Akortor

Package leaflet: Information for the user

Akortor, 10 mg, tablets
Hydrocortisone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Contents of the leaflet

1. What Akortor is and what it is used for
2. Important information before taking Akortor
3. How to take Akortor
4. Possible side effects
5. How to store Akortor
6. Contents of the pack and other information

1. What Akortor is and what it is used for

Akortor tablets contain hydrocortisone as the active substance. Hydrocortisone belongs to a group of medicines called steroids. Their full name is corticosteroids. Corticosteroids occur naturally in the body and help maintain health and well-being. Providing additional corticosteroid (such as hydrocortisone) is an effective way of treating various inflammatory conditions. Hydrocortisone reduces inflammation, which otherwise could lead to worsening of the patient's condition. To achieve the proper treatment outcome, the medicine should be taken regularly.

Akortor tablets are used:

• in adults, children and adolescents for replacement therapy due to impaired adrenal gland function when hydrocortisone is not present in sufficient amounts
• for emergency treatment of severe asthma, drug hypersensitivity reactions, serum sickness (hypersensitivity reaction to heterologous protein), localized angioedema of the skin and (or) mucous membranes, and life-threatening allergic reaction (anaphylactic reaction).

2. Important information before using Akortor

When not to use Akortor

• if the patient is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6),
• if the patient has tuberculosis or any other acute or chronic bacterial, fungal, viral, or parasitic infection and is not receiving appropriate antimicrobial treatment.

High doses of corticosteroids may weaken the immune system. In such a case, the patient
must not be given vaccines containing live, attenuated viruses or bacteria, as this may
lead to infection.
Before starting treatment with Akortor
Before starting treatment with Akortor, tell the doctor:

• if the patient has or has ever had severe depression, manic-depressive illness (bipolar disorder). This also includes cases where depression occurred before or during treatment with steroids such as hydrocortisone.
• if any of the above conditions occurred in the patient's immediate family members. If any of the above situations apply to the patient, the doctor must be informed before taking hydrocortisone.

Warnings and precautions
Before starting treatment with Akortor, discuss with the doctor if the patient has or has had in the past:

• diabetes
• peptic ulcer disease of the stomach or intestines
• osteoporosis (thinning of the bones)
• glaucoma – increased pressure in the eye
• heart diseases (heart failure, recent heart attack)
• high blood pressure
• kidney or liver function disorders
• epilepsy
• inflammatory bowel diseases
• the patient recently underwent a surgical anastomosis (creation of an artificial connection between two naturally separate spaces)
• mood disorders
• thyroid disorders
• myasthenia (a disease affecting muscles) and the patient is simultaneously taking anticholinesterases
• chickenpox, measles, or shingles. Avoid contact with people infected with or suffering from chickenpox, measles, or shingles. If the patient has been exposed to these diseases, contact the doctor immediately.
• intestinal worm infections (e.g. amoebiasis or ascariasis). Hydrocortisone may activate or worsen such infections.
• tuberculosis
• eye infection caused by herpes simplex virus. Hydrocortisone may activate or worsen fungal and viral eye infections.
• muscle weakness after previous steroid use
• suspicion or diagnosis of pheochromocytoma (a rare adrenal gland tumor)
• if the patient has hyperthyroidism (overactive thyroid).

Contact the doctor if any new infections occur during treatment with Akortor tablets. Long-term and high-dose use of hydrocortisone may increase the risk of infection, as treatment with hydrocortisone may mask the usual symptoms of infection.
If the patient experiences blurred vision or other visual disturbances, contact the doctor.
If the patient develops muscle weakness, muscle pain, cramps, or muscle stiffness during hydrocortisone treatment, contact the doctor immediately. These may be symptoms of a condition called periodic paralysis associated with thyrotoxicosis, which may occur in patients with hyperthyroidism (hyperthyroidism) treated with hydrocortisone. Additional treatment may be necessary to relieve symptoms of this condition.
Psychiatric disorders during hydrocortisone treatment
Psychiatric disorders may occur during treatment with steroids such as hydrocortisone (see also section 4 "Possible side effects").
These disorders may be serious.
They usually occur within a few days or weeks after starting treatment.
The likelihood of their occurrence is higher with high doses of the drug.
Most of these disorders resolve when the dose is reduced or treatment is discontinued. However, if the disorders persist, appropriate treatment may be necessary.
Inform the doctor if the patient (or someone taking this medicine) experiences any symptoms of psychiatric disorders, especially if the patient has low mood or suicidal thoughts during dose reduction or after discontinuation of the drug. In rare cases, psychiatric disorders may occur during this period.
Stress situations, injuries, surgical procedures
If the patient is currently taking or has recently taken Akortor and becomes ill, is under stress, has sustained an injury, or is scheduled for surgery, inform the doctor. It may be necessary to increase the dose of Akortor (or temporarily resume treatment) to prevent a sudden drop in blood pressure.
Vaccinations
If the patient is to be vaccinated during corticosteroid treatment, be aware that vaccine protection may not be as effective as usual. During corticosteroid treatment, certain vaccines should be avoided; see section "When not to use Akortor".
Blood clotting
Corticosteroid treatment may affect blood clotting; therefore, caution is required when using any drugs affecting blood clotting simultaneously (see section "Akortor with other medicines").
Children
Corticosteroid treatment may delay growth and increase the risk of adverse effects in children.
If hydrocortisone is administered to premature infants, monitoring of heart function and cardiac muscle imaging may be necessary.
Akortor with other medicines
Inform the doctor about all medicines currently or recently taken by the patient, including those available without a prescription.
Some medicines may enhance the effect of Akortor, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
In particular, do not take this medicine and inform the doctor or pharmacist if the patient is taking any of the following medicines:

• phenytoin, carbamazepine, and barbiturates (medicines used in epilepsy treatment)
• rifampicin and rifabutin (medicines used in tuberculosis treatment)
• herbal medicines containing St John's wort ( Hypericum perforatum )
• efavirenz and nevirapine (medicines used in HIV infection treatment)
• antifungal medicines (ketoconazole, itraconazole, posaconazole, voriconazole, amphotericin B)
• erythromycin, telithromycin, clarithromycin, fluoroquinolones (antibiotics)
• estrogen-containing products and oral contraceptives
• antihypertensive medicines
• medicines reducing blood coagulation (anticoagulants), e.g. warfarin
• acetylsalicylic acid (aspirin)
• medicines used in diabetes treatment
• anticholinesterases (e.g. pyridostigmine)
• "drying" tablets (diuretics)
• cardiac glycosides (used in heart failure treatment) e.g. digoxin
• theophylline and beta-sympathomimetics, e.g. bambuterol, fenoterol, formoterol, rytodryna, salmeterol, salbutamol, terbutaline (used in asthma or other breathing disorders treatment)
• anti-inflammatory and pain-relieving medicines (called non-steroidal anti-inflammatory drugs (NSAIDs)), e.g. ibuprofen, diclofenac, or naproxen
• somatropin (growth hormone)
• mifepristone (used to terminate pregnancy)
• vaccines. Corticosteroids may reduce vaccine effectiveness and increase the risk of neurological complications. Simultaneous administration of vaccines containing live, attenuated viruses or bacteria must be completely avoided (see section "When not to use Akortor").

Akortor with food and drink
The medicine can be taken during meals or independently of them.
Avoid drinking grapefruit juice during treatment, as it may increase the concentration of
hydrocortisone in the blood.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Hydrocortisone crosses the placenta. Except for replacement therapy, caution should be exercised
when using other systemic-acting corticosteroids during pregnancy. If the patient received
therapeutic doses of hydrocortisone during pregnancy, newborns should be monitored for
insufficient hormone production by the adrenal glands.
Breastfeeding
The active substance of Akortor passes into breast milk. Long-term use of high doses of Akortor
during breastfeeding may impair the infant's ability to produce adequate amounts of steroid
hormones.
Fertility
Corticosteroids may affect fertility, as they may cause deterioration in semen quality and loss of
menstruation (absence of menstruation).
Driving and operating machinery
Akortor usually does not affect the ability to drive vehicles or operate machinery.
However, in some patients, steroids may cause a sensation of movement even while remaining still,
which may lead to dizziness (central vertigo). Visual field changes or muscle weakness may also
occur. If such symptoms occur, do not drive vehicles or operate machinery.
Akortor contains lactose
One Akortor tablet contains 64.4 mg of lactose. If the patient has previously been diagnosed with
intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to take Akortor

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The dose and duration of treatment will depend on the type of illness the patient has.
In replacement therapy, the first dose taken in the morning is usually higher than subsequent doses, to mimic the normal daily rhythm of cortisol secretion.
The tablet may be divided into equal doses.
Tablets should be swallowed with liquid, during or independently of meals.
If you feel that the effect of Akortor is too strong or too weak, consult your doctor.

Treatment of emergency conditions in adults

• The usual dose is 6 to 8 tablets (60–80 mg) every 4–6 hours over 24 hours. Afterwards, the dose should be gradually reduced over several days, as directed by your doctor.

Replacement therapy in children and adolescents (aged 1 month to 18 years)
Akortor may be used in children from 1 month of age up to 18 years of age when a 10 mg tablet dose is considered appropriate for the patient.

• Congenital adrenal hyperplasia: Your doctor will determine the dose individually based on the patient's height and body weight. The daily dose is divided into 3 doses. The doctor will adjust the dose according to the patient's response to treatment.
• Inadequate production of steroid hormones by the adrenal glands (adrenal insufficiency): Your doctor will determine the dose individually based on the patient's height and body weight. The daily dose is divided into 3 doses. The doctor will adjust the dose according to the patient's response to treatment: higher doses may be required.

Replacement therapy in adults
The usual replacement therapy dose is typically 15–25 mg per day, divided into 2–3 doses. Your doctor will adjust the dose according to your response to treatment.

Use in special patient groups or special situations
Your doctor may wish to adjust the dose or monitor treatment carefully if the patient is elderly, has impaired liver or adrenal function, is under stress, has suffered trauma, has an infection, or is scheduled for surgery.

Taking more Akortor than prescribed
If you take more Akortor than prescribed, contact your doctor immediately.
In cases of significant overdose, activated charcoal may be administered as first aid; however, you should contact your doctor as soon as possible for further treatment.

If you forget to take Akortor
Do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Akortor
Akortor must only be discontinued or stopped after consulting your doctor. Rapidly reducing the dose of Akortor can be dangerous. Your doctor will gradually reduce the dose.
Stopping Akortor may result in insufficient levels of steroid hormones in the body. Abruptly stopping Akortor may cause withdrawal symptoms such as muscle and joint pain, fever, weakness, general malaise, increased intracranial pressure, and decreased arterial blood pressure.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects may be more pronounced in elderly patients and in children.
The occurrence of adverse effects in patients taking hydrocortisone to replace naturally occurring hormones in the body is less likely than in patients using this medicine to treat other diseases. Your doctor will regularly monitor whether any adverse effects occur.

Treatment with this medicine may sometimes cause serious adverse effects. You should immediately inform the doctor if any of the following conditions occur in the patient, or if the patient suspects an increased risk of infection (e.g. the patient has been in contact with an infected person):

• potentially life-threatening allergic reaction causing, among others, skin rash, facial swelling, or wheezing,
• irregular, very fast or very slow heartbeat, fainting,
• in children: headache with vomiting, lack of energy and drowsiness. These are symptoms of pseudotumour cerebri (also known as idiopathic intracranial hypertension), which causes increased intracranial pressure and usually occurs after stopping treatment,
• perforation or bleeding of gastrointestinal ulcers (manifested by abdominal pain, particularly radiating to the back, bleeding from the lower gastrointestinal tract, black stools, and vomiting blood),
• acute pancreatitis (abdominal pain possibly accompanied by shock, i.e. low blood pressure, reduced urine output, and often loss of consciousness),
• blood clot (thrombosis) in a leg vein, manifested by swelling, redness, increased warmth, and muscle tenderness,
• heart failure – heart function disorders manifested by ankle swelling, chest pain, breathing difficulties, palpitations, or irregular heartbeat,
• irregular, very fast or very slow heartbeat; high blood pressure (hypertension, manifested by headache and general malaise).

Serious adverse effects: contact the doctor immediately
Steroids, including hydrocortisone, may cause severe psychiatric disorders. These disorders are common in both adults and children. They may occur in approximately 5 out of 100 patients taking medicines such as hydrocortisone.

• depressed mood, including suicidal thoughts,
• elevated mood (mania) or mood swings,
• feelings of anxiety, sleep disturbances, difficulty thinking, or feelings of disorientation and memory loss,
• experiencing, seeing, or hearing things that do not exist in reality. Strange and frightening thoughts, changes in behaviour, and feelings of isolation. You should immediately inform the doctor if any of these conditions occur.

Other adverse effects reported with hydrocortisone:
Common (may affect up to 1 in 10 people):

• high blood pressure
• increased susceptibility to infections, masking of infection symptoms
• insufficient secretion of hormones by the pituitary gland (adrenocorticotropic hormone, ACTH) and adrenal glands (cortisol) during long-term use
• rounded or "moon" face
• worsening or development of diabetes
• muscle cramps and spasms caused by loss of potassium from the body. In rare cases, potassium loss may lead to palpitations (feeling of irregular heartbeat)
• sodium retention in the body
• thin or fragile skin, delayed healing of cuts and wounds, scarring, red or purple spots, acne, striae, bruising
• muscle weakness or atrophy, osteoporosis (brittle bones – increased susceptibility to fractures).

Uncommon (may affect up to 1 in 100 people):

• increased appetite
• mood changes, depression, mania (feeling of elevated mood), psychosis (experiencing, seeing, or hearing things that do not exist in reality, strange and frightening thoughts, changes in behaviour, and feelings of isolation), insomnia
• visual disturbances due to cataract or glaucoma (increased intraocular pressure).

Rare (may affect up to 1 in 1000 people):

• seizures
• bone fractures due to reduced blood supply, tendon rupture (pain and/or swelling).

Unknown frequency (cannot be estimated from available data):

• increased white blood cell count
• reduced response to stress (e.g. injury, surgery, or illness)
• increased blood glucose levels
• loss of potassium and calcium, loss of nitrogen due to breakdown of body protein stores, fluid retention
• mood disturbances, behavioural disorders, irritability or restlessness, sleep problems, difficulty thinking (including disorientation and memory loss)
• central dizziness, headache
• optic disc swelling (papilledema), thinning of superficial layers of the eye, exophthalmos (protruding eyes), blurred vision
• rupture of the heart muscle following a recent heart attack
• hypertrophic cardiomyopathy (thickening of the heart muscle) in premature infants
• hiccups
• erosive oesophagitis, bloating, indigestion, oesophageal thrush
• small, round spots on the skin or mucous membranes, skin redness, persistent dilation of small blood vessels in the skin or mucous membranes, excessive sweating, allergic dermatitis, urticaria, excessive body and facial hair growth in women
• steroid-induced myopathy, bone fractures or cracks
• irregular or absent menstruation in women
• weight gain, nausea, discomfort, and fatigue.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Akortor

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, cardboard box, and label of the glass container. The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature.
Store the medicine in its blister pack or in a tightly closed container to protect it from light and moisture.
The glass bottle contains a desiccant which protects the tablets from moisture. Do not remove the desiccant from the bottle. Do not swallow the desiccant.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Akortor contains

• The active substance is hydrocortisone. Each tablet contains 10 mg of hydrocortisone.
• The other ingredients are: monohydrate lactose, maize starch, talc, gelatin and magnesium stearate.

What Akortor looks like and contents of the pack
White, smooth tablets with bevelled edges and a division line of approximately 7 mm in diameter,
imprinted with the code "ORN35".
Akortor is available in blisters, in packages containing 20, 30 or 100 tablets, or in an amber glass
bottle with a capacity of 15 mL with an aluminium closure and a desiccant, containing 100 tablets.
Outer packaging: cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
Joensuunkatu 7
24100 Salo
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Finland: Hydrocortisone Orion 10 mg tabletit/tabletter
Sweden, Denmark: Hydrokortison Orion 10 mg tabletter
Iceland: Hydrokortison Orion 10 mg töflur
Poland: Akortor
Slovenia: Hidrokortizon Orion 10 mg tablete
United Kingdom (Northern Ireland): Hydrocortisone 10 mg Tablets