Rennie Antacidum

Package Leaflet: Information for the Patient

RENNIE ANTACIDUM

Calcium carbonate + Magnesium carbonate heavy
680 mg + 80 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 the patient leaflet or as directed by
the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet

• 1. What is Rennie Antacidum and what is it used for
• 2. Important information before taking Rennie Antacidum
• 3. How to take Rennie Antacidum
• 4. Possible side effects
• 5. How to store Rennie Antacidum
• 6. Package contents and other information

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

Rennie Antacidum is a medicine that neutralizes excess stomach acid.
Rennie Antacidum is used for the symptomatic treatment of disorders associated with excessive acidity
of stomach juice, such as:

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

2. Important information before taking Rennie Antacidum

When not to take Rennie Antacidum:

• If the patient is allergic to the active substances or any of the other ingredients of the medicine (listed in section 6).
• If the patient has elevated calcium levels in the blood (hypercalcemia).
• If the patient has kidney stones with calcium.
• If the patient has severe kidney failure.
• If the patient has low levels of inorganic phosphates in the blood (hypophosphatemia).

Warnings and precautions

Before starting to take Rennie Antacidum, the patient should discuss it with their doctor or pharmacist.
When taking Rennie Antacidum, the patient should be particularly cautious if:

• they have kidney failure; they should then regularly check their calcium, phosphate, and magnesium levels in the blood,
• they have excessive excretion of calcium in the urine (hypercalciuria),
• they take the medicine for a long time and in high doses; this may cause (especially in people with kidney failure) an increase in magnesium and calcium levels in the blood and milk-alkali syndrome (a condition caused by excessive intake of calcium compounds orally). This, in turn, may cause nausea, vomiting, excessive urine production, increased thirst, dehydration, fatigue, and disturbances of orientation and thinking (so-called confusion); increased risk of kidney stone formation; muscle weakness.

Rennie Antacidum and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
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:

• antibiotics from the tetracycline group and other antibacterial medicines - 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 hypercalcemia when using thiazide diuretics, calcium levels in the serum should be regularly monitored.

Rennie Antacidum with food and drink

The medicine should be taken after a meal. The medicine should not be taken with large amounts of milk or
dairy products.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Rennie Antacidum can be used during pregnancy and breastfeeding. However, the recommended doses should be strictly followed and the medicine should be used as indicated. The medicine should not be used for more than 2 weeks.

Driving and using machines

There is 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 some sugars, they should consult their doctor before taking the medicine.

3. How to take Rennie Antacidum

This medicine should always be taken exactly as described in the patient leaflet or as directed by
the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Recommended dose
Adults and children over 12 years old:
1 to 2 tablets at a time, 1 hour after a meal and before bedtime.
No more than 11 tablets should be taken per day.
Method of administration

• Take orally, tablets can be sucked or chewed.
• In case of heartburn or pain associated with excessive acidity, an additional 1 or 2 tablets can be taken between regular doses.
• Long-term use of the medicine should be avoided. Long-term use of the medicine and in high doses may cause side effects (see section 4).

If symptoms do not improve within 7 daysor improve only partially, the patient should consult a doctor, as tests are recommended to rule out a more serious disease.

Use in children

Rennie Antacidum should not be used in children under 12 years old.

Overdose of Rennie Antacidum

In case of overdose, the medicine should be discontinued and plenty of fluids should be given to drink.
The following overdose symptoms may occur:

• nausea, vomiting, muscle weakness, drowsiness. If the symptoms are severe, medical advice should be sought, as other methods of hydration (e.g., infusions) may be necessary.

4. Possible side effects

Like all medicines, Rennie Antacidum can cause side effects, although not everybody gets them.
Rennie Antacidum may cause the following side effects:

• hypersensitivity reactions (very rarely reported); clinical symptoms may include: rash, urticaria, itching, angioedema, dyspnea, and anaphylactic shock;
• nausea, vomiting, stomach discomfort, constipation, and diarrhea;
• muscle weakness.

Long-term use of high doses, especially in patients with impaired kidney function, may cause hypermagnesemia (elevated magnesium levels in the blood) or hypercalcemia (elevated calcium levels in the blood) and alkalosis (elevated levels of bases in the blood).
Symptoms of milk-alkali syndrome:

• taste disorders;
• calcifications;
• weakness;
• headaches;
• excess nitrogen in the blood (azotemia).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. Side effects can be reported 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, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rennie Antacidum

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rennie Antacidum contains

The active substances of the medicine are: calcium carbonate and magnesium carbonate heavy.
The other ingredients (excipients) are: sucrose, corn starch, potato starch, magnesium stearate, talc, light liquid paraffin, peppermint flavor (peppermint oil, maltodextrin, gum arabic, silicon dioxide), lemon flavor (flavoring substances - 100% lemon oil, maltodextrin, α-tocopherol).

What Rennie Antacidum looks like and contents of the pack

The medicine is in the form of white, square tablets with the inscription: "Rennie". The tablets are packaged in blisters.
The pack contains 12, 24, 36, 48, 60, or 96 chewable tablets.

Marketing authorization holder

Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel: 22 572 35 00

Manufacturer

Delpharm Gaillard
33, rue de l'Industrie
74240 Gaillard
France
Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany

Date of last revision of the leaflet: 01.2024