NOTICE
ANSM - Last updated: 26/07/2017
Name of the medicinal product
RENNIE SANS SUGRE, chewable tablet
Calcium Carbonate / Magnesium Carbonate
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 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 contact your doctor if you experience no improvement or feel less well after 10 days.
What is in this leaflet?
1. What is RENNIE WITHOUT SUGAR, chewable tablet and in which cases it is used?
2. What should be known before taking RENNIE SANS SUGRE, chewable tablet?
3. How to take RENNIE WITHOUT SUGAR, chewable tablet?
4. What are the possible side effects?
5. How to store RENNIE WITHOUT SUGAR, chewable tablet?
6. Package contents and other information.
1. WHAT IS RENNIE WITHOUT SUGAR, chewable tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ANTIACIDES -code ATC: A02A.
This medication is indicated in adults (from 15 years) in heartburn and acid reflux.
2. BEFORE YOU TAKE RENNIE WITHOUT SUGAR, chewable tablet?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Never take RENNIE WITHOUT SUGAR, chewable tablet:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· if you have a serious kidney disease,
· if you suffer from hypercalcemia (abnormally high levels of calcium in the blood).
· if you suffer from nephrolithiasis (calcium deposits in the renal tissue),
· if you have hypophosphatemia (abnormally low blood phosphate levels).
Warnings and Precautions
You should only use this medication after consulting your doctor:
· if your disorders are associated with weight loss,
· if you have difficulty swallowing or persistent abdominal discomfort,
· if you are suffering from digestive problems for the first time or if these disorders have recently changed,
· if you suffer from kidney disease.
· if you have hypercalciuria (abnormally high calcium in the urine).
The use of this medication is not recommended in patients with fructose intolerance (rare hereditary disease).
Use this medicine with caution:
· If the intensity and / or frequency of the symptoms persist without improvement or worsen after 10 days of treatment, do not increase the dose but take the advice of your doctor or pharmacist.
· If you are required to exceed 4 to 8 tablets per day, this treatment should be of short duration. It should not be continued after the disappearance of the symptoms.
You should not exceed 12 tablets per day.
children
Not applicable.
Other medicines and RENNIE WITHOUT SUGAR, chewable tablet
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
This medicine contains antacids (calcium carbonate and magnesium carbonate) . Other medicines contain it. Do not combine them, so as not to exceed the recommended maximum doses (see HOW TO TAKE RENNIE WITHOUT SUGAR, chewable tablet).
Antacids can decrease the effect of many other drugs. You should always report any other medications you are taking to your doctor or pharmacist.
Antacid and other medicines should not be taken at the same time.
This other medication may be taken away from the antacid (eg 2 hours before).
RENNIE WITHOUT SUGAR, chewable tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
This medication will only be used during pregnancy on the advice of your doctor.
Use of this medication is possible during breast-feeding.
Driving and using machines
Not applicable.
RENNIE WITHOUT SUGAR, chewable tablet contains sorbitol.
3. HOW TO TAKE RENNIE WITHOUT SUGAR, chewable tablet?
RESERVED FOR THE ADULT (from 15 years).
Dosage:
· 1 to 2 tablets at the time of heartburn or acid lifts, ie 4 to 8 tablets per day.
· In case of more intense pain, the dose may be increased to 12 tablets per day for a short period.
· The duration of treatment will be limited to 10 days.
Method and route of administration
Oral use.
Suck or chew the tablet (s)
Frequency of Administration
Take 1 to 2 tablets at the time of pain. Follow the maximum dosage.
The duration of use is limited to 10 days.
If you take more RENNIE WITHOUT SUGAR, chewable tablet than you should have
In case of overdose, transit disorders may appear (diarrhea), in this case it is recommended to discontinue the treatment and to consult a doctor.
If you forget to take RENNIE WITHOUT SUGAR, chewable tablet
Do not take a double dose to make up for a missed dose.
If you stop taking RENNIE WITHOUT SUGAR, chewable tablet
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
- Immune System Disorders
Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic shock.
- Metabolic and nutrition disorders
In some patients, especially those with renal impairment, prolonged use of high doses may lead to hypermagnesemia, hypercalcaemia and alkalosis, which may increase gastrointestinal symptoms and muscle weakness.
- Gastrointestinal disorders
Nausea, vomiting, abdominal pain and diarrhea.
- Musculoskeletal and connective tissue disorders
Muscular weakness.
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 RENNIE WITHOUT SUGAR, chewable 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 carton. The expiry date refers to the last day of that month.
For packaging in thermoformed blister (PVC / Aluminum):
Store at a temperature not exceeding 25 ° C. Store in the original package in order to protect from moisture.
For sheet packaging (paper / Aluminum):
Store at a temperature not exceeding 25 ° C in the original package, away from moisture.
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 RENNIE SANS SUGRE contains, chewable tablet
· The active substances are:
Calcium carbonate............................................... .................................................. ... 680 mg
Heavy magnesium carbonate .............................................. .......................................... 80 mg
For a chewable tablet.
· The other components are sorbitol, potato starch, pregelatinized corn starch, magnesium stearate, talc, light liquid paraffin, mint flavor *, saccharin sodium.
* Composition of the mint aroma: mixture of essential oils of Mentha spicata L and Mentha piperita.
What is RENNIE SANS SUGRE, chewable tablet and contents of the pack
This medication is in the form of a chewable tablet. Box of 12, 24, 36, 48, 60, 72 and 96 tablets.
Marketing Authorization Holder
BAYER HEALTHCARE SAS
220, avenue de la Recherche
59120 LOOS
Marketing Authorization Operator
BAYER HEALTHCARE SAS
33, rue de l'Industrie
74240 GAILLARD
Maker
DELPHARM GAILLARD
33, rue de l'Industrie
74240 GAILLARD
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).
Health Education Council:
This medication is intended to relieve your stomach ache.
Burns, heartburn, acid uplifts can be due to modifications of the diet (acidic or spicy dishes, alcoholic beverages ...) or to the taking of certain medicines (aspirin, anti-inflammatories ...) . Do not hesitate to talk to your doctor or pharmacist.
In order to limit the onset of symptoms, respect the following hygiene rules as much as possible:
· avoid tobacco and limit alcohol consumption,
· avoid abundant and high-fat meals,
· avoid certain foods such as chocolate, spices, peppers, citrus juices, soft drinks,
· eat slowly,
· vary your diet,
· normalize your weight,
· avoid exertion after the meal.
YOUR PHARMACIST, YOUR DOCTOR, KNOWS THE MEDICINES WELL.
DO NOT HESITATE TO ASK FOR THEM.
NEVER LEAVE A MEDICINE TO THE REACH OF CHILDREN.