400 IU soft capsules 
cholecalciferol ( vitamin D3)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Benferol is and what it is used for 
2. What you need to know before you use Benferol 
3. How to use Benferol 
4. Possible side effects 
5. How to store Benferol 
6. Contents of the packaging and other information 

1. What Benferol is and what it is used for

Benferol contains vitamin D3, which regulates the uptake and turnover of calcium as well as the storage of calcium in bone tissue.

Benferol is used to prevent and treat vitamin D3 deficiency in adults and adolescents.

Your doctor may prescribe Benferol as a supplement to specific drug treatment for bone loss.

2. What you need to know before you use Benferol

Do not use Benferol

– if you are allergic to 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 (increased amount 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 taking Benferol.

Warnings and cautions

Talk to your doctor or pharmacist before taking Benferol:

– if you have sarcoidosis (a specific type of connective tissue disease that affects the lungs, skin, and joints)

– if you are taking other medicines containing vitamin D.

– if you have kidney problems or have had kidney stones.

If any of the above apply to you, talk to your doctor or pharmacist before taking Benferol.

Other medicines and Benferol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, in particular, any of the following:

– cholestyramine (used to treat high cholesterol )

– phenytoin or barbiturates (used to treat epilepsy )

– laxatives containing paraffin oil

– thiazide diuretics (for the treatment of high blood pressure )

– glucocorticoids (for the treatment of inflammation )

Cardiac glycosides (for the treatment of heart disease), e.g. digoxin

– actinomycin ( chemotherapy )

– imidazole (antifungal)

Orlistat (weight loss aid).

Benferol with food, drink, and alcohol

See section 3 “How to take Benferol”

Pregnancy, breastfeeding, and fertility

During pregnancy, the daily intake should not exceed 600 IU of vitamin D.

Benferol should only be used during pregnancy if vitamin D deficiency has been determined by healthcare professionals.

Benferol can be used during breast-feeding. Vitamin D3 passes into breast milk. Take this into account if you are giving extra vitamin D to a breastfed baby.

If you are pregnant, breast-feeding, or planning to have a baby, ask your doctor or pharmacist for advice before using Benferol.

Driving and using machines

Benferol has no known effects on the ability to drive and use machines.

3. How to use Benferol

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The capsules should be swallowed whole with water.

Benferol can be taken with or without food.

The recommended dose for adults and adolescents is 1-2 capsules every day.

The daily dose should not exceed 10 capsules.

Use for children

Benferol should not be used in children younger than 6 years and should be used with caution in children aged 6-12 years, as they may not be able to swallow the capsules and may put them in the throat. Other forms of this medicine may be more suitable for children in these age groups, consult a doctor or pharmacist.

The recommended dose for children is 1 capsule every day.

The most common symptoms of overdose are nausea, vomiting, increased thirst, production of large amounts of urine for 24 hours, constipation and dehydration, and high levels of calcium in the blood ( hypercalcemia and hypercalciuria ) which can be seen in laboratory tests.

If you forget to use Benferol

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

If you stop using Benferol

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.

Stop taking Benferol and contact a doctor immediately if you experience symptoms of severe allergic reactions, such as:

• swelling of the face, lips, tongue, or throat

• difficulty swallowing

• hives and difficulty breathing.

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

Hypercalcemia (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 (pruritus / urticaria).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Benferol

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 carton and blister after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store the blister in the outer carton. 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 ( vitamin D3). Each soft capsule contains 0.01 mg of cholecalciferol, equivalent to 400 IU of vitamin D3.

The other ingredients are all-rac-alpha-tocopherol (E307), medium triglycerides, glycerol, gelatin, and Opcode white label ink (consisting of shellac (E904), titanium dioxide (E171), and simethicone).

What the medicine looks like and the contents of the pack

Benferol 400 IU is a clear, oval, soft capsule that contains a pale yellow, oily liquid. Each capsule has “0.4” printed in white ink. The capsule measures 10.5 x 7 mm.

Each pack contains 28 or 90 capsules packed in blister cards (pressure packs).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Consilient Health Limited

th Floor, Beaux Lane House

Mercer Street Lower

Dublin 2

Ireland

Manufacturer

McGregor Cory Limited

Middleton Close, Banbury, Oxfordshire

OX16 4RS, UK

Consilient Health Limited

Block 2A, Richview Office Park

Clonskeagh, Dublin 14

D14 Y0A5, Ireland

This medicinal product is authorized under the European Economic Area under the following names:

Denmark: Benferol

Finland: Benferol

Netherlands: Ben 400 IU soft capsules

Norway: Benferol


Muhammad Nadeem

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