Package Insert: Information for the User

Aldexina 25,000 IU Hard Capsules

Aldexina 50,000 IU Hard Capsules

Colecalciferol (Vitamin D3)

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Aldexinacontains the active ingredient colecalciferol (vitamin D3). Vitamin D3 can be found in some foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes the absorption of calcium in the kidneys and intestines, aiding in bone formation. Deficiency of vitamin D is the main cause of rickets (inadequate mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults).

Colecalciferolis used to prevent and treat vitamin D deficiency in adults.

Do not takeAldexina:

• if you are allergic to vitamin D3or any of the other components of this medication (listed in section 6)
• if you have high levels of calcium in your blood (hypercalcemia) or urine (hypercalciuria)
• if you have kidney stones (renal calculi) or severe kidney failure
• if you have high levels of vitamin D3in your blood (hypervitaminosis D)
• if you are allergic to peanuts or soy, as it contains soy oil.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to takecolecalciferol, if you:

• are being treated with certain medications for heart disease (e.g. cardiac glycosides, such as digoxin)
• have sarcoidosis (an autoimmune disease that can cause an increase in vitamin D levels in the body)
• are being treated with diuretics (e.g. benzothiadiazine)
• are bedridden
• have pseudohypoparathyroidism
• are being treated with medications containing vitamin D3, or take foods or milk enriched with vitamin D3
• are likely to be exposed to a lot of sunlight while using colecalciferol
• are taking other supplements containing calcium. Your doctor will need to monitor your calcium levels in the blood to ensure they are not too high while you are taking colecalciferol
• have kidney disease or kidney damage and are prone to forming kidney stones. Your doctor may want to monitor your calcium levels in the blood and urine
• your doctor will need to monitor your calcium levels in the blood through laboratory tests if your daily intake of vitamin D3exceeds 1,000 UI for a prolonged period.

Children and adolescents.

The use is not recommended in children and adolescents under 18 years old.

Other medications andAldexina

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is especially important if you are taking:

• medications used to treat heart or kidney disease, such as cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumetazide). When these medications are used at the same time as vitamin D3, they can cause a significant increase in calcium levels in the blood and urine
• medications containing vitamin D3or foods rich in vitamin D3, such as some types of milk enriched with vitamin D3
• actinomycin (a medication used to treat certain types of cancer) and imidazole antifungals (e.g. clotrimazole and ketoconazole, which are medications used to treat fungal diseases). These medications can interfere with the processing of vitamin D3in the body
• medications used to treat tuberculosis, such as rifampicin and isoniazid
• the following medications, as they may interfere with the effect or absorption of vitamin D3:
• • antiepileptic medications (anticonvulsants), barbiturates;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
  • medications that reduce cholesterol levels in the blood (such as cholestyramine or colestipol).;
  • some medications used to lose weight by reducing fat absorption (e.g. orlistat).;
  • some laxatives (such as liquid paraffin).

TakingAldexinawith food, drinks, and alcohol

You should takecolecalciferolpreferably with food to help with the absorption of vitamin D3.

Pregnancy, breastfeeding, and fertility

Ifyou are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using thismedication.

This high concentration is not recommended for use in pregnant women and breastfeeding women.

Driving and operating machinery

The information on possible effects of this medication on the ability to drive is limited. However, it is not expected to affect your ability to drive and use machinery.

Excipients

Sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Soy oil

This medication contains soy oil. Do not use this medication if you are allergic to peanuts or soy.

Yellow orange S

This medication may cause allergic reactions.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The capsule should be swallowed whole (for example, with water).

Colecalciferol should be taken preferably with food.

Use in adults

The recommended dose is one capsule of 25,000 UI per week for the first month. After the first month, the dose may be reduced.

Higher doses may be required:

50,000 UI/week for 6–8 weeks.

This initial treatment may be followed by maintenance therapy, as indicated by your doctor.

Your doctor will adjust the dose for you.

Pediatric population

Colecalciferol is not recommended in children and adolescents under 18 years old.

Pregnancy and Lactation

Colecalciferol is not recommended.

If you take moreAldexinathan you should

If you take more than the prescribed amount, stop taking the medication and call your doctor. If you are unable to contact your doctor, go to the nearest hospital emergency department and bring the packaging with the medication.

You can also contact the Toxicological Information Service, phone 915620420, indicating the medication and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for up to 24 hours, constipation, dehydration, and elevated levels of calcium in the blood and urine (hypercalcemia and hypercalciuria) determined by clinical tests.

If you forgot to takeAldexina

If you forget to take a dose ofcolecalciferol, take the missed dose as soon as possible. Then, take the next dose at the usual time. However, if you are close to the time of the next dose, do not take the missed dose and instead take the next dose at the usual time.

If you have any other questions 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.

The possible adverse effects associated with the use ofcolecalciferolmay be:

Rare(affect up to 1 in 100 people):

• Excess calcium in the blood (hypercalcemia)
• Excess calcium in the urine (hypercalciuria)

Uncommon(affect up to 1 in 1000 people):

• Rash (skin eruption or dermatitis)
• Pruritus (itching)
• Urticaria

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on 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 after CAD. The expiration date is the last day of the month indicated.

Store below 25 °C.

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

Composition ofAldexina

Theactive principleis colecalciferol (vitamin D3)

One capsule contains:

25,000 UI (0.625 mg) of colecalciferol in the form of colecalciferol concentrate (powder).

50,000 UI (1.250 mg) of colecalciferol in the form of colecalciferol concentrate (powder).

The other excipients are:

Aldexina25,000 UI hard capsules:

Content of the hard capsule

Gelatin, sucrose, cornstarch, partially hydrogenated soybean oil, all-rac-α-tocopherol, silicon dioxide.

Composition of the capsule

Capsule body: quinoline yellow (E-104), sunset yellow S (E-110), titanium dioxide (E-171), gelatin.

Capsule lid: iron oxide red (E-172), sunset yellow S (E-110), titanium dioxide (E-171), gelatin.

Aldexina50,000 UI hard capsules:

Content of the hard capsule

Gelatin, sucrose, cornstarch, partially hydrogenated soybean oil, all-rac-α-tocopherol, silicon dioxide.

Composition of the capsule

Capsule body: quinoline yellow (E-104), sunset yellow S (E-110), titanium dioxide (E-171), gelatin.

Capsule lid: iron oxide black (E-172), titanium dioxide (E-171), gelatin.

Appearance of the product and contents of the package

Aldexina25,000 UI is a hard capsule with a yellow body and a clear orange lid. The capsule size is 18 mm. It contains a white-yellowish powder and is supplied in Poliamida/Aluminio/ PVC - Aluminio blisters in cardboard boxes.

Each box may contain 4 and 8 capsules.

Aldexina50,000 UI is a hard capsule with a yellow body and a black lid. The capsule size is 24 mm. It contains a white-yellowish powder and is supplied in Poliamida/Aluminio/ PVC - Aluminio blisters in cardboard boxes.

Each box may contain 2 and 4 capsules.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet: February 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.