Gutron

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 carefully the entire leaflet before taking this 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Gutron is and what it is used for
2. Important information before taking Gutron
3. How to take Gutron
4. Possible side effects
5. How to store Gutron
6. 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
accumulation of excessive 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, hypertension, cardiac arrhythmias;
• severe obstructive or spastic vascular diseases (e.g. cerebral vessel obstruction 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);
• adrenal medulla chromaffin cell tumour (phaeochromocytoma);
• hyperthyroidism;
• narrow-angle glaucoma;
• during pregnancy or breastfeeding.

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

• if the patient suffers from other diseases [especially right ventricular enlargement due to lung disease, intraocular hypertension (increased pressure inside the eye), liver and kidney function disorders];
• in case of allergies;
• when taking other medicines simultaneously, 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 lying, sitting, and standing positions.
At the beginning of treatment, the doctor will assess the risk of developing hypertension in lying or sitting position.
Be alert for symptoms indicating hypertension (palpitations, headache, dizziness, visual disturbances) or bradycardia (e.g. slow pulse, intensified dizziness, loss of consciousness).
In such cases, treatment must be stopped immediately and the doctor contacted.
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 taken or recently used, as well as any medicines the patient intends to use.
Concomitant use of Gutron with certain medicines, e.g. perphenazine (an antipsychotic, also used in anxiety disorders), amiodarone (used in cardiac arrhythmias), metoclopramide (anti-nausea and antiemetic medicine), may enhance their effects.
Interactions may occur with sympathomimetics (e.g. 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 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 might be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
Gutron should not be taken during pregnancy or breastfeeding.
If the patient becomes pregnant during treatment, she should inform the doctor immediately.

Driving and operating machinery
Caution: this medicine may affect reaction speed and ability to drive vehicles.
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 anxiety, restlessness, and irritability may occasionally occur.

3. How to take Gutron

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Adults and adolescents (aged over 12 years):
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.
Dosage in patients with hypotension undergoing 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
optionally a 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 available data.
Elderly patients:
No available data.
Patients with impaired liver or kidney function:
No available data.
Gutron must not be used in patients with acute kidney inflammation and/or severe renal
insufficiency (see section "When not to take Gutron").
The duration of treatment is determined by the doctor.
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 a 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 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 will experience them.
The following adverse effects 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 disturbances, 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 effects
If any adverse effects occur, including any adverse effects 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Gutron

Store below 25°C in the original packaging.
Keep the medicine out of 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 you no longer 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, anhydrous colloidal silicon dioxide, microcrystalline cellulose PH 101, corn starch.

What Gutron looks like and contents of the pack
Gutron is a white, round tablet, with the letters "GU" engraved above and the dosage strength "2.5" below a break line.
The pack contains 20 tablets in two PVC/PVDC/Al blisters.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Romania, country of export:
Cheplapharm Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Takeda GmbH
Plant Oranienburg, Lehnitzstrasse 70-98
DE-16515 Oranienburg
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorization numbers in Romania, country of export: 7023/2014/02
7023/2014/01
7023/2014/03
Parallel import authorization number: 316/22