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PLENACHOL 20 000 IU CAPSULES

Active substance(s): COLECALCIFEROL

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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.
5. How to store PLENACHOL Capsules

What PLENACHOL Capsules looks like and
contents of the pack:
Plenachol Capsules are hard white capsules containing a
clear, slightly yellowish oily liquid.

Not all pack sizes may be marketed.

Store this medicinal product in the original package in order
to protect from light.

Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.,
Whiddon Valley, Barnstaple,
North Devon, EX32 8NS, UK

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 to
protect the environment.
6. Contents of the pack and other information
What PLENACHOL Capsules contains:
The active ingredient is cholecalciferol (also known as
vitamin D3).

PLENACHOL 20 000 IU CAPSULES & PLENACHOL 40 000 IU CAPSULES (Cholecalciferol)
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.

Plenachol 20 000 IU Capsules and Plenachol 40 000 IU
Capsules are available in boxes of 4, 10 & 20 capsules.

Keep this medicine out of the sight and reach of children.

Do not use Plenachol Capsules after the expiry date on the
carton and blister as [EXP XX/YYYY]. The expiry date
refers to the last day of that month.

Patient Information Leaflet

In this leaflet:






Manufacturer:
Encap Drug Delivery, Units 4, 5 & 6, Oakbank Park Way,
Livingston, West Lothian, EH53 0TH, UK
This leaflet was last revised in January 2016.

For information in large print,
on tape, on CD or in Braille,
phone +44 (0)1271 385 257.

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

1. What PLENACHOL is and what it is used for
Plenachol Capsules contains the active ingredient cholecal­
ciferol (also known as vitamin D3).Vitamin D is required in
the body to help in the absorption of calcium.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 intestine absorb calcium which helps build
bones.

Each Plenachol 20 000 IU Capsule contains cholecalciferol
equivalent to 0.5 mg of vitamin D3.
Each Plenachol 40 000 IU Capsule contains cholecalciferol
equivalent to 1.0 mg of vitamin D3.

Plenachol capsules are used for:
• The prevention of vitamin D deficiency when there is a
significant risk of deficiency or an increased demand for
vitamin D.
• The treatment vitamin D deficiency that has been
confirmed by laboratory tests.

The capsules also contain medium-chain triglycerides,
butylhydroxyanisole, colloidal anhydrous silica, hypromellose,
gellan gum (E418) and sodium citrate.
The capsule shell contains hypromellose and titanium
dioxide (E171).
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Plenachol (Colecalciferol) 20000/40000 IU capsules hard leaflet - UK
item no:
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origination date:
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dimensions:

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4.
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Technical Approval

revised by:

date sent:

13.01.16

technically app. date:

15.01.16

IL/Encap Ltd.

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6.

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revision date:

supplier:

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pharmacode:
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colours/plates:

1. Profile
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* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

2. What you need to know before you take
PLENACHOL Capsules
Do not take PLENACHOL Capsules:
• If you are allergic (hypersensitive) to cholecalciferol or any
of the ingredients of Plenachol Capsules (see Section 6
Further information).
• If you have raised levels of calcium in the blood
(hypercalcaemia) and/or raised levels of calcium in the
urine (hypercalcuria).
• If you have severe kidney problems.
• If you have a tendency to form calcium containing kidney
stones.
• If you have high levels of vitamin D in your blood
(hypervitaminosis)
• For a child under 12 years as they may not be able to
swallow the capsules and might then choke.

Special Precautions
Check with your doctor or pharmacist before taking your
medicine if any of the following apply to you:
• Are undergoing treatment with certain medicines used to
treat heart disorder (e.g. cardiac glycosides, such as
digoxin).
• Have sarcoidosis (an immune system disorder which may
cause increased levels of vitamin D in the body).
• Are taking medicines containing vitamin D, or eating foods
or milk enriched with vitamin D.
• Are likely to be exposed to a lot of sunshine whilst using
Plenachol Capsules
• Take additional supplements containing calcium.Your
doctor will monitor your blood levels of calcium to make
sure they are not too high whilst you are using Plenachol
Capsules.
• Have kidney damage or disease.Your doctor may want to
measure the levels of calcium in your blood or urine.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.

Driving and using machines
There is limited information on the possible effects of this
medicine on your ability to drive. However, it is not
expected that it would affect your ability to drive or use
heavy machinery.

• Medicines containing vitamin D or eating food rich in
vitamin D, such as some types of vitamin D-enriched milk.
• Actinomycin (a medicine used to treat some forms of
cancer) and imidazole antifungals (e.g. clotrimazole and
ketoconazole, medicines used to treat fungal disease).
These medicines may interfere with the way your body
processes vitamin D.
• The following medicines because they can interfere with
the effect or the absorption of vitamin D:
> Antiepileptic medicines (such as phenytoin) or
medicines to treat sleep disorders and epilepsy
(barbiturates such as phenobarbitone).
> Glucocorticoids (steroid hormones such as
hydrocortisone and prednisolone). These can
decrease the effect of vitamin D.
> Medicines that lower the level of cholesterol in the
blood (such as cholestyramine or colestipol).
> Certain medicines for weight loss that reduce the
amount of fat your body absorbs (such as orlistat).
> Certain laxatives (such as liquid paraffin).

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription. Taking some medicines
together can be harmful.

If you are unsure of the types of medicines you are taking,
ask your doctor or pharmacist.

In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• Medicines that act on the heart or kidneys, such as
cardiac glycosides (e.g. digoxin) or diuretics (e.g.
bendroflumethiazide). When used at the same time as
vitamin D these medicines may cause a large increase
in the level of calcium in the blood and urine.

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.
This high strength formulation is not recommended for use
in pregnant and breast feeding women.

3. How to take PLENACHOL Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you.You should check with them if you
are not sure. Plenachol Capsules should be taken orally.
Swallow the capsules whole (not chewed) with a drink of
water.You should take Plenachol Capsules preferably
together with a large meal.
Initial treatment of vitamin D deficiency:
• Plenachol 20 000 IU Capsules:
Two capsules to be taken weekly for 7 weeks
• Pleanchol 40 000 IU Capsules:
One capsule to be taken weekly for 7 weeks

Taking Plenachol Capsules with food and drink
You should take this medicine preferably together with a
large meal to help your body absorb the vitamin D.

print proof no:
origination date:
originated by:
approved for print/date

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If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. Possible side effects

Uncommon (affects less than 1 in 100 people)
• Too much calcium in your blood (hypercalcaemia)
• Too much calcium in your urine (hypercalciuria)

148x350

dimensions:

min pt size:

colours/plates:
1. Black
2.
3.

pharmacode:
9pt (font size)

4.
5.
6.

DR

Non Printing Colours

Technical Approval

revised by:

date sent:

13.01.16

technically app. date:

15.01.16

IL/Encap Ltd.

If you forget to take PLENACHOL Capsules:
Do not worry. If you miss a dose, take another as soon as
you remember, unless it is almost time for your next dose.
Then go on as before. Do not take a double dose to make
up for a forgotten dose.

During long-term treatment, the calcium levels in the blood
and urine should be monitored regularly and kidney
function tested by measurement of serum creatinine. If
necessary, the dosage must be adjusted according to the
blood calcium values (see Section 2 Special Precautions).

revision date:

supplier:

Your doctor will treat you accordingly in case of an
overdose.

Like all medicines, Plenachol Capsules can have side effects,
although not everybody gets them. Possible side effects may
include:

If you take more PLENACHOL Capsules than
you should:
If you accidentally take too many capsules, or someone else
takes any of your medicine, you should tell your doctor at
once or contact the nearest accident and emergency
department. Show any left-over medicines or the empty
packet to the doctor.

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Signs and symptoms of an overdose can be nausea
(feeling sick), vomiting, excessive thirst, the production of
large amounts of urine over 24 hours, constipation and
dehydration.

The doctor must decide on an individual basis whether any
further treatment (follow-on or long-term) with Plenachol
Capsules is necessary.

Plenachol (Colecalciferol) 20000/40000 IU capsules hard leaflet - UK
item no:

An overdose can lead to increased levels of calcium in the
blood (hypercalcaemia) and in the urine (hypercalciuria),
shown by lab tests.

1. Profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

Rare (affects less than 1 in 1000 people)
• Skin rash
• Itching
• 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.

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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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