Plantago ovata CINFA 3.5 g powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

plantago ovata cinfa 3.5 g oral suspension powder

Plantago Ovata

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What plantago ovata cinfa is and what it is 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. How to store plantago ovata cinfa
6. Contents of the pack and other information

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

plantago ovata cinfa belongs to a group of medicines called bulk-forming laxatives. The active substance is the seed husks of a plant called Plantago ovata. These husks have a high capacity for retaining liquid, increasing the volume of the faecal mass and giving it an appropriate consistency to regulate intestinal transit.

plantago ovata cinfa is used:

• For the symptomatic treatment of constipation.
• In situations where facilitating bowel movements is desirable, for example, painful defecation following rectal or anal surgery, anal fissures, and haemorrhoids.
• In patients in whom increasing daily fibre intake is recommended, for example, as an adjunct in constipation associated with irritable bowel syndrome and as a dietary adjunct in hypercholesterolaemia.

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 to any of the other ingredients of this medicine 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 stools), 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 poorly controlled diabetes mellitus.
• If you have undiagnosed rectal bleeding.
• If you are unable to defecate after using a laxative.
• If you have diseases affecting the esophagus or cardia (the junction between the esophagus and stomach).

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 a prolonged period, you may have become allergic to these products due to continuous inhalation. If allergic reactions (listed in section 4) are confirmed, do not use this product (see section “Do not take plantago ovata cinfa”).

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

Taking this product without sufficient liquid intake may cause blockage in the throat or esophagus.

Do not take this preparation and lie down immediately afterwards.

If abdominal pain, nausea, or vomiting occur, discontinue treatment and consult a doctor.

Children and adolescents

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

Taking plantago ovata cinfa with other medicines

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

• If you are taking other medicines such as minerals (calcium, iron, lithium, zinc), vitamins (vitamin B12), anticoagulants (so-called coumarin derivatives), or medications for heart conditions known as cardiac glycosides, you should take plantago ovata at least 1 hour before or after taking your medication, as fiber may interfere with their absorption.

• Do not take plantago ovata if you are taking medications for diarrhea or drugs that inhibit intestinal motility (movement) (such as diphenoxylate, loperamide, opioids), as intestinal obstruction may occur.

• In diabetic patients treated with insulin, it may be necessary to reduce the insulin dose when this medicine is taken with meals.

• Concomitant use with thyroid hormones requires medical supervision, as a dose adjustment of these hormones may be necessary.

Taking plantago ovata cinfa with food and drinks

Fiber can be taken before or after meals. If taken half an hour before meals, it may reduce appetite.

Pregnancy and breastfeeding

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.

Pregnancy:

Soluble fiber absorbs organic, inorganic, and mineral substances; therefore, to avoid the risk of excessive elimination of these substances during pregnancy, it is recommended not to exceed the doses prescribed by your doctor.

Breastfeeding:

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

plantago ovata cinfa contains aspartame (E-951)

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

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

plantago ovata cinfa contains the colouring agent sunset yellow FCF (E-110)

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take plantago ovata cinfa

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

Adults, elderly patients, adolescents, and children over 12 years of age:

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

Its use is not recommended in pediatric patients under 12 years of age as a supplement to daily fiber intake.

Children aged 6 to 12 years:

• For indications related to constipation: 1 to 2 sachets per day (equivalent to 3 – 8 g of Ispaghula husk per day), according to need and response.

Its use is not recommended in pediatric patients under 6 years of age for indications related to constipation.

Method of administration:

plantago ovata cinfa is administered orally.

For proper administration, it is recommended to empty the contents of the sachet into a glass of cold water or any other liquid (200 mL), stir the mixture until uniform, and drink immediately. It is recommended to drink another glass of liquid afterwards. Additionally, it is advised to drink 1 to 2 liters of water per day during treatment.

Do not lie down immediately after taking the preparation.

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

Remember to take your medicine.

If you take more plantago ovata cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

However, in the case of massive ingestion, symptomatic treatment should be administered. Overdose with Ispaghula may cause abdominal discomfort, 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 missed doses.

If you stop treatment with plantago ovata cinfa

Your doctor will advise you on the duration of treatment with plantago ovata cinfa. Do not discontinue treatment prematurely, as the desired effect may not occur.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Plantago ovata seeds contain substances that may cause allergic reactions after oral administration, following skin contact, or, in the case of powder formulations, by inhalation.

Allergic symptoms may include nasal congestion, eye redness, breathing difficulty, skin reactions, itching, and in some cases anaphylaxis (a sudden and generalized allergic reaction that may cause life-threatening shock). Individuals who frequently handle 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 sensation of fullness may occur. These usually disappear within a few days without the need to discontinue the medication.

In some cases, abdominal pain may occur.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 plantago ovata cinfa

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plantago ovata Cinfa

• The active substance is the seed husk of Plantago ovata. Each sachet contains 3.5 g of Plantago ovata seed husk.
• The other components are maltodextrin, citric acid monohydrate (E-330), aspartame (E-951), orange flavour, and orange-yellow S dye (E-110).

Appearance of the product and contents of the pack

Each single-dose sachet contains brownish-orange speckled powder. The sachets are composed of coated paper/aluminum/extruded polyethylene and thermofusible resin. Each sachet contains 5.8 grams of powder for oral suspension.

Each pack contains 15 or 30 single-dose sachets.

Only certain pack 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 most recent review of this leaflet: April 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) at http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68088/P_68088.html

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