NATISPRAY 0.30 MG Roztwór do nebulizacji

Treść ulotki

1. NATISPRAY 0,30 mg/dose sublingual spray
   1. What is NATISPRAY 0.30 mg/dose sublingual spray and what is it used for?
   2. What you need to know before using NATISPRAY 0.30 mg/dose sublingual spray
   3. How to use NATISPRAY 0.30 mg/dose sublingual spray
   4. Possible side effects
   5. How to store NATISPRAY 0.30 mg/dose sublingual spray
   6. Contents of the pack and other information

NATISPRAY 0,30 mg/dose sublingual spray

Nitroglycerin

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What NATISPRAY 0,30 mg/dose sublingual spray is and what it is used for
• 2. What you need to know before you use NATISPRAY 0,30 mg/dose sublingual spray
• 3. How to use NATISPRAY 0,30 mg/dose sublingual spray
• 4. Possible side effects
• 5. How to store NATISPRAY 0,30 mg/dose sublingual spray
• 6. Contents of the pack and other information

1. What is NATISPRAY 0.30 mg/dose sublingual spray and what is it used for?

This medicine is used in angina pectoris (characterized by pain that
occurs in the chest when the heart does not receive enough blood):

• to treat an angina attack,
• to avoid an imminent angina attack very quickly.

2. What you need to know before using NATISPRAY 0.30 mg/dose sublingual spray

Do not use NATISPRAY 0.30 mg/dose sublingual spray:

• if you are allergic to nitroglycerin or any of the other ingredients contained in the medicine (listed in section 6),
• in the days following a myocardial infarction (heart attack)
• if you have severe anemia,
• if you suffer from closed-angle glaucoma,
• if you suffer from hypotension,
• if you suffer from hypovolemia,
• if you have increased intracranial pressure due to head trauma or cerebral hemorrhage,
• if you have obstructive hypertrophic cardiomyopathy (a heart muscle disease that causes heart failure)
• if you suffer from aortic stenosis, constrictive pericarditis or mitral stenosis
• if you are taking sildenafil (a medicine that treats erectile dysfunction).

Warnings and precautions
Talk to your doctor or pharmacist before using NATISPRAY 0.30 mg/dose, sublingual
spray.

• This medicine should be used with caution in case of:
• renal insufficiency,
• severe hepatic insufficiency (severe liver disease),
• hypothyroidism (thyroid abnormality),
• malnutrition,
• hypothermia.
• Because the product may cause headache, it may be necessary, in the first days of therapy, to administer lower doses or to associate an analgesic.
• If you have already developed resistance to a medicine from the nitrite and nitrate family, it is possible that this medicine also has reduced efficacy.
• In order to avoid the onset of a sudden drop in blood pressure when standing up (postural hypotension), especially if you are elderly, and, in particular in case of association with other drugs that lower blood pressure. Take the first dose of the drug while you are in a sitting position.

Other medicines and NATISPRAY 0.30 mg/dose sublingual spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• Avoid the association with sildenafil due to the risk of a significant decrease in blood pressure (see section “Do not use NATISPRAY 0.30 mg/dose, sublingual spray”).
• Be careful if you are taking diuretics and vasodilators, drugs against hypertension, may require special precautions, especially if you are an elderly patient.

NATISPRAY 0.30 mg/dose sublingual spray with alcohol
Alcohol can enhance the effects of the drug.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.
Use NATISPRAY 0.30 mg/dose sublingual sprayonly if necessary and under strict
medical control.

Driving and using machines
No effects on the ability to drive and operate machines are known.

Athletes
For those who play sports, the use of medicines containing ethyl alcohol may determine
positive results in doping tests in relation to the concentration limits indicated by
some sports federations.

3. How to use NATISPRAY 0.30 mg/dose sublingual spray

Always use this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.

Dosage
(1 dose = 300 mcg of nitroglycerin)

• Treatment of angina pectoris crisis: 1 spray under the tongue. If the crisis persists, repeat the spray 1-2 times at intervals of 2 or 3 minutes.
• To avoid a predictable angina pectoris crisis in a very short time: 1 spray 2-3 minutes before the circumstance that may determine an angina crisis. This may be: physical exertion, sudden exposure to cold, sexual intercourse, or all other occasions of crisis to be defined with the attending physician.

Method of administration
Take the medicine sublingually, that is to say, under the tongue.

• Before the first use of the bottle, actuate the pump five times to activate it.
• Hold the bottle vertically with the dispenser upwards.
• Place the tip of the dispenser as close as possible to the mouth and spray onto the oral mucosa, under the tongue, without swallowing.
• It may be necessary to reactivate the pump (that is, actuate it several times) if the bottle has not been used for more than a few days.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may limit therapy, especially in the
initial stages or when angina is severe or when patients are hypersensitive to the effects of
nitrates:

• hot flushes,
• headache which generally disappears during treatment,
• postural hypotension (drop in blood pressure after moving to an upright position)

The following have also been reported:

• Dizziness, headache
• Blurred vision
• Tachycardia, palpitations, paradoxical bradycardia, syncope (cardiac disorders)
• Postural hypotension
• Nausea, digestive disorders
• Rash (skin eruption)
• Hot flushes with erythema (redness), weakness, sweating
• on the nebulization area: burning, erythema

Rarely (occur in less than 1 in 1000 patients):

• Methemoglobinemia (a condition of red blood cells) in case of prolonged treatments or with high dosages.

Very rarely:

• Cyanosis (bluish discoloration of the skin caused by a circulatory disorder)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist.
You can also report side effects directly through the Italian Medicines Agency
at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store NATISPRAY 0.30 mg/dose sublingual spray

Store at a temperature not exceeding 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the packaging. The expiry
date of the product indicated on the packaging refers to the product in intact packaging,
correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsNATISPRAY 0.30 mg/dose sublingual spray
Alcoholic solution of nitroglycerin 4%.
Active ingredient: nitroglycerin: 300 mcg per one spray
Other ingredients: alcohol, peppermint aroma, monoethyl ether of diethylene glycol (Transcutol)

Description of the appearance of NATISPRAY 0.30 mg/dose sublingual spray and contents of the pack
NATISPRAY 0.30 mg/dose is presented in a pack containing a pressurized bottle
with a metering valve containing 18 ml of solution equivalent to 300 doses

Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Italy

Manufacturer:
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia