Cidimus

1. What is Cidimus and what is it used for

Cidimus belongs to a group of so-called immunosuppressivedrugs.
After organ transplantation (e.g., liver, kidney, heart), the patient's immune system tries to
reject the new organ.
Cidimus is used to control the immune system's response and allow the body to accept the
transplanted organ.
Cidimus is often used in combination with other drugs that also suppress the immune system.
Cidimus can also be used in cases of ongoing rejection of a transplanted liver, kidney, heart, or other
organs, or when previous treatment has not been able to control the immune response after transplantation.

2. Important information before taking Cidimus

When not to take Cidimus

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

Warnings and precautions

Before taking Cidimus, the patient should discuss it with their doctor or pharmacist.
Cidimus should be taken every day for as long as it is necessary to suppress the immune system to
prevent rejection of the transplanted organ. The patient should regularly consult their doctor.
During treatment with Cidimus, the doctor may occasionally recommend a series of tests (including
blood, urine, heart rate, vision, and neurological tests). This is a common practice that will help the
doctor determine the correct dose of Cidimus.
The patient should avoid taking herbal medicines, such as St. John's Wort ( Hypericum perforatum) or
other plant-based medicines, as they may affect the efficacy of Cidimus and its required dose. In case
of doubts before taking any herbal medicine, the patient should consult their doctor.
If the patient has liver function disorders or has had a disease that may have affected liver function, they
should inform their doctor. This may be relevant to the dose of Cidimus administered.
The patient should tell their doctor if they experience severe abdominal pain with other symptoms such
as chills, fever, nausea, or vomiting, or without such symptoms.
If the patient has diarrhea lasting more than 1 day, they should inform their doctor, as it may be necessary
to adjust the dose of Cidimus.
The patient should tell their doctor if they have been diagnosed with changes in the electrical activity of
the heart, so-called QT interval prolongation.
During treatment with Cidimus, the patient should limit their exposure to sunlight and UV radiation by
wearing protective clothing and using creams with a high protection factor. This is due to the increased
risk of developing skin cancer during immunosuppressive treatment.
If the patient is to undergo any vaccination, they should inform their doctor in advance. The doctor will
advise on the best course of action.
In patients taking Cidimus, there is an increased risk of developing lymphoproliferative disorders (see
section 4). The doctor will provide explanations on this matter.

Cidimus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have
recently taken, as well as any medicines they plan to take, including those that are available without a
prescription and herbal preparations.
Cidimus should not be taken at the same time as cyclosporin.
Other medicines taken at the same time may affect the blood levels of Cidimus, and Cidimus may affect
the blood levels of other medicines. It may be necessary to stop taking them, increase or decrease the
dose of Cidimus.

The patient should especially inform their doctor if they are taking or have recently taken the following medicines:

antifungal and antibiotic medicines (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 drug 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);
hormonal therapy with ethinylestradiol (e.g., oral contraceptive pill) or danazol;
medicines used to treat high blood pressure or heart rhythm disorders, such as nifedipine, nicardipine,
diltiazem, and verapamil;
anti-arrhythmic medicines (e.g., amiodarone) used to control heart rhythm;
statin medicines used to treat high cholesterol and triglyceride levels;
anti-epileptic medicines - phenytoin or phenobarbital;
corticosteroids prednisolone and methylprednisolone;
antidepressant nefazodone;
herbal medicines containing St. John's Wort ( Hypericum perforatum) or extracts of Chinese schisandra
( Shisandra sphenanthera);
metamizole, a medicine used to treat pain and fever;
cannabidiol (a medicine used, among other things, to treat seizures).
The patient should immediately tell their doctor if they experience:
vision problems, such as blurred vision, changes in color vision, difficulty seeing details, or restricted
field of vision.
The patient should tell their doctor if they intend to or need to take ibuprofen, amphotericin B, or antiviral
medicines (such as acyclovir). These medicines, when taken with Cidimus, may increase kidney or
nerve disorders.
The doctor should also be informed if the patient is taking potassium supplements or potassium-sparing
diuretics (e.g., amiloride, triamterene, or spironolactone) or trimethoprim or cotrimoxazole antibiotics,
which may increase blood potassium levels, certain painkillers (so-called non-steroidal anti-inflammatory
drugs, NSAIDs, e.g., ibuprofen), anticoagulants, or oral antidiabetic drugs.
If the patient is to undergo any vaccination, they should inform their doctor in advance.

Cidimus with food and drink

Basically, 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, the patient should avoid eating grapefruits and drinking grapefruit
juice.

Pregnancy and breastfeeding

If a woman is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should
consult her doctor or pharmacist before taking this medicine.
Cidimus passes into breast milk. During its use, the patient should not breastfeed.

Driving and using machines

If after taking Cidimus the patient feels dizzy, sleepy, or has vision disturbances, they should not drive
vehicles or operate machinery. These symptoms are more common when taking Cidimus and drinking
alcohol at the same time.

Cidimus contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which means it is
considered "sodium-free".

3. How to take Cidimus

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should
consult their doctor or pharmacist.
When dispensing the prescription, the patient should make sure that the same medicine containing tacrolimus
is always dispensed, unless a transplant specialist has recommended switching to another medicine containing
tacrolimus.
The medicine should be taken twice a day. If the medicine looks different than usual or the dosage
recommendations have changed, the patient should contact their doctor or pharmacist as soon as possible to
make sure they have been given the correct medicine.
The initial dose used to prevent rejection of the transplanted organ is determined by the doctor based on the
patient's 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 the patient's overall condition and the other immunosuppressive medicine
being taken. To determine the correct dose and adjust it, the doctor will order regular blood tests. After the
patient's condition has stabilized, the doctor will usually reduce the dose of Cidimus. The doctor will specify
how many capsules to take and how often.
Cidimus is taken orally twice a day, usually in the morning and evening. Basically, 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, washed down with a glass of water.
The capsules should be taken immediately after removal from the blister.
During treatment with Cidimus, the patient should avoid eating grapefruits and drinking grapefruit juice.
The patient should not swallow the desiccant contained in the foil packaging.

Taking a higher dose of Cidimus than recommended

In case of accidental ingestion of too much Cidimus, the patient should immediately contact their doctor or go
to the emergency room of the nearest hospital.

Missing a dose of Cidimus

The patient should not take a double dose to make up for a missed dose. If the patient has forgotten to take
the medicine, they should wait until the next dose is due and then continue with the usual dosage schedule.

Stopping treatment with Cidimus

Stopping treatment with Cidimus may increase the risk of rejection of the transplanted organ.
The patient should not stop treatment without their doctor's advice.
In case of any further doubts about taking this medicine, the patient should consult their 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 defense mechanism to prevent rejection of the transplanted organ. As a result,
the body will not fight infections as effectively as it normally would. Therefore, when taking Cidimus, the
patient 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.
The patient should immediately inform their doctor if they experience symptoms of infection, including:

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

Severe side effects can occur, including reactions described below. If the patient notices or suspects any of the
following severe side effects, they should immediately contact their doctor.
Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
During treatment, mild and malignant tumors have been reported due to immunosuppression, including skin
cancer and a rare type of cancer that can manifest as skin changes, called Kaposi's sarcoma. Symptoms
include skin changes, such as new or changed discoloration, spots, or bumps (frequency not known
(frequency cannot be estimated from the available data)):
Thrombotic thrombocytopenic purpura - a disorder characterized by fever and the formation of bruises under
the skin (which may look like red dots), which may be accompanied by (or not): very severe fatigue of
unknown cause, confusion, jaundice (yellowing of the skin or eyes), and symptoms of acute kidney failure
(passing small amounts of urine or no urine).
Reports of selective red cell aplasia (significant reduction in red blood cell count), hemolytic anemia (reduction
in red blood cell count due to abnormal breakdown, along with fatigue), and febrile neutropenia (reduction in
white blood cell count fighting infections, with fever).
The exact frequency of these side effects is not known. The patient may not experience any symptoms or, depending
on the severity of the disease, they may feel tired, apathetic, have unusually pale skin, shortness of breath, headache,
chest pain, and feel cold in their hands and feet.
Cases of agranulocytosis (significant reduction in white blood cell count with the formation of ulcers in the mouth,
fever, and susceptibility to infections). The disorder may be asymptomatic or the patient 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 disorders, seizures, and vision disturbances.
Heart rhythm disorders of the torsades de pointes type: change in heart rate, which may be accompanied by (or not)
such symptoms as chest pain (angina pectoris), fainting, dizziness, or nausea, palpitations (feeling of heartbeat),
and breathing difficulties.
Perforation in the digestive tract: severe abdominal pain with other symptoms such as chills, fever, nausea, or
vomiting, or without such symptoms.
Stevens-Johnson syndrome: unexplained, widespread skin pain, facial swelling, serious illness 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 ulcers and blisters on 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 disorder with the following symptoms: small amounts of urine or no urine (acute
kidney failure), very severe fatigue, jaundice (yellowing of the skin or eyes), and abnormal bruising or bleeding.
Insufficient function of the transplanted organ.
During treatment with Cidimus, the patient may also experience the following side effects:
Very common side effects (may occur in more than 1 in 10 people):
increased blood sugar levels, diabetes, increased potassium levels in the blood
sleep disorders
tremors, headache
increased blood pressure
diarrhea, nausea
kidney function disorders
Common side effects (may occur in less than 1 in 10 people):
decreased magnesium, phosphate, potassium, calcium, or sodium levels in the blood, fluid retention,
increased uric acid or lipid levels in the blood, decreased appetite, increased blood acidity, other changes in
blood electrolyte levels
anxiety symptoms, confusion and disorientation, depression, mood changes, nightmares, hallucinations,
psychiatric disorders
seizures, impaired consciousness, tingling and numbness (sometimes painful) of hands and feet, dizziness,
reduced writing ability, nervous system disorders
blurred vision, increased sensitivity to light, eye diseases
ringing in the ears
reduced blood flow in the coronary arteries, accelerated heart rate
bleeding, partial or complete blockage of blood vessels, decreased blood pressure
breathing difficulties, changes in lung tissue, fluid accumulation in the space around the lungs, inflammation
of the throat, cough, flu-like symptoms
liver enzyme activity changes, jaundice due to liver function disorders, liver tissue damage, and liver inflammation
itching, rash, hair loss, acne, excessive sweating
joint pain, limb pain, back pain, and foot pain
insufficient kidney function, reduced 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 occur in less than 1 in 100 people):
blood clotting changes, reduction 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, brain function disorders, speech and language disorders, memory problems
cataracts
hearing loss
irregular heartbeat, cardiac arrest, impaired heart function, heart muscle disorders, heart muscle enlargement,
increased heart rate, abnormal ECG, abnormal heart rate and rhythm
blood clot in a limb vein, shock
breathing difficulties, respiratory tract disorders, asthma
intestinal obstruction, increased amylase activity in the blood, reflux, delayed stomach emptying
skin inflammation, sensitivity to sunlight
joint diseases
urination difficulties, painful menstruation, and abnormal menstrual bleeding
organ failure, flu-like symptoms, increased sensitivity to heat and cold, feeling of pressure in the chest, nervousness
or changed well-being, increased lactate dehydrogenase activity in the blood, weight loss
Rare side effects (may occur in less than 1 in 1000 people):
minor bleeding in the skin due to blood clots
increased muscle stiffness
vision loss
hearing loss
fluid accumulation in the space around the heart
acute shortness of breath
pancreatic cyst formation
liver blood flow disorders
increased hair growth
thirst, falls, feeling of pressure in the chest, reduced mobility, ulcers
Very rare side effects (may occur in less than 1 in 10,000 people):
muscle weakness
abnormal heart echo
liver failure, bile duct narrowing
painful urination, blood in the urine
increased fat tissue
Unknown frequency (frequency cannot be estimated from the available data):
optic nerve disorders (optic neuropathy)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell
their 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 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 to gather more information on the safety of this medicine.

5. How to store Cidimus

The medicine should be stored out of sight and reach of children.
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 month.
Shelf life after first opening 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.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist
how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Cidimus contains

The active substance of the medicine is tacrolimus. Each capsule contains 0.5 mg, 1 mg, or 5 mg of tacrolimus
monohydrate.
Other ingredients are:
Capsule contents:hypromellose, lactose monohydrate, croscarmellose sodium (Ac Di Sol), magnesium
stearate
Cidimus, 0.5 mg
Capsule (body):titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate, gelatin
Capsule (cap):yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate,
gelatin
Cidimus, 1 mg
Capsule (body):titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate, gelatin
Capsule (cap):yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), titanium dioxide
(E171), sodium lauryl sulfate, sorbitan laurate, gelatin
Cidimus, 5 mg
Capsule (body):titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate, gelatin
Capsule (cap):red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate, sorbitan laurate, 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 PVC/PE/PVDC/Aluminum blisters in a polyester/Aluminum/PE bag with a
desiccant.
The desiccant should not be swallowed.
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.
ul. 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 the medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:02/2025
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