Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Gutron (Гутрон), 2.5 mg, tablets
Midodrini hydrochloridum
Gutron and Гутрон are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Gutron is and what it is used for
Important information before taking Gutron
How to take Gutron
Possible side effects
How to store Gutron
Contents of the pack and other information

1. What Gutron is and what it is used for

Gutron raises low blood pressure by constricting small veins and arteries and prevents excessive pooling of blood in the lower limbs. Low blood pressure and pooling of blood in the lower limbs may cause dizziness and cerebral hypoperfusion.
It is indicated for the treatment of severe orthostatic hypotension (a drop in blood pressure upon standing, leading to dizziness or fainting) caused by dysfunction of the autonomic nervous system, when causal treatment is not possible.

2. Important information before taking Gutron

When not to take Gutron:

if the patient is allergic to midodrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
if the patient has:
- severe organic heart and circulatory disorders, hypertension, cardiac arrhythmias;
- severe obstructive or spastic vascular diseases (e.g. cerebral vessel occlusion and spasms);
- acute nephritis, severe renal insufficiency, enlarged prostate gland with prolonged urinary retention, mechanical impairment of urination, urinary retention;
- proliferative diabetic retinopathy (diabetic eye retinal disorders);
- adrenal gland chromaffin cell tumor ( phaeochromocytoma );
- hyperthyroidism;
- narrow-angle glaucoma;
during pregnancy or breastfeeding.

Warnings and precautions
Before starting treatment with Gutron, discuss it with a doctor or pharmacist.
Special caution is required when using Gutron:

if the patient suffers from other diseases [particularly right ventricular hypertrophy due to lung disease, intraocular hypertension (increased pressure within the eye), impaired liver or kidney function];
in case of allergies;
when taking other medicines concurrently, especially those containing vasoconstrictive substances (see section "Gutron and other medicines");
during pregnancy and breastfeeding.

All the above-mentioned conditions should be reported to the doctor. The doctor may recommend additional tests to avoid adverse effects.
During treatment, arterial blood pressure should be monitored regularly in the lying, sitting, and standing positions.
At the beginning of treatment, the doctor will assess the risk of developing hypertension in the lying or sitting position.
Be alert for symptoms indicating hypertension (palpitations, headache, dizziness, visual disturbances) or bradycardia (e.g. slow pulse, severe dizziness, loss of consciousness). In such cases, treatment must be stopped immediately and medical advice sought.
Continuation of midodrine treatment is recommended only if initial therapy has proven effective.
If significant changes/fluctuations in blood pressure occur, treatment with the medicine should be discontinued.

Gutron and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Concurrent use of Gutron with certain medicines, such as perphenazine (an antipsychotic also used in anxiety disorders), amiodarone (used in cardiac arrhythmias), or metoclopramide (an antiemetic) may enhance their effects.
Interactions may occur with sympathomimetics (components of eye or nasal drops – phenylephrine, oxymetazoline, pseudoephedrine) and other agents containing vasoconstrictive substances (e.g. reserpine, guanethidine, antidepressants, antihistamines, thyroid hormones), other drugs used for heart conditions and circulatory diseases (alpha-adrenergic receptor blockers – e.g. phentolamine, prazosin, dihydroergotamine; beta-adrenergic receptor blockers – e.g. propranolol, metoprolol, atenolol, timolol), digoxin, MAO inhibitors, medicines containing atropine, or products containing cortisone (tablets, injections).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Gutron should not be taken during pregnancy or breastfeeding.
If a patient becomes pregnant during treatment, she should inform her doctor immediately.

Driving and operating machinery
Caution: this medicine may affect reaction speed and ability to drive or operate machinery.
Studies on the effect of midodrine on reaction speed and driving ability have not been conducted. When driving vehicles or operating machinery, bear in mind that anxiety, restlessness, and irritability may occasionally occur.

3. How to take Gutron

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Adults and adolescents (over 12 years of age):
Initially, 1 to 2 times half a tablet per day. If the therapeutic effect is insufficient, the dose may be
increased to 2–3 times one tablet per day.
Dosing in patients with hypotension during treatment with psychotropic agents:
2 times one tablet per day. If the therapeutic effect is insufficient, the dose may be increased
to 2–3 times two tablets per day.
The maximum daily dose is 30 mg.
Gutron should be taken during the day, when the patient is in an upright position and engaged in
daily activities.
The medicine should be taken at intervals of at least 3 to 4 hours.
The first dose should be taken shortly after waking up in the morning, the second at lunchtime, and, if necessary, the third in the late afternoon.
To minimize the risk of excessive increase in supine arterial hypertension,
Gutron should not be taken after dinner or later than 4 hours before going to bed.
Children under 12 years of age:
No data available.
Elderly patients:
No data available.
Patients with hepatic or renal impairment:
No data available.
Gutron must not be used in patients with acute nephritis and/or severe renal insufficiency (see section "When not to take Gutron").
The duration of treatment is determined by the physician.
Tablets should be taken orally with liquid. Gutron may be taken with food.
Taking more Gutron than recommended
In case of overdose, the adverse reactions listed in section 4 may occur in an intensified form, particularly: arterial hypertension, goosebumps, chills, bradycardia, and urinary retention. Immediately inform your doctor if any of these occur.
Missing a dose of Gutron
Do not take a double dose to make up for a missed tablet.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Gutron:
Very common (affects more than 1 in 10 patients):

goosebumps;
painful urination.

Common (affects more than 1 in 100 patients):

supine hypertension (with doses above 30 mg per day);
itching, chills, hot flushes, rash;
nausea, heartburn, inflammation of the oral mucosa;
sensory disturbances (tingling);
urinary retention.

Uncommon (affects more than 1 in 1,000 patients):

sleep disturbances, insomnia;
slowed heart rate (bradycardia), palpitations;
sudden urge to urinate;
headache, anxiety, restlessness, irritability.

Rare (affects more than 1 in 10,000 patients):

increased heart rate (tachycardia), cardiac arrhythmias;
liver function disorders, increased liver enzyme activity.

Frequency not known (cannot be estimated from available data):

anxiety, confusion;
abdominal pain, vomiting, diarrhoea.

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

5. How to store Gutron

Store below 25°C.
Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater 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 Gutron contains

The active substance is midodrine hydrochloride.
The other ingredients are: magnesium stearate, talc, colloidal anhydrous silica, microcrystalline cellulose, corn starch.

What Gutron looks like and contents of the pack
Gutron is a white, round tablet with the letters "GU" imprinted above and the dose "2.5" below the break line.
The pack contains 20 tablets in two blisters made of PVC/PVDC/Al foil.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Bulgaria, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald, Germany
Manufacturer:
Takeda Austria GmbH
St.-Peter-Strasse 25
A-4020 Linz, Austria
Takeda Pharma A/S
Langebjerg 1
DK-4000 Roskilde, Denmark
Takeda GmbH
Plant Oranienburg
Lehnitzstr. 70-98, DE-16515 Oranienburg, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Bulgaria, country of export, marketing authorisation number: 20020886
Parallel import authorisation number: 8/23