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SMECTA SACHETS N10 APELSĪNU GARŠA

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
SMECTA-ORANGE-drug/medicine aproximate price on "SMECTA SACHETS N10 APELSĪNU GARŠA" in Riga city, Latvia is:
  • 4.15€  4.49$  3.55£  479Rub  47.8SEK  18PLN  16.52₪ 

SMECTA, 3 g, milteliai geriamajai suspensijai, N10


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine  SMECTA SACHETS N10 APELSĪNU GARŠA     Recheck

Reģ. Nr.: 93-0524

ATC codeA07BC05 

Active substances: Diosmectitum

 


Vendor, principal: Beaufour Ipsen International
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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SMECTA 3 g paciņas, 10 gab.

 .

SMECTA 3G N10

Package leaflet: Information for the patient

Smecta

powder for oral suspension

Diosmectite

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Smecta is and what it is used for
2.   What you need to know before you use Smecta
3.   How to use Smecta
4.   Possible side effects
5.   How to store Smecta
6.   Contents of the pack and other information

1. What Smecta is and what it is used for

Smecta is natural purified and standardised clay.
Smecta covers the mucous membrane of the digestive tract and protects it by increasing mucous membrane resistance as well as binding pathogens such as bacteria, viruses, and toxins.
This medicine is used for the treatment of acute diarrhoea in adults and children (including babies) with oral rehydration support and for the symptomatic treatment of chronic functional diarrhoea in adults.
If you have acute diarrhoea, you must contact your doctor if you are not feeling better or are feeling worse after three days.
Using Smecta long-term without consulting a doctor is not recommended.

2. What you need to know before you use Smecta Do not take Smecta:

-   if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).
-   if you have rare hereditary fructose intolerance, glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency.

Warnings and precautions

Diosmectite must be used with caution by patients with a history of severe chronic constipation
Talk to your doctor or pharmacist before using Smecta:
-   if you have been told by your doctor that you have an intolerance to certain sugars,
-   if you have previously suffered from acute constipation.
Consult your doctor:
-   if the symptoms of acute diarrhoea are not relieved within three days
-   if high fever or vomiting are accompanied by pain.
Children and adolescents
To prevent dehydration due to diarrhoea, children and infants with diarrhoea must be provided immediate oral rehydration support.
Additional nutritional guidelines:
-   ensure adequate hydration by consuming generous amounts of salty or sweet drinks, to compensate for the fluid loss caused by diarrhoea (the average daily fluid requirement for an adult is 2 litres);
-   continue eating for the duration of the diarrhoea, but avoid certain foods, especially raw fruit and vegetables, greens, spicy foods, and frozen food or drinks;
-   grilled meat and rice are recommended

Other medicines and Smecta

As Smecta’s adsorbent properties can affect the time and/or extent of absorption of other substances, it is not recommended to take Smecta with other medicines but to leave a gap of at least two hours before or after taking other medicines.
Tell your doctor if you are using, have recently used, or are planning to use any other medicines, including over-the-counter medicines.

Smecta with food and drink

As Smecta’s adsorbent properties can affect the time and/or extent of absorption of other substances, it is not recommended to take Smecta with meals.

Pregnancy, breast-feeding and fertility

Smecta may be used during pregnancy or breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Smecta can be used during pregnancy and breast-feeding, as it does not undergo chemical transformation or absorption in the body.

Driving and using machines

No studies on Smecta’s effect have been conducted, but the medicine is not expected to have any effect on the ability to drive and use machines.

Smecta contains glucose and sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before using this medication.
Smecta contains 0.679 g of glucose per sachet. This must be considered in the case of patients with diabetes.

3. How to take Smecta

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Treatment of acute diarrhoea
Infants and children:
Under 1 year: 3g (1 sachet) a day.
Over 1 year: 6g (2 sachets) a day.
The dose may be doubled in the initial phase of acute diarrhoea.
Adults:
- 9g (3 sachets) a day
The dose may be doubled in the initial phase of acute diarrhoea.
Other indications:
Adults:
The average daily dose is 9g (3 sachets).
Method of administration:
Oral. Mix the contents of the sachet into half a glass of water just before use.
Children and infants: the contents of the sachet can be mixed with 50 ml of water or with a semi-liquid food (e.g., broth, compote, puree, or baby food).
When treating acute diarrhoea in children, administer Smecta with oral rehydration products to prevent dehydration (deficit of water in the body).
In adults, rehydration therapy may be used if necessary.

If you take more Smecta than you should

Over-dosage can cause acute constipation or a non-soluble formation in the intestines.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.   Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Common (may affect 1 in 10 people)
-   Constipation (reported in approx. 7% of adults and approx. 1% of children. If constipation develops, diosmectite must be discontinued and if necessary, administered again in a smaller dosage.

Occasional (may affect 1 in 100 people)

-   Rash

Rare (may affect 1 in 1.000 people)

-   Urticaria (pruritic rash)
Unknown incidence (cannot be estimated based on available data)
-   Symptoms of allergic reaction such as reddened skin, pruritus, swelling, breathing difficulties, fainting or collapse.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Smecta

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions
Do not use Smecta after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Smecta contains

The active substance is diosmectite.
Excipients include: glucose monohydrate, sodium saccharine, vanilla aroma and flavour*, orange aroma and flavour**.
* Composition of vanilla aroma and flavour:
maltodextrin, sucrose, glyceryl triacetate (E1518), silicon dioxide (E551), ethyl alcohol, soya lecithin (E322), vanilla aroma and flavour.
** Composition of orange aroma and flavour:
maltodextrin, sucrose, acacia gum(E414), mono- and diacetyltartic esters of mono- and diglycerides of fatty acids (E472e), silicon dioxide (E551), orange essential oil.

What Smecta looks like and contents of the pack

Smecta is a whitish to light beige powder with a light orange flavour that can be smelled while preparing the suspension.
One carton contains 10 or 30 sachets.

Marketing Authorisation Holder

Ipsen Pharma 65, quai Georges Gorse 92100 Boulogne Billancourt Cedex, France

This leaflet was last revised in January 2018.






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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