PLANTABEN 3.5 g EFFERVESCENT POWDER
How to use PLANTABEN 3.5 g EFFERVESCENT POWDER
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Plantaben 3.5 g effervescent powder
husk of Plantago ovataseeds (ispaghula husk)
Read the entire package leaflet carefullybefore starting to take thismedication,as it contains important informationfor you
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist or nurse.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if it worsens or does not improve after 3 days
Contents of the package leaflet:
- What is Plantaben and what is it used for
- What you need to know before taking Plantaben
- How to take Plantaben
- Possible side effects
- Storage of Plantaben
Package contents and additional information
1. What is Plantaben and what is it used for
Plantaben 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. This husk has a great capacity to retain liquid, increasing the volume of the fecal mass and giving it a suitable consistency to regulate intestinal transit.
Plantaben is used:
- For the symptomatic treatment of constipation.
- In situations where it would be desirable to facilitate the deposition of feces, for example in cases of painful bowel movements after rectal or anal surgery, anal fissures, and hemorrhoids.
You should consult a doctor if it worsens or does not improve after 3 days.
2. What you need to know before taking Plantaben
Do not takePlantaben
- If you are allergic to Plantago ovata seeds or any of the other components of this medication, including those listed in section 6 (see "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 diabetes mellitus that is difficult to control.
- If you have undiagnosed rectal bleeding.
- If you have an inability to defecate after using a laxative.
- If you have esophageal or cardia (esophagus-stomach junction) diseases.
- If you have intestinal paralysis or megacolon.
Warnings and precautions
Consult your doctor or pharmacist or nurse before starting to take Plantaben.
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 "Do not take Plantaben").
During treatment, you should drink 1 to 2 liters of water per day. Ingestion of this product without adequate liquid can 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 will be interrupted and a doctor will be consulted.
Children and adolescents
It is not recommended for use in children under 6 years of age.
Other medications and Plantaben
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 medications for heart conditions (digitalis), you should take Plantaben 1 hour before or after ingestion of your medication, as the fiber may interfere with its absorption.
- Do not take Plantaben 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 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 Plantaben with food and drinks and alcohol
Fiber can be administered before or after meals. If taken 30 minutes before meals, it may reduce appetite.
Pregnancy and 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 using 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 recommended doses in this package leaflet or prescribed by your doctor.
Driving and using machines
No effects have been described that affect the ability to drive or use hazardous machinery.
Plantaben contains sodium saccharin, sodium bicarbonate, 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 26.7% of the maximum recommended daily sodium intake for an adult.
Consult your doctor or pharmacist if you need Plantaben daily or for a prolonged period, especially if you have been recommended a low-salt (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 Plantaben
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist or nurse. If in doubt, ask your doctor or pharmacist or nurse.
Plantaben is administered orally.
The recommended dose is:
Use in adults, elderly patients, and children over 12 years:
2 to 3 sachets per day (equivalent to 7-11 g of Ispaghula husk per day), as needed and according to response.
Use in children from 6 to 12 years of age:
1 to 2 sachets per day (equivalent to 3-8 g of Ispaghula husk per day), as needed and according to response.
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.
It should be taken in an upright position.
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.
Use in children and adolescents
It is not recommended for use in children under 6 years of age.
If you take more Plantaben than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
No intoxication phenomena have been described due to overdosing, as the active components of this preparation are not absorbed.
However, in case of massive ingestion, symptomatic treatment will be performed. Overdose with Ispaghula can cause abdominal discomfort and flatulence and even intestinal obstruction. Adequate fluid intake should be maintained.
If you forget to take Plantaben
Do not take a double dose to make up for forgotten doses.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medications, Plantaben 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 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 distension may occur.
If ingested without sufficient liquid, there is a risk of intestinal or esophageal obstruction or fecal impaction (accumulation of hardened feces).
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Plantaben
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date shown on the packaging 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 in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment
6. Package contents and additional information
Composition of Plantaben
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 essence, and yellow-orange colorant S (E-110).
Appearance of the product and package contents
Plantaben is presented in boxes containing 30 sachets with 5 g of effervescent powder, beige in color and orange in aroma, for oral administration, once dispersed in water.
Marketing authorization holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
Netherlands
Manufacturer of the medication
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:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 - Barcelona
Spain
Date of the last revision of this package leaflet: April 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/
- Country of registration
- Availability in pharmacies
Supply issue reported
Data from the Spanish Agency of Medicines (AEMPS) indicates a supply issue affecting this medicine.<br><br>Availability may be limited in some pharmacies.<br><br>For updates or alternatives, consult your pharmacist. - Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to PLANTABEN 3.5 g EFFERVESCENT POWDERDosage form: ORAL SOLUTION/SUSPENSION, 52g, 2.2g, (6.74-13.15)g/100 gActive substance: ispaghula (psylla seeds)Manufacturer: Cooper Consumer Health B.V.Prescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, -Active substance: ispaghula (psylla seeds)Manufacturer: Cooper Consumer Health B.V.Prescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 3.5 g/ sachetActive substance: ispaghula (psylla seeds)Manufacturer: Laboratorios Cinfa S.A.Prescription required
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