Rennie Antacidum

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Rennie Antacid (Rennie)

680 mg + 80 mg, chewable tablets

Calcium carbonate + Magnesium carbonate heavy
Rennie Antacid and Rennie are different trade names for the same medicine.

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 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, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

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

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

2. Important information before taking Rennie Antacid

When not to take Rennie Antacid:

• 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 high levels of calcium in the blood (hypercalcemia).
• If the patient has kidney stones with calcium.
• If the patient has severe kidney impairment.
• If the patient has low levels of phosphate in the blood (hypophosphatemia).

Warnings and precautions

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

• they have kidney impairment; 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 patients with kidney impairment) an increase in magnesium and calcium levels in the blood and milk-alkali syndrome (a condition caused by excessive intake of calcium compounds). This, in turn, may cause nausea, vomiting, excessive urine production, increased thirst, dehydration, fatigue, and disturbances of orientation and thinking (confusion); increased risk of kidney stone formation; muscle weakness.

Rennie Antacid with other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Rennie Antacid may affect the absorption of other medicines. Therefore, all medicines, especially those listed below, should be taken 1 or 2 hours before or after taking Rennie Antacid:

• 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 other things, in hypothyroidism),
• eltrombopag (used in the treatment of thrombocytopenia),
• phosphates,
• fluorides,
• iron preparations,
• thiazide diuretics. Due to the increased risk of hypercalcemia when taking thiazide diuretics, calcium levels in the blood should be regularly monitored.

Rennie Antacid 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 Antacid can be used during pregnancy and breastfeeding. However, the recommended doses should be strictly followed, and the medicine should be used as directed. The medicine should not be used for more than 2 weeks.

Driving and using machines

There is no effect.

Rennie Antacid 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 Antacid

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
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 excess stomach acid, an additional 1 or 2 tablets can be taken between regular doses.
• Long-term use of the medicine should be avoided. Long-term intake 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 their doctor, as tests may be necessary to rule out a more serious disease.

Use in children

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

Overdose of Rennie Antacid

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 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 Antacid can cause side effects, although not everybody gets them.
Rennie Antacid may cause the following side effects:

• allergic reactions (very rarely reported); clinical symptoms may include: rash, urticaria, itching, angioedema, dyspnea, and anaphylactic shock;
• nausea, vomiting, discomfort in the stomach, 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 disturbances;
• calcifications;
• weakness;
• headaches;
• excessive levels of nitrogen in the blood (azotemia).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Rennie Antacid

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store 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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rennie Antacid contains

The active substances of the medicine are: calcium carbonate and magnesium carbonate heavy. One tablet contains 680 mg of calcium carbonate and 80 mg of magnesium carbonate heavy.
The other ingredients (excipients) are: sucrose, maize starch, potato starch, magnesium stearate, talc, light liquid paraffin, peppermint flavor (peppermint oil, maltodextrin, gum arabic, colloidal silica), lemon flavor (flavoring substances - lemon oil, maltodextrin, α-tocopherol).

What Rennie Antacid looks like and contents of the pack

The medicine is in the form of cream-white, square tablets with rounded edges, with the inscription "RENNIE" on both sides. The tablets are packaged in blisters. The pack contains 12, 24, 36, 48, 60, or 96 chewable tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Bayer B.V.
Siriusdreef 36
2132 WT Hoofddorp
Netherlands

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Netherlands, the country of export: RVG 08892

Parallel import authorization number: 313/24

Date of leaflet approval: 31.07.2024

[Information about the trademark]