Package Insert: Information for the User

Gutron 5mg Tablets

midodrine hydrochloride

Read this entire package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

1. What is Gutron and for what it is used

2. What you need to know before starting to take Gutron

3. How to take Gutron

4. Possible adverse effects

5. Conservation of Gutron

6. Contents of the package and additional information

Gutron is a cardiac stimulant that contains the active ingredient midodrine hydrochloride.

Gutron is a medication used for the severe treatment of low blood pressure when other treatments have not been satisfactory.

Do not take Gutron:

•if you are allergic to midodrine hydrochloride or any of the other components of this medication (listed in section 6).

•if you have high blood pressure

•if you have a slow pulse

•if you have difficulty urinating

•if you have any type of heart or vascular disease

•if you have high eye pressure (glaucoma) and vision problems due to diabetes

•if you have hyperactivity of the thyroid gland

•if you have hormonal disorders due to an adrenal gland tumor (pheochromocytoma)

•if you have severe kidney failure

•if you have an enlarged prostate gland

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gutron:

•if you have high blood pressure when lying down, then your blood pressure will be controlled when standing and sitting due to the risk of high blood pressure when lying down, for example at night.

If you have high blood pressure when lying down and it does not change when reducing the dose, then the treatment with Gutron must be discontinued.

This is important when taking Gutron.

Avoid taking Gutron at night. The risk of blood pressure increase is also reduced if you sleep with your head elevated.

Patients should be monitored due to possible hypotensive side effects.

•if you have a severe alteration of the autonomic nervous system, as Gutron may lead to a further decrease in blood pressure when standing. If this is the case, the treatment with midodrine should be stopped.

•if you have alterations of the circulatory system in the arteries.

•if you have prostate problems due to the fact that it may cause difficulty urinating.

It is recommended that your renal function and blood pressure be controlled before starting treatment with Gutron. During treatment with Gutron, your doctor should monitor your blood pressure from time to time to adjust your dose if necessary.

It is essential that you immediately report symptoms related to high blood pressure, such as: rapid heart rate, headache, and blurred vision. Your doctor will decide whether to adjust your dose or discontinue treatment with Gutron.

Consult your doctor if any of the circumstances described above have occurred at any time.

Children

Gutron should not be used in children due to the limited information available on the use of midodrine hydrochloride in this population.

Taking Gutron with other medications

•Midodrine may affect how some medications work. Among them are, perphenazine (for the treatment of psychosis (altered sense of reality), manic episodes (extremely elevated mood)), amiodarone (for the treatment of irregular heart rhythm), metoclopramide (for the treatment of nausea and vomiting). Taking Midodrine with these medications may increase their respective effects.

•Treatment with sympathomimetics (substances with a stimulating effect on certain parts of the nervous system) and other vasoconstrictors (agents that cause narrowing of blood vessels) such as reserpine, guanetidine, tricyclic antidepressants (substances for depression), antihistamines (substances for hypersensitivity reactions), thyroid hormones, and MAO inhibitors (which inhibit the monoamine oxidase enzyme that breaks down neurotransmitters, thereby increasing the level of neurotransmitters and reducing depression) should be avoided due to the risk of increased blood pressure.

•As with other medications of the same class, the effect of midodrine is nullified by medications such as prazosin and fentolamine (medication for heart disease)

•It is not recommended to use simultaneously with digitalis preparations (medications used for heart disease) due to the risk of alterations in cardiac function.

•Midodrine may increase the hypertensive effect of fluorocortisone acetate (corticosteroid anti-inflammatory).

•If midodrine is combined with other medications, they may directly or indirectly reduce heart rate, it is recommended to monitor by your doctor.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Gutron is not recommended during pregnancy.

You should not take Gutron during lactation.

Driving and operating machines

The effect of Gutron is insignificant, however, in case of dizziness or mild drowsiness, you should exercise caution when driving vehicles or operating machinery.

Gutron contains the yellow-orange colorant S

It may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The initial dose is 2.5 mg three times a day. (Gutron can be divided into equal doses of 2.5 mg). This dose can be increased weekly up to 10 mg three times a day, which is the normal maintenance dose of 30 mg per day.

The total recommended daily dose should be administered in three separate daily doses.

No information is available on the use in children, in elderly patients, in patients with renal insufficiency, and in patients with altered liver function.

Take the tablets with a small amount of water. The medication can be taken with food.

The tablet can be divided into equal doses.

Avoid nighttime administration. The last dose should be taken 4 hours before bedtime. Elevating the head at night reduces the risk of blood pressure increase. See more information in this prospectus in the "Warnings and precautions" section.

Your doctor will indicate the duration of treatment with Gutron. Treatment is usually long-term. If you have any impression that the effect of Gutron is very strong or very weak, talk to your doctor or pharmacist.

If you take more Gutron than you should

If you have taken too much Gutron, contact your doctor or pharmacist.

Excessive intake can cause:

• high blood pressure

• slow heart rate (bradycardia)

• difficulty urinating

• goosebumps

• feeling cold

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Gutron

Do not take a double dose of Gutron to compensate for the missed individual dose due to the risk of high blood pressure when lying down.

Avoid nighttime administration.

If you interrupt treatment with Gutron

No sudden drop in blood pressure will occur.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very common (may affect more than 1 in 10 people):

Goosebumps, itching on the head, and pain while urinating.

Common (may affect up to 1 in 10 people):

Tickling and itching, increased blood pressure while lying down, headache, nausea, heartburn, inflammation of the mucous membrane of the mouth, flushing, skin rash, chills, difficulty urinating.

Uncommon (may affect up to 1 in 100 people)

Sleep disorders, including difficulty sleeping, excitability, agitation, and irritability, slow heart rate, urinary urgency.

Rare (may affect up to 1 in 1,000 people)

Palpitations, rapid heart rate, altered liver function, including elevated liver enzymes.

Frequency not known (its frequency cannot be estimated with the available data)

Anxiety, abdominal pain, vomiting, and diarrhea.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or

nurse, even if it is a possible adverse effect that does not appear in this prospectus.

You can also report them directly through the Spanish System of Pharmacovigilance

of Medicines for Human Use: www.notificaram.es

By reporting adverse effects, you can contribute to providing more

information on the safety of this medication

Keep this medication out of the sight and reach of children.

Store at a temperature below25°C. Store in its original packaging.

Keep the blister pack in its cardboard box.

Gutron has a 3-year shelf life. Do not use Gutron after the expiration date indicated on the cartons after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

What is Gutron?

The active ingredient is midodrine hydrochloride

The other components in Gutron are magnesium stearate, talc, anhydrous colloidal silica, microcrystalline cellulose, cornstarch, E 110 yellow-orange S.

Appearance of the product and contents of the packaging

Tablets

Orange, round, biplanar tablets with a beveled edge, scored, on one face “GU” above and “5” below the score.

Presentations of 20, 30 or 50 tablets.

100-tablet glass bottle.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for Manufacturing:

Takeda GmbH

Plant Oranienburg

Lehnitzstr., 70-98

DE-16514 Oranienburg

Germany

Local Representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

NetherlandsGutron 5, 5mg tablets

SpainGutron 5mg tablets

Last review date of this leaflet: February 2016.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es