Benferol Choque 50.000 IU soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Benferol choque 50,000 IU soft capsules

Benferol choque 100,000 IU soft capsules

colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

1. What Benferol choque is and what it is used for
2. What you need to know before taking Benferol choque
3. How to take Benferol choque
4. Possible adverse effects
5. How to store Benferol choque
6. Contents of the pack and other information

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

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

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

Your doctor may prescribe this medicine as an adjunct to specific treatment for bone loss. Consult your doctor or pharmacist if you have any further questions, and always follow their instructions.

2. What you need to know before taking Benferol choque

Do not take Benferol choque:

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

If you have any of the above conditions, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have sarcoidosis (a special type of connective tissue disease affecting the lungs, skin, and joints).
• when using other medicines containing vitamin D at the same time.
• if you have kidney problems or have previously had kidney stones.

Children

This medicine is not suitable for use in children under 12 years of age.

Taking Benferol choque with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially:

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

Taking Benferol choque with food and drinks

See section 3 "How to take Benferol choque".

Pregnancy, breastfeeding, and fertility

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

This medicine should only be used during pregnancy if vitamin D deficiency has been clinically diagnosed.

This medicine may be used during breastfeeding. Vitamin D3 passes into breast milk. This should be taken into account when administering additional vitamin D to the infant.

There are no data available on the effects of vitamin D3 on fertility. However, normal levels of vitamin D are not expected to have adverse effects on fertility.

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

Driving and using machines

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

Benferol choque 100,000 IU soft capsules contain Allura Red AC (E129) and Sunset Yellow FCF (E110), which may cause allergic-type reactions.

Benferol choque 50,000 IU soft capsules contain Allura Red AC (E129), which may cause allergic-type reactions.

If you are allergic to any of the above colorants, consult your doctor or pharmacist.

3. How to take Benferol choque

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

The capsules must be swallowed whole with water.

You should take this medicine preferably with a substantial meal to ensure adequate absorption of vitamin D3.

Adults and adolescents

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

For vitamin D deficiency, the dose may be adjusted according to blood levels of vitamin D (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 within one week. A maintenance dose of 25,000 IU per month may then be considered.

Use in children

This medicine is not intended for use in children under 12 years of age. Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

If you take more Benferol choque than you should

If you have taken more of this medicine than prescribed, or if a child has accidentally ingested it, contact your doctor or an emergency department immediately to assess the risk involved, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. Bring the medicine container with you.

It is recommended to bring the medicine’s packaging and 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 levels of calcium in the blood (hypercalcemia and hypercalciuria), which are detected by laboratory tests.

If you forget to take Benferol choque

Do not take a double dose to make up for the missed dose.

If you stop taking Benferol choque

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

You should immediately stop taking the medicine 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 breathing difficulties

Uncommon adverse effects (occur in fewer than 1 in 100 people): Hypercalcemia (increased calcium levels in blood) and hypercalciuria (increased calcium levels in urine).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Benferol choque

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or blister after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Benferol choque

50,000 IU

• The active substance is colecalciferol (vitamin D3). Each soft capsule contains 1.25 mg of colecalciferol, equivalent to 50,000 IU of vitamin D3.

100,000 IU

• The active substance is colecalciferol (vitamin D3). Each soft capsule contains 2.5 mg of colecalciferol, equivalent to 100,000 IU of vitamin D3.

The other components are: all-rac-α-tocopherol (E307), medium-chain triglycerides, glycerol, gelatin, white printing ink Opacode (shellac (E904), titanium dioxide (E171) and simethicone), Allura red AC (E129) and sunset yellow FCF (E110) (only 100,000 IU).

What Benferol choque looks like and contents of the pack

50,000 IU

Benferol choque 50,000 IU is a soft, oval, red capsule, printed with "50" in white ink. It contains a slightly yellow oily liquid.

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

100,000 IU

Benferol choque 100,000 IU is a soft, oval, orange capsule, printed with "100" in white ink. It contains a slightly yellow oily liquid.

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

Only certain pack sizes may be commercially available.

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

For further information about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area countries under the following names:

Denmark: Benferol 50,000 IU soft capsules and Benferol 100,000 IU soft capsules

Finland: Benferol 50,000 IU capsules, soft and Benferol 100,000 IU capsules, soft

Norway: Benferol 50,000 IU soft capsules and Benferol 100,000 IU soft capsules

Sweden: Benferol 50,000 IU soft capsules and Benferol 100,000 IU soft capsules

Spain: Benferol choque 50,000 IU soft capsules and Benferol choque 100,000 IU soft capsules

Date of the most recent revision of this leaflet: January 2024