Domnisol 266 micrograms soft capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes possible side effects not listed in this leaflet. See Section 4.

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

• If you are allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6).
• If you have hypercalcaemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
• If you have kidney stones.
• If you have high levels of vitamin D in your blood (hypervitaminosis D).

Talk to your doctor or pharmacist before taking Domnisol:

• If you are taking other Vitamin D medicines, as it is important that you do not take more Vitamin D than recommended by your doctor. (see section 3, paragraph If you take more Domnisol than you should).
• Your doctor may ask you to take blood or urine tests (e.g. for calcium, phosphorus) while you are taking this medicine or before you start. This is to check that your medicine is working correctly.
• If you have kidney damage or disease. Your doctor may want to take blood tests (e.g. for calcium) to monitor your treatment.
• If you have heart disease. Your doctor may want to take blood tests (e.g. for calcium) to monitor your treatment, especially those receiving treatment with cardiac glycosides (see in this section paragraph ‘taking Domnisol with other drugs’).
• If you have hypoparathyroidism (a condition where your parathyroid glands in your neck produce too little parathyroid hormone.
• If you have a tendency to get calcium-containing kidney stones, your doctor should monitor your blood calcium levels.
• Patients with prolonged immobilization may need lower dose of Domnisol
• Patients with sarcoidosis (disease with nodules, usually on the skin), tuberculosis or other diseases with nodules should be especially careful with this medication, as they have more risk of side effects at lower doses than the recommended ones. Periodic analyses should be performed to control the levels of calcium in blood and urine.
• Your doctor must inform you and your family and/or caregivers of the importance of taking the drug at the doses indicated by him/her and of recommendations about your diet and calcium supplements intake to avoid overdosing.
• Interference with laboratory tests: If you are going to have any diagnostic test done (including blood, urine, skin tests using allergen, etc.) inform the doctor that you are taking this medication because it may influence the results. For example, in a cholesterol test.

Domnisol is not recommended for use in children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can alter the way this medicine works. On the other hand, Domnisol, or its active ingredient calcifediol monohydrate can affect the effectiveness of other drugs taken simultaneously.

Therefore, they may interact with the following drugs:

• Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing drugs (favouring the reduction of Domnisol effect).
• Heart medicines and/or hypertension and cardiac glycosides, thiazide diuretics or verapamil.
• Cholestyramine, colestipol (for cholesterol), orlistat (for obesity). Intake of these drugs and calcifediol monohydrate should be separated at least 2 hours
• Mineral oil or paraffin, (laxatives): Using another type of laxative or separating intake of both drugs is recommended.
• Some antibiotics (such as penicillin, neomycin, and chloramphenicol)
• Magnesium salts
• Other products with Vitamin D
• Calcium supplements
• Corticosteroids (anti-inflammatory drugs).

Some foods and drinks are supplemented with vitamin D. This should be considered since the effects could be added to the effects of this medicine and therefore be excessive.

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.

Domnisol is not recommended during pregnancy.

Calcifediol monohydrate is poorly excreted into breast milk. Nevertheless, in case you are a breast-feeding woman, this should be considered by your doctor or pharmacist when prescribing a vitamin D supplement.

Domnisol should not affect your ability to drive or operate machinery.

This medicine contains 5 mg of alcohol (ethanol) in each capsule. The amount in 1 capsule of this medicine is equivalent to less than 1 ml beer or wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 22 mg of sorbitol in each capsule.

If you take more Domnisol than the dose prescribed by your doctor (overdose) and/or for a long time, hypercalcemia (high blood calcium levels) and phosphates in urine and blood may appear, possibly leading to kidney failure. Some symptoms of toxicity can appear early and others later. Initial symptoms include weakness, fatigue, headache, loss of appetite, dry mouth, digestive disorders such as vomiting, abdominal cramps, constipation or diarrhoea, increased thirst, increased urination, muscle pain. Some symptoms that may occur later are itching, weight loss, stunted growth in children, kidney disorders, intolerance to sunlight, conjunctivitis, increased cholesterol, transaminases, inflammation of the pancreas, calcification (calcium salts deposits) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disorders, irregular heartbeat. The symptoms of overdose usually improve or disappear when treatment is stopped, but if intoxication is severe kidney or heart failure can occur.

Do not take a double dose to make up for a forgotten capsule.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.

• The active substance is calcifediol monohydrate. Each capsule contains 266 micrograms of calcifediol monohydrate.
• The other ingredients are anhydrous ethanol, medium chain triglycerides and the components of the capsule include gelatin, glycerol, sorbitol (E-420), titanium dioxide (E-171) and iron oxide yellow (E-172).

Domnisol capsules are yellow coloured oval soft gelatin capsule containing a clear, low viscous liquid free from particles packed in PVC/PVDC-Al blisters containing 1, 3, 5 or 10 capsules.