SOLINITRINA FUERTE 5 mg/ml injectable solution

Introduction

Package Leaflet: Information for the User

Solinitrina Fuerte 5 mg/ml Solution for Injection

Nitroglycerin

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any serious side effects, or any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What is Solinitrina Fuerte and what is it used for
2. Before using Solinitrina Fuerte
3. How to use Solinitrina Fuerte
4. Possible side effects
5. Storage of Solinitrina Fuerte
6. Further information

1. What is SOLINITRINA FUERTE and what is it used for

Solinitrina Fuerte is a medicine administered as a solution for intravenous infusion AFTER DILUTION and is presented in a package containing 12 ampoules.

The active ingredient, nitroglycerin, belongs to the group of drugs called nitrites and related substances.

This medicine is used in the following cases:

• Rapid control of hypertension (high blood pressure) during surgical procedures, especially in cardiovascular surgery (heart operations).
• Maintenance of controlled hypotension (low blood pressure) in surgical interventions.
• Congestive heart failure (inability of the heart to pump enough blood) associated with acute myocardial infarction (heart attack).
• Treatment of angina pectoris in patients who have not responded to conventional therapy.

2. Before using SOLINITRINA FUERTE

Do not use Solinitrina Fuerte

• If you are allergic (hypersensitive) to nitroglycerin or any of the other components of Solinitrina Fuerte.
• In case of anemia (decrease in red blood cells), cerebral hemorrhage (bleeding in the brain), or cranioencephalic trauma (trauma to the skull) with increased intracranial pressure (increased pressure in the brain).
• If you have uncorrected hypovolemia (decreased blood volume) or severe hypotension (low blood pressure).
• If you have an increase in intraocular pressure (increased pressure in the eyes).
• If you have a history of allergy to nitro derivatives.
• If you have been diagnosed with obstructive cardiomyopathy (heart disease), especially if associated with aortic or mitral stenosis (narrowing of the heart valves) or constrictive pericarditis (inflammation of the heart lining).
• If you are being treated with sildenafil or other similar drugs used for erectile dysfunction.

Be careful with Solinitrina Fuerte

• If you have ischemic heart failure (inability of the heart to pump enough blood) or severe cerebral ischemia (lack of blood flow to the brain), as the decrease in oxygen supply could reduce the effect of nitroglycerin.
• If you have thyroid problems, malnutrition, severe kidney or liver disease, hypothermia (low body temperature), and if you are prone to closed-angle glaucoma (eye disease characterized by pain, halos around lights, increased eye pressure, and nausea and vomiting).
• If you have had a recent acute myocardial infarction (heart attack) or acute heart failure, as you may require careful clinical monitoring.
• In case of shock (a condition that occurs when the body is not receiving enough blood flow), drugs that increase cardiac tone should be administered simultaneously.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Use of other medicines

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

• Avoid excessive alcohol consumption.
• Precautions should be taken if nitroglycerin is administered simultaneously with other drugs that act similarly to nitroglycerin (papaverine, ergotamine, vincamine, etc.) due to the possibility of increased effect.
• Concomitant treatment with other medicines such as calcium antagonists, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants, and major tranquilizers may enhance the hypotensive effect (decrease in blood pressure) of nitroglycerin.
• It cannot be excluded that the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory substances may decrease the response to nitroglycerin.
• The action of this medicine on the heart may be altered if used in conjunction with preparations containing sildenafil or other similar drugs used for erectile dysfunction.

Note that these instructions may also apply to medicines that have been taken/used before or may be taken/used after.

Pregnancy and breastfeeding

Pregnancy

If you are, or think you may be, pregnant, or if you plan to become pregnant, you should inform your doctor, who will decide whether it is convenient for you to receive Solinitrina.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

It is unknown whether nitroglycerin is excreted in breast milk. The risk to newborns/children cannot be excluded.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Solinitrina may cause flushing, dizziness, or decreased blood pressure, especially at the start of treatment. If you experience any of these effects, avoid driving or using machines.

The amount of alcohol in this medicine may impair your ability to drive or use machinery.

Important information about some of the components of Solinitrina Fuerte

The presence of ethanol may be a risk factor in patients with liver disease, alcoholism, epilepsy, pregnant women, and children.

This medicine contains 100% (10 ml) of ethanol (alcohol), which corresponds to 8.4 g of ethanol per ampoule, approximately equivalent to 210 ml of beer or 90 ml of wine.

This medicine is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk populations, such as patients with liver disease or epilepsy.

The amount of alcohol in this medicine may alter the effects of other medicines.

The amount of alcohol in this medicine may impair your ability to drive or use machinery.

3. How to use SOLINITRINA FUERTE

Solinitrina Fuerte is a hospital medicine.

This medication should be administered by your doctor or nurse.

Solinitrina Fuerte is a solution for intravenous infusion.

THIS PREPARATION SHOULD NEVER BE INJECTED DIRECTLY.

It should be diluted beforehand in 5% glucose (dextrose) or physiological saline solution (0.9% sodium chloride).

The dissolution of one 50 mg ampoule in 100 ml gives a concentration of 500 mcg/ml.

A solution of 400 mcg/ml or less is recommended, depending on the planned dose.

The usual dose for adults is 10-200 mcg/min. It is recommended to start the infusion at a low level and gradually increase it until the desired effect is achieved. In some surgical interventions, doses of 400 mcg/min or higher may be necessary.

During administration, clinical evaluation and frequent blood pressure measurements should be performed. Whenever possible, measures of pulmonary artery wedge pressure or cardiac output should be used to adjust the dose to the patient's needs.

If possible, a infusion pump or other suitable microdosing device (made of rigid plastic) should be used to ensure correct dosing.

Indicatively, the following dosage guidelines are suggested:

Surgery:

• For the control of hypertensive episodes, doses of 25 mcg/min are recommended, increasing by 25 mcg/min at 5-minute intervals until the desired blood pressure is achieved.

Although most patients respond to doses of 100-200 mcg/min, in some surgical interventions, doses higher than 400 mcg/min have been necessary. In the treatment of preoperative myocardial ischemia, the recommended dose is 15-20 mcg/min, increasing by 10-15 mcg/min until the desired response is achieved.

• Congestive heart failure associated with myocardial infarction: the initial recommended dose is 20-25 mcg/min, which can be reduced to 10 mcg/min or increased by 20-25 mcg/min at 15-30 minute intervals until the desired effect is achieved.
• Unstable angina: the initial recommended dose is 10 mcg/min, increasing by 5-10 mcg/min at approximately 30-minute intervals.

If you think the action of Solinitrina Fuerte is too strong or too weak, inform your doctor.

Your doctor will indicate the duration of your treatment with Solinitrina Fuerte. Do not stop treatment before, as a possible withdrawal reaction may occur.

Guidelines for correct administration:

It should be taken into account that nitroglycerin is absorbed by many types of plastic, and therefore the solution should always be made in a GLASS CONTAINER. It is possible that certain plastic containers (polyethylene) are compatible with the solution, but containers made of polyvinyl chloride can absorb 40-80% of the nitroglycerin and should be avoided absolutely.

Since most infusion equipment is made using polyvinyl chloride tubing, there will be a variable degree of absorption, and the concentration in the vial will not coincide with that received by the patient. For this reason, it is essential that the dosage be adjusted according to the clinical response.

There are special infusion equipment on the market made of material that does not absorb nitroglycerin. If these devices are used, it should be taken into account that, since most clinical experiences have been carried out with standard polyvinyl chloride equipment, the application of standard dosage guidelines may result in excessively high responses. It is necessary to be extremely careful when adjusting the dose.

If you are given more Solinitrina Fuerte than you should

The medicine should be administered by your doctor/nurse. In the unlikely event that you receive an excessive amount of nitroglycerin, you may experience some of the undesirable effects listed below: flushing of the face and neck, dizziness, hypotension, tachycardia, and headache.

Your doctor/nurse will initiate symptomatic and supportive treatment.

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 injected.

4. Possible side effects

Like all medicines, Solinitrina Fuerte can cause side effects, although not everyone gets them.

It can cause headaches that usually disappear after a few days. This headache can be treated with analgesics, although it may be necessary to reduce the dose or interrupt treatment. Other side effects that may occur are flushing, nausea, dizziness, hypotension, and tachycardia. Vomiting and bluish discoloration of the skin have been occasionally described.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of SOLINITRINA FUERTE

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

The solvent is volatile, and precautions should be taken to avoid the formation of concentrated nitroglycerin. Do not leave open, unused ampoules. The contents should be discarded with plenty of running water. In case of breakage of the ampoules or accidental spillage of the contents, clean immediately with a cloth dampened in a slightly alkaline solution.

No special storage conditions are required.

Do not use Solinitrina Fuerte after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of Solinitrina Fuerte

• The active ingredient of Solinitrina Fuerte 5 mg/ml solution for injection is nitroglycerin. Each 10 ml ampoule of solution for injection contains 50 mg of nitroglycerin.
• The other ingredients are: ethanol.

Appearance of the product and packaging contents

A package containing 12 amber glass ampoules of 10 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

INDUSTRIAS FARMACEUTICAS ALMIRALL PRODESFARMA, S.L.

Ctra. Nacional II, Km. 593

Sant Andreu de la Barca 08740 Spain

or

• BRAUN MEDICAL, S.A.

Ronda de Los Olivares, parcela 11. Polígono Industrial Los Olivares

23009 Jaén Spain

This leaflet was approved in June 2011.

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