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STEXEROL-D3 25 000 IU FILM-COATED TABLETS

Active substance(s): COLECALCIFEROL CONCENTRATE (POWDER FORM)

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Package leaflet: Information for the user

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.

Stexerol-D3 1,000 IU Film-coated Tablets
Stexerol-D3 25,000 IU Film-coated Tablets
Colecalciferol (Vitamin D3)

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Stexerol-D3 is and what it is used for
What you need to know before you take Stexerol-D3
How to take Stexerol-D3
Possible side effects
How to store Stexerol-D3
Contents of the pack and other information

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- 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

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).

? 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. It is very unlikely that this side effect will happen to you 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
Other side effects:
- hypercalciuria (too much calcium in your urine)
- itching
- skin rash
- 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. By reporting side effects you can
help provide more information on the safety of this medicine.

2. What you need to know before you take Stexerol-D3
X 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
- if you are taking medicines from a group known as cardiac glycosides used to treat heart conditions (e.g. digoxin, digitalis)
- if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Your doctor may wish to do blood or urine tests to monitor your treatment.

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 25oC
- 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.

X 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.
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)

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:
Marketing Authorisation Holder and Manufacturer
25,000 IU Tablet:
1,000 IU Tablet:
Marketing Authorisation Holder:
Tablet Core:
Tablet Core:
Kyowa Kirin Limited
Microcrystalline cellulose
Modified maize starch
Croscarmellose sodium
Sucrose
Galabank Business Park
Magnesium stearate
Mannitol
Galashiels
Modified maize starch
Croscarmellose sodium
UK
Colloidal anhydrous silica
Polacrilin potassium
TD1 1QH
Sucrose
Silicon dioxide, colloidal
Tel.: 01896 664000
Sodium ascorbate
Sodium ascorbate
Fax.: 01896 664001
Triglycerides, medium chain
Triglycerides, medium chain
Silicon dioxide, colloidal
Colloidal anhydrous silica
all-rac-α-tocopherol
Magnesium stearate
all-rac-α-tocopherol
Manufacturer

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.

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.
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.

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

Reminder Service:

How to join:
• To receive text messages simply text the appropriate word (DAILY, WEEKLY or MONTHLY) to 66777 depending on how often you need to
take your tablet(s) as prescribed by your doctor.

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.

You can opt out of this service at any time by texting DAILY STOP, WEEKLY STOP or MONTHLY STOP to 66777 to stop text messages.
1

The messaging service described in this leaflet is provided to you by Kyowa Kirin Limited.
By enrolling for this messaging service, you agree that:
• Kyowa Kirin Limited may use the telephone number you have provided for the purpose of providing you with the messaging service and may
transfer your telephone number to its service providers for the purpose of providing the messaging service.
• Kyowa Kirin Limited can contact you by text message (as indicated by you) to:
- Remind you to take your monthly dose of Stexerol-D3.
• That you are aged 18 or over.

Please tick the appropriate box:
Amend &
Re-Submit
Approved
for Print
only

Approved
& Proceed
Signature
Date

This Proof has been ‘enabled for commenting’ in Acrobat.
Please review, add comments if appropriate then click the
‘Send Comments’ button on the toolbar.

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

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.

A free reminder service1 is available to make it easier for you to remember when to take your tablet(s). Reminders will be sent in the form of a text
message.

Kyowa Kirin Limited
Galabank Business Park,
Galashiels, UK, TD1 1QH
Tel:
+44 1896 664000
Fax: +44 1896 664001
Email: artwork@prostrakan.com

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

This leaflet was last revised in 05/2016.

LFT-STE-GB-003

Product No:

LFT-STE-GB-003

Product Name:

Stexerol-D3 Blisters

Item Description:

Leaflet

Cutter Ref:

-

Pharmacode:

-

Manufacturer Code:

-

Actual Size:

180x297 mm

Market:

UK

Language(s):

English

Proof No:

3

Date Issued:

23-06-2016

Issued By:

-

Colours Used
Black

Font Size:

7pt

Font Type:

Helvetica, Helvetica Bold and Myriad Pro

Reason for Change: Rebranding: Change ProStrakan to Kyowa Kirin

Package leaflet: Information for the user

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.

Stexerol-D3 1,000 IU Film-coated Tablets
Stexerol-D3 25,000 IU Film-coated Tablets
Colecalciferol (Vitamin D3)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

- 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.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Stexerol-D3 is and what it is used for
What you need to know before you take Stexerol-D3
How to take Stexerol-D3
Possible side effects
How to store Stexerol-D3
Contents of the pack and other information

? 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. It is very unlikely that this side effect will happen to you 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
Other side effects:
- hypercalciuria (too much calcium in your urine)
- itching
- skin rash
- 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. By
reporting side effects you can help provide more information on the safety of this medicine.

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 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).

2. What you need to know before you take Stexerol-D3
X 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)

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.

? 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
- if you are taking medicines from a group known as cardiac glycosides used to treat heart conditions
(e.g. digoxin, digitalis)
- if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
Your doctor may wish to do blood or urine tests to monitor your treatment.

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:

X 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.
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.

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.

1,000 IU Tablet:

25,000 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

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)

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.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Kyowa Kirin Limited
Galabank Business Park
Galashiels
UK
TD1 1QH
Tel.: 01896 664000
Fax.: 01896 664001

Reminder Service:
A free reminder service1 is available to make it easier for you to remember when to take your tablet(s). Reminders will
be sent in the form of a text message.

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

How to join:
• To receive text messages simply text (DAILY, WEEKLY or MONTHLY) to 66777 depending on how often you
need to take your tablet(s) as prescribed by your doctor.
You can opt out of this service at any time by texting DAILY STOP, WEEKLY STOP or MONTHLY STOP to 66777 to
stop text messages.

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.

1

The messaging service described in this leaflet is provided to you by Kyowa Kirin Limited.
By enrolling for this messaging service, you agree that:
• Kyowa Kirin Limited may use the telephone number you have provided for the purpose of providing you with the
messaging service and may transfer your telephone number to its service providers for the purpose of providing
the messaging service.
• Kyowa Kirin Limited can contact you by text message (as indicated by you) to:
- Remind you to take your monthly dose of Stexerol-D3.

This leaflet was last revised in 05/2016.

LFT-STE-GB-003

• That you are aged 18 or over.
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.

Kyowa Kirin Limited
Galabank Business Park,
Galashiels, UK, TD1 1QH
Tel:
+44 1896 664000
Fax: +44 1896 664001
Email: artwork@prostrakan.com
Please tick the appropriate box:
Amend &
Re-Submit

Approved
& Proceed

Approved
for Print
only

Signature
Date

This Proof has been ‘enabled for commenting’ in Acrobat.
Please review, add comments if appropriate then click the
‘Send Comments’ button on the toolbar.

Product No:

LFT-STE-GB-003

Product Name:

Stexerol-D3 Blisters

Item Description:

Leaflet

Cutter Ref:

-

Pharmacode:

-

Manufacturer Code:

-

Actual Size:

148x360 mm

Market:

UK

Language(s):

English

Proof No:

2

Date Issued:

20-05-2016

Colours Used
Black

Issued By:

-

Font Size:

7pt

Font Type:

Helvetica, Helvetica Bold and Myriad Pro

Reason for Change:

Please create a new PIL with the current artwork and the
new QRD provided

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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