NOTICE
ANSM - Updated on: 23/07/2014
Name of the medicinal product
RENNIE ORANGE, chewable tablet
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 10 days, consult a physician.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS RENNIE ORANGE, chewable tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE RENNIE ORANGE, chewable tablet?
3. HOW TO TAKE RENNIE ORANGE, chewable tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE RENNIE ORANGE, chewable tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS RENNIE ORANGE, chewable tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTIACIDE (A: digestive system and metabolism).
Therapeutic indications
This medication is indicated in adults (from 15 years) in heartburn and acid reflux.
2. BEFORE YOU TAKE RENNIE ORANGE, chewable tablet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take RENNIE ORANGE chewable tablets in the following cases:
· a history of allergy to any of the components of the tablet,
· of kidney disease,
· hypercalcaemia (abnormally high levels of calcium in the blood).
Precautions for use; special warnings
Take special care with RENNIE ORANGE chewable tablet:
Precaution of use
You should only use this medication with the advice of 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.
Due to the presence of sucrose, this drug should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
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 medication contains 475 mg of sucrose per tablet: take it into account in the daily diet in case of a low sugar diet or diabetes.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
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 Precautions for use and Dosage ). |
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).
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
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
This medication will only be used during pregnancy on the advice of your doctor.
feeding
Use of this medication is possible during breast-feeding.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a known effect: sucrose.
3. HOW TO TAKE RENNIE ORANGE, chewable tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
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 of time,
· The duration of treatment will be limited to 10 days.
If you feel that the effect of RENNIE ORANGE, chewable tablet is too strong or too weak, talk to your doctor or pharmacist.
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 the treatment
The duration of use is limited to 10 days. |
Symptoms and Instructions for Overdose
If you take more RENNIE ORANGE, chewable tablet than you should: in case of overdose, transit disorders may appear (diarrhea), in this case it is recommended to discontinue the treatment and to consult a doctor.
Instructions for omission of one or more doses
If you forget to take RENNIE ORANGE, chewable tablet: do not take a double dose to make up for a forgotten dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, RENNIE ORANGE chewable tablet is likely to have side effects, although not everyone is subject to it.
· Possibility of digestive disorders (diarrhea).
· At high and prolonged doses, possible occurrence of hypercalcemia (abnormally high levels of calcium in the blood), kidney stones and severe kidney problems.
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.
5. HOW TO STORE RENNIE ORANGE, chewable tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use RENNIE ORANGE, chewable tablet after the expiry date which is stated on the carton.
Storage conditions
For packaging blister packs (PVC / Aluminum): Store at a temperature not exceeding + 25 ° C. Store in the original package.
Sheet (Paper / Aluminum): Store at a temperature not exceeding + 25 ° C. Store in the original package in order to protect from moisture.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains RENNIE ORANGE Chewable Tablet?
The active substances are :
Calcium carbonate ............................................... .................................................. ...................... 680 mg
Heavy magnesium carbonate .............................................. .................................................. 80 mg
For a chewable tablet
The other components are :
Sucrose, pregelatinized maize starch, potato starch, talc, magnesium stearate, light liquid paraffin, orange flavor, saccharin sodium.
Pharmaceutical form and content
What is RENNIE ORANGE, chewable tablet and contents of the pack?
This medication is in the form of a chewable tablet; box of 12, 24, 25, 36, 48, 50, 60, 72, 84, 96, 100 to 120 tablets.
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
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
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.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
ADVICE / HEALTH EDUCATION
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.