Rennie Fruit

Package Leaflet: Information for the Patient

RENNIE FRUIT

Calcium carbonate + Magnesium carbonate heavy
680 mg + 80 mg, chewable tablets

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 as advised by
the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform the doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact the doctor.

Table of Contents of the Leaflet

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

Rennie Fruit contains two locally acting antacids, calcium carbonate and magnesium carbonate, which neutralize excess stomach acid.
Rennie Fruit is used for the symptomatic treatment of heartburn, indigestion, and other symptoms 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 Fruit.

When not to take Rennie Fruit:

• 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 (hypercalcaemia),
• if the patient has kidney stones with calcium deposits,
• if the patient has severe kidney impairment,
• if the patient has low levels of phosphate in the blood (hypophosphataemia).

Warnings and precautions

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

• they have kidney impairment; they should then regularly have their calcium, phosphate, and magnesium blood levels checked,
• they have excessive excretion of calcium in the urine (hypercalciuria),
• they take the medicine for a long time and in high doses, which may cause (especially in patients with kidney impairment) increased levels of magnesium and calcium in the blood and milk-alkali syndrome (a condition caused by excessive intake of calcium compounds). This can lead to 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 Fruit with other medicines

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

• 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 hypercalcaemia when taking thiazide diuretics, calcium levels in the blood serum should be regularly monitored.

Rennie Fruit 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 Fruit can be used during pregnancy and breastfeeding. The recommended doses should then be strictly followed and the medicine taken as directed. The medicine should not be taken for longer than 2 weeks.

Driving and using machines

There is no effect.

Rennie Fruit 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.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Rennie Fruit

This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.
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 use and high doses may cause side effects (see section 4).

If symptoms do not improve within 7 daysor only partially improve, the patient should consult their doctor, as tests may be necessary to rule out a more serious condition.

Use in children

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

Overdose of Rennie Fruit

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

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

Long-term use of high doses, especially in patients with impaired kidney function, may cause hypermagnesaemia (elevated magnesium levels in the blood) or hypercalcaemia (elevated calcium levels in the blood) and alkalosis (elevated blood pH).
Symptoms of milk-alkali syndrome:

• taste disturbances;
• calcifications;
• weakness;
• headaches;
• excessive blood urea (azotemia).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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.
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rennie Fruit

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Fruit contains

The active substances are calcium carbonate and magnesium carbonate heavy.
The other ingredients (excipients) are: sucrose, maize 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

The medicine is in the form of white, square tablets with the inscription: "Rennie". The tablets are packaged in blisters.
The pack contains 12, 24, 36, or 48 chewable 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

Date of last revision of the leaflet: