The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: calcium carbonate, colecalciferol; cholecalciferolOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Calcium carbonate, Colecalciferol; cholecalciferol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Calcium carbonate, Colecalciferol; cholecalciferol

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Cacit D3 contains the active substances calcium carbonate and colecalciferol (Vitamin D3). This medicine is used in the elderly for the treatment of deficiency of calcium and vitamin D. It is also used in combination with osteoporosis treatments in patients with, or at high risk of, vitamin D and calcium combined deficiencies.

What you need to know before you take it

e Cacit D3

Do not take Cacit D3: if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6), if you have a disease and/or condition which has resulted in a high concentration of calcium in your urine (hypercalciuria) or blood (hypercalcaemia), if you have kidney stones, if you have excessive vitamin D levels in your blood (hypervitaminosis D). Warnings and Precautions Talk to your doctor or pharmacist before taking Cacit D3. if you have impaired kidney function or have a tendency to form kidney stones. Your treatment will need to be monitored carefully if your kidneys are not working properly to ensure you do not build up to much calcium in your blood. if you have sarcoidosis (an inflammatory disease of unidentified origin characterised by formation of lumps in different locations). if you are an immobilised patient with osteoporosis. If you are on long-term treatment your doctor may, from time to time wish to check the level of calcium in your blood and take urine sample to monitor kidney function. Depending upon the results, your doctor may reduce the dosage or decide to discontinue the treatment.

Children and adolescents

1.3.1 Pg. 1

Cacit D3 is not intended for the use in children. Other medicines and Cacit D3 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Consult your doctor if you take any of the following medicines: heart medicines such as digoxin or other cardiac glycosides, bisphosphonates or sodium fluoride (medicines used to treat bone disorders), thiazide diuretics (water tablets), phenytoin or barbiturates (medicines used in to treat epilepsy) glucocorticosteroids, tetracycline antibiotics, other medicines containing vitamin D or calcium. Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken at least two hours before or after Cacit D3. Cacit D3 with food drink and alcohol This medicinal product can interact with certain food containing oxalic acid (e.g. spinach and rhubarb), phosphates (e.g. bran) or phytic acid (e.g. whole cereals), since these may reduce the absorption of calcium contained in Cacit D3. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy, the daily intake should not exceed 1500 mg calcium and 600 IU vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia is related to adverse effects on the developing foetus. Cacit D3 can be used during breast-feeding, but your doctor should be informed as calcium and vitamin D gets into the breast milk. This should be considered when giving additional vitamin D to the child. Driving and using machines Cacit D3 is not expected to affect your ability to drive or operate machinery. Cacit D3 contains potassium, sodium, sorbitol and sucrose This medicine contains 2.1 mmol potassium (81.6 mg) in each sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially `sodium-free ́. Cacit D3 contains 0.6 mg of sorbitol per sachet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.

How to take it

Cacit D3

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure. Adults Pour the contents of the sachet into a glass, add a large quantity of water, stir, then drink immediately the fizzing has stopped. The recommended dosage is one or two sachets per day. Your doctor or pharmacist will tell you how many sachets you need to take a day. If you take more Cacit D3 than you should

1.3.1 Pg. 2

When taking an excessive dose of this medication, the following symptoms may appear: nausea, vomiting, intense thirst, need to pass urine more often, constipation. If any of these effects occur, tell your doctor immediately and take the necessary measures. In case of prolonged overdose, calcifications may occur in vessels or tissues. If you forget to take Cacit D3 Do not take a double dose to make up for the missed dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You may suffer an allergic reaction. If you experience rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue, stop taking the medicine immediately and seek urgent medical help. Uncommon (may affect up to 1 in 100 people): high concentration of calcium in the blood (hypercalcaemia). Symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst, needing to pass urine more often, muscle weakness, drowsiness and confusion increased calcium content of the urine (hypercalciuria) Rare (may effect up to 1 in 1,000 people): constipation, flatulence, nausea, abdominal pain, diarrhoea itching, rash and urticaria (hives) Not known (frequency cannot be estimated from the available data) milk alkali syndrome which is associated with high concentration of calcium in the blood (hypercalcaemia), blood pH elevation (alkalosis) and renal insufficiency. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Goggle play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Cacit D3

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on carton after EXP. The expiry date refers to the last day of that month. Do not store above 25° C. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Cacit D3 contains

1.3.1 Pg. 3

The active substances in one sachet of 4 g are: Calcium carbonate 1250 mg equivalent to calcium element 500 mg or 12.5 mmol Colecalciferol concentrate (powder form) equivalent to colecalciferol (Vitamin D3)

440 IU 11 μg

The other ingredients are citric acid, malic acid, gluconolactone, maltodextrin, sodium cyclamate, saccharin sodium, lemon flavour (containing: sorbitol), rice starch, potassium carbonate, sodium ascorbate, modified starch, all-rac-alpha-tocopherol, sucrose, triglycerides medium chain and colloidal anhydrous silica. What Cacit D3 looks like and content of the pack 4 g sachets (paper/aluminium/polyethylene); boxes of 20, 28, 30, 46, 50, 56, 60 or 100 sachets, sample pack of 10 sachets and multipacks containing 90 (3 packs of 30) sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland Manufacturer Hermes Pharma GmbH Schwimmschulweg 1a 9400 Wolfsberg Austria Marketing Authorisation Number: PL 49876/0014 This leaflet was last revised in October 2022.

1.3.1 Pg. 4

Frequently asked questions about Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets

How do I take Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets?

Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets comes as oral solution containing 500mg / 440iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets?

The active substance in Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets is calcium carbonate, colecalciferol; cholecalciferol.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: calcium carbonate, colecalciferol; cholecalciferol
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Calcium carbonate (45 medicines), Calcium carbonate, colecalciferol; cholecalciferol (12 medicines), Colecalciferol; cholecalciferol (34 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Correction of vitamin D and calcium combined deficiency in elderly people.

Vitamin D and calcium supplementation as an adjunct to specific therapy for osteoporosis treatment, in patients with established, or at high risk of vitamin D and calcium combined deficiencies.

4.2. Posology and method of administration

Posology

One or two sachets per day.

Method of administration

Oral.

Pour the contents of the sachet into a glass, add a large quantity of water, then drink immediately.

4.3. Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

• Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria

• Nephrolithiasis

• Hypervitaminosis D

4.4. Special warnings and precautions for use

Calcium and alkali intake from other sources (food, enriched foods, or other medicinal products) should be monitored when calcium carbonate is prescribed. When high calcium doses are given together with alkaline substances such as carbonate, there is a risk of milk-alkali syndrome (see sections 4.8 and 4.9). Calcium levels in serum should be monitored when administering high doses of calcium carbonate.

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function, treatment with calcium/vitamin D3 sachets should be discontinued.

Vitamin D3 should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolised normally and another form of vitamin D should be used (see section 4.3)

Calcium/vitamin D3 sachets should be used with caution in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite. In these patients, serum calcium levels and urinary calcium excretion must be monitored.

Calcium/vitamin D3 sachets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

The dose of vitamin D3 in the sachets should be considered when prescribing other drugs containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

Cacit D3 sachets are not intended for use in children.

Cacit D3 contains sorbitol, sucrose, potassium and sodium.

This medicinal product contains 0.6 mg sorbitol in each sachet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicial product. May be harmful to the teeth.

This medicinal product contains 2.1 mmol potassium (81.6 mg) in each sachet. This should be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet.

This medicinal product contains less than 1 mmol of sodium (23 mg) per sachet, that is to say essentially `sodium free´.

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use requiring precautions:

- Digitalis and other cardiac glycosides: the oral administration of calcium combined with vitamin D increases the toxicity of digitalis (risk of dysrythmia). Strict medical supervision, and if necessary, monitoring ECG and calcaemia are necessary.

- Bisphosphonate, sodium fluoride: it is advisable to allow a minimum period of two hours before taking the calcium (risk of reduction of the gastrointestinal absorption of bisphosphonate and sodium fluoride).

- Thiazide diuretics: reduce urinary elimination of calcium therefore supervision of calcaemia is recommended.

- Phenytoin or barbiturates: can decrease the effect of vitamin D because of metabolic inactivation.

- Glucocorticosteroid: can decrease the effect of vitamin D.

- Tetracyclines by oral route: it is advisable to delay taking the calcium by at least three hours (calcium salts reduce the absorption of tetracyclines).

- Possible interactions with food (e.g. containing oxalic acid, phosphate or phytinic acid).

- Iron, zinc and strontium: Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium ranelate preparations should be taken at least two hours before or after calcium/cholecalciferol.

4.6. Fertility, pregnancy and lactation

The product may be used during pregnancy and lactation. However, the daily intake should not exceed 1500mg calcium and 600IU vitamin D.

In pregnancy overdoses of colecalciferol must be avoided

- Overdoses of vitamin D have shown teratogenic effects in pregnant animals.

- In humans overdoses of vitamin D must be avoided, as permanent hypercalcaemia can lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy in the child.

There are several case reports of administration of very high doses in hypoparathyroidism in the mother, where normal children were born.

Vitamin D and its metabolites pass into the breast milk.

4.7. Effects on ability to drive and use machines

No remarkable findings. No effect expected.

4.8. Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).

Immune system disorders

Not known: Hypersensitivity reactions such as angio-oedema or laryngeal oedema

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Not known: Milk-alkali syndrome associating hypercalcaemia, alkalosis and renal impairment. (see sections 4.4 and 4.9)

Gastrointestinal disorders

Rare: Constipation, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

Other special populations

Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Goggle play or Apple App store.

4.9. Overdose

In case of overdose, there is a risk of Milk-alkali syndrome (see sections 4.4 and 4.8).

Consequence of overdose are hypercalciuria and hypercalcaemia. Symptoms include: nausea, vomiting, thirst, polydipsia, polyuria, constipation.

Chronic overdoses can lead to vascular and organ calcifications as a result of hypercalcaemia.

Treatment

Stop all intake of calcium and vitamin D, rehydration.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Calcium carbonate, Colecalciferol; cholecalciferol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

VITAMIN D3 KRKA 7000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
VITAMIN D3 KRKA 30000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
BONFAL 20000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
VIGANTOLETTEN 1000 prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
BONFAL 10000 UI prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth
VIGANTOLETTEN 500 prescription partial — not the same combinationCOLECALCIFEROLUM · taken by mouth

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

Vigantol partial — not the same combinationCholecalciferolum · taken by mouth
Vigantoletten 1000 partial — not the same combinationCholecalciferolum · taken by mouth
Vigantoletten 500 partial — not the same combinationCholecalciferolum · taken by mouth
Juvit D3 partial — not the same combinationCholecalciferolum · taken by mouth
Orocal D3 partial — not the same combinationCalcium + Cholecalciferolum · taken by mouth
Orocal D3 Lemon partial — not the same combinationCalcium + Cholecalciferolum · taken by mouth

💬 Ask about this leaflet

Ask anything about Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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