Neofordex - Dexamethasone uses, dose and side effects

Neofordex is a medicine that contains the active substance dexamethasone. Dexamethasone is a type of hormone called a glucocorticoid and is sometimes called cortisone, corticoid, or corticosteroid. Dexamethasone has different types of effects, including effects on white blood cells, which are part of the immune system (the body’s natural defenses). Dexamethasone is similar to glucocorticoids that are produced naturally in the body.

Neofordex is used to treat adult patients with multiple myeloma, a type of cancer in the blood that affects the white blood cells that make antibodies. Neofordex is given in combination with other medicines for multiple myeloma. They work together by killing white blood cells with cancer.

What you need to know before using Neofordex

Do not use Neofordex

if you are allergic to dexamethasone 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 have an untreated psychiatric illness.

Warnings and cautions

Treatment with a high-dose corticosteroid can reduce the body’s ability to fight infection. This can sometimes lead to infections caused by microorganisms that rarely cause disease under normal conditions (called opportunistic infections ). If you get an infection of any kind while you are being treated with this medicine, you should contact a doctor immediately. This is especially important if you notice signs of pneumonia: cough, fever, shortness of breath, and chest pain. You may also feel confused, especially if you are an older person. You should also tell your doctor if you have had tuberculosis if you have resided in regions where round machine infections are common.

Note: While taking Neofordex, you must avoid all contact with people who have chickenpox, measles, or shingles. Contact a doctor immediately if you think you have been in contact with someone who has one of these diseases.

High-dose corticosteroids, including dexamethasone, can cause psychological problems that can sometimes be serious. Talk to your doctor before taking Neofordex if you or someone in your immediate family has had, or is currently having, severe depression or manic attacks. This is especially important if you feel depressed or may have suicidal thoughts.

Tell your doctor if you have symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, vision loss or visual disturbances, and shortness of breath.

During treatment with this medicine, you must maintain a balanced diet. Your doctor will advise you on a suitable diet and may prescribe potassium, calcium, or vitamin D supplements.

If you have previously had blood clots, tell your doctor before taking Neofordex. The combination of dexamethasone with thalidomide, lenalidomide, or pomalidomide (medicines used to treat multiple myeloma ) increases the risk of blood clots in the veins and arteries. You must tell your doctor immediately if you experience shortness of breath, chest pain, or swelling in your arms or legs.

The combination of dexamethasone with lenalidomide or pomalidomide may lead to a decrease in the number of normal white blood cells (which help fight infections ) and/or platelets (which help prevent bleeding). Your doctor will arrange for appropriate blood tests before and during treatment.

Treatment with this drug can cause central serous chorioretinopathy, an eye disease that leads to blurred vision or distorted vision. This usually happens in one of the eyes. If you notice blurred vision or distorted vision that lasts for several days, consult a doctor.

Treatment with this drug can cause tendonitis. In extremely rare cases, a tendon may rupture. This risk is increased by treatment with certain antibiotics and by kidney problems. Contact your doctor if you feel painful, stiff, or swollen joints or tendons.

You should inform any doctor, dentist, or someone who may prescribe a treatment for you that you are currently taking or have recently taken dexamethasone.

If you become ill or are involved in an accident, or if you need to have surgery (including at the dentist) or need to be vaccinated (especially “live” virus vaccine), tell your treating doctor that you are taking or have recently taken corticosteroids. dos.

If you need to take samples (especially for infections ), inform the person performing the tests as dexamethasone may interfere with the results.

Talk to your doctor before taking Neofordex

you have liver or kidney disease,
you have heart disease or have recently had a heart attack,
you have high blood pressure , high cholesterol or if you smoke,
you have diabetes or someone has had diabetes in your family before,
you have osteoporosis , especially if you are a woman who has gone through menopause,
you have glaucoma (increase in pressure in the eye) or someone has had glaucoma in your family before,
you have myasthenia gravis (a disease that affects the muscles),
you have a peptic ulcer (ulcer in the stomach or duodenum ), or have previously had a peptic ulcer, stomach bleeding or perforation ,
you have inflammation of the colon, diverticulitis , or have recently undergone bowel surgery,
you have inflammation in a tendon.

Your doctor will monitor you more closely if you have any of these diseases.

If you are an elderly person, some of the side effects of Neofordex may be more serious, especially thin bones ( osteoporosis ), high blood pressure, low potassium levels, diabetes, susceptibility to infections, and thin skin. Your doctor will monitor you more closely.

Children and young people

Children do not develop multiple myeloma. This medicine should not be given to children (ie someone under the age of 18).

Other medicines and Neofordex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must read the package leaflets of all medicines taken in combination with Neofordex for information on these medicines before starting treatment with Neofordex. When using thalidomide, lenalidomide, or pomalidomide, special attention must be paid to pregnancy tests and to prevent pregnancy.

If you are taking any of the following medicines, talk to your doctor before taking Neofordex:

Anticoagulants (which thin the blood)
Acetylsalicylic acid , a substance found in many medicines used to relieve pain and lower fever, and other medicines used to relieve pain, inflammation and lower fever:for example ibuprofen , naproxen , diclofenac , meloxicam.
Medicines for the treatment of high blood pressure or heart disease.
Drugs for the treatment of diabetes .
Medicines for stomach problems (for example, antacids) and cholestyramine (to lower cholesterol).
Drugs that lower the potassium levels in the blood: for example, certain diuretics or laxatives.
Cortisone or other corticosteroids , tetracosactide (used to test adrenal function) or aminoglutethimide (used to treat Cushing’s syndrome or breast cancer).
Antibiotics , with names of active substances ending in ycmycin and ‑floxacin; antifungals (for the treatment of fungal infections) with names of active substances ending in ‑conazole or amphotericin B injection; and HIV drugs with names of active substances ending in ‑navir.
Rifampicin, rifabutin or isoniazid (used to treat tuberculosis ).
Prazikvantel or ivermectin (used for certain machine infections).
Estrogen hormone including birth control pills and hormone replacement therapy ( HRT ).
Antiepileptics (used to treat epilepsy ) and midazolam (used as a sleeping pill and to treat epilepsy ).
Aprepitant or fosaprepitant (used to treat nausea and vomiting after surgery or as a result of chemotherapy [cancer treatment]).
Some medicines used to treat cancer: docetaxel, cyclophosphamide, lapatinib or methotrexate. Methotrexate is also used to treat rheumatism or psoriasis .
Erythropoietin (epo, for the treatment of anemia ).
Ciclosporin (for the treatment of psoriasis , atopic dermatitis , rheumatoid arthritis or nephrotic syndrome and for inhibiting immune reactions after organ or bone marrow transplantation).
Ephedrine (for treating asthma attacks or relieving nasal congestion).

You should also tell your doctor if you have recently been vaccinated or if you are planning to get vaccinated.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Neofordex should not be taken if you are pregnant unless your doctor clearly states that you should.

You must avoid becoming pregnant while being treated with Neofordex. You and your partner must use appropriate contraception. Tell your doctor immediately if you are pregnant or if you become pregnant during treatment.

You should not breastfeed during treatment.

Driving and using machines

Do not drive, use tools or machines, and do not perform dangerous tasks if you experience side effects such as confusion, hallucinations, dizziness, fatigue, drowsiness, fainting, or blurred vision.

Neofordex contains lactose

Neofordex contains lactose, a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Neofordex

Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.

Your doctor will determine the dose one and tell you which days you should take it. The recommended dose is one tablet at a time. If you are older than 65 years and/or have fragile health, your doctor may prescribe half a tablet at a time. Do not take more or less than the prescribed dose. You must take this medicine on the right days, exactly as prescribed.

Your doctor may change the dose and interval of administration based on certain factors such as analysis of your blood tests, how you are feeling, other medicines that have been prescribed for you, and how you are responding to the treatment.

Swallow the prescribed dose which is one tablet (40 mg) or half a tablet (20 mg) in the morning with a glass of water.

If your dose is half a tablet (20 mg), the tablet can be divided into two halves. Take half a tablet at a time. You should not save half the tablet to take it another day as this medicine may deteriorate once the tablet is split and removed from the pack. Then store the remaining half of the tablet in a safe place, out of sight and reach of children, until you can dispose of it properly, as you should not throw medicines down the drain or with household waste. Ask the pharmacy staff how to dispose of medicines. If it is difficult to remove the tablet from the blister pack or divide the tablet, ask someone to help you.

If you use more Neofordex than you should

If you take more Neofordex than you should, contact your doctor or hospital immediately.

If you forget to use Neofordex

If you forget to take Neofordex at the usual time and

if you are less than 12 hours late taking it: take the tablet immediately.
if you are more than 12 hours late taking it: 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 forgotten tablet.

If you stop using Neofordex

You may get serious side effects if you suddenly stop taking this medicine. You may get low blood pressure if you stop taking this medicine too quickly. You may also feel a “withdrawal symptom”. These can be headaches, vision problems (including pain or swelling in the eyes), malaise or illness, fever, pain in muscles and joints, swelling inside the nose, weight loss, itchy skin, and conjunctivitis. If your treatment needs to be stopped, follow your doctor’s advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 benefits and risks of your treatment.

The following side effects were seen when dexamethasone was taken in the treatment of multiple myeloma and the treatment of other diseases. In some cases, the combination of several drugs may increase the side effects of any of these drugs compared to when taken separately.

Neofordex can cause serious psychiatric disorders. These side effects are common (may affect more than 1 in 10 people) and may include

to feel depressed (including suicidal thoughts),
to feel playful (mania), very happy ( euphoria ) or to have moods that go up and down,
feeling anxious, having difficulty concentrating and suffering from memory loss,
to feel, see or hear things that do not exist or to believe in things that are not real, to have gloomy thoughts, to change the way we behave.

Talk to your doctor immediately if you notice any of these symptoms.

Other possible side effects:

Very common: may affect more than 1 in 10 people

Increased blood sugar levels, constipation.
Difficulty falling asleep.
Muscle cramps, muscle weakness.
Fatigue, weakness, swelling of body and face.

Common: may affect less than 1 in 10 people

Bacterial infections, viral or fungal infections, including pneumonia , shingles , infections of the nose, mouth, tonsils or throat, bronchitis , herpes , bladder infection .
Decreased number of red or white blood cells and / or platelets , or increased number of white blood cells , decreased levels of potassium or of albumin (a protein ) in the blood, increased levels of uric acid in the blood, changes in liver function tests.
Cushing’s syndrome, i.e. weight gain in the torso and face, heavy sweating, stretch marks in the skin, visible swollen capillaries (small blood vessels) and dry skin, growth of extra facial hair (especially in women) and thin hair.
Development of diabetes , lost or increased appetite, weight gain or loss, water retention (the body retains too much fluid).
Aggression, confusion, irritability, nervousness, restlessness, mood swings.
Sensitivity, numbness, tingling or burning sensation in the skin, or pain in the hands and feet, due to nerve damage, dizziness, trembling, headache, lost or altered taste.
Cataracts , blurred vision.
Rapid or irregular heartbeat, too high or too low blood pressure , formation of blood clots that can clog blood vessels (eg in bones or lungs), swelling in arms or legs, redness of the skin on face or body.
Cough, difficulty breathing, difficulty speaking, sore throat or mouth, hoarseness, dry mouth, hiccups, inflammation of the mucous membranes.
Vomiting, nausea, diarrhea, indigestion, flatulence, bloating and / or stomach pain.
Skin rash, itching , redness of the skin.
Muscle loss, pain in muscles, joints, skeleton or arms and legs.
Frequent urination.
Pain, fever, chills, fainting, dizziness, fatigue, drowsiness, impaired balance.

Uncommon: may affect less than 1 in 100 people

Fever due to lack of certain white blood cells , lack of all types of blood cells , decreased coagulation of the blood, decreased levels of magnesium or calcium in the blood.
Decreased ability of the thyroid gland to produce normal amounts of hormones ( hypothyroidism ).
Lack of body water (dehydration) with thirst or headache.
Stroke , coordination or movement problems, fainting.
Inflammation of the eyes and / or eyelids, increased tearing.
Myocardial infarction, abnormally slow heart rate.
Hives .
Kidney failure .

No known frequency: the frequency can not be calculated from the available data

Infection , inflammation throughout the body due to infection ( sepsis ).
Inability of the body to respond normally to severe stress such as accidents, surgery or illness due to insufficient functioning of the adrenal glands, severe unusual headache with visual disturbances associated with withdrawal of treatment, irregular menstruation in women.
Increased need for diabetes drugs, imbalance in blood salinity, potassium loss due to low carbon dioxide levels (a condition called metabolic alkalosis ).
Epileptic seizures.
Increased pressure in the eye, including glaucoma , or diseases of the choroid and retina (chorioretinopathy).
Inability of the heart to pump around enough blood in the body ( heart failure ).
Sores, perforation and / or bleeding in the esophagus, stomach or intestines, inflamed pancreas (which may manifest itself in pain in the back and abdomen).
Slow wound healing, acne , thin skin, bruising, red or purple discoloration of the skin (purpura).
Thin skeleton with increased fracture risk, bone disease, tendon rupture.

How to store Neofordex

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 carton and blister after “EXP”. The expiration date is the last day of the specified month.

Do not use this medicine if you notice that the tablets or pack show signs of deterioration.

No special storage instructions. Keep the tablets in the blister pack until you are ready to take them. If you use a dose, you can use the perforation to separate the individual tablets without opening the blister.

Discard half tablets that you have not taken. 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 to protect the environment.

Contents of the pack and other information

Content declaration

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

What the medicine looks like and contents of the pack

Each tablet is white and oblong, with a notch on one side. The tablet can be divided into two equal halves.

Each carton contains 10 x 1 tablet in perforated unit dose blisters of OPA / aluminum / PVC ‑ aluminum.

Marketing Authorisation Holder

CTRS Laboratories

63, rue de l’Est

92100 Boulogne-Billancourt

France

Manufacturer