VARCODES 2 mg Эффервесцентная Таблетка

Содержание инструкции

1. Varcodes 2 mg effervescent tablets, 4 mg effervescent tablets, 8 mg effervescent tablets
   1. What Varcodes is and what it is used for
   2. What you need to know before taking Varcodes
   3. How to take Varcodes
   4. Possible side effects
   5. How to store Varcodes

Varcodes 2 mg effervescent tablets, 4 mg effervescent tablets, 8 mg effervescent tablets

Dexamethasone
Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Varcodes is and what it is used for
• 2. What you need to know before you take Varcodes
• 3. How to take Varcodes
• 4. Possible side effects
• 5. How to store Varcodes
• 6. Contents of the pack and other information

1. What Varcodes is and what it is used for

Varcodes belongs to a group of medicines called corticosteroids.
Corticosteroids are hormones that are naturally found in the body and help to keep it healthy.
Strengthening your body with the administration of corticosteroids, such as desamethasone, is a way
to effectively treat various diseases involving inflammation in the body. Desamethasone
reduces inflammation, which could otherwise worsen your condition. Take this medicine
as directed by your doctor.
This medicine is indicated for the treatment in adults of a wide variety of disorders sensitive to glucocorticoid therapy and for the control of cerebral edema in association with other therapies.

2. What you need to know before taking Varcodes

Do not take Varcodes:

• if you are allergic (hypersensitive) to desamethasone or to any of the other ingredients of this medicine (listed in section 6).
• if you have an infection that affects your whole body (unless you are receiving specific treatment against that infection)
• if you have a fungal infection that affects your whole body
• in case of gastric or duodenal ulcer
• if you suffer from a parasitic infection (worms) after a trip to a tropical area
• if you have been given a live viral vaccine
• if you are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Varcodes:

• if you have ever had a severe depression or manic depression(bipolar disorder) or if you have experienced episodes of depression before or during the taking of steroid medicines such as desamethasone.
• if any of your close relatives have had these diseases

Mental health problems while taking Varcodes
Mental health problems can occur while taking steroids such as desamethasone.

• These illnesses can be serious.
• They usually start within a few days or weeks of starting the medicine.
• It is more likely to happen at high doses.
• Most of these problems disappear with a reduction in dose and with discontinuation of treatment. However, if problems occur, they may require treatment.

Consult your doctor if you (or someone taking the medicine) experiences any symptoms of mental health problems. This is particularly important if you are depressed, or you might think about suicide. In some cases, mental health problems have manifested when the doses are lowered or treatment is stopped.

Talk to your doctor before taking this medicine if:

• you suffer from a bacterial or viral infection(such as hepatitis, poliomyelitis)
• you have problems with your kidneys or liver
• you have high blood pressure, heart disease or have recently had a heart attack
• you have diabetes or there is a family history of diabetes
• ·you have osteoporosis (thinning of the bones), especially if you are a post-menopausal woman
• you have suffered in the past from muscle weaknesswith this or other steroids
• you have glaucoma(high eye pressure) or there is a family history of glaucoma
• in case of myasthenia gravis (a condition that causes muscle weakness)
• you suffer from an intestinal disorder(ulcerative colitis or diverticulitis), have recently had surgery on your intestines or a stomach ulcer (peptic or gastrointestinal ulcer)
• in case of psychiatricproblems or a psychiatric illness that has been aggravated by this type of medicine
• you suffer from epilepsy(a condition in which repeated seizures or convulsions occur)
• you have migraine
• your thyroidis underactive (hypothyroidism)
• you have a parasitic infection (worms) or an internal fungal infection
• you have tuberculosis (TB) or have recently had a reaction to a vaccine for tuberculosis
• you have septicemia
• in case of fungal infection in the eyes, a wound or ulcer on the surface of the eye (corneal ulcer)
• you have cerebral malaria
• you have herpes(herpes labialis or genital herpes)
• you have asthma
• you have been diagnosed with a suspected or identified adrenal gland tumor (pheochromocytoma)The conditions listed above may affect the dose prescribed by your doctor, who may decide to administer other medicines at the same time. The conditions listed above may be aggravated by desamethasone.

Further important information about taking the medicine

• Talk to your doctor if it is necessary to stop the treatment. Discontinuation of treatment must be gradual.
• Taking this medicine can increase the risk of contracting an infection. It can also mask the symptomsof an existing or developing infection and make it more difficult to discover any infections. If you develop an infection while taking this medicine, consult your doctor.
• Tell your doctor that you are taking or have taken Varcodes if an accident, illness or surgery (even from the dentist) occurs during or at the end of treatment
• Tell your doctor if you are given a vaccine (especially with 'live virus') as it may not be effective or you may have a greater chance of contracting an infection from a 'live' vaccine.
• If you need to have an allergy test, a suppression test (test for hormone levels) or a test for an infection, you must inform the person performing the test that you are taking Varcodes as it may interfere with the results.
• For those who play sports: the use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test.
• The doctor may decide to perform regular checkswhile you are taking Varcodes. These checks may be more frequent if you have other health problems (such as diabetes or kidney problems) or if you are elderly, as any side effects may be more serious.
• If you are taking the medicine for a long period of time, you should be subjected to regular checks (every 3 months).
• If you are taking high doses, the doctor may monitor potassium levels in the blood. The doctor may reduce the amount of salt in the diet and prescribe you a potassium supplement while taking this medicine.

Varcodes and viral infections

• It is important that, while taking the medicine, you avoid contact with someone who has chickenpox, shingles or measles. Consult your doctor immediately if you think you have been exposed to any of these diseases.
• Tell your doctor if you have ever had infectious diseases such as measles or chickenpox and if you have been vaccinated for these diseases in the past.

Taking other medicines and Varcodes
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
If you are taking any of the following medicines, you must consult your doctor before taking Varcodes:

• anticoagulantmedicines that thin the blood (e.g. warfarin, coumarin)
• aspirinor NSAIDs (non-steroidal anti-inflammatory drugs) such as indometacin
• medicines used for the treatment of diabetes
• medicines used to treat high blood pressure
• diuretics
• injectable amphotericin B
• phenytoin, carbamazepine, (medicines used to treat epilepsy)
• rifabutin, rifampicin (antibioticsused to treat tuberculosis)
• antacidsor charcoal
• barbiturates (medicines used to promote sleep and relieve anxiety)
• aminoglutethimide (anti-cancertreatment)
• carbenoxolone (used in the treatment of gastric ulcers)
• ephedrine (nasal decongestant)
• acetazolamide (used for glaucomaand epilepsy)
• hydrocortisone, cortisone and other corticosteroids
• ketoconazole (for fungal infections)
• ritonavir (for HIV)
• antibiotics, including erythromycin
• cholestyramine (for high cholesterol levels)
• estrogen hormones, including the contraceptive pill
• tetracosactide (used in the test for adrenal function)
• sultopride (used to calm emotions)
• cyclosporine(used to prevent rejection after transplants)
• thalidomide
• Praziquantel (given for worm infections)
• isoniazid for tuberculosis

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 or pharmacist before taking this medicine.
Varcodes may be prescribed during pregnancy, only if the benefits outweigh the risks to the mother and the child, especially in the first trimester. If you become pregnant while using the product, inform your doctor immediately.
Children born to mothers who have been treated with considerable doses of Varcodes during pregnancy should be subjected to accurate checks to ascertain any signs of reduced adrenal gland function.

Breastfeeding
Do not use Varcodes if you are breastfeeding, because Varcodes is excreted in breast milk.

Driving and using machines
Varcodes has no influence on the ability to drive vehicles and use machinery.

Important information about some excipients
Varcodes 2 mg effervescent tablets
This medicine contains 14.96 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 0.75% of the recommended maximum daily intake with the diet of an adult.
This medicine contains 0.06 mg of yellow sunset per tablet. This excipient may cause allergic reactions.

Varcodes 4 mg effervescent tablets
This medicine contains 29.95 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 1.5% of the recommended maximum daily intake with the diet of an adult.
This medicine contains 0.12 mg of yellow sunset per tablet. This excipient may cause allergic reactions.

Varcodes 8 mg effervescent tablets
This medicine contains 59.88 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 3% of the recommended maximum daily intake with the diet of an adult.
This medicine contains 0.24 mg of yellow sunset per tablet. This excipient may cause allergic reactions.

3. How to take Varcodes

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.
Varcodes is for oral use only. Your doctor will prescribe the most appropriate dose to treat your condition.
The tablets must be taken as a drink after dissolving them in a glass of water.
Take the tablets in a single dose each morning, unless your doctor gives other instructions.
The recommended dose is:

Adults:
The recommended dose of dexamethasone is 0.5 mg to 10 mg per day. If your doctor believes you should
take less than 2 mg per day, you will be prescribed a different dexamethasone product than Varcodes.
If Varcodes is administered to you as part of some tests in hospital, the recommended dose is 2 mg for
a short period of time.

If you take more Varcodes than you should
In case of accidental ingestion/taking of an excessive dose of Varcodes, immediately inform your
doctor or go to the nearest hospital.

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

If you stop taking Varcodes
Do not suddenly stop taking this medicine. If treatment needs to be stopped,
follow your doctor's advice, who will gradually reduce the amount of medicine you take until
discontinuation.
Symptoms that have been reported when treatment has been stopped too quickly include low
blood pressure and, sometimes, relapse of the disease for which the medicine was given.
A 'withdrawal syndrome' can also occur, which includes fever, muscle and joint pain,
inflammation of the nasal mucosa (rhinitis), weight loss, itching and inflammation of the eye
(conjunctivitis). If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately report to your doctor if you experience serious mental health problems.These may affect people taking medicines such as Varcodes. These problems include:

• feeling depressed, including suicidal thoughts
• hypersensitivity (mania) or mood swings with highs and lows
• feeling anxious, having sleep problems, difficulty thinking or confusion, and memory loss
• perceiving, seeing or hearing things that do not exist. Having strange and terrifying thoughts, changing the way you act or feeling alone.

Talk to your doctor immediately or go to hospital immediately if you experience any of the
following side effects:

• red and granular skin rash
• difficulty breathing
• swelling of the face, mouth, lips or eyelids

Other side effects may include:

• mental health problems:a feeling of dependence, a severe headache with visual disturbances (related to stopping treatment), worsening of schizophrenia (where you may perceive, see or hear things that do not exist, become introverted or have false beliefs or suspicions)
• problems of the stomach and intestines:nausea, vomiting, hiccups, increased appetite, stomach discomfort, abdominal bloating, inflammation and ulcers in the esophagus, heartburn, ulcers that may bleed, inflammation of the pancreas (with pain in the back and abdomen), tearing of the intestine, especially if you have inflammatory bowel disease, unusual fat deposits.
• metabolism and problems with salt levels:weight gain, salt imbalance, fluid retention in the body, loss of potassium due to low carbon dioxide levels (hypokalemic alkalosis), loss of proteins and calcium balance, increased need for diabetic medications, increased cholesterol levels
• problems of the heart and blood:blood clots, congestive heart failure in susceptible people, rupture of the heart muscle (especially if you have recently had a heart attack), high blood pressure, increase or decrease in red and white blood cell levels, inflammation and worsening of veins or arteries

cuore), high blood pressure, increase or decrease in red and white blood cell levels,
inflammation and worsening of veins or arteries

• problems of the muscles, bones and skin:thinning of the bones, with an increased risk of fractures, bone diseases, torn tendons, muscle atrophy, weakness, increased hair growth (especially in women), slow wound healing, delicate fragile skin, specific marks on the skin, bruising, redness and inflammation of the skin, stretch marks, dilated capillaries, acne, increased sweating, altered reaction to skin tests, skin rashes, hair thinning
• immune system disorders:sore throat, increased susceptibility to infections, recurrence of tuberculosis if it has already been contracted, blood diseases due to infection
• eye problems:cataracts, increased pressure in the eye, eye swelling, thinning of the eye membranes, worsening of existing eye infections, protrusion of the eyeballs
• problems of the reproductive system:irregular or absent menstruation, impotence
• hormonal problems:impairment of hormonal regulation, slowed growth in children and adolescents, swelling and weight gain of the body and face (Cushingoid state)
• problems of the nervous system:seizures and worsening of epilepsy, dizziness, headache
• other general effect:change in the effectiveness of the drug following stress and trauma, surgery or illness; withdrawal syndrome (fever, muscle and joint pain, inflammation of the eyes or nose, itching and weight loss)

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

5. How to store Varcodes

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date printed on the blister and the carton after "Scad". The expiry
date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines you no longer use. This will help protect the environment.

What Varcodes contains
The active ingredient is dexamethasone.
Each 2 mg effervescent tablet contains 2 mg of dexamethasone (as dexamethasone sodium phosphate).
Each 4 mg effervescent tablet contains 4 mg of dexamethasone (as dexamethasone sodium phosphate).
Each 8 mg effervescent tablet contains 8 mg of dexamethasone (as dexamethasone sodium phosphate).
The other ingredients are: sodium bicarbonate, sodium citrate 1.5 hydrate, povidone K 30, sodium saccharin, sodium
benzoate, yellow orange S (E110).

Description of the appearance of Varcodes and contents of the pack
Varcodes 2 mg effervescent tablets are salmon-colored, oblong tablets.
Varcodes 4 mg effervescent tablets are salmon-colored, round, biconvex tablets.
Varcodes 8 mg effervescent tablets are salmon-colored, round, biconvex tablets, with '8' imprinted
on one side.
Varcodes is available in blisters containing 30 effervescent tablets in PA/Alu/PVC-Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EPIONPHARMA GROUP S.R.L.
Via Leone 2 – Centro Commerciale
83025 Montoro (AV)

Manufacturer

All stages:
RAFARM S.A.
Thesi Pousi-Xatzi, Agiou Louka Street, Paiania, Attiki, TK 19002, Greece

Secondary packaging and batch release:
La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino 77
80056 Ercolano (NA) - Italy

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