NOTICE
ANSM - Last updated: 04/07/2017
Name of the medicinal product
RENNIE, tablet
Calcium carbonate, heavy 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 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 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, tablet and in which cases it is used?
2. What information should be known before taking RENNIE tablet?
3. How to take RENNIE tablet?
4. What are the possible side effects?
5. How to store RENNIE tablets?
6. Package contents and other information.
1. WHAT IS RENNIE, tablet AND WHAT IT IS USED FOR?
ANTIACIDES- ATC code: A02A
This medication is indicated in adults (from 15 years) in heartburn and acid reflux.
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING RENNIE, tablet?
Do not take RENNIE tablets:
· if you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.
· if you have a serious kidney disease,
· if you have hypercalcemia (abnormally high calcium in the blood),
· if you suffer from nephrolithiasis (calcium deposits in the renal tissue),
· if you have hypophosphatemia (abnormally low level of phosphate in the blood).
Warnings and Precautions
Talk to your doctor or pharmacist before taking RENNIE tablets .
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 suffer from digestive problems for the first time or if these disorders have changed recently,
· If you are suffering 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, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Use this medicine only 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.
· This medicine contains 475 mg of sucrose per tablet: take it into account in the daily diet in the case of a low-sugar diet or diabetes.
children
Not applicable.
Other medications and RENNIE, tablet
Inform your doctor or pharmacist if you are taking, have recently taken or used 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 maximum recommended doses ( see Dosage / Administration Frequency ). |
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).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
RENNIE, tablet with food and beverages 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.
Do not take this medicine without consulting your doctor or pharmacist. |
Pregnancy
This medication will only be used during pregnancy on the advice of your doctor.
feeding
Use of this medication is possible during breast-feeding.
Driving and using machines
Not applicable.
Rennie, tablet contains sucrose.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE RENNIE, tablet?
Dosage
RESERVED FOR THE ADULT (from 15 years).
· 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.
Administration mode
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.
Duration of treatment
The duration of use is limited to 10 days. |
If you take more RENNIE, 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, tablet
Do not take a double dose to make up for the single dose that you have forgotten to take.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, RENNIE tablets can cause side effects, although not everybody gets them.
Immune System Disorders
Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic shock.
Metabolic and Nutritional 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, 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. The expiry date refers to the last day of that month.
For wrapping (PVC / Aluminum):
No special storage conditions.
For sheet packaging (paper / Aluminum):
For climatic zones I and II: Store in a dry place away from moisture or store in the original packaging.
For climatic zones III: Do not store above 30 ° C. Store in a dry place away from moisture or store in the original container.
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 contains, tablet
· The active substances are:
Calcium carbonate ............................................... .................................................. 680.00 mg
Heavy magnesium carbonate .............................................. ....................................... 80.00 mg
For a tablet.
· The other components are:
Potato starch, gelatinous corn starch, magnesium stearate, talc, light liquid paraffin, mint flavor (peppermint essential oil 16 to 20 percent, maltodextrin, gum arabic), lemon flavoring (lemon essential oil, maltodextrin of maize, alpha-tocopherol), sucrose.
What is RENNIE, tablet and contents of the pack
This medication is in the form of tablets.
Box of 12, 24, 25, 36, 48, 50, 60, 72, 84 or 96.
Marketing Authorization Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
Marketing Authorization Operator
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
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.