Aldexina 25,000 IU hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aldexina 25,000 IU hard capsules
Aldexina 50,000 IU hard 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, pharmacist or nurse.
- 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 may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Aldexina is and what it is used for
- What you need to know before taking Aldexina
- How to take Aldexina
- Possible adverse effects
- How to store Aldexina
- Contents of the pack and other information
1. What Aldexina is and what it is used for
Aldexina contains the active substance colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestine, thereby aiding bone formation. Vitamin D deficiency is the main cause of rickets (inadequate bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).
Colecalciferol is used for the prevention and treatment of vitamin D deficiency in adults.
2. What you need to know before taking Aldexina
Do not take Aldexina:
- if you are allergic to vitamin D3 or to any of the other ingredients of this medicine (listed in section 6)
- if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria)
- if you have kidney stones (renal calculi) or severe renal failure
- if you have high levels of vitamin D3 in your blood (hypervitaminosis D)
- if you are allergic to peanuts or soya, as it contains soya oil.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking colecalciferol if you:
- are being treated with certain medicines for heart conditions (e.g. cardiac glycosides such as digoxin)
- suffer from sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D in the body)
- are being treated with diuretics (e.g. benzothiadiazides)
- are immobilized
- suffer from pseudohypoparathyroidism
- are being treated with medicines containing vitamin D3, or consume foods or milk enriched with vitamin D3
- are likely to be exposed to intense sunlight while using colecalciferol
- take other supplements containing calcium. Your doctor should monitor your blood calcium levels to ensure they do not become too high during treatment with colecalciferol
- have kidney disease or kidney damage and are prone to developing kidney stones. Your doctor may wish to monitor your blood and urine calcium levels
- your doctor should monitor blood calcium levels via laboratory tests if your daily intake of vitamin D3 exceeds 1,000 IU over a prolonged period.
Children and adolescents
Use is not recommended in children and adolescents under 18 years of age.
Other medicines and Aldexina
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is especially important if you are taking:
- medicines used to treat heart or kidney conditions, such as cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in blood and urine
- medicines containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3-fortified milk
- actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g. clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D3
- medicines used to treat tuberculosis, such as rifampicin, isoniazid
- the following medicines, as they may interfere with the effect or absorption of vitamin D3:
- antiepileptic drugs (anticonvulsants), barbiturates;
- glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
- medicines that reduce cholesterol levels in blood (such as cholestyramine or colestipol);
- some medicines used for weight loss by reducing fat absorption (e.g. orlistat);
- some laxatives (such as liquid paraffin).
Taking Aldexina with food, drinks and alcohol
You should preferably take colecalciferol with food to help absorption of vitamin D3.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This high concentration is not recommended for use in pregnant or breast-feeding women.
Driving and using machines
Information about possible effects of this medicine on the ability to drive is limited. However, it is not expected to affect your ability to drive or use machinery.
Excipients
Sucrose
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Soya oil
This medicine contains soya oil. Do not use this medicine if you are allergic to peanuts or soya.
Orange Yellow S
This medicine may cause allergic-type reactions.
3. How to take Aldexina
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The capsule should be swallowed whole (for example, with water).
Colecalciferol should preferably be taken with food.
For patients who have difficulty swallowing, the capsule may be opened and the dispersible granules poured into half a glass of water to facilitate administration.
Use in adults
The recommended dose is one 25,000 IU capsule per week for the first month. After the first month, the dose may be reduced.
Higher doses may be required:
50,000 IU/week for 6–8 weeks.
This initial treatment may be followed by maintenance therapy, according to your doctor's instructions.
Your doctor will adjust the dose for you.
Paediatric population
Colecalciferol is not recommended in children and adolescents under 18 years of age.
Pregnancy and Lactation
Colecalciferol is not recommended.
If you take more Aldexina than you should
If you take more than the prescribed amount, stop taking the medicine and contact your doctor. If you cannot reach your doctor, go immediately to the nearest hospital emergency department and take the medicine packaging with you.
You may also contact the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation, dehydration, and elevated calcium levels in blood and urine (hypercalcaemia and hypercalciuria) as determined by clinical tests.
If you forget to take Aldexina
If you forget to take a dose of colecalciferol, take the missed dose as soon as possible. Then take the next dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose; instead, take the next dose at the usual time.
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 can cause adverse effects, although not everyone will experience them.
Possible adverse effects associated with the use of colecalciferol may include:
Uncommon (affects up to 1 in 100 people):
- High levels of calcium in the blood (hypercalcemia)
- High levels of calcium in the urine (hypercalciuria)
Rare (affects up to 1 in 1000 people):
- Skin rash (rash or skin eruption)
- Pruritus (itching)
- 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aldexina
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Store below 25 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aldexina
The active substance is colecalciferol (vitamin D3).
One capsule contains:
25,000 IU (0.625 mg) of colecalciferol in the form of concentrated colecalciferol (powder).
50,000 IU (1.250 mg) of colecalciferol in the form of concentrated colecalciferol (powder).
The other excipients are:
Aldexina 25,000 IU hard capsules:
Capsule contents:
Gelatin, sucrose, corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol, silicon dioxide.
Capsule composition:
Capsule body: quinoline yellow (E-104), orange yellow S (E-110), titanium dioxide (E-171), gelatin.
Capsule cap: red iron oxide (E-172), orange yellow S (E-110), titanium dioxide (E-171), gelatin.
Aldexina 50,000 IU hard capsules:
Capsule contents:
Gelatin, sucrose, corn starch, partially hydrogenated soybean oil, all-rac-α-tocopherol, silicon dioxide.
Capsule composition:
Capsule body: quinoline yellow (E-104), orange yellow S (E-110), titanium dioxide (E-171), gelatin.
Capsule cap: black iron oxide (E-172), titanium dioxide (E-171), gelatin.
Appearance of the product and contents of the pack
Aldexina 25,000 IU is a hard capsule with a yellow body and light orange cap. The capsule size is 18 mm. It contains a yellowish-white powder and is supplied in blisters made of Polyamide/Aluminum/PVC - Aluminum, packed in cardboard boxes.
Each box may contain 4 or 8 capsules.
Aldexina 50,000 IU is a hard capsule with a yellow body and black cap. The capsule size is 24 mm. It contains a yellowish-white powder and is supplied in blisters made of Polyamide/Aluminum/PVC - Aluminum, packed in cardboard boxes.
Each box may contain 2 or 4 capsules.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
Spain
Date of the most recent revision of this leaflet: February 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.