Patient Information Leaflet: Information for the User

CITADVANCE 750 mg medicated chewing gum, cool mint flavour

Calcium carbonate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, talk to your doctor or pharmacist. This includes side effects not listed in this leaflet. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 consecutive days of treatment.

Contents of this leaflet

What CITADVANCE is and what it is used for
What you need to know before taking CITADVANCE
How to take CITADVANCE
Possible side effects
How to store CITADVANCE
Contents of the pack and other information

1. What CITADVANCE is and what it is used for

CITADVANCE is a sugar-free medicated chewing gum with a mint flavour.
It provides fast and effective relief from:

heartburn,
stomach pain,
other symptoms associated with excess acid in the stomach causing acid reflux and indigestion.

Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days of continuous treatment.

2. What you need to know before taking CITADVANCE

Do not take CITADVANCE if

you are allergic to calcium carbonate or to any of the other ingredients of this medicine (see section 6 for a full list);
you have high levels of calcium in your blood;
you have high levels of calcium in your urine, or kidney stones composed of calcium;
you have severely reduced kidney function;
you have low levels of phosphate in your blood.

Warnings and precautions
Do not exceed the recommended dose and do not use CITADVANCE for more than 7 days unless advised by your doctor.
Talk to your doctor or pharmacist before taking CITADVANCE if you have mild or moderate kidney problems, as regular blood tests are recommended.
Children under 12 years of age
CITADVANCE is not recommended for this age group.
Other medicines and CITADVANCE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking any of the following medicines, inform your doctor or pharmacist before taking CITADVANCE, as it may affect how these medicines work:

antibiotics known as tetracyclines or quinolones, used to treat bacterial infections;
medicines used to treat osteoporosis and similar conditions known as bisphosphonates;
medicines used to treat fluid retention and high blood pressure known as thiazide diuretics;
digoxin (used to treat certain heart conditions);
dolutegravir (used to treat HIV infection);
levothyroxine (used to treat thyroid hormone deficiency);
eltrombopag (used to increase platelet count);
fluorides (used to prevent tooth decay);
phosphates (e.g. used to clear the bowel before surgery);
iron-containing medicines;
medicines containing vitamin D.

Take CITADVANCE 1 or 2 hours after taking any other medicine to maximize the benefits of all medicines used.
CITADVANCE with food and drink
Avoid consuming large amounts of milk or dairy products when taking CITADVANCE.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
CITADVANCE may be used during pregnancy if taken according to instructions and prolonged use of high doses is avoided.
CITADVANCE may be used during breastfeeding if taken according to instructions.
CITADVANCE provides a significant amount of calcium in addition to dietary calcium. Therefore, during treatment with CITADVANCE, pregnant women should:

strictly limit use of CITADVANCE to the maximum recommended daily dose;
avoid excessive intake of milk (1 litre contains up to 1.2 g of calcium) and dairy products.

Driving and using machines
CITADVANCE has no influence on the ability to drive vehicles or operate machinery.
CITADVANCE contains isomalt, sorbitol and sodium
This medicine contains isomalt and 170 mg of sorbitol per medicated chewing gum. Sorbitol is a source of fructose. If your doctor has informed you that you (or your adolescent child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which a person cannot metabolize fructose, discuss this with your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per medicated chewing gum, i.e. essentially “sodium-free”.

3. How to take CITADVANCE

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults and children from 12 years of age
The recommended dose is 1 or 2 tablets as a single dose after meals and at bedtime,
in case of heartburn or stomach pain.
If symptoms recur, additional doses may be taken, but do not exceed a maximum of 8
tablets per day.
For pregnant women, do not exceed a maximum of 5 tablets per day.
Chew the tablets for at least 15 minutes. Do not swallow the remaining residue, but dispose of it properly.
As with all medicines that reduce gastric acid, inform your doctor if symptoms persist
despite treatment. In such cases, diagnostic investigations are strongly recommended to
exclude a more serious condition.
If you take more CITADVANCE than you should
Drink plenty of water and consult your doctor or pharmacist. Symptoms of overdose include nausea
and vomiting, fatigue, constipation, and muscle weakness.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment immediately and consult your doctor if you experience any of the following:

allergic reactions to the components, which have been reported rarely, such as:
- skin rash, itching;
- difficulty breathing;
- swelling of the face, mouth or throat;
- sudden and severe allergic shock. Typical symptoms include low blood pressure, shock, palpitations, difficulty breathing, narrowing of the airways, skin reactions, abdominal pain or cramps, vomiting, diarrhoea and constipation.
prolonged use of high doses may lead to high levels of calcium in the blood, especially in people with impaired kidney function
muscle weakness
nausea, vomiting, stomach discomfort, diarrhoea, constipation
in very rare cases, milk-alkali syndrome may occur due to prolonged use of high doses. This may cause reduced sense of taste, increased calcium levels in blood and soft tissues, increased blood urea levels, fatigue and headache.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CITADVANCE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of unused medicine via household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CITADVANCE contains
The active substance is calcium carbonate. Each medicated chewing gum contains 750 mg
of calcium carbonate.
The other components are potassium acesulfame, isomalt, menthol, copovidone, sorbitol, sucralose,
magnesium stearate, brilliant blue dye, extra peppermint flavour, and chewing gum base.
Description of the appearance of CITADVANCE and pack contents
The bistrato medicated chewing gums, 16 mm in diameter and round, are packaged in
PVC/PVdC/aluminium blisters. These are contained in cardboard boxes with 10 or 20 medicated chewing gums.
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER
Bayer S.p.A
Viale Certosa 130, 20156 Milan, Italy
Manufacturer
Fertin Pharma A/S
Dandyvej 19
7100 Vejle
Denmark
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
France: Rennaxt, chewing gum
Hungary: Rennie Gum cukormentes 750 mg
gyógyszeres rágógumi
Ireland: Rennie 750 mg Medicated Chewing-Gum
Italy: Citadvance 750 mg medicated chewing gum, cold mint flavour
Netherlands: Rennie kauwgom calciumcarbonaat 750 mg suikervrij
Slovenia: Rupugum 750 mg zdravilni žvečilni gumiji