Rennie Extra

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Rennie Extra

Calcium carbonate+ Magnesium heavy carbonate + Alginic acid
625 mg + 73.50 mg + 150 mg, chewable tablets

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this leaflet for the patient, or according to the doctor's or pharmacist's instructions.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Rennie Extra and what is it used for
• 2. Important information before taking Rennie Extra
• 3. How to take Rennie Extra
• 4. Possible side effects
• 5. How to store Rennie Extra
• 6. Contents of the package and other information

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

Rennie Extra relieves heartburn and indigestion associated with excess stomach acid.
Rennie Extra works in two ways:

• 1. Alginic acid forms a protective barrier in the stomach, which prevents acid from flowing up into the esophagus, thus relieving the burning pain in the upper abdomen.
• 2. Calcium carbonate and magnesium carbonate provide quick and long-lasting neutralization of excess acid in the stomach.

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:

Like other antacids, taking this medicine may mask the symptoms of other, more serious underlying diseases. If symptoms do not disappear within fourteen days, you should consult a doctor.
Before taking Rennie Extra, you should consult a doctor or pharmacist if you have any kidney problems, have been diagnosed with sarcoidosis (an inflammatory disease affecting many organs in the body), have severe or chronic gastrointestinal symptoms or gastrointestinal diseases.

Rennie Extra with other medicines:

• You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.
• If you are taking antibiotics (tetracyclines, quinolones), cardiac glycosides (digoxin, digitoxin), bisphosphonates (used to treat osteoporosis), dolutegravir (an antiretroviral medicine used to treat HIV infection), levothyroxine (thyroid hormone), or eltrombopag (a medicine used to increase platelet count), you should consult a doctor before taking Rennie Extra, as it may affect the action of these medicines. To get the most benefit from taking all your medicines, you should take Rennie Extra 1 to 2 hours after taking each other medicine.
• If you are taking any thiazide diuretics (e.g., bendroflumethiazide), which are used to increase urine production, you should inform your doctor before taking Rennie Extra, as your doctor may recommend monitoring your blood calcium levels.

Rennie Extra with food and drink

Like all antacids that contain calcium, you should avoid consuming large amounts of milk or dairy products.

Pregnancy and breastfeeding

Before taking any medicine, you should consult a doctor or pharmacist.
Rennie Extra can be taken during pregnancy if used as directed.
Rennie Extra can be taken during breastfeeding if used as directed (see section 3).
Since Rennie Extra contains significant amounts of calcium in addition to dietary calcium, pregnant women should strictly follow the recommended maximum daily dose and avoid excessive consumption of milk (1 liter contains up to 1.2 g of elemental calcium) and dairy products.

Rennie Extra contains sodium, glucose, and sucrose

One tablet of the medicine contains 14 mg of sodium (the main component of common salt), which is equivalent to 0.7% of the recommended maximum daily intake of sodium for an adult.
One tablet of the medicine also contains 230 mg of sucrose and approximately 555.2 mg of glucose (including that derived from dextrans), which should be taken into account in patients with diabetes.
If the patient has been informed by their doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Glucose and sucrose can also be harmful to teeth.

3. HOW TO TAKE RENNIE EXTRA

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Adults and children over 12 years old:2 chewable tablets, preferably 1 hour after meals and before bedtime. If heartburn occurs, you can take an additional 2 tablets between regular doses. Do not take more than 12 tablets in 24 hours.
Rennie Extra can be taken during pregnancy and breastfeeding if used as directed.
If symptoms do not disappear within 14 days, you should consult a doctor to rule out a more serious underlying disease. You should avoid long-term use. Do not use in children under 12 years old.

Taking more than the recommended dose of Rennie Extra

You should drink plenty of water and consult a doctor or pharmacist. The following overdose symptoms may occur: nausea and vomiting, constipation, fatigue, increased urine production, increased thirst, dehydration, and unusual muscle weakness.
If you have any doubts about taking this medicine, you should consult a doctor or pharmacist.

Missing a dose of Rennie Extra

You should not take a double dose to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The occurrence of side effects when taking the recommended dose is unlikely.
Rarely, allergic reactions to the ingredients have been reported, such as rash, itching, difficulty breathing, and swelling of the face, mouth, or throat, and anaphylactic shock. If such reactions occur, you should stop the treatment and consult a doctor immediately.
Long-term use in high doses may cause high levels of calcium and magnesium in the blood, especially in people with kidney disease. This can cause nausea and vomiting, stomach upset, diarrhea, fatigue, muscle weakness, confusion, increased urine production, increased thirst, and dehydration.
Taking Rennie Extra with milk or dairy products for a long time may lead to the development of milk-alkali syndrome, which can cause high levels of calcium in the blood. Specific symptoms of milk-alkali syndrome may include taste disturbances, headache, kidney problems, fatigue, and lumps under the skin.

Reporting side effects:

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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.
You can also report side effects to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. HOW TO STORE RENNIE EXTRA

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Rennie Extra contains:

The active substances of the medicine are calcium carbonate (625 mg), magnesium heavy carbonate (73.5 mg), and alginic acid (150 mg).
The other ingredients are sodium bicarbonate, sodium saccharin, sucrose, glucose monohydrate, dextrans, povidone K30, talc, magnesium stearate, peppermint flavor (contains peppermint oil, maltodextrin, gum arabic, silicon dioxide), cream-citrus flavor (contains citronella oil, orange oil, lemon oil, levomenthol, vanillin, maltodextrin, gum arabic, ascorbic acid, butylhydroxyanisole (E 320)).

What Rennie Extra looks like and what the package contains:

Rennie Extra is a white, speckled, round, and flat tablet for chewing and sucking with beveled edges.
The tablets are packaged in soft LDPE/Aluminum blisters and then in a cardboard box containing this leaflet.
The medicine is available in packages containing 12, 18, 24, 30, 36, or 48 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder Manufacturer

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

Date of the last update of the leaflet: