Rennie 680 mg/80 mg chewable tablets with sucrose
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rennie 680 mg/80 mg chewable tablets with sucrose
Calcium carbonate/Magnesium carbonate
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor, pharmacist, or nurse, even if these effects 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 leaflet:
- What Rennie is and what it is used for
- What you need to know before taking Rennie
- How to take Rennie
- Possible adverse effects
- How to store Rennie
Contents of the pack and other information
1. What Rennie Chewable Tablets with Sucrose Is and What It Is Used For
Rennie belongs to the group of medicines known as aluminum, calcium, and magnesium combinations and complexes.
It contains as active ingredients calcium carbonate and magnesium carbonate, which act by neutralizing excess stomach acid.
Rennie is indicated for the relief and symptomatic treatment of acidity and heartburn in adults and adolescents over 12 years of age.
You should consult a doctor if symptoms worsen or do not improve after 7 days.
2. What you need to know before taking Rennie
Do not take Rennie:
- If you are allergic to any of the active substances or to any of the other ingredients of this medicine (listed in section 6).
- If you have severe renal insufficiency, hypercalcemia (high levels of calcium in the blood), or hypophosphatemia (low phosphate concentrations in the blood).
- If you have a history of calcium kidney stones.
- 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 administration of this medicine in patients with impaired renal function may cause hypercalcemia (elevated blood calcium levels) and metabolic alkalosis (milk-alkali syndrome).
- If symptoms worsen or persist for more than 7 days, you must consult a doctor.
- This medicine should not be taken with large amounts of milk or dairy products.
Children and adolescents
Do not administer to children under 12 years of age without consulting a doctor.
Taking Rennie with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Before taking Rennie, inform your doctor or pharmacist if you are taking any of the following medicines, as it may affect their efficacy:
- calcitonin,
- sodium phosphate and other phosphates,
- oral contraceptives,
- thiazide diuretics (medicines used to increase urine excretion rate),
- fluorides (medicines for prevention of dental caries),
- amphetamines or quinidine,
- salicylates (medicines with anti-inflammatory, analgesic, and antipyretic properties),
- vitamin D,
- heart medications such as glycosides (digoxin), bisphosphonates, or dolutegravir,
- levothyroxine (a thyroid hormone),
- eltrombopag (a medicine used to increase platelet count),
- other medicines prescribed by a doctor (e.g. etidronate, iron-containing products, antidyskinetics, antimuscarinics, phenothiazines, benzodiazepines, ketoconazole, diflunisal, H2 antihistamines, sucralfate, oral anticoagulants derived from coumarin or indandione, antibiotics such as tetracyclines or quinolones), as it may interfere with their absorption.
It is recommended to separate the administration of antacids and other medicines by 1 to 2 hours.
Interference with diagnostic tests
If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Taking Rennie with food and drinks
Like all calcium-containing antacids, Rennie should not be taken with large amounts of milk or dairy products, as this may lead to increased levels of calcium or magnesium in the blood and to milk-alkali syndrome.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Rennie chewable tablets with saccharose may be used during pregnancy and breastfeeding if taken in accordance with these recommendations and not for longer than 2 weeks.
Pregnant or breastfeeding women must not take more than the amount of medicine indicated in section 3 (How to take Rennie) and must not simultaneously consume large amounts of dairy products and milk (1 liter of milk contains 1.2 grams of elemental calcium), because this medicine provides a significant amount of calcium in addition to daily dietary intake.
There is no evidence indicating that Rennie has adverse effects on human fertility.
Driving and use of machines
No effects on the ability to drive or operate machinery have been reported.
Rennie chewable tablets with saccharose contain saccharose and sodium
This medicine contains saccharose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially “sodium-free”.
3. How to take Rennie
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.
Dosage
The recommended dose is:
Adults and adolescents over 12 years of age: 1 or 2 tablets, preferably taken 1 hour after meals and before bedtime. Additionally, if necessary, an extra dose may be taken. Do not take more than 6 tablets in 24 hours. Do not take for longer than 2 weeks.
Method of administration
For oral use.
Remove the tablets from the packaging. Rennie tablets should be chewed or allowed to dissolve slowly in the mouth. They must not be swallowed whole.
Use in children and adolescents:
Do not administer to children under 12 years of age.
If symptoms persist for more than 7 days, consult your doctor to rule out more serious conditions.
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 such 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 contact the Toxicology Information Service, telephone: 91 562 04 20, stating the medication and the amount ingested.
It is recommended to bring the medication packaging and leaflet to the healthcare professional.
If you forget to take Rennie
If you forget to take a dose, wait until the next scheduled dose. Do not take a double dose to make up for forgotten doses.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Rennie may cause adverse effects, although not everyone experiences them.
When used normally, at the recommended doses, the occurrence of adverse effects is not expected.
The adverse reactions listed below are based on spontaneous reports, and their frequency has not been accurately established:
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 any of these reactions, stop taking this medicine immediately and consult your doctor without delay.
Metabolism and nutrition disorders:
Prolonged use of high doses may lead to hypermagnesemia (elevated magnesium levels in blood) or hypercalcemia (elevated calcium levels in blood) and milk-alkali syndrome, especially in patients with impaired renal function.
Gastrointestinal disorders:
Prolonged use of high doses may result in nausea, vomiting, stomach discomfort, constipation, and diarrhea, particularly in patients with impaired renal function.
Constipation has occurred in some cases. Flatulence (gas), belching, and stomach bloating may also occur.
Musculoskeletal and connective tissue disorders:
Abnormal muscle weakness, especially in patients with impaired renal function.
Specific symptoms of milk-alkali syndrome may include taste disturbances, headache, kidney problems, fatigue, and lumps under the skin.
If you notice any of these or any other adverse reactions not mentioned above, consult your doctor or pharmacist.
Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 expiry date stated on the container, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rennie chewable tablets with sucrose:
- The active substances are: calcium carbonate, 680 mg and magnesium carbonate, 80 mg. The other components (excipients) are: Sucrose, sodium carboxymethylstarch (Type A) (derived from potato starch), pregelatinized corn starch, magnesium stearate, talc, liquid paraffin, peppermint flavor, lemon flavor.
Appearance of the product and contents of the pack
Rennie are white-cream square tablets with a minty odor.
Rennie is available in packs containing 48 or 84 chewable tablets. It is presented in aluminum/PVC blisters.
Only certain 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 most recent revision of this leaflet: January 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/