Stexerol-D3 1 000 IU film-coated tablets – patient leaflet, side effects, dosage

1. What Stexerol-D3 is and what it is used 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 used in adults and adolescents over 12 years old to prevent and treat 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).

Populations at higher risk of vitamin D deficiency are e.g.:

• People who are 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 medications (e.g. anticonvulsants,

  glucocorticoids)

• People with conditions causing reduced vitamin D

  absorption, including inflammatory bowel disease and coeliac disease

• People with bones that become thin, weak and fragile

  (osteoporosis)

• People recently treated for vitamin D deficiency and requiring

  maintenance therapy

You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before you take Stexerol-D₃ X Do not take Stexerol-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 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)

• if you have increased levels of calcium in the kidneys

  (nephrocalcinosis)

• if you have a special type of connective tissue disease that

  affects the lungs, skin and joints (sarcoidosis)

• if you have disturbed parathyroid hormone metabolism

  (pseudohypoparathyroidism)

• if you are taking medicine to treat high blood pressure

  (thiazide diuretics)

• if you are taking medicine to treat heart conditions (cardiac

  glycosides) such as digoxin

• if you are under 12 years of age

If any of the above applies to you, talk to your doctor or pharmacist before taking Stexerol- D₃.

? Warnings and precautions

Talk to your doctor or pharmacist before taking Stexerol- D₃:

• If you have problems with your kidney

• if you are already taking other medicines or supplements

  containing vitamin D, or food or milk enriched with vitamin D.

  • If you are taking any other medicines, particularly medicines for the heart.

X Children

This medicine should not be given to children under 12 years old. Check with your doctor before taking Stexerol-D₃ if you:

• have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine.
• are taking medicine from a group known as cardiac glycosides used to treat heart conditions (e.g. digoxin, digitalis)
• are taking medicine to treat high blood pressure (thiazide diuretics).
• have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)

• are already taking additional doses of calcium or vitamin D.

  Whilst you are taking Stexerol-D₃ your doctor will monitor your blood levels of calcium to make sure they are not too high.

  ! 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) or medicines used to treat high blood pressure (e.g. thiazide diuretics).

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)
• a chemotherapy medicine called dactinomycin
• a group of antifungal medicines called imidazole
• a weight loss aid called orlistat

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.

Stexerol-D3 should only be used in pregnancy and breast feeding when recommended by a doctor.

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 IU tablet, that is to say essentially ‘sodium-free’.

3. How to take 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. Adults:

The recommended dose in adults is 1 tablet (1,000 IU) per day. Some adults may require higher doses of up to a maximum of 4,000 IU (4 tablets) per day. The duration should not exceed 10 weeks without consultation with your doctor.

Adults: Do not take more than 4 tablets (4,000 IU) in one day. Adolescents 12 years and over:

The recommended dose in adolescents over 12 years is 1 tablet (1,000 IU) a day.

Some adolescents may require higher doses of up to a maximum of 2,000 IU (2 tablets) per day. The duration should not exceed 6 weeks without consultation with your doctor.

Adolescents 12 years and over: Do not take more than 2 tablets (2,000 IU) a day.

The tablets can be swallowed whole, or crushed. Use in children

Stexerol-D₃ 1000 IU film-coated tablets are not intended for use in children under 12 years of age. Other forms of this medicine maybe more suitable for children; ask your doctor or pharmacist. If you take more Stexerol-D₃ than you should

If you take several more tablets than you should, or if a child accidentally has taken the medicine, 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 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 25°C
• Store in the original packaging in order to protect from light and moisture

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 1,000 IU of colecalciferol which is equivalent to 25 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

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.

The 1,000 IU tablets are available in blister packs containing 28 tablets

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 04/2026.

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