NEOFORDEX 40 mg Tablet

Зміст інструкції

1. Neofordex 40 mg tablet
   1. What is Neofordex and what is it used for
   2. What you need to know before taking Neofordex
   3. How to take Neofordex
   4. Possible side effects
   5. How to store Neofordex
   6. Contents of the pack and other information

Neofordex 40 mg tablet

dexamethasone

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Neofordex and what is it used for

Neofordex is a medicine that contains the active substance desamethasone. Desamethasone is a type of
hormone defined as a glucocorticoid, sometimes called a cortisone or corticosteroid, with various actions that include
effects on white blood cells, which are part of the immune system (the body's natural defenses). Desamethasone is similar to glucocorticoids produced naturally in the body.
Neofordex is used for the treatment of adult patients with multiple myeloma, a cancer of the blood that
affects white blood cells that produce antibodies. Neofordex will be administered in association with other
medicines for multiple myeloma; they work together by killing cancerous white blood cells.

2. What you need to know before taking Neofordex

Do not take Neofordex

• if you are allergic to desamethasone or any of the other ingredients of this medicine (listed in section 6);
• if you have a viral infection, in particular viral hepatitis, herpes, chickenpox or shingles;
• if you suffer from an untreated psychiatric illness.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Neofordex, especially if
administered with other medicines.
Risk of infection
Treatment with Neofordex (a high-dose corticosteroid) may reduce the body's ability to
fight infections (particularly those caused by bacteria, yeasts and/or parasites). This can lead to infections
caused by germs that rarely cause infection under normal circumstances (so-called opportunistic infections). If you contract an infection of any kind 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 should inform
your doctor also if you have had tuberculosis or if you have stayed in regions where nematode infections are
common.

Note:during treatment with Neofordex, it is important to avoid contact with anyone who is affected by
chickenpox, measles or shingles. If you think you have been in contact with someone with these conditions,
inform your doctor immediately.
Psychiatric disorders
High-dose corticosteroids, including desamethasone, can cause psychological problems, sometimes
serious. Consult your doctor before taking Neofordex if you or a close family member has suffered or is suffering
currently from severe depression or manic attacks. This is particularly important if you feel depressed
or have suicidal thoughts. Insomnia can be minimized by administering Neofordex in the morning.
Tumor lysis syndrome
Talk to your doctor if you have symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness,
confusion, loss or disturbances of vision 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 can lead to hypertension.
Your doctor will advise you on an appropriate diet and may prescribe you potassium, calcium or
vitamin D supplements.
Therapy with glucocorticoids such as desamethasone may reduce the effect of medicines for the treatment of
diabetes or hypertension. The dose of these medicines may need to be increased by your doctor.
Hematology
If you have had blood clots in the past, you should inform your doctor before taking Neofordex.
The combination of desamethasone with thalidomide, lenalidomide or pomalidomide (medicines for the treatment
of multiple myeloma) increases the risk of blood clots in the veins and arteries. You should inform
your doctor immediately if you experience shortness of breath, chest pain or swelling in your arms or legs.
The combination of desamethasone with lenalidomide or pomalidomide can 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 can cause pheochromocytoma crisis which can be fatal. The
pheochromocytoma is a rare tumor of the adrenal glands. The crisis can occur with the following symptoms:
headache, sweating, palpitations and high blood pressure. Contact your doctor immediately if you experience any of
these symptoms.
Eye disorders
Treatment with this medicine can 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 that lasts for several days, contact your doctor.
Tendinitis
Treatment with this medicine can cause inflammation of the tendons. In extremely rare cases, tendon rupture may occur. This risk increases with treatment with certain antibiotics and in case of
kidney problems. Contact your doctor if you notice pain, stiffness or swelling of the joints or tendons.
Tell any doctor, dentist or person who may prescribe you treatment that you are taking or have
recently taken desamethasone (see section “Other medicines and Neofordex”).
If you should become ill or be involved in an accident, or if you need to undergo surgery
(even from the dentist) or a vaccination (high doses of glucocorticoids can decrease the effect of vaccines
containing “live viruses”), you must inform your treating doctor that you are taking or have recently taken
high-dose corticosteroids.
If you need to undergo tests (especially for infections), you should inform the person performing the tests because the
desamethasone can interfere with the results.
Before taking Neofordex tell your doctor

• if you have a liver or kidney disease,
• if you have a 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 history of diabetes in your family,
• if you have osteoporosis, especially if you are a postmenopausal woman,
• if you have glaucoma (increased pressure in the eye) or a history of glaucoma in your family,
• if you have myasthenia gravis (a disease that affects the muscles), inflammation of a tendon (tendinitis),
• if you have a peptic ulcer (ulcer in the stomach or duodenum) or a history of peptic ulcers, bleeding or perforation of the stomach,
• if you have inflammation of the colon, diverticulitis or have recently undergone intestinal surgery,
• if you have or are suspected of having pheochromocytoma (a tumor of the adrenal glands).

The doctor will monitor you more closely if you have any of these conditions.
Elderly
If you are elderly, some of the side effects of Neofordex may be more serious, particularly
thinning of the bones (osteoporosis), high blood pressure, low potassium levels, diabetes,
susceptibility to infections and thinning of the skin. Your doctor will monitor you closely.

Children and adolescents
Multiple myeloma does not develop in children. Do not administer this medicine to children (i.e.
anyone under the age of 18 years).

Other medicines and Neofordex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
association with Neofordex, to have all the necessary information. When taking thalidomide,
lenalidomide or pomalidomide, special attention must be paid to the requirements regarding testing and
pregnancy prevention.
If you are taking any of the following medicines, consult your doctor before taking Neofordex:

The followingco-administrations must be avoided

• acetylsalicylic acid, a substance present in many medicines used for the relief of mild pain and fever (may increase the risk of bleeding);

Also tell your doctor if you have recently undergone or plan to undergo a vaccination (see
section “Warnings and precautions”).

The followingco-administration require precautions

• medicines that reduce potassium levels in the blood: e.g. some diuretics or laxatives, amphotericin B injection, tetracosactide, due to the risk of decreasing potassium levels. The doctor may need to monitor the potassium level;
• medicines that can increase the risk of heart rhythm abnormalities (e.g. some medicines for the treatment of heart disease, such as digoxin), as low potassium levels increase the risk of heart rhythm abnormalities;
• medicines for the treatment of hypertension, as their effect may be reduced. The doctor may need to adjust the dose of antihypertensive treatment;
• medicines for the treatment of anemia such as erythropoietin (EPO) or other medicines such as hormone replacement therapy, may increase the risk of blood clots (see sections “Warnings and precautions” and “Possible side effects”);
• medicines for the treatment of pain, inflammation and fever (non-steroidal anti-inflammatory drugs) e.g. ibuprofen, naproxen, diclofenac, meloxicam and others may increase the risk of bleeding or ulcers in the stomach;
• medicines for the treatment of diabetes, as Neofordex can change the glucose level. It is important to self-monitor blood glucose levels, especially at the beginning of treatment. The doctor may need to adjust the dose of antidiabetic medicines;
• some antibiotics (such as fluoroquinolones) may increase the risk of tendinitis and, in rare cases, tendon rupture, especially after long-term treatment;
• some medicines for the treatment of cancer (such as methotrexate) may increase the risk of infection, bleeding or anemia.

The following medicines can influence the effect of Neofordex
These medicines can reduce the effect of Neofordex:

• aminoglutethimide (medicine for the treatment of Cushing's syndrome or breast cancer);
• anticonvulsants (for the treatment of epilepsy) such as carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone;
• rifampicin (used for the treatment of tuberculosis);
• medicines for stomach upset (e.g. antacids) and cholestyramine (to lower cholesterol); the administration of these medicines with Neofordex must be done at least two hours apart;
• ephedrine (for the treatment of asthma attacks or for nasal congestion).These medicines can increase the effect of Neofordex:
• aprepitant or fosaprepitant (for the treatment of nausea and vomiting after surgery or caused by chemotherapy [cancer treatment]);
• antibiotics, with the active ingredient name ending in -mycin and antifungals (for the treatment of fungal infections) with the active ingredient name ending in -conazole; and anti-HIV medicines with the active ingredient name ending in -navir

Neofordex can influence the effect of these medicines

• the effect of oral contraceptives and hormone replacement therapy (HRT) may be reduced. Effective contraception measures must be adopted (see section “Pregnancy, breastfeeding and fertility”);
• the effect of oral anticoagulants may be increased, leading to an increased risk of bleeding. The doctor may need to monitor your coagulation parameters carefully;
• the effect of some medicines for the treatment of cancer (such as docetaxel and cyclophosphamide) may be reduced;
• the liver effects of lapatinib (used for the treatment of cancer) may be increased;
• the effect of cyclosporine (a medicine used to suppress immune reactions) may be reduced. In addition, seizures have been reported with the concomitant use of desamethasone and cyclosporine. The concomitant use of Neofordex and cyclosporine should be avoided;
• the effect of midazolam (used as a sleeping pill and for the treatment of epilepsy) may be reduced;
• the effect of ivermectin (for some worm infections) may be reduced, so ivermectin treatment must be completed successfully before the administration of Neofordex (see section “Warnings and precautions”);
• the effect of rifabutin and isoniazid (used for the treatment of tuberculosis) may be reduced;
• the effect of indinavir (used for the treatment of HIV) may be reduced;
• the effect of erythromycin may be reduced;
• the effect of praziquantel (for some worm infections) may be reduced with the risk of treatment failure, so praziquantel and Neofordex treatment must be separated by at least one week.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
You should avoid becoming pregnant during treatment with Neofordex as it can cause
congenital malformations. You and your partner should use adequate contraception.
You should not use Neofordex during pregnancy unless your clinical condition requires treatment
with desamethasone. Tell your doctor immediately if you are pregnant or become pregnant during
treatment.
Glucocorticoids are excreted in breast milk, so a risk to
newborns/infants cannot be excluded. Tell your doctor if you are breastfeeding or intend to do so. The doctor will help you decide whether to
stop breastfeeding or stop therapy with Neofordex, considering the
benefit of breastfeeding for the baby and the benefit of Neofordex for the mother.

Driving and operating machinery
Neofordex moderately impairs the ability to drive and operate machinery. Do not drive, do not use
tools or machinery or perform hazardous activities if side effects occur, such as confusion,
hallucinations, dizziness, fatigue, drowsiness, fainting or blurred vision.

Neofordex contains lactose
Neofordex contains lactose, a sugar. If your doctor has told you that you have an intolerance to some sugars,
consult them before taking this medicine.

3. How to take Neofordex

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The doctor will decide the dose and how often to take Neofordex. This may vary depending on your
condition and any other associated treatments. The recommended dose is one tablet at a time. If you are
over 65 years of age and/or are in poor health, your doctor may decide to prescribe another product containing
a lower dose of dexamethasone. Do not take a higher or lower dose than prescribed. You must
take this medicine on the appropriate days, exactly as prescribed by your doctor.
The doctor may modify the dose and frequency of administration based on certain parameters, including
blood tests, your general condition, other prescribed medicines and the response to treatment.
Swallow the prescribed dose of one tablet (40 mg) in the morning with a glass of water.
If you have difficulty removing the tablet from the blister pack, ask someone for help.
Insomnia can be minimized by administering Neofordex in the morning.

If you take more Neofordex than you should
If you take an excessive dose of Neofordex, contact your doctor or a hospital immediately.

If you forget to take Neofordex
If you forget to take Neofordex at the usual time and

• if you are less than 12 hours late: take the tablet immediately;
• if you are more than 12 hours late: do not take the tablet, but take the next tablet at the usual time.

Do not take a double dose to make up for a missed tablet.

If you stop taking Neofordex
Serious side effects may occur if you suddenly stop taking this medicine
If you stop treatment with this medicine too quickly, you may experience a
drop in blood pressure. You may also experience a “withdrawal symptom” which may
include headache, vision problems (including eye pain or swelling), nausea or vomiting,
fever, muscle and joint pain, swelling inside the nose, weight loss, itching and
conjunctivitis. If treatment needs to be stopped, follow your doctor's advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss these with you and explain the potential risks and benefits of treatment.
The side effects listed below have been observed when desametasone was used for the
treatment of multiple myeloma and for the treatment of other diseases. In some cases, the co-administration
of different medicines may increase the side effects of one or the other medicine taken
separately.
Neofordex can cause serious mental health problems. These are common (may affect up to 1
in 10 people) and may include:

• a feeling of depression (including suicidal thoughts),
• a feeling of elation (mania), great happiness (euphoria) or mood swings,
• anxiety, difficulty concentrating and memory loss,
• perceiving, seeing or hearing things that are not there or believing in things that are not real, dark thoughts, changes in behaviour. If you notice any of these symptoms, consult your doctor immediately.

Other possible side effects are:

Very common: may affect more than 1 in 10 people

• increased blood sugar levels (hyperglycaemia);
• constipation;
• difficulty sleeping (insomnia);
• muscle cramps, muscle weakness;
• tiredness, weakness, swelling of the body and face. Common: may affect up to 1 in 10 people
• bacterial, viral or fungal infections, including pneumonia, herpes zoster, infections of the nose, mouth, tonsils or throat, bronchitis, herpes, bladder infection, candida infection;
• reduction in the number of red blood cells or white blood cells and/or platelets, or increase in the number of white blood cells, reduction in potassium or albumin (a protein) levels in the blood, increased levels of uric acid in the blood, changes in liver function tests;
• Cushing's syndrome, i.e. increased weight of the trunk and face, excessive sweating, stretch marks, visible and swollen small blood vessels, and dry skin, growth of additional hair on the face (especially in women) and thinning of hair;
• development of diabetes, loss or increase of appetite, weight gain or loss, fluid retention;
• aggressiveness, confusion, irritability, nervousness, restlessness, altered mood;
• numbness, tingling or burning sensation on the skin, or pain in the hands or feet due to nerve damage, dizziness, tremor, headache, loss or altered sense of taste;
• cataracts, blurred vision;
• fast or irregular heartbeat, blood pressure too high or too low, formation of blood clots that can block blood vessels (e.g. in the legs or lungs), swelling of the arms or legs, redness of the skin of the face or body;
• cough, difficulty breathing, difficulty speaking, sore throat or inflammation of the mouth, hoarseness, dry mouth, hiccups, inflammation of the mucous membranes;
• vomiting, nausea, diarrhoea, indigestion, flatulence, bloating and/or stomach pain;
• skin rash, itching, redness of the skin, excessive sweating (hyperhidrosis), dry skin, hair loss (alopecia);
• muscle deterioration, muscle pain, joint pain, bone pain or limb pain;
• frequent need to urinate;
• pain, fever, chills, fainting, dizziness, fatigue, drowsiness, altered sense of balance. Uncommon: may affect up to 1 in 100 people
• fever due to deficiency of certain white blood cells, deficiency of all types of blood cells, reduced ability of the blood to clot;
• inability of the thyroid gland to produce normal amounts of hormones (hypothyroidism);
• insufficient fluid levels in the body (dehydration), with thirst or headache, reduced levels of magnesium or calcium in the blood;
• mood swings, hallucinations;
• stroke, difficulty with coordination or movement, fainting;
• inflammation of the eye and/or eyelids, increased tearing;
• heart attack, excessively slow heartbeat;
• urticaria;
• kidney failure. Not known: frequency cannot be estimated from available data
• infection, inflammation of the whole body due to infection (sepsis);
• inability of the body to respond normally to severe stress, such as accidents, surgery or illness due to insufficient adrenal function, unusual intense headache with visual disturbances related to stopping treatment, irregular menstrual cycles in women, excessive hair growth (hirsutism);
• increased need for antidiabetic medicines, imbalance of salts, loss of potassium due to low levels of carbon dioxide (a condition called metabolic alkalosis);
• seizures;
• increased pressure in the eye, including glaucoma, diseases of the choroid and retina (chorioretinopathy);
• inability of the heart to pump enough blood into the body (heart failure);
• ulcers, perforations and/or bleeding in the esophagus (throat), stomach or intestine, inflammation of the pancreas (which can manifest as back and abdominal pain);
• delayed wound healing, acne, thinning of the skin, bruising, red or purple spots on the skin (purpura);
• thinning of the bones with increased risk of fracture, bone disease, tendon rupture.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system indicated in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Neofordex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after Scad/EXP.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice defects or signs of deterioration of the tablets or packaging.
This medicine does not require any particular storage temperature. Store the tablets
in the blister pack until the time of taking them. If you are using a pill box, use the
perforation to separate the individual tablets from the blister without opening the packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment,

6. Contents of the pack and other information

What Neofordex contains

• The active ingredient is dexamethasone. Each tablet contains dexamethasone acetate, equivalent to 40 mg of dexamethasone.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate and anhydrous colloidal silicon dioxide (see section 2).

Description of the appearance of Neofordex and contents of the pack
The tablets are white, oblong in shape, with the inscription “40 mg” imprinted on one side.
Each cardboard pack contains 10 x 1 tablets in perforated blister packs for unit dose in
OPA/Aluminum /PVC-Aluminum.

Marketing authorisation holder and manufacturer
THERAVIA
16 Rue Montrosier
92200 Neuilly-sur-Seine
France
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
THERAVIA
Tél/Tel: +32 (0)2 40 11 442
[email protected]
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]

България
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]

Luxembourg/Luxemburg
THERAVIA
Tél/Tel: +352 278 62 329
[email protected]

Česká republika
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]

Magyarország
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]

Danmark
Immedica Pharma AB
Tlf: +46 (0)8 533 39 500
[email protected]

Malta
THERAVIA
Tel: +356 2776 1358
[email protected]

Deutschland
THERAVIA
Tel: +49 (0)3022153008
[email protected]

Nederland
THERAVIA
Tel: +31 (0)2 070 38 155
[email protected]

Eesti
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]

Norge
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]

Ελλάδα
RAFARM AEBE
Τηλ: + 302 106776550

Österreich
THERAVIA
Tel: +43 (0) 800 909 699
[email protected]

España
THERAVIA
Tel: + 34 914 146 613
[email protected]

Polska
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]

France
THERAVIA
Tél: +33 (0)1 72 69 01 86
[email protected]

Portugal
THERAVIA
Tel: +33 (0)1 72 69 01 86
[email protected]

Hrvatska
THERAVIA
Tel: +33 (0)1 72 69 01 86
[email protected]

Ireland
THERAVIA
Tel : 016950063
[email protected]

România
THERAVIA
Tel: +33 (0)1 72 69 01 86
[email protected]

Slovenija
THERAVIA
Tel: +33 (0)1 72 69 01 86
[email protected]

Ísland
Immedica Pharma AB
Sími: + 46 (0)8 533 39 500
[email protected]

Slovenská republika
THERAVIA
Tel.: +33 (0)1 72 69 01 86
[email protected]

Italia
THERAVIA
Tel: +39 (0) 800 959 161
[email protected]

Suomi/Finland
Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 500
[email protected]

Κύπρος
RAFARM AEBE
Τηλ: + 302 106776550

Sverige
Immedica Pharma AB
Tel: +46 (0)8 533 39 500
[email protected]

Latvija
Immedica Pharma AB
Tel: +46 (0)8 533 39 500
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.