Leaflet: information for the user

Solinitrina Fuerte 5 mg/ml injectable solution

Nitroglycerin

Read this leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience severe side effects or any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

1. What Solinitrina Fuerte is and for what it is used

2. Before using Solinitrina Fuerte

3. How to use Solinitrina Fuerte

4. Possible side effects

5. Storage of Solinitrina Fuerte

6. Additional information

Solinitrina Fuerte is a medication administered in the form of an intravenous infusion solution PREVIA DILUCIÓN and is presented in a container with 12 ampoules.

The active ingredient, nitroglycerin, belongs to the group of drugs known as nitrates and related substances.

This medication is used in the following cases:

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

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 in the blood), cerebral hemorrhage (bleeding in the brain), or cranial trauma (head trauma) with increased intracranial pressure (increased pressure in the brain).
• If you have uncorrected hypovolemia (decrease in 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 nitroderivatives.
• If you have been diagnosed with obstructive cardiomyopathy (heart disease), especially if it is associated with aortic or mitral stenosis (narrowing of the heart valves) or constrictive pericarditis (inflammation of the heart sac).
• If you are being treated with sildenafil or other similar acting medications (medications used for penile erection disorders).

Be especially careful with Solinitrina Fuerte

• If you have ischemic heart failure (heart failure to pump enough blood) or severe cerebral ischemia (lack of blood flow to the brain) as the decrease in oxygen supply may decrease the effect of nitroglycerin.
• If you have thyroid problems, malnutrition, severe kidney or liver disease, hypothermia (low body temperature), and if you are predisposed to angle-closure glaucoma (eye disease that includes pain, perception of 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 (heart failure to pump enough blood) as you may require careful clinical monitoring.
• In case of shock (situation where the body is not receiving enough blood flow), simultaneous administration of medications that increase cardiac tone should be administered.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription.

• Avoid excessive alcohol consumption.
• Precautions should be taken if nitroglycerin is administered simultaneously with other medications that act similarly to nitroglycerin (papaverine, ergotamine, vincamine, etc.) due to the possibility of a greater effect.
• The simultaneous treatment with other medications such as calcium channel blockers, beta blockers, diuretics, antihypertensives, tricyclic antidepressants, and major tranquilizers may potentiate the hypotensive effect (decrease in blood pressure) of nitroglycerin.
• The possibility of the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory substances decreasing the response to nitroglycerin cannot be excluded.
• The action of this medication on the heart may be altered if used concurrently with preparations containing sildenafil or other similar medications used for penile erection disorders.

Take note that these instructions may also apply to medications that have been taken/used before or may be taken/used afterwards.

Pregnancy and lactation

Pregnancy

If you are, or suspect you are, pregnant, or wish to become pregnant, you should inform your doctor and he will decide whether Solinitrina should be administered or not.

Consult your doctor or pharmacist before using any medication.

Lactation

The elimination of nitroglycerin through breast milk is unknown. The risk in newborns/children cannot be excluded.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Solinitrina may cause hot flashes, dizziness, or decreased blood pressure, especially at the beginning of treatment. If you experience any of these effects, avoid driving vehicles or operating machinery.

The amount of alcohol in this medication may decrease your ability to drive or operate 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 medication contains 100% (c.s.p. 10 ml) of ethanol (alcohol) corresponding to 8.4 g of ethanol per ampoule, which is approximately equivalent to 210 ml of beer or 90 ml of wine.

This medication is harmful to people with alcoholism.

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

The amount of alcohol in this medication may alter the effects of other medications.

The amount of alcohol in this medication may decrease your ability to drive or operate machinery.

Solinitrina Fuerte is a hospital medication.

This medication should be administered by your doctor or nurse.

Solinitrina Fuerte is an intravenous infusion solution.

THIS PREPARATION MUST NEVER BE INJECTED DIRECTLY.

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

Dilution of one 50 mg vial in 100 ml gives a concentration of 500 mcg/ml.

It is recommended to prepare a solution of 400 mcg/ml or less, depending on the planned dose.

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

During administration, clinical evaluation and frequent measurements of blood pressure should be performed. When possible, use arterial wedge pressure or cardiac output measurements to adjust the dose to the patient's needs.

If possible, use an infusion pump or other suitable microdosing device (rigid plastic) to ensure correct dosing.

As an example, the following dosing guidelines are suggested:

Surgery:

• For the control of hypertensive episodes, doses of 25 mcg/min are recommended, increasing by 25 mcg/min at five-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 myocardial ischemia prior to surgical intervention, the recommended dose is 15-20 mcg/min, increasing by 10-15 mcg/min until the desired response is achieved.

• Heart failure associated with myocardial infarction: the recommended initial 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 recommended initial dose is 10 mcg/min, increasing by 5-10 mcg/min at approximately 30-minute intervals.

If you estimate that 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 discontinue treatment beforehand, as a possible withdrawal reaction may occur.

Guidelines for correct administration:

It should be noted that nitroglycerin is absorbed by many types of plastic, and therefore the solution must always be made in GLASS CONTAINER. It is possible that certain plastic containers (polyethylene) may be compatible with the solution, but PVC containers can absorb 40-80% of the nitroglycerin and should be avoided absolutely.

Since most infusion equipment is made using PVC tubing, there is a variable degree of absorption, and the concentration of the vial will not match the concentration received by the patient. For this reason, it is essential to adjust the dosing according to the clinical response.

There are special infusion equipment available on the market made from materials that do not absorb nitroglycerin. If these devices are used, it should be noted that, since most clinical experiences have been made with standard PVC equipment, the application of standard dosing guidelines may result in excessively high responses. It is necessary to exercise extreme caution in adjusting the dose.

If you are administered more Solinitrina Fuerte than you should

The medication 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 following undesirable effects: facial and neck flushing, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount injected.

Like all medications, Solinitrina Fuerte can produce adverse effects, although not all people may experience them.

It may cause headaches that usually disappear within a few days. This headache can be treated with pain relievers, although it may be necessary to reduce the dose or discontinue treatment. Other adverse effects that may occur include redness, nausea, dizziness, hypotension, and tachycardia. Occasionally, vomiting and blue discoloration of the skin have been described.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

The solvent is volatile and precautions must be taken to prevent the formation of nitroglycerin concentrate. Do not leave unused ampoules open. The contents must be flushed with abundant running water. In case of ampoule breakage or accidental spillage of the contents, clean immediately with a damp cloth in a slightly alkaline solution.

No special storage conditions are required.

Do not use Solinitrina Fuerte after the expiration date appearing on the packaging 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. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Solinitrina Fuerte

• The active ingredient ofSolinitrina Fuerte 5 mg/ml injectable solutionis nitroglycerin. Each ampoule of 10 ml of injectable solution contains 50 mg of nitroglycerin
• The other components are: ethanol.

Appearance of the product and contents of the package

Package containing 12 glass ampoules of topaz color of 10 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

or

INDUSTRIAS FARMACEUTICAS ALMIRALL PRODESFARMA, S.L.

National Highway II, Km. 593

Sant Andreu de la Barca 08740 Spain

or

B. BRAUN MEDICAL, S.A.

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

23009 Jaén Spain

This leaflet was approved in June 2011.

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