Skip to Content

ERGOCALCIFEROL INJECTION BP 300 000 UNITS

Active substance(s): ERGOCALCIFEROL

View full screen / Print PDF » Download PDF ⇩
Transcript
282849_B01-MU-Erg_UK_Layout 1 17/12/2014 14:58 Page 1

Ergocalciferol 300,000U Injection BP, Calciferol, Vitamin D2

Patient Information Leaflet:

Read all of this leaflet carefully before you are given this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• In this leaflet, Ergocalciferol 300,000U Injection BP will
be called Ergocalciferol.
In this leaflet:
1. What Ergocalciferol is for
2. Before you are given Ergocalciferol
3. How you will be given Ergocalciferol
4. Possible side effects
5. How to store Ergocalciferol
6. Further information.

1. What Ergocalciferol is for
Ergocalciferol is a form of Vitamin D.
Ergocalciferol increases levels of calcium and phosphate in
the blood by increasing their absorption from the gut and
reducing the amount removed by the kidneys.
Ergocalciferol is used to treat:
• Low levels of phosphate in the blood
• Weak bones and teeth (called ‘Rickets’)
• Other problems with how bones are formed.
These disorders are due to poor absorption of Vitamin D
within the body usually caused by diseases of the gut, liver
or gall bladder.
It is important that you have this medicine so that your
bones and teeth form properly.

2. Before you are given Ergocalciferol
You should not be given Ergocalciferol if:
• You are allergic to Vitamin D
• You are allergic to the other ingredient of Ergocalciferol
(see section 6)
• You have high levels of calcium in your blood
• You already have high levels of Vitamin D in your blood,
or if you are especially sensitive to Vitamin D
• You have kidney problems.
• You have an accumulation of calcium salts in the body's
tissue.
If any of the above applies to you talk to your doctor or
nurse.
Check with your doctor before being given Ergocalciferol:
• As it is important that you are taking enough calcium in
your diet so that your body can respond properly to your
medicine
• If you have heart disease, problems with your kidneys or
with your circulation
• If you have kidney stones
• If you have low levels of parathyroid hormone (PTH)
• If you already have high levels of Vitamin D in your
blood or if you are especially sensitive to Vitamin D.

Tell your doctor if you are taking any of the following
medicines:
• Drugs for heart disease such as digoxin or verapamil as
these can cause high levels of calcium in the blood
leading to an irregular or fast heart beat
• Antacids containing magnesium for indigestion. If you
are on kidney dialysis this can lead to high levels of
magnesium in the blood which causes muscle weakness,
low blood pressure, depression and coma
• Thiazide diuretics to relieve water retention such as
bendrofluazide as these can lead to high levels of calcium
if your body does not produce enough parathyroid
hormone (PTH)
• Phenytoin, carbamazepine, primidone or phenobarbital
used for the treatment of epilepsy as these may cause
Ergocalciferol to be lost from the body too quickly
• Any other medicine, including medicines obtained
without a prescription.
If any of the above applies to you talk to your doctor or
nurse before using Egrocaliferol.
Pregnancy and breast-feeding
If you are pregnant or trying to become pregnant tell your
doctor or nurse before being given Ergocalciferol. Your
doctor will tell you if you need to have Ergocalciferol and
you are pregnant.
You should not be given Ergocalciferol if you are breast-feeding.
This medicine will be given to you in pregnancy only if your
doctor decides it is necessary.

Driving and using machines
Ergocalciferol may cause drowsiness or your eyes to
become very sensitive to light. If this happens to you, do
not drive or use machinery.

3. How you will be given Ergocalciferol
Ergocalciferol will be given to you by your doctor or nurse.
Important: Your doctor will choose the dose that is right
for you.
You will be given Ergocalciferol by your doctor or nurse as
an injection into a muscle. You may be given it just once
or it may be repeated daily depending on how much your
body needs.
Your doctor may also prescribe for you other medicines
containing calcium and phosphorus.
Adults
You should not normally have more than 40,000 units per
day (1 mg per day).
Children
You should not normally have more than 10,000 units per
day (0.25 mg per day).
Medical check-ups
While you are receiving this medicine, your doctor will test
your blood and urine regularly. This is to make sure that
your medicine is working properly and that the dose you
are taking is right for you. If the level of sugar in your
blood becomes higher than normal your doctor will stop
your treatment of Ergocalciferol.
MU-Erg-UK

282849_B01-MU-Erg_UK_Layout 1 17/12/2014 14:58 Page 2

If you are given more Ergocalciferol than you should
If you think you have been given too much Ergocalciferol
you should tell your doctor.
If you have too much Ergocalciferol you may get increased
calcium levels in your blood which may lead to the
following: feeling sick, feeling weak, weight loss, stiffness,
constipation, diarrhoea, hallucinations, fainting, increased
levels of urination or feeling thirsty.
If you have any further questions about the use of this
medicine, ask your doctor or nurse.

4. Possible side effects
Effects on the heart and blood
• Hardening of the blood vessels
• Irregular heart beat
• High blood pressure
• High cholestrol
• Imbalanced salt levels.
Effects on liver or kidneys
• Kidney problems including kidney stones
• Increase in liver enzymes
• Protein in the urine.
Effects on the stomach and bowel
• Inflammation of the pancreas, which causes severe pain
in the abdomen and back
• Feeling sick or being sick
• Constipation

• Diarrhoea
• Loss of appetite
• Weight loss.
Effects on thirst and urinating
• Dry mouth
• A metallic taste
• Drinking a lot
• Passing a lot of urine especially at night.
Effects on the eyes and skin
• Conjunctivitis
• Sensitivity to light
• Itchy skin.
Effects on mood
• Psychosis – a change in personality
• Being irritable
• Loss of sex drive.
Effects on the nervous system
• Weakness
• Headache
• Dizziness
• Sleepiness.
Other effects
• Calcium deposits in parts of the body other than bone
• Muscle pain
• Bone pain

• Tiredness
• Feeling too hot
• Runny nose.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow
Card Scheme on the MHRA 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 Ergocalciferol
Keep out of the reach and sight of children.
Do not use Ergocalciferol after the expiry date on the box.
The expiry date refers to the last day of that month.
Store below 25ºC. Keep Ergocalciferol in the original
packaging in order to protect it from light.
Your doctor or nurse will make sure your medicine is
correctly stored and disposed of.

6. Further information
What Ergocalciferol contains
The active substance is ergocalciferol at a strength of
0.75%.
The only other ingredient is ethyl oleate.

What Ergocalciferol looks like
Ergocalciferol 300,000U is a pale yellow liquid which
comes in a 1 ml glass ampoule.
These come in packs of either 5 or 10 ampoules.
Marketing Authorisation Holder
RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Haninge,
Sweden.
Distributed by Focus Pharmaceuticals Ltd.
Manufacturer
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne,
Lancashire, OL7 9RR, UK
This leaflet was last updated December 2014

If this leaflet is difficult to see or read or you
would like it in a different format, please
contact
RPH Pharmaceuticals AB,
Lagervägen 7,
136 50 Haninge,
Sweden.

MU-Erg-UK

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.

Hide