HYDRAPRES 20 mg POWDER FOR INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

HYDRAPRES 20 mg powder for solution for injection

Hydralazine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Hydrapres is and what it is used for
2. What you need to know before you use Hydrapres
3. How to use Hydrapres
4. Possible side effects
5. Storage of Hydrapres
6. Contents of the pack and further information

1. What Hydrapres is and what it is used for

Hydrapres belongs to a group of medicines known as antihypertensive agents that act on the smooth muscle of the arterioles to decrease blood pressure.

Hydrapres is used to treat:

• Hypertensive emergencies, when the oral route is not possible or it is necessary to urgently decrease blood pressure. Preeclampsia and eclampsia (high blood pressure during pregnancy).

2. What you need to know before you use Hydrapres

Do not use Hydrapres

• If you are allergic (hypersensitive) to hydralazine or any of the other ingredients of this medicine (listed in section 6).
• If your heart beats too fast (tachycardia).
• If you have heart disease.

If you think you may be in one of these situations, consult your doctor or pharmacist.

Warnings and precautions

See section "Use with other medicines".

Use of Hydrapres with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor if you are using any of the following medicines:

• other potent antihypertensive agents (e.g. diazoxide) by intravenous or intramuscular route.
• monoamine oxidase inhibitors (medicines for the treatment of depression, such as fluoxetine, citalopram)

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant or might become pregnant. Your doctor will decide if you can be given Hydrapres.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Your doctor will advise you on the benefits and risks of using Hydrapres while breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

The influence of Hydrapres injectable on the ability to drive and use machines is nil.

3. How to use Hydrapres

This medicine will always be administered by a healthcare professional.

Follow exactly the administration instructions of Hydrapres given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual doses are indicated below.

Adults

The usual therapeutic dose in adults is 1/2 to 2 ampoules (10 mg to 40 mg) by intramuscular, slow intravenous or intermittent perfusion route, and the dose may be repeated if necessary.

Blood pressure should be frequently monitored.

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 impaired renal function

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

Use in children

The safety and efficacy in children have not been established, although there is experience of 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.

The initial dose should not exceed 20 mg. Generally, most patients can switch to oral treatment within the first 24-48 hours.

If you use more Hydrapres than you should

You may experience: a drop in blood pressure (hypotension), an increase in heart rate (tachycardia), flushing of the skin (generalized cutaneous flushing) and severe headache (intense headache). It can also lead to irregular heartbeats (cardiac arrhythmias) and heart attack (myocardial ischemia). In severe cases, it can cause deep shock (coma).

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 medicine and the amount ingested.

Information for the doctor: treatment will be symptomatic. The most important thing is cardiovascular support. Shock can be treated with a plasma volume expander and, if possible, without using vasopressors. If they are necessary, one that does not precipitate or worsen cardiac arrhythmias will be used. Digitalization may be necessary. Renal function will be monitored and improved if necessary. There is no experience with extracorporeal or peritoneal dialysis.

4. Possible side effects

Like all medicines, Hydrapres can cause side effects, although not everybody gets them.

Hydralazine can cause a clinical picture similar to lupus erythematosus in certain patients. Adverse reactions are normally reversible when the dose is reduced and only in some cases is it necessary to discontinue treatment.

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

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

Rarely, it can cause: hepatitis, blood disorders, increased spleen size (splenomegaly), inflammation of the lymph nodes in the neck, armpit, or groin (lymphadenopathy), difficulty urinating, constipation, and difficulty breathing (dyspnea).

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Hydrapres

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

Do not store above 30°C.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

6. Contents of the pack and further information

Composition of Hydrapres

• The active ingredient is hydralazine hydrochloride.

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

Appearance and packaging

Neutral glass Type I ampoule of the European Pharmacopoeia, containing 20 mg of hydralazine hydrochloride.

Marketing authorization holder and manufacturer

Laboratorios Rubió, S.A.

Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal –Barcelona

Spain

Date of last revision of this leaflet:

June-2008

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

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This information is intended only for healthcare professionals:

INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE PREPARATION

Hydrapres powder for solution for injection must be reconstituted before use.

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

The administered volume should not exceed 1 ml (concentration of the reconstituted solution 20 mg hydralazine hydrochloride/ml).

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

Since hydralazine reacts with metals, the injectable should be prepared with a non-metallic filter and used quickly once prepared after extraction with a needle into a syringe.

It is compatible with conventional liquids for intravenous perfusion, but intravenous administration of hydralazine in glucose solution is not recommended.

Continuous perfusion is not recommended.

Blood pressure should be monitored during treatment.