Patient leaflet - Vitamin D3 A.Forall Access 800 IU soft capsules
1. What Vitamin D3 A.forall Access is and what it is used for
Vitamin D3 A.forall Access contains the active substance Colecalciferol.
Vitamin D is found in the diet and is also produced in the skin after exposure to the sun. Often vitamin D is given in combination with calcium. Vitamin D3 A.forall Access is recommended for use when you have a normal intake of dietary calcium.
Vitamin D3 A.forall Access may be prescribed by your doctor to treat or prevent vitamin D deficiency. Deficiency of vitamin D may occur when your diet or lifestyle does not provide you enough vitamin D or when your body requires more vitamin D (for instance when you are pregnant). Vitamin D3 A.forall Access may also be prescribed for certain bone conditions, such as thinning of the bone (osteoporosis) when it will be given to you with other medicines.
2. What you need to know before you take Vitamin D3 A.forall Access
Do not take Vitamin D3 A.forall Access
if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6)
if you have high levels of vitamin D in your blood (hypervitaminosis D)
if you have high blood levels of calcium (hypercalcaemia) or high urine levels of calcium (hypercalciuria)
if you have kidney stones or serious kidney problems.
If any of the above applies to you, tell your doctor or pharmacist before taking Vitamin D3 A.forall Access.
Warnings and precautions
Talk to your doctor before taking Vitamin D3 A.forall Access
- if you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine.
- if you are being treated for heart disease
- if you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)
- if you are already taking additional doses of calcium or vitamin D. Whilst you are taking Vitamin D3 A.forall Access your doctor will monitor your blood levels of calcium to make sure they are not too high.
Other medicines and Vitamin D3 A.forall Access
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
In particular the following medicines may interact with Vitamin D3 A.forall Access:
- Heart medicines (cardiac glycosides such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure the levels of calcium in your blood.
- Thiazide diuretics (used to treat high blood pressure) reduce the urinary excretion of calcium and can increase risk of hypercalcaemia.
- Medicines used to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) can decrease the effects of vitamin D.
- Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) can decrease the effects of vitamin D.
- Laxatives (such as paraffin oil), or a cholesterol lowering drug called cholestyramine, may reduce the absorption of vitamin D.
- Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) may interfere with the metabolism of vitamin D.
Vitamin D3 A.forall Access with food and drink
You can take Vitamin D3 A.forall Access with or without food and drink.
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 or pharmacist for advice before taking this medicine.
Driving and using machines
Vitamin D3 A.forall Access should not affect your ability to drive or operate machinery.
3. How to take Vitamin D3 A.forall Access
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dose of vitamin D depends on severity of the disease, as well as patient’s response to treatment. The dose and the duration of treatment has to be established individually by a physician.
The recommended dose is:
Adults
Prevention of vitamin D deficiency and as an adjunct to specific therapy for osteoporosis:
Recommended dose range is 600 IU- 800 IU per day.
Treatment of vitamin D deficiency:
800 IU per day. The daily dose should not exceed 4,000 IU.
Use in children and adolescents
Vitamin D3 A.forall Access 800 IU, 1000 IU & 3200 IU capsules should not be given to children under 12 years of age due to the risk of choking. Other form(s) of this medicine may be more suitable for children; ask your doctor or pharmacist.
For treatment of vitamin D deficiency in adolescents, the daily dose should not exceed 4,000 IU per day.
Pregnancy
The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be vitamin D3 deficient a higher dose may be required (up to 2 000 IU/day – 2 capsules of 1000 IU).
For other conditions such as obese patients, patients with malabsorption syndromes, and patients on medications affecting vitamin D3 metabolism, higher doses are required for the treatment and prevention of vitamin D3 deficiency.
If you take more Vitamin D3 A.forall Access than you should
If you accidentally take one capsule too many, nothing is likely to happen. If you accidentally take several capsules too many, tell your doctor or get other medical advice immediately. If possible, take the capsules, the box and this leaflet with you to show the doctor. If you take too many capsules, you may feel or be sick, become constipated or have stomach pains, weak muscles, tiredness, lack of appetite, kidney problems and in severe cases irregular heartbeats.
If you forget to take Vitamin D3 A.forall Access
If you forget to take your capsules, take them as soon as you can. Do not take a double dose to make up for a forgotten dose. After that, take the next capsule in accordance with the instructions given to you by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with Vitamin D3 A.forall Access 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
- Hives
Not known (cannot be estimated from the available data)
- swelling of voice box/throat (laryngeal oedema) or swelling of skin layers (angioedema)
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 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.
5. How to store Vitamin D3 A.forall Access
Keep this medicine out of the sight and reach of children. This medicine does not require any special temperature storage conditions. Keep the blister in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton as “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 Vitamin D3 A.forall Access contains
- The active substance is Colecalciferol
- The other ingredients are:
Capsule fill
Medium-chain triglycerides
Capsule shell
Gelatin (E 441)
Glycerol (E 422)
Patent blue V (E131) (1000 IU capsule only)
Purified water
What Vitmin D3 A.forall Access looks like and contents of the pack
800 IU: Transparent, light yellow, oval, soft capsules, filled with light yellow viscous liquid.
Available in packs of 30, 80, 90 capsules packed in Al/PVC/PVDC blisters
1000 IU: Transparent, blue, oval, soft capsules, filled with light yellow viscous liquid.
Available in packs of 30, 40, 100, 120 capsules packed in Al/PVC/PVDC blisters
3200 IU: Transparent, light yellow, round, soft capsules, filled with light yellow viscous liquid.
Available in packs of 30 or 90 capsules packed in Al/PVC/PVDC blisters
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
A.forall Access Ltd.
Stephenstown Industrial Park,
Balbriggan Co. Dublin, K32 VR92
Ireland
Manufacturer
Medana Pharma S.A.,
ul. Władysława Łokietka 1098-200 Sieradz,
Poland