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1. Carvasin 5 mg sublingual tablets, 10 mg tablets, 40 mg tablets
   1. What is Carvasin and what is it used for
   2. What you need to know before taking Carvasin
   3. How to take Carvasin
   4. Possible side effects
   5. How to store Carvasin
   6. Contents of the pack and other information

Carvasin 5 mg sublingual tablets, 10 mg tablets, 40 mg tablets

isosorbide dinitrate
Read this leaflet carefully before you start taking 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Carvasin is and what it is used for
• 2. What you need to know before you take Carvasin
• 3. How to take Carvasin
• 4. Possible side effects
• 5. How to store Carvasin
• 6. Contents of the pack and other information

1. What is Carvasin and what is it used for

Carvasin contains the active substance isosorbide dinitrate, a substance that dilates blood vessels and
is used to treat heart problems.
Carvasin is used for:

• the treatment of coronary insufficiency (reduction of blood flow in the coronary arteries, blood vessels that supply the heart);
• the prevention and treatment of angina pectoris, a heart disease that manifests with chest pain.

Sublingual Carvasin is indicated when a rapid effect is desired and for this reason it is used to treat
angina. Furthermore, since its effect lasts approximately 2 hours, it can be used to prevent an attack of
angina when engaging in an effort that may provoke it, e.g. muscular activity, sexual act,
abundant meal.
Carvasin tablets have a less rapid action but which lasts longer over time and therefore is used
to prevent angina attacks and in the treatment of coronary insufficiency.

2. What you need to know before taking Carvasin

DO NOT take Carvasin

• if you are allergic to isosorbide dinitrate, to other nitrates or to any of the other components of this medicine (listed in section 6);
• if you are taking medicines that inhibit the phosphodiesterase enzyme such as sildenafil, verdanafil, tadalafil, used for the treatment of impotence (see "Other medicines and Carvasin").
• if you are having a heart attack
• if you have blood circulation problems;
• if you suffer from heart function problems (difficulty pumping blood throughout the body);
• if you suffer from low blood pressure (systolic <90 mmHg);
• if you suffer from heart disorders due to an increase in the thickness of the heart walls (obstructive hypertrophic cardiomyopathy);
• if you suffer from inflammation of the membrane surrounding the heart (constrictive pericarditis);
• if you have problems related to the amount of blood in the veins (severe hypovolemia);
• if you suffer from a disease that causes the accumulation of fluid or blood inside the membrane surrounding the heart (cardiac tamponade);
• if you suffer from increased blood pressure in the lungs (primary pulmonary hypertension).

Warnings and precautions
Talk to your doctor or pharmacist before taking Carvasin.
Pay particular attention and tell your doctor:

• if you have glaucoma (high pressure inside the eye);
• if you have headaches, because Carvasin may cause severe and continuous headaches at the beginning of treatment. The doctor will assess whether to reduce the dose of Carvasin or give you a medicine to reduce the pain;
• if you have recently had a heart attack: the doctor will carefully assess your condition and give you Carvasin only if necessary;
• if you are using medicines that increase urine production (diuretics) to lower blood pressure (see section “Other medicines and Carvasin”),
• if you experience, even at low doses, a further decrease in blood pressure, especially when standing up (orthostatic hypotension). Hypotension may be accompanied by a slowing of the heartbeat (bradycardia) or heart problems (worsening of angina pectoris);
• if you are using medicines to lower blood pressure belonging to the class of calcium antagonists (see section “Other medicines and Carvasin”), because you may have a further decrease in blood pressure, especially when standing up;
• if you have a heart disease called hypertrophic cardiomyopathy, in which there is an increase in the thickness of the heart walls. Therapy with Carvasin may worsen angina caused by this condition or may cause rebound angina attacks after stopping the medicine;
• if the motility of your stomach or intestine is excessive or increased (gastrointestinal hypermotility) or you have problems with absorption through the stomach or intestine. The doctor will prescribe the dosage of Carvasin most suitable for you;
• if you notice a loss of response (tolerance) to treatment with Carvasin. This can also occur with other medicines in the class of nitrites and nitrates.
• if cyanosis occurs (bluish discoloration of the skin) the doctor may want to measure the level of a substance in the blood, methemoglobin.

During treatment, a temporary condition characterized by a
reduction in the amount of oxygen present in the blood (hypoxemia) with possible consequences
on the heart (myocardial hypoxia) may occur, especially if you suffer from a disease that affects the
coronary arteries (coronary artery disease).
Carvasin, in sensitive subjects, can further reduce the blood supply to the heart
(ischemia) and lead to an increase in damage to the heart muscle and a reduction in the heart's ability
to pump blood into the body (congestive heart failure).

Children
The safety and efficacy of Carvasin in children has not been studied.

Elderly patients
Currently, there is not enough data available on the use of Carvasin in patients aged 65 years or older.
The doctor will carefully assess, based on your condition, how much medicine to give you and
will start with the lowest dose.

Other medicines and Carvasin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking:

• medicines to treat impotence (sildenafil, verdenafil, tadalafil), because they increase the effects of Carvasin (see DO NOT take Carvasin);
• medicines to reduce blood pressure and treat heart or blood vessel problems (calcium antagonists, beta-blockers, vasodilators, diuretics, ACE inhibitors) or medicines used to treat mental illnesses (neuroleptics) or depression (tricyclic antidepressants) as the simultaneous use of Carvasin with these medicines may potentiate the hypotensive effect (lowering of blood pressure).

This medicine can also reduce the action of norepinephrine, acetylcholine and histamine.

Carvasin with alcohol
Do not drink alcohol during treatment with Carvasin because alcohol can increase the effect of
Carvasin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Talk to your doctor, who will assess whether to give you Carvasin during pregnancy.
Breastfeeding
The amount of medicine that passes into breast milk is currently unknown. Talk to your doctor, who
will assess whether to stop breastfeeding or treatment with Carvasin.

Driving and operating machinery
Adverse effects such as dizziness, vertigo and low blood pressure have been reported, which may impair the ability to drive vehicles and operate machinery.

Carvasin 5 mg sublingual tablets contains lactose
Carvasin 5 mg sublingual tablets contains lactose: if your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine.

Carvasin 10 mg tablets contains lactose and sucrose
Carvasin 10 mg tablets contains lactose and sucrose: if your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine.

Carvasin 40 mg tablets contains lactose
Carvasin 40 mg tablets contains lactose: if your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

3. How to take Carvasin

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Carvasin 5 mg sublingual tablets
The recommended initial dose is 5 mg.
Let a tablet dissolve under the tongue (the tablets dissolve in 20 seconds). Carvasin
can be taken every 2-3 hours.
Carvasin 10 mg tablets
The recommended dose is one tablet 4 times a day, before the three meals (breakfast, lunch and
dinner) and before going to bed.
Carvasin 40 mg tablets
The recommended dose is one tablet every 12 hours.
The doctor will decide whether to give you sublingual Carvasin or Carvasin tablets based on your condition.
The doctor will prescribe the lowest effective dosage and then assess whether to modify it.

If you take more Carvasin than you should
In case of accidental ingestion of an excessive dose of Carvasin, immediately inform your
doctor or go to the nearest hospital.
Symptoms due to taking an excessive dose of this medicine may include:

• a sudden decrease in blood pressure
• heart rhythm alterations and changes in blood hemoglobin with bluish discoloration of the skin (cyanosis) resulting in rapid and deep breathing, anxiety, loss of consciousness and cardiac arrest;
• weak pulse;
• headache, dizziness, lightheadedness when getting up from a lying position;
• weakness, drowsiness;
• paleness;
• visual disturbances;
• hot flashes and sweating (skin becomes cold and bluish);
• nausea, vomiting and diarrhea;
• increased pressure inside the skull with confusion and moderate fever;

If you forget to take Carvasin
Do not take a double dose to make up for a missed dose.

If you stop taking Carvasin
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Do not abruptly stop taking Carvasin because angina attacks have been
reported in patients after discontinuation of nitrate treatment. The doctor will tell you
when and how to gradually stop using the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment, some of the following side effects may occur:

Very rare(may affect up to 1 in 10,000 people);

Rare(may affect up to 1 in 1,000 people);

Uncommon(may affect up to 1 in 100 people);

Common(may affect up to 1 in 10 people);

Not known(frequency cannot be estimated from available data)
Very rare: heartburn (pyrosis), muscle pain (myalgia).
Uncommon: worsening of chest pain (angina pectoris), circulatory collapse (sometimes
accompanied by slowing of the heartbeat and loss of consciousness), vomiting, diarrhea, allergic skin
reactions (e.g. rash) and redness.
Common: dizziness, drowsiness, increased heart rate (tachycardia), low blood pressure
when standing up (orthostatic hypotension), nausea, physical weakness (asthenia).
Very common: headache.
Not known: low blood pressure (hypotension), severe skin inflammation
(exfoliative dermatitis), decreased effectiveness of the drug and similar drugs (development of
tolerance and cross-tolerance to other nitrates).
During treatment with Carvasin, a decrease in blood oxygen may occur
(temporary hypoxemia). This can lead to a decrease in oxygen to the heart (myocardial hypoxia),
especially in patients with coronary artery disease (coronary heart disease).
With the use of this class of medicines, severe drops in blood pressure may occur,
including nausea, vomiting, weakness, agitation, paleness, excessive sweating and
collapse. Alcohol can intensify this effect.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at
http://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 Carvasin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
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 Carvasin contains
Carvasin 5 mg sublingual tablets

• The active ingredient is isosorbide dinitrate. Each sublingual tablet contains 5 mg of isosorbide dinitrate.
• The other ingredients are lactose, starch, erythrosine (E127), powdered cellulose, magnesium stearate.

Carvasin 10 mg tablets

• The active ingredient is isosorbide dinitrate. Each tablet contains 10 mg of isosorbide dinitrate.
• The other ingredients are lactose, mannitol, starch, sucrose, magnesium stearate.

Carvasin 40 mg tablets

• The active ingredient is isosorbide dinitrate. Each tablet contains 40 mg of isosorbide dinitrate.
• The other ingredients are lactose, aluminium tristearate, magnesium stearate, talc, methylcellulose, sodium silico aluminate, potassium polyacrilin.

Description of the appearance of Carvasin and contents of the pack
Carvasin 5 mg sublingual tablets
Each pack contains 50 sublingual tablets.
Carvasin 10 mg tablets
Each pack contains 50 tablets.
Carvasin 40 mg tablets
Each pack contains 50 tablets.

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

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