa than 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 performed. Overdose with Ispaghula may cause abdominal discomfort and flatulence, and even intestinal obstruction. Adequate fluid intake should be maintained.

If you forget to take plantago ovata cinfa

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

If you stop taking plantago ovata cinfa

Your doctor will indicate the duration of treatment with plantago ovata cinfa. Do not stop treatment before, as the effect may not occur.

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

4. Possible Side Effects

Like all medications, this medication can cause side 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 likely to experience 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 within a few days without needing to stop the medication.

In some cases, abdominal pain may occur.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of plantago ovata cinfa

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, consult your pharmacist on how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of plantago ovata cinfa

• The active ingredient is the cuticle of Plantago Ovata seeds. Each sachet contains 3.5 g of Plantago Ovata seed cuticle.
• The other components are maltodextrin, citric acid monohydrate (E-330), aspartame (E-951), orange flavor, and yellow-orange colorant S (E-110).

Appearance of the Product and Package Contents

Each single-dose sachet contains brown-orange and speckled powder. It is presented in sachets composed of coated paper/aluminum/polyethylene extrusion and thermofusible resin. Each sachet contains 5.8 grams of oral suspension powder.

Each package contains 15 or 30 single-dose sachets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:April 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68088/P_68088.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68088/P_68088.html