Cidimus

1. What is Cidimus and what is it used for

Cidimus belongs to a group of so-called immunosuppressivemedicines.
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 medicines 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 body's immune response after transplantation.

2. Important information before taking 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 it with your doctor or pharmacist.
Cidimus should be taken daily for as long as it is necessary 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 a series of tests (including blood, urine, heart rate, vision, and neurological tests). This is a common 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 plant 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 function disorders or have had a disease that may have affected liver function, you should inform your doctor. This may be relevant to the dose of Cidimus administered.
Tell your doctor if you experience severe abdominal pain with other symptoms such as chills, fever, nausea, or vomiting, or without such 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.
Tell your doctor if you have been diagnosed with changes in the electrical activity of the heart, so-called QT interval prolongation.
During treatment with Cidimus, you should limit your exposure to sunlight and UV radiation, wearing protective clothing and using creams with a high protection factor. This is due to the 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 on the best course of action.
Patients taking Cidimus have been reported to have an increased risk of developing lymphoproliferative disorders (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 plan to take, including those that are available without a prescription and herbal preparations.
Cidimus must not be taken at the same time as cyclosporin.
Other medicines taken at the same time may affect the level of Cidimus in your blood and Cidimus may affect the level of other medicines in your blood. It may be necessary to stop taking them, 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 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 pharmacokinetics, 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 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 Chinese schisandra ( Shisandra 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:
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 need to take ibuprofen, amphotericin B, or antiviral medicines (such as acyclovir). These medicines, when taken with Cidimus, may increase kidney or nervous system disorders.
Your doctor should also be informed if, while taking Cidimus, you are also taking potassium supplements or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) or antibiotics trimethoprim or cotrimoxazole, which may increase potassium levels in the blood, some painkillers (so-called non-steroidal anti-inflammatory drugs, NSAIDs, e.g. ibuprofen), anticoagulant or oral anti-diabetic medicines.
If you are going to have any vaccination, you should inform your doctor in advance.

Cidimus with food and drink

As a rule, 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 breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Cidimus passes into breast milk. During its use, do not breastfeed.

Driving and using machines

If, after taking Cidimus, you experience dizziness, drowsiness, or vision disturbances, 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 diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, which is considered to be "sodium-free".

3. How to take Cidimus

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor or pharmacist.
When your prescription is being dispensed, make sure you are given 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 than usual or the dosage instructions have changed, you should contact your doctor or pharmacist as soon as possible to make sure you have been given 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 order regular blood tests. 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. As a rule, 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 packaging.

Taking a higher dose of Cidimus than recommended

In case of accidental ingestion of a higher dose of Cidimus than recommended, contact your doctor or go to the emergency room of the nearest hospital immediately.

Missing a dose of Cidimus

Do not take a double dose to make up for a missed dose. If you have missed a dose, 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.
Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, 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 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, 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 may include bacterial, viral, fungal, parasitic, or other infections.
Tell your doctor immediately if you experience symptoms 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 caused by a very rare, serious brain infection that can be life-threatening (progressive multifocal leukoencephalopathy, PML).

Severe side effects may occur, including the following reactions. If you notice or suspect any of the following severe side effects, contact your doctor immediately:
Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
During treatment, mild and malignant tumors have been reported, including skin cancers and a rare type of cancer that may appear as skin changes, called Kaposi's sarcoma. Symptoms include skin changes, such as new or changed skin discolorations, spots, or lumps (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, and signs 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, 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, may experience fatigue, apathy, pale skin, shortness of breath, headache, chest pain, and feel cold in hands and feet.
Cases of agranulocytosis (significant reduction in white blood cell count with the formation of ulcers in the mouth, with 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 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) symptoms such as chest pain (angina pectoris), fainting, dizziness, or nausea, palpitations (feeling of heartbeat), and difficulty breathing.
Gastrointestinal perforation: 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, 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 disorder with the following symptoms: small amounts of urine or no urine (acute kidney failure), very severe fatigue, jaundice, and abnormal bruising or bleeding.
Transplanted organ failure.
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 function disorders
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, accelerated 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, stomach bleeding, inflammation or ulcers of the mouth mucosa, 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 tissue damage, and liver inflammation
itching, rash, hair loss, acne, excessive sweating
joint pain, limb pain, back pain, and foot pain, muscle cramps
kidney function impairment, 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 disorders
Uncommon side effects (may affect up to 1 in 100 people):
blood clotting disorders, 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 function disorders, speech and language disorders, memory problems
cataract
hearing impairment
irregular heartbeat, cardiac arrest, decreased heart function, heart muscle disorders, heart muscle enlargement, increased heart rate, abnormal ECG, abnormal heart rate, and abnormal pulse
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, burning sensation when exposed 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 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
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 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, bile duct narrowing
painful urination, blood in the urine
increased fat tissue
Frequency not known (frequency cannot be estimated from the available data):
optic nerve disorders (optic neuropathy)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cidimus

Keep the medicine out of the 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 stated.
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 pack.
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. Ask your pharmacist how to dispose of medicines that are no longer needed. 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:
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 laurate, gelatin
Capsule (cap):iron oxide yellow (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):iron oxide yellow (E172), iron oxide red (E172), iron oxide black (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):iron oxide red (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 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 about this medicine and its names in the Member States of the European Economic Area, 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
Sandoz logo