Package Insert: Information for the User

Solinitrina 1 mg/ml Injectable Solution

Nitroglycerin

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 package insert, inform your doctor or pharmacist.

1. What Solinitrina is and for what it is used

2. Before using Solinitrina

3. How to use Solinitrina

4. Possible side effects

5. Storage of Solinitrina

6. Additional information

Solinitrina is a medication administered in the form of an intravenous solution for infusion AFTER DILUTION 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:

• Acute myocardial infarction (heart attack) in its acute phase.
• Refractory or resistant angina pectoris.
• Left ventricular congestive heart failure (inability of the heart to pump sufficient blood).
• Pulmonary edema (accumulation of fluid in the lungs).
• Cardiac surgery (heart operations).

Do not use Solinitrina

• If you are allergic (hypersensitive) to nitroglycerin or any of the other components of Solinitrina.
• In case of anemia (decrease in red blood cells in the blood), cerebral hemorrhage (bleeding in the brain), or 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 erectile dysfunction).

Be especially careful with Solinitrina

• 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 previously mentioned circumstances 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 nonsteroidal 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 erectile dysfunction.

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

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. 5 ml) of ethanol (alcohol) corresponding to 4,135 g of ethanol per ampoule, which is approximately equivalent to 100 ml of beer or 50 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.

This medication should be administered by your doctor or nurse.

The average dose is 2 to 3 mg of nitroglycerin per hour, administered intravenously drop by drop, after dilution in serum.

The duration of administration can range from a few hours to a few days (3 to 5 days). Continuous administration represents a daily dose of approximately 70 mg.

The minimum dose is 0.3 mg/hour and the maximum is 4.0 mg/hour, in subjects weighing around 70 kg.

Solinitrina 1 mg/ml injectable solution is a solution for intravenous perfusion, so the usual mode of administration is to dilute a 5 ml ampoule of 1‰ nitroglycerin solution in 250 to 500 ml of serum, saline, or glucose, which will contain respectively 2 mg or 1 mg of nitroglycerin per 100 ml of serum to be administered.

In cases of extreme urgency, 1 to 3 mg of nitroglycerin can be injected directly into the vein, after dilution to 10% (i.e., to a dilution of 0.1‰), in a period of 30 seconds.

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

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

Guidelines for administration:

It should be noted 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) may be compatible with the solution, but containers made of chlorinated polyvinyl chloride may absorb 40-80% of the nitroglycerin and should be avoided absolutely.

Since most infusion equipment is made using polyvinyl chloride 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 of material that does not absorb nitroglycerin. If these equipment are used, it should be noted that, since most clinical experiences have been made with standard polyvinyl chloride 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 than you should

The medication should be administered by your doctor/nurse. In the unlikely event that you received 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 may have adverse effects, although not everyone 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 are 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 are experiencing are severe, or if you notice any adverse effect not mentioned in this leaflet, 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 leaflet. 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.

No special storage conditions are required.

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 the event of ampoule breakage or accidental spillage of the contents, clean immediately with a damp cloth moistened in a slightly alkaline solution.

Do not use Solinitrina 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 injectable

• The active ingredient of Solinitrina 1 mg/ml injectable solution is nitroglycerin. Each ampule of 5 ml of injectable solution contains 5 mg of nitroglycerin
• The other components are: ethanol.

Appearance of the product and contents of the package

Package containing 12 glass ampules of topaz color of 5 ml.

Marketing authorization holder

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 medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es