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Neofordex (dexamethasone) – Package leaflet - H02AB02

Updated on site: 08-Oct-2017

Medication nameNeofordex
ATC CodeH02AB02
Substancedexamethasone
ManufacturerLaboratoires CTRS 

Package leaflet: Information for the patient

Neofordex 40 mg tablet

Dexamethasone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 Neofordex is and what it is used for

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

Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white blood cells that produce antibodies. Neofordex will be given with other medicines for multiple myeloma. They act together by killing cancerous white blood cells.

2. What you need to know before you take Neofordex

Do not take Neofordex

if you are allergic to dexamethasone or one of the other ingredients of this medicine (listed in section 6),

if you have a viral infection, especially viral hepatitis, herpes, chickenpox or shingles,

if you have an untreated psychiatric illness.

Warnings and precautions

Treatment with a high-dose corticosteroid may reduce your body’s ability to fight infection. This can sometimes lead to infections caused by germs that rarely cause infection under normal circumstances (called opportunistic infections). If you get 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, particularly if you are elderly. You should also tell your doctor if you have had tuberculosis or if you have stayed in regions where roundworm infections are common.

Note: It is important that while you are taking Neofordex you avoid contact with anyone who is suffering from chickenpox, measles or shingles. If you think you may have had contact with anyone with these conditions, you should inform your doctor immediately.

High-dose corticosteroids, including dexamethasone, can cause psychological problems that may sometimes be serious. Talk to your doctor before taking Neofordex if you or a member of your immediate family have suffered, or currently suffer from severe depression or manic attacks. This is especially important if you feel depressed or might be thinking about suicide.

During treatment with this medicine it is important to maintain a balanced diet. Your doctor will advise on an appropriate diet, and may prescribe potassium, calcium or vitamin D supplements.

If you have had blood clots in the past you should inform your doctor before taking Neofordex. The combination of dexamethasone with thalidomide, lenalidomide or pomalidomide (medicines 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 the arms or legs.

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

Treatment with this medicine may cause central serous chorioretinopathy, an eye disease that leads to blurred or distorted vision. This happens usually in one of the eyes. If you notice blurring or distorted vision that lasts for several days, please contact your doctor.

Treatment with this medicine may cause tendon inflammation. 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 notice painful, stiff or swollen joints or tendons.

Please inform any doctor, dentist or person 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 surgery (even at the dentist) or require a vaccination (particularly “live virus” vaccines) you should inform the doctor treating you that you are taking or have recently taken high-dose corticosteroids.

If you need tests (in particular for infections) you should inform the person performing the tests as dexamethasone may interfere with the results.

Talk to your doctor before taking Neofordex

-if you have liver or kidney disease,

-if you have heart disease or you have recently had a heart attack,

-if you have high blood pressure, high cholesterol or you are a smoker,

-if you have diabetes or if there is a history of diabetes in your family,

-if you have osteoporosis, especially if you are a woman who has been through the menopause,

-if you have glaucoma (increased eye pressure) or if there is a history of glaucoma in your family,

-if you have myasthenia gravis (a disease affecting the muscles),

-if you have a peptic ulcer (ulcer in your stomach or duodenum), or a history of peptic ulcers, stomach bleeding or perforation,

-if you have inflammation of the colon, diverticulitis, or have recently had surgery on the intestine,

-if you have inflammation of a tendon.

You doctor will observe you more closely if you have any of the listed diseases.

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

Children and adolescents

Children do not develop multiple myeloma. This medicine should not be given to children (i.e. anyone below 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 medicines.

You must read the package leaflets of all medicinal products to be taken in combination with Neofordex for information related to these medicines before starting treatment with Neofordex. When thalidomide, lenalidomide or pomalidomide is used, particular attention to pregnancy testing and prevention requirements is needed.

If you are taking any of the following medicines, you should consult your doctor before taking Neofordex:

-Anticoagulant medicines (which thin the blood)

-Acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever, and other medicines to treat pain, inflammation and fever: ibuprofen, naproxen, diclofenac, meloxicam and others;

-Medicines for treatment of hypertension or heart disease;

-Medicines for treatment of diabetes;

-Medicines for an upset stomach (for example antacids) and colestyramine (to lower cholesterol);

-Medicines that reduce blood potassium levels: for example some diuretics or laxatives;

-Cortisone or other corticosteroids, tetracosactide (used to test for adrenal function) or aminogluthetimide (used to treat Cushing’s syndrome or breast cancer);

-Antibiotics, with active substance names ending in –mycin and in –floxacin; antifungals (to treat fungal infections) with active substance names ending in –conazole or amphotericin B injection; and anti-HIV medicines with active substance names ending in –navir;

-Rifampicin, rifabutin or isoniazid (used to treat tuberculosis);

-Praziquantel or ivermectin (for certain worm infections);

-Oestrogen hormones including the contraceptive pill and hormone replacement therapy (HRT);

-Anticonvulsants (for the treatment of epilepsy) and midazolam (used as sleeping pill and for the treatment of epilepsy);

-Aprepitant or fosaprepitant (for the treatment of nausea and vomiting after surgery or caused by chemotherapy [cancer treatment]);

-Certain medicines to treat cancer: docetaxel, cyclophosphamide, lapatinib or methotrexate. Methotrexate is also used to treat rheumatism or psoriasis;

-Erythropoietin (EPO, to treat anaemia)

-Ciclosporin (for the treatment of psoriasis, atopic dermatitis, rheumatoid arthritis or nephrotic syndrome, and to suppress immune reactions after an organ or bone marrow transplantation)

-Ephedrine (to treat asthma attacks or relieve nasal congestion).

You should also tell your doctor if you have recently received a vaccination or are planning to be vaccinated.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 clearly indicated by your doctor.

You must avoid getting pregnant during treatment with Neofordex. You and your partner must use appropriate contraception. Inform your doctor immediately if you are pregnant or if you become pregnant during treatment.

You must not breast-feed during treatment.

Driving and using machines

Do not drive, use any tools or machines or carry out any hazardous tasks if you experience side effects, such as confusion, hallucinations, dizziness, tiredness, sleepiness, fainting or blurred vision.

Neofordex contains lactose

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

3.How to take Neofordex

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Your doctor will decide the dose and tell you on which days you should take it. The recommended dose is one tablet each time. If you are over 65 years old and/or frail, your doctor may prescribe a half tablet each time. Do not exceed or take less than the prescribed dose. You must take this medicine on the appropriate days, exactly as your doctor prescribed.

Your doctor may change the dose and frequency of administration based on certain parameters including your blood analyses, your general condition, other medicines prescribed to you and your response to the treatment.

Swallow the prescribed dose of 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 should be divided into two equal halves. Take one half tablet straightaway. Do not save the spare half tablet to take on another day as this medicine may deteriorate once divided and taken out of its packaging. Then, keep the spare half tablet in a safe place, out of the sight and reach of children, until you can throw it away properly, as you should not throw away any medicines in wastewater or household waste. Ask your pharmacist how to throw them away. If you have difficulties taking the tablet out of the blister or breaking the tablet, ask somebody for help.

If you take more Neofordex than you should

If you take too much Neofordex contact your doctor or 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 forgotten tablet.

If you stop taking Neofordex

You may experience serious side effects if you stop taking this medicine suddenly. If you stop taking this medicine too quickly, you may have low blood pressure. You may also feel a ‘withdrawal symptom’. This may include headache, problems with your vision (including pain or swelling in the eye), feeling or being sick, fever, pain in your muscles and joints, swelling in the inside of your nose, weight loss, itchy skin and conjunctivitis. If your treatment is 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 will explain the potential risks and benefits of your treatment.

The side effects listed below were seen when dexamethasone was taken for the treatment of multiple myeloma and for the treatment of other diseases. In some cases, the combination of several medicines can increase the side effects of one or the other of these medicines taken separately.

Neofordex may cause serious mental health problems. These are common (may affect up to 1 in 10 people) and may include:

-feeling depressed (including thinking about suicide)

-feeling high (mania), very happy (euphoria) or moods that go up and down,

-feeling anxious, having difficulty in concentrating and memory loss,

-feeling, seeing or hearing things that do not exist or believing in things that are not real, having gloomy thoughts, changing how you act.

If you notice any of these symptoms talk to a doctor straight away.

Other possible side effects may be:

Very common: may affect more than 1 in 10 people

Increased blood sugar levels, constipation;

Having trouble sleeping;

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, shingles, infections of the nose, mouth, tonsils or throat, bronchitis, herpes, bladder infection;

Reduction in the 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 of the trunk and face, excessive sweating, stretch marks, visible swollen capillaries (small blood vessels) and dryness of the skin, growth of extra facial hair (especially in women) and thinning of the hair;

Development of diabetes, loss or increase of appetite, weight gain or weight loss, water retention;

Aggression, confusion, irritability, nervousness, restlessness, altered mood;

Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet due to nerve damage, dizziness, trembling, headache, loss of or change in the sense of taste;

Cataract, blurred vision;

Fast or irregular heart rhythm, too high or too low blood pressure, formation of blood clots that may clog blood vessels (for example in legs or lungs), swelling of arms or legs, reddening of the skin of the face or body;

Cough, breathing difficulties, difficulties speaking, sore throat or mouth, hoarseness, dry mouth, hiccough, inflammation of the mucous membranes;

Vomiting, nausea, diarrhoea, indigestion, bloating, swollen and/or painful stomach;

Rash, itching, reddened skin;

Muscle wasting, pain of the muscles, joints, bones or limbs;

Frequent urination;

Pain, fever, chills, fainting, vertigo, exhaustion, drowsiness, impaired sense of balance.

Uncommon: may affect up to 1 in 100 people

Fever due to a lack of certain white blood cells, lack of all types of blood cells, diminished blood clotting, decreased magnesium or calcium levels in the blood;

Failure of the thyroid gland to produce normal amounts of hormones (hypothyroidism);

Lack of body water (dehydration) with thirst or headache;

Stroke, difficulties in coordination or movement, fainting;

Inflammation of the eye and/or eyelids, increased tearing;

Heart attack, abnormally slow heartbeat;

Hives;

Failure of the kidneys.

Not known: frequency cannot be estimated from the 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 function of the adrenal glands, severe unusual headache with visual disturbances linked to the withdrawal of treatment, irregularity of menstrual cycles in women;

Increased need for diabetes medicine, salt imbalance, potassium loss due to low carbon dioxide levels ( a condition called metabolic alkalosis);

Epileptic fits;

Increased pressure in the eye including glaucoma, choroid and retinal disorders (chorioretinopathy);

Inability of the heart to pump enough blood round the body (heart failure);

Ulcers, perforations and/or bleeding in the oesophagus (gullet), stomach or intestine, inflamed pancreas (which may show as pain in the back and abdomen);

Slow wound healing, acne, thinning of the skin, bruising, red or purple discolorations on the skin (purpura);

Thinning of the bones with increased risk of fracture, bone disease, ruptured tendon.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

in this leaflet. You can also report side effects directly via the national reporting system listed 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 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 expiry date refers to the last day of that month.

Do not use this medicine if you notice any defects, or any signs of deterioration of the tablets or packaging.

This medicine does not require any special storage conditions. Keep tablets in the blister packaging until you take them. If you are using a pill organiser box, use the perforation to separate individual tablets from the blister without opening the packaging.

Throw away half tablets that you have not taken. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Neofordex contains

-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 Neofordex looks like and contents of the pack

Each tablet is white, oblong in shape, with a score line on one face. The tablet can be divided into two equal halves.

Each carton contains 10 x 1 tablets in OPA/Aluminium /PVC-Aluminium perforated unit dose blister.

Marketing Authorisation Holder

Laboratoires CTRS 63, rue de l’Est

92100 Boulogne-Billancourt France

Manufacturer

Amatsi

17, Parc des Vautes 34980 Saint Gély du Fesc France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Laboratoires CTRS

Medical Need Europe AB

63, rue de l‘Est

Teatergatan 3

F-92100 Boulogne-Billancourt, France

SE-111 48 Stockholm, Sweden

Tél/Tel: +32 (0)2 40 11 442

Tel/Puh: +46 (0)8 533 39 500

ctrs@ctrs.fr

info@medicalneed.com

България

Luxembourg/Luxemburg

Laboratoires CTRS

Laboratoires CTRS

63, rue de l‘Est

63, rue de l‘Est

F-92100 Boulogne-Billancourt, France

F-92100 Boulogne-Billancourt, France

Teл.: + 33 (0)1 707 60 637

Tél/Tel: +352 278 62 329

ctrs@ctrs.fr

ctrs@ctrs.fr

Česká republika

Magyarország

Pharma East v.o.s.

Pharmacenter Hungary Kft.

Roháče z Dubé 13

Bartók Béla út 15/a. I/18.

CZ – 370 01 České Budějovice

H-1114 Budapest

Tel: +420 602 695 106

Tel.: +36-1-2095927

pharmacenter@pharmacenter.hu

pharmacenter@pharmacenter.hu

Danmark

Malta

Medical Need Europe AB

Laboratoires CTRS

Teatergatan 3

63, rue de l‘Est

SE-111 48 Stockholm, Sweden

F-92100 Boulogne-Billancourt, France

Tlf: +46 (0)8 533 39 500

Tel: + 33 (0)1 707 60 637

info@medicalneed.com

ctrs@ctrs.fr

Deutschland

Nederland

Laboratoires CTRS

Laboratoires CTRS

63, rue de l‘Est

63, rue de l‘Est

F-92100 Boulogne-Billancourt, France

F-92100 Boulogne-Billancourt, France

Tel: +49 (0)6 922 221 311

Tel: +31 (0)2 070 38 155

ctrs@ctrs.fr

ctrs@ctrs.fr

Eesti

Norge

Medical Need Europe AB

Medical Need Europe AB

Teatergatan 3

Teatergatan 3

SE-111 48 Stockholm, Sweden

SE-111 48 Stockholm, Sweden

Tel/Puh: +46 (0)8 533 39 500

Tel/Puh: +46 (0)8 533 39 500

info@medicalneed.com

info@medicalneed.com

Ελλάδα

Österreich

RAFARM AEBE

Laboratoires CTRS

Κορίνθου 12, Ν. Ψυχικό

63, rue de l‘Est

τκ 15451

F-92100 Boulogne-Billancourt, France

Αθήνα, Ελλάδα

Tel: +43 (0)7 208 16 847

Τηλ: + 302106776550

ctrs@ctrs.fr

España

Polska

Laboratoires CTRS

Laboratoires CTRS

63, rue de l‘Est

63, rue de l‘Est

F-92100 Boulogne-Billancourt, France

F-92100 Boulogne-Billancourt, France

Tel: + 33 (0)1 707 60 637

Tel.: + 33 (0)1 707 60 637

ctrs@ctrs.fr

ctrs@ctrs.fr

France

Portugal

Laboratoires CTRS

Laboratoires CTRS

63, rue de l‘Est

63, rue de l‘Est

F-92100 Boulogne-Billancourt

F-92100 Boulogne-Billancourt, France

Tél: + 33 (0)1 707 60 637

Tel: + 33 (0)1 707 60 637

ctrs@ctrs.fr

ctrs@ctrs.fr

Hrvatska

România

Laboratoires CTRS

Laboratoires CTRS

63, rue de l‘Est

63, rue de l‘Est

F-92100 Boulogne-Billancourt, France

F-92100 Boulogne-Billancourt, France

Tel: + 33 (0)1 707 60 637

Tel: + 33 (0)1 707 60 637

ctrs@ctrs.fr

ctrs@ctrs.fr

Ireland

Slovenija

Laboratoires CTRS

Laboratoires CTRS

63, rue de l‘Est

63, rue de l‘Est

F-92100 Boulogne-Billancourt, France

F-92100 Boulogne-Billancourt, France

Tel: +353 (0)1 695 00 63

Tel: + 33 (0)1 707 60 637

ctrs@ctrs.fr

ctrs@ctrs.fr

Ísland

Slovenská republika

Medical Need Europe AB

Pharmacenter Slovakia s.r.o.

Teatergatan 3

Kremnická 26

SE-111 48 Stockholm, Sweden

SK-85101 Bratislava

Sími: + 46 (0)8 533 39 500

Tel: + 4212 622 50013

info@medicalneed.com

office@pharmacenter.sk

Italia

Suomi/Finland

Laboratoires CTRS

Medical Need Europe AB

63, rue de l‘Est

Teatergatan 3

F-92100 Boulogne-Billancourt, France

SE-111 48 Stockholm, Sweden

Tel: + 33 (0)1 707 60 637

Tel/Puh: +46 (0)8 533 39 500

ctrs@ctrs.fr

info@medicalneed.com

Κύπρος

Sverige

RAFARM AEBE

Medical Need Europe AB

Κορίνθου 12, Ν. Ψυχικό

Teatergatan 3

τκ 15451

SE-111 48 Stockholm, Sweden

Αθήνα, Ελλάδα

Tel: +46 (0)8 533 39 500

Τηλ: + 302106776550

info@medicalneed.com

Latvija

United Kingdom

Medical Need Europe AB

Laboratoires CTRS

Teatergatan 3

63, rue de l‘Est

SE-111 48 Stockholm, Sweden

F-92100 Boulogne-Billancourt, France

Tel: +46 (0)8 533 39 500

Tel: +44 (0)3 301 002 375

info@medicalneed.com

ctrs@ctrs.fr

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

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