NOTICE
ANSM - Updated on: 21/12/2015
Name of the medicinal product
SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in sachet dose
Ispaghul (seed coat of)
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
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.
Review summary
What this leaflet contains:
1. What is SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet and in which cases it is used?
2. What should I know before taking SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet ?
3. How to take SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet ?
4. What are the possible side effects?
5. How to store SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet ?
6. Additional information.
1. WHAT IS SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic group
LAXATIVE OF LEST
Therapeutic indications
Herbal medication indicated in the symptomatic treatment of constipation.
2. BEFORE YOU TAKE SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take SPAGULAX WITHOUT SUGAR 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 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
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 WITHOUT SUGAR is taken with an insufficient amount of fluid, it can cause an obstruction of the throat or esophagus and result in a respiratory shock. Associated symptoms may include 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 people on a strict sodium diet.
Interaction with other medicines
Other drugs and SPAGULAX WITHOUT SUGAR:
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 WITHOUT SUGAR:
· 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.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
SPAGULAX WITHOUT SUGAR contains sodium.
3. HOW TO TAKE SPAGULAX WITHOUT SUGAR, effervescent powder for oral suspension in a dose sachet?
Instructions for proper use
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 WITHOUT SUGAR immediately before bedtime.
SPAGULAX WITHOUT SUGAR should be taken at least ½ hour to 1 hour before taking other medicines.
When preparing the oral suspension, avoid inhaling the powder.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Usually, the dosage is one sachet-dose before or after each of the main meals.
It is not recommended to use SPAGULAX WITHOUT SUGAR in children and adolescents under 18 years of age.
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 WITHOUT SUGAR 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 WITHOUT SUGAR 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 WITHOUT SUGAR:
Continue the treatment, but do not take a double dose to replace the missed dose.
Risk of withdrawal syndrome
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 swallowed SPAGULAX is swallowed with insufficient amounts of water).
· Allergic reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases anaphylactic shock.
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.
Expiration date
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.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains SPAGULAX WITHOUT SUGAR?
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 flavor, orange yellow S, sucrose.
Pharmaceutical form and content
Aspect of SPAGULAX WITHOUT SUGAR 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.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
ALMIRALL SA
RONDA GENERAL MITER, 151
08022 BARCELONA
SPAIN
exploiting
ALMIRALL SAS
1 BOULEVARD VICTOR
75015 PARIS
Maker
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.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.