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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Stexerol-D3 25,000 IU Film-coated Tablets

⚠ 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 Stexerol-D3 contains vitamin D3 which is essential for healthy bones. Vitamin D3 belongs to a group of medicines called vitamin supplements which are used to correct and maintain levels of the vitamin in your body. Vitamin D is produced naturally by your skin after exposure to the sun and is also found in some foods. When levels of vitamin D in the body are too low this can cause bones to become fragile. Stexerol-D3 is available in two strengths and is used in adults and adolescents over 12 years old to prevent and treat: very low levels of vitamin D (deficiency) Stexerol-D3 can also be used in combination with other medicines to treat certain bone conditions such as thinning of the bones (osteoporosis).

What you need to know before you take it

e Stexerol-D3

Do not take Stexerol-D3: if you are allergic to vitamin D 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 kidney stones or serious kidney problems if you have high levels of calcium in your blood (hypercalcaemia) if you have high levels of calcium in your urine (hypercalciuria) Warnings and precautions Talk to your doctor or pharmacist before taking Stexerol-D3: if you have problems with your kidneys if you have sarcoidosis (inflammation that produces lumps of cells in various organs in the body). Your doctor will be able to tell you if you do if you are already taking other medicines or supplements containing vitamin D Your doctor may wish to do blood or urine tests to monitor your treatment. Children This medicine should not be given to children under 12 years old. Other medicines and Stexerol-D3 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist before taking Stexerol-D3: if you are taking medicines from a group known as cardiac glycosides used to treat heart conditions (e.g. digoxin, digitalis). The following medicines may decrease the effects of Stexerol-D3: medicines used to treat epilepsy (e.g. phenytoin) medicines used to help you sleep (e.g. barbiturates) laxatives (e.g. paraffin oil) cholesterol lowering medicines (e.g. cholestyramine) steroids from a group known as glucocorticoids often used to treat allergies or asthma (e.g. hydrocortisone, prednisolone) The following medicines may increase the effects of Stexerol-D3 a group of medicines called thiazide diuretics which are mainly used to treat high blood pressure (e.g. bendroflumethiazide) Stexerol-D3 with food and drink You can take this medicine 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.

Driving and using machines Stexerol-D3 should not affect your ability to drive or operate machines. Stexerol-D3 Film-coated Tablets contain Sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per 1,000 or 25,000 IU tablet, that is to say essentially 'sodium-free'. 3.

How to take it

Stexerol-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. Dose for treatment of Vitamin D deficiency The dose needed to treat vitamin D deficiency will depend on how low your vitamin D levels are. Your doctor will advise you on the strength and number of tablets to take and how often you should take them – usually up to 75,000 IU for adolescents or up to 300,000 IU for adults, which may be spread over several weeks. After this you may need to take regular doses to maintain your vitamin D levels. Dose for prevention of deficiency, and maintenance after treatment of deficiency The recommended dose is 1,000 IU a day, in some cases higher doses may be required. Your doctor will prescribe the correct dose for you. Addition to specific therapy for osteoporosis: Adults: 25,000 IU/month or 1,000 IU/day The tablets can be swallowed whole, or crushed. If you take more Stexerol-D3 than you should If you take one more tablet than you should it is unlikely that this will cause any harm. However, if you are concerned, contact your doctor or pharmacist. If you take several more tablets than you should, seek medical advice immediately and if possible take the tablets, box and this leaflet with you. Signs of overdose include: nausea, vomiting excessive passing of urine loss of appetite weakness apathy thirst constipation drowsiness dizziness

If you forget to take Stexerol-D3 If you forget to take your medicine, take it as soon as possible and continue to take the tablets as normal. 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. Serious side effects: Allergic reaction. The likelihood of this side effect happening to you is not known, however, stop taking Stexerol-D3 and seek immediate medical help if you have any signs of serious allergic reaction such as a swollen face, lips, tongue or throat, difficulty swallowing or breathing Hypercalcaemia (too much calcium in your blood). This is an uncommon side effect of Stexerol-D3 which can cause nausea, vomiting, excessive passing of urine, loss of appetite, weakness, apathy, thirst, constipation, drowsiness or dizziness. Stop taking Stexerol-D3 and seek immediate medical help if these symptoms occur. Your doctor should monitor your blood calcium level during long-term treatment with Stexerol-D3. Other side effects: Uncommon (may affect up to 1 in 100 people) hypercalciuria (too much calcium in your urine) which can cause increased frequency of urination, pain on urination, abdominal pain, bladder or kidney stones and urinary tract infections Rare (may affect up to 1 in 1,000 people) itching skin rash Frequency not known (frequency cannot be estimated from the available data) nausea, vomiting 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 the 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. 5.

How to store it

Stexerol-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 the blister strip or bottle after EXP. The expiry date refers to the last day of that month. Do not store above 25oC Store in the original packaging in order to protect from light and moisture

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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 protect the environment. 6.

Contents of the pack and other information

What Stexerol-D3 contains The active substance is vitamin D3 as colecalciferol. Each tablet contains either 1,000 IU or 25,000 IU of colecalciferol which is equivalent to 25 or 625 micrograms of vitamin D3. The other ingredients are: 1,000 IU Tablet: Tablet Core: Microcrystalline cellulose Croscarmellose sodium Magnesium stearate Modified maize starch Colloidal anhydrous silica Sucrose Sodium ascorbate Triglycerides, medium chain Silicon dioxide, colloidal all-rac-α-tocopherol

25,000 IU Tablet: Tablet Core: Modified maize starch Sucrose Mannitol Croscarmellose sodium Polacrilin potassium Silicon dioxide, colloidal Sodium ascorbate Triglycerides, medium chain Colloidal anhydrous silica Magnesium stearate all-rac-α-tocopherol

Film-coat: Hypromellose Talc Macrogol 6000 (PEG) Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)

What Stexerol-D3 looks like and the contents of the pack Stexerol-D3 1,000 IU Film-coated tablets are orange, 8.5 mm long, oval shaped tablets. Stexerol-D3 25,000 IU Film-coated tablets are orange, 14 mm long, capsule shaped tablets. The 1,000 IU tablets are available in blister packs containing 28 tablets or in bottles containing 56 tablets.

The 25,000 IU tablets are available in blister packs containing 12 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Grünenthal Ltd TOR Building Saint Cloud Way Maidenhead Berkshire SL6 8BN United Kingdom

Manufacturer allphamed PHARBIL Arzneimittel GmbH Hildebrandstr. 10-12 37081 Göttingen Germany

Other sources of information If you have been prescribed Stexerol-D3 Film-coated Tablets for the treatment or prevention of osteoporosis and would like further information you should speak to your doctor or pharmacist. This leaflet was last revised in 05/2024.

Frequently asked questions about Stexerol-D3 25,000 IU Film-coated Tablets

How do I take Stexerol-D3 25,000 IU Film-coated Tablets?

Stexerol-D3 25,000 IU Film-coated Tablets comes as tablet containing 25iu. 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 Stexerol-D3 25,000 IU Film-coated Tablets?

The active substance in Stexerol-D3 25,000 IU Film-coated Tablets is colecalciferol; cholecalciferol.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Stexerol-D3 25,000 IU Film-coated Tablets, 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 Stexerol-D3 25,000 IU Film-coated Tablets 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

Stexerol-D3 is indicated in adults, the elderly and adolescents for prevention and treatment of vitamin D deficiency.

As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.

4.2. Posology and method of administration

Posology

Paediatric population

Stexerol-D3 is not recommended for children under 12 years.

Method of Administration

The tablets can be swallowed whole, or crushed. The tablets can be taken with food.

Treatment of deficiency (< 25 ng/ml):

Adults: 50,000 IU/week for 6 weeks or, 3,000 - 4,000 IU/day for 10-12 weeks

Adolescents 12 years and over: 25,000 IU once every 2 weeks for 6 weeks (i.e. total dose 75,000 IU), or 2,000 IU/day for 6 weeks

Maintenance therapy following treatment of deficiency:

Adults: 25,000 IU/month or 1,000 IU/day. In certain situations (see below) higher doses of up to 50,000 IU/month or up to 4,000 IU/day may be required if patients cannot be maintained at the lower doses.

Adolescents 12 years and over: 1,000 IU/day

25(OH)D should be measured approximately 3 to 4 months after beginning maintenance therapy to confirm that target level has been reached.

Prevention of deficiency:

Adolescents 12 years and over: 25,000 IU every 6 weeks

Adjunct to specific therapy for osteoporosis:

Adults: 25,000 IU/month or 1,000 IU/day

Certain populations are at higher risk of vitamin D deficiency and may require higher doses, e.g.:

- People who are institutionalised or hospitalised long term

- Darker skinned people, especially at higher latitudes

- People whose effective sun exposure is limited due to covering up with clothing or constant use of sun screens

- Obese people

- People using certain concomitant medications (e.g. anticonvulsants, glucocorticoids)

- People with conditions causing malabsorption, including inflammatory bowel disease and coeliac disease

- People with osteoporosis

- People recently treated for vitamin D deficiency and requiring maintenance therapy

4.3. Contraindications

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

• Hypervitaminosis D

• Nephrolithiasis

• Nephrocalcinosis

• Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria(e.g. myeloma, bone metastases or other malignant bone disease, primary hyperparathyroidism)

• Severe renal impairment

4.4. Special warnings and precautions for use

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).

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

Treatment with vitamin D has the potential to unmask primary hyperparathyroidism. Serum calcium levels should be monitored in susceptible patients. If calcium levels are raised then the potential for vitamin D treatment to have unmasked primary hyperparathyroidism should be considered.

During long-term treatment, serum calcium levels and renal function (through measurements of serum creatinine) should be monitored. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with an increased tendency to calculus formation. In the 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.

The total dose of vitamin D should be considered and adjusted accordingly when prescribing Stexerol-D3 with other medicinal products containing vitamin D.

The calcium status and dietary intake of individual patients should also be considered at the same time as starting vitamin D3 replacement or treatment.

Monitoring may be necessary in patients with increased sensitivity to vitamin D therapy.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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

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

Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D due to increase in the rate of its metabolism.

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

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

Increased levels of vitamin D can induce hypercalcaemia, which may increase the risk of digitalis toxicity and serious arrhythmias due to the additive inotropic effects. The electrocardiogram (ECG) and serum calcium levels of patients should be closely monitored.

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.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The recommended daily intake for pregnant women is up to 600 IU. However, in women who are considered to be vitamin D deficient, a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their deficiency and their response to treatment. There are no indications that vitamin D at therapeutic doses is teratogenic in humans.

Breast-feeding

Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother.

Fertility

There are no data on the effect of Stexerol-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

Stexerol-D3 has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions frequencies are defined as: uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or not known (cannot be estimated from the available data)

System Organ Class

Frequency

Adverse Reaction

Immune system disorders

Not known

Hypersensitivity reactions

Gastrointestinal disorders

Not known

Nausea, vomiting

Metabolism and nutrition disorders

Uncommon

Hypercalcaemia, hypercalciuria

Skin and subcutaneous disorders

Rare

Pruritus, rash, 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 the 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, somnolence and vertigo. 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 Stexerol-D3 25,000 IU Film-coated Tablets. 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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