PACKAGE LEAFLET: INFORMATION FOR THE USER

Rennie Extra
Calcii carbonas + Magnesii subcarbonas ponderosus + Acidum alginicum
625 mg + 73.50 mg + 150 mg, chewable tablets
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms persist or worsen after 14 days, consult your doctor.

Contents of the leaflet

What Rennie Extra is and what it is used for
Important information before taking Rennie Extra
How to take Rennie Extra
Possible side effects
How to store Rennie Extra
Contents of the pack and other information

1. WHAT RENNIE EXTRA IS AND WHAT IT IS USED FOR

Rennie Extra relieves heartburn and dyspepsia associated with gastric hyperacidity.
Rennie Extra works in two ways:

Alginic acid forms a protective barrier in the stomach that prevents acid from rising into the oesophagus, thereby relieving the burning pain in the upper abdomen.
Calcium carbonate and light magnesium carbonate provide rapid and long-lasting neutralisation of excess stomach acid.

2. IMPORTANT INFORMATION BEFORE TAKING RENNIE EXTRA

When not to take Rennie Extra:

if the patient has severe kidney disease or kidney stones,
if the patient has high calcium levels or low phosphate levels in the blood,
if the patient is allergic to any of the ingredients of the medicine.

Warnings and precautions:
As with other medicines that neutralize gastric acid, taking these tablets may mask symptoms of other, more serious underlying diseases. If symptoms do not resolve within fourteen days, consult a doctor.
Before starting to take Rennie Extra, consult a doctor or pharmacist if the patient has any kidney problems, diagnosed sarcoidosis (an inflammatory disease affecting multiple organs in the body), severe or chronic gastrointestinal symptoms, or gastrointestinal disorders.
Rennie Extra and other medicines:

Inform your doctor or pharmacist about all medicines currently taken or taken recently, including those available without a prescription.
If the patient is taking antibiotics (tetracyclines, quinolones), cardiac glycosides (digoxin, digitoxin), bisphosphonates (used in the treatment of osteoporosis), dolutegravir (an antiretroviral drug used in the treatment of HIV infection), levothyroxine (thyroid hormone), eltrombopag (a medicine used to increase platelet count), or other prescribed medicines (e.g. fluorides, phosphates, iron preparations), consult a doctor before starting Rennie Extra, as it may affect the action of these medicines. To achieve optimal benefit from all medicines taken, Rennie Extra should be taken 1 to 2 hours after taking any other medicine.
If the patient is taking thiazide diuretics (e.g. bendroflumethiazide), used to increase urine production, inform the doctor before taking Rennie Extra, as the doctor may recommend monitoring blood calcium levels.

Rennie Extra with food and drink
As with all antacids containing calcium, large amounts of milk or dairy products should be avoided.
Pregnancy and breastfeeding
Consult a doctor or pharmacist before taking any medicine.
Rennie Extra may be taken during pregnancy if used according to recommendations.
Rennie Extra may be taken during breastfeeding if used according to recommendations (see section 3).
Since Rennie Extra contains significant amounts of calcium in addition to dietary calcium intake, pregnant women should strictly adhere to the recommended maximum daily dose and avoid simultaneously consuming excessive amounts of milk (1 litre contains up to 1.2 g elemental calcium) and dairy products.
Rennie Extra contains sodium, glucose and sucrose
One tablet contains 14 mg of sodium (a main component of table salt), equivalent to 0.7% of the recommended maximum daily intake of sodium for an adult.
One tablet also contains 230 mg of sucrose and approximately 555.2 mg of glucose (including that derived from dextrates), which should be taken into account in patients with diabetes.
If the patient has been advised by a doctor that they have an intolerance to certain sugars, they should consult their doctor before starting this medicine.
Glucose and sucrose may also be harmful to teeth.

3. HOW TO TAKE RENNIE EXTRA

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
Adults and children over 12 years of age: 2 chewable tablets, preferably 1 hour after meals and before bedtime. If heartburn occurs, an additional 2 tablets may be taken between regular dosing times. Do not take more than 12 tablets within 24 hours.
RENNIE EXTRA may be used during pregnancy and breastfeeding if taken according to the above recommendations.
If symptoms do not resolve within 14 days, consult a doctor to rule out a more serious condition. Prolonged use should be avoided. Do not use in children under 12 years of age.
Taking more than the recommended dose of RENNIE EXTRA
Drink plenty of water and consult a doctor or pharmacist. The following symptoms of overdose may occur: nausea and vomiting, constipation, fatigue, increased urine production, excessive thirst, dehydration, and unusual muscle weakness.
If you have any doubts regarding the use of this medicine, consult a doctor or pharmacist.
Missed dose of RENNIE EXTRA
Do not take a double dose to make up for a missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are unlikely when the recommended dose is used.
Allergic reactions to ingredients have been reported rarely, for example rash, itching, breathing difficulties, facial swelling, swelling of the oral cavity or throat, and anaphylactic shock. If any such reactions occur, treatment must be stopped immediately and medical advice should be sought.
Prolonged use at high doses may lead to elevated levels of calcium and magnesium in the blood, especially in patients with kidney disease. This may result in nausea and vomiting, stomach upset, diarrhoea, fatigue, muscle weakness, confusion, increased urine production, excessive thirst and dehydration.
Long-term use of Rennie Extra together with milk or dairy products may lead to the development of milk-alkali syndrome, which may cause high levels of calcium in the blood. Specific symptoms of milk-alkali syndrome may include taste disturbances, headache, kidney problems, feeling of fatigue and subcutaneous nodules.
Reporting of adverse reactions:
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel: +48 22 49-21-301, Fax: +48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. HOW TO STORE RENNIE EXTRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Rennie Extra contains:
The active substances in this medicine are calcium carbonate (625 mg), heavy magnesium carbonate (73.5 mg), and alginic acid (150 mg).
Other ingredients are: sodium hydrogen carbonate, sodium saccharin, sucrose, monohydrate glucose, dextrins, povidone K30, talc, magnesium stearate, peppermint flavour (containing peppermint oil, maltodextrin, arabic gum, silicon dioxide), cream-citrus flavour (containing lemon oil, orange oil, lemongrass oil, levomenthol, vanillin, maltodextrin, arabic gum, ascorbic acid, butylated hydroxyanisole (E 320)).

What Rennie Extra looks like and contents of the pack:
Rennie Extra is a white, speckled, round, flat, biconvex tablet with bevelled edges, intended to be chewed.
The tablets are packed in soft blisters made of LDPE/aluminium foil, then placed in a cardboard box containing this leaflet.
The medicine is available in packs containing 12, 18, 24, 30, 36 or 48 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer
Bayer Sp. z o.o. Delpharm Gaillard
Al. Jerozolimskie 158 33 rue de l’Industrie
02-326 Warszawa 74240 Gaillard
Tel.: +48 22 572 35 00 France