Plantago ovata Viatris 3.5 g effervescent powder
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Plantago Ovata Viatris 3.5 g effervescent powder
Plantago ovata seed husk (Ispaghula husk)
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Plantago Ovata is and what it is used for
- What you need to know before taking Plantago Ovata
- How to take Plantago Ovata
- Possible adverse effects
- How to store Plantago Ovata
- Contents of the pack and other information
1. What Plantago Ovata is and what it is used for
Plantago Ovata belongs to a group of medicines called bulk-forming laxatives. The active substance consists of the seed husks of a plant called Plantago ovata. These husks have a high capacity to retain liquid, thereby increasing the volume of stool and giving it an appropriate consistency to regulate intestinal transit.
Plantago Ovata is used:
In adults, adolescents, and children over 6 years of age:
- For the treatment of occasional or chronic constipation.
- In situations where it would be desirable to facilitate defecation, for example, in cases of painful bowel movements following rectal or anal surgery, anal fissures, and hemorrhoids.
In adults and adolescents (over 12 years of age):
- In patients in whom increasing daily fiber intake is recommended, for example, as a supplement in constipation associated with irritable bowel syndrome, and as a complement to the diet in hypercholesterolemia.
2. What you need to know before taking Plantago Ovata
Do not take Plantago Ovata
- 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 gastrointestinal tract, fecal impaction (accumulation of hardened stools), 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.
- If you experience a sudden change in your bowel habits that persists for more than two weeks.
- If you have undiagnosed rectal bleeding or blood in your stools and the cause is unknown.
- If you have already taken a laxative and are still constipated.
- If you have difficulty swallowing or any throat problems.
- If you have a blocked intestine (dry, hard stools with abdominal pain, nausea, and vomiting), unless directed by a doctor, as these symptoms may indicate a potential or existing intestinal obstruction (ileus).
Warnings and precautions
Talk to your doctor or pharmacist before taking Plantago Ovata.
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 allergy 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 this medicine with plenty of water.
Taking this product without sufficient liquid may cause blockage in the throat or esophagus. If constipation does not resolve within 3 days, or if you develop abdominal pain, rectal bleeding, or notice changes in your stools (e.g. blood in the stool), stop taking Plantago Ovata and consult your doctor.
Before using laxatives, you should first try increasing physical activity, changing your diet, or using bulking agents to relieve constipation. Seek advice from your pharmacist or doctor.
Children and adolescents
Its use is not recommended in children under 6 years of age.
Other medicines and Plantago Ovata
Tell 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 drugs used to treat heart conditions known as digitalis glycosides, you should take Plantago Ovata at least 2 hours before or 2 hours after taking your other medication, as fiber may interfere with their absorption.
- Do not take Plantago Ovata if you are taking medications for diarrhea or drugs that reduce intestinal motility (such as difenoxilato, loperamide, or opioids), as this may lead to intestinal obstruction.
- In diabetic patients treated with insulin, a reduction in insulin dosage may be necessary.
- Concomitant use with thyroid hormones requires medical supervision, as the dose of these hormones may need adjustment.
Taking Plantago Ovata with food and drinks
Fiber can be taken before or after meals. Taking it half an hour before meals may reduce appetite. Wait between half an hour and one hour after taking any other medication before taking Plantago Ovata.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Soluble fiber can bind organic, inorganic, and mineral substances; therefore, to avoid the risk of excessive elimination of these substances during pregnancy, it is advisable not to exceed the doses prescribed by your doctor.
Driving and using machines
No effects affecting the ability to drive or operate machinery have been reported.
Plantago Ovata contains sodium and the colour Orange Yellow S (E-110)
This medicine contains 178.36 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 8.9% of the maximum daily recommended sodium intake 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-salt (low-sodium) diet.
This medicine may cause allergic reactions as it contains the colour Orange Yellow S (E-110). It may cause asthma, particularly in patients allergic to acetylsalicylic acid.
3. How to take Plantago Ovata
Follow exactly the administration instructions for Plantago Ovata provided by your doctor. If in doubt, consult your doctor or pharmacist again.
Plantago Ovata Viatris 3.5 g is administered orally.
Use in adults and adolescents (over 12 years of age):
- For indications related to constipation: the recommended dose is 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 fibre intake: the recommended dose is 2 to 6 sachets per day (equivalent to 7–20 g of Ispaghula husk per day), according to need and response.
Use in children
Its use is not recommended in children under 12 years of age as a supplement to daily fibre 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 children under 6 years of age.
Elderly patients
The same doses as in adults are recommended.
Method of administration
For correct 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. In addition, it is recommended to drink 1 to 2 litres of water per day during treatment.
When preparing the product for administration, avoid inhaling the powder.
It must be taken in an upright position.
Do not lie down immediately after taking the preparation.
Remember to take your medicine.
This medicine should be taken at least half to one hour before or after taking any other medicine. It should not be taken immediately before going to bed.
Duration
For indications related to constipation, consult your doctor or pharmacist if symptoms persist for more than 3 days despite taking the medicine.
If you take more Plantago Ovata 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 phenomena 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 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
Do not take a double dose to make up for missed doses.
If you stop treatment with Plantago Ovata
Your doctor will advise you on the duration of treatment with Plantago Ovata. Do not discontinue treatment prematurely, as the 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, Plantago ovata may cause adverse effects, although not everyone experiences them.
The seeds of Plantago ovata contain substances that may cause allergic reactions after oral administration, skin contact, or, in the case of powder formulations, by inhalation.
Allergic symptoms may include nasal congestion, eye redness, difficulty breathing, 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 or diarrhea may occur.
If taken without sufficient liquid, there is a risk of intestinal or esophageal obstruction or fecal impaction (accumulation of hardened stools). Ispaghula husk contains substances that may cause allergic reactions orally or by contact.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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
Keep Plantago Ovata out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Plantago Ovata Viatris
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 sodium saccharin, sodium bicarbonate, tartaric acid granules, orange flavour, and the colouring agent Sunset Yellow FCF (E-110).
Presentation of the product and contents of the pack
Plantago Ovata Viatris is available in packs containing 30 effervescent powder sachets of 5 g, beige in colour and with an orange aroma, for oral administration after dispersion in water.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer
ROTTAPHARM Ltd.
Damastown, Ind. Park, Mulhuddart, Dublin 15, Ireland
Further information about this medicinal product can be requested from the local representative of the Marketing Authorisation Holder:
Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain
Date of the most recent review of this leaflet: September 2025
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/