The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: 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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STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242)

⚠ 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 Colecalciferol; cholecalciferol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Colecalciferol; cholecalciferol

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for STRIVIT-D3 contains the active substance Colecalciferol (vitamin D3). Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Vitamin D3 regulates the uptake and metabolism of calcium as well as the incorporation of calcium in bone tissue. Often vitamin D is given in combination with calcium. STRIVIT-D3 may be prescribed by your doctor to treat or prevent vitamin D deficiency. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant).

What you need to know before you take it

e Colecalciferol Do not take STRIVIT-D3:

if you are allergic to colecalciferol or any of the other ingredients of this medicine (listed in section 6);
if you have high levels of vitamin D in your blood (hypervitaminosis D);
if you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria);
if you have kidney stones or serious kidney problems. If any of the above applies to you, do not take STRIVIT-D3. Warnings and precautions Talk to your doctor or pharmacist before taking STRIVIT-D3: • •

if you have kidney damage or disease and long term treatment with this medicine. Your doctor may want to measure the levels of calcium in your blood or urine; if you are being treated for heart disease;

• •

you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes); if you are already taking additional doses of calcium or vitamin D. Whilst you are taking STRIVIT-D3 your doctor will monitor your blood levels of calcium to make sure they are not too high.

Children and adolescents STRIVIT-D3 is not suitable for children under 12 years. Other medicines and STRIVIT-D3 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular the following medicines may interact with STRIVIT-D3: • • • • • •

Heart medicines (cardiac glycosides such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure the levels of calcium in your blood. Thiazide diuretics (used to treat high blood pressure) reduce the urinary excretion of calcium and can increase risk of hypercalcaemia. Medicines used to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) can decrease the effects of vitamin D. Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) can decrease the effects of vitamin D. Laxatives (such as paraffin oil), or a cholesterol lowering drug (colestyramine, colestipol), orlistat may reduce the absorption of vitamin D. Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) may interfere with the metabolism of vitamin D.

STRIVIT-D3 with food and drink You can take STRIVIT-D3 with or without food and drink. Pregnancy and breast-feeding 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. If you require extra vitamin D, do not take it without the supervision of your doctor. Too much vitamin D may harm your baby. Driving and using machines Colecalciferol should not affect your ability to drive or operate machinery. Colecalciferol contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 3,200 IU, that is to say essentially 'sodium-free'.

How to take it

STRIVIT-D3 Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The capsules should be swallowed whole with water and can be taken with or without food. The recommended dose is: In severe vitamin D deficiency (for adults and the elderly)

Your doctor will usually prescribe you a dose of 1 capsule daily for up to 12 weeks. The amount will depend on how low your vitamin D levels are and how you respond to treatment. Use in pregnancy and breast-feeding To treat vitamin D deficiency:Your doctor will usually prescribe 1 capsule daily for up to 12 weeks. Use in children STRIVIT-D3 is not suitable for children under 12 years. If you take more STRIVIT-D3 than you should If you accidentally take one capsule too many, nothing is likely to happen. If you accidentally take several capsules too many, tell your doctor or get other medical advice immediately. If possible, take the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules, you may feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of appetite, kidney problems and in severe cases irregular heartbeats. If you forget to take STRIVIT-D3 If you forget to take your capsules, take them as soon as you can. After that, take the next capsule in accordance with the instructions given to you by your doctor. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Colecalciferol and seek immediate medical help if you experience symptoms of serious allergic reactions, such as:

swollen face, lips, tongue or throat
difficulty to swallow
hives and difficulty breathing.

Possible side effects

with STRIVIT-D3 may include: Uncommon (may affect up to 1 in 100 people)

too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion;
too much calcium in your urine (hypercalciuria). Rare (may affect up to 1 in 1,000 people)
skin rash;
itching;
hives. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google 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

STRIVIT-D3 Keep this medicine out of the sight and reach of children.

This medicine does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What STRIVIT-D3 contains

The active ingredient is colecalciferol. Each capsule contains 3,200 IU colecalciferol (equivalent to 80 micrograms Vitamin D3).
The other ingredients are: Capsule Content: maize oil, refined Capsule Shell: gelatin, glycerol (E 422), chlorophyllin copper complex sodium (E141) What STRIVIT-D3 looks like and contents of the pack STRIVIT-D3 3,200 IU Capsule is a translucent green to greenish yellow coloured and has no markings. It is available in blister packs containing 7, 10, 14, 20, 28, 30, 56, 60, 84 or 90 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Ltd. Unit 4, The Metro Centre Dwight Road, Watford WD18 9SS United Kingdom This leaflet was last revised in 07/2024.

Frequently asked questions about STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242)

How do I take STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242)?

STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242) comes as capsule containing 3200iu. 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 STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242)?

The active substance in STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242) is colecalciferol; cholecalciferol.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242), 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 STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242) 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: 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: 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

For the treatment of vitamin D deficiency (serum 25(OH)D <25 nmol/l). STRIVIT-D3 is indicated in adults and the elderly.

4.2. Posology and method of administration

Posology

Vitamin D deficiency in adults and the elderly (serum levels <25 nmol/l (<10 ng/ml)) 1 capsule (3,200 IU) daily for up to 12 weeks dependent upon the severity of the disease and the patient's response to treatment.

Not all given recommended doses can be achieved with this product.

Dosage in hepatic impairment

No dose adjustment is required.

Dosage in renal impairment

In patients with mild or moderate renal impairment, no specific adjustment is required. STRIVIT-D3 should not be used in patients with severe renal impairment (see section 4.3).

Paediatric population

Not recommended for use in children.

Method of administration

Oral

The capsules should be swallowed whole (not chewed) with water. The capsules should not be chewed in order to facilitate the swallowing of the capsule content. In order to enhance absorption, it is recommended to take vitamin D with a meal.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Hypervitaminosis D

• Nephrolithiasis

• Nephrocalcinosis

• Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria

• Severe renal impairment

4.4. Special warnings and precautions for use

In the case of therapeutic treatment the dose should established on an individual basis for the patients by regular checking (initially weekly, then once every 2-4 weeks) of plasma calcium levels. During long-term treatment, serum calcium level, urinary calcium excretion and renal function should be monitored by measuring the serum creatinine level. In case of hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Renal impairment

Vitamin D 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 colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3).

Sarcoidosis

STRIVIT-D3 should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.

Use of additional supplements

Allowances should be made for vitamin D supplements from other sources.

The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.

Medical supervision is required whilst on treatment to prevent hypercalcaemia.

Paediatric population

STRIVIT-D3 3,200 IU Capsules should not be given to children.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per 3,200 IU, that is to say essentially 'sodium-free'.

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

Thiazide diuretics reduce the urinary excretion of calcium. Due to the increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation.

Concomitant use of glucocorticoids can decrease the effect of vitamin D.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Simultaneous treatment with bile-acid binding resins (i.e. cholestyramine, colestipol), orlistat or laxatives such as paraffin oil, may reduce the gastrointestinal absorption of vitamin D.

The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25- dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are limited data from the use of STRIVIT-D3 in pregnant women. Vitamin D deficiency is harmful for mother and child. High doses of vitamin D have been shown to have teratogenic effects in animal experiments (see section 5.3).

Overdose of vitamin D must be avoided during pregnancy, as prolonged hypercalcaemia may lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy of the child.

Where there is a vitamin D deficiency the recommended dose is dependent on national guidelines, however, the maximum recommended dose during pregnancy is 4,000 I.U./day vitamin D3. For treatment during pregnancy at higher doses, STRIVIT-D3 is not recommended during pregnancy.

Breastfeeding

Vitamin D3 and its metabolites are excreted in breast milk. No adverse events have been observed in infants. STRIVIT-D3 can be used at recommended doses during lactation in case of a vitamin D deficiency. This should be considered when giving additional vitamin D to the child.

Fertility

There are no data on the effect of STRIVIT-D3 on fertility. However, normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.

4.7. Effects on ability to drive and use machines

STRIVIT-D3 has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).

Immune system disorders:

Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angio-oedema or laryngeal oedema.

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria. Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

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 Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

The most serious consequence of acute or chronic overdose is hypercalcaemia due to vitamin D toxicity. Symptoms may include nausea, vomiting, polyuria, anorexia, weakness, apathy, thirst and constipation. Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcaemia. Treatment should consist of stopping all intake of vitamin D and 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 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 STRIVIT-D3 3200 IU Capsules, Soft (PL 13606/0242). 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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