Plantaben 30 sobres
Symptomatic treatment of constipation.
Increases volume of fecal bulk and gives a proper consistency to regulate the intestinal transit.
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1. WHAT IS PLANTABEN AND WHAT IT IS USED
PLANTABEN belongs to the group of medicines called bulk-forming laxatives. The active ingredient cuticles are the seeds of a plant called Plantago ovata. These cuticles have a great ability to retain fluid, increasing the volume of the fecal mass and giving proper consistency to regulate the 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 after rectal or anal surgery, anal fissures and haemorrhoids.
You should consult a doctor if worsens or does not improve after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU BEGIN TO TAKE PLANTABEN
Do not take PLANTABEN if:
- If you are allergic to the Plantago ovata seeds or 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 (hardened accumulation of feces), lethargy (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 difficult to regulate.
- If you have undiagnosed rectal bleeding.
- If you inability to defecate after using a laxative.
- If you suffer from diseases of the esophagus and cardia (junction of the esophagus and stomach).
Warnings and Precautions
Consult your doctor or pharmacist or nurse before taking PLANTABEN.
If you are a healthcare professional or caregiver who has manipulated for a long time with powdered products Plantago ovata seeds, it may have become allergic to these products due to their continued inhalation. If confirmed symptoms (listed in Section 4) are due to allergic reaction, do not use this product (see section "Do not take PLANTABEN").
During treatment should drink 1 or 2 liters of water a day. Ingestion of this product without adequate fluid may cause a blockage in the throat or esophagus. Do not take this preparation and lie down immediately afterwards.
If abdominal pain, nausea or vomiting occurs, treatment will stop and consult a doctor.
Children and adolescents
Its use is not recommended in children under 6 years old.
PLANTABEN use with other medicines
Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.
- If you are taking other medicines such as minerals (calcium, iron, lithium, zinc), vitamins (vitamin B12), medicines to prevent blood clotting (so-called coumarin derivatives) or medicines for the treatment of diseases of the heart type of digitalis called, should take PLANTABEN 1 hour before or after ingestion of the medicine, since the fiber could hinder its absorption.
- Do not take PLANTABEN if you are taking medicines for medicines that prevent diarrhea or bowel motility (such as diphenoxylate, loperamide, opiates), because an intestinal obstruction may occur.
- In diabetic patients treated with insulin, it may be necessary to reduce the dose of insulin, when this medicine is taken with meals.
- Concomitant use with thyroid hormones requires medical supervision since a dose adjustment of these hormones may be necessary.
Taking PLANTABEN with food and drink and alcohol
The fiber can be administered before or after meals. If you take half an hour before meals, can decrease appetite.
Pregnancy and breast feeding and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
Soluble fiber absorbs organic, inorganic and mineral substances, so to avoid the risk of excessive removal of these substances during pregnancy, it is advisable not to exceed the recommended in this leaflet or prescribed by your doctor.
Driving and using machines
No effects have been reported which affect the ability to drive or operate hazardous machinery.
PLANTABEN contains Sodium Saccharin, Sodium Bicarbonate and orange coloring S (E-110)
Patients with sodium diet should be aware that this medicine contains 178.26 mg sodium per sachet.
This medicine may cause allergic reactions because it contains yellow dye orange S (E-110). It can cause asthma, especially in patients allergic to aspirin.
3. HOW TO TAKE PLANTABEN
Follow exactly the instructions of medicine administration in this leaflet or as 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 and children over 12 years:
2 to 3 sachets per day (equivalent to 7 to 11 g of ispaghula husk per day), according to need and response.
Use in children 6 to 12 years old:
1 to 2 sachets per day (equivalent to 3 - 8 g of Ispaghula husk daily), as needed and response.
For the good administration it is recommended to empty the contents of the envelope in a glass of cold water or any other liquid (200 cc), stirring the mixture until uniform, and drink immediately. It is then recommended to drink another glass of liquid. It is also recommended to drink 1 to 2 liters of water a day during treatment.
During the preparation of the product for administration seeks to avoid inhaling dust.
You should not take the preparation and lie down immediately afterwards. Remember to take your medicine.
If you take more than you should PLANTABEN
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call poison control center, call +34 91 562 04 20 indicating the medicine and the amount taken.
There have been no overdosage phenomena of poisoning because the active components of this preparation are not absorbed.
However, in case of massive ingestion will proceed to symptomatic treatment. Ispaghula overdose 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 missed doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all PLANTABEN medicines can cause side effects, although not everybody gets them.
Plantago ovata seeds contain substances that can cause allergic reactions after taking the medicine orally, after contact with the skin or, in the case of powder formulations for inhalation.
Allergy symptoms may include stuffy nose, red eyes, shortness of breath, skin reactions, itching, and in some cases anaphylaxis (generalized allergic reaction that can cause sudden and life-threatening shock). People who regularly handle powder formulations of the product, are more likely to suffer these reactions (see section 2).
At the start of treatment and, depending on the dose, some annoyances as flatulence (gas) and fullness, which disappear in a few days without leaving the medication may occur.
In some cases may appear bloating.
If swallowed without enough fluids risk of esophageal or intestinal obstruction or fecal impaction (accumulation of hardened feces) can occur.
If you experience side effects, consult your doctor or pharmacist or nurse, even if it comes to possible side effects not listed in this leaflet.
5. HOW TO STORE PLANTABEN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. CONTENTS AND ADDITIONAL INFORMATION PLANTABEN
The active substance is the cuticle of Plantago ovata seeds. Each sachet contains 3.5 g of cuticle Plantago ovata seeds.
The other ingredients are sodium saccharin, sodium bicarbonate, tartaric acid grittiness, orange essence, orange yellow S (E-110).
Looks like and contents of the pack
PLANTABEN comes in boxes containing 30 single-dose sachets with 5 g of effervescent powder, beige and orange aroma, for administration orally, once dispersed in water.
Holder of the marketing authorization
Avenida Diagonal, 67-69, 08019. - Barcelona
Responsible for manufacturing the medicine
Damastown, Ind. Park, Mulhuddart, Dublin 15, Ireland.
Source: Spanish Agency for Medicines and Health Products