PATIENT INFORMATION LEAFLET

HYDRAPRES 20 mg powder for injection

Hidralazine hydrochloride

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

• Keep this leaflet, as 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 others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

Hydrapres belongs to a group of medications known as active arteriolar smooth muscle antihypertensives that decrease blood pressure.

Hydrapres is used to treat:

• Hypertensive emergencies, when oral administration is not possible or urgent blood pressure reduction is required. Preeclampsia and eclampsia (high blood pressure during pregnancy).

Do not use Hydrapres

• If you are allergic (hypersensitive) to hydralazine or to any of the other components of this medication (listed in section 6).
• If your heart beats quickly (tachycardia).
• If you have heart disease.

If you think you are in any of the above situations, consult your doctor or pharmacist.

Warnings and precautions

See the section “Use of other medications”.

Use of Hydrapres with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Especially, inform your doctor if you are using any of the following medications:

• Other powerful antihypertensive medications (for example diazoxide), administered intravenously or intramuscularly.
• Monamine oxidase inhibitors (medications for the treatment of depression, such as fluoxetine, citalopram)

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant or may become pregnant. Your doctor will decide if you can be administered Hydrapres.

Breastfeeding

Inform your doctor if you are in the breastfeeding period or are going to start it. Your doctor will advise you on the benefits and risks of administering Hydrapres while breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machines

The influence of Hydrapres injectable on the ability to drive and operate machines is null.

This medication will be administered by a healthcare professional at all times.

Follow exactly the administration instructions for Hydrapres indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual doses are listed below.

Adults

The usual therapeutic dose in adults is 1/2 ampoule to 2 ampoules (10 mg to 40 mg) administered intramuscularly, intravenously slowly or intermittent infusion, and the dose may be repeated if necessary.

Blood pressure should be controlled frequently.

In preeclampsia and eclampsia, the normal initial intravenous dose for adults is 5 mg followed by intravenous doses of 5-10 mg (range 5-20 mg) every 20-30 minutes.

Use in patients with altered renal function

Certain patients (especially those with significant renal insufficiency) may require a lower dose.

Use in children

The safety and efficacy have not been established in children, although there is experience with its use in children. In children, doses of 1.7-3.5 mg/kg/day or 50-100 mg/m²/day, divided into 4-6 doses, are recommended.

It is not recommended that the initial dose exceed 20 mg. Generally, most patients can be switched to oral treatment within the first 24-48 hours.

If you use more Hydrapres than you should

You may experience: a decrease in blood pressure (hypotension), an increase in heart rate (tachycardia), a generalised redness of the skin (generalised cutaneous flush) and a severe headache (intense headache). It may also lead to irregular heartbeats (cardiac arrhythmias) and heart attack (myocardial ischemia). In severe cases, deep shock (coma) may occur.

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

Information for the doctor: treatment will be symptomatic. The most important thing is to support the cardiovascular system. Shock can be treated with a plasma volume expander and, if possible, without using vasopressors. If these are necessary, one that is not capable of precipitating or worsening cardiac arrhythmias should be used. Digitalization may be necessary. Renal function will be monitored and improved if necessary. There is no experience with hemodialysis or peritoneal dialysis.

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

Hydralazine may produce a clinical picture similar to lupus erythematosus in certain patients. Adverse reactions are normally reversible when the dosage is reduced, and only in some cases is it necessary to suspend treatment.

The most frequent adverse reactions are: severe headache, palpitations, increased heart rate, decreased appetite, nausea, vomiting, and diarrhea. It may also trigger chest pain in heart patients.

The less frequent adverse reactions are: sudden drop in blood pressure, fluid retention, nasal congestion, skin redness, conjunctivitis, numbness, sensation of spinning (dizziness), peripheral neuritis (cramps, pain in hands and feet), tremor, muscle cramps, anxiety, depression, allergic reactions such as urticaria, itching, fever, and eosinophilia (blood disease).

Rarely, hepatitis, blood disorders, enlargement of the spleen (splenomegaly), inflammation of the lymph nodes in the neck, armpits, or groin (lymphadenopathies), difficulty urinating, constipation, and difficulty breathing (dyspnea) may occur.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Do not store at a temperature above30°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Hydrapres

• The active principle is hydrochlorothiazide.

• The other components are: mannitol (E-421), hydrochloric acid to adjust the pH to 3.5-4.2.

Appearance of the product and contents of the packaging

Neutral glass Type I ampoule from the European Pharmacopeia, containing 20 mg of hydrochlorothiazide.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Rubió, S.A.

Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal –Barcelona

Spain

Date of the last review of this leaflet:

June-2008

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

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This information is intended solely for doctors or healthcare professionals:

INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE PREPARATION

Hydrapres powder for injectable solution must be reconstituted before use.

Reconstitute the contents of the ampoule in 1.1 ml of the appropriate solvent and inject immediately after reconstitution.

The administered volume must not exceed 1 ml (concentration of the reconstituted solution 20 mg hydrochlorothiazide/ml).

Administration in solutions containing glucose, fructose, lactose, and maltose is not recommended.

Due to the reaction of hydralazine with metals, the injectable must be prepared with a non-metallic filter and used quickly once prepared after being extracted with a syringe into a syringe.

It is compatible with conventional venous perfusion liquids, but administration of hydrochlorothiazide intravenously in glucose solution is not recommended.

Continuous perfusion is not recommended.

Monitoring of blood pressure during treatment is required.