AKORTOR 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Akortor, 10 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Akortor and what is it used for
4. Important information before taking Akortor
   1. When not to take Akortor
   2. Before taking Akortor
   3. Warnings and precautions
   4. Stressful situations, injuries, surgical procedures
   5. Vaccinations
   6. Blood clotting
   7. Children
   8. Akortor and other medicines
   9. Akortor with food and drink
   10. Pregnancy, breastfeeding, and fertility
   11. Driving and using machines
   12. Akortor contains lactose
5. How to take Akortor
   1. Taking a higher dose of Akortor than recommended
   2. Missing a dose of Akortor
   3. Stopping Akortor treatment
6. Possible side effects
   1. Serious side effects: you should immediately contact your doctor
   2. Reporting side effects
7. How to store Akortor
8. Contents of the pack and other information
   1. What Akortor contains
   2. What Akortor looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: 03.2025

Package Leaflet: Information for the User

Akortor, 10 mg, Tablets

Hydrocortisone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Akortor and what is it 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 is Akortor and what is it 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 the body with an additional corticosteroid (such as hydrocortisone) is an effective way to treat various diseases related to inflammatory conditions. Hydrocortisone reduces inflammation, which could otherwise worsen the patient's condition.
To achieve the proper treatment effect, the medicine should be taken regularly.
Akortor tablets are used:

• in adults, children, and adolescents for replacement therapy due to inadequate function of the adrenal glands, when hydrocortisone is not present in sufficient quantities
• for emergency treatment of severe asthma, allergic reactions to medicines, serum sickness (allergic reaction to foreign protein), local skin and/or mucous membrane edema (angioedema), and life-threatening allergic reactions (anaphylactic reaction).

2. Important information before taking Akortor

When not to take Akortor

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

High doses of corticosteroids can weaken the immune system. In such cases, patients should not receive live, attenuated virus or bacterial vaccines, as this may cause infection.

Before taking Akortor

Before taking Akortor, tell your doctor:

• if you have or have had severe depression, manic-depressive illness (bipolar disorder). This also applies to cases where you have had depression before or during treatment with steroids, such as hydrocortisone.
• if any of the above conditions have occurred in your close family members. If any of the above situations apply to you, you must tell your doctor before taking hydrocortisone.

Warnings and precautions

Before starting Akortor, discuss with your doctor if you have or have had:

• diabetes
• stomach or intestinal ulcers
• osteoporosis (thinning of the bones)
• glaucoma - increased pressure in the eye
• heart disease (heart failure, recent heart attack)
• high blood pressure
• kidney or liver dysfunction
• epilepsy
• inflammatory bowel disease
• you have recently undergone an anastomosis (creation of an artificial connection between two naturally separate spaces)
• mood disorders
• thyroid disease
• myasthenia (a disease affecting the muscles) and you are taking anticholinesterases
• chickenpox, measles, or shingles. You should avoid contact with people who are infected or sick with chickenpox, measles, or shingles. If you are exposed to these diseases, you should contact your doctor immediately.
• worm infestations (e.g., amoebiasis or trichinosis). Hydrocortisone may activate or exacerbate such infections.
• tuberculosis
• herpes simplex virus infection in the eye. Hydrocortisone may activate or exacerbate fungal and viral eye infections.
• muscle weakness after previous steroid use
• suspected or diagnosed adrenal gland tumor (a rare tumor of the adrenal gland).

You should contact your doctor if you experience any new infections while taking Akortor tablets. Long-term treatment with hydrocortisone and high doses may increase the risk of infection, as hydrocortisone treatment may mask the usual symptoms of infection.
If you experience blurred vision or other vision disturbances, you should contact your doctor.
Psychiatric disorders during hydrocortisone treatment
During treatment with steroids, such as hydrocortisone, psychiatric disorders may occur (see also section 4 "Possible side effects").
These disorders can be serious.
They usually occur within a few days or weeks after starting treatment.
The greater likelihood of their occurrence exists after taking high doses of the medicine.
Most of these disorders disappear after reducing the dose or discontinuing treatment. However, if the disorders persist, it may be necessary to apply appropriate treatment.
You should tell your doctor if you (or the person taking this medicine) experience any symptoms of psychiatric disorders, especially if you have a low mood or suicidal thoughts during dose reduction or after discontinuation of treatment. In rare cases, psychiatric disorders may occur during this period.

Stressful situations, injuries, surgical procedures

If you are taking or have recently taken Akortor and become ill, are under stress, have been injured, or are scheduled for surgery, you should tell your doctor. It may be necessary to increase the dose of Akortor (or it may be necessary to restart treatment for a short period) to prevent a sudden decrease in blood pressure.

Vaccinations

If you are to be vaccinated during corticosteroid treatment, you should be aware that post-vaccination protection may not be as effective as usual. During corticosteroid treatment, you should avoid receiving certain vaccines; see the section "When not to take Akortor".

Blood clotting

Corticosteroid treatment may affect blood clotting, so caution should be exercised when taking any medications that affect blood clotting (see the section "Akortor and other medicines").

Children

Corticosteroid treatment may cause growth retardation and increase the risk of side effects in children.
If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image.

Akortor and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, including those available without a prescription.
Some medicines may enhance the effect of Akortor, and your doctor may want to closely monitor your condition when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
In particular, do not take this medicine and tell your doctor or pharmacist if you are taking any of the following medicines:

• phenytoin, carbamazepine, and barbiturates (medicines used to treat epilepsy)
• rifampicin and rifabutin (medicines used to treat tuberculosis)
• herbal medicines containing St. John's Wort (Hypericum perforatum)
• efavirenz and nevirapine (medicines used to treat HIV infection)
• antifungal medicines (ketoconazole, itraconazole, posaconazole, voriconazole, amphotericin B)
• erythromycin, telithromycin, clarithromycin, fluoroquinolones (antibiotics)
• estrogen products and oral contraceptives
• antihypertensive medicines
• blood thinners (anticoagulants), e.g., warfarin
• acetylsalicylic acid (aspirin)
• medicines used to treat diabetes
• anticholinesterases (e.g., pyridostigmine)
• "water tablets" (diuretics)
• cardiac glycosides (used to treat heart failure), e.g., digoxin
• theophylline and beta-sympathomimetics, e.g., bambuterol, fenoterol, formoterol, rytodryna, salmeterol, salbutamol, terbutaline (used to treat asthma or other respiratory disorders)
• anti-inflammatory and pain-relieving medicines (non-steroidal anti-inflammatory drugs, NSAIDs), e.g., ibuprofen, diclofenac, or naproxen
• somatropin (growth hormone)
• mifepristone (used to terminate pregnancy)
• vaccines. Corticosteroids may reduce the effectiveness of vaccines and increase the risk of neurological complications. You should completely avoid receiving live, attenuated virus or bacterial vaccines (see the section "When not to take Akortor").

Akortor with food and drink

The medicine can be taken with or without food.
You should avoid drinking grapefruit juice during treatment, as it may increase the level of hydrocortisone in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Hydrocortisone passes into the placenta. Except for replacement therapy, caution should be exercised when using other systemic corticosteroids during pregnancy. If you received therapeutic doses of hydrocortisone during pregnancy, newborns should be monitored for inadequate production of adrenal hormones.
Breastfeeding
The active substance of Akortor passes into breast milk. Long-term use of high doses of Akortor during breastfeeding may weaken the baby's ability to produce the necessary amount of steroid hormones.
Fertility
Corticosteroids may affect fertility, as they can cause a decrease in sperm quality and loss of menstrual cycle (amenorrhea).

Driving and using machines

Akortor usually does not affect the ability to drive and use machines.
However, some patients may experience a feeling of movement, even when standing still, which can cause dizziness (central dizziness). They may also experience changes in the field of vision or muscle weakness. If you experience such symptoms, you should not drive or operate machinery.

Akortor contains lactose

One Akortor tablet contains 64.4 mg of lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Akortor

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The dose and duration of treatment will depend on the type of disease you are suffering from.
In replacement therapy, the first dose, given in the morning, is usually larger than the subsequent doses to mimic the normal daily rhythm of cortisol secretion.
The tablet can be divided into equal doses.
Tablets should be swallowed with a drink of water, with or without food.
If you feel that the effect of Akortor is too strong or too weak, you should consult your doctor.
Treatment of emergency conditions in adults

• You should take 6 to 8 tablets (60-80 mg) every 4-6 hours for 24 hours. Then, you should gradually reduce the dose over several days, as directed by your doctor.

Replacement therapy in children and adolescents (from 1 month to 18 years)
Akortor can be used in children from 1 month to 18 years when a 10 mg tablet dose is considered suitable for the patient.

• Congenital adrenal hyperplasia:The doctor will determine the dose individually, based on the patient's growth 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.
• Adrenal insufficiency (adrenal cortex insufficiency):The doctor will determine the dose individually, based on the patient's growth 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 necessary.

Replacement therapy in adults
The dose used in replacement therapy is usually 15-25 mg per day and is divided into 2-3 doses. The doctor will adjust the dose according to the patient's response to treatment.
Use in special patient groups or situations
Your doctor may want to change the dose or closely monitor treatment if you are elderly, have liver or adrenal dysfunction, are in a stressful situation, have been injured, have an infection, or are scheduled for surgery.

Taking a higher dose of Akortor than recommended

If you take more Akortor than recommended, you should contact your doctor immediately.
In case of significant overdose, activated charcoal can be given as first aid, but you should contact your doctor as soon as possible for further treatment.

Missing a dose of Akortor

You should not take a 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 treatment

Treatment can only be stopped or terminated after consulting your doctor. Stopping Akortor treatment too quickly can be dangerous. Your doctor will gradually reduce the dose of the medicine.
Stopping Akortor treatment may cause the body to have insufficient steroid hormones. Suddenly stopping Akortor treatment may cause withdrawal symptoms, such as muscle and joint pain, fever, weakness, general malaise, increased intracranial pressure, and decreased blood pressure.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Akortor can cause side effects, although not everybody gets them.
Side effects may be more severe in elderly patients and children.
The occurrence of side effects in patients taking hydrocortisone to replace natural hormones is less likely than in patients taking this medicine to treat other diseases. Your doctor will regularly check for these side effects.
Treatment with this medicine may sometimes cause serious side effects. You should immediately tell your doctor if you experience any of the following conditions or if you suspect you have an increased risk of infection(e.g., you have had contact with an infected person):

• potentially life-threatening allergic reaction, which causes, among other things, skin rash, facial swelling, or wheezing
• irregular, very fast, or slow heartbeat, fainting,
• in children, headache with vomiting, lack of energy, and sleepiness. These are symptoms of a pseudo-brain tumor, which causes increased intracranial pressure and usually occurs after treatment has ended.
• perforation or bleeding of stomach ulcers (manifested by abdominal pain, possibly radiating to the back, bleeding from the lower digestive tract, black stools, and vomiting with blood)
• acute pancreatitis (abdominal pain with possible accompanying shock, i.e., low blood pressure with reduced urine output and often loss of consciousness),
• blood clot (thrombosis) in a leg vein, manifested by swelling, redness, increased warmth, and tenderness of the muscle
• heart failure - disturbances in heart function, manifested by swelling around the ankles, chest pain, difficulty breathing, palpitations, or irregular heartbeat; high blood pressure (high blood pressure, manifested by headaches and general malaise).

Serious side effects: you should immediately contact your doctor

Steroids, including hydrocortisone, can cause serious psychiatric disorders. These disorders are common in both adults and children. They may occur in about 5 out of 100 patients taking such medicines as hydrocortisone.

• low mood, including suicidal thoughts,
• increased mood (mania) or mood swings,
• feeling anxious, sleep disturbances, difficulty thinking, or feeling disoriented and losing memory,
• feeling, seeing, or hearing things that do not actually exist. Strange and frightening thoughts, changes in behavior, and feeling lonely. You should immediately inform your doctorif you experience any of these conditions.

Other side effects reported for hydrocortisone:
Frequently (may occur in up to 1 in 10 people):

• high blood pressure
• increased susceptibility to infections, masking of infection symptoms
• inadequate production of hormones by the pituitary gland (adrenocorticotropic hormone, ACTH) and adrenal glands (cortisol) during long-term treatment
• round or so-called moon face
• worsening or development of diabetes
• cramps and spasms caused by potassium loss from the body. In rare cases, potassium loss can lead to heart palpitations (feeling of irregular heartbeat)
• accumulation of sodium in the body
• thin or fragile skin, delayed wound healing, scars, red or purple spots, acne, stretch marks, bruising
• weakness or atrophy of muscles, osteoporosis (bone fragility - susceptibility to fractures).

Less frequently (may occur in up to 1 in 100 people):

• increased appetite
• mood changes, depression, mania (feeling of elevated mood), psychosis (feeling, seeing, or hearing things that do not actually exist, strange and frightening thoughts, changes in behavior, and feeling lonely), insomnia
• vision disturbances due to cataracts or glaucoma (increased pressure in the eye).

Rarely (may occur in up to 1 in 1,000 people):

• seizures
• bone fractures caused by reduced blood circulation, tendon rupture (pain and/or swelling).

Unknown (frequency cannot be estimated from available data):

• increased white blood cell count
• decreased response to stress (e.g., injury, surgery, or illness)
• increased blood sugar levels
• potassium and calcium loss, nitrogen loss due to breakdown of body protein stores, fluid retention
• mood disorders, behavioral disorders, irritability, or restlessness, sleep problems, difficulty thinking (including disorientation and memory loss)
• dizziness of central origin, headache
• swelling of the optic nerve head (papilledema), thinning of the superficial layers of the eye, exophthalmos, blurred vision
• heart muscle rupture after a recent heart attack
• hypertrophic cardiomyopathy (heart muscle thickening) in premature infants
• hiccups
• esophageal ulceration, bloating, indigestion, thrush in the esophagus
• 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 skin inflammation, hives, excessive hair growth on the body and face in women
• steroid-induced muscle disease, bone fractures or ruptures
• irregular menstrual periods or absence of menstruation in women
• weight gain, nausea, feeling unwell, and fatigue.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Akortor

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

6. Contents of the pack and other information

What Akortor contains

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

What Akortor looks like and contents of the pack

White, smooth tablets with beveled edges, with a dividing line, approximately 7 mm in diameter, with the inscription "ORN35".
Akortor is available in blisters, in packs containing 20, 30, or 100 tablets, or in a 15 mL orange glass bottle with an aluminum cap and a desiccant, containing 100 tablets. Outer packaging: carton box.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Finland:Hydrocortisone Orion 10 mg tablets
Sweden, Denmark:Hydrokortison Orion 10 mg tablets
Iceland:Hydrokortison Orion 10 mg tablets
Poland:Akortor
Slovenia:Hidrokortizon Orion 10 mg tablets
United Kingdom (Northern Ireland):Hydrocortisone 10 mg Tablets

Date of last revision of the leaflet: 03.2025