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SOLICOL D3 20 000 IU TABLETS

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

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Package leaflet: Information for the user

SoliCol D3 20,000 IU TABLETS
®

Colecalciferol

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. What SoliCol D3 20,000 IU Tablets are and what they are used for
2. What you need to know before you take SoliCol D3 20,000 IU Tablets
3. How to take SoliCol D3 20,000 IU Tablets
4. Possible side effects
5. How to store SoliCol D3 20,000 IU Tablets
6. Contents of the pack and other information

1. WHAT SOLICOL D3 20,000 IU TABLETS
ARE AND WHAT THEY ARE USED FOR
SoliCol D3 20,000 IU Tablets contain the active ingredient
colecalciferol (Vitamin D3). Vitamin D can be found in some
foods and is also produced by the body when skin is exposed
to sunlight. Vitamin D helps the kidneys and intestines absorb
calcium and also build bones.
This medicine is used
• to prevent vitamin D deficiency. This may occur when your
diet or life style does not provide you with enough vitamin D
• to treat vitamin D deficiency diagnosed by your doctor
• with other medicines to treat certain bone conditons such as
thinning of the bone (osteoporosis) in patients with vitamin
D deficiency.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SOLICOL D3 20,000 IU TABLETS
Do not take SoliCol D3 20,000 IU Tablets:
• if you are allergic to vitamin D or any of the ingredients
listed in section 6
• if you have high levels of calcium in your blood
(hypercalcaemia) or high levels of calcium in your urine
(hypercalciuria)
• if you have kidney problems, including kidney stones
• If you have high levels of vitamin D in your blood
(hypervitaminosis D).
Warnings and precautions:
Talk to your doctor or pharmacist before taking SoliCol D3
20,000 IU Tablets if you:
• suffer from heart disease or narrowing of the arteries
• suffer from sarcoidosis (an immune system disorder
which may affect your liver, lungs, skin or lymph nodes)
• have previously been told by your doctor that
you have an intolerance to some sugars
• are currently taking any other medication, including other
forms of vitamin D and calcium or consuming foods or
drinking milk and other products enriched with vitamin D.

Children
SoliCol D3 20,000 IU Tablets should not be given to infants and
children under 12 years of age.
Other medicines and SoliCol D3 20,000 IU Tablets:
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines especially the
following:
• other vitamin D containing medicines such as multivitamins
• calcium supplements
• biophosphates (for osteoporosis) or sodium fluoride (for
cavities in the teeth)
• ion exchange resins, Cholestyramine (for high cholesterol),
antacids, or laxatives containing paraffin oil
• glucocorticoids (steroids)
• diuretics (water tablets) such as thiazide diuretics (for blood
pressure)
• medicines for epilepsy such as barbiturates or other
anticonvulsant (e.g. Carbamazepine, Phenobarbitol,
Phenytoin, Primidone)
• medicines to control the rate of your heart beat (e.g. Digoxin,
Digitoxin)
• medicines to treat some forms of cancer (Chemotherapy) such
as actinomycin or antifungals (for skin infection).
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. If you require
extra vitamin D, do not take it without the supervision of your
doctor. Too much vitamin D may harm your baby.
Driving and using machines
SoliCol D3 20,000 IU Tablets should not affect your ability to
drive or operate machinery.
SoliCol D3 20,000 IU Tablets contain Sucrose
If you have been told by your doctor that you have an
intolerance to some sugars, please ask your doctor before
taking this medicine.

Your doctor may want you to have regular blood tests to
check the amount of calcium in your blood.
Please
Turn Over

3. HOW TO TAKE SOLICOL D3 20,000 IU
TABLETS
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
These tablets should not be chewed but swallowed whole
with a glass of water, preferably together with a large meal.
SoliCol D3 20,000 IU Tablets are not recommended for infants
and children below 12 years.
Recommended dose and schedules
Adults:
• Treatment of vitamin D deficiency
Take two tablets (20,000 IU x 2 ) per week for 7 weeks,
followed by maintenance therapy as directed by your doctor
(such as 1400 - 2000 IU/day which is equivalent to 2-3 tablets
of SoliCol D3 20,000 IU every 4 weeks).
• Prevention of vitamin D deficiency:
One tablet (20,000 IU) every four weeks. Higher doses may be
required in certain situations as directed by your doctor.
Use in Children (12 - 18 years):
SoliCol D3 Tablets should only be given to children and
adolescents aged 12 years and older.
• Treatment of vitamin D deficiency:
One tablet (20,000 IU) every 2 weeks for 6 weeks.
• Prevention of vitamin D deficiency:
One tablet (20,000 IU) once every six weeks.
If you have problems absorbing vitamin D3 or have other
conditions such as liver disease, the dose of vitamin D3 may be
different. This will be decided by your doctor.
During long-term treatment, the calcium levels in the blood
and urine, and the functions of the kidneys will be monitored
regularly by your doctor to ensure the safety of your medicine
and check that you are taking the correct dose.
DO NOT EXCEED THE RECOMMENDED DOSE
If you take more SoliCol D3 20,000 IU Tablets than you should:
If you take too many SoliCol D3 20,000 IU Tablets by mistake,
go to the casualty department (A&E) of the nearest hospital
immediately. You may get any of the side effects listed in
section 4, these can be serious.
Take this leaflet, and any tablets that you still have, to show
the doctor.
If you forget to take SoliCol D3 20,000 IU Tablets:
If you forget to take a dose, take it as soon as you remember.
However, if it is almost time for your next dose, skip the
missed dose and resume your medicine 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.
Taking a higher dose of Vitamin D than necessary can lead to a
high calcium level in the blood, which can give rise to a
number of side effects. Tell your doctor immediately if you:
• are sick or are feeling sick
• have loss of appetite
• feel very thirsty
• are passing more urine than normal
• have stomach ache
• have diarrhoea or feel constipated
• have headaches

• have lost weight
• experience fatigue
• have bone pain and muscle weakness
• suffer from vertigo (loss of balance with dizziness)
• feel drowsy or confused
• have kidney stones and there are changes in the way
the kidneys are working
• have an irregular heartbeat
• raised concentrations of calcium in the urine may
occur, which can result in kidney stones
• red and lumpy skin rash, swollen eyelids, face, lips,
mouth or tongue, itching, difficulty breathing or
swallowing. This could be an allergic reaction.
Rare (may affect upto 1 in 1,000 people)
• skin rash
• itching
• raised itchy rash (hives)
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 (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE SOLICOL D3 20,000 IU
TABLETS
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 label. The expiry date refers to the last day of that month.
Store below 25o C. Keep blisters in outer carton to protect from
light.
Do not throw away any medicine via waste water or household
waste. Ask your pharmacist how to throw away any medicines
you no longer use. These measures will help protect the
environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What SoliCol D3 20,000 IU Tablets contain:
The active substance is colecalciferol and each tablet contains
500 micrograms (20,000 IU) of the active substance.
The other ingredients are: DL-alpha-tocopherol,
Medium-chain triglycerides, Sodium ascorbate crystalline,
Silicon dioxide & Sucrose.
What SoliCol D3 20,000 IU Tablets look like and contents of the
pack
SoliCol D3 20,000 IU Tablets are off white to yellowish oval
tablets debossed on one side with ‘4’. The tablets are supplied
in blister packs of 30 tablets.
Marketing Authorisation Holder & Manufacturer:
Pharmaceutics (UK) Ltd
Unit A, 5 Boulton Road
Reading, RG2 0NH
United Kingdom

This leaflet was revised in April 2015

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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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