Leaflet: information for the user

Benferol monthly 25,000 UI soft capsules

colecalciferol (vitamin D3)

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Benferol monthly and what it is used for

2. What you need to know before starting to take Benferol monthly

3. How to take Benferol monthly

4. Possible adverse effects

5. Storage of Benferol monthly

6. Contents of the pack and additional information

This medication contains vitamin D3that regulates the absorption and metabolism of calcium, as well as the incorporation of calcium into bone tissue.

Benferol monthly is used to prevent and treat vitamin D3deficiency in adults and adolescents (children ≥ 12 years of age).

Your doctor may prescribe this medication as a complement to specific medication for bone loss. Consult with your doctor or pharmacist if you have additional questions, and always follow their instructions.

Do not take Benferol monthly:

• if you are allergic to colecalciferol or any of the other components of this medication (listed in section 6).
• if you have hypercalcemia (elevated calcium levels in the blood) or hypercalciuria (elevated calcium levels in the urine).
• if you have hypervitaminosis D (elevated vitamin D levels in the blood).
• if you have kidney stones.

If you have any of the above, consult your doctor or pharmacist before taking Benferol monthly.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication:

• if you have sarcoidosis (a special type of connective tissue disease that affects the lungs, skin, and joints).
• when using other medications that contain vitamin D simultaneously.
• if you have kidney problems or have had kidney stones.

Children

This medication is not suitable for use in children under 12 years old.

Benferol monthly with other medications

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, particularly:

- Colestiramine (used to treat high cholesterol).

- Phenobarbital or barbiturates (used to treat epilepsy).

- Laxatives containing paraffin oil.

- Thiazide diuretics (to treat high blood pressure).

- Glucocorticoids (to treat inflammation).

- Cardiotonic glucosides (to treat heart conditions), e.g. digoxin.

- Actinomycin (chemotherapy)

- Imidazole (antifungal)

- Orlistat (weight loss)

Benferol monthly with food and drinks

See section 3 “How to take Benferol monthly”.

Pregnancy, breastfeeding, and fertility

During pregnancy, daily vitamin D intake should not exceed 600 UI.

Benferol monthly will only be used during pregnancy if a clinical deficiency of vitamin D has been diagnosed.

This medication can be used during breastfeeding. Vitamin D3 passes into breast milk. This should be taken into consideration when administering additional vitamin D to the infant.

There are no data on the effects of vitamin D3 on fertility. However, it is not anticipated that normal levels of vitamin D will have adverse effects on fertility.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication has no known effects on the ability to drive or operate machinery.

Benferol monthly contains Red Allura AC (E129) whichmay cause allergic reactions.

If you are allergic to the colorant, consult your doctor or pharmacist.

Follow exactly the administration instructions indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

The capsules must be swallowed whole with water.

This medication should be taken preferably with a full meal so that your body absorbs vitamin D3.

Adults and adolescents

The recommended dose is one capsule of 25.000 IU per month.

The dose can be adjusted according to the levels of vitamin D in the blood (25(OH)D levels) for vitamin D deficiency.

For symptomatic vitamin D deficiency treatment, the recommended dose is one capsule of 100,000 IU or two capsules of 50,000 IU in one week. A maintenance dose of 25,000 IU per month may be considered.

Use in children

This medication is not intended for use in children under 12 years old. There are other presentations of this medication that may be more suitable for children; ask your doctor or pharmacist.

If you take more Benferol monthly than you should

If you have taken more of this medication than prescribed, or if a child has accidentally taken this medication, contact your doctor or emergency services to evaluate the existing risk or call the toxicology information service, phone 91 562 04 20 indicating the medication and the amount used, and bring the packaging with the medication. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The most frequent symptoms of overdose are: nausea, vomiting, excessive thirst, large amounts of urine produced in 24 hours, constipation, and dehydration, and high levels of calcium in the blood (hypercalcemia and hypercalciuria) detected in laboratory tests.

If you forgot to take Benferol monthly

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Benferol monthly

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

You should stop taking the medication immediately and consult with your doctor if you experience severe allergic reaction symptoms, such as:

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

•Difficulty swallowing

•Hives and difficulty breathing

Less Common Adverse Effects(occur in fewer than 1 in 100 patients): Hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine).

Rare(occur in fewer than 1 in 1,000 patients): Itching, skin rash (pruritus/urticaria).

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging or blister after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Benferol monthly

The active principle is colecalciferol (vitamin D3). Each soft capsule contains 0.625 mg of colecalciferol which corresponds to 25,000 UI of vitamin D3.

The other components are: all-rac-α-tocoferol (E307), medium-chain triglycerides, glycerol, gelatin, white Opacode printing ink (lacquer (E904), titanium dioxide (E171) and simethicone) and red Allura AC (E129).

Appearance of Benferol monthly and content of the container

Soft, oval, red capsule, with “25” printed in white ink. Contains a oily liquid, slightly yellow.

Each box contains 1, 2, 3 or 4 capsules in blister strips.

Only some container sizes may be commercially marketed.

Holder of the Marketing Authorization

Consilient Health Limited.

Floor 3, Block 3, Miesian Plaza,

Dublin 2, D02 Y754

Ireland

Responsible for manufacturing

Consilient Health Limited,

Block 2A Richview Office Park,

Clonskeagh, Dublin 14,

D14 Y0A5, Ireland

or

Pharma Pack Hungary Ltd.,

Vasút utca 13., Budaörs,

2040, Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

This medication is authorized in the member states of the European Economic Area with the following names:

Denmark: Benferol 25,000 IE bløde capsules

Finland: Benferol 25,000 IU soft capsules

Norway: Benferol 25,000 IU myke capsules

Sweden: Benferol 25,000 IU mjuka capsules

Spain: Benferol monthly 25,000 UI soft capsules

Last review date of this leaflet:January 2024.