Mastical 500 mg 60 comprimidos masticables View larger

Mastical 500 mg 60 comprimidos masticables

Indicated for people with calcium deficiency or need higher production (growing age children, pregnant women, infants, the elderly ...), osteoporosis or hyperphosphatemia

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COMPOSITION
Each tablet contains 500 mg calcium as calcium carbonate. Calcium carbonate containing 40% calcium.

ACTION
- Calcium and phosphorus are the main component of bone. In addition, calcium prevents bone demineralization because it inhibits the release of parathyroid hormone.
Each tablet contains 500 mg calcium as calcium carbonate. Calcium carbonate containing 40% calcium.

INDICATIONS
- Prevention and treatment of those in deficit calcium, usually associated with an increase in demand (growth-age children, pregnant women, infants, the elderly, pre and postmenopausal women).
- In the prevention and treatment of osteoporosis as an adjunct to specific treatment.
- Hyperphosphatemia since calcium is a chelator of phosphate ions.

POSOLOGY
- Adults:
* Calcium deficiency, osteoporosis: 1 to 3 tablets a day.
* Hyperphosphatemia: 4 to 16 tablets a day, divided into 2,3 or 4 doses.
- Children and adolescents under 18 years old:
* Calcium Deficit: 1 to 2 tablets a day.

RULES FOR PROPER MANAGEMENT
As a general rule, it is recommended calcium preferably after meals, as certain foods (those high in glucose, lactose or galactose) improve the absorption of calcium ion. Similarly, the calcium carbonate antacid is a powerful rebound hyperacidity may occur in patients receiving this supplement fasting.
By contrast, other authors recommend administering 1-2 hours after meals to prevent calcium absorption interfere other cations contained in the food. Should avoid eating certain foods before fiber or other compounds such as oxalic acid (spinach) or phytic (cereals), which interfere with the absorption of calcium.
In patients with hyperphosphatemia, it is recommended calcium carbonate with meals, to complex phosphate food.
If the supplement is administered once a day, you must do at night, since PTH levels follow a circadian rhythm and at night when lower are, thereby decreasing bone degradation and favoring the incorporation of calcium the same.
In the treatment of osteoporosis, when combined with calcitonin, calcium is administered at least one hour after calcitonin. When combined with diphosphonates, it will be administered in the periods between doses of diphosphonates.
chewable tablets: Chew or suck on the tablets.

CONTRAINDICATIONS
- Hypersensitivity to calcium carbonate or any other ingredients.
- Situations hypercalcemia and hypercalciuria, which could be aggravated by calcium.
- Patients with kidney stones. The calcium may precipitate in the kidney, favoring the growth of calculus.

WARNINGS EXCIPIENTES:
- This medicine contains sorbitol. Patients with hereditary fructose intolerance should not take this medicine.
- This product contains isomalt. Patients with hereditary fructose intolerance should not take this medicine.
- This medicine contains aspartame as an excipient, which must be taken into account by people with phenylketonuria.

PRECAUTIONS
- Hypercalcemia. Administration of excessive amounts of calcium salts may lead to hypercalcemia. This hypercalcemia usually associated with gastrointestinal symptoms (such as nausea and vomiting, thirst, dehydration, constipation, anorexia), cardiovascular (hypertension and vasomotor disturbances) and renal (polyuria). In more severe cases may also appear neurological symptoms such as confusion, delirium, stupor and even coma. However, it is unlikely that a severe hypercalcemia occurs after administration of oral calcium preparations.
Hypercalcemia usually occurs in people treated with high doses of calcium, especially in combination with high doses of vitamin D, in case of severe renal impairment (CrCl <30 ml / min), where disposal is reduced in diseases that could increase by themselves plasma calcium levels (sarcoidosis, lymphoma, leukemia) or in combination with medicines hipercalcemiantes.
In these patients, as well as those showing symptoms of hypercalcemia, it is recommended to monitor serum and urinary calcium levels regularly. If hypercalcemia or hypercalciuria, it is recommended to decrease the dose of calcium or temporarily discontinue treatment until normal values ​​recover.
Moreover, hypercalcemia may worsen the condition in patients with heart disease, and increase the toxicity of medicines such as digitalis.
- History of urinary stones. Could precipitate calcium in the urine, favoring the appearance of urinary calculi, or increasing the size of stones already formed. Its use is contraindicated in patients with urinary stones. Moreover, it is recommended to be used with caution in patients with a history of calculations because patients are especially prone to their formation.
- Hypochlorhydria. Calcium carbonate requires an acidic pH for absorption. In patients with hypochlorhydria it may happen that the absorption is not adequate, so that a dose adjustment or change to another more soluble calcium salt may be necessary.

ADVICE TO THE PATIENT
- Do not exceed the recommended dose.
- Notify your physician and / or pharmacist if the patient notices symptoms such as nausea and vomiting, constipation, increased thirst, loss of appetite or increased urinary frequency.

SPECIAL WARNINGS
- If hypercalcemia, the dose should be reduced or temporarily stop treatment until levels return to normal.
- Monitoring:
* Serum calcium and urinary calcium periodically in patients at high risk of hypercalcemia and in patients who show symptoms poisoning calcium. If hypercalcemia or hypercalciuria, reduce the dose or temporarily stop treatment until these levels return to normal.
* ECG in patients concomitantly treated with calcium salts and digitalis.

INTERACTIONS
- Calcium channel blockers. They could be reduced antihypertensive effects.
- Medicines that reduce calcium absorption:
* Some agents such as bisphosphonates, phenytoin, fosfomycin, iron salts, levothyroxine, quinolones (except moxifloxacin) or tetracyclines, may form insoluble complexes with calcium, limiting the absorption of both medicines. It is recommended to administer these medicines 2 h before or 4-6 h after calcium supplements.
* Corticosteroids. Reduce calcium absorption by an unknown mechanism of action. increased dose of calcium may be necessary.
- Digoxin. If hypercalcemia may increase digitalis toxicity. It is recommended periodic monitoring of ECG and serum calcium levels in these patients.
- Thiazide diuretics. They could increase the risk of hypercalcemia due to decreased renal elimination of calcium. periodically monitor serum calcium.
- Minerals.
* Aluminum. Calcium may promote absorption of aluminum, especially in patients with renal insufficiency, resulting in neurological toxicity.
* Magnesium. Calcium may reduce the absorption of magnesium. Moreover, both metals could compete in renal elimination, especially in patients with renal failure.
* Zinc. Both metals compete in absorption. It is recommended to distance the administration.
- Foods. In general, foods rich in sugars (glucose, galactose or lactose) favor calcium absorption, so it is advised to take calcium supplements after meals. However, keep in mind that certain components of some foods, such as oxalic acid (found in spinach), phytic acid (found in bran cereals) or phosphates (in milk) may form insoluble complexes with calcium, reducing its absorption.

PREGNANCY
Supplementation of vitamins and minerals is normally considered safe during pregnancy. The most current dietary recommendations provide a contribution in pregnant women 1200-1500 mg Ca / 24 h. These doses do not appear to pose risks to the mother or child, and promote fetal bone mineralization, also preventing bone demineralization of the mother.
The administration of high doses of calcium carbonate (7.5-10.5 g / 24 h) in pregnant women since the middle of the first quarter until delivery resulted in a neonatal hypocalcemia (6.3 mg / dl), together with hyperphosphatemia (8.2 mg / dl) and serum calcitriol reduced (12 ng / dl) and PTH (20 pg / ml) levels. After intravenous administration of phenobarbital and calcium, there was a gradual increase in serum calcium and infants recovered without sequelae.
Prophylactic calcium supplementation may be necessary in some patients to maintain normal serum calcium levels. Supplementation if needed to reach the recommended calcium in pregnant women daily dose, the dose should be estimated by clinical condition and / or determinations of serum calcium.

LACTATION
Calcium is excreted in breast milk in amounts up to 210 mg / 24 h. The most current dietary recommendations provide a contribution in lactating women 1200-1500 mg Ca / 24 h. These doses do not appear to pose risks to the mother or child, and prevent bone demineralization of the mother.

CHILDREN
Prophylactic calcium supplementation may be necessary in some patients to maintain normal serum calcium levels. Supplementation if needed to reach the recommended daily dose calcium in children, the dose should be estimated by clinical condition and / or determinations of serum calcium.

ELDERLY
No specific problems foreseen. However, keep in mind that in the elderly is very common hypochlorhydria, which may limit the absorption of calcium carbonate.

ADVERSE REACTIONS
Adverse reactions are usually mild and transient.
Adverse reactions more features are hypercalcemia. Can be mild hypercalcemia is usually asymptomatic or with mild or severe hypercalcemia symptoms.
MedDRA adverse reactions: very common (> 10%), common (1-10%), rare (0.1-1.0%), rare (0.01-0.1%), specific (< 0.01%).
- Digestive: Rare: nausea, constipation, flatulence, epigastric pain, diarrhea.
- Urinary: Uncommon: hypercalciuria.
- Dermatologic: Very rare: pruritus, urticaria, rash eruptions.
- Metabolic Uncommon: hypercalcemia.

OVERDOSE
Symptoms: calcium overdose may cause mild hypercalcemia (serum calcium 10.5-12 mg / dl), which can be asymptomatic or present with gastrointestinal symptoms (nausea and vomiting, constipation, anorexia, dry mouth, intense thirst, dehydration) , renal (polyuria, nephrocalcinosis, kidney stone formation) or cardiovascular (hypertension, cardiac arrhythmias and vasomotor disturbances).
In severe cases (serum calcium> 12 mg / dl) irritability, lethargy, stupor and coma may occur, but because of its low oral absorption and the absorption process is saturable, it is unlikely that these pictures appear.
Treatment: Usually hypercalcemia of oral calcium salts is mild, and does not require further action to reduce the dose or withdraw calcium supplement. It may be advisable to also suspend other medicines that could be affected negatively by hypercalcemia (digitalis, lithium) or that could favor the accumulation of calcium (thiazide diuretics, vitamins A or D).
It is recommended to monitor the patient's electrolyte levels, correcting any imbalances and kidney function and urine output. In more severe cases, it may be necessary to also control the ECG.
Hypercalcemia may be treated with isotonic phosphate, together with administration of calcitonin and steroids, preventing the patient is exposed to sunlight.

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