Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - neofordex

Document Subject

Generated Narrative: MedicinalProductDefinition mpf5d1cf53e3b7ba5026efaf532ce60eaa

identifier: http://ema.europa.eu/identifier/EU/1/15/1053/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Neofordex 40 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f5d1cf53e3b7ba5026efaf532ce60eaa

identifier: http://ema.europa.eu/identifier/EU/1/15/1053/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - neofordex

Attesters

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

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 in combination with other medicines for multiple myeloma. They act together by killing cancerous white blood cells.

Do not take 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, especially viral hepatitis, herpes, chickenpox or shingles; if you have an untreated psychiatric illness.

Warnings and precautions
Talk to your doctor, pharmacist, nurse, before taking Neofordex especially if given with other medicinal products.

Risk of infection Treatment with Neofordex (a high-dose corticosteroid) may reduce your body s ability to fight infection (in particular due to bacteria, yeasts and/or parasites). 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.

Psychiatric disorders 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. Insomnia may be minimised by administering Neofordex in the morning.

Tumour lysis syndrome You should tell your doctor if you have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath

Long-term treatment During treatment with this medicine it is important to maintain a balanced diet (low in sugar and sodium, high in protein). Water and sodium retention is common and can lead to hypertension.
Your doctor will advise on an appropriate diet, and may prescribe potassium, calcium or vitamin D supplements.

Glucocorticoid therapy like dexamethasone may reduce the effect of medicines to treat diabetes or hypertension. The dose of these medicines may have to be increased by your doctor.

Haematology
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.

Pheochromocytoma crisis
Treatment with this medicine may cause pheochromocytoma crisis, which can be fatal. Pheochromocytoma is a rare tumor of the adrenal glands. Crisis can occur with the following symptoms: headaches, sweating, palpitations, and hypertension. Contact your doctor immediately if you experience any of these signs.

Eye disorders 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.

Tendonitis
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 (see section Other medicines and Neofordex ).

If you become ill or are involved in an accident, or if you need surgery (even at the dentist) or require a vaccination (high dose of glucocorticoid may diminish the effect of 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), inflammation of a tendon (tendonitis),
• 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 or are suspected of having pheochromocytoma (a tumor of the adrenal glands).

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

Elderly 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 medicines 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:

The following combinations should be avoided

• Acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever (may increase the risk of bleeding);
• You should also tell your doctor if you have recently received a vaccination or are planning to be vaccinated (please see section Warnings and precautions ).

The following combinations require precautions

• Medicines that reduce blood potassium levels: for example, some diuretics or laxatives, amphotericin B injection, tetracosactide, due to the risk of decreased potassium levels. Your doctor may need to monitor the level of potassium;
• Medicines that can increase the risk of abnormal heart rhythm (e.g. some medicines for treatment of heart disease, as digitalis), since low levels of potassium increase the risk of abnormal heart beats;
• Medicines to treat hypertension, since their effect can be reduced. Your doctor may need to adjust the dose of anti-hypertensive treatment;
• Medicines to treat anaemia such as Erythropoietin (EPO) or other medicines such as hormone replacement therapy, may increase the risk of formation of blood clots (please see sections Warnings and precautions and Possible side effects );
• Medicines to treat pain, inflammation and fever (non-steroidal anti-inflammatory drugs) e.g. ibuprofen, naproxen, diclofenac, meloxicam and others may increase the risk of bleeding or open sores in the stomach;
• Medicines for treatment of diabetes, as Neofordex can modify glucose level. It is important to self- monitor blood glucose levels, especially during the initiation of treatment. Your doctor may need to adjust the dose of anti-diabetic medicines;
• Some antibiotics (such as fluoroquinolones) may increase the risk of tendonitis and, in exceptional cases, rupture of the affected tendon, particularly after long-term treatment;
• Certain medicines to treat cancer (such as methotrexate) may increase the risk of infection, bleeding or anaemia.

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

• Aminogluthetimide (medicine to treat Cushing s syndrome or breast cancer);

• Anticonvulsants (for the treatment of epilepsy) such as carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone;

• Rifampicin (used to treat tuberculosis);

• Medicines for an upset stomach (for example antacids) as well as colestyramine (to lower cholesterol); The administration of such medicines with Neofordex should be separated by at least two hours;

• Ephedrine (to treat asthma attacks or relieve nasal congestion). These medicines may 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 active substance names ending in mycin and antifungals (to treat fungal infections) with active substance names ending in conazole; and anti-HIV medicines with active substance names ending in navir.

Neofordex may influence the effect of these medicines

• The effect of oral contraceptives and hormone replacement therapy (HRT) may be reduced. Effective measures to avoid pregnancy must be taken (see section Pregnancy, breast-feeding and fertility );
• The effect of oral anticoagulants may be increased, leading to increased bleeding risk. Your doctor may need to monitor closely your blood coagulation parameters;
• The effect of certain medicines to treat cancer (such as docetaxel and cyclophosphamide) may be reduced;
• The liver effects of lapatinib (used to treat cancer) may be increased;
• The effect of ciclosporin (a medicine used to suppress immune reactions) may be reduced. In addition, convulsions have been reported with concurrent use of dexamethasone and ciclosporin. Concomitant use of Neofordex and ciclosporine should be avoided;
• The effect of midazolam (used as sleeping pill and for the treatment of epilepsy) may be reduced;
• The effect of ivermectin (for certain worm infections) may be reduced, therefore the treatment with ivermectin must be successfully terminated before Neofordex administration (see section Warnings and precautions );
• The effect of rifabutin or isoniazid (used to treat tuberculosis) may be reduced;
• The effect of indinavir (used in the treatment of HIV) may be reduced;
• The effect of erythromycin may be reduced;
• The effect of praziquantel (for certain worm infections) may be reduced with a risk of failure of treatment, therefore treatment with praziquantel and Neofordex should be separated by at least one week.

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must avoid getting pregnant during treatment with Neofordex which may cause congenital malformations. You and your partner must use appropriate contraception.
You should not use Neofordex during pregnancy unless your clinical condition requires treatment with dexamethasone. Inform your doctor immediately if you are pregnant or if you become pregnant during treatment.

Glucocorticoids are excreted in human milk, therefore, a risk to the newborns/infants cannot be excluded. Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Neofordex, considering the benefit of breast-feeding to the baby and the benefit of Neofordex to the mother.

Driving and using machines Neofordex has moderate influence on the ability to drive and use 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.

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 how often you should take Neofordex. This can vary according to your condition and to other associated treatment(s). The recommended dose is one tablet each time. If you are over 65 years old and/or frail, your doctor may decide to prescribe another product containing a lower dose of dexamethasone. 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) in the morning with a glass of water.

If you have difficulties taking the tablet out of the blister, ask somebody for help.
Insomnia may be minimised by administering Neofordex in the morning.

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.

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 (hyperglycaemia); Constipation; Having trouble 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, shingles, infections of the nose, mouth, tonsils or throat, bronchitis, herpes, bladder infection, candida 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, excessive sweating (hyperhidrosis), dry skin, hair loss (alopecia); 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,; Failure of the thyroid gland to produce normal amounts of hormones (hypothyroidism);
Lack of body water (dehydration) with thirst or headache, decreased magnesium or calcium levels in the blood; Mood swings, hallucinations; 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, excessive hair growth (hirsutism); 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.

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 temperature 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.

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.

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 40 mg engraved on one side..

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

Marketing Authorisation Holder and Manufacturer

THERAVIA 16 Rue Montrosier 92200 Neuilly-sur-Seine France

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

Belgi /Belgique/Belgien THERAVIA T l/Tel: +32 (0)2 40 11 question@theravia.com

Lietuva Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 info@immedica.com

THERAVIA Te .: +33 (0)1 72 69 01 question@theravia.com

Luxembourg/Luxemburg THERAVIA T l/Tel: +352 278 62 question@theravia.com

esk republika THERAVIA Tel.: +33 (0)1 72 69 01 question@theravia.com

Magyarorsz g THERAVIA Tel.: +33 (0)1 72 69 01 question@theravia.com
Danmark Immedica Pharma AB
Tlf: +46 (0)8 533 39 info@immedica.com
Malta THERAVIA Tel: +356 2776 1question@theravia.com

Deutschland THERAVIA Tel: +49 (0)3022153question@theravia.com

Nederland THERAVIA Tel: +31 (0)2 070 38 question@theravia.com

Eesti Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 info@immedica.com
Norge Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 info@immedica.com

RAFARM AEBE : + 302 106776 sterreich THERAVIA Tel: +43 (0) 800 909 question@theravia.com

Espa a THERAVIA Tel: + 34 914 146 question@theravia.com

Polska THERAVIA Tel.: +33 (0)1 72 69 01 question@theravia.com

France THERAVIA T l: +33 (0)1 72 69 01 question@theravia.com

Portugal THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

Hrvatska THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

Ireland THERAVIA Tel : 016950question@theravia.com

Rom nia THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

Slovenija THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

sland Immedica Pharma AB
S mi: + 46 (0)8 533 39 info@immedica.com
Slovensk republika THERAVIA Tel.: +33 (0)1 72 69 01 question@theravia.com

Italia THERAVIA Tel: +39 (0) 800 959 question@theravia.com

Suomi/Finland Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 info@immedica.com

RAFARM AEBE : + 302 106776Sverige Immedica Pharma AB
Tel: +46 (0)8 533 39 info@immedica.com

Latvija Immedica Pharma AB
Tel: +46 (0)8 533 39 info@immedica.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: