Natispray

Patient Information Leaflet

NATISPRAY 0,30 mg/dose sublingual spray

Nitroglycerin
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 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

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

This medicinal product is used in angina pectoris (characterized by chest pain occurring when the heart does not receive sufficient blood):

• to treat an acute angina attack,
• to prevent an impending 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 to any of the other ingredients of this medicine (listed in section 6),
• during the days following a myocardial infarction (heart attack),
• if you have severe anaemia,
• 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 haemorrhage,
• if you have obstructive hypertrophic cardiomyopathy (a heart muscle disease leading to heart failure),
• if you suffer from aortic stenosis, constrictive pericarditis, or mitral stenosis,
• if you are taking sildenafil (a medicine used to treat 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 if you have:
• renal failure,
• severe hepatic impairment (severe liver disease),
• hypothyroidism (thyroid disorder),
• malnutrition,
• hypothermia.
• Since this product may cause headache, it may be necessary during the first days of treatment to administer lower doses or to associate an analgesic.
• If you have already developed resistance to medicines belonging to the nitrite and nitrate family, this medicine may also have reduced efficacy.
• To avoid sudden drop in blood pressure when standing up (postural hypotension), especially if you are elderly, and particularly if you are also taking other medicines that lower blood pressure, the first dose should be taken while sitting.

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

• Avoid concomitant use with sildenafil due to the risk of a significant drop in blood pressure (see section "Do not use NATISPRAY 0.30 mg/dose sublingual spray").
• Be cautious if you are taking diuretics and vasodilators, or antihypertensive medicines; special precautions may be required, especially in elderly patients.

NATISPRAY 0.30 mg/dose sublingual spray and alcohol
Alcohol may enhance the effects of this medicine.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Use NATISPRAY 0.30 mg/dose sublingual spray only if strictly necessary and under close medical supervision.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Athletes
For individuals engaged in sports activities, the use of medicines containing ethyl alcohol may lead to positive results in anti-doping tests, depending on the alcohol concentration limits established by certain sports federations.

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

Always use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage
(1 dose = 300 mcg of nitroglycerin)

• Treatment of angina pectoris attack: 1 spray under the tongue. If the attack persists, repeat the spray 1–2 times at intervals of 2 or 3 minutes.
• To prevent a foreseeable angina pectoris attack shortly beforehand: 1 spray 2–3 minutes before the event likely to trigger an attack. This may include: physical exertion, sudden exposure to cold, sexual intercourse, or any other situations likely to provoke an attack, as defined with your treating physician.

Method of administration
Take the medicine sublingually, i.e., under the tongue.

• Before the first use of the bottle, prime the pump by actuating it five times.
• Hold the bottle vertically with the dispenser pointing 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 re-prime the pump (i.e., actuate it several times) if the bottle has not been used for several days.

4. Possible side effects

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

• Flushing,
• Headache, which usually disappears during treatment,
• Postural hypotension (drop in blood pressure upon standing up)

The following have also been reported:

• Dizziness, headache
• Blurred vision
• Tachycardia, palpitations, paradoxical bradycardia, syncope (cardiac disorders)
• Postural hypotension
• Nausea, digestive disturbances
• Rash (skin eruption)
• Flushing with erythema (redness), weakness, sweating
• At the site of nebulization: burning sensation, erythema

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

• Methaemoglobinaemia (a disorder of red blood cells) with prolonged treatment or high doses.

Very rarely:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) 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 below 25 °C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date stated on the pack refers to the product in its original, unopened packaging and properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NATISPRAY 0.30 mg/dose sublingual spray contains
Alcoholic solution of 4% nitroglycerin.
Active substance: nitroglycerin: 300 mcg per spray
Other components: alcohol, peppermint flavour, monoethyl ether of diethylene glycol (Transcutol)
Description of the appearance of NATISPRAY 0.30 mg/dose sublingual spray and contents of the package
NATISPRAY 0.30 mg/dose is presented in a carton containing a pressurized bottle with a metering valve, containing 18 ml of solution corresponding to 300 doses.
Marketing Authorization 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