GUTRON 2.5 MG Coated tablet

Зміст інструкції

1. GUTRON 2.5 mg tablets, 2.5 mg/ml oral drops, solution, 5 mg/2 ml injectable solution
   1. What is GUTRON and what is it used for
   2. What you need to know 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

GUTRON 2.5 mg tablets, 2.5 mg/ml oral drops, solution, 5 mg/2 ml injectable solution

midodrine hydrochloride

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What GUTRON is and what it is used for
• 2. What you need to know before you take 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 is GUTRON and what is it used for

GUTRON contains the active ingredient midodrine hydrochloride which has antihypertensive activity (increases blood
pressure).
GUTRON is used in adults for the treatment of orthostatic dysregulation (lowering of blood
pressure caused by a change in body position from lying down to standing) resulting from:

• hypotensive-asthenic syndrome (lowering of blood pressure associated with lack of strength);
• essential hypotension (constant lowering of blood pressure);
• orthostatic hypotension (decrease in blood pressure due to a change in body position from lying down to standing);
• hypotensive (lowering of blood pressure) states post-operative (following surgery), post-infectious (following an infection), post-partum (after childbirth);
• climatic-based hypotension;
• hypotension resulting from treatment with psychotropic drugs (medicines used to treat mental illnesses).

2. What you need to know before taking GUTRON

Do not take GUTRON

• If you are allergic to the active ingredient (midodrine hydrochloride) or to any of the other ingredients of this medicine (listed in section 6);
• if you have arterial hypertension (high blood pressure);
• if you have pheochromocytoma (adrenal gland tumor);
• if you suffer from vasculopathies (diseases of the blood vessels) of an obliterating (occlusive) and spastic nature (caused by the contraction of the blood vessel muscles);
• if you have severe coronary artery disease (diseases of the coronary arteries, i.e., the blood vessels that carry blood to the heart);
• if you have advanced vascular sclerosis (hardening of the arteries);
• if you suffer from closed-angle glaucoma (increased internal pressure of the eye);
• if you have prostatic hypertrophy (enlargement of the prostate) with urinary retention;
• if you have mechanical obstructions (such as the presence of stones, mineral salt aggregations) in the urinary tract or narrowing of the urethra) to urinary outflow;
• if you have thyrotoxicosis (presence of an excess of thyroid hormones in the blood).

Warnings and precautions
Talk to your doctor or pharmacist before taking GUTRON.
If you have diabetes, you should undergo more frequent checks of your blood glucose levels (glucose concentration
in the blood).
During prolonged treatment with GUTRON, periodic monitoring of
renal function (kidneys) is recommended.
The possible occurrence of reflex bradycardia (decreased heart rate resulting
from increased blood pressure following administration of the medicine) and other symptoms of
overdosage (taking an excessive dose of the medicine), such as an excessive increase in blood
pressure, can be rapidly countered by the administration of atropine and/or beta-
blockers (see “If you take more GUTRON than you should”).
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
There is no data on the use of GUTRON in pediatric age.

Other medicines and GUTRON
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Do not take monoamine oxidase inhibitors (MAOIs, antidepressant drugs) during
treatment with GUTRON, as the vasopressor effect (increased blood pressure) of the product may be
increased.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, take GUTRON only in conditions of absolute and ascertained necessity.
Breastfeeding
There is no data on the use of GUTRON during breastfeeding.

Driving and operating machinery
No particular precautions need to be taken.

GUTRON 2.5 mg/ml oral drops, solution contains ethanol.This medicine contains 6 mg of alcohol
(ethanol) in each drop. The amount per dose of this medicine (10-20 drops, equivalent to 60-120 mg of ethanol)
is equivalent to 1.5-3 ml of beer or 0.6-1.2 ml of wine.
The small amount of alcohol in this medicine will not have any significant effects.

GUTRON 5 mg/2 ml injectable solution contains sodium.This medicine contains less than 1 mmol
(23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

GUTRON 5 mg/2 ml injectable solution contains propylene glycol.This medicine contains 415 mg
of propylene glycol per vial, equivalent to 207.5 mg/ml.

3. How to take GUTRON

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will establish the dosage of GUTRON individually in relation to the different response of each
patient.
It is advisable to start treatment with dosages proportional to the extent (severity) of the symptoms,
modifying them subsequently based on the therapeutic response:

• in cases of mild to moderate hypotension, the average dose is 1.25-2.5 mg (10-20 drops or half-1 tablet) to be taken up to three times a day.
• in more severe hypotensive states and in hypotension following treatment with psychotropic drugs, the average dose is 2.5-5 mg (1-2 tablets or 1 vial) to be taken up to three times a day.

Method of administration
Take the drops diluted in water or on a sugar lump.
The tablet can be divided (see “Description of the appearance of GUTRON and contents of the
pack”).
The vial formulation can be administered intramuscularly (injection into the muscle),
intravenously (injection into a vein) slowly, possibly diluted in the usual infusion solutions.

If you take more GUTRON than you should
Following the intake of an excessive dose of the medicine, reflex bradycardia and other
overdose symptoms may occur, such as an excessive increase in blood pressure, pilomotor reactions (goose
bumps) especially on the scalp, sensations of cold, increased urge to urinate (expulsion of
urine), headache, palpitations (excessive increase in heart rate).
These symptoms can be quickly counteracted by administering atropine and/or alpha-blocking
drugs (drugs that increase heart rate and reduce blood pressure).

If you forget to take GUTRON
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These may occur in some patients (with frequency not known): a feeling of dizziness (lightheadedness) or
vertigo (sensation of loss of balance) and tingling in the head and trunk (upper body).
The possible onset of these phenomena, with oral administration, occurs approximately 1 or 2 hours
after taking the medicine and may persist for approximately 3-5 hours.
Excessive doses of GUTRON can cause pilomotor reactions (goosebumps), especially on the scalp,
a sensation of cold, increased urge to urinate, headache, palpitations and, sometimes,
reflex bradycardia (see “If you take more GUTRON than you should”).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store GUTRON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label on the packaging. The expiry date
refers to the last day of that month.
GUTRON 2.5 mg tablets
Store in a dry place and protected from light.
GUTRON 2.5 mg/ml oral drops, solution and GUTRON 5 mg/2 ml injectable solution
Store protected from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GUTRON contains
GUTRON 2.5 mg tablets
Each 0.130 g tablet contains:

Active ingredient:Midodrine hydrochloride 2.5 mg

Other ingredients:Starch, Microcrystalline cellulose, Silicon dioxide, Talc, Magnesium stearate.
GUTRON 2.5 mg/ml oral drops, solution
Each 100 ml of solution contains:

Active ingredient:Midodrine hydrochloride 0.25 g

Other ingredients:95% Ethyl alcohol, Purified water.
GUTRON 5 mg/2 ml injectable solution
Each 2 ml vial contains:

Active ingredient:Midodrine hydrochloride 5 mg

Other ingredients: Sodium chloride, Propylene glycol, Water for injections.

Description of the appearance of GUTRON and contents of the pack
GUTRON 2.5 mg tablets
White, round tablets, with a fracture line on one side and Gutron marking on the other. 2 transparent PVC blisters each containing 15 divisible tablets in a cardboard box.
GUTRON 2.5 mg/ml oral drops, solution
Oral drops, solution. Amber glass bottle containing 30 ml of clear and colorless solution with
integrated dropper and sealed with a screw cap fitted with a sealing gasket
GUTRON 5 mg/2 ml injectable solution
Clear and colorless injectable solution. Pack containing 6 transparent glass vials of 2 ml each.

Marketing authorisation holder and manufacturer
LUSOFARMACO Istituto Luso Farmaco d’Italia S.p.A. - Milanofiori – Strada 6 – Edificio L – Rozzano
(MI) under license from Takeda Austria GmbH

Manufacturer
GUTRON 2.5 mg tablets

• A. Menarini Manufacturing Logistics and Services S.r.l. - Località Campo di Pile - L'Aquila Laboratorios Menarini S.A. - C/Alfonso XII, 587 - 08918 Badalona (Barcelona) – Spain
• A. Menarini Manufacturing Logistics and Services S.r.l. - Via Sette Santi, 3 - Firenze GUTRON 5 mg/2 ml injectable solution
• A. Menarini Manufacturing Logistics and Services S.r.l. - Via Sette Santi, 3 - Firenze

GUTRON 2.5 mg/ml oral drops, solution
Berlin-Chemie AG - Glienicker Weg 125 - Berlin (Germany)

• A. Menarini Manufacturing Logistics and Services S.r.l. - Via Sette Santi, 3 – Firenze