SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre

SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre View larger

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Indications :

 

    • Constipation (INDICATION)

 

    • Constipation (INDICATION_GROUP)

 

    • Soin palliatif (INDICATION_GROUP)


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Pour connaître les mises en garde, les précautions d'emploi et les contre-indications, veuillez consulter la notice d'utilisation de SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre sans ordonnance. Description de SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre

Molécules :

 

    • 17844 : SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre (ITEM - )

 

    • alcool butylique (MOLECULE - Excipient)

 

    • ispaghul tégument de graine (MOLECULE - Substance Active)

 

    • acide acétique (MOLECULE - Excipient)

 

    • pipéronal (MOLECULE - Excipient)

 

    • saccharine sodique (MOLECULE - Excipient)

 

    • acétaldéhyde (MOLECULE - Excipient)

 

    • pomme arôme (MOLECULE - Excipient)

 

    • maltodextrine (MOLECULE - Excipient à effet notoire)

 

    • vanilline (MOLECULE - Excipient)

 

    • maltol (MOLECULE - Excipient)

 

    • sodium (MOLECULE - Excipient à effet notoire)

 

    • acide citrique anhydre (MOLECULE - Excipient)

 

    • acide propionique (MOLECULE - Excipient)

 

    • gomme arabique (MOLECULE - Excipient)

 

    • bicarbonate de sodium (MOLECULE - Excipient)

 

    • macrogol (MOLECULE - Excipient)


Indication de SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre

Indications :

 

    • Constipation (INDICATION)

 

    • Constipation (INDICATION_GROUP)

 

    • Soin palliatif (INDICATION_GROUP)


Conseil d'utilisation et posologie de SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre Présentation de SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre Mises en garde sur les médicaments Attention, le médicament SPAGULAX poudre effervescente suspension buvable en Sachets-dose sans sucre sans ordonnance n'est pas un produit comme les autres. Lire attentivement la notice du médicament avant de le commander. Ne laissez pas les médicaments à la portée des enfants. Si les symptômes persistent, demandez l'avis de votre médecin ou de votre pharmacien. Attention aux incompatibilités sur vos produits en cours. Veuillez informer votre pharmacien en ligne des traitements en cours afin d'identifier d'éventuelles incompatibilités. Le formulaire de validation de commande contient un champ de message personnalisé prévu à cet effet. Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé. Pharmacovigilance: Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

VIDAL OF THE FAMILY

SPAGULAX

Laxative of ballast

ispaghul

. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

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

COMPOSITION (summary)
p sachet p sachet
Ispaghul, seed coat 2.143 g 2.143 g
Sucrose 1.4 g
Sodium 120 mg 120 mg

INDICATIONS (summary)
This medicine is a laxative of ballast . It contains a natural substance that is neither digested nor absorbed. It imbibes water and makes the stools more voluminous and less firm.
It is used in the symptomatic treatment of constipation.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • inflammatory bowel disease,
  • intestinal occlusion or condition predisposing to occlusion,
  • abdominal pain of unknown cause,
  • fecal matter (stool plug).
WARNING (Contents)
It is necessary to drink plenty of water, especially in case of dilation of the colon, bed rest, and in the elderly.
Laxatives should not be used prolonged without medical advice.
The use of laxatives must remain exceptional in children.
This drug contains salt (sodium) in significant quantities.
PREGNANCY AND BREAST-FEEDING (summary)
This medication can be used to treat constipation of pregnant or nursing women.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication can be taken indifferently 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.
TIPS (summary)
The laxative effect is usually obtained after 1 or 2 days.
Treatment failure may be related to the presence of fecal matter , particularly in the elderly.
The treatment of constipation is essentially based on hygiene measures: high-fiber food, abundant drinks, regular physical activity and time to get to the saddle.
POSSIBLE ADVERSE EFFECTS (summary)
Sensation of bloating.


GLOSSARY (summary)


fecal impaction
Stool plug in the rectum or in the colon. It is to be feared in the elderly or constipated, or those who remain bedridden for a long time. It exposes to a risk of obstruction of the digestive tract.


laxative of ballast
Laxative which has the property of swelling on contact with water: it increases the volume of the stools and makes them less hard. It is devoid of toxicity.


salt
Chemical substance of which the best known is sodium chloride, or table salt. The diet salt does not contain sodium; this is generally replaced by potassium.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

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.

Constipation drug Pharmacy Online: Order your medication to treat your transit in your bio online pharmacy.

 

Bloating, gastric acidity, diarrhea during gastroenteritis or food poisoning, constipation, indigestion, acid reflux, are all presenting symptoms of gastric and intestinal dysfunction. You will find here the drugs to relieve digestive disorders.

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