Package leaflet: Information for the patient

MANTI Extra
10 mg + 165 mg + 800 mg, chewable tablets
Famotidine + Magnesium hydroxide + Calcium carbonate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any unlisted possible side effects mentioned in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 15 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Manti Extra is and what it is used for
Important information before taking Manti Extra
How to take Manti Extra
Possible side effects
How to store Manti Extra
Contents of the pack and other information

1. What Manti Extra is and what it is used for

Manti Extra is a combination of three active substances: famotidine, used to reduce hydrochloric acid production in the stomach, and two acid-neutralizing agents (reducing gastric acid concentration) – calcium carbonate and magnesium hydroxide. Manti Extra is intended to relieve symptoms of indigestion or gastric hyperacidity.
The active substances in Manti Extra work in two ways: calcium carbonate and magnesium hydroxide act by rapidly neutralizing excess acid already produced in the stomach, providing fast relief from pain, while famotidine inhibits hydrochloric acid production in the stomach and exerts a longer-lasting effect, reducing gastric acidity for 10–12 hours. The combination of these two actions effectively maintains normal acidity in the stomach, allowing relief of irritated mucosa.
Manti Extra is used in adults and adolescents over 16 years of age for short-term symptomatic treatment of discomfort associated with gastric hyperacidity, such as:

heartburn,
indigestion,
epigastric pain and burning.

2. Important information before taking Manti Extra
When not to use Manti Extra

if you are allergic to famotidine, magnesium hydroxide, calcium carbonate, or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to other drugs reducing hydrochloric acid concentration (such as ranitidine, cimetidine, etc.);
if you have renal insufficiency;
children and adolescents under 16 years of age should not take Manti Extra;
if you are pregnant or breastfeeding.

Warnings and precautions
Before starting to take Manti Extra, discuss with your doctor or pharmacist if you have:

chest pain (or in shoulder area), shallow breathing, sweating, radiating pain to upper limbs, neck, arms, or jaw (especially if accompanied by difficulty breathing);
difficulty swallowing or pain during swallowing;
dizziness, nausea, vomiting;
vomiting blood or vomit resembling coffee grounds;
bleeding or blood in stool, black stools;
heartburn lasting longer than 3 months;
heartburn associated with pain, dizziness, and excessive sweating;
persistent abdominal pain;
unintended weight loss;
if you are over 40 years old and have recently developed new or changed symptoms of indigestion or heartburn.

Precautions
Contact your doctor:

if you have gastric or duodenal ulcer, a malignant condition should be excluded (Manti Extra, by relieving symptoms, may delay diagnosis of underlying disease);
if you are taking other medications used to treat gastric hyperacidity;
if you are taking non-steroidal anti-inflammatory drugs (NSAIDs);
if you have previously experienced peptic ulcer or alarming symptoms such as unintentional weight loss, difficulty swallowing, recurrent vomiting, bloody or coffee-ground-like vomiting, tarry stools;
if you have confirmed hypercalcemia (increased calcium levels in the body), as the product contains calcium;
if you have confirmed hypophosphatemia (decreased phosphorus levels in the body), as the product may worsen this condition;
if you have confirmed hypercalciuria (increased calcium excretion in urine) or urinary tract stones;
if you have impaired kidney function, the product should be administered only under medical supervision, and serum calcium and magnesium levels should be monitored;
if you have impaired liver or kidney function, Manti Extra should be used with caution;
in case of prolonged use, especially during treatment with other calcium-containing drugs and/or vitamin D supplements, due to the risk of elevated blood calcium levels and subsequent development of kidney failure.

If symptoms do not improve after 15 days of continuous treatment or if they worsen,
contact your doctor.
Children and adolescents
Children and adolescents under 16 years of age should not take Manti Extra.
Manti Extra and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Acid-neutralizing drugs may alter the absorption of many medicines.
As a precaution, it is recommended to take Manti Extra at least two hours apart from other medicines, and at least four hours apart from quinolone antibiotics.

The use of Manti Extra may reduce the effectiveness of posaconazole oral suspension (a medicine used to prevent and treat certain fungal infections).
The use of Manti Extra may reduce the effectiveness of dasatinib, erlotinib, gefitinib, pazopanib (medicines used in cancer treatment).

Before taking Manti Extra, consult your doctor or pharmacist if you are taking any of the following medicines:

antiviral medicine used in HIV therapy (atazanavir);
antifungal medicines (e.g. itraconazole, ketoconazole);
medicines used in osteoporosis treatment, such as bisphosphonates (e.g. alendronate);
medicines used in bacterial infections – tetracycline antibiotics (e.g. doxycycline, tetracycline), quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), or protozoal infections (chloroquine);
medicines used in thyroid disorders (e.g. levothyroxine);
medicines used in hypertension or ischemic heart disease (e.g. diltiazem, verapamil), beta-blockers (atenolol, metoprolol, propranolol, sotalol), or medicine used in heart failure or cardiac arrhythmias (digoxin);
medicines affecting blood potassium or phosphorus levels, such as sodium polystyrene sulfonate, phosphorus supplements (e.g. potassium phosphate);
non-steroidal anti-inflammatory drugs – salicylates (acetylsalicylic acid, diflunisal), indomethacin;
anticancer medicines such as estramustine (due to the presence of calcium salts);
medicines used in allergy (fexofenadine);
iron salts used in anemia;
medicines used in dentistry, such as sodium fluoride;
anti-inflammatory medicines – glucocorticosteroids;
medicines reducing gastric acid concentration (lansoprazole);
medicines used in joint inflammation (penicillamine);
medicines used in psychiatric disorders – neuroleptics (phenothiazine derivatives) or anxiolytic, sedative, hypnotic agents (benzodiazepines);
medicines used in epilepsy or neuropathic pain (gabapentin);
medicine used in gout (probenecid);
thiazide diuretics (increasing urine excretion). In patients undergoing dialysis, the medicine may reduce the effectiveness of calcium carbonate used as a medication to lower excessively high blood phosphate levels (hyperphosphatemia).

Check which medicines you are taking, as they may contain aspirin or non-steroidal anti-inflammatory drugs similar to aspirin (e.g. ibuprofen, naproxen), which may irritate the stomach. Ask your doctor about safe use of these medicines.
Do not stop taking low-dose aspirin prescribed by your doctor to prevent heart attack or stroke (usually 81 ÷ 125 mg per day).
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy is not recommended due to insufficient safety data.
Famotidine may pass into breast milk in small amounts. Magnesium salts may pass into breast milk, causing diarrhea in newborns. Use of this medicine during breastfeeding is not recommended.
Page 3 of 6
Fertility
There is no data on the effect of the medicine on fertility in men and women.
Driving and operating machinery
There is no data on contraindications to driving and operating machinery during treatment with medicines containing famotidine. However, in some patients, side effects such as dizziness have been observed, which may impair psycho-motor performance. If such side effects occur, do not drive or operate machinery.
Manti Extra contains a source of glucose (dextrates).
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Manti Extra

This medicine should always be taken exactly as described in this leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and adolescents over 16 years of age: chew one tablet to relieve symptoms.
Do not swallow the tablet whole.
To prevent indigestion, take one tablet 15 to 60 minutes before consuming food or drinks that cause digestive discomfort.
The maximum daily dose is two tablets.
Do not take this medicine for longer than 15 days without consulting a doctor.
Taking more than the recommended dose of Manti Extra
If more than the recommended dose has been taken, contact a doctor or pharmacist.
If you forget to take Manti Extra
If you are taking the medicine regularly and miss a dose, take it as soon as possible, then return to your regular dosing schedule.
Do not take a double dose to make up for a forgotten tablet.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects with Manti Extra are reported rarely. They are usually mild, resolve quickly, and
are reversible upon discontinuation of the product. The most commonly observed
adverse effects are: headache, nausea, and diarrhoea.
Adverse effects are listed below according to frequency of occurrence:
Common (affects not more than 1 in 10 people)

headache.

Uncommon (affects not more than 1 in 100 people)

anxiety, dizziness;
nausea, diarrhoea, abdominal discomfort, bloating and abdominal pain, dyspepsia, burping, dry mouth, increased thirst, disturbances in taste perception; Page 4 of 6
tingling and numbness in hands and feet (paraesthesia).

Frequency not known (frequency cannot be estimated from the available data)

rash, itching, urticaria and severe skin reactions (toxic epidermal necrolysis);
severe allergic reactions causing breathing difficulties or dizziness (anaphylaxis), difficulty breathing or wheezing (bronchospasm);
cholestatic jaundice (impaired bile flow), increased liver enzyme activity (serum aminotransferases, gamma-GT, alkaline phosphatase) and elevated bilirubin levels;
hallucinations, confusion, insomnia, convulsions, somnolence, anxiety and depression;
muscle cramps;
decreased platelet count with increased risk of bleeding or bruising (thrombocytopenia), low white blood cell count which increases the potential risk of infection (leukopenia), severe reduction in white blood cells with increased risk of infection (agranulocytosis), and marked reduction in all blood cells leading to weakness, bruising or increased risk of infection (pancytopenia);
impotence, decreased libido.

Antacids, such as magnesium or calcium, may cause changes in
frequency and consistency of stools, bloating and a feeling of fullness.
Reporting of adverse effects
If any adverse effects occur in a patient, including any possible adverse effects
not listed in this leaflet, inform a doctor, pharmacist or
nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects allows the collection of further information on the
safety of the medicine's use.

5. How to store Manti Extra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
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 Manti Extra contains

The active substances are: Famotidine 10 mg, Magnesium hydroxide 165 mg, Calcium carbonate 800 mg.
Other ingredients: pregelatinized corn starch, corn starch, dextrates, sodium carboxymethyl starch (type A), sodium cyclamate (E 952), mint flavour SD (acacia gum, flavouring preparations, natural flavouring substances including L-menthol), magnesium stearate. Page 5 of 6

What Manti Extra looks like and contents of the pack
White or almost white, round, flat tablets with bevelled edges.
Available in packs of 6, 12 or 24 tablets in PVC/Aluminium or PVC/PVDC/Aluminium blisters, with a cardboard carton and patient leaflet.

Marketing Authorisation Holder and Manufacturer:
US Pharmacia Sp. z o.o.
Ziębicka 40, 50-507 Wrocław, Poland

For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35, 02-822 Warsaw, Poland, Tel. +48 (22) 543 60 00
Page 6 of 6