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For warnings, precautions for use and contraindications, please consult the instructions for use of SPAGULAX effervescent powder oral suspension in sachets-dose without prescription.
The factors favoring the appearance of constipation are numerous: Physical inactivity and physical inactivity are two important risk factors for constipation. Wanting to delay the moment of bowel movement at all costs may encourage the onset of constipation. Women are 3 times more likely than men to experience constipation.
As a prevention, it is preferable to eat properly (balanced diet, using a diet rich in fiber), by hydrating correctly (drink around 1.5L of water per day and move enough to maintain proper bowel movement and thus avoid episodes of constipation, usually a change in diet is enough to restore transit.
This medication can be taken either before or after meals.
Dissolve the contents of the sachet in a large glass of water.
Usual dosage : 1 sachet at each of the main meals.
Spagulax comes in the form of sachets.
Please note that the drug SPAGULAX effervescent powder oral suspension in non-prescription dose sachets is not a product like any other. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 21/12/2015
SPAGULAX, effervescent powder for oral suspension in sachet dose
Ispaghul (seed coat of)
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the 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 experience no improvement or feel less well after 3 days.
1. What is SPAGULAX, an effervescent powder for oral suspension in a dose sachet and in which cases it is used?
2. What should I know before taking SPAGULAX, an effervescent powder for oral suspension in a dose sachet ?
3. How to take SPAGULAX, effervescent powder for oral suspension in a dose sachet ?
4. What are the possible side effects?
5. How to store SPAGULAX, effervescent powder for oral suspension in a dose sachet ?
6. Additional information.
LAXATIVE OF LEST
Herbal medication indicated in the symptomatic treatment of constipation.
2. BEFORE YOU TAKE SPAGULAX, effervescent powder for oral suspension in a dose sachet?
List of information needed before taking the medication
Never take SPAGULAX in the following cases:
· Certain diseases of the esophagus,
· If you are allergic to the seed coat of ispaghul, or to any of the other ingredients of this medication mentioned in section 6,
· In case of abrupt change in intestinal function persisting for more than 2 weeks.
· Rectal bleeding of unknown cause or in the absence of an exemption after taking another laxative,
· certain diseases of the bowel and colon, such as rectocolitis, Crohn's disease, intestinal occlusion,
· in the case of abdominal pain (stomach pains) or fecal matter (fecal plug),
· If you have swallowing difficulties or throat problems.
.
Precautions for use; special warnings
Warnings and Precautions
Warnings
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Occasional constipation
It may be related to a recent change in lifestyle (eg travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation)
It can be linked to two causes:
· a bowel disease that requires a physician to take care of;
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);
· increased consumption of water and fruit juices;
· an increase in physical activities (sports, walking, etc.);
· rehabilitation of the defecation reflex;
· sometimes, adding sound to the diet.
Special cases of child and adolescent
In children and adolescents the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, diet rich in original products vegetable, addition of fruit juice. The use of a laxative requires medical advice.
Precautions for use
In case of impaired colonic drive and in patients confined to bed, caution should be exercised in taking this medication (risk of fecal impaction).
The contents of the sachet must be swallowed with sufficient water.
When SPAGULAX is taken with insufficient fluid, it may cause an obstruction of the throat or esophagus and result in respiratory shock. Associated symptoms can be chest pain, vomiting or difficulty swallowing or breathing.
In case of abdominal pain or irregular stools, stop treatment and consult your doctor.
This medicinal product contains 120 mg sodium per sachet-dose: take this into account in the following people with a strict sodium diet.
Interaction with other medicines
Other drugs and SPAGULAX:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
The medicines mentioned below should be taken under medical supervision with SPAGULAX,
· Minerals, vitamins, cardiac glycosides derived from coumarin, carbamazepine
· Medicines for treating diabetes,
· Thyroid hormones
This medication should be taken during the day, at least ½ hour or 1 hour before or after any other medication.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication will only be used during pregnancy and lactation only on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
SPAGULAX contains sucrose, sodium and orange yellow S (E110).
3. HOW TO TAKE SPAGULAX, effervescent powder for oral suspension in a dose sachet?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Do not take SPAGULAX immediately before bedtime.
SPAGULAX should be taken at least ½ hour to 1 hour before taking other medicines.
When preparing the oral suspension, avoid inhaling the powder.
Dosage
Usually, the dosage is one sachet-dose before or after each of the main meals.
SPAGULAX is not recommended for use in children and adolescents under the age of 18 years.
The effect of Spagulax occurs on average within 12 to 24 hours after administration, at the start of treatment.
If you feel that the effect of SPAGULAX is too strong or too weak, talk to your doctor or pharmacist
Administration mode
Oral use.
Dilute the powder in a large glass of water. Shake and drink immediately the preparation.
Duration of treatment
The duration of treatment varies according to the symptomatology. If symptoms persist beyond 3 days of treatment, talk to your doctor or pharmacist
Symptoms and Instructions for Overdose
If you take more SPAGULAX than you should:
Overdose with the seed coat of ispaghul may cause abdominal discomfort and flatulence, or even intestinal occlusion.
Appropriate hydration should be ensured with symptomatic monitoring.
Instructions for omission of one or more doses
If you forget to take SPAGULAX:
Continue the treatment, but do not take a double dose to replace the missed dose.
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Depending on the dose, certain disorders may appear such as:
· Bloating, flatulence.
· Cases of oesophageal obstruction (bezoars), most often requiring endoscopy, have been reported in elderly patients, some of whom have impaired oesophageal motor function (particularly when SPAGULAX is swallowed with insufficient amounts of oesophageal reflux, water).
· Allergic reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases anaphylactic shock.
· Due to the presence of orange yellow S (E110), there is a risk of allergic reactions.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE SPAGULAX, effervescent powder for oral suspension in a dose sachet?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Full list of active substances and excipients
What does SPAGULAX contain?
The active substance is:
Ispaghul (seed coat of) ......................................... .................................................. ........ 2,1430 g
For a sachet-dose.
The other components are:
Anhydrous citric acid, sodium bicarbonate, sodium saccharin, mandarin dry flavoring, orange yellow S (E110), sucrose.
Pharmaceutical form and content
Aspect of SPAGULAX and contents of the pack
This medication is in the form of an effervescent powder for oral suspension. Box of 20 or 30 sachets-dosages.
ALMIRALL SA
RONDA GENERAL MITER, 151
08022 BARCELONA
SPAIN
ALMIRALL SAS
1 BOULEVARD VICTOR
75015 PARIS
INDUSTRIAS FARMACEUTICAS ALMIRALL, SL
CTRA. NACIONAL II, KM 593
E-08740 SANT ANDREU DE LA BARCA
BARCELONA
SPAIN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was revised is MM / YYYY.
AMM under exceptional circumstances
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Not applicable.
Laxative of ballast
ispaghul
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
SPAGULAX: effervescent powder for oral suspension (mandarin flavoring); box of 20 sachets-dose.
Refunded at 30%. - price: 2,74 euro (s).
SPAGULAX WITHOUT SUGAR: effervescent powder for oral suspension (apple flavoring); box of 20 sachets-dose.
Refunded at 30%. - price: 2,74 euro (s).
Laboratory Almirall SAS
| p sachet | p sachet | |
| Ispaghul, seed coat | 2.143 g | 2.143 g |
| Sucrose | 1.4 g | |
| Sodium | 120 mg | 120 mg |
Usual dosage:
1 sachet at each of the main meals.
