Solderol

Package Leaflet: Information for the User

Solderol, 7000 IU, coated tablets
Solderol, 30 000 IU, coated tablets
Cholecalciferol (Vitamin D)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.

Table of Contents of the Leaflet

• 1. What is Solderol and what is it used for
• 2. Important information before taking Solderol
• 3. How to take Solderol
• 4. Possible side effects
• 5. How to store Solderol
• 6. Contents of the pack and other information

1. What is Solderol and what is it used for

The active substance of Solderol is vitamin D.
Vitamin D helps the body absorb calcium, increases bone formation, and reduces the concentration of parathyroid hormone (PTH).
This medicine is recommended:

• for certain bone conditions such as reduced bone mass (osteoporosis), when the medicine will be administered with other medicines;
• for the prevention or treatment of vitamin D deficiency. Vitamin D deficiency may occur when the diet or lifestyle does not provide enough vitamin D or when the body needs more vitamin D (e.g., during pregnancy).

Solderol is intended for use in adults, the elderly, and adolescents.

2. Important information before taking Solderol

When not to take Solderol:

• if the patient is allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6),
• if there is a high concentration of calcium in the blood or urine,
• if there are kidney stones or calcifications in the kidneys,
• if there is severe kidney failure,
• if the patient is already taking vitamin D (e.g., in the form of multivitamin preparations or dietary supplements containing vitamin D).

Warnings and precautions

The doctor should be informed if:

• the patient has a tendency to form kidney stones,
• the patient has cancer or another disease that may affect the bones,
• the patient has a disorder of parathyroid hormone balance (pseudo-hypoparathyroidism).

If the patient has any of the following conditions, the doctor will monitor the concentration of calcium or phosphates in the blood or the concentration of calcium in the urine:

• in the case of long-term treatment with this medicine,
• if the patient has kidney function disorders,
• if the patient has sarcoidosis, an immune system disease that may affect the liver, lungs, skin, or lymph nodes.

Solderol and other medicines

The doctor should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
In particular, the doctor should be informed if the patient is taking the following medicines:

• diuretics (which increase urine production) - the concentration of calcium in the blood will be regularly monitored,
• corticosteroids ("steroids", e.g., prednisolone, dexamethasone) - there may be a need to increase the dose of vitamin D,
• cholestyramine (a cholesterol-lowering medicine) or laxatives (e.g., paraffin oil) - these medicines reduce the absorption of vitamin D,
• heart medicines (digitalis glycosides) - the patient should be monitored by a doctor who will control the ECG and calcium concentration in the blood,
• antiepileptic medicines (used to treat epilepsy), sedatives (e.g., hydantoin, barbiturates), or primidone - these medicines reduce the effect of vitamin D,
• calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin - these medicines reduce the concentration of calcium in the blood,
• products containing large amounts of calcium: may increase the risk of high calcium concentration in the blood,
• products containing magnesium (e.g., antacids) - should not be used during treatment with vitamin D due to the risk of high magnesium concentration in the blood,
• products containing large amounts of phosphorus - increase the risk of high phosphate concentration in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine.
If the patient is breastfeeding, the doctor will monitor the concentration of calcium or phosphates in the blood or the concentration of calcium in the urine.

Driving and using machines

There is no known effect of the medicine on driving or using machines.

Solderol contains lactose and sucrose

If the patient has been diagnosed with intolerance to some sugars, the patient should contact a doctor before taking the medicine.

3. How to take Solderol

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.

Taking Solderol with food and drink

Solderol can be taken with or without food.

Recommended dose

The dose of vitamin D will depend on the concentration of vitamin D in the patient's body and the response to treatment.
It should be taken into account that Solderol 7000 IU and Solderol 30 000 IU contain amounts equivalent to weekly and monthly doses of vitamin D, respectively.
Prevention of vitamin D deficiency (maintenance therapy):

• in adults and the elderly: 800 to 1600 IU per day, or equivalent weekly or monthly dose.
• in adults and the elderly with osteoporosis: up to 2000 IU per day, or equivalent weekly or monthly dose.
• Treatment of vitamin D deficiency in adults and the elderly (initial dose): 800 to 4000 IU per day, or equivalent weekly or monthly dose.

If it is not possible to achieve the recommended dose using Solderol, other available medicines containing cholecalciferol in smaller doses (800 IU and 1000 IU) should be used.
The appropriate dose of Solderol for the patient will be determined by the doctor.

Patients with kidney function disorders

The doctor may recommend regular blood and urine tests.

Use in children

Solderol is not intended for use in children under 12 years of age.
In adolescents (12-18 years):

• 800 IU per day, depending on the severity of the disease and the response to treatment. The medicine should be used only under medical supervision.

Achieving a dose of 800 IU is possible using another available medicine containing cholecalciferol.

Taking a higher dose of Solderol than recommended

The following symptoms may occur: loss of appetite, increased thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, frequent urination, bone pain, kidney function disorders, and in severe cases, irregular heartbeat, coma, or even death.
In case of taking too many tablets, contact a doctor or go to the nearest hospital emergency department immediately. Take the medicine package and any unused tablets with you.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Solderol can cause side effects, although not everybody gets them.
Stop taking Solderol and consult a doctor immediately if the following symptoms of a severe allergic reaction occur:

• swelling of the face, lips, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

Uncommon side effects(may affect up to 1 in 100 people):

• high concentration of calcium in the blood (hypercalcemia) - symptoms include nausea, vomiting, loss of appetite, constipation, abdominal pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness, and confusion,
• high concentration of calcium in the urine (hypercalciuria).

Rare side effects(may affect up to 1 in 1000 people):

• itching, rash, and hives.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Solderol

Store the medicine out of sight and reach of children.
Blister packs: Store in a temperature below 25°C.
To protect from light, store in the original package.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Solderol contains

The active substance is cholecalciferol (vitamin D).
Solderol, 7000 IU, coated tablets: each coated tablet contains 175 micrograms of cholecalciferol (equivalent to 7000 IU of vitamin D).
Solderol, 30 000 IU, coated tablets: each coated tablet contains 750 micrograms of cholecalciferol (equivalent to 30 000 IU of vitamin D).
Other ingredients are:

• Tablet core: cellactose 80 (lactose monohydrate and powdered cellulose (E460)), maize starch modified, maize starch, croscarmellose sodium (E468), sucrose, colloidal anhydrous silica (E551), colloidal hydrated silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium-chain triglycerides, all-rac-alpha-tocopherol (E307).
• Coating: Opadry II Yellow 85F 32659: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol, talc (E553b), quinoline yellow, lake (E104), iron oxide yellow (E172).

What Solderol looks like and contents of the pack

Solderol, 7000 IU, coated tablets:
yellow, round, coated tablet with a diameter of 7.2 mm, with a smooth, convex surface on both sides and the letter 'W' embossed on one side.
Pack sizes: 4, 8, 12, or 32 coated tablets in a non-transparent PVC/PVdC-Alu blister pack, sealed in a carton.
Solderol, 30 000 IU, coated tablets:
yellow, round, coated tablet with a diameter of 13.2 mm, with a smooth, convex surface on both sides.
Pack sizes: 1, 2, 3, 4, 6, 8, or 12 coated tablets in a non-transparent PVC/PVdC-Alu blister pack, sealed in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

Pharmaceutical Company LEK-AM Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
tel.: +48 22 785 27 60
fax: +48 22 785 27 60 ext. 106

Manufacturer

Pharma Patent Kft.
Váci út 36-38. 4. em.,
1132 Budapest
Hungary
This medicine is authorized in the Member States of the European Economic Area under the following names:
Netherlands
Cholespark 800 IE film-coated tablets
Cholespark 1000 IE film-coated tablets
Cholespark 7000 IE film-coated tablets
Cholespark 30000 IE film-coated tablets
Ireland
Colecalciferol 800 IU Film-coated Tablets
Colecalciferol 1000 IU Film-coated Tablets
Colecalciferol 7000 IU Film-coated Tablets
Colecalciferol 30000 IU Film-coated Tablets
Lithuania
Solfelix 800 IU film-coated tablets
Solfelix 1000 IU film-coated tablets
Solfelix 7000 IU film-coated tablets
Solfelix 30000 IU film-coated tablets
Czech Republic
Vitamin D3 Axonia 1000 IU film-coated tablets
Vitamin D3 Axonia 7000 IU film-coated tablets
Vitamin D3 Axonia 30000 IU film-coated tablets
Slovakia
Vitamin D3 Axonia 1000 IU film-coated tablets
Vitamin D3 Axonia 7000 IU film-coated tablets
Vitamin D3 Axonia 30000 IU film-coated tablets
United Kingdom
Colecalciferol 800 IU Film-coated Tablets
Colecalciferol 1000 IU Film-coated Tablets
Colecalciferol 7000 IU Film-coated Tablets
Colecalciferol 30000 IU Film-coated Tablets
Poland
Solderol, 7000 IU, coated tablets
Solderol, 30 000 IU, coated tablets
Date of last revision of the leaflet:06.03.2025