Rennie fruit

Package leaflet: Information for the patient

RENNIE FRUIT
Calcii carbonas + Magnesii subcarbonas ponderosus
680 mg + 80 mg, chewable tablets
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

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

Rennie Fruit contains two substances which locally neutralize excess hydrochloric acid in the stomach (calcium carbonate and heavy magnesium carbonate).
Rennie Fruit is used for the symptomatic treatment of conditions related to gastric hyperacidity, such as:

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

2. Important information before using Rennie Fruit.

When not to use Rennie Fruit:

• if the patient is allergic to the active substances or to any of the other ingredients of the medicine (listed in section 6),
• if the patient has increased calcium levels in the blood (hypercalcaemia),
• if the patient has calcium kidney stones,
• if the patient has severe renal insufficiency,
• if the patient has low levels of inorganic phosphate in the blood (hypophosphataemia).

Warnings and precautions
Before starting to use Rennie Fruit, discuss this with your doctor or pharmacist.
Exercise particular caution when using Rennie Fruit if:

• the patient has renal insufficiency; in such cases, calcium, phosphate and magnesium levels in blood should be monitored regularly,
• the patient has excessive excretion of calcium in urine (hypercalciuria),
• the patient uses the medicine long-term and in high doses, which may lead to (particularly in patients with renal insufficiency) increased levels of magnesium and calcium in blood and to milk-alkali syndrome (a disorder caused by excessive oral intake of calcium compounds). This, in turn, may cause nausea, vomiting, excessive urination, increased thirst, dehydration, fatigue, and disturbances in orientation and thinking (so-called confusion); increased risk of developing kidney stones; muscle weakness.

Rennie Fruit and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Rennie Fruit 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 Fruit:

• tetracycline antibiotics and other antibacterial agents – quinolones,
• cardiac glycosides, such as digoxin,
• bisphosphonates (used in the treatment of osteoporosis),
• dolutegravir (an antiretroviral agent 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 hypercalcaemia when thiazide diuretics are used concomitantly, serum calcium levels should be monitored regularly.

Rennie Fruit with food and drink
The medicine should be taken after meals. The medicine should not be taken with large amounts of milk or dairy products.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Rennie Fruit may be used during pregnancy and breastfeeding. In such cases, the recommended doses should be strictly followed and the medicine used according to indications. The medicine should not be used for longer than 2 weeks.
Driving and operating machinery
No effect.
Rennie Fruit contains sucrose.
One tablet contains 475 mg of sucrose. This should be taken into account in patients with diabetes.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to take Rennie Fruit

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults and children over 12 years of age:
1 to 2 tablets at a time, one hour after meals and before bedtime.
Do not take more than 11 tablets per day.

Method of administration

• Take orally. The tablets may be sucked or chewed.
• In case of heartburn or pain associated with excess acidity, one or two additional tablets may be taken between regular dosing times.
• Prolonged use of the medicine should be avoided. Long-term use and use in high doses may lead to the occurrence of adverse effects (see section 4).

If symptoms do not improve within 7 days or improve only partially, consult your doctor, as further investigations may be necessary to exclude a more serious condition.

Use in children
Rennie Fruit must not be used in children under 12 years of age.

Accidental overdose of Rennie Fruit
If you have taken more than the recommended dose, stop taking the medicine and drink plenty of fluids.

The following symptoms of overdose may occur:

• nausea, vomiting, muscle weakness, drowsiness.

If symptoms are severe, seek medical advice immediately, as other rehydration methods (e.g. infusions) may be necessary.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Rennie Fruit may cause the following adverse reactions:

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

Long-term use of high doses, particularly in patients with impaired renal function,
may lead to hypermagnesaemia (increased magnesium blood levels) or hypercalcaemia
(increased calcium blood levels) and alkalosis (increased blood base concentration).
Symptoms of milk-alkali syndrome:

• taste disturbances;
• calcifications;
• weakness;
• headaches;
• excess nitrogen in the blood (azotaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rennie Fruit

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Rennie Fruit contains
The active substances in Rennie Fruit are: calcium carbonate and heavy magnesium carbonate.
The other ingredients (excipients) are: sucrose, pregelatinized corn starch, potato starch,
talc, magnesium stearate, light liquid paraffin, sodium saccharin, orange flavour (orange oil, maltodextrin, water).

What Rennie Fruit looks like and contents of the pack
Rennie Fruit is in the form of white, square tablets marked with the word "Rennie". The tablets are packed in blisters.
The pack contains 12, 24, 36 or 48 suckable tablets.

Marketing Authorisation 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