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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.    ^

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 25°C. 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, Lagervagen 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,

Lagervagen 7,

136 50 Haninge,

Sweden.

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