NOTICE
ANSM - Updated on : 19/11/2024
Product name
PSYLIA, effervescent powder for drinkable suspension in sachet
Ispaghul (Ispaghul seed coat)
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Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 3 days.
What does this leaflet contain?
1. What is PSYLIA, effervescent powder for drinkable suspension in sachet and what is it used for?
2. What do I need to know before taking PSYLIA, effervescent powder for drinkable suspension in sachet?
3. How should I take PSYLIA, effervescent powder for drinkable suspension in sachet?
4. What are the possible side effects?
5. How to store PSYLIA, effervescent powder for drinkable suspension in sachet?
6. Package contents and other information.
1. WHAT IS PSYLIA, effervescent powder for drinkable suspension in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: LEST LAXATIVE - A06AC01
Herbal medicine indicated for the symptomatic treatment of constipation.
This drug is a laxative which modifies stool consistency and increases fecal mass.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING PSYLIA, effervescent powder for drinkable suspension in sachet?
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Never take PSYLIA, effervescent powder for drinkable suspension in sachet:
- if you are allergic to the active substance (also known as psyllium blond), or to any of the other ingredients listed in section 6.
- in the event of sudden changes in bowel function lasting more than 2 weeks,
- in the event of rectal bleeding of unknown cause and lack of relief after taking another laxative,
- if you suffer from certain diseases of the esophagus, intestine or colon, such as rectocolitis, Crohn's disease or intestinal obstruction,
- if you have abdominal pain (stomach ache) or fecal impaction (fecal plug),
- if you have difficulty swallowing or throat problems.
Warnings and precautions
Warnings
Talk to your doctor or pharmacist before taking PSYLIA, effervescent powder for drinkable suspension.
Do not use PSYLIA effervescent powder for oral suspension for prolonged periods without medical advice.
- Occasional constipation
This may be due to a recent change in lifestyle (travel, etc.).
This medicine can be used as a short-term treatment. However, any recent constipation unexplained by a change in lifestyle, or any constipation accompanied by pain, fever or swelling of the abdomen, should be referred to a physician.
- Chronic constipation (long-term constipation)
There are two possible causes of chronic constipation:
o either a bowel disease requiring medical attention,
o or an imbalance in intestinal function due to dietary and lifestyle habits.
In the latter case, treatment involves, among other things:
o increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit, etc.),
o increased consumption of water and fruit juices,
o increased physical activity (sports, walking, etc.),
o reeducation of the defecation reflex,
o sometimes add bran to food.
Precautions for use
In cases of impaired colonic motricity and in bedridden patients, this drug should be taken with caution (risk of fecal impaction).
The contents of the sachet should be swallowed with a sufficient quantity of water (200 mL).
When PSYLIA, effervescent powder for oral suspension in sachet, is taken with insufficient liquid, it may cause obstruction of the throat or esophagus, leading to respiratory shock. Associated symptoms may include chest pain, vomiting or difficulty swallowing or breathing.
In the event of abdominal pain or irregular bowel movements, stop treatment and consult your doctor.
This medicine contains potassium. This medicine contains 3.75 mmol (or 146.63 mg) of potassium per dose. To be taken into account in patients with renal insufficiency or in patients controlling their dietary intake of potassium.
This medicine contains sorbitol. Sorbitol is a source of fructose. If your doctor has informed you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before taking this medicine.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Other medicines and PSYLIA, effervescent powder for drinkable suspension in sachet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
The medicines listed below should be taken under medical supervision with PSYLIA, effervescent powder for drinkable suspension in sachet:
- minerals, vitamins, cardiac glycosides, coumarin derivatives, carbamazepine, lithium,
- medicines to treat diabetes,
- thyroid hormones.
This medicine should be taken during the day, at least ½ hour or 1 hour before or after any other medication.
PSYLIA, effervescent powder for drinkable suspension in sachet with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore taking this medicine.
Driving and use of machinery
Not applicable.
PSYLIA, effervescent powder for drinkable suspension in sachet contains potassium and sorbitol (E420).
3. HOW TO TAKE PSYLIA, effervescent powder for drinkable suspension in sachet?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults
The recommended dosage is 1 sachet, one to three times a day.
PSYLIA, effervescent powder for drinkable suspension in sachet, should be taken at least ½ hour to 1 hour before taking other medications.
Never take PSYLIA immediately before bedtime, or while lying down.
The effect of PSYLIA, effervescent powder for drinkable suspension in sachet, is felt on average 12 to 24 hours after the first administration.
If you feel that the effect of PSYLIA, effervescent powder for drinkable suspension in sachet is too strong or too weak, consult your doctor or pharmacist.
Use in children and adolescents
PSYLIA effervescent powder for drinkable suspension in sachet should not be used by children and adolescents under 18 years of age.
Method of administration
Oral administration.
Dilute powder in a large glass of water (200 mL). Shake and drink immediately.
When preparing the drinkable suspension, avoid inhaling the powder.
Duration of treatment
Duration of treatment varies according to symptomatology. If symptoms persist beyond 3 days of treatment, consult your doctor or pharmacist.
If you have taken more PSYLIA, effervescent powder for drinkable suspension in sachet, than you should have
Overdosage with dispaghul seed coat may cause abdominal discomfort and flatulence, or even intestinal obstruction.
Appropriate hydration must be ensured, and treatment is symptomatic.
If you forget to take PSYLIA, effervescent powder for drinkable suspension in sachet
Continue treatment, but do not take a double dose to make up for the one you forgot to take.
If you stop taking PSYLIA, effervescent powder for drinkable suspension in sachet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, PSYLIA may cause undesirable effects, but these do not always occur in everyone.
Certain disorders may occur, such as
- Flatulence, which may disappear during treatment.
- Bloating, risk of sophageal obstruction or intestinal obst ructionand fecal impaction, particularly when PSYLIA, effervescent powder for drinkable suspension in sachet, is swallowed with insufficient water.
- Allergic reactions such as rhinitis, conjunctivitis, bronchospasm and, in a few cases, anaphylactic shock.
The frequency of this type of reaction is unknown. If you experience any side effects not mentioned above, please consult your doctor or a qualified healthcare professional.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE PSYLIA, effervescent powder for drinkable suspension in sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Store in a dry place.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PSYLIA, effervescent powder for drinkable suspension in sachet, contains
- The active substance is :
Ispaghul(Plantago ovata Forssk) (seed coat).................................................. 3.6 g
for a 6.9 g sachet
- Other ingredients include
Citric acid anhydrous, sorbitol (E420), potassium bicarbonate, sodium bicarbonate, calcium carbonate, sodium saccharin, lemon flavour (essential oils deterpenated from lemon-maltodextrin).
What PSYLIA, effervescent powder for drinkable suspension in sachet is and what it contains
This medicine comes in the form of effervescent powder for drinkable suspension in sachet. Boxes of 10, 20 or 24.
Marketing authorization holder
LABORATOIRES TECHNI-PHARMA
7 RUE DE LINDUSTRIE - BP 717
MC98014 MONACO CEDEX
MONACO
Marketing authorization holder
LABORATOIRES TECHNI-PHARMA
7 RUE DE LINDUSTRIE - BP 717
MC98014 MONACO CEDEX
MONACO
Manufacturer
LABORATOIRES TECHNI-PHARMA
7 RUE DE LINDUSTRIE - BP 717
MC98014 MONACO CEDEX
MONACO
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.