Soligamma

Package leaflet: Information for the user

Soligamma, coated tablets, 5,000 IU
Soligamma, coated tablets, 10,000 IU
Soligamma, coated tablets, 20,000 IU
Cholecalciferolum
For use in adults
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient
Keep this leaflet, as you may need to read it again.

• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Soligamma is and what it is used for

Soligamma contains cholecalciferol as the active substance.
Vitamin D is present in the diet and is also produced in the skin upon exposure to sunlight.
Soligamma may be prescribed by a doctor to initiate treatment of severe vitamin D deficiency.
Vitamin D deficiency may occur when diet or lifestyle do not provide sufficient vitamin D, or when the body requires increased vitamin D intake.
Soligamma is intended for use in adults.

2. Important information before using Soligamma

When not to take the medicine:

• if the patient is allergic to cholecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has high levels of vitamin D3 in the blood (hypervitaminosis D);
• if the patient has elevated calcium levels in the blood (hypercalcemia) or in the urine (hypercalciuria), or if conditions or diseases causing hypercalcemia or hypercalciuria have been diagnosed;
• if the patient has kidney stones or severe kidney problems.

Warnings and precautions
Before starting treatment with Soligamma, consult a doctor or pharmacist if:

• the patient has kidney damage or kidney disease. The doctor will need to carefully monitor treatment by measuring calcium and phosphate levels in blood and urine;
• the patient tends to develop calcium-containing kidney stones;
• the patient has a chronic multisystem inflammatory disease called sarcoidosis, which may affect the lungs, heart, and kidneys; in such cases, there is a risk of increased conversion of vitamin D into its active form;
• the patient is taking supplements containing vitamin D or its derivatives, or consuming food or drinking milk fortified with vitamin D;
• the patient has resistance to parathyroid hormone (pseudohypoparathyroidism).

Adequate dietary calcium intake should be ensured. The doctor may order regular laboratory tests to check calcium levels in blood and urine.
If the patient receives more than 1,000 IU of vitamin D per day from diet, other medications, or dietary supplements, the doctor will order certain blood tests. These tests are particularly important in elderly patients or those with limited mobility, as well as in patients also taking cardiac glycosides or diuretics (see section "Soligamma and other medicines").
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Soligamma and other medicines:
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
The following medicines may interact with Soligamma:

• antiepileptic drugs (such as phenytoin) or sedatives (barbiturates such as phenobarbital), as these may reduce the effectiveness of vitamin D;
• glucocorticoids (steroid hormones such as hydrocortisone or prednisolone). These may reduce the effectiveness of vitamin D;
• cardiac glycosides (such as digoxin). The doctor should monitor heart function using electrocardiography (ECG) and measure calcium levels in blood and urine;
• laxatives (such as liquid paraffin), a cholesterol-lowering medicine called cholestyramine, or a medicine used to reduce fat absorption from the diet called orlistat, which may reduce absorption of vitamin D;
• actinomycin (a medicine used in the treatment of certain types of cancer) and imidazole antifungal agents (such as clotrimazole and ketoconazole, used to treat fungal infections), as they may interfere with vitamin D metabolism;
• rifampicin and isoniazid (used in the treatment of tuberculosis) may reduce the effectiveness of vitamin D;
• diuretics – medicines that increase urine excretion (such as benzothiadiazine derivatives) – may increase the risk of elevated calcium levels in blood (hypercalcemia) or in urine (hypercalciuria);
• phosphates, when administered in high doses, may increase the risk of elevated phosphate levels in blood (hyperphosphatemia).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Pregnancy
Soligamma is not recommended during pregnancy and a product with lower potency should be used.
Vitamin D overdose should be avoided during pregnancy, as prolonged hypercalcemia (elevated calcium levels in blood) may lead to delayed physical and mental development, as well as congenital heart defects and eye abnormalities in the child.
Breastfeeding
Vitamin D and its metabolites pass into breast milk. If vitamin D treatment is clinically indicated during breastfeeding, this should be considered when administering additional vitamin D doses to the infant. Soligamma is not recommended during breastfeeding and a product with lower potency should be used.
Driving and using machines
Soligamma has no effect on the ability to drive or operate machinery.
Soligamma contains sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Soligamma contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
3. How to take Soligamma?
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
The required dose will depend on the patient's vitamin D levels. The doctor will determine the strength and number of tablets to take, and how often to take them.
Use in adults
Recommended dose:

• Initial treatment of vitamin D deficiency in adults: equivalent of 20,000 IU weekly for 4 to 5 weeks.

Soligamma 5,000 IU coated tablets: 4 tablets weekly
Soligamma 10,000 IU coated tablets: 2 tablets weekly
Soligamma 20,000 IU coated tablets: 1 tablet weekly

• After 4 to 5 weeks of treatment, a lower maintenance dose should be considered.

The tablet should be swallowed whole with water, preferably with the main meal of the day.
Soligamma 20,000 IU coated tablets:
The tablet break line is intended solely to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
Use in children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Taking more Soligamma than recommended
It is important not to exceed the prescribed dose.
If the patient accidentally takes more tablets than recommended, contact a doctor or seek immediate medical advice.
If possible, bring the tablets, packaging, and this leaflet to show the doctor.
If too many tablets are taken, the patient may experience nausea or vomiting, constipation or stomach pain, muscle weakness, fatigue, loss of appetite, kidney problems, and in severe cases, heart rhythm disturbances may occur.
Missing a dose of Soligamma
If the patient forgets to take a tablet, it should be taken as soon as possible. Then, the next dose should be taken at the usual time, according to the doctor's instructions.
However, if it is already time for the next dose, the missed dose should not be taken; instead, continue with the next dose as usual.
Do not take a double dose to make up for a missed dose.
Stopping Soligamma treatment
The medicine should be taken until the doctor advises stopping treatment. Do not discontinue this medicine just because the patient feels better. If the patient stops taking the medicine too early, symptoms may worsen or recur.
In case of any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions with Soligamma may include:

Uncommon: may affect up to 1 in 100 people

• elevated calcium levels in the blood (hypercalcaemia). The patient may experience nausea or vomiting, loss of appetite, constipation, stomach pain, intense thirst, muscle weakness, drowsiness, or confusion
• elevated calcium levels in the urine (hypercalciuria)

Rare: may affect up to 1 in 1,000 people

• skin rash
• itching
• raised, itchy rash (urticaria)

Frequency not known: frequency cannot be estimated from the available data

• constipation
• bloating
• nausea
• abdominal pain
• diarrhoea
• hypersensitivity reactions, such as angioedema or laryngeal oedema (swelling around the mouth, nose, throat, gastrointestinal tract, or swelling of the larynx)

Inform a doctor or pharmacist if any of the adverse reactions become
severe or if any adverse reactions not listed above occur.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Soligamma

Keep this medicine out of sight and reach of children.
Store below 30°C. Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Soligamma contains

• The active substance in Soligamma is cholecalciferol (vitamin D3).

Each tablet of Soligamma, coated tablets, 5,000 IU contains 125 micrograms of
cholecalciferol (vitamin D3, equivalent to 5,000 IU, in the form of a cholecalciferol concentrate in
powder form).
Each tablet of Soligamma, coated tablets, 10,000 IU contains 250 micrograms of
cholecalciferol (vitamin D3, equivalent to 10,000 IU, in the form of a cholecalciferol concentrate in
powder form).
Each tablet of Soligamma, coated tablets, 20,000 IU contains 500 micrograms of
cholecalciferol (vitamin D3, equivalent to 20,000 IU, in the form of a cholecalciferol concentrate in
powder form).

• Other ingredients are: all-rac-alpha-tocopherol, sodium ascorbate, medium-chain triglycerides, sucrose, sodium octenylsuccinate starch, colloidal anhydrous silica, sodium croscarmellose, microcrystalline cellulose, magnesium stearate.
  Coating: Opadry White (contains: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc)

What Soligamma looks like and contents of the pack

• Soligamma, coated tablets, 5,000 IU are white to slightly yellowish, round tablets with the engraved logo “5”, approximately 7 mm in diameter.
• Soligamma, coated tablets, 10,000 IU are white to slightly yellowish, oblong tablets with the engraved logo “10”. Tablet dimensions are approximately 13 mm in length and 6.7 mm in width.
• Soligamma, coated tablets, 20,000 IU are white to slightly yellowish, oval tablets with a double score line. Tablet dimensions are approximately 17 mm in length and 9.5 mm in width.
• Soligamma, coated tablets, 5,000 IU is available in packs containing 30, 40 or 60 coated tablets in PVC/PVDC/Aluminium blisters.
• Soligamma, coated tablets, 10,000 IU is available in packs containing 10 or 20 coated tablets in PVC/PVDC/Aluminium blisters.
• Soligamma, coated tablets, 20,000 IU is available in packs containing 4, 10 or 20 coated tablets in PVC/PVDC/Aluminium blisters.

Soligamma, coated tablets, 5,000 IU
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Manufacturer
Saneca Pharmaceuticals a.s
Nitrianska 100, 92027 Hlohovec
Slovakia

Soligamma, coated tablets, 10,000 IU
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Manufacturer
Saneca Pharmaceuticals a.s
Nitrianska 100, 92027 Hlohovec
Slovakia
or
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Soligamma, coated tablets, 20,000 IU
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany
Manufacturer
Saneca Pharmaceuticals a.s
Nitrianska 100, 92027 Hlohovec
Slovakia
or
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Trederol 5,000 I.E. Filmtabletten
Trederol 10,000 I.E. Filmtabletten
Trederol 20,000 I.E. Filmtabletten
Bulgaria: Soligamma 5,000 IU film-coated tablets
Soligamma 10,000 IU film-coated tablets
Soligamma 20,000 IU film-coated tablets
Czech Republic: Trederol
Estonia: Trederol
Spain: Trederol 5,000 UI comprimidos recubiertos con película
Trederol 10,000 UI comprimidos recubiertos con película
Trederol 20,000 UI comprimidos recubiertos con película
Hungary: Soligamma 5000 NE filmtabletta
Soligamma 10000 NE filmtabletta
Soligamma 20000 NE filmtabletta
Lithuania: Trederol 5000 TV plėvele dengtos tabletės
Trederol 10000 TV plėvele dengtos tabletės
Trederol 20000 TV plėvele dengtos tabletės
Latvia: Trederol 5000 SV apvalkotās tabletes
Trederol 10000 SV apvalkotās tabletes
Trederol 20000 SV apvalkotās tabletes
Romania: Bonfal 5000 UI comprimate filmate
Bonfal 10000 UI comprimate filmate
Bonfal 20000 UI comprimate filmate
Slovakia: Trederol 5000 IU filmom obalené tablety
Trederol 10000 IU filmom obalené tablety
Trederol 20000 IU filmom obalené tablety

For further information, please contact the local representative of the Marketing Authorisation Holder:
Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81
fax (+48) 22 877 13 70