Leaflet: information for the user

Plantago ovata cinfa 3.5 g powder for oral suspension

Plantago Ovata

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Plantago Ovata Cinfa belongs to the group of medications known as Volume-Forming Laxatives. The active ingredient is the cuticles of the seeds of a plant called Plantago Ovata. These cuticles have a large capacity to retain liquid, increasing the volume of the fecal mass and giving it an adequate consistency to regulate intestinal transit.

Plantago Ovata Cinfa is 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.
• 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 take Plantago ovata cinfa:

• If you are allergic to Plantago ovata seeds or any of the other components of this medication included 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 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 have difficulty defecating after using a laxative.
• If you have esophageal and cardia diseases (union of the esophagus to the 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 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 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.

This preparation should not be taken and then lying down immediately after.

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.

Plantago ovata cinfa with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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), you should take Plantago ovata 1 hour before or after taking your medication, as the fiber may hinder its absorption.

• You should 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 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.

Plantago ovata cinfa with food and beverages:

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

Pregnancy and lactation:

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

Pregnancy:

Fiber soluble 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.

Lactation:

Consult your doctor or pharmacist before taking the medication.

Driving and operating machinery:

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

Plantago ovata cinfa contains aspartame (E-951)

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

Aspartame contains a source of phenylalanine that 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 correctly.

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

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

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

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

• For indications related to constipation: 2 to 3 packets per day (equivalent to 7 – 11 g ofIspaghula huskper day), as needed and in response.
• As a daily fiber supplement: 2 to 6 packets per day (equivalent to 7 – 20 g ofIspaghula huskper day), as needed and in response.

This product is not recommended for use in pediatric patients 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 ofIspaghula huskper day), as needed and in response.

This product is not recommended for use in pediatric patients under 6 years old for indications related to constipation.

Administration form:

Plantago ovata cinfa is administered orally.

For 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.

Do not take the preparation and lie down immediately afterwards.

During the 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

No adverse effects 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. You should maintain an adequate intake of liquid.

If you forgot to take plantago ovata cinfa

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

If you interrupt the treatment with plantago ovata cinfa

Your doctor will indicate the duration of treatment with plantago ovata cinfa. Do not suspend treatment before, 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, this medication may produce adverse effects, although not all people 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 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 medication.

In some cases, abdominal pain may appear.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Plantago ovata cinfa

• The active principle is the cuticle of the seeds ofPlantago ovata.Each sachet contains 3.5 g of cuticle of seeds ofPlantago ovata.
• The other components are maltodextrin, citric acid monohydrate (E-330), aspartame (E-951), orange aroma and yellow-orange S dye (E-110).

Appearance of the product and contents of the packaging

Each single-dose sachet contains brown-orange powder with speckles. It is presented in composite paper-coated/aluminum/polyethylene extruded and thermofusible resin sachets. Each sachet contains 5.8 grams of powder for oral suspension.

Each package contains 15 or 30 single-dose sachets.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:April 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the 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