D3 10000 IU

Colecalciferol (Vitamin D3)

• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any
  possible side effects not listed in this leaflet. See section 4.

1. What FLORENCE D3 is and what it is used for:

FLORENCE D3 contains vitamin D3 which is essential for healthy bones. Vitamin D3 belongs to a group of medicines called vitamin supplements which are used to correct and maintain levels of the vitamin in your body.
Vitamin D is produced naturally by your skin after exposure to the sun and is also found in some foods. When levels of vitamin D in the body are too low this can cause bones to become fragile.
FLORENCE D3 is available in two strengths and is used in adults and adolescents over 12 years old to prevent and treat:

• Very low levels of vitamin D (deficiency)
• Can also be used in combination with other medicines to treat certain bone conditions such as thinning of the bones (osteoporosis).

2. What you need to know before you take FLORENCE D3:
   Do not take:
   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 kidney stones or serious kidney problems.
• If you have high levels of calcium in your blood (hypercalcaemia).
• If you have high levels of calcium in your urine (hypercalciuria)

Warnings and precautions

Talk to your doctor or pharmacist before taking FLORENCE D3:

• If you have problems with your kidneys.
• If you have sarcoidosis (inflammation that produces lumps of cells in various organs in the body). Your doctor will be able to tell you if you do.
• If you are already taking other medicines or supplements containing vitamin D
  Your doctor may wish to do blood or urine tests to monitor your treatment.

Children
This medicine should not be given to children under 12 years old.

Other medicines and FLORENCE D3
Tell your doctor or pharmacist if you are taking, have recently taken or might take any othermedicines.

Tell your doctor or pharmacist before taking FLORENCE D3:If you are taking medicines from a group known as cardiac glycosides used to treat heart conditions (e.g. digoxin, digitalis).

The following medicines may decrease the effects of FLORENCE D3:

• Medicines used to treat epilepsy (e.g. phenytoin).
• Medicines used to help you sleep (e.g. barbiturates).
• Laxatives (e.g. paraffin oil).
• Cholesterol lowering medicines (e.g. cholestyramine).
• Steroids from a group known as glucocorticoids often used to treat allergies or asthma (e.g. hydrocortisone, prednisolone).

The following medicines may increase the effects of FLORENCE D3:A group of medicines called thiazide diuretics which are mainly used to treat high blood pressure (e.g. bendroflumethiazide).

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.

3. How to take FLORENCE D3
   Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dose for treatment of Vitamin D deficiency
The dose needed to treat vitamin D deficiency will depend on how low your vitamin D levels are. Your doctor will advise you on the strength and number of tablets to take and how often you should take them – usually up to 50,000 IU for adolescents or up to 100,000 IU for adults, which may be spread over several weeks.
After this you may need to take regular doses to maintain your vitamin D levels.
Dose for prevention of deficiency, and maintenance after treatment of deficiency
The recommended dose is 5,000 IU a WEEK, in some cases higher doses may be required. Your doctor will prescribe the correct dose for you.
Signs of overdose include:

• Nausea, vomiting
• Excessive passing of urine
• Loss of appetite
• Weakness
• Apathy
• Thirst
• Constipation
• Drowsiness
• Dizziness

If you forget to take FLORENCE D3

If you forget to take your medicine, take it as soon as possible and continue to take the tablets 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, this medicine can cause side effects, although not everybody gets them.
   Serious side effects:

• Allergic reaction. The likelihood of this side effect happening to you is not known, however, stop taking FLORENCED3 and seek immediate medical help if you have any signs of serious allergic reaction such as a swollen face, lips, tongue or throat, difficulty swallowing or breathing.
• Hypercalcaemia (too much calcium in your blood). This is an uncommon side effect of
  FLORENCE D3 which can cause nausea, vomiting, excessive passing of urine, loss of appetite, weakness, apathy, thirst, constipation, drowsiness or dizziness. Stop taking FLORENCE D3 and seek immediate medical help if these symptoms occur. Your doctor should monitor your blood calcium level during long-term treatment with FLORENCE D3.

Other side effects:
Uncommon (may affect up to 1 in 100 people)

• Hypercalciuria (too much calcium in your urine) which can cause increased frequency of urination, pain on urination, abdominal pain, bladder or kidney stones and urinary tract infections
  Rare (may affect up to 1 in 1,000 people)
• Itching
• Skin rash
  Frequency not known (frequency cannot be estimated from the available data)
• Nausea, vomiting.

5. How to store FLORENCE D3
   Keep this medicine out of the sight and reach of children.

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

• Do not store above 25˚C.
• Store in the original packaging in order to protect from light and moisture.
• Do not throw away any medicines via wastewater or household waste.
• Keep Out of Reach of Children.
• Do not expose to direct sunlight.

6. Contents of the pack and other information

What FLORENCE D3 contains
The active substance is vitamin D3 as Colecalciferol. Each tablet contains either 5,000 IU. 10,000 IU. 25,000 IU or 50,000IU of Colecalciferol.