NOTICE
ANSM - Updated on: 10/08/2017
Name of the medicinal product
SODIUM PICOSULFATE FRUCTIN 5 mg, sucked tablet
Sodium (picosulfate)
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine by following the instructions 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 side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is SODIUM PICOSULFATE 5 mg, sucked tablet and in which cases is it used?
2. What should I watch out for before taking SUCCESS PICOSULFATE 5 mg SODIUM PICOSULFATE, sucked tablet?
3. How to take FRUCTINES WITH SODIUM PICOSULFATE 5 mg, sucked tablet?
4. What are the possible side effects?
5. How to store SODIUM PICOSULFATE FRICTIONS 5 mg, sucked tablet?
6. Package contents and other information.
1. WHAT IS SODIUM PICOSULFATE FRESH 5 mg, sucked tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Stimulating laxative.
This medication is a stimulant laxative (it stimulates intestinal evacuation).
It is recommended in occasional constipation.
2. BEFORE YOU TAKE SUCCESS FRICTIONS WITH SODIUM PICOSULFATE 5 Mg, sucked tablet?
Do not take SODIUM PICOSULFATE 5 mg SUCCESS, SUCCESSFUL:
· certain diseases of the intestine and colon,
· in case of abdominal pain (stomach pains),
· in the case of chronic constipation (long-lasting constipation),
· in children under 12 years of age.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
This medicine contains an azo agent (E 110) and may cause allergic reactions.
This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
NEVER LEAVE TO CHILDREN.
NO EXTENDED USE WITHOUT MEDICAL ADVICE: do not exceed 8 to 10 days of treatment.
· Occasional constipation . It may be linked to a recent change in lifestyle (travel ...). The drug may be an aid in short treatment. Any recent constipation unexplained by a change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen, must have the physician's opinion sought.
· Chronic constipation (long duration constipation)
It should not be treated with a stimulant laxative.
It can be linked to two causes:
- or to a bowel disease that requires management by the physician.
- 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.
It is helpful to seek advice from your doctor or pharmacist.
Other medicines and FRESTINES WITH SODIUM PICOSULFATE 5 mg, sucked tablet
These drugs can cause loss of potassium . Combination with other medications (such as certain diuretics or certain heart medicines) can be dangerous.
In order to avoid possible interactions with other medicines, this treatment should be reported to your doctor and pharmacist.
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
SODIUM PICOSULFATE FRUCTIN 5 mg, sucked tablet with food and drink
Not applicable.
Breastfeeding Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
In the absence of data in humans, it is preferable, as a precaution not to use SODIUM PICOSULFATE FRUCTINES, during pregnancy.
In the absence of data on passage through breast milk, it is preferable, as a precaution not to use SODIUM PICOSULFATE FRUCTINES, during breast-feeding.
Driving and using machines
Not applicable.
SODIUM PICOSULFATE FRUCTIN 5 mg, sucking tablet contains: sucrose, orange yellow S (E 110).
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FRUCTINES WITH SODIUM PICOSULFATE 5 Mg, sucked tablet?
Dosage:
Adults: 1 tablet (or if necessary 2 tablets) to suck or chew, in the evening at bedtime or possibly in the morning.
This treatment should be taken only for a short period (maximum 8 to 10 days).
If the effect of the treatment is insufficient, do not increase the dose or prolong the use but ask your doctor or pharmacist.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
If you take more than 5 mg SODIUM PICOSULFATE FRUCTINES, sucked tablet you should not have
Possible overdose may cause severe diarrhea with electrolyte loss and hypokalaemia.
If you forget to take SODIUM PICOSULFATE FRUCTINES 5 Mg, sucked tablet
Not applicable.
If you stop taking SODIUM PICOSULFATE FRUCTINES 5 Mg, sucked tablet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, SODIUM PICOSULFATE FRICTIES 5 mg, sucked tablet is likely to have side effects, although not everyone is subject to it:
· it is possible that pains of the belly occur. You should stop treatment and tell your doctor.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
Declaration of side effects
If you experience any side effects, talk to 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: 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 FRESHES WITH SODIUM PICOSULFATE 5 mg, sucked tablet?
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 package.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What is SODIUM PICOSULFATE FRUCTINES 5 Mg, sucked tablet
· The active substance is:
Sodium Picosulfate ............................................... .................................................. ......... 0.005 g
For a tablet to suck.
· The other ingredients are: Sucrose, talc, gum arabic, anhydrous colloidal silica, orange essential oil, mandarin essential oil, orange-yellow S, magnesium stearate.
What is SODIUM PICOSULFATE 5 mg, sucked tablets and contents of the pack
This medication is in the form of a tablet to be sucked; box of 30 tablets to suck.
Marketing Authorization Holder
DB PHARMA LABORATORIES
1 BIS, RUE DU COMMANDANT RIVIERE
94210 LA VARENNE SAINT-HILAIRE
Marketing Authorization Operator
DB PHARMA LABORATORIES
1 BIS, RUE DU COMMANDANT RIVIERE
94210 LA VARENNE SAINT-HILAIRE
Maker
LABORATORY AJC PHARMA
FONTAURY PLANT
16120 CHATEAUNEUF-SUR-CHARENTE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).