Patient Information Leaflet: Instructions for Use

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Gutron, 2.5 mg, tablets
Midodrini hydrochloridum
Please read this leaflet carefully before taking the 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 another person, even if their symptoms are identical.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents:

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 package and other information

1. WHAT GUTRON IS AND WHAT IT IS USED FOR

Gutron increases low blood pressure by constricting small veins and arteries and prevents the pooling 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 disorders of autonomic nervous system function, 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, enlarged prostate gland with prolonged urinary retention, mechanical impairment of urination, urinary retention;
- proliferative diabetic retinopathy (retinal disorders due to diabetes);
- 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 special caution 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), 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, intensified 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 should be discontinued.

Gutron and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for use.
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 in 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 might 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 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 exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Adults and adolescents (aged over 12 years)
Initially, half a tablet once or twice daily. If the effect is insufficient, the dose may be increased
to one tablet two or three times daily.
Dosage in patients with hypotension during treatment with psychotropic agents: one tablet twice daily.
If the effect is insufficient, the dose may be increased to two tablets two or three times daily.
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
normal 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 impaired liver or kidney function
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 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 in such cases.
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 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 of 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 helps to provide more information on the safety of this medicine.

5. HOW TO STORE GUTRON

Store below 25°C 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 container.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such practices help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Gutron contains

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

What Gutron looks like and contents of the pack
Gutron is a white, round tablet with the letters "GU" engraved above and the strength "2.5" below the break line.
The pack contains 20 tablets in two blisters of 10 tablets each.
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:
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 authorization numbers in Romania, country of export: 7023/2014/01
7023/2014/02
7023/2014/03
Parallel import authorization number: 696/15