Polcortolon

Package Leaflet: Information for the Patient

Polcortolon, 4 mg, Tablets

(Triamcinolone)

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any further questions, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others.
• The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

Polcortolon belongs to a group of medications called steroids (full name: glucocorticosteroids).
Polcortolon has a strong anti-inflammatory effect. It contains a synthetic (artificial) adrenal cortex hormone.

Polcortolon is indicated for use in the treatment of:

• hormonal disorders (e.g., primary adrenal insufficiency, adrenogenital syndrome);
• rheumatic diseases;
• collagenoses (connective tissue diseases);
• skin diseases (e.g., psoriasis, severe eczema, pemphigus);
• severe allergic diseases that do not respond to other treatments;
• eye diseases (e.g., conjunctivitis, keratitis, uveitis, and scleritis);
• respiratory diseases (e.g., sarcoidosis, pulmonary tuberculosis);
• hematopoietic diseases;
• cancer (as symptomatic treatment);
• gastrointestinal diseases (ulcerative colitis, Crohn's disease);
• multiple sclerosis.

2. Important information before taking Polcortolon

When not to take Polcortolon

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of Polcortolon (see section 6);
• if the patient has fungal infections;
• if the patient is to be vaccinated, especially with live virus vaccines.

Warnings and precautions

The following situations require special caution when taking Polcortolon:

• severe course of some infectious diseases, such as chickenpox, shingles, and measles. In case of infection, the doctor will recommend appropriate action. Patients who have not had these diseases before should avoid exposure to infection;
• reduced immunity to infection. The medication may mask (hide) symptoms of infection.

Before taking Polcortolon, the patient should inform their doctor if they have:

• stomach or duodenal ulcers;
• intestinal diseases (e.g., fresh intestinal anastomoses, diverticulitis, colitis),
• thrombophlebitis;
• renal failure;
• osteoporosis (especially in postmenopausal women);
• excessive muscle weakness and fatigue (myasthenia);
• fungal or viral infections;
• glaucoma;
• increased cholesterol and triglyceride levels;
• decreased protein levels in the blood;
• high blood pressure;
• congestive heart failure;
• epilepsy,
• impaired liver function, liver cirrhosis;
• ocular herpes;
• acute psychosis and mental disorders. The medication may exacerbate symptoms of these diseases;
• tuberculosis;
• hypothyroidism;
• diabetes;
• blood coagulation factor deficiency (prothrombin) and concurrent aspirin use.

Polcortolon may reveal strongyloidiasis (a gastrointestinal disease caused by a parasite - strongyloides).

Polcortolon and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Some medications may enhance the effect of Polcortolon, and the doctor may want to closely monitor the patient's condition when taking such medications (including some HIV medications: ritonavir, cobicistat).
The patient should inform their doctor if they are taking any of the following medications:

• insulin and oral antidiabetic medications;
• diuretics;
• coumarin derivatives, indandione, heparin (anticoagulant medications);
• streptokinase, urokinase (thrombolytic medications);
• nonsteroidal anti-inflammatory medications (NSAIDs), e.g., ibuprofen;
• anabolic steroids, androgens (medications used to treat hormonal disorders);
• oral contraceptives containing estrogens;
• vaccines (Polcortolon reduces the effectiveness of vaccines);
• amphotericin B (an antifungal medication);
• carbonic anhydrase inhibitors (medications used to treat glaucoma);
• cholinolytic medications (mainly atropine);
• tricyclic antidepressant medications (medications used to treat depression);
• medications used to treat hyperthyroidism and thyroid hormones;
• cardiac glycosides (e.g., digitalis glycosides used to treat heart failure);
• isoniazid (a medication used to treat tuberculosis);
• mexiletine (a medication used to treat heart rhythm disorders);
• folic acid (Polcortolon increases the body's demand for this medication).

Polcortolon with food, drink, or alcohol

Polcortolon can be taken with or without food.
The medication increases sodium retention in the body, which may cause edema and increased blood pressure. Therefore, salt intake should be limited.
During treatment, the patient should not drink alcohol, as there is a risk of gastrointestinal bleeding.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medication.
Pregnancy
Polcortolon should not be used in pregnant women.
Breastfeeding
Polcortolon should not be used during breastfeeding. Small amounts of the medication pass into breast milk.

Driving and operating machinery

Polcortolon may cause headaches, dizziness, and even mental disturbances. If such symptoms occur, the patient should not drive vehicles, operate machinery, or perform other activities that require concentration.

Polcortolon contains lactose

One tablet contains 200 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor or pharmacist before taking the medication.

3. How to take Polcortolon

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dose of Polcortolon and the duration of treatment are determined by the doctor.
Usually, it is recommended to take the medication once a day, in the morning.

Adults:

Typically used dose:
from 4 mg to 48 mg per day.
Sometimes higher doses may be necessary.

Use in children

The doctor determines the dosage individually. The dose size depends on the type of disease and the child's body weight.
The patient should attend regular medical check-ups. Polcortolon may cause growth and development disorders in infants and children (especially if the medication is used for a long time).

Taking a higher dose of Polcortolon than recommended

In case of taking a higher dose than recommended, the patient should stop taking the medication and immediately consult their doctor.
Overdose symptoms may occur, such as increased blood pressure and edema.

Missing a dose of Polcortolon

In case of missing a dose, the patient should take the medication as soon as possible. If it is close to the time of the next dose, the missed dose should be skipped.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Polcortolon

The decision to stop treatment with Polcortolon is made by the doctor.
The following symptoms of glucocorticosteroid withdrawal syndrome may occur:
fever, muscle and joint pain, malaise.
In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Polcortolon can cause side effects, although not everybody gets them.
The patient should immediately contact their doctorif they experience any of the following symptoms:
Unknown (frequency cannot be estimated from the available data):

• severe allergic reaction (rash, itching, swelling of the face, lips, tongue, difficulty breathing), chest tightness;
• persistent nausea or vomiting, vomiting with blood, black stools or stools with fresh blood;
• menstrual disorders;
• seizures;
• rapid and irregular heartbeat;
• prolonged sore throat, cold, and fever;
• psychotic symptoms;
• swelling of the feet or legs;
• bruises or bleeding;
• weight gain;
• vision disturbances;
• mental disorders (unnatural excessive joy, deep sadness, personality disorders).

Other side effects:

Unknown (frequency cannot be estimated from the available data):

• congestive heart failure;
• increased blood pressure;
• muscle weakness, osteoporosis, increased risk of bone fractures, aseptic necrosis of the femoral and humeral heads;
• increased appetite, weight gain, nausea, abdominal pain, bloating, heartburn;
• stomach ulcers, gastrointestinal bleeding, pancreatitis;
• impaired wound healing, excessive hair growth, acne, wide purple streaks on the skin; skin thinning;
• edema, redness of the skin on the leg, pain worsening when walking, increased skin temperature (thrombophlebitis);
• insomnia, dizziness, and headaches;
• Cushing's syndrome - characteristic appearance: moon face, rounded torso, thin limbs;
• growth retardation in children;
• increased blood sugar levels (diabetes);
• increased risk of blood clots;
• increased calcium excretion;
• blurred vision

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 or its representative.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Polcortolon

The medication should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Do not use the medication after the expiration date stated on the label and carton after: "Expiration Date". The expiration date refers to the last day of the given month.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Polcortolon contains

The active substance of the medication is triamcinolone.
One tablet contains 4 mg of triamcinolone.
The other ingredients are: potato starch, magnesium stearate, lactose monohydrate.

What Polcortolon looks like and what the pack contains

Tablets are white or almost white, round, flat on both sides, with the inscription "o" on one side and "
" on the other side.
The packaging contains 20 tablets.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Date of the last update of the leaflet:04.2023