What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL41344/0001.

Aviticol 20 000 IU Capsules

Package leaflet: Information for the Patient

Aviticol 20 000 IU Capsules

Colecalciferol (Vitamin D3), hard capsule

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, 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 any possible side effects not listed in this leaflet.

What is in this leaflet

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

1. What Aviticol Capsules are and what they are used for

Aviticol Capsules contain the active ingredient colecalciferol. Colecalciferol is a form of vitamin D used in the initial treatment of clinically relevant vitamin D deficiency conditions in adults.

Aviticol 20 000 IU Capsules contain the equivalent of 500 micrograms vitamin D3 which is involved in bone formation. The active ingredient, colecalciferol, is identical to the vitamin D3 that is found in the human body.

Deficiency of vitamin D may occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant).

2. What you need to know before you take Aviticol Capsules

Do not take Aviticol

  • if you are allergic (hypersensitive) to colecalciferol or any of the other ingredients in the capsules (these are listed in section 6, Contents of the pack and other information)
  • if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria)
  • if you suffer from pseudohypoparathyroidism (disorder of the parathyroid hormone balance)
  • if you suffer from severe renal impairment
  • if you have kidney stones (renal calculi)
  • if you have high levels of vitamin D in your blood (hypervitaminosis D)
  • if you already take other medicines containing vitamin D (e.g. multivitamin preparations)

Warnings and precautions

Talk to your doctor or pharmacist before taking Aviticol:

  • if you suffer from heart disease or narrowing of the arteries
  • if you suffer from sarcoidosis (a multisystem chronic inflammatory condition which can affect your lungs, heart and kidneys), then there is a risk of increased conversion of vitamin D into its active form
  • If you are taking medicines containing vitamin D, or eating foods or drinking milk enriched with vitamin D
  • if your renal function is impaired
  • if you have a tendency to form calcium-containing renal calculi
  • if you need additional calcium supplementation. Calcium supplements should be given only under close medical supervision.

Your doctor may want you to have regular blood tests to check the amount of calcium in your blood.

During treatment with an equivalent daily dose exceeding 1,000 IU vitamin D the serum and renal calcium levels must be monitored and renal function checked via serum creatinine determination. Such monitoring is particularly important in elderly patients and during concomitant treatment with cardiac glycosides or diuretics (see section “Other medicines and Aviticol”). This also applies to patients who are particularly susceptible to the formation of kidney stones that contain calcium.

During pregnancy Aviticol should be taken only when strictly indicated and dosed only as it is absolutely necessary to correct the vitamin D deficiency.

Children and adolescents

This product should not be used in young children and adolescents aged up to 18.

Other medicines and Aviticol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

  • medicines for epilepsy such as barbiturates or other anti-convulsants (e.g. carbamazepine, phenobarbital, phenytoin, primidone)
  • other vitamin D containing medicines including multi-vitamins
  • cardiac glycosides for the treatment of cardiovascular disease (e.g. digoxin, digitoxin)
  • thiazide diuretics (water tablets) such as hydrochlorothiazide
  • calcium supplements
  • medicines to treat tuberculosis e.g rifampicin, isoniazid
  • medicines leading to fat malabsorption e.g orlistat, cholestyramine, liquid paraffin
  • medicines to treat fungal infections i.e ketoconazole, itraconazole
  • actinomycin (a medicine used to treat some forms of cancer) as it may interfere with the metabolism of vitamin D
  • glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone).

Aviticol Capsules with food and drink

Aviticol should preferably be taken together with food and drink.

Pregnancy, breast-feeding and fertility

Pregnancy

During pregnancy Aviticol should be taken only when strictly indicated and dosed only as it is absolutely necessary to correct the vitamin D deficiency. Overdoses of vitamin D must be avoided during pregnancy, as prolonged hypercalcaemia (increased blood level of calcium) may lead to physical and mental disability as well as to congenital heart and eye diseases in the child.

Breast-feeding

Vitamin D and its metabolites are excreted in human milk. There have been no observed cases of overdose produced in this way among infants. This should, however, be borne in mind when administering additional vitamin D to the child. Treatment with high-dose vitamin D in breast-feeding women is not recommended.

Fertility

Normal endogenous levels of vitamin D are not expected to have any adverse effects on fertility.

Driving and using machines

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

3. How to take Aviticol Capsules

Always take this medicine exactly as your doctor or pharmacist has told you and as written on the label. Check with your doctor or pharmacist if you are not sure.

Recommended Dose and Dosage Schedules

Adults

Initial treatment of clinically relevant vitamin D deficiency:

  • 1 capsule twice per week (equivalent to 40,000 IU/week) for 7 weeks (corresponding to a loading dose of 280,000 IU).

Maintenance therapy with lower doses of vitamin D equivalent to 800 to 1000 IU daily may be considered one month after the end of initial treatment with Aviticol 20 000 IU Capsules.

For this purpose other preparations are available. The doctor in charge shall decide on the individual dosage and the duration of treatment.

Use in children and adolescents

Aviticol 20 000 IU Capsules should not be used in infants or young children (under 12 years) as they may not be able to swallow the capsules and might choke. Instead, it is advisable to use drops or dissolvable tablets. Due to the lack of data on posology the administration in adolescents between the ages of 12 – 18 years is not recommended.

If you have problems absorbing vitamin D, or have other conditions such as liver or kidney disease, the dose may be different and will depend on your medical condition.

The capsules should be swallowed whole with a glass of water, preferably with the main meal of the day.

It is important not to exceed the prescribed dose.

If you take more Aviticol Capsules than you should

If you accidentally take more capsules than you have been prescribed, contact your doctor or get medical advice immediately.

If possible, take the capsules, the box and this leaflet with you to show the doctor.

If you forget to take Aviticol Capsules

If you forget to take your capsules, take them as soon as possible. Then take the next dose at the correct time, in accordance with the instructions given to you by your doctor. However, if it is almost time to take the next dose, do not take the dose you have missed; just take the next dose as normal.

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

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

4. Possible side effects

Like all medicines, Aviticol can cause side effects, although not everybody gets them.

Side effects with Aviticol may include:

Uncommon side effects

(affecting less than 1 in 100 people)

  • too much calcium in your blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion
  • too much calcium in your urine (hypercalciuria).

Rare side effects

(affecting less than 1 in 1000 people)

  • skin rash
  • itching
  • raised itchy rash (hives)

Tell your doctor or pharmacist if any of the side effects become serious or if you notice any side effects not listed.

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.

You can also report side effects directly to the relevant medicine authority (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

The Yellow Card Scheme
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ
United Kingdom
Website: www.mhra.gov.uk/yellowcard

Malta:

ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3
Rue D’Argens
GŻR-1368 Gżira
Malta
Website: www.medicinesauthority.gov.mt

Germany:

Bundesinstitut für Arzneimittel und MedizinprodukteAbt.
PharmakovigilanzKurt-Georg-Kiesinger Allee
3D-53175 Bonn
Website: http://www.bfarm.de

5. How to store Aviticol Capsules

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

Store below 25°C. Store blister foil in the original container in order to protect from light.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

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 Aviticol Capsules contain

The active substance is colecalciferol (vitamin D3 ).

The other ingredients are medium-chain triglycerides, butylated hydroxytoluene (BHT), colloidal silicon dioxide, titanium dioxide E171, yellow iron oxide E172 and gelatin.

What Aviticol 20 000 IU Capsules look like and contents of the pack

Aviticol 20 000 IU Capsule is an ivory unprinted hard gelatin capsule containing a clear, slightly oily liquid.

It is available in Germany in blister packs containing 14 hard capsules, and in UK and Malta in blister packs containing 10, 14, 20, 28, 30, 56, 60, 84 and 100 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Colonis Pharma Limited
Quantum House
Hobson Industrial Estate
Burnopfield
County Durham
NE16 6EA
United Kingdom

Manufacturers

MW Encap Limited
Oakbank Park
Building 1
Units 4, 5 & 6
Livingston
West Lothian
EH53 0TH
United Kingdom

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorised in other Member States of the EEA under the following names:

Malta: Aviticol 20 000 IU Capsules

Colecalciferol 20 000 IU Capsules

Germany: Dekristol 20.000 IE N

This leaflet was last revised in May 2018.

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