SOLINITRINA 0.8 mg SUBLINGUAL COATED TABLETS

Introduction

Leaflet: Information for the user

Solinitrina 0.8 mg sublingual coated tablets

Nitroglycerin

Read the entire leaflet carefully before starting to take the medication.

• Keep this leaflet 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 serious side effects or any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What is Solinitrina and what is it used for
2. Before taking Solinitrina
3. How to take Solinitrina
4. Possible side effects
5. Storage of Solinitrina
6. Additional information

1. What is SOLINITRINA and what is it used for

Solinitrina is a medication administered sublingually and presented in tablet form.

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

It is used:

• As an emergency medication in painful crisis of angor pectoris(chest angina), stenocardia, and precordial pain (pain in the chest, at the level of the heart), determined by myocardial ischemia (lack of oxygen in the heart).
• To prevent effort angina (chest angina caused by effort), stress angina (chest angina caused by stress), and nocturnal angina (chest angina that occurs at night).
• To achieve faster evolution and recovery of the myocardial areas (of the heart) damaged after a heart attack.
• In left ventricular congestive heart failure (inability of the heart to pump enough blood).

2. BEFORE TAKING SOLINITRINA

Do not take 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), cerebral hemorrhage (bleeding in the brain), or cranioencephalic trauma (head trauma) 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 increased 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 (a 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 erection disorders.

Be careful with Solinitrina

• 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 need careful clinical monitoring.

Consult your doctor, even if any of the above circumstances have occurred to you at some point.

Use of other medications

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

• Precautions are recommended 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 medications 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 reduce the response to nitroglycerin.
• The action of this medication on the heart may be altered if used in conjunction with preparations containing sildenafil or other similar drugs used for erection disorders.

Keep in mind that these instructions may also apply to medications that have been taken/used before or may be taken/used after.

Taking Solinitrina with food and drinks

Avoid consuming alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor, who will decide whether it is convenient for you to take Solinitrina or not.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Important information about some of the components of Solinitrina

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. HOW TO TAKE SOLINITRINA

Follow the administration instructions of Solinitrina indicated by your doctor exactly.

Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

Place a tablet in your mouth, chew it, and then place it under your tongue to achieve faster absorption. After about 10 minutes, you can repeat the dose of one tablet if the pain has not disappeared completely. A third tablet can be administered after another 10 minutes if the pain persists.

Solinitrina can be used as many times as necessary during the day. As a preventive measure, it is used about 10 minutes before starting the effort or work that is suspected to cause angina pain.

In the treatment of ischemic disorders, in the acute phase of myocardial infarction, one Solinitrina tablet will be administered regularly at intervals of 3 to 6 hours, for several consecutive days.

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

Keep in mind that in chronic treatments with high doses, the effects of nitroglycerin may decrease.

If you take more Solinitrina than you should

A hypotension, shock, and bluish discoloration of the skin may occur.

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 medication and the amount ingested.

If you forget to take Solinitrina

Do not take a double dose to make up for the forgotten dose.

If you stop taking Solinitrina

Your doctor will indicate the duration of your treatment with Solinitrina. Do not stop the treatment before, as a possible withdrawal reaction may occur. It is recommended to gradually decrease the dose.

4. Possible side effects

Like all medications, Solinitrina can cause side effects, although not everyone experiences them.

It can cause headaches that usually subside after a few days. This headache can be treated with analgesics, although it may be necessary to decrease the dose or interrupt the 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 side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of SOLINITRINA

Keep out of the reach and sight of children.

If you carry a small amount of tablets with you, use a suitable container and store them in it without removing them from the blister pack. Avoid carrying the container close to your body, as your body heat may affect the medication.

Store preferably in the original packaging and in a cool, dry place. Do not store in the refrigerator.

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

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Solinitrina 0.8 mg sublingual coated tablets

• The active ingredient of Solinitrina is nitroglycerin. Each tablet contains 0.8 mg of nitroglycerin.
• The other components are: Core: talc, colloidal silica, sucrose, and semi-synthetic solid glycerides. Coating: magnesium carbonate, sucrose, talc, titanium dioxide (E-171), and macrogol.

Appearance of the product and packaging content

Coated tablets with a film, round, biconvex, white-ivory color. Each package contains 30 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II,

Venus 72

08228 Terrassa (Barcelona)

This leaflet was approved in June 2011

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