Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ergocalciferol 300,000IU Solution for Injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ergocalciferol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
This medicine contains the active ingredient ergocalciferol which is a form of vitamin D. It belongs to a group of medicines called vitamin D and analogues. 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.
What you need to know before you take it
Ergocalciferol
You must not be given Ergocalciferol: • • • • •
if you are allergic to ergocalciferol (vitamin D) or any of the other ingredients of this medicine (listed in section 6) if you have high levels of calcium in your blood if you already have high levels of vitamin D in your blood, or if you are especially sensitive to vitamin D if you have kidney problems if 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. Warnings and precautions Talk to your doctor or nurse before being given Ergocalciferol: • 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.
It is important that you are taking enough calcium in your diet so that your body can respond properly to your medicine Other medicines and Ergocalciferol Tell your doctor if you are taking, have recently taken or might take any other medicines. • • • • •
Medicines 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 ('water tablets') to relieve water retention such as bendroflumethiazide 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 being given Ergocalciferol. 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 for advice before being given this medicine. Your doctor will tell you if you need to have Ergocalciferol when 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 to take it
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. Use in adults and elderly The recommended dose is typically a single dose of 300,000 IU every 3-6 months. Use in children The recommended dose in children of 1-12 years is a single dose of 300,000 IU generally given in 2 divided doses. 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 with 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 on the use of this medicine, ask your doctor or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects
include: Very common: may affect more than 1 in 10 people • Too much calcium in blood (hypercalcaemia) • Decrease activity of parathyroid gland (hypoparathyroidism) • Disturbed parathyroid hormone metabolism (pseudohypoparathyroidism) • Increased levels of creatinine in the blood which may indicate kidney problems. Rare: may affect up to 1 in 1,000 people •
Psychosis – changes in abilities and personality.
Not known: frequency cannot be estimated from the available data Effects on the heart and blood • • • • •
Hardening of the blood vessels Irregular heart beat High blood pressure High cholesterol 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 • •
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Ergocalciferol
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store below 25oC. Keep the ampoules in the outer carton in order to protect it from light. Your doctor or nurse will make sure your medicine is correctly stored and disposed of. 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. 6.
Contents of the pack and other information
What Ergocalciferol contains The active substance is ergocalciferol. Each 1 ml ampoule contains 300,000 IU of ergocalciferol The only other ingredient is ethyl oleate. What Ergocalciferol looks like and contents of the pack
Ergocalciferol is a colourless to pale yellow solution for injection. The product is available in clear glass (Type I) ampoules in packs containing 5 or 10 ampoules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder RPH Pharmaceuticals AB Box 603 101 32 Stockholm Sweden Manufacturer Biologici Italia Laboratories S.r.l. Via, Filippo Serpero 2 20060 Masate (MI) Italy This leaflet was last revised in 05/2025 If this leaflet is difficult to see or read or you would like it in a different format, please contact: RPH Pharmaceuticals AB Box 603 101 32 Stockholm Sweden
Frequently asked questions about Ergocalciferol 300,000IU Solution for Injection
How do I take Ergocalciferol 300,000IU Solution for Injection?
Ergocalciferol 300,000IU Solution for Injection comes as injection containing 300iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ergocalciferol 300,000IU Solution for Injection?
The active substance in Ergocalciferol 300,000IU Solution for Injection is ergocalciferol.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ergocalciferol 300,000IU Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ergocalciferol 300,000IU Solution for Injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ergocalciferol
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Intramuscular therapy with Ergocalciferol Injection is used in patients with gastrointestinal, liver or biliary disease associated with malabsorption of Vitamin D, resulting in hypophosphataemia, rickets, and osteomalacia.
4.2. Posology and method of administration
Route of Administration: IM injection
Posology
Adults and Elderly
Ergocalciferol Injection is typically administered as a single dose of 300,000 IU every 3-6 months.
Paediatric population
In children 1-12 years, a bolus dose 300,000IU ergocalciferol is generally given in 2 divided doses.
However, for all age groups dosage should be individualised by the clinician for each patient dependent upon clinical response and requirements.
Serum and urinary calcium concentrations, phosphate and BUN should be monitored at regular intervals, initially weekly, in order to achieve optimum clinical response and to avoid hypercalcaemia.
Calcium and phosphorous supplements should be administered where necessary.
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Hypercalcaemia, evidence of vitamin D toxicity, hypervitaminosis D, decreased renal function, metastatic calcification.
4.4. Special warnings and precautions for use
Adequate dietary calcium is necessary for clinical response to Ergocalciferol therapy.
Caution should be used when the injectable forms are used in patients with vitamin D resistant rickets as the range between the toxic and therapeutic dosage is narrow.
Vitamin D should be administered with caution to infants and patients who may have an increased sensitivity to its effects. Use with care in patients with renal impairment, renal calculi or heart disease or arteriosclerosis who might be at increased risk of organ damage if hypercalcaemia were to occur.
Ergocalciferol is not recommended for use in hypoparathyroidism. In the event of hypoparathyroidism when Ergocalciferol is used, calcium, parathyroid hormone or dihydrotachysterol may be required.
Dosage should be individualised. Frequent serum and urinary calcium, phosphate and urea nitrogen determinations should be carried out. Adequate fluid intake should be maintained.
Should hyperglycaemia develop, Ergocalciferol should be discontinued immediately.
Because of the effect on serum calcium, Ergocalciferol should only be administered to patients with renal stones when potential benefits outweigh possible hazards.
4.5. Interaction with other medicinal products and other forms of interaction
Ergocalciferol and:-
i) Magnesium-containing antacids: hypermagnesaemia may develop in patients on chronic renal dialysis.
ii) Digitalis glycosides: hypercalcaemia in patients on digitalis may precipitate cardiac arrhythmias.
iii) Verapamil atrial fibrillation has recurred when supplemental calcium and Ergocalciferol have induced hypercalcaemia.
iv) Anti-convulsants: vitamin D requirements may be increased in patients taking anti-convulsants (e.g. carbamazepine, phenobarbital, phenytoin and primidone).
v) Thiazide diuretics: hypoparathyroid patients on Ergocalciferol may develop hypercalcaemia due to increased Ergocalciferol (although Ergocalciferol is not recommended for use in hypoparathyroidism).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of ergocalciferol in pregnant women. Ergocalciferol Injection should not be used in pregnancy unless the potential benefit outweighs the potential hazards to the foetus.
Animal studies have shown foetal abnormalities associated with hypervitaminosis D. Calcifediol and calcitriol are teratogenic in animals when given in doses several times the human dose. The offspring of a woman administered 17-144 times the recommended dose of calcitriol during pregnancy manifested mild hypercalcaemia in the first 2 days of life, which returned to normal at day 3.
Breast-feeding
Ergocalciferol is excreted in human milk in limited amounts and effects have been shown in infants of treated women. In a mother given large doses of Ergocalciferol, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcaemia in the child. Monitoring of the infants serum calcium is required in such cases. Ergocalciferol should not be administered to breast-feeding mothers.
Fertility
None stated.
4.7. Effects on ability to drive and use machines
Ergocalciferol may cause drowsiness and can affect the ability to drive and use machines. If affected, patients should not drive or operate machinery.
4.8. Undesirable effects
Adverse events are generally associated with excessive intake of ergocalciferol leading to the development of hypercalcaemia.
The following convention has been used for the classification of frequency:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
System Organ Class
Adverse event
Frequency
Metabolism and nutrition disorders
Hypercalcaemia *
Very common
Hypercholesterolaemia†
Not known
Muscle weakness§
Not known
Muscle pain§
Not known
Mild acidosis†
Not known
Polydipsia†
Not known
Anorexia†
Not known
Psychiatric disorders
Overt psychosis†
Rare
Somnolence§
Not known
Nervous system disorders
Headache§
Not known
Endocrine disorders
Hypoparathyroidism* pseudohypopathyroidism*
Very common
Eye disorders
Conjunctivitis (calcific)
Not known
Photophobia
Not known
Cardiac disorders
Cardiac arrhythmias
Not known
Rebal disorders
Elevated serum creatinine levels*
Very common
Vascular disorders
Generalised vascular calcification†
Not known
Hypertension†
Not known
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea†
Not known
Gastrointestinal disorders
Pancreatitis†
Not known
Nausea§
Not known
Vomiting§
Not known
Dry mouth§
Not known
Constipation§
Not known
Diarrhoea§
Not known
Abdominal pain§
Not known
Skin and subcutaneous tissue disorders
Pruritus†
Not known
Musculoskeletal and connective tissue disorders
Bone pain§
Not known
Ectopic calcification†
Not known
Renal and urinary disorders
Polyuria†
Not known
Nocturia†
Not known
Nephrocalcinosis†
Not known
Albuminuria†
Not known
Reversible azotemia†
Not known
Reproductive system and breast disorders
Decreased libido†
Not known
General disorders and administration site conditions
Hyperthermia†
Not known
Fatigue§
Not known
Irritability†
Not known
Weakness§
Not known
Investigations
Elevated AST †
Not known
Elevated ALT†
Not known
Elevated BUN†
Not known
Weight loss†
Not known
Surgical and medical procedures
Metallic taste§
Not known
*In clinical studies on hypoparathyroidism and pseudohypopathyroidism, hypercalcaemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).
§ Possible early symptoms of hypercalcaemia
†Possible late symptoms of hypercalcaemia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms
Administration to patients in excess of their daily requirement can cause hypercalcaemia (see section 4.8), hypercalciuria and hyperphosphataemia. Concomitant high intake of calcium and phosphate may lead to similar abnormalities.
Management
Treatment of chronic overdose with resulting hypercalcaemia consists of immediate withdrawal of the vitamin, a low calcium diet and generous fluid intake. Severe cases may require hydration with intravenous saline together with symptomatic and supportive treatment as indicated by the patient's clinical condition. Plasma calcium U & E's should be monitored.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Vitalipid N AdultRetinoli palmitas 194.1 mcg + Fitomenadion 15 mcg + Ergocalciferol 0.5 mcg + int
- Vitalipid N InfantRetinoli palmitas 135.3 mcg + Fitomenadion 20 mcg + Ergocalciferol 1 mcg + int-r
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ergocalciferol 300,000IU Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.