Leaflet: information for the user

Solinitrina 0.8 mg sublingual coated tablets

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 is and for what it is used

2. Before taking Solinitrina

3. How to take Solinitrina

4. Possible side effects

5. Storage of Solinitrina

6. Additional information

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

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

It is used:

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

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 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 (a 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

• If you have ischemic heart failure (heart failure unable 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 renal (kidney) or hepatic (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 recently had an acute myocardial infarction (heart attack) or acute heart failure as you may require careful clinical monitoring.

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 taking, or have recently taken, any other medication, including those purchased without a prescription.

• Caution is recommended if nitroglycerin is administered simultaneously with other medications that act similarly to nitroglycerin (papaverine, ergotamine, vincamine, etc.) due to the possibility of increased 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 reduced response to nitroglycerin cannot be excluded with the ingestion of acetylsalicylic acid and non-steroidal anti-inflammatory substances.
• 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.

Taking Solinitrina with food and beverages

Avoid consuming alcoholic beverages.

Pregnancy and breastfeeding

If you are, or suspect you are, pregnant, or wish to become pregnant, you must inform your doctor and they will decide whether you should take or not Solinitrina.

The excretion of nitroglycerin in breast milk is unknown, so the risk in newborns/infants 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.

Important information about some of the components of Solinitrina

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

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

Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

Insert a tablet into your mouth, chew it immediately and place it under your tongue, in order to achieve faster absorption. After 10 minutes, you can repeat the dose with another tablet if the pain has not completely disappeared. You can administer a third tablet after 10 more minutes if the pain continues.

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, a Solinitrina tablet will be administered regularly at intervals of 3 to 6 hours, for several consecutive days.

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

You should be aware that in chronic treatments with high doses, the effects of nitroglycerin may decrease.

If you take more Solinitrina than you should

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

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 ingested.

If you forgot to take Solinitrina

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Solinitrina

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

Like all medications, Solinitrina may produce adverse effects, although not everyone may experience them.

It may cause headaches that usually subside within a few days. This headache can be treated with analgesics, 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

If you carry a small quantity of tablets, use an appropriate container and store them in it without removing them from the blister pack in which each one is included. Avoid carrying the container near the body because the body heat itself can affect the medication.

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

Do not use Solinitrina after the expiration date indicated on the container 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 containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

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 solid semisynthetic glycerides. Coating: magnesium carbonate, sucrose, talc, titanium dioxide (E-171), and macrogol.

Appearance of the product and contents of the package

Coated tablets with a white ivory color, rounded, biconvex. Each package contains 30 tablets,

Holder of the marketing authorization and Responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II,

Venus 72

08228 Terrassa (Barcelona)

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)www.aemps.gob.es