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 the entire leaflet carefully 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, 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 reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 increases 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 or cardiovascular disorders, hypertension, cardiac arrhythmias;
  • severe obstructive or spastic vascular diseases (e.g. cerebral vessel stenosis and spasms);
  • acute nephritis, severe renal insufficiency, benign prostatic hyperplasia 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, consult a 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, 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.

Inform the 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 supine or sitting hypertension.
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, discontinue treatment immediately and contact a doctor.
Continuation of midodrine treatment is recommended only if initial therapy has proven effective.
If significant changes/fluctuations in blood pressure occur, discontinue the use of the medicine.

Gutron and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Concurrent 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 and cardiovascular 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 is planning to become pregnant, she should consult a doctor before using this medicine.
Do not take Gutron during pregnancy or while 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 or operate machinery.
Studies on the effect of midodrine on reaction speed and driving ability have not been conducted. When driving a vehicle 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 effect is insufficient, the dose may be
increased to 2–3 times one tablet per day.
Dosing in patients with hypotension during therapy 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 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. Medical advice should be sought immediately.
If you forget to take Gutron
Do not take a double dose to make up for a missed tablet.
If you have any further doubts concerning 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 patients):

• goosebumps;
• painful urination.

Common (affects more than 1 in 100 patients):

• hypertension in the supine position (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;
• slow 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department for Monitoring 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
Reporting adverse effects 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 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 packaging and other information

What Gutron contains

• The active substance is midodrine hydrochloride. Each tablet contains 2.5 mg of midodrine hydrochloride.
• The other ingredients are: magnesium stearate, talc, colloidal anhydrous silica, microcrystalline cellulose PH 101, maize starch.

What Gutron looks like and contents of the pack
Gutron is a white, round tablet embossed with the letters "GU" above and the dose strength "2.5" below the breakline.
The pack contains 20 tablets in two PVC-PVDC/Al blisters.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Romania, country of export:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer:
Takeda GmbH
Lehnitzstrasse 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
Marketing Authorisation numbers in Romania, country of export: 7023/2014/01
7023/2014/02
7023/2014/03
Parallel Import Licence number: 28/18