Stexerol-D3 1,000 IU Film-coated Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor or pharmacist if you do not feel better or if you feel worse after 2 weeks.

1. What Stexerol-D₃ is and what it is used for
2. What you need to know before you take Stexerol-D₃
3. How to take Stexerol-D₃
4. Possible side effects
5. How to store Stexerol-D₃
6. Contents of the pack and other information

• 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.

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.

This medicine should not be given to children under 12 years old.

• 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.

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)

You can take this medicine with or without food and drink.

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.

Stexerol-D₃ should not affect your ability to drive or operate machines.

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’.

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 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 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.

• 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.

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

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.

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)

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:

Manufacturer