Cortmuper

Package Leaflet: Information for the User

Cortmuper 10 mg effervescent tablets, 20 mg effervescent tablets

dexamethasone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Cortmuper is and what it is used for

Cortmuper is a medicine containing the active substance desametasone.
Desametasone is a synthetic glucocorticoid, sometimes referred to as a corticoid or corticosteroid, similar to a hormone naturally produced by the adrenal glands.
Desametasone exerts various actions, including effects on white blood cells, which are part of the immune system (the body's natural defenses).

Cortmuper is indicated in adults, within specific therapeutic protocols, for the treatment of conditions requiring high doses of desametasone:

• Idiopathic thrombocytopenic purpura
• Symptomatic multiple myeloma
• Acute lymphoblastic leukemia
• Hodgkin’s lymphoma
• Non-Hodgkin’s lymphoma

Cortmuper is also indicated for the prevention of nausea and vomiting induced by chemotherapy with high emetogenic potential.

2. What you need to know before taking Cortmuper

Do not take Cortmuper:

• if you are allergic to dexamethasone or to any of the other ingredients of this medicine (listed in section 6);
• if you have a systemic infection (unless you are receiving specific treatment for such infection);
• if you have a systemic fungal infection;
• if you have a stomach or duodenal ulcer;
• if you have an eye infection (ocular herpes simplex);
• if you suffer from untreated psychiatric illness or mental disorders (psychosis);
• if you have a viral infection, particularly viral hepatitis, herpes, chickenpox or shingles;
• if you are breastfeeding;
• if you have received a live viral vaccine;
• if you are breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cortmuper.
Risk of infection
Treatment with Cortmuper (a high-dose corticosteroid) may reduce your body’s ability to
fight infections (particularly those caused by bacteria, yeasts and/or parasites). This may lead to infections
caused by microorganisms that rarely cause infection under normal circumstances (so-called opportunistic
infections). If you develop any type of infection during treatment with this medicine,
contact your doctor immediately. This is particularly important if you notice signs of pneumonia: cough, fever,
shortness of breath and chest pain. You may also feel confused, especially if you are elderly. You must inform
your doctor if you have had tuberculosis or if you have stayed in regions where infections with nematodes are
common.
Note: during treatment with Cortmuper, it is important to avoid contact with anyone affected by
chickenpox, measles or shingles. If you think you have been exposed to someone with any of these conditions,
inform your doctor immediately. Inform your doctor if you have ever had infectious diseases such as measles or
chickenpox and if you have been vaccinated against these diseases in the past.
Psychiatric disorders
High-dose corticosteroids, including dexamethasone, may cause psychological problems, sometimes
severe. Consult your doctor before taking Cortmuper if you or a close family member have suffered or are currently suffering
from severe depression or manic episodes. This is particularly important if you feel depressed
or have suicidal thoughts. Insomnia can be minimized by taking Cortmuper in the morning.
Tumor lysis syndrome
Contact your doctor if you experience symptoms of tumor lysis syndrome such as muscle cramps,
muscle weakness, confusion, vision loss or disturbances, and shortness of breath.
Long-term treatment
During treatment with this medicine, it is important to follow a balanced diet (low in sugar and sodium, rich in
protein). Fluid and sodium retention is common and may lead to hypertension. Your doctor will
advise you on an appropriate diet and may prescribe potassium, calcium or
vitamin D supplements.
Treatment with glucocorticoids such as dexamethasone may reduce the effectiveness of medicines used to treat
diabetes or hypertension. The dose of these medicines may need to be increased by your doctor.
Hematology
If you have previously had blood clots, you must inform your doctor before taking Cortmuper.
The combination of dexamethasone with thalidomide, lenalidomide or pomalidomide (medicines used to treat
multiple myeloma) increases the risk of blood clots in veins and arteries. You must inform your
doctor immediately if you experience shortness of breath, chest pain or swelling in the arms or legs.
The combination of dexamethasone with lenalidomide or pomalidomide may cause a reduction in the number of
white blood cells (blood cells that help fight infections) and/or platelets (which
help prevent bleeding). Your doctor will arrange appropriate blood tests before and during
treatment.
Pheochromocytoma crisis
Treatment with this medicine may cause a pheochromocytoma crisis, which can be fatal.
Pheochromocytoma is a rare tumor of the adrenal glands. The crisis may occur with the following symptoms:
headache, sweating, palpitations and hypertension. Contact your doctor immediately if you experience any of
these symptoms.
Eye disorders
Treatment with this medicine may cause central serous chorioretinopathy, an eye disease
that leads to blurred or distorted vision. This usually affects only one eye. If you notice blurred or distorted
vision lasting several days, contact your doctor.
Tendinitis
Treatment with this medicine may cause tendon inflammation. In extremely rare cases, tendon rupture may
occur. This risk increases when taking certain antibiotics and in case of kidney problems. Contact your doctor if you notice pain, stiffness or swelling in joints or tendons.
Inform any doctor, dentist or healthcare provider who may prescribe treatment for you that you are taking or have
recently taken dexamethasone (see section “Other medicines and Cortmuper”).
If you become ill or are involved in an accident, or if you need surgery (including dental procedures) or
vaccination (high doses of glucocorticoids may reduce the effectiveness of vaccines containing “live
viruses”), you must inform your doctor that you are taking or have recently taken high-dose corticosteroids.
If you need to undergo tests (particularly for infections or allergy tests), inform the person performing the tests,
because dexamethasone may interfere with the results.
Before taking Cortmuper, inform your doctor:

• if you have liver or kidney disease,
• if you have heart disease or have recently had a heart attack,
• if you have high blood pressure, high cholesterol or smoke,
• if you have diabetes or a family history of diabetes,
• if you have osteoporosis, especially if you are a postmenopausal woman,
• if you have glaucoma (increased eye pressure) or a family history of glaucoma,
• if you have myasthenia gravis (a disease affecting muscles), or tendon inflammation (tendinitis),
• if you have a peptic ulcer (ulcer in the stomach or duodenum) or a history of peptic ulcers, gastrointestinal bleeding or perforation,
• if you have colitis, diverticulitis or have recently undergone intestinal surgery,
• if you have or suspect you have pheochromocytoma (a tumor of the adrenal glands). Your doctor will monitor you more closely if you have any of these conditions.

Elderly
If you are elderly, some of the side effects of Cortmuper may be more severe, particularly
bone thinning (osteoporosis), high blood pressure, low potassium levels, diabetes,
increased susceptibility to infections and skin thinning. Your doctor will monitor you closely.
Children and adolescents
Cortmuper is not indicated for use in children.
Other medicines and Cortmuper
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Before starting treatment with Cortmuper, read the package leaflet of all medicines you are taking in combination
with Cortmuper to obtain all necessary information. Special attention must be paid to testing and
pregnancy prevention requirements when taking thalidomide,
lenalidomide or pomalidomide.
If you are taking any of the following medicines, inform your doctor before taking Cortmuper:

• anticoagulant medicines (blood thinners);
• acetylsalicylic acid, a substance present in many medicines used for mild pain and fever relief, and other medicines for treating pain, inflammation and fever: ibuprofen, naproxen, diclofenac, meloxicam and others;
• medicines for treating hypertension or heart disease;
• medicines for treating diabetes;
• medicines for stomach disorders (e.g. antacids) and cholestyramine (to lower cholesterol);
• medicines that reduce potassium levels in the blood: e.g. certain diuretics or laxatives;
• cortisone or other corticosteroids, tetracosactide (used for adrenal function tests) or aminoglutethimide (used to treat Cushing's syndrome or breast cancer);
• macrolide antibiotics such as clarithromycin, erythromycin, telithromycin; fluoroquinolones such as ciprofloxacin and levofloxacin; antifungal medicines such as itraconazole, ketoconazole, posaconazole, voriconazole or amphotericin B; anti-HIV medicines such as nelfinavir, ritonavir, indinavir;
• rifampicin, rifabutin or isoniazid (used to treat tuberculosis);
• praziquantel or ivermectin (for certain parasitic infections);
• estrogen hormones, including oral contraceptives and hormone replacement therapy (HRT);
• anticonvulsants (for treating epilepsy) and midazolam (used as a sleeping pill and for treating epilepsy);
• aprepitant or fosaprepitant (to prevent nausea and vomiting caused by chemotherapy);
• certain anticancer medicines: docetaxel, cyclophosphamide, lapatinib or methotrexate. Methotrexate is also used to treat rheumatism or psoriasis;
• erythropoietic medicines such as erythropoietin (EPO, for treating anemia);
• cyclosporine (for treating psoriasis, atopic dermatitis, rheumatoid arthritis or nephrotic syndrome, and to suppress immune reactions after organ or bone marrow transplantation);
• ephedrine (for nasal decongestion).

Also inform your doctor if you have recently undergone or plan to undergo vaccination.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
Pregnancy
Cortmuper must not be used during pregnancy unless clearly indicated by your doctor.
You should avoid becoming pregnant during treatment with Cortmuper. You and your partner must
use adequate contraception. Inform your doctor immediately if you become pregnant or suspect pregnancy during treatment.
Breastfeeding
Do not use Cortmuper if you are breastfeeding, as Cortmuper is excreted in breast milk.
Driving and using machines
Cortmuper may moderately impair the ability to drive and use machines.
Do not drive, operate tools or machinery or perform hazardous activities if you experience side effects
such as confusion, hallucinations, dizziness, fatigue, drowsiness, fainting or blurred vision.
Cortmuper contains sodium
Cortmuper 10 mg effervescent tablets
This medicine contains 32.82 mg of sodium (the main component of table salt) per tablet.
This corresponds to 1.64% of the maximum daily recommended dietary intake for an adult.
Cortmuper 20 mg effervescent tablets
This medicine contains 65.64 mg of sodium (the main component of table salt) per tablet.
This corresponds to 3.28% of the maximum daily recommended dietary intake for an adult.
Cortmuper contains benzoate
Cortmuper 10 mg effervescent tablets
This medicine contains 9 mg of sodium benzoate per tablet.
Cortmuper 20 mg effervescent tablets
This medicine contains 18 mg of sodium benzoate per tablet.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Cortmuper

Take Cortmuper exactly as prescribed by your doctor or pharmacist. Your doctor will decide how long you should take dexamethasone. If you have any doubts, consult your doctor or pharmacist.
Cortmuper is for oral use only. Your doctor will prescribe the most appropriate dose for your condition.
The tablets should be taken as a drink after dissolving them in a glass of water.
Take the tablets as a single dose each morning, unless otherwise directed by your doctor.

The recommended dose is:
Adults:

• Idiopathic thrombocytopenic purpura: 40 mg/day for 4 days. Dexamethasone is used as part of specific treatment protocols that include multiple interventions. Dosage and dosing schedule must be determined by a physician experienced in the treatment of idiopathic thrombocytopenic purpura. Prescribing physicians must carefully evaluate the dexamethasone dose to be used, taking into account the patient's condition and disease status, and monitor the patient for the occurrence of adverse effects.
• Symptomatic multiple myeloma, non-Hodgkin lymphoma: 40 mg/day as part of specific treatment protocols, in combination with other medicinal products. In some treatment protocols, a dose of 20 mg/day is recommended as part of specific treatment protocols, in combination with other medicinal products. Treatment must be initiated and monitored by physicians experienced in treating these conditions. The dose and frequency of administration vary depending on the therapeutic protocol and associated treatments. Administration of Cortmuper must follow the instructions for dexamethasone administration described in the Summary of Product Characteristics of the associated treatment(s), if reported. Local or international treatment protocols and guidelines must be followed. Prescribing physicians must carefully evaluate the dexamethasone dose to be used, taking into account the patient's condition and disease status. When dexamethasone is included in the treatment regimen of pomalidomide in combination with bortezomib, the initial dose of dexamethasone for patients over 75 years of age is 10 mg per day in cycles. A dose of 10 mg per day is also indicated for patients aged 75 years or younger, for dose reduction in case of adverse reactions related to dexamethasone.
• Hodgkin lymphoma: 40 mg/day as part of specific treatment protocols, in combination with other medicinal products. Treatment must be initiated and monitored by physicians experienced in treating Hodgkin lymphoma. The dose and frequency of administration vary depending on the therapeutic protocol and associated treatments. Administration of Cortmuper must follow the instructions for dexamethasone administration described in the Summary of Product Characteristics of the associated treatment(s), if reported. Local or international treatment protocols and guidelines must be followed. Prescribing physicians must carefully evaluate the dexamethasone dose to be used, taking into account the patient's condition and disease status.
• Acute lymphoblastic leukemia: 40 mg/day as part of specific treatment protocols, in combination with other medicinal products. In some treatment protocols, a dose of 20 mg/day or 10 mg/day is recommended as part of specific treatment protocols, in combination with other medicinal products. Treatment must be initiated and monitored by physicians experienced in treating acute lymphoblastic leukemia. The dose and frequency of administration vary depending on the therapeutic protocol and associated treatments. Administration of Cortmuper must follow the instructions for dexamethasone administration described in the Summary of Product Characteristics of the associated treatment(s), if reported. Local or international treatment protocols and guidelines must be followed. Prescribing physicians must carefully evaluate the dexamethasone dose to be used, taking into account the patient's condition and disease status.
• Prevention of acute and delayed chemotherapy-induced nausea and vomiting, as part of antiemetic treatment: 20 mg* on day 1 of each chemotherapy cycle, followed by 8 mg twice daily on days 3–4 (*dose reduction to 12 mg in case of co-administration with aprepitant, netupitant, or fosaprepitant).

If you take more Cortmuper than you should
If you accidentally ingest/overdose on Cortmuper, contact your doctor immediately or go to the nearest hospital.

If you forget to take Cortmuper
Do not take a double dose to make up for the missed dose.

If you stop taking Cortmuper
Do not stop taking this medicine abruptly. If treatment needs to be discontinued, follow your doctor's advice, who will gradually reduce the amount of medicine you take until stopping completely.
Symptoms reported when treatment was stopped too quickly include low blood pressure and, sometimes, relapse of the disease for which the medicine was prescribed.
A withdrawal syndrome may also occur, including fever, muscle and joint pain, inflammation of the nasal mucosa (rhinitis), weight loss, itching, and eye inflammation (conjunctivitis).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people):

• High blood sugar levels
• Difficulty sleeping
• Constipation
• Muscle weakness or cramps
• Feeling tired or weak
• Swelling of the face or legs

Common side effects (may affect up to 1 in 10 people):

• Infections (pneumonia, herpes, sore throat, cough, urinary tract infections)
• Anaemia, increased risk of infections or bleeding
• Low levels of salts in the blood
• Increased or decreased appetite
• Swelling due to fluid retention
• Sadness, anxiety, restlessness
• Mood changes, feeling euphoric or irritable
• Headache, dizziness, tremors, difficulty concentrating
• Drowsiness
• Blurred or cloudy vision
• Irregular or fast heartbeat
• High or low blood pressure
• Hot flushes
• Cough, shortness of breath, hoarseness or hiccups
• Stomach ache, nausea, vomiting, diarrhoea
• Dry mouth, bloating
• Increased liver enzymes
• Skin rashes or irritation, itching, dry skin
• Excessive sweating, hair loss
• Pain in bones, joints or muscles
• Need to urinate frequently
• Weight gain or loss
• Fever or chills
• Inflammation of the mouth or throat
• General malaise

Uncommon side effects (may affect up to 1 in 100 people):

• Fever due to low immune defences
• Dehydration
• Mood swings or seeing things that are not there (hallucinations)
• Fainting or loss of balance
• Inflammation of the eyes or excessive tearing
• Slow heartbeat
• Inflammation of the pancreas (severe abdominal pain)
• Kidney problems
• Hives (swellings and itching of the skin)
• Weaker bones, increased risk of fractures
• Tendon rupture

Rare or frequency not known side effects:

• Severe allergic reactions with swelling or difficulty breathing
• Hormonal problems with weight gain or facial swelling
• Problems with menstrual cycle or sexual function
• Severe mental disorders, confusion or hallucinations
• Seizures (involuntary shaking)
• Heart attack or heart problems
• Blood clots (thrombosis or embolism)
• Ulcers or bleeding in the stomach or intestines
• Liver problems
• Acne, thin skin or stretch marks
• Serious bone problems (osteonecrosis)
• Wounds that heal slowly

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cortmuper

Keep this medicine out of the sight and reach of children.
Store this medicine at a temperature not exceeding 30°C.
Keep this medicine in the original packaging to protect it from moisture.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cortmuper contains
The active substance is dexamethasone.
Each 10 mg effervescent tablet contains 10 mg of dexamethasone (as dexamethasone sodium phosphate).
Each 20 mg effervescent tablet contains 20 mg of dexamethasone (as dexamethasone sodium phosphate).
The other components are: sodium hydrogen carbonate (E500), disodium hydrogen citrate, povidone K30,
sodium saccharin (E954), sodium benzoate (E211), erythrosine (E127).

Description of the appearance of Cortmuper and the contents of the pack
Cortmuper 10 mg effervescent tablets are pink, oblong tablets.
Cortmuper 20 mg effervescent tablets are pink, round tablets.
Cortmuper is available in blisters containing 10, 20, 30 or 50 effervescent tablets in PA/Al/PVC-Al blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
ELLEVA PHARMA S.r.l., Via San Francesco n. 5/7, 80034 Marigliano (NA) – Italy

Manufacturer
RAFARM S.A.
Thesi Pousi-Xatzi, Agiou Louka Street, AttiKi Odos, Peania, 19002, Greece