Fultium-D3 3 200 Iu Capsules
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Package Leaflet: Information for the user
Fultium-D3 3,200 IU Capsules
(Colecalciferol)
Read all of this leaflet carefully before you start taking this medicine.
I Keep this leaflet. You may need to read it again.
I If you have any further questions, ask your doctor or pharmacist.
I This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
I If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Fultium-D3 is and what it is taken for
2. Before you take Fultium-D3
3. How to take Fultium-D3
4. Possible side effects
5. How to store Fultium-D3
6. Further information
1. What Fultium-D3 is and what it is taken for
Fultium-D3 are capsules. They contain the active ingredient:
I Vitamin D3 (3,200 IU colecalciferol equivalent to 80 micrograms Vitamin D3)
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. Fultium-D3 is recommended for use when you have a normal intake of dietary calcium.
Fultium-D3 may be prescribed by your doctor to treat 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).
2. Before you take Fultium-D3
Do not take Fultium-D3 if you I are allergic (hypersensitive) to vitamin D or any of the other ingredients in the capsules (these are listed in section 6, Further information)
I have high levels of vitamin D in your blood (hypervitaminosis D)
I have high blood levels of calcium
(hypercalcaemia) or high urine levels of calcium (hypercalciuria)
I have kidney stones or serious kidney problems. Check with your doctor before taking Fultium-D3 if
I you have kidney damage or disease. Your doctor may want to measure the levels of calcium in your blood or urine
I you are being treated for heart disease I you have sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or lymph nodes)
I you are already taking additional doses of calcium or vitamin D. Whilst you are taking Fultium-D3 your doctor will monitor your blood levels of calcium to make sure they are not too high.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular the following medicines may interact with Fultium-D3:
I 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 I Medicines to treat epilepsy (such as phenytoin) or medicines to make you sleep (barbiturates such as phenobarbitone) as these medicines can decrease the effect of vitamin D
I Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These can decrease the effect of vitamin D.
I Laxatives (such as paraffin oil) or a cholesterol lowering drug called colestyramine may reduce the absorption of vitamin D I Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) as they may interfere with the metabolism of vitamin D.
Taking Fultium-D3 with food and drink
You can take Fultium-D3 with or without food and drink.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant or you are breast-feeding you should talk to your doctor or pharmacist before you take Fultium-D3.
Driving and using machines
Fultium-D3 should not affect your ability to drive or operate machinery.
3. How to take Fultium-D3
Always take Fultium-D3 exactly as your doctor has told you.
Dose
In severe vitamin D deficiency (for adults and the elderly)
Your doctor will usually prescribe you a dose of 1 capsule daily for up to12 weeks. The amount will depend on how low your vitamin D levels are and how you respond to treatment.
You should check with your doctor or pharmacist if you are unsure.
The capsules should be swallowed whole (not chewed) with water.
Fultium-D3 is not suitable for children.
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If you take more Fultium-D3 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 Fultium-D3 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, Fultium-D3 can cause side effects, although not everybody gets them.
Side effects with Fultium-D3 may include:
Uncommon side effects (affecting less than 1 in 100 people)
I 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
I too much calcium in your urine (hypercalciuria). Rare side effects
(affecting less than 1 in 1000 people)
I skin rash I itching I hives
Tell your doctor or pharmacist if any of the side effects become serious or if you notice any side effects not listed.
5. How to store Fultium-D3
Keep out of the reach and sight of children.
Do not store above 30°C.
Store blister foil in the original container in order to protect from light.
Do not use Fultium-D3 after the expiry date which is stated on the carton as "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Fultium-D3 contains
The active ingredient (which makes the medicine work) is colecalciferol. Each capsule contains 3,200 IU colecalciferol (equivalent to 80 micrograms Vitamin D3).
The other ingredients are:
Capsule Content Maize oil, refined
Butylated hydroxytoluene (BHT) (E321)
Capsule Shell
Gelatin
Glycerol
Chlorophyllin copper complex sodium (E141) Purified Water.
What Fultium-D3 looks like and contents of the pack
Fultium-D3 3,200 IU Capsule is a small green coloured translucent capsule which has no markings.
It is available in blister packs containing 7, 10, 14, 20, 28, 30, 56, 60, 84 or 90 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder and Manufacturer is:
Jenson Pharmaceutical Services Ltd
Carradine House
237 Regents Park Road
London, N3 3LF
United Kingdom
Distributed by: Internis Pharmaceuticals Ltd.
237 Regents Park Road, London, N3 3LF United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Fultium-D3 3,200 IU
Capsules
This leaflet was last revised in 07/2014