Osvical D 600 mg/400 IU effervescent granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Osvical D 600 mg/400 IU effervescent granules

Calcium pidolate / Colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Osvical D is and what it is used for
2. What you need to know before taking Osvical D
3. How to take Osvical D
4. Possible adverse effects
5. How to store Osvical D
6. Contents of the pack and other information

1. What Osvical D is and what it is used for

Osvical D is a calcium and vitamin D supplement.

Osvical D is used:

• To prevent and treat calcium and vitamin D deficiency states in elderly individuals.
• To provide vitamin D and calcium as complementary therapy in osteoporosis (fragile bones).

2. What you need to know before taking Osvical D

Do not take Osvical D

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia);
• if you excrete too much calcium in your urine (hypercalciuria);
• if you have overactivity of the parathyroid glands (hyperparathyroidism);
• if you have bone marrow cancer (myeloma);
• if you have cancer that has spread to the bones (bone metastases);
• if you have limited limb movement (prolonged immobilization) accompanied by hypercalcemia and/or hypercalciuria;
• if you have kidney stones (nephrolithiasis);
• if you have excess vitamin D (hypervitaminosis D);
• if you have severe kidney problems;
• if you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Osvical D, especially if any of the following apply to you:

• Long-term treatment

During long-term treatment, calcium levels in blood and urine and kidney function should be monitored periodically. This is particularly important if you have a tendency to develop kidney stones. Depending on blood levels, your doctor may reduce the dose or stop treatment.

• If you are receiving concomitant treatment with cardiac glycosides or thiazide diuretics (medicines that increase urine excretion) for heart problems.

In this case, calcium levels in blood and urine and kidney function should be monitored periodically, especially if you are elderly. Depending on blood levels, your doctor may reduce the dose or stop treatment.

• Kidney problems

If you have kidney problems, you should take this medicine with special caution. This is especially important if you are also taking other medicines containing aluminium, as the citric acid present in this medicine may increase aluminium absorption. Your calcium levels in blood and urine should be monitored. If you have severe kidney problems, use other forms of vitamin D instead of colecalciferol.

• Taking additional supplements of calcium and vitamin D

Medical supervision is required, and your doctor will need to frequently monitor calcium levels in blood and urine.

• Sarcoidosis (an immune disorder that may affect the liver, lungs, skin, or lymph nodes)

Take special care when taking this medicine if you have sarcoidosis. There is a risk that the effect of this medicine may become too strong, potentially leading to calcium overdose in the body. Calcium levels in blood and urine should be monitored.

• Immobilization and osteoporosis

In these cases, this medicine should be used with particular caution, as it could increase blood calcium levels.

Children and adolescents

This medicine is not intended for use in children or adolescents under 18 years of age (see “Do not take Osvical D”).

Osvical D and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If you are taking cardiac glycosides (cardiotonic glycosides derived from the digitalis plant) at the same time, heart arrhythmias may occur. Therefore, strict medical monitoring, including ECG and blood calcium level determination, is necessary.
• If diuretics of the thiazide class (also known as medicines to increase urine excretion) are taken simultaneously, blood calcium levels should be monitored periodically, as thiazides reduce calcium excretion in urine.
• The absorption and, therefore, the effectiveness of certain antibiotics (called tetracyclines) decreases when taken at the same time as Osvical D. These medicines should be taken at least 2 hours before or 4 to 6 hours after this medicine.
• Other medicines such as sodium fluoride (used to strengthen tooth enamel or treat osteoporosis) and bisphosphonates (used to treat osteoporosis) are also affected by interactions. Therefore, these medicines should be taken at least 3 hours before Osvical D.
• The longest possible interval should be left between administration of colestyramine (a medicine to reduce high cholesterol levels) or laxatives such as liquid paraffin and this medicine, otherwise vitamin D may not be properly absorbed.
• Simultaneous administration of Osvical D and phenytoin (a medicine for the treatment of epilepsy) or barbiturates (hypnotics) may reduce the effect of vitamin D.
• Simultaneous administration of Osvical D and glucocorticoids (e.g., cortisone) may reduce the effect of vitamin D and lower blood calcium levels.
• Additional supplements of calcium and vitamin D should only be taken under medical supervision, and frequent monitoring of calcium levels in blood and urine is required.
• Calcium may reduce the effect of levothyroxine (used to treat thyroid insufficiency). Therefore, levothyroxine should be taken at least 4 hours before or 4 hours after this medicine.
• The effect of quinolone antibiotics may be reduced if taken at the same time as calcium. Take quinolone antibiotics at least 2 hours before or 6 hours after taking this medicine.
• Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron, zinc, or strontium ranelate preparations should be taken at least 2 hours before or after Osvical D lemon flavour.
• Orlistat (used to treat obesity) may alter the absorption of fat-soluble vitamins, such as vitamin D3.

Taking Osvical D with food, drinks, and alcohol

You may take this medicine at any time, with or without food.

Please note that oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) may reduce the amount of calcium absorbed in the intestine. Patients should not take calcium-containing medicines within 2 hours before or after consuming foods high in oxalic acid or phytic acid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, you may take this medicine if you have a deficiency of calcium and vitamin D.

The daily dose of one sachet should not be exceeded. During pregnancy, the total daily amount of calcium should not exceed 1,500 mg, and the total daily amount of vitamin D3 should not exceed 600 IU (International Units).

Long-term overdose of calcium and vitamin D during pregnancy should be avoided, as it may lead to high blood calcium levels and may have a negative effect on the fetus.

This medicine may be used during breastfeeding. Since calcium and vitamin D pass into breast milk, consult your doctor beforehand if your baby is receiving other products containing vitamin D.

Driving and using machines

There are insufficient data regarding the effects of this medicine on the ability to drive and operate machinery. However, such effects seem unlikely.

Osvical D contains aspartame

This medicine contains 30 mg of aspartame per sachet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Osvical D contains sunset yellow FCF

May cause allergic-type reactions. May cause asthma, especially in patients allergic to acetylsalicylic acid.

Osvical D contains sodium

Consult your doctor or pharmacist if you need to take 2 or more sachets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

Osvical D contains glucose

This medicine contains glucose (from maltodextrin and dextrin). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Osvical D contains sorbitol

This medicine contains 0.4 mg of sorbitol (E420) per sachet, equivalent to 0.05 mg/g.

3. How to take Osvical D

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Unless otherwise instructed by your doctor, the recommended dose is:

Adults and elderly patients: 1 to 2 sachets per day (corresponding to 600 or 1,200 mg of calcium and 400 or 800 IU (International Units) of vitamin D3).

Pregnant women may take only 1 sachet per day. The daily dose of 1 sachet must not be exceeded.

Use in children and adolescents

The safety and efficacy of this medicine have not been established in children, therefore its use is not recommended in this age group.

Method of administration

Oral use.

Dissolve the contents of the sachet in a glass of tap water. Osvical D can be taken at any time of day, with or without food.

Duration of treatment

Osvical D should be taken as a long-term treatment. Talk to your doctor about the duration of your treatment with Osvical D (see also section 2 "Warnings and precautions").

If you take more Osvical D than you should

An overdose of Osvical D may cause symptoms such as nausea, vomiting, thirst or excessive thirst, increased urine output, dehydration, or constipation.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Osvical D

If you forget to take Osvical D, take it as soon as you remember. Do not take a double dose to make up for missed doses.

If you stop taking Osvical D

If you wish to interrupt or discontinue the treatment, consult your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Osvical D and contact a doctor immediately if you experience any of the following serious adverse effects:

Very rare (may affect up to 1 in 10,000 people)

• Allergic reaction.
• Swelling of the face, lips, tongue, or throat with sudden breathing difficulty and severe skin rash.

Other reported adverse effects are:

Uncommon adverse effects (may affect up to 1 in 100 people)

• High levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria).

Rare adverse effects (may affect up to 1 in 1,000 people)

• Feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation, flatulence, bloating (abdominal distension).
• Skin rash, itching, hives.
• Allergy.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Milk-alkali syndrome (also known as Burnett's syndrome; generally occurs only after excessive calcium intake). Symptoms include urgent need to urinate frequently, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, along with high levels of calcium in the blood and disturbances in kidney function.

If you have renal insufficiency, there may be a risk of elevated phosphate levels in the blood, elevated calcium levels in the kidneys, and kidney stones.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Osvical D

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Osvical D

• The active substances are calcium pidolate and colecalciferol. Each sachet contains 4,500 mg of calcium pidolate (equivalent to 600 mg of calcium) and 4 mg of colecalciferol (vitamin D3) (equivalent to 400 IU of vitamin D3).
• The other components are: aspartame (E951), sodium bicarbonate, anhydrous sodium carbonate, anhydrous citric acid, anhydrous sodium citrate, orange flavour (contains natural flavours, wheat maltodextrin and pea starch dextrin), lemon flavour [contains natural flavours, manitol (E421), D-glucono-1,5-lactone (E575), wheat and/or potato maltodextrin and sorbitol (E420)], orange yellow S (E110), povidone 30.

Appearance of the product and contents of the pack

Orange-coloured granules with an orange flavour and odour.

Osvical D is available in sachets, in packs containing 60 sachets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: June 2018.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.