Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Rennie Antacidum (Rennie), 680 mg + 80 mg, chewable tablets
Calcii carbonas + Magnesii subcarbonas ponderosus
Rennie Antacidum and Rennie are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve after 7 days, or if you feel worse, consult your doctor.

Table of contents:

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

1. What Rennie Antacidum is and what it is used for

Rennie Antacidum is a medicine that neutralizes excess hydrochloric acid in the stomach.
It contains two active substances: calcium carbonate and heavy magnesium carbonate.
Rennie Antacidum is used for symptomatic relief of conditions associated with gastric hyperacidity, such as:

heartburn,
indigestion,
bloating,
nausea,
feeling of fullness or heaviness in the upper abdomen,
belching.

2. Important information before using Rennie Antacidum

When not to use Rennie Antacidum:

If the patient is allergic to the active substances or to any of the other ingredients of the medicine (listed in section 6).
If the patient has increased calcium levels in the blood (hypercalcaemia).
If the patient has calcium kidney stones (nephrolithiasis).
If the patient has severe renal insufficiency.
If the patient has low levels of inorganic phosphate in the blood (hypophosphataemia).

Warnings and precautions
Before starting treatment with Rennie Antacidum, consult a doctor or pharmacist.
Exercise particular caution when using Rennie Antacidum if:

the patient has renal insufficiency; in such cases, calcium, phosphate, and magnesium levels in blood should be monitored regularly,
the patient has excessive excretion of calcium in urine (hypercalciuria),
the patient is using the medicine long-term and in high doses; this may lead to (especially in patients with renal insufficiency) increased levels of magnesium and calcium in blood, and to milk-alkali syndrome (a condition caused by excessive oral intake of calcium compounds). This may result in nausea, vomiting, excessive urination, increased thirst, dehydration, fatigue, and disturbances in orientation and thinking (so-called confusion); increased risk of kidney stone formation; muscle weakness.

Rennie Antacidum and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Rennie Antacidum may affect the rate and extent of absorption of other medicines. Therefore, all medicines, especially those listed below, should be taken 1 or 2 hours before or after taking Rennie Antacidum:

tetracycline antibiotics and other antibacterial agents – quinolones,
cardiac glycosides, such as digoxin,
bisphosphonates (used in the treatment of osteoporosis),
dolutegravir (an antiretroviral medicine used in the treatment of HIV infection),
levothyroxine (used, among others, in hypothyroidism),
eltrombopag (used in the treatment of thrombocytopenia),
phosphates,
fluorides,
iron preparations,
thiazide diuretics. Due to the increased risk of hypercalcaemia when thiazide diuretics are used concomitantly, serum calcium levels should be monitored regularly.

Rennie Antacidum with food and drink
The medicine should be taken after meals. The medicine should not be taken with large amounts of milk or dairy products.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Rennie Antacidum may be used during pregnancy and breastfeeding. In such cases, recommended doses should be strictly followed and the medicine used only as indicated. The medicine should not be used for longer than 2 weeks.
Driving and operating machinery
No effect.
Rennie Antacidum contains sucrose.
One tablet contains 475 mg of sucrose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Rennie Antacidum

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults and children over 12 years of age:
1 to 2 tablets at a time, one hour after meals and before bedtime.
Do not take more than 11 tablets per day.
Method of administration:

For oral use. The tablets may be sucked or chewed.
In case of heartburn or pain associated with excess acidity, an additional one or two tablets may be taken between regular dosing times.
Prolonged use of the medicine should be avoided. Long-term use and high doses may lead to the occurrence of adverse effects (see section 4).

If symptoms do not resolve within 7 days or resolve only partially, consult your doctor, as further investigations may be required to exclude a more serious condition.
Use in children
Rennie Antacidum should not be used in children under 12 years of age.
Overdose of Rennie Antacidum
If more than the recommended dose has been taken, discontinue the medicine and drink plenty of fluids.
The following symptoms of overdose may occur:

nausea, vomiting, muscle weakness, drowsiness. If symptoms are severe, seek medical advice, as alternative hydration methods (e.g. infusions) may be necessary.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Rennie Antacidum may cause the following adverse reactions:

hypersensitivity reactions (very rarely reported); clinical symptoms may include: rash, urticaria, pruritus, angioedema, dyspnoea, and anaphylactic shock;
nausea, vomiting, gastric discomfort, constipation, and diarrhoea;
muscle weakness.

Long-term use of high doses, particularly in patients with impaired renal function,
may lead to hypermagnesaemia (increased magnesium concentration in blood), hypercalcaemia
(increased calcium concentration in blood), and alkalosis (increased concentration of bases in blood).
Symptoms of milk-alkali syndrome:

taste disturbances;
calcifications;
weakness;
headache;
excess nitrogen in blood (azotaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rennie Antacidum

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Rennie Antacidum contains
The active substances in this medicine are: calcium carbonate and heavy magnesium carbonate.
The medicine contains 680 mg of calcium carbonate and 80 mg of heavy magnesium carbonate.
Other ingredients are: sucrose, pregelatinized corn starch, potato starch,
magnesium stearate, talc, light liquid paraffin, peppermint flavour, lemon flavour.

What Rennie Antacidum looks like and contents of the pack
The medicine is in the form of white, square tablets with the imprint: "RENNIE". Tablets are packed in blisters.
Pack contains 12, 24, 36, 48 or 96 tablets for sucking.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Bayer s.r.o., Siemensova 2717/4, 155 00 Prague 5, Czech Republic

Manufacturer:
Delpharm Gaillard, 33, rue de l’Industrie, 74240 Gaillard, France

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in the Czech Republic, country of export: 09/852/94-C
Parallel Import Authorisation Number: 14/19