RENNIE 680 MG/80 MG CHEWABLE TABLETS WITH SUCROSE

Introduction

PATIENT INFORMATION LEAFLET

Rennie 680 mg/80 mg Chewable Tablets with Sucrose

Calcium Carbonate/Magnesium Carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience 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 it worsens or does not improve after 7 days.

Contents of the leaflet:

1. What Rennie is and what it is used for
2. What you need to know before you start taking Rennie
3. How to take Rennie.
4. Possible side effects
5. Storage of Rennie.

Contents of the pack and additional information

1. What Rennie chewable tablets with sucrose are and what they are used for

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

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

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

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before you start taking Rennie

Do not take Rennie:

• If you are allergic to any of the active ingredients or to any of the other components of this medicine (listed in section 6).
• If you have severe kidney failure, hypercalcemia (high blood calcium levels), and hypophosphatemia (low phosphate levels in the blood).
• If you have a history of kidney stones made of calcium.
• If you have hypercalciuria (high 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 medicine in subjects with altered renal function can cause hypercalcemia (high blood calcium levels) and metabolic alkalosis (milk-alkali syndrome).
• If symptoms worsen or persist for more than 7 days, you should consult a doctor.
• The medicine should not be taken with large amounts of milk or dairy products.

Children and Adolescents

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

Taking Rennie with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

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

Interference with analytical tests

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

Taking Rennie with food and drinks

Like all antacids that contain calcium, it should not be taken with large amounts of milk or dairy products, as it may increase calcium or magnesium levels in the blood and cause milk-alkali syndrome.

Pregnancy, breastfeeding, and fertility

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

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

Pregnant or breastfeeding women should not take more than the indicated amount of medicine in section 3 (How to take Rennie) and should not take large amounts of dairy products and milk at the same time (1 liter of milk contains 1.2 grams of elemental calcium), as this medicine provides a significant amount of calcium in addition to their daily intake.

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

Driving and using machines

No effects on the ability to drive and use machines have been described.

Rennie chewable tablets with sucrose contain sucrose and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Rennie

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Posology

The recommended dose is:

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

Method of administration

Oral route.

Remove the tablets from the packaging. Rennie tablets should be chewed or allowed to dissolve slowly in the mouth. They should not be swallowed whole.

Use in children and adolescents:

Do not administer to children under 12 years old.

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or go to the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Rennie

If you forget to take a dose, wait for the next one. Do not take a double dose to make up for the forgotten doses.

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

4. Possible side effects

Like all medicines, Rennie can cause side effects, although not everybody gets them.

When used normally, at the recommended doses, it is not expected to cause side effects.

The adverse reactions mentioned below are based on spontaneous notifications and their frequency has not been established with precision:

Immune system disorders:

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

Metabolism and nutrition disorders:

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

Gastrointestinal disorders:

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

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

Musculoskeletal and connective tissue disorders:

Muscle fatigue, especially in patients with altered renal function.

The specific symptoms of milk-alkali syndrome may include taste disorders, headache, kidney problems, fatigue, and lumps under the skin.

If you notice any of these or any other adverse reaction not mentioned above, consult your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rennie

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Rennie chewable tablets with sucrose:

• The active ingredients are: calcium carbonate, 680 mg, and magnesium carbonate, 80 mg. The other ingredients (excipients) are: sucrose, sodium carboxymethyl starch (Type A) (derived from potato starch), pregelatinized corn starch, magnesium stearate, talc, liquid paraffin, peppermint flavor, lemon flavor.

Appearance of the product and packaging contents

Rennie are white-cream colored square tablets with a mint flavor.

Rennie is available in packs containing 48 or 84 chewable tablets each. It is presented in aluminum/PVC blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

BAYER HISPANIA, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

DELPHARM GAILLARD

33 Rue de L’Industrie

74240 Gaillard (France)

Date of the last revision of this leaflet:January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/