Manti Extra

Package Leaflet: Information for the Patient

MANTI Extra

10 mg + 165 mg + 800 mg, chewable tablets

Famotidine + Magnesium hydroxide + Calcium carbonate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 15 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet

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

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

Manti Extra is a combination of three active substances: famotidine, used to reduce stomach acid production, and two acid-neutralizing agents (reducing stomach acid concentration) - calcium carbonate and magnesium hydroxide. Manti Extra is intended to relieve symptoms of heartburn or stomach acid.

• heartburn,
• indigestion,
• stomach pain and burning.

2. Important information before taking Manti Extra

When not to take 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 acid-reducing medicines (such as ranitidine, cimetidine, etc.);

Page 1 6

• if you have kidney failure;
• children and adolescents under 16 years of age should not take Manti Extra;
• if you are pregnant or breastfeeding.

Warnings and precautions

Before taking Manti Extra, discuss with your doctor or pharmacist if you have:

• chest pain (or arm pain), shortness of breath, sweating, radiation of pain to the upper limbs, neck, shoulders, or jaw (especially if accompanied by difficulty breathing);
• difficulty swallowing and pain when swallowing;
• dizziness, nausea, vomiting;
• bloody vomit or vomit resembling coffee grounds;
• bleeding or blood in the stool, black stools;
• heartburn lasting more than 3 months;
• heartburn combined with pain, dizziness, and excessive sweating;
• persistent stomach pain;
• unintentional weight loss;
• if you are over 40 years old and have recently experienced new or changed symptoms of heartburn and indigestion.

Precautions

Consult your doctor:

• if you have stomach or duodenal ulcers, rule out cancer (Manti Extra may mask symptoms and delay diagnosis of the underlying disease);
• if you are taking other medicines for stomach acid;
• if you are taking non-steroidal anti-inflammatory drugs;
• if you have a history of stomach ulcers or worrying symptoms such as unintentional weight loss, difficulty swallowing, recurring vomiting, bloody or coffee-ground-like vomit, tarry stools;
• if you have confirmed hypercalcemia (elevated calcium levels in the body), as the product contains calcium;
• if you have confirmed hypophosphatemia (reduced phosphorus levels in the body), as the product may exacerbate this condition;
• if you have confirmed hypercalciuria (increased calcium excretion in the urine) or kidney stones;
• if you have kidney function disorders, the product should be administered under medical supervision, and calcium and magnesium levels in the serum should be monitored;
• in case of liver or kidney impairment, Manti Extra should be used with caution;
• in case of long-term use, especially during treatment with other calcium-containing medicines and/or vitamin D-containing medicines, due to the risk of elevated calcium levels in the blood with subsequent development of kidney failure.

If symptoms do not improve after 15 days of uninterrupted treatment or worsen, consult your doctor.

Children and adolescents

Children and adolescents under 16 years of age should not take Manti Extra.

Manti Extra and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• The use of Manti Extra may reduce the effectiveness of posaconazole in 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 to treat cancer).

Before taking Manti Extra, consult your doctor or pharmacist if you are taking:

• antiviral medicine used in HIV therapy (atazanavir),
• antifungal medicines (e.g., itraconazole, ketoconazole),
• medicines used to treat osteoporosis, such as bisphosphonates (e.g., alendronate),
• medicines used to treat bacterial infections - tetracycline antibiotics (e.g., doxycycline, tetracycline), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), or protozoal infections (chloroquine),
• medicines used to treat thyroid disorders (e.g., levothyroxine),
• medicines used to treat high blood pressure or coronary heart disease (e.g., diltiazem, verapamil), beta-blockers (atenolol, metoprolol, propranolol, sotalol), a medicine used to treat heart failure or arrhythmias (digoxin),
• medicines that affect potassium or phosphorus levels in the blood, such as polystyrene sulfonate sodium, phosphorus supplements (e.g., potassium phosphate),
• non-steroidal anti-inflammatory drugs - salicylates (acetylsalicylic acid, diflunisal), indomethacin,
• cancer medicines, such as estramustine (due to the presence of calcium salts),
• medicines used to treat allergies (fexofenadine),
• iron salts used to treat anemia,
• medicines used in dentistry, such as sodium fluoride,
• anti-inflammatory medicines - corticosteroids,
• medicines that reduce stomach acid (lansoprazole),
• medicines used to treat joint inflammation (penicillamine),
• medicines used to treat mental illnesses - neuroleptics (phenothiazine derivatives) or anxiolytics, sedatives, hypnotics (benzodiazepines),
• medicines used to treat epilepsy or neuropathic pain (gabapentin),
• a medicine used to treat gout (probenecid),
• thiazide diuretics (increasing urine production). In patients undergoing dialysis, the medicine may reduce the effectiveness of calcium carbonate used to reduce high phosphorus levels in the blood (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 can cause stomach irritation. Ask your doctor about the safe use of these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

There is no data on contraindications for driving vehicles and operating machines during the use of medicines containing famotidine. However, some patients have reported side effects such as dizziness, which can impair physical and mental performance. If such side effects occur, do not drive vehicles or operate machines.

Manti Extra contains a source of glucose (dextrates).

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Manti Extra

Take this medicine always exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose

Adults and adolescents over 16 years of age: chew one tablet to relieve symptoms.

If you take more Manti Extra than you should

If you have taken more than the recommended dose of Manti Extra, consult your doctor or pharmacist.

If you forget to take Manti Extra

If you regularly take the medicine and miss a dose, take it as soon as possible and then return to your regular dosing schedule.

4. Possible side effects

Like all medicines, Manti Extra can cause side effects, although not everybody gets them.

Common (less than 1 in 10 people)

• headache.

Uncommon (less than 1 in 100 people)

• anxiety, dizziness;
• nausea, diarrhea, abdominal discomfort, bloating, and abdominal pain, indigestion, belching, dry mouth, increased thirst, taste disturbances; Page 4 6
• feeling of numbness and tingling in hands and feet (paresthesia).

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

5. How to store Manti Extra

Keep the medicine out of the sight and reach of children.

6. Contents of the pack and other information

What Manti Extra contains

• The active substances are: Famotidine 10 mg, Magnesium hydroxide 165 mg, Calcium carbonate 800 mg.
• The other ingredients are: maize starch, maize starch, dextrates, sodium carboxymethylcellulose (type A), sodium cyclamate (E 952), peppermint flavor SD (gum arabic, flavoring preparations, natural flavoring substances including L-menthol), magnesium stearate. Page 5 6

What Manti Extra looks like and contents of the pack

White or almost white, round, flat tablets with beveled edges.

Marketing authorization holder and manufacturer:

US Pharmacia Sp. z o.o.

Date of last revision of the leaflet:

Page 6 6