Gutron

Patient Information Leaflet

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 increases low blood pressure by constricting small veins and arteries and prevents the pooling 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, 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, consult a doctor or pharmacist.
Exercise particular caution when using Gutron:

• if the patient suffers from other diseases [especially right ventricular enlargement due to lung disease, increased intraocular pressure, 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, blood pressure should be monitored regularly in the supine, sitting, and standing positions.
At the beginning of treatment, the doctor will assess the risk of developing hypertension in the supine 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 should be discontinued.

Gutron and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the patient plans 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. 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 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, products containing cortisone (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 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 operate 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 (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.

Dosage 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 doses 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 available data.

Elderly patients:
No available data.

Patients with hepatic or renal function disorders:
No available data.

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 doctor.

The 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 a doctor in such cases.

If you forget to take Gutron
Do not take a double dose to make up for the 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 may cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with Gutron:

Very common (more frequent than in 1 out of 10 patients):

• goosebumps;
• painful urination.

Common (more frequent than in 1 to 10 out of 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 (more frequent than in 1 to 10 out of 1,000 patients):

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

Rare (more frequent than in 1 to 10 out of 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 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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Gutron

Store below 25°C.
Keep in the original packaging to protect from light.
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 the sewage system 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 packaging 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" imprinted above and the dose strength "2.5" below the break line.
The pack contains 20 tablets in two blisters made of PVC/PVDC/Aluminum foil, packed in a cardboard box.
For further information about the medicinal product, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorization Number in Bulgaria, country of export: 20020886
Parallel Import Authorization Number: 156/24