Package leaflet: Information for the patient

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

midodrine hydrochloride
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What GUTRON is and what it is used for
What you need to know before taking GUTRON
How to take GUTRON
Possible side effects
How to store GUTRON
Contents of the pack and other information

1. What GUTRON is and what it is used for

GUTRON contains the active substance midodrine hydrochloride, which has anti-hypotensive activity (increases blood pressure).
GUTRON is used in adults for the treatment of orthostatic dysregulation (a drop in blood pressure caused by changing body position from lying down to standing) due to:

hypotensive-asthenic syndrome (low blood pressure associated with weakness);
essential hypotension (persistent low blood pressure);
orthostatic hypotension (drop in blood pressure due to change in body position from lying down to standing);
post-operative (following surgery), post-infectious (following an infection), post-partum (after childbirth) hypotensive states (low blood pressure);
climatically-induced hypotension;
hypotension resulting from treatment with psychotropic drugs (medicines used to treat mental disorders).

2. What you need to know before taking GUTRON

Do not take GUTRON

If you are allergic to the active substance (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 phaeochromocytoma (a tumor of the adrenal gland);
if you suffer from obliterative (occlusive) and spastic (caused by contraction of blood vessel muscles) vasculopathies (blood vessel disorders);
if you have severe coronary artery disease (diseases of the coronary arteries, i.e. the blood vessels supplying the heart);
if you have advanced vascular sclerosis (hardening of blood vessel walls);
if you have closed-angle glaucoma (increased internal eye pressure);
if you have prostatic hypertrophy (enlarged prostate) with urinary retention;
if you have mechanical obstructions (such as presence of stones, mineral salt deposits, in the urinary tract or urethral narrowing) impairing urinary outflow;
if you have thyrotoxicosis (excess thyroid hormones in the blood).

Warnings and precautions
Talk to your doctor or pharmacist before taking GUTRON.
If you have diabetes, you should have more frequent checks of your blood glucose levels (blood glucose concentration).
During prolonged treatment with GUTRON, periodic monitoring of renal function (kidney function) is advisable.
Should reflex bradycardia (decrease in heart rate due to increased blood pressure following medicine intake) or other symptoms of overdose (taking an excessive dose of the medicine), such as excessive rise in blood pressure, occur, they can be rapidly counteracted by administration of atropine and/or β-blockers (see "If you take more GUTRON than you should").
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
There are no data on the use of GUTRON in pediatric patients.

Other medicines and GUTRON
Inform 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 (blood pressure increase) of this product may be enhanced.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Take GUTRON during pregnancy only if absolutely necessary and under medical supervision.

Breastfeeding
There are no data on the use of GUTRON during breastfeeding.

Driving and using machines
No special precautions are required.

GUTRON 2.5 mg/ml oral drops, solution contains ethanol. This medicine contains 6 mg of alcohol (ethanol) per drop. The amount in a dose of this medicine (10–20 drops, equivalent to 60–120 mg of ethanol) corresponds 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 produce 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the dosage of GUTRON individually, depending on the individual patient's response.
It is advisable to start treatment with doses proportional to the severity of symptoms, adjusting them later according to the therapeutic response:

In mild to moderate forms of hypotension, the usual dose is 1.25–2.5 mg (10–20 drops or half to 1 tablet), taken up to three times a day.
In more severe hypotensive states and in hypotension resulting from treatment with psychotropic drugs, the usual dose is 2.5–5 mg (1–2 tablets or 1 ampoule), taken up to three times a day.

Instructions for use
Take the drops diluted in water or on a sugar lump.
The tablet may be divided (see “Description of the appearance of GUTRON and contents of the pack”).
The formulation in ampoules can be administered by intramuscular injection (injection into the muscle), or by slow intravenous injection (injection into a vein), possibly diluted in standard infusion solutions.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience (frequency not known) dizziness or vertigo (sensation of loss of balance) and tingling sensations in the head and trunk (upper part of the body).
When these phenomena occur following oral administration, they usually appear about 1 to 2 hours after intake and may last for approximately 3 to 5 hours.
Excessive doses of GUTRON may cause pilomotor reactions (goosebumps), especially on the scalp, sensation of cold, increased urge to urinate, headache, palpitations and, occasionally, reflex bradycardia (see "If you take more GUTRON than you should").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label of the pack. 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
Protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What GUTRON contains
GUTRON 2.5 mg tablets
Each 0.130 g tablet contains:
Active substance: Midodrine hydrochloride 2.5 mg
Other components: Starch, Microcrystalline cellulose, Silicon dioxide, Talc, Magnesium stearate.

GUTRON 2.5 mg/ml oral drops, solution
Each 100 ml of solution contains:
Active substance: Midodrine hydrochloride 0.25 g
Other components: Ethanol 95%, Purified water.

GUTRON 5 mg/2 ml injection solution
Each 2 ml vial contains:
Active substance: Midodrine hydrochloride 5 mg
Other components: 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 break line on one side and the mark "Gutron" on the other. Pack containing 2 transparent PVC blisters, each with 15 divisible tablets, in a cardboard carton.

GUTRON 2.5 mg/ml oral drops, solution
Oral drops, solution. Amber glass bottle containing 30 ml of clear, colourless solution, with an integrated dropper, sealed with a screw cap and sealing gasket.

GUTRON 5 mg/2 ml injection solution
Clear, colourless injection solution. Carton pack containing 6 transparent glass vials of 2 ml each.

Marketing Authorization Holder and Manufacturer
LUSOFARMACO Istituto Luso Farmaco d’Italia S.p.A. - Milanofiori – Strada 6 – Edificio L – Rozzano (MI), under licence 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 - Florence

GUTRON 5 mg/2 ml injection solution
A. Menarini Manufacturing Logistics and Services S.r.l. - Via Sette Santi, 3 - Florence

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 – Florence