Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Gutron, 2.5 mg, tablets
Midodrine hydrochloride
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What is Gutron and what is it 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 is Gutron and what is it used for

Gutron raises low blood pressure by constricting small veins and arteries and prevents
accumulation of a larger volume of blood in the lower limbs. Low blood pressure and pooling
of blood in the lower limbs may cause dizziness and cerebral hypoperfusion.
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, arterial hypertension, cardiac arrhythmias;
severe obstructive or spastic vascular diseases (e.g. cerebral vessel occlusion and spasms);
acute nephritis, severe renal insufficiency, prostate enlargement with prolonged urinary retention, mechanical impairment of urination, urinary retention;
proliferative diabetic retinopathy (diabetic eye retinal disorders);
pheochromocytoma;
hyperthyroidism;
narrow-angle glaucoma;
during pregnancy or breastfeeding.

Warnings and precautions
Before starting treatment with Gutron, discuss this with your doctor or pharmacist.
Exercise particular caution when using Gutron:

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

Inform your doctor about all the conditions listed above. 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.
Pay attention to 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, the use of the medicine should be discontinued.

Gutron and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Concomitant use of Gutron with certain medicines, e.g. perphenazine (an antipsychotic also used in anxiety disorders), amiodarone (used in cardiac arrhythmias), metoclopramide (an antiemetic), may enhance their effects.
Interactions may occur with sympathomimetics (e.g. ingredients of eye or nasal drops – phenylephrine, oxymetazoline, pseudoephedrine) and other agents containing vasoconstrictive substances (e.g. reserpine, guanethidine, antidepressants, antihistamines, thyroid hormones), other medicines 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, cortisone-containing products (tablets, injections).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Gutron must 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 the ability to drive or operate machinery.
No studies have been conducted on the effect of midodrine on reaction speed and driving ability. When driving or operating machinery, bear in mind that restlessness, agitation, 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 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 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 less 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 failure (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 prescribed
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 this occurs.
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 people):

goosebumps;
painful urination.

Common (affects more than 1 in 100 people):

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 people):

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

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

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 or pharmacist. 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 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Gutron

Store below 25°C. Keep in the original packaging to protect from light.
The medicine should be stored in a place inaccessible and out of sight 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 required. 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" embossed above and the dose strength "2.5" below the break line.
The pack contains 20 tablets in two PVC/PVDC/Al blisters.
For further detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Hungary, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Takeda GmbH
Lehnitzstr. 70-98
DE-16515 Oranienburg
Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Hungary, country of export: OGYI-T-4239/02
Parallel Import Licence Number: 157/24