BENFEROL MENSUAL 25,000 IU Soft Capsules

Introduction

Package Leaflet: Information for the User

Benferol Monthly 25,000 IU Soft Capsules

colecalciferol (vitamin D3)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Package Leaflet Contents

1. What Benferol Monthly is and what it is used for
2. What you need to know before taking Benferol Monthly
3. How to take Benferol Monthly
4. Possible side effects
5. Storage of Benferol Monthly
6. Package Contents and Additional Information

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

This medication contains vitamin D3, which regulates calcium absorption and metabolism, as well as calcium incorporation into bone tissue.

Benferol Monthly is used to prevent and treat vitamin D3 deficiency in adults and adolescents (children ≥ 12 years of age).

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

2. What you need to know before taking Benferol Monthly

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 conditions, 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 of age.

Taking Benferol Monthly with other medications

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

• Colestyramine (used to treat high cholesterol).
• Phenytoin or barbiturates (used to treat epilepsy).
• Laxatives containing mineral oil.
• Thiazide diuretics (for high blood pressure).
• Glucocorticoids (for inflammation).
• Cardiac glycosides (for heart conditions), e.g., digoxin.
• Actinomycin (chemotherapy)
• Imidazole (antifungal)
• Orlistat (weight loss)

Taking Benferol Monthly with food and beverages

See section 3 "How to take Benferol Monthly".

Pregnancy, Breastfeeding, and Fertility

Daily intake of vitamin D during pregnancy should not exceed 600 IU.

Benferol Monthly will only be used during pregnancy if a vitamin D deficiency has been clinically 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 expected that normal levels of vitamin D will have adverse effects on fertility.

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

Driving and Using Machines

This medication has no known effects on the ability to drive or use machines.

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

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

3. How to take Benferol Monthly

Follow your doctor's instructions for administration exactly. If you have any doubts, consult your doctor or pharmacist again.

The capsules should be swallowed whole with water.

You should take this medication preferably with a large meal so that your body can absorb the vitamin D3.

Adults and Adolescents

The recommended dose is one 25,000 IU capsule per month.

For vitamin D deficiency, the dose can be adjusted based on vitamin D levels in the blood (25(OH)D levels).

For the treatment of symptomatic vitamin D deficiency, the recommended dose is one 100,000 IU capsule or two 50,000 IU capsules in 1 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 of age. Other formulations of this medication 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 assess the risk or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and quantity used, and take the package and medication with you. It is recommended to take the package and package leaflet to the healthcare professional.

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

If you forget to take Benferol Monthly

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

If you stop taking Benferol Monthly

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You should stop taking the medication immediately and consult your doctor 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 side effects(occurring in less than 1 in 100 patients): Hypercalcemia (elevated calcium levels in the blood) and hypercalciuria (elevated calcium levels in the urine).

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Benferol Monthly

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

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

Do not store above 30°C. Store in the original packaging to protect from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Benferol Monthly

The active ingredient is colecalciferol (vitamin D3). Each soft capsule contains 0.625 mg of colecalciferol, equivalent to 25,000 IU of vitamin D3.

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

Appearance of Benferol Monthly and Package Contents

Soft capsule, oval, light red in color, with "25" printed in white ink. Contains a slightly yellow, oily liquid.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Consilient Health Limited.

Floor 3, Block 3, Miesian Plaza,

Dublin 2, D02 Y754

Ireland

Manufacturer

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 from the local representative of the Marketing Authorization Holder:

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3ª planta, módulo A-Edificio Australia

08840 Viladecans, Barcelona (España)

This medication is authorized in the Member States of the European Economic Area under the following names:

Denmark: Benferol 25,000 IE soft capsules

Finland: Benferol 25,000 IU capsules, soft

Norway: Benferol 25,000 IU soft capsules

Sweden: Benferol 25,000 IU soft capsules

Spain: Benferol mensual 25,000 UI soft capsules

Date of the last revision of this package leaflet:January 2024.