Soligamma

Package Leaflet: Information for the Patient

Soligamma, Coated Tablets, 5,000 IU

Soligamma, Coated Tablets, 10,000 IU

Soligamma, Coated Tablets, 20,000 IU

Cholecalciferol
For use in adults

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 specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4

Table of Contents of the Leaflet

• 1. What is Soligamma and what is it 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 is Soligamma and what is it used for

Soligamma contains the active substance cholecalciferol.
Vitamin D is present in the diet and is also produced in the skin after exposure to sunlight.
Soligamma may be prescribed by a doctor to start treating severe vitamin D deficiency. Vitamin D deficiency may occur when the diet or lifestyle does not provide enough vitamin D or when the body requires more vitamin D.
Soligamma is intended for adults.

2. Important information before taking 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 a high level of vitamin D3 in the blood (hypervitaminosis D)
• if the patient has an elevated level of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria) or has been diagnosed with diseases or conditions that cause hypercalcemia or hypercalciuria
• if the patient has kidney stones or severe kidney problems

Warnings and precautions

Before starting Soligamma, discuss it with your doctor or pharmacist if:

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

Ensure adequate calcium intake from food. The doctor may order regular laboratory tests to check the amount of calcium in the blood and urine.
If the patient is receiving more than 1,000 IU of vitamin D per day from their diet, other medicines, or dietary supplements, the doctor will order certain blood tests. These tests are particularly important for elderly patients or those with limited mobility, as well as for people taking digitalis glycosides or diuretics (see the 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:

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, the following medicines may interact with Soligamma:

• antiepileptic drugs (such as phenytoin) or sedatives (barbiturates such as phenobarbital), as these medicines may reduce the effectiveness of vitamin D
• glucocorticoids (steroid hormones, such as hydrocortisone or prednisolone). They may reduce the effectiveness of vitamin D
• digitalis glycosides (such as digoxin). The doctor should monitor heart function using electrocardiography (ECG) and measure calcium levels in the blood and urine
• laxatives (such as paraffin oil), a cholesterol-lowering drug called cholestyramine, or a drug used to reduce fat absorption from food, called orlistat, may reduce vitamin D absorption
• actinomycin (a drug used to treat certain types of cancer) and imidazole antifungal drugs (such as clotrimazole and ketoconazole, used to treat fungal diseases), as they may disrupt vitamin D metabolism
• rifampicin and isoniazid (used to treat tuberculosis) may reduce the effectiveness of vitamin D
• diuretics - medicines that increase urine production (such as benzothiadiazine derivatives), may increase the risk of elevated calcium levels in the blood (hypercalcemia) or urine (hypercalciuria)
• phosphates, when given in high doses, may increase the risk of elevated phosphate levels in the blood (hyperphosphatemia)

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Soligamma is not recommended during pregnancy and a lower-strength product should be used.
During pregnancy, it is essential to avoid overdosing on vitamin D, as prolonged hypercalcemia (elevated calcium levels in the blood) can lead to delayed physical and mental development, as well as congenital heart and eye defects in the child.
Breastfeeding
Vitamin D and its metabolites pass into breast milk. If treatment with vitamin D is clinically indicated during breastfeeding, this should be taken into account, and an additional dose of vitamin D should be given to the child. Soligamma is not recommended during breastfeeding, and a lower-strength product should be used

Driving and using machines

Soligamma has no effect on the ability to drive and use machines.
Soligamma contains sucrose.If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Soligamma contains sodium.The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free"

3. How to take Soligamma

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The required dose of the medicine will depend on the patient's vitamin D levels. The doctor will determine the strength and number of tablets to take, as well as how often to take them

Use in adults

Recommended dose:

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

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

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

Swallow the tablet whole with water, preferably with the main meal of the day.
Soligamma 20,000 IU coated tablets:
The dividing line on the tablet is only 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 prescribed

It is essential not to exceed the prescribed dose.
If the patient has taken more tablets than prescribed, they should consult their doctor or seek medical advice immediately.
If possible, they should take the tablets, packaging, and this leaflet to show the doctor.
If the patient has taken too many tablets, they may experience nausea or vomiting, loss of appetite, constipation, stomach pain, excessive thirst, muscle weakness, fatigue, or may be disoriented

Missing a dose of Soligamma

If the patient forgets to take a tablet, they should take it as soon as possible. Then, they should take the next dose at the usual time, as instructed by their doctor.
However, if it is already time for the next dose, they should not take the missed dose, just take 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 the treatment. Do not stop taking this medicine just because the patient feels better. If the patient stops taking the medicine too early, the symptoms may worsen or return.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist

4. Possible side effects

Like all medicines, Soligamma can cause side effects, although not everybody gets them.
Soligamma side effects may include:

Uncommon: may affect up to 1 in 100 people

• high levels of calcium in the blood (hypercalcemia). The patient may experience nausea or vomiting, loss of appetite, constipation, stomach pain, excessive thirst, muscle weakness, drowsiness, or may be disoriented
• high levels of calcium in the urine (hypercalciuria)

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

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

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

• constipation
• bloating
• nausea
• abdominal pain
• diarrhea
• allergic reactions, such as angioedema or throat swelling (swelling of the lips, face, throat, or tongue)

Tell your doctor or pharmacist if any of the side effects become serious or if you notice any side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine

5. How to store Soligamma

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

6. Contents of the pack and other information

What Soligamma contains

• The active substance of Soligamma is cholecalciferol (vitamin D3)

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

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

What Soligamma looks like and contents of the pack

• Soligamma 5,000 IU coated tablets are white to light yellow, round tablets with a logo "5" embossed on them, approximately 7 mm in diameter
• Soligamma 10,000 IU coated tablets are white to light yellow, elongated tablets with a logo "10" embossed on them, approximately 13 mm long and 6.7 mm wide
• Soligamma 20,000 IU coated tablets are white to light yellow, oval tablets with a double score line, approximately 17 mm long and 9.5 mm wide
• Soligamma 5,000 IU coated tablets are available in packs of 30, 40, or 60 tablets in PVC/PVDC/Aluminum blisters
• Soligamma 10,000 IU coated tablets are available in packs of 10 or 20 tablets in PVC/PVDC/Aluminum blisters
• Soligamma 20,000 IU coated tablets are available in packs of 4, 10, or 20 tablets in PVC/PVDC/Aluminum blisters

Soligamma, coated tablets, 5,000 IU

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Authorization Holder and Manufacturer

Marketing Authorization 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 Authorization Holder and Manufacturer

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:
Trederol 5,000 IU film-coated tablets
Trederol 10,000 IU film-coated tablets
Trederol 20,000 IU film-coated tablets
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 film-coated tablets
Trederol 10,000 UI film-coated tablets
Trederol 20,000 UI film-coated tablets
Hungary
Soligamma 5,000 NE film tablets
Soligamma 10,000 NE film tablets
Soligamma 20,000 NE film tablets
Lithuania
Trederol 5,000 IU film-coated tablets
Trederol 10,000 IU film-coated tablets
Trederol 20,000 IU film-coated tablets
Latvia
Trederol 5,000 IU film-coated tablets
Trederol 10,000 IU film-coated tablets
Trederol 20,000 IU film-coated tablets
Romania
Bonfal 5,000 UI film-coated tablets
Bonfal 10,000 UI film-coated tablets
Bonfal 20,000 UI film-coated tablets
Slovakia
Trederol 5,000 IU film-coated tablets
Trederol 10,000 IU film-coated tablets
Trederol 20,000 IU film-coated tablets

For more detailed information, please contact the local representative of the Marketing Authorization Holder:

Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
phone: (+48) 22 863 72 81
fax: (+48) 22 877 13 70

Date of last revision of the leaflet: 03/2025