Divifarm 800 iu film-coated tablets
Cholecalciferol ( vitamin D 3 ) – 20 micrograms
1. What Divifarm Is And What It Is Used For
Divifarm contains vitamin D 3 which regulates the uptake and metabolism of calcium as well as the storage of calcium in the skeleton.
This tablet is used to prevent and treat vitamin D 3 deficiency in adults and adolescents.
Your doctor may prescribe this medicine as an adjunct to specific therapy for osteoporosis ( osteoporosis ).
Cholecalciferol contained in Divifarm may also be approved for the treatment of other conditions not mentioned in this product information.
Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What You Need To Know Before Using Divifarm
Do Not Take
- If you are allergic to divifarm cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
- If you have hypercalcemia (increased amount of calcium in the blood) or hypercalciuria (increased amount of calcium in the urine).
- If you have hypervitaminosis D (an excess of vitamin D in your blood).
- If you have kidney stones.
If any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Warnings And Cautions
Talk to your doctor or pharmacist before using the tablet.
- If you suffer from sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints, among other things).
- If you are taking other medicines that contain vitamin D.
- If you have impaired kidney function or have had kidney stones.
Other Medicines And Divifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This applies to the following medicines:
- Cholestyramine (used to treat high cholesterol ).
- Phenytoin or barbiturates (used to treat epilepsy ).
- Laxatives (used in the treatment and/or to prevent constipation) if they contain paraffin oil.
- Thiazide – diuretics (for high blood pressure ).
- Glucocorticoids (for the treatment of inflammation ).
- Digoxin, digitoxin (for irregular heartbeat).
- Actinomycin ( cytostatics ).
- Imidazole (for fungal infections).
- Orlistat (for weight loss).
Pregnancy, Breastfeeding, And Fertility
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 because divifarm side effects may cause
- During pregnancy, the daily intake should not exceed 600 IU of vitamin D.
- This tablet should only be used during pregnancy if vitamin D deficiency has been determined by a doctor.
- This medicine can be used during breastfeeding. Vitamin D 3 passes into breast milk. This should be considered if the breastfed baby is already receiving vitamin D supplements.
Driving And Using Machines
Some Divifarm side effects can effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to Divifarm cholecalciferol side effects and effects.
Descriptions of cholecalciferol side effects and effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Divifarm Contains Sucrose And Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How To Use
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The Divifarm 800 iu tablet can be swallowed whole or crushed. The tablets can be taken with a meal.
- The recommended dose is 1 tablet daily.
- The daily dose should not exceed 4000 IU (5 tablets).
Use For Children
Divifarm cholecalciferol should not be used in children under 12 years of age, as there is no evidence from clinical trials.
If You Take More Divifarm Then You Should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If You Forget To Take Divifarm
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Cholecalciferol Side Effects
Possible Cholecalciferol side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking medicine and contact a doctor immediately if you get any of the following divifarm cholecalciferol side effects ( angioedema ):
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing
Uncommon (may affect up to 1 in 100 people):
- Hypercalcaemia (increased amount of calcium in the blood) and hypercalciuria (increased amount of calcium in the urine)
Rare (may affect up to 1 in 1,000 people):
- Itching
- Rash
- Hives
5. How To Store Divifarm
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
- Blister: Do not store above 25 ° C. Store the blister in the outer carton. Sensitive to light.
- Tablet jar: Store in the original jar. Sensitive to light.
- 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. Contents Of The Packaging And Other Information
Content Declaration
- The active substance is cholecalciferol 20 micrograms, equivalent to divifarm 800 iu cholecalciferol vitamin D 3.
- Other ingredients are:
- Tablet core: lactose monohydrate; cellulose powder; modified starch; corn starch; croscarmellose sodium; sucrose; colloidal anhydrous silica; magnesium stearate; sodium ascorbate; medium-chain triglycerides; all- rac -α-Tokoferol
- Film coating: poly (vinyl alcohol); titanium dioxide (E171); macrogol; talc; quinoline yellow aluminum lacquer (E104); yellow iron oxide (E172).
What The Medicine Looks Like And The Contents Of The Pack
- Divifarm 800 iu tablet color is a yellow, round, 6.1 mm diameter film-coated tablet with a smooth, convex surface on both sides.
- Pack sizes of divifarm 800 iu tablet: 90 pieces in opaque PVC / PVdC aluminum blister or 250 tablets in a plastic jar and outer carton.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
- Local representative
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
- Manufacturer
Pharma Patent Ltd.
Népfürdő utca 22. Duna torony B épület, 10. emelet
1138 Budapest
Hungary