NOTICE
ANSM - Updated on: January 9, 2025
Drug Name
CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet
Calcium carbonate/cholecalciferol
Box
Please read this package insert carefully before taking this medication, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor, pharmacist, or nurse. This also applies to any side effects not listed in this leaflet. See Section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
What is in this package insert?
1. What is CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet, and what is it used for?
2. What information should you know before taking CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet?
3. How should you take CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet?
4. What are the possible side effects?
5. How should you store CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in sachets?
6. Package contents and other information.
1. WHAT IS CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet, AND WHAT IS IT USED FOR?
CACIT VITAMIN D3 contains two active ingredients: calcium carbonate and cholecalciferol (vitaminD3).
This medication is used in older adults to treat calcium and vitamin D deficiencies. It is also used in combination with osteoporosis treatments in patients who are deficient in or at high risk of vitamin D and calcium deficiency.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a packet?
Never take CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet:
· if you are allergic to the active ingredients or any of the other ingredients in this medication, listed in Section 6,
· if you have a disease and/or condition that has caused high levels of calcium in your urine (hypercalciuria) or in your blood (hypercalcemia),
· if you have kidney stones,
· if you have high levels of vitamin D in your blood (hypervitaminosis D).
Warnings and Precautions
Consult your doctor or pharmacist before taking CACIT VITAMIN D3:
· if you have impaired kidney function or are prone to developing kidney stones. If your kidneys are not functioning properly, your treatment will need to be closely monitored to ensure that calcium does not build up in your blood,
· if you have sarcoidosis (an inflammatory disease of unknown origin characterized by the formation of lumps in various locations),
· if you are a bedridden patient with osteoporosis.
If you are on long-term treatment, your doctor may want to check your blood calcium levels from time to time and collect urine samples to monitor your kidney function. Depending on the results, your doctor may reduce the dose or decide to discontinue treatment.
Children and Adolescents
CACIT VITAMIN D3 is not intended for use in children.
Other Medications and CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a packet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
Consult your doctor if you are taking any of the following medications:
· heart medications such as digoxin or other digitalis preparations,
· bisphosphonates or sodium fluoride (medications used to treat bone problems),
· thiazide diuretics,
· phenytoin or barbiturates (medications used to treat epilepsy),
· glucocorticoids,
· tetracycline antibiotics,
· other medications containing vitamin D or calcium.
Calcium salts may reduce the absorption of iron, zinc, and strontium ranelate. Therefore, iron-, zinc-, or strontium ranelate-based preparations should be taken at least two hours before or after CACIT VITAMIN D3.
CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a packet—with food, beverages, and alcohol
This medication may interact with certain foods containing oxalic acid (e.g., spinach and rhubarb), phosphates (e.g., wheat bran), or phytic acid (e.g., whole grains) because they may reduce the absorption of the calcium contained in CACIT VITAMIN D3.
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medication.
Due to the high vitamin D content, this product is not recommended during pregnancy or while breastfeeding. In pregnant women, calcium and vitamin D overdoses should be avoided, as persistent hypercalcemia can have adverse effects on the developing fetus.
CACIT VITAMIN D3 may be used while breastfeeding, but your doctor should be informed, as calcium and vitamin D are excreted in breast milk. This should be taken into account if your child is receiving supplemental vitamin D.
Driving and Operating Machinery
CACIT VITAMIN D3 is not likely to affect your ability to drive or operate machinery
CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet, contains potassium, sodium, sorbitol, and sucrose
· This medication contains 4.2 mmol of potassium ( 163 mg) in each sachet. This should be taken into account by patients with renal insufficiency or those on a controlled potassium diet.
· This medication contains less than 1 mmol (23 mg) of sodium per packet, meaning it is essentially “sodium-free.”
· CACIT VITAMIN D3 contains 1.1 mg of sorbitol in each packet.
· If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medication. May be harmful to teeth.
3. HOW TO TAKE CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet?
Always take this medication exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Check with your doctor, pharmacist, or nurse if you have any questions.
Adults
Pour the contents of the packet into a glass, add plenty of water, stir, and drink immediately after the fizzing stops. The recommended dose is one packet per day.
Your doctor or pharmacist will tell you how many sachets to take per day.
If you have taken more CACIT VITAMIN D3 1000 mg/880 IU effervescent granules for oral solution in a sachet than you should have
If you take an excessive dose of this medication, the following symptoms may occur: nausea, vomiting, intense thirst, more frequent urination, and constipation. If such effects occur, notify your doctor immediately so they can take the necessary measures.
In the event of prolonged overdose, calcifications may develop in the blood vessels or tissues.
If you forget to take CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet
Do not take a double dose to make up for the dose you missed.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
You may experience an allergic reaction. If you develop a rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue, stop taking this medication immediately and seek medical attention right away.
Uncommon (may affect up to 1 in 100 people):
· high levels of calcium in the blood (hypercalcemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, intense thirst, increased urination, muscle weakness, drowsiness, and confusion;
· increased calcium levels in the urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people):
· constipation, flatulence, nausea, abdominal pain, diarrhea;
· itching, rash, and hives.
Frequency unknown (cannot be estimated based on available data)
· Burnett’s syndrome, which is associated with high blood calcium levels (hypercalcemia), elevated blood pH (alkalosis), and kidney failure.
Reporting Side Effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not listed in this package insert. You can also report side effects directly through the national reporting system: the French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: www.signalement-sante.gouv.fr.By reporting adverse reactions, you help provide more information on the safety of this medication.
5. HOW SHOULD CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet, be stored?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the box after “EXP.” The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25 °C.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in a sachet contains
· The active ingredients are:
Calcium carbonate............................................................................................... 2500.00 mg
Amount corresponding to elemental calcium ............................................ 1000.00 mg, or 25 mmol
Concentrated cholecalciferol in powder form.............................................................. 880 IU
Amount corresponding to cholecalciferol (Vitamin D3)..................................................... 22 µg
Per 8 g sachet.
Other ingredients are: citric acid, malic acid, gluconolactone, maltodextrin, sodium cyclamate, sodium saccharin, lemon flavoring (containing: sorbitol), rice starch, potassium carbonate, sodium ascorbate, all-rac-alpha-tocopherol, modified starch, sucrose, medium-chain triglycerides, and anhydrous colloidal silica.
What is CACIT VITAMIN D3 1000 mg/880 IU, effervescent granules for oral solution in sachets and outer packaging contents
8 g per sachet (Paper/Aluminum/PE). Box of 10 (for samples), 20, 30, 46, 50, or 100 sachets, and multipack of 90 (3 boxes of 30) sachets.
Not all strengths may be marketed.
Marketing Authorization Holder
THERAMEX IRELAND LIMITED
3RD FLOOR, KILMORE HOUSE
PARK LANE, SPENCER DOCK
DUBLIN 1, D01YE64,
IRELAND
Marketing Authorization Holder
THERAMEX FRANCE
83 Avenue Charles de Gaulle
92200 NEUILLY-SUR-SEINE
Manufacturer
HERMES PHARMA Ges M.b.H
SCHWIMMSCHULWEG 1a
9400 WOLFSBERG
AUSTRIA
Trade names of the drug in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with current regulations.
[to be completed later by the marketing authorization holder]
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information about this medication is available on the ANSM (France) website.