Ketoconazole HRA
ketoconazole
ketoconazole
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 Ketoconazole HRA is and what it is used for
What you need to know before you take Ketoconazole HRA
How to take Ketoconazole HRA
Possible side effects
How to store Ketoconazole HRA
Contents of the pack and other information
Ketoconazole HRA is a medicine that contains the active substance ketoconazole with an anticorticosteroid activity. It is used to treat endogenous Cushing’s syndrome (when the body produces an excess of cortisol) in adults and adolescents above the age of 12 years.
Cushing’s syndrome is caused by overproduction of a hormone called cortisol which is produced by the adrenal glands. Ketoconazole HRA is able to block the activity of the enzymes responsible for the synthesis of cortisol and consequently is able to decrease the over-production of cortisol by your body and to improve the symptoms of Cushing’s syndrome.
if you are allergic to ketoconazole and/or to any imidazole antifungal medicine, or to any of the other ingredients of this medicine (listed in section 6)
if you have liver problems
if you are pregnant
if you are breastfeeding
if you have a history of an irregular heart beat
if you are taking any of the following medicines:
certain medicines for lowering blood cholesterol: simvastatin, atorvastatin, lovastatin
certain heart medicines: epleronone, dronedarone, disopyramide, felodipine, nisoldipine, ranolazine
certain medicines used for the treatment of the paludism: quinidine, halofantrine
certain medicines used for severe mental health disorders and severe depression: pimozide, sertindole, lurasidone, quetiapine
certain medicines used for the allergies: mizolastine
dabigatran – medicine used to prevent the formation of blood clots
certain medicines to help to sleep and for anxiety: triazolam, alprazolam, midazolam (taken by mouth)
certain medicines used for migraine attacks: dihydroergotamine, ergometrine (ergonovine) ergotamine and methylergometrine (methylergonovine)
certain medicines used in cancers: irinotecan, everolimus
sirolimus: used to prevent your body from rejecting a kidney transplant
tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”
vardenafil in men older than 75 years – medicine to treat erectile dysfunction in adults men
certain medicines for HIV: saquinavir/ritonavir, saquinavir
certain medicines to treat long-term (chronic) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus): Paritaprevir/Ombitasvir (ritonavir)
methadone: medicine to treat dependence to drugs
In patients with renal disorders:
colchicine: medicine to treat gout
fesoterodine and solifenacin: medicines to treat the symptoms of an overactive bladder
telithromycin and clarithromycin: medicine used to treat infections
Do not take Ketoconazole HRA if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ketoconazole HRA.
Talk to your doctor or pharmacist before taking Ketoconazole HRA.
Liver disease
Speak with your doctor if you have a history of liver disease. You should know that your liver enzyme tests will be regularly monitored before starting the treatment, once weekly during the first month after Ketoconazole HRA initiation and then monthly for 6 months due to the risk of serious hepatic toxicity. They will be checked again after that in case your doctor increases your daily ketoconazole dose. You should stop your treatment and contact your doctor immediately if you feel unwell or experience symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine.
Specific dosing regimen
If you take concomitant glucocorticoid replacement therapy with your Ketoconazole HRA treatment, your doctor should inform you how to adapt your glucocorticoid replacement therapy dose if you are under stress or have surgery or an infection. In addition, you should receive an emergency card and should be equipped with an emergency glucocorticoid set.
Adrenal function
Your adrenal function will be monitored at regular intervals as this is the standard care in the follow-up of Cushing’s syndrome therapy and since adrenal insuficiency can occur during the treatment. You should contact your doctor immediately if you have symptoms such as weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure.
Heart disease
Ketoconazole HRA can change how your heart beats – this can be serious. Contact your doctor immediately, if you get palpitations or an irregular heartbeat during treatment.
Coexisting inflammatory/autoimmune disorders
Tell your doctor if you suffer from an autoimmune disorder, you will be closely supervised.
This medicine is not recommended for children under 12 years due to the lack of data in these patients.
Tell your doctor or phamacist if you are taking, have recently taken or might take any other medicines. There are some medicines that must not be taken with Ketoconazole HRA (see section 2). Ask your doctor or pharmacist for more information if you are taking Ketoconazole HRA with other medicines.
Medicines that can interact with Ketoconazole HRA include:
pasireotide, another drug used to treat a subset of the Cushing’s syndrome because it can lead to severe side effects in patients suffering from cardiac disorders
medicines taken by mouth that prevent blood clots from forming: rivaroxaban, apixaban, edoxaban, cilostazol, warfarin and others coumarin like
HIV medicines such as maraviroc, indinavir, nevirapine, ritonavir
certain medicines used for cancer such as vinca alkaloids, busulfan, docetaxel, erlotinib, imatinib, dasatinib, sunitinib, lapatinib, nilotinib, bortezomib, paclitaxel, vincristine, vinblastine, cabozantinib, dabrafenib, cabazitaxel, crizotinib, ibrutinib
certain medicines used to treat infections: rifabutin, telithromycin, rifampicin, isoniazide, clarithromycin, isavuconazole
certain antidiabetics: repaglinide, saxagliptin, tolbutamide
certain medicines used for mental disorders: buspirone, aripipazole, haloperidol, reboxetine, risperidone
certain heart medicines – verapamil, digoxin, nadolol, aliskiren
certain anticonvulsivants: carbamazepine, phenitoin
certain glucocorticoids – such as budesonide, fluticasone, dexamethasone, methylprednisolone, ciclesonide
certain stong painkillers (narcotics) – such as alfentanyl, fentanyl, buprenorphine (injection and sublingual), oxycodone
certain medicines used for nausea and vomiting: domperidone, aprepitant
naloxegol (medicine for treatment of constipation specifically caused by strong pain medicines)
solifenacin, fesoterodine in patients with renal impairment
others: sildenafil, , tolterodine, mitotane, praziquantel, eletriptan, , salmeterol, bosentan, midazolam (by injection), tadalafil, vardenafil, temsirolimus, cinalcacet, tacrolimus, ebastine, ciclosporine, colchicine
You should not take antacids (eg aluminium hydroxide) or other medicines for acid indigestion for at least 2 hours after the intake of Ketoconazole HRA (see section Warning and Precautions).
No alcohol should be consumed during treatment with ketoconazole.
Do not take this medicinal product during pregnancy. 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. Do not breastfeed your baby if you are taking Ketoconazole HRA.
Dizziness or somnolence have been reported during treatement with Ketoconazole HRA. Do not drive or operate machines if you experience these symptoms.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Initiation and follow up of the treatment must be supervised by specialists in endocrinology.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will test your blood before you start the treatment and regularly during the treatment to detect any possible abnormalities and also to measure the levels of cortisol. The dose will be adapted to your condition with the aim to restore normal cortisol levels.
The recommended initial dose is usually 600 mg per day taken orally (3 tablets per day in 3 divided times). A daily dose from 400 mg per day (2 tablets) to 1,200 mg per day (6 tablets) taken orally in 2 to 3 divided doses may be required to restore your normal cortisol levels.
If you have taken more than the prescribed dose of Ketoconazole HRA, you must contact your doctor immediately.
Do not take a double dose to make up for a forgotten dose. If you forget to take one dose, take this dose as soon as you remember. Then go on with regular schedule as prescribed. Do not change the prescribed dose yourself.
If you interrupt your treatment with Ketoconazole HRA your cortisol level may increase again and your symptoms may come back. Therefore, do not stop taking Ketoconazole HRA unless your doctor tells you.
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.
Some side effects may be serious. Liver problems can rarely happen (may affect up to 1 in 1,000 people). Stop taking Ketoconazole HRA and tell your doctor straight away if you experience any of the following:
long-lasting severe headache or blurred vision
severe lack of appetite (anorexia)
weight loss
nausea or vomiting
unusual tiredness or fever
stomach pain
muscle weakness
yellowing of the skin or whites of the eyes
unusually dark urine or pale stools
Adrenal insufficiency is common and can be a serious side effect. Ketoconazole HRA may temporarily lower the amount of hormones produced by your adrenal gland (cortisol) to below the normal range, but your doctor will correct this using appropriate hormone medicines or by adjusting the dose of Ketoconazole HRA. You should contact your doctor immediately if you have symptoms such as weakness, fatigue, loss of appetite, nausea, vomiting, low blood pressure.
An elevated levels of liver enzymes in your blood
Nausea
Abdominal pain
Vomiting
Diarrhoea
Skin reactions (pruritus, rash)
Allergic reactions which can, rarely, be serious
Change in laboratory markers
Platelet count decreased
Headache
Dizziness
Sleepiness
Skin reactions (urticaria)
Hair loss
Fatigue
Pyrexia (fever)
Insomnia
Nervousness
Intolerance to alcohol
Loss of appetite or increased appetite
Headache
Sensation of tingling or pricking
Aversion to light
Bleeding from the nose
Dyspepsia (impaired digestion)
Flatulence
Tongue discoloration
Dry mouth
Distortion of the sense of taste
Skin redness, drying, itching
Photosensitivity (increase in the reaction to sunlight: redness, itching rash)
Myalgia (muscle pain)
Arthralgia (joint pain)
Menstrual disorders
Azoospermia (no sperm count)
Erectile dysfunction
Gynaecomastia (enlargement in breast tissues in male)
Oedema peripheral (dropsy in extremities)
Malaise
Hot flush
Transient decrease of testosterone, a male hormone (androgen) made by the body, mostly produced in the testes
If you get any side effects, talk to your doctor. 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 on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions
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.
The active substance is ketoconazole. Each tablet contains 200 milligram ketoconazole
The other ingredients are maize starch, lactose monohydrate (see section 2), povidone, microcrystalline cellulose, silica colloidal, magnesium stearate
Ketoconazole HRA is available in packs containing 60 tablets.
The tablet is off-white to light cream, round, 10 mm diameter, biconvex.
HRA Pharma Rare Diseases 200 avenue de Paris
92320 CHATILLON
France
Tel : + 33 1 40 33 93 14
Centre Spécialités Pharmaceutiques 76-78 avenue du Midi
63800 Courron d‘Auvergne France
Polfarmex S.A. | |
ul. Józefów 9, 99-300 Kutno | |
Poland | |
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