INFORMATION FOR THE USER

Rennie 680 mg/80 mg Chewable Tablets with Saccharose

Calcium Carbonate/Magnesium Carbonate

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the pack and additional information

Rennie belongs to the group of medicines called combinations and complexes of aluminum, calcium and magnesium.

It contains as active principles calcium carbonate and magnesium carbonate, which act by neutralizing excess acid in the stomach.

Rennie is indicated for the relief and symptomatic treatment of stomach acid and heartburn in adults and adolescents over 12 years old.

Consult a doctor if it worsens or does not improve after 7 days.

Do not take Rennie:

• if you are allergic to any of the active ingredients or to any of the other components of this medication (listed in section 6).
• if you have severe kidney failure, hypercalcemia (elevated levels of calcium in the blood), and hypophosphatemia (low levels of phosphate in the blood).
• if you have a history of calcium kidney stones.
• if you have hypercalciuria (elevated levels of calcium in the urine)

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Rennie.

• Avoid prolonged use.
• Do not exceed the recommended dose (see section 3).
• Consult your doctor or pharmacist before taking Rennie if you have kidney problems, as the administration of this medication in subjects with altered renal function may cause hypercalcemia (elevated levels of calcium in the blood) and metabolic alkalosis (milk-alkali syndrome).
• If symptoms worsen or persist for more than 7 days, you should consult your doctor.
• This medication should not be taken with large quantities of milk or dairy products.

Children and adolescents

Do not administer to children under 12 years old, without consulting your doctor.

Taking Rennie with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Before taking Rennie, inform your doctor or pharmacist if you are taking any of the following medications, as they may affect the efficacy of these medications:

• calcitonin,
• sodium phosphate and other phosphates,
• oral contraceptives,
• thiazide diuretics (medications used to increase urine excretion),
• fluorides (medications for the prevention of tooth decay),
• amphetamine or quinidine,
• salicylates (medications with anti-inflammatory, analgesic, and antipyretic properties),
• vitamin D,
• heart medications such as glycosides (digoxin, bisphosphonates, or dolutegravir),
• levothyroxine (a thyroid hormone),
• eltrombopag (a medication used to increase platelet count),
• other medications prescribed by a doctor (e.g., etidronate, products containing iron, antiemetics, antimuscarinics, phenothiazines, benzodiazepines, ketoconazole, diflunisal, H2 antihistamines, sucralfate, oral anticoagulants derived from coumarin or indandione, or antibiotics such as tetracyclines or quinolones), as they may interfere with its absorption.

It is recommended to space out the administration of antacids with other medications by 1 or 2 hours.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Rennie with food and drinks

Like all calcium-containing antacids, do not take with large quantities of milk or dairy products, as it may cause an increase in calcium or magnesium levels in the blood and milk-alkali syndrome.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Rennie chewable tablets with saccharose may be used during pregnancy and lactation if taken according to these recommendations and not taken for more than 2 weeks.

Pregnant or breastfeeding women cannot take more than the indicated amount of medication in section 3 (How to take Rennie) and cannot take large quantities of dairy products and milk (1 liter of milk contains 1.2 grams of elemental calcium) at the same time, as this medication provides a significant amount of calcium in addition to what they take daily.

There is no evidence to indicate that Rennie has adverse effects on human fertility.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

Rennie chewable tablets with saccharose contain saccharose and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.If you have any doubts, ask your doctor, pharmacist, or nurse.

Dosage

The recommended dose is:

Adults and adolescents over 12 years:1 or 2 tablets, preferably taken 1 hour after meals and before bedtime. Additionally, if necessary, an extra dose may be administered. Do not take more than 6 tablets in 24 hours. Do not take for more than 2 weeks.

Administration Form

Oral route.

Remove the tablets from the packaging. Rennie tablets must be chewed or slowly dissolved in the mouth. Do not swallow them whole.

Use in children and adolescents:

Do not administer to children under 12 years.

If symptoms persist after 7 days of treatment, consult your doctor to rule out more serious diseases.

If you take more Rennie than you should

The symptoms of overdose include nausea, vomiting, constipation, fatigue, difficulty and pain urinating, and kidney stones. In these cases, discontinue treatment, drink plenty of water, and consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or contact the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Rennie

If you forgot to take a dose, wait for the next one. Do not take a double dose to compensate for the missed doses.

If you have any doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, Rennie can produce adverse effects, although not everyone will experience them.

When used normally at the recommended doses, it is not expected that adverse effects will occur.

The adverse reactions listed below are based on spontaneous reports and the frequency has not been established with precision:

Immune System Disorders:

Very rarely, allergic reactions have been reported, such as skin rashes, itching, difficulty breathing, swelling of the face, mouth, or throat, and anaphylaxis. If you experience these reactions, stop taking this medication and consult your doctor immediately.

Metabolism and Nutrition Disorders:

Prolonged use of high doses may cause hypermagnesemia (elevated magnesium levels in the blood) or hypercalcemia (elevated calcium levels in the blood) and milk-alkali syndrome, especially in patients with renal function disorders.

Gastrointestinal Disorders:

Prolonged use of high doses may lead to the occurrence of nausea, vomiting, stomach discomfort, constipation, and diarrhea, especially in patients with renal function disorders.

In some cases, constipation has been reported. Flatulence (gas), belching, and stomach bloating may also occur.

Musculoskeletal and Connective Tissue Disorders:

Abnormal muscle fatigue, especially in patients with renal function disorders.

The specific symptoms of milk-alkali syndrome may include taste dysfunction, headache, kidney problems, fatigue, and skin nodules.

If you observe any of these or any other adverse reactions not described above, consult your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rennie chewable tablets with saccharose:

• The active principles are: calcium carbonate, 680 mg and magnesium carbonate, 80 mg. The other components (excipients) are: Saccharose, carboxymethylamidone sodium (Type A) (derived from potato starch), pregelatinized cornstarch, magnesium stearate, talc, liquid paraffin, peppermint aroma, lemon aroma.

Appearance of the product and contents of the packaging

Rennie are white-cream colored square tablets with a peppermint odor.

Rennie is presented in packaging containing 48 or 84 chewable tablets each. It is presented in aluminum/PVC blister packaging.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

DELPHARM GAILLARD

33 Rue de L’Industrie

74240 Gaillard (France)

Date of the last review of this leaflet:January 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/