Sandocal D 1000/880 granules, 100 pcs

Upute za korištenje Sandocal D 1000/880 granules, 100 pcs

Important notes (compulsory information):

Sandocal-D 1000 mg / 880 I.e. shower granulate. Applications: For the prevention and treatment of vitamin D and calcium deficiency states in older people and vitamin D and calcium supplement to support specific therapy for the prevention and treatment of osteoporosis.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Sandocal-D 1000 mg / 880 I.e. shower granules
Active substances: Calcium carbonate and colecalciferol

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this leaflet:

1. What is Sandocal-D and what is it used for?
2. What should you consider before taking Sandocal-D?
3. How is Sandocal-D to take?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Sandocal-D?
6. Content of the pack and more information

1. What is Sandocal-D and what is it used for?

Sandocal-D is a vitamin and mineral preparation. Sandocal-D is used for the prevention and treatment of vitamin D and calcium deficiency states in older people and as vitamin D and calcium supplement to support specific therapy for the prevention and treatment of osteoporosis.

2. What should you consider before taking Sandocal-D?

Sandocal-D must not be taken:

• if they are allergic to calcium carbonate, colecalciferol, soy, peanut or one of the other ingredients of this medicine referred to in section 6,
• with too high calcium concentrations in the blood (hypercalcaemia) and / or increased calcium excretion in the urine (Hypercalzuria),
• if you are suffering from disease states or conditions apply to you, the high calcium concentrations in the blood (Hypercalcaemia) or in the urine (e.g., overfunction of the side turtle glands, a disease of the bone marrow myeloma, a malignant bone tumor bone metastases ),
• if you have a severe impairment of renal function,
• if you are under calcium deposits in kidney tissue (Nephrocalcinalosis) or renal stones (nephrolithiasis) suffer,
• if you have too high vitamin D mirror (Hypervitaminosis).

Warnings and Precautions:
Please talk to your doctor or pharmacist before taking Sandocal-D.

• If you are at a specific pulmonary disease (sarcoidosis) suffering, there is a risk of increased transformation of vitamin D to its effective form. The calcium level in the blood and urine should be monitored.
• During a long-term treatment with Sandocal-D, your doctor must control the scales serum levels and monitor kidney function by measuring the serum creatinine value. Monitoring is particularly important in older patients who at the same time preserve certain drugs that increase the cardiac power (forced glycosides), or urinary drugs (diuretics) (See "Taking Sandocal-D along with other medicines"). This gilt, too, if you have a pronounced tendency to stone formation. If a hypercalemia occurs (high calcium concentrations in the blood) or signs of a kidney function failure, the dose must be reduced or the intake of Sandocal-D can be terminated.
• If you simultaneously prescribe other vitamin D preparations, your doctor should be the dose of Sandocal-D 880 I.e. Consider Vitamin D per bag. An additional intake of other vitamin D-containing preparations should only be carried out under narrow-scale medical supervision. In these cases, regular monitoring of calcium levels is required in the blood and urine.
• When they suffer from immobilization osteoporosis, there is an increased risk of hypercalemia occurrence (high calcium concentrations in the blood).
• If you suffer from a kidney impairment, vitamin D is careful to use calcium and phosphate levels monitoring. In a serious kidney function disorder, vitamin D in the form of colecalciferol is not metabolized normally. Your doctor should therefore prescribe a different vitamin D preparation (See "Sandocal-D must not be taken").
• There are literature reports that indicate that citrate salts may lead to increased aluminum intake. Sandocal-D contains citric acid. If you have severely limited renal function and take aluminum-containing preparations, you should therefore consult with your doctor before taking Sandocal-D.
• Taking Sandocal-D should the calcium and alkali recording (e.g., carbonates) from other sources (Foods, enriched foods or other medicines) be considered. If high doses of calcium are simultaneously taken with e.g. carbonates, this can lead to a milk alkaline syndrome (burnnet syndrome). The milk-alkaline syndrome is a calcium metabolic disorder with an increase in the calcium level in the blood (hypercalcaemia), the inumulation of the blood (Metabolic alkalosis), renal failure and soft tissue calcification. When taking high doses, the calcium level should be checked in serum and urine.

Children and adolescents:
Sandocal-D is not intended for taking children and adolescents.

Taking Sandocal-D along with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied or intend to take / use other medicines. The effect of Sandocal-D can be influenced by simultaneous administration of subsequent drugs or preparation groups:

Reinforcement of the effect of Sandocal-D:

• Certain urinary drugs, so-called thiazide type diuretics, can reduce the excretion of calcium. In this case, the serum calcium level is regularly controlled. Made to the effect of Sandocal-d.
• Medicines containing corticosteroids (cortisone and cortisone accounts). These medicines can reduce the recording of calcium and make an increased dose of Sandocal-D necessary.
• Orlistat (a weight reduction medicine), Ion exchange resins such as colestyramine or laxatives such as paraffin oil. These medicines can reduce the intake of vitamin D.
• Rifampicin (an antibiotic), phenytoin (a drug against epilepsy) and barbiturates (medicines that help them sleep) can affect the effect of vitamin D3.

The effect of subsequently called drugs or Preparate groups can be influenced by simultaneous treatment with Sandocal-D:

• With simultaneous treatment with certain medicines that boost the heart force (forced glycosides), their toxicity can increase. For this reason, patients who receive heart-flow glycosides with the help of the electrocardiogram (ECG) and monitored by the determination of the calcium content in the blood.
• The recording and thus the effectiveness of certain antibiotics (oral tetracycline) can be done by the Glightweight intake of Sandocal-D are reduced. For this reason, tetracycline-containing medicines should be at least 2 hours before or 4-6 Hours after taking Sandocal-D are taken.
• With simultaneous treatment with bisphosphonates or sodium fluoride preparations (medicines for the treatment of osteoporosis) or fluoroquinones (a particular antibiotic type) Should these be taken at least 3 hours before Sandocal-D because of the risk of restricted inclusion of these medicines in the gastrointestinal tract.
• Calcium can reduce the absorption of iron, zinc and strontium ranelate as well as estramustine (a drug used in chemotherapy) and thyroid hormones.

Please take medicines that contain iron, zinc, strontium ranelate, estramustine or thyroid hormones, at least 2 hours before or 2 hours after taking Sandocal-d.

Taking Sandocal-D along with food and beverages:
Oxalic acid (included in spinach and rhubarb) as well as phytic acid (Including full grain products) can reduce the calcium uptake into the body by forming insoluble complexes with calcium ions. You should not occupy calcium-containing medicinal products during the first 2 hours after the inclusion of high content of oxalic or phytic acid.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
Sandocal-D should not be taken due to the high dosage of vitamin D during pregnancy. During pregnancy, the daily intake should be 1,500 mg calcium and 600 I.E. Do not exceed Vitamin D3. Overdosings of calcium and vitamin D must be avoided in pregnant women because a permanently increased calcium levels in the blood was associated with undesirable effects on the developing fetus.

Latving:
Sandocal-D can be taken during breast-feeding. Calcium and vitamin D go into breast milk. This is to be considered if the child receives additional gifts of vitamin D.

Driving and ability to operate machines:
There are no data on the influence of Sandocal-D on the ability to drive. However, an influence is unlikely.

Sandocal-D contains sorbitol, sucrose and potassium carbonate:
Please take Sandocal-D only after consultation with your doctor if you are known to suffer from any intolerance to certain sugars. 1 bag Sandocal-D contains 4.2 mmol (163.2 mg) potassium. If you suffer from restricted renal function or a potassium controlled diet (diet with low potassium content) should be taken into account. Note for diabetics: 1 bag Sandocal-D does not contain more than 0.02 bread units (BE).

3. How to take Sandocal-D?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: Take the content of 1 bag of shower granules per day. Patients with renal or hepatic impairment: Sandocal-D may not be taken by patients with severe renal impairment. For hepatic impairment, no dose adjustment is required.

Type of application:
To resolve after taking. The content of a bag is dissolved in a glass of water under stirring and drunk immediately. You can take Sandocal-D for food or between meals. Please talk to your doctor or pharmacist if you have the impression that the effect of Sandocal-D is too strong or too weak.

If you take a greater amount of Sandocal-D when you should:
A unique overdose is usually consequently. Overdose phenomena are to be expected only for permanent, excessive use of Sandocal-D or additional use of other calcium preparations. Signs of overdose are: Nausea, vomiting, increased Durstempfindinden and Liquidtermanity, loss of appetite, increased urinary excretion, dehydration and constipation, abdominal pain, muscle weakness, exhaustion, mental disorders, bone pain, lime deposits in kidneys and kidney stones. In severe cases, cardiac arrhythmias can occur. Chronic overdose can lead to vascular and organ calcification. If you suspect an overdose, please notify your doctor. It can decide according to the severity of overdose over the necessary measures.

If you forget to take Sandocal-D:
Do not take the double amount if you forgot the previous ingestion, but remain at the previous dosage.

If you have further questions about taking this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

Possible side effects:
Occasionally (can concern up to 1 of 100 treated):
Increased calcium content in the blood (hypercalcalemia), increased calcium excretion in urine (hypercalzuria).

Rarely (can concern up to 1,000 treated):
Hypersensitivity reactions, itching, rash, hives, bloating, constipation, diarrhea, nausea, vomiting, abdominal pain.

Very rare (can be up to 1 out of 10,000 treated):
Single cases of systemic allergic reactions (Anaphylactic reaction, facial edema, angioneurotic edema)

If you have limited kidney function, the risk of developing increased phosphate quantities in the blood, kidney stones and increased calcium levels in the kidneys. Other potential side effects hydrogenated soybean oil (ph.eur.) Can very rarely cause allergic reactions.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Sandocal-D?

Keep this medicine inaccessible to children. You may not use this medicine after the expiration date specified on the outer carton and the container according to "until". The expiration date refers to the last day of the specified month. This medicinal product does not require special storage conditions. Do not dispose of medicines in the wastewater. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Sandocal-D contains:
The active ingredients are: calcium carbonate and colecalciferol. 1 bag with 8 g shower granules contains 2,500 mg of calcium carbonate (corresponding to 1,000 mg or 25 mmol of calcium ions) and 880 I.e. Colecalciferol (vitamin D3) (corresponding to 22 μg vitamin D3). The other ingredients include: malic acid, citric acid, gelatin, D-glucono-1,5-Iactone, potassium carbonate, maltodextrin, corn starch, sodium cyclamate, hydrogenated soybean oil (ph.eur.), Rice starch, saccharin sodium, sucrose, all-rac Alpha-Tocopherol (Ph.eur.), Lemon flavor (contains sorbitol Ph.eur., Mannitol Ph.eur., D-Glucono-1,5-Iactone, maltodextrin, arab rubber, lemon oil).

Like Sandocal-D looks and content of the pack:
White shower granulate. Sandocal-D is in packs with 20, 50, 100 and 120 bags each with 8 g of shower granules available. Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: [email protected]

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Bar life

This leaflet was recently revised in August 2015.

Source: Information of the packinggarnish
Status: 09/2016