Cidimus

1. What Cidimus is and what it is used for

Cidimus belongs to a group of medicines called immunosuppressants.
After an organ transplant (e.g. liver, kidney, heart), the body's immune system tries to
reject the new organ.
Cidimus is used to control the body's immune response and allow the transplanted organ to be accepted by the body.
Cidimus is often used in combination with other medicines that also suppress the immune system.
Cidimus can also be used to treat ongoing rejection of a transplanted liver, kidney, heart, or other organs, or when previous treatment has not controlled the body's immune response after transplantation.

2. Before you take Cidimus

When Not to Take Cidimus

if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6);
if you are allergic (hypersensitive) to any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).

Warnings and Precautions

Before taking Cidimus, discuss this with your doctor or pharmacist.
Cidimus should be taken every day as long as it is needed to suppress the immune system to prevent rejection of the transplanted organ. You should have regular check-ups with your doctor.
During treatment with Cidimus, your doctor may occasionally recommend that you have a series of tests (including blood, urine, heart, vision, and neurological tests). This is a routine practice that will help your doctor determine the correct dose of Cidimus.
You should avoid taking herbal medicines, such as St. John's Wort (Hypericum perforatum) or other herbal medicines, as they may affect the effectiveness of Cidimus and its required dose. If in doubt, consult your doctor before taking any herbal medicine.
If you have liver problems or have had a disease that may have affected liver function, you should inform your doctor. This may be important for the dose of Cidimus given to you.
You should tell your doctor if you experience severe abdominal pain with other symptoms such as chills, fever, nausea, or vomiting, or without these symptoms.
If you have diarrhea lasting more than 1 day, you should inform your doctor, as it may be necessary to adjust the dose of Cidimus.
You should tell your doctor if you have changes in the electrical activity of the heart, so-called QT prolongation.
During treatment with Cidimus, you should limit your exposure to sunlight and UV radiation by wearing protective clothing and using sunscreens with a high protection factor. This is because there is an increased risk of developing skin cancer during treatment that reduces the body's defenses.
If you are going to have any vaccination, you should inform your doctor in advance. Your doctor will advise you on the best course of action.
Patients taking Cidimus have been reported to have an increased risk of developing lymphoproliferative disorders (a condition affecting the lymphatic system), see section 4. Your doctor will provide explanations on this.

Cidimus and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal preparations.
Cidimus must not be taken at the same time as ciclosporin.
Other medicines taken at the same time may affect the levels of Cidimus in your blood, and Cidimus may affect the levels of other medicines in your blood. It may be necessary to stop treatment, increase or decrease the dose of Cidimus.
In particular, tell your doctor if you are taking or have recently taken any of the following medicines:

antifungal medicines and antibiotics (especially macrolide antibiotics) used to treat infections, such as ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, and isavuconazole, erythromycin, clarithromycin, josamycin, rifampicin, and flucloxacillin;
letermovir, used to prevent diseases caused by human cytomegalovirus (CMV);
HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), a medicine that increases the pharmacokinetics of cobicistat, and combination tablets used to treat HIV infection;
HCV protease inhibitors (e.g. telaprevir, boceprevir, and ombitasvir/paritaprevir/ritonavir with or without dasabuvir) used to treat hepatitis C;
nilotinib and imatinib (used to treat certain cancers);
mycophenolic acid, used to suppress the immune system to prevent transplant rejection;
medicines used to treat stomach ulcers and reflux (e.g. omeprazole, lansoprazole, or cimetidine);
anti-emetic medicines used to treat nausea and vomiting (e.g. metoclopramide);
medicines used to treat heartburn containing magnesium hydroxide and aluminum hydroxide (antacids);
hormone therapy with ethinylestradiol (e.g. oral contraceptive pill) or danazol;
medicines used to treat high blood pressure or heart problems, such as nifedipine, nicardipine, diltiazem, and verapamil;
anti-arrhythmic medicines (e.g. amiodarone) used to control heart rhythm;
statins, used to treat high cholesterol and triglycerides;
anti-epileptic medicines – phenytoin or phenobarbital;
corticosteroids prednisolone and methylprednisolone;
antidepressant nefazodone;
herbal medicines containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra chinensis (Schisandra sphenanthera);
metamizole, a medicine used to treat pain and fever;
cannabidiol (a medicine used, among other things, to treat seizures).
Tell your doctor immediately if you experience any of the following while taking Cidimus:

vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or restricted field of vision.
Tell your doctor if you plan to take or are taking ibuprofen, amphotericin B, or antiviral medicines (such as acyclovir). These medicines taken at the same time as Cidimus may increase kidney or nervous system problems.
Your doctor should also be informed if you are taking potassium supplements or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) or trimethoprim or cotrimoxazole antibiotics, which may increase potassium levels in the blood, certain painkillers (so-called non-steroidal anti-inflammatory drugs, NSAIDs, e.g. ibuprofen), anticoagulants, or oral antidiabetic medicines.
If you are going to have any vaccination, you should inform your doctor in advance.

Cidimus with Food and Drink

Cidimus should be taken on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. During treatment with Cidimus, you should avoid eating grapefruits and drinking grapefruit juice.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cidimus passes into breast milk. During treatment with Cidimus, you should not breast-feed.

Driving and Using Machines

If you experience dizziness, drowsiness, or vision disturbances after taking Cidimus, you should not drive or operate machinery. These symptoms are more common when taking Cidimus and drinking alcohol at the same time.

Cidimus Contains Lactose and Sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, which is essentially 'sodium-free'.

3. How to Take Cidimus

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
When your medicine is dispensed, make sure you receive the same medicine containing tacrolimus each time, unless a transplant specialist has advised you to switch to a different tacrolimus medicine.
The medicine should be taken twice a day. If the medicine looks different from what you are used to or the dosage instructions have changed, you should contact your doctor or pharmacist as soon as possible to make sure you have received the correct medicine.
The initial dose used to prevent rejection of the transplanted organ is determined by your doctor based on your body weight. Initial doses given shortly after transplantation are usually in the range of 0.075 to 0.30 mg/kg body weight per day (depending on the transplanted organ).
The recommended dose depends on your overall condition and what other immunosuppressive medicine you are taking. To determine the correct dose and adjust it, your doctor will regularly have blood tests done.
After the condition has stabilized, your doctor will usually reduce the dose of Cidimus. Your doctor will tell you exactly how many capsules to take and how often.
Cidimus is taken orally twice a day, usually in the morning and evening. The medicine should be taken on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal.
The capsules should be swallowed whole with a glass of water.
The capsules should be taken immediately after removal from the blister pack.
During treatment with Cidimus, you should avoid eating grapefruits and drinking grapefruit juice.
Do not swallow the desiccant contained in the foil package.

If You Take More Cidimus Than You Should

If you accidentally take too much Cidimus, contact your doctor or go to the emergency room at your nearest hospital immediately.

If You Forget to Take Cidimus

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, wait until the next dose is due and then continue with your normal schedule.

Stopping Cidimus Treatment

Stopping Cidimus treatment may increase the risk of rejection of the transplanted organ. Do not stop treatment without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Cidimus can cause side effects, although not everybody gets them.
Cidimus weakens the body's immune system, so it can fight off infections less effectively. Therefore, if you are taking Cidimus, you may be more prone to infections of the skin, mouth, stomach, intestines, lungs, and urinary tract. Some infections can be severe or life-threatening and can include infections caused by bacteria, viruses, fungi, parasites, or other infections.
Tell your doctor immediately if you experience any signs of infection, including:

• fever, cough, sore throat, weakness, or general feeling of being unwell
• memory loss, difficulty thinking, difficulty walking, or loss of vision - these may be symptoms of a rare, serious brain infection that can be life-threatening (progressive multifocal leukoencephalopathy, PML).

Severe side effects can occur, including the following reactions. If you experience any of these severe side effects, contact your doctor immediately:

Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
During treatment, mild and severe tumors have been reported, including skin cancers and a rare type of cancer that can appear as skin changes, called Kaposi's sarcoma. Symptoms include skin changes, such as new or changed skin discoloration, spots, or lumps (frequency not known):
Thrombotic thrombocytopenic purpura - a condition characterized by fever and the formation of blood clots under the skin (which can look like red dots), which may be accompanied by (or not): extreme tiredness for no apparent reason, confusion, jaundice (yellowing of the skin or eyes), and signs of acute kidney failure (passing little or no urine).
Reports of selective red cell aplasia (a significant decrease in red blood cells), hemolytic anemia (a decrease in red blood cells due to abnormal breakdown), and febrile neutropenia (a decrease in white blood cells that fight infection, with a fever).
The exact frequency of these side effects is not known. You may not experience any symptoms or, depending on the severity of the condition, you may feel tired, apathetic, have pale skin, shortness of breath, headache, chest pain, and feel cold in your hands and feet.
Cases of agranulocytosis (a significant decrease in white blood cells with the formation of ulcers in the mouth, with fever and susceptibility to infections). The condition may be asymptomatic or you may experience sudden fever, chills, and sore throat.
Allergic and anaphylactic reactions with the following symptoms: sudden onset of itchy rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and a feeling of fainting.
Reversible posterior leukoencephalopathy syndrome: headache, mental disturbances, seizures, and vision disturbances.
Heart rhythm disturbances of the type torsades de pointes: change in heart rate, which may be accompanied by (or not) symptoms such as chest pain (angina pectoris), fainting, dizziness, nausea, or palpitations (feeling of heartbeat) and difficulty breathing.
Gastrointestinal perforation: severe abdominal pain with other symptoms such as chills, fever, nausea, or vomiting, or without these symptoms.
Stevens-Johnson syndrome: unexplained, widespread skin pain, facial swelling, severe disease with blistering of the skin, mouth, eyes, and genitals, hives, tongue swelling, red or purple spreading rash, and skin peeling.
Toxic epidermal necrolysis: formation of blisters and peeling of the skin or mucous membranes, redness and swelling of the skin, which may peel off over large areas of the body.
Hemolytic uremic syndrome - a condition with the following symptoms: little or no urine output or acute kidney failure (acute kidney injury), extreme tiredness, jaundice (yellowing of the skin or eyes), and abnormal bruising or bleeding.
Insufficient function of the transplanted organ.
During treatment with Cidimus, the following side effects may also occur:

Very common side effects (may affect more than 1 in 10 people):
increased blood sugar levels, diabetes, increased potassium levels in the blood
sleep disturbances
tremors, headache
increased blood pressure
diarrhea, nausea
kidney problems
Common side effects (may affect up to 1 in 10 people):
decreased levels of magnesium, phosphates, potassium, calcium, or sodium in the blood, fluid retention, increased levels of uric acid or lipids in the blood, decreased appetite, increased blood acidity, other changes in blood electrolytes
anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations, mental disorders
seizures, impaired consciousness, tingling and numbness (sometimes painful) of hands and feet, dizziness, decreased writing ability, nervous system disorders
blurred vision, increased sensitivity to light, eye diseases
ringing in the ears
decreased blood flow in the coronary arteries, rapid heart rate
bleeding, partial or complete blockage of blood vessels, decreased blood pressure
shortness of breath, changes in lung tissue, fluid accumulation in the space around the lungs, inflammation of the throat, cough, flu-like symptoms
inflammation or ulcers causing abdominal pain or diarrhea, gastrointestinal bleeding, inflammation or ulcers of the mouth, fluid accumulation in the abdominal cavity, vomiting, abdominal pain, indigestion, constipation, bloating (also with gas), loose stools, stomach problems
changes in liver enzyme activity, jaundice due to liver function disorders, liver damage, and liver inflammation
itching, rash, hair loss, acne, excessive sweating
joint pain, limb pain, back pain, and foot pain, muscle cramps
insufficient kidney function, decreased urine production, painful or difficult urination
general weakness, fever, fluid accumulation in the body, pain, and malaise, increased alkaline phosphatase activity in the blood, weight gain, feeling of temperature disturbances
Uncommon side effects (may affect up to 1 in 100 people):
changes in blood clotting, decrease in all types of blood cells
dehydration, decreased protein or sugar levels in the blood, increased phosphate levels in the blood
coma, brain bleeding, stroke, paralysis, brain disorders, speech and language disorders, memory problems
cataracts
hearing loss
irregular heartbeat, cardiac arrest, decreased heart function, heart muscle disorders, heart enlargement, increased heart rate, abnormal ECG, abnormal heart rate, and abnormal pulse
blood clots in the veins of the limbs, shock
breathing difficulties, respiratory disorders, asthma
intestinal obstruction, increased amylase activity in the blood, reflux of stomach contents into the esophagus, delayed stomach emptying
skin inflammation, sensitivity to sunlight
joint diseases
inability to urinate, painful menstruation, and abnormal menstrual bleeding
organ failure, flu-like symptoms, increased sensitivity to heat and cold, feeling of chest tightness, nervousness, or changed well-being, increased lactate dehydrogenase activity in the blood, weight loss
Rare side effects (may affect up to 1 in 1,000 people):
minor bleeding into the skin due to blood clots
increased muscle stiffness
loss of vision
loss of hearing
fluid accumulation in the space around the heart
acute shortness of breath
formation of pancreatic cysts
disorders of blood flow through the liver
increased hair growth
thirst, falls, feeling of chest tightness, decreased mobility, ulcers
Very rare side effects (may affect up to 1 in 10,000 people):
muscle weakness
abnormal heart echo
liver failure, narrowing of the bile ducts
painful urination and blood in the urine
increased fat tissue
Unknown frequency (frequency cannot be estimated from the available data):
optic neuropathy (nerve damage affecting vision)

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Cidimus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening of the aluminum packaging covering the blister:
12 months. After opening the aluminum packaging, do not store above 25°C.
The capsules should be taken immediately after removal from the blister pack.
Do not store above 30°C. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Cidimus Contains

The active substance is tacrolimus. Each capsule contains 0.5 mg, 1 mg, or 5 mg of tacrolimus monohydrate.
The other ingredients are:
Contents of the capsule:hypromellose, lactose monohydrate, croscarmellose sodium (Ac-Di-Sol), magnesium stearate
Cidimus, 0.5 mg
Capsule (body):titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurian, gelatin
Capsule (cap):yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurian, gelatin
Cidimus, 1 mg
Capsule (body):titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurian, gelatin
Capsule (cap):yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurian, gelatin
Cidimus, 5 mg
Capsule (body):titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurian, gelatin
Capsule (cap):red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurian, gelatin

What Cidimus Looks Like and Contents of the Pack

Cidimus 0.5 mg: hard capsules with a white, matte body and an ivory cap (length 14.5 mm), containing a white or off-white powder.
Cidimus 1 mg: hard capsules with a white, matte body and a light brown cap (length 14.5 mm), containing a white or off-white powder.
Cidimus 5 mg: hard capsules with a white, matte body and an orange cap (length 15.8 mm), containing a white or off-white powder.
Cidimus capsules are packaged in blisters of PVC/PE/PVDC/Aluminum in a polyester/Aluminum/PE bag with a desiccant.
Do not swallow the desiccant.
Package sizes: 30, 50, 60, and 100 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
Domaniewska 50 C
02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz, S.R.L.
Livezeni Street no 7A
Targu Mures, Romania

For More Information on This Medicinal Product, Please Contact:

Sandoz Poland Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Leaflet:02/2025
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