Vitamin D Sandoz 1,000 I.e. Tablets, 50 pcs

Instructions for use for Vitamin D Sandoz 1,000 I.e. Tablets, 50 pcs

Important notes (compulsory information):

Vitamin D- Sandoz ® 1,000 I.e. Tablets. Active substance: COLECALCIFEROL dry concentrate (powder form). Application areas: For the prevention of rachitis (calcification disorders of the skeleton in the growth age) in children and premature babies; For the prevention of recognizable risk of vitamin D deficiency disease in otherwise healthy without resorption disorder (disruption of the intake of vitamin D in the intestine) in children and adults; For supportive treatment of osteoporosis (bone loss) in adults. Contains sucrose.

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


Instructions for use: Information for users
Vitamin D- Sandoz ® 500 I.e. Tablets
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 vitamin D- Sandoz 1,000 I.e. Tablets and what is it used for?
2. What should you before taking Vitamin D Sandoz 1,000 I.E. Note tablets?
3. What is vitamin D- Sandoz 1,000 I.e. Tablets take?
4. Which side effects are possible?
5. What is Vitamin D Sandoz 1,000 I.e. Keep tablets?
6. Content of the pack and further information

1. What is vitamin D-Sandoz 1,000 I.e. Tablets and what is it used for?

Vitamin D- Sandoz 1,000 I.E. Tablets contains the active substance vitamin D3 (colecalciferol). Vitamin D3 plays an important role in recording and processing calcium in the body as well as when installing calcium into the bone tissue.
Vitamin D- Sandoz 1,000 I.E. Tablets is applied:

• for the prevention of Rachitis (calcification disorders of the skeleton in the growth age) in children and premature babies
• for the prevention of recognizable risk of vitamin D deficiency disease in otherwise healthy without resorption disorder (disruption of the inclusion of vitamin D in the intestine) in children and adults
• for supportive treatment of osteoporosis (bone loss) In adults

2. What should you take 1,000 I.E before taking vitamin D-Sandoz. Note tablets?

Vitamin D- Sandoz 1,000 I.e. Tablets may not be taken:

• if you are allergic to vitamin D or one of the section 6 mentioned ingredients of this medicinal product are
• in case of increased calcium concentration in the blood (hypercalcalemia)
• in case of increased calcium concentration in the urine (hypercalzuria)
• for renal stones (Nephrolithiasis)
• for calcium deposits in kidney fabrics (nephrocalcinosis)
• with excessive parathyroid release from the side turtle glands (primary hyperparathyroidism)
• with an increased vitamin D level in the blood (hypervitaminosis D).

Warnings and Precautions:
Please talk to your doctor or pharmacist before you vitamin D- Sandoz 1,000 I.E. Take tablets. If one of the following warnings aif it applies, you may have a risk for increased calcium concentration in the blood and urine (Hypercalemia and hypercalzuria). Your doctor must be during treatment with vitamin D- Sandoz 1,000 I.E. Tablets observe the calcium concentration in the blood and / or urine to ensure that it is not too high if you

• tend to education calcium-containing kidney stones
• Have problems with the excretion of calcium and phosphate over the kidneys
• Thiazid-Diuretics (medicines for promoting urinary excretion) take
• suffer from immobility
• to sarcoidosis (a disease of the immune system, which may affect liver, lung, skin or lymph nodes), as the effect of vitamin Dsandoz 1,000 I.e. Tablets may be too strong
• have a light or moderate renal function disorder. If there is a severe renal impairment failure, you may vitamin D Sandoz 1,000 I.E. Do not take tablets.

If you suffer from pseudohyparathyroidism (disorder of parathyroid release), you should vitamin D Sandoz 1,000 I.E. Do not take tablets because in this case your needs changes to vitamin D and may be the risk of long-term overdose. Ask your doctor or pharmacist about other medicines with a similar effect.
If you already take another vitamin D-containing medicinal product, the dose of vitamin Dsandoz 1,000 I.e must be adjusted accordingly. Your doctor must be your calcium level in the blood and / or urine during treatment with vitamin Dsandoz 1,000 I.E. Monitor tablets.

Daily doses over 500 I.e.:
During long term treatment with vitamin Dsandoz 1,000 I.e. Tablets should be monitored their calcium blood mirror. This review is especially important if you also heart glycosides (Medicines for the treatment of heart problems) or thiazide diuretics (medicinal products for promoting urinary excretion) Take, in elderly patients and patients with strong tendency to renal stones. If you experience an increased calcium concentration in the blood or signs of reduced kidney function, the dose of vitamin Dsandoz 1,000 must I.E. Reduces tablets or interrupt the treatment.

Children:
Vitamin D- Sandoz 1,000 I.E. Tablets may not be properly given infants and toddlers, as they may not be able to swallow and suffocate the tablets. It is necessary to resolve the tablets as indicated instead instead (see section 3).

Taking Vitamin D- Sandoz 1,000 I.e. Tablets together 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.

• A treatment with phenytoin (medicinal products for the treatment of epilepsy) or barbiturates (medicines for the treatment of epilepsy and sleep disorders as well as for anesthesia) can reduce the effect of vitamin D.
• Thiazid-Diuretics (medicinal products for promoting urinary excretion) can lead to increased calcium concentration in the blood by reducing the calcium excretion over the kidneys. Your calcium levels in the blood and urine should therefore be monitored during a long-term treatment.
• Glucocorticoids (medicinal products for the treatment of certain allergic diseases) can reduce the effect of vitamin D.
• The combination of vitamin D- Sandoz 1,000 I.E. Tablets with products containing substances that are similar to the degradation of vitamin D in the body or are similar (eg calcitriol), Only recommended in exceptional cases. Your calcium blood mirror should be monitored.
• Rifampicin or Isoniazide (medicines for the treatment of tuberculosis) can increase the degradation of vitamin D and therefore its effect reducingeN.
• Colestyramine or laxatives such as Paraffi Nöl can reduce the intake of vitamin D in the intestine and thus reduce its effect.
• Actinomycin and imidazole (medicinal products for the treatment of fungal infections) can affect the conversion of vitamin D into its active form and thus reduce the effect of vitamin D.
• If you provide specific medicines for the treatment of heart problems (digitalis and other heart glycosides) simultaneously with vitamin D- Sandoz 1,000 I.E. Taking tablets, increases your risk for cardiac arrhythmias. In this case, their cardiac function (by electrocardiogram) and the calcium concentration in the blood and urine must be monitored. If necessary, the blood levels of heart medication must also be monitored.

Pregnancy, lactation and reproductive capability:
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:
Vitamin D- Sandoz 1,000 I.E. Tablets may be applied during pregnancy, but only if your doctor has diagnosed a vitamin D deficiency. In this case, you may be up to 600 I.e. O.ce Colecalciferol. This corresponds to a tablet vitamin D- Sandoz 1,000 I.e. Tablets daily. Pregnant women may not take more than 600 I.e. COLECALCIFEROL daily. Overdoses of vitamin D During pregnancy, as a longer-term increased calcium levels in the blood can lead to physical and mental impairment as well as heart and eye diseases in the child.

Latving:
Vitamin D and its metabolic products go into breast milk. In breastfed children whose mothers occupy vitamin D-containing medicines, however, no problems were observed. Contact your doctor if you are vitamin D- Sandoz 1,000 I.E. Take tablets in lactation.

Reproductive ability:
Under Colecalciferol no effects on fertility were observed.

Driving and ability to operate machines:
Vitamin D- Sandoz 1,000 I.e. Tablets has no or a negligible influence on their ability to drive and capability to operate machines.

Vitamin D- Sandoz 1,000 I.E. Tablets contains sucrose:
Please take Vitamin D- Sandoz 1,000 I.e. Tablets only after consulting with your doctor if you are familiar with any intolerance to certain sugars.

3. What is Vitamin D-Sandoz 1,000 I.e. Tablets take?

Always take this medicine as described in this leaflet or just as your doctor is told you. Ask your doctor or pharmacist if you are not sure.

The recommended dose is:
Prevention of Rachitis in children:
Tablet (12.5 microgram colecalciferol, corresponding to 500 I.E.) Every day

Prevention of Rachitis in premature babies:
The dosage must be determined by the attending physician. Earlyborn

• with a birth weight over 1,500 g: ½ tablet (12.5 Microgram colecalciferol, corresponding to 500 I.e.) Daily
• with a birth weight of 700-1,500 g: 1 tablet (25 Microgram colecalciferol, corresponding to 1,000 I.e.) Daily

For premature born with a birth weight below 700 g, there are no data for dosing and the dose must be specified individually by the doctor. Normally they will be treated with 1,000 I.e. Vitamin D treated daily.

Prevention of recognizable risk of vitamin D deficiency disease in otherwise healthy without resorption disorder in children and adults:
Tablet (12.5 microgram colecalciferol, corresponding to 500 I.E.) Every day

Supportive treatment of osteoporosis in adults:
1 tablet (25 microgram colecalciferol, corresponding to 1,000 I.e.) Every day

During a long-term treatment with vitamin D Sandoz 1,000 I.E. Tablets and daily doses over 500 I.. Should the calcium levels in the blood and in the Urine monitored and the renal function can be checked by measuring the serum scientinine. If necessary, your doctor will adjust the dose (see section 2).

Kidney problems:
Vitamin D- Sandoz 1,000 I.E. Tablets may only be used with particular care in patients with light to moderate kidney problems. In patients with severe renal problems, vitamin D- Sandoz 1,000 I.E. Tablets are not used (See also Section 2 under "Warnings and Precautions").

Older people:
No special dosage recommendations.

Type of application:

Infants and toddlers:
For unwanted complications, such. For example, to avoid accidental penetration of the tablet into the airways ("swallowing"), the tablet infants and toddlers must never be administered unused.
The tablet prior to administration on a teaspoon or in a small transparent vessel (eg a small glass) Leave in about 5-10 ml of water. The decay of the tablet requires some time (at least 2 minutes). Moving with light up and forth can accelerate the decay.
The dissolved tablet then give the child, best during a meal, directly in the mouth.
The addition of the decayed tablets to a bottle or beamplace for infants is not recommended because there is no complete supply to be guaranteed here.
If the tablets are nevertheless to be administered with the food, the addition takes place after a boil and then cool. When using vitaminized food, the vitamin D quantity contained therein must be taken into account.

Children, adolescents and adults:
Remove the tablets with sufficient fluid, preferably a glass of drinking water.

Duration of application:
Infants and toddlers:
Infants receive vitamin D- Sandoz 1,000 I.E. Tablets from the second week of life to the end of the first year of life. In the second year of life, further gifts of vitamin D- Sandoz 1,000 I.E. Tablets recommended, especially during the winter months.

Children, adolescents and adults:
The therapy duration depends on your condition.

Please talk to your doctor or pharmacist if you have the impression that the effect of vitamin D Sandoz 1,000 I.E. Tablets too strong or too weak.

If you have a greater amount of vitamin D- Sandoz 1,000 I.E. Have taken tablets as they should:
If symptoms of overdose occur, the intake of vitamin D- Sandoz 1,000 I.E. To cancel tablets and visit a doctor immediately. This will take adequate measures.
If you (or a child) too much vitamin D- Sandoz 1,000 I.E. Tablets taken (HAS) can increase the calcium and / or phosphate levels in the blood (hypercalemia and / or hyperphosphate agents). This can be used for soft tissue calcification as well as lead to heart, blood vessels and kidneys.
Symptoms of overdose are appetitelessness, energy deficiency, nausea, constipation or diarrhea, increased thirst feeling or increased urinary excretion, fatigue, headache and dizziness. In severe cases, cardiac arrhythmias can occur. An extremely high calcium concentration in the blood can cause coma and lead to death. Infants and children are generally receiving for such effects.

If you take vitamin D Sandoz 1,000 I.E. Forgot tablets:
If you forget to take a tablet and it's already time for the next dose, leave the forgotten dose and take the next tablet to the regular time. Do not take the double amount when you forget the previous taking.

If you take vitamin D Sandoz 1,000 I.e. Cancel tablets:
If you treat the treatment with vitamin D- Sandoz 1,000 I.E. Cancel tablets, your condition can deteriorate or the symptoms can occur again. Please contact your doctor if you want to cancel the treatment.

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

4. Which side effects are possible?

Like all medicines can bech have this medicine side effects, but they do not have to occur each other.
Exit the intake of vitamin D- Sandoz 1,000 I.e. Tablets and contact your doctor immediately when one of the following signs of a serious allergic reaction occurs:

• Swelling of the lips, the throat, the face or tongue
• Skin rash
• Respiratory difficulty

Occasionally (can concern up to 1 of 100 treated):

• increased calcium concentrations in the blood and / or urine (Hypercalcaemia and hypercalzuria)

Rarely (can concern up to 1,000 treated):

• Itching, rash and hives (urticaria)

Unknown (frequency is not estimated on the basis of the available data):

• Hypersensitivity reactions (allergic reactions) that can be severe, such as swelling swelling, for example, the face, tongue, the hands or the throat
• Complaints in the gastrointestinal tract such as constipation, flatulence, nausea, abdominal pain or diarrhea

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 share effects directly
Federal Institute for Pharmaceuticals and Medical Products
Dept. Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. What is vitamin D-Sandoz 1,000 I.e. Keep tablets?

Keep this medicine inaccessible to children.
Keep this medicine as described on the carton.
Do not store more than 25 ° C. Store in the original packaging to protect the content from light and moisture.
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.

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 vitamin D- Sandoz 1,000 I.e. Tablets

• Each tablet contains 10 mg colecalciferol dry concentrate (Powder form), corresponding to 1,000 I.e. (25 micrograms) Colecalciferol (Vitamin D3).
• The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate (ph.eur.) PFL. Iron (III) oxide (E 172), modifi corn corn starch, sucrose, sodium ascorbate, medium-chain triglycerides, high-dispenser silica, all-rac alpha-tocopherol

Like vitamin D- Sandoz 1,000 I.e. Tablets looks like and content of the pack:
Vitamin D- Sandoz 1,000 I.e. Tablets are red, speckled, round tablets (diameter 7.5 mm), curved on both sides, with one-sided breaker.
The tablet can be shared in the same doses.
The medicine is in folding cartons with aluminum / Aluminum blister packs or transparent PVC / PVDC // aluminum blister packs available.
Packs of 50 and 100 tablets
Not all pack sizes may be placed on the market.

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

Manufacturer:
Lek Pharmaceuticals D.D.
Verovskova 57
1526 Ljubljana
Slovenia

This medicine is admitted to the Member States of the European Economic Area (EEA) under the following terms:
Germany: Vitamin D- Sandoz 1,000 I.e. Tablets
Poland: Vitamin D3 Sandoz
Slovenia: Vitamin D3 Lek 1000 I.e. tablete

This leaflet was recently revised in April 2017.

Source: Information of the leaflet
Stand: 09/2017