Stexerol-D3 25,000 IU Film-coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

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 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)

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.

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

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)

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 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 or 25,000 IU tablet, that is to say essentially ‘sodium-free’.

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.

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.

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

The tablets can be swallowed whole, or crushed.

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 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 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

Film-coat:

Hypromellose

Talc

Macrogol 6000 (PEG)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Red iron oxide (E172)

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)

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:

Manufacturer

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.