CURCIX 6.25 MG Таблетки

Содержание инструкции

1. CURCIX 6.25 mg tablets, 25 mg tablets
   1. What is CURCIX and what is it used for
   2. What you need to know before you take CURCIX
   3. How to take CURCIX
   4. Possible side effects
   5. How to store CURCIX
   6. Contents of the pack and other information

CURCIX 6.25 mg tablets, 25 mg tablets

carvedilol
Generic medicine

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

1. What is CURCIX and what is it used for

CURCIX contains the active substance carvedilol, belonging to a group of medicines called alpha and beta-adrenergic receptor blockers.
Curcix is indicated for the treatment of high blood pressure and can be used alone or in
combination with other medicines that stimulate diuresis (diuretics).
Curcix is also indicated for the treatment of angina pectoris and heart failure.

2. What you need to know before you take CURCIX

Do not take CURCIX

• If you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from unstable/decompensated heart failure.
• If you suffer from severe heart failure (called class IV cardiac decompensation) for which medicines are administered intravenously.
• If you suffer from severe liver disease or dysfunction.
• If you suffer from disturbances of the heart's conduction system (so-called atrioventricular block of 2nd and 3rd degree or sick sinus syndrome, including sinoatrial block).
• If you have a very weak pulse (bradycardia) or very low blood pressure (severe hypotension).
• If you suffer from severe impairment of cardiac function (cardiogenic shock).
• If you suffer from asthma or other chronic lung diseases (e.g., bronchospasm, even previous, chronic obstructive pulmonary disease (COPD) with bronchospastic component).
• If you are pregnant or breastfeeding (see section 6).
• If you suffer from untreated hyperfunction of the adrenal glands (pheochromocytoma).
• If you suffer from a condition called metabolic acidosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking CURCIX:

• If you suffer from heart failure: at the beginning of therapy you may experience a worsening of this condition and increased fluid retention, your doctor may decide to reduce the dose of CURCIX or temporarily suspend treatment;
• If you suffer from heart failure accompanied by:
• Low blood pressure
• Impaired blood and oxygen supply to the heart (ischemic heart disease) and vascular diseases
• Kidney problems You may experience a worsening of kidney and vascular problems: the doctor will closely monitor your kidney function and may decide to reduce the dose of CURCIX;
• If you are taking medicines that stimulate the action of the heart, called digitalis glycosides
• If you have had an acute heart attack;
• If you suffer from respiratory problems: the doctor will closely monitor you, especially at the beginning of therapy, and may decide to reduce the dose of CURCIX;
• If you have diabetes: CURCIX may mask the symptoms of low blood sugar, the doctor will assess the actual need for you to take CURCIX and will closely monitor your blood sugar levels;
• If you suffer from Raynaud's phenomenon (the fingers of the hands and feet turn first bluish, then whitish and then reddish accompanied by pain) or vascular problems of the limbs: CURCIX may worsen your symptoms;
• If you have hyperthyroidism, with high production of thyroid hormone, CURCIX may mask the symptoms;
• If you are going to undergo an operation that involves anesthesia;
• If you have a very weak pulse (less than 55 beats per minute);
• If you have had severe allergic reactions in the past or are undergoing desensitization therapy: CURCIX may increase your sensitivity and the severity of allergic reactions;
• If you suffer from psoriasis: the doctor will carefully assess the need for you to take CURCIX;
• If you are being treated with other medicines for blood pressure control (verapamil, diltiazem or other antiarrhythmics);
• If you suffer from a disease called pheochromocytoma (increased activity of the adrenal glands);
• If you suffer from a condition called Prinzmetal's variant angina;
• If you wear contact lenses: CURCIX may reduce tear production;
• If you are lactose intolerant (see below “CURCIX contains lactose”)
• If you are sucrose intolerant (see below “CURCIX contains sucrose”)

Children
The safety and efficacy of carvedilol in children under 18 years of age have not been established.

Other medicines and CURCIX
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:

• Digoxin (used to treat heart failure): concomitant administration of carvedilol and digoxin may increase digoxin levels in the blood;
• Insulin or oral hypoglycemic agents (medicines used to reduce blood sugar levels): concomitant administration of carvedilol may induce an increase in the effects of these medicines and mask the symptoms of low blood sugar levels;
• Rifampicin (antibiotic used in the treatment of tuberculosis);
• Cimetidine (antacid used in the treatment of gastric ulcer)
• Medicines containing Reserpine, Clonidine, monoamine oxidase inhibitors, other medicines for the treatment of high blood pressure (antihypertensives, such as calcium channel blockers): concomitant administration of carvedilol (contained in CURCIX) and these medicines may determine an excessive decrease in blood pressure and/or heart rate;
• Cyclosporine (used to suppress the immune system, prevent organ rejection after transplantation);
• Cardiac glycosides such as Verapamil and Diltiazem or other antiarrhythmics (used in case of irregular heartbeat);
• Medicines used during anesthesia;
• Amiodarone, a medicine used in case of accelerated heartbeat;
• Fluoxetine, a medicine used to treat some psychological disorders such as depression;
• Non-steroidal anti-inflammatory drugs (NSAIDs);
• Other medicines used in the treatment of respiratory diseases such as asthma (beta-agonists).

CURCIX with food and drink
CURCIX can be taken either on an empty stomach or after meals (see 3. How to Take
CURCIX).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The risk of harmful effects to the fetus following the administration of carvedilol cannot be excluded.
Carvedilol may cause intrauterine fetal death and immature and premature births. In addition, adverse reactions (especially hypoglycemia and bradycardia) may occur in the fetus and newborn, and there may be an increased risk of cardiac and pulmonary complications in the newborn.
If you are pregnant, you should only take carvedilol under direct medical supervision, who
will assess whether the potential benefits outweigh the possible risks.
Breastfeeding
It is not known whether carvedilol is excreted in human breast milk. The risk of harmful effects to the
child following the administration of carvedilol by the mother cannot be excluded. If you are breastfeeding, you
should only take carvedilol under direct medical supervision, who will assess whether the potential benefits
outweigh the possible risks.

Driving and using machines
There is no evidence that carvedilol alters the ability to drive vehicles or operate machinery.
At the beginning of treatment, after dose increases, with a change of product and in combination with
alcohol, reactions such as dizziness and fatigue may occur. If you feel dizzy or weak
while taking CURCIX, your ability to drive and operate machinery may be impaired.

CURCIX contains lactose
This medicine contains lactose. If your doctor has diagnosed you with lactose intolerance, contact
him or her before taking this medicine.

CURCIX contains sucrose
This medicine contains sucrose. If your doctor has diagnosed you with sucrose intolerance
contact him or her before taking this medicine.

3. How to take CURCIX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is:

• for the treatment of essential hypertensionAdults: the recommended dosage for the start of therapy is 12.5 mg once a day for the first two days. Afterwards, the recommended dosage is 25 mg once a day. If necessary, the dosage may be gradually increased at intervals of no less than two weeks, up to reaching the maximum recommended dose of 50 mg per day to be taken in a single administration or divided into 25 mg twice a day. Elderly: the recommended dose for the start of therapy is 12.5 mg once a day. This dosage has allowed for adequate control of blood pressure values in a part of the patients. If the response should be inadequate, the dosage may be increased at intervals of no less than two weeks up to reaching the maximum recommended dose of 50 mg, to be taken divided into 25 mg twice a day.
• for the treatment of Angina pectorisAdults: the recommended dosage for the start of therapy is 12.5 mg twice a day for the first two days. Afterwards, the recommended dosage is 25 mg twice a day. It is recommended not to exceed this dosage. Elderly: the recommended dose for the start of therapy is 12.5 mg twice a day. Afterwards the dose may be increased, after an interval of at least two days, to 25 mg twice a day (maximum dose not to be exceeded).
• For the treatment of heart failureThe decision to start therapy with carvedilol for heart failure must be made by an experienced doctor and the dosage must be personalized for you and must be reached gradually, the doctor will carefully monitor you throughout the period necessary to reach the established dose. The recommended dose for the start of therapy is 3.125 mg (½ 6.25 mg tablet) twice a day for at least two weeks. If this dosage is well tolerated, the dosage may then be increased, at intervals of no less than two weeks, and first brought to 6.25 mg twice a day, then to 12.5 mg twice a day and finally to 25 mg twice a day. The dosage should be increased up to the highest dose tolerated by the patient. The maximum recommended dose is 25 mg twice a day in all patients with severe heart failure and in patients with mild or moderate heart failure with a body weight of less than 85 kg. In patients with mild or moderate heart failure with a body weight greater than 85 Kg, the maximum recommended dose is 50 mg twice a day.

Use in children
The safety and efficacy of carvedilol in children under 18 years of age are not known.

Method of administration
Take the tablets with a sufficient amount of liquid.
You can take the tablets with or without food; however, if you suffer from heart failure, carvedilol
should be taken with meals to slow down absorption and reduce the incidence of
postural effects such as orthostatic hypotension.
The tablets can be divided into two equal halves.

If you take more CURCIX than you should
In case of accidental ingestion/intake of an excessive dose of CURCIX, immediately notify your
doctor or go to the nearest hospital.
In case of overdose, severe lowering of blood pressure, decreased
heart rate, heart failure, cardiogenic shock and cardiac arrest may occur. You may also experience
difficulty and breathing problems, bronchospasm, vomiting, altered state of
consciousness and generalized convulsions.

If you forget to take CURCIX
Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for
the next dose, do not take the missed dose and continue as usual. Do not take a double dose to
compensate for forgetting a dose.

If you stop taking CURCIX
Do not stop taking CURCIX abruptly and without first consulting your doctor.
If you need to stop treatment, you must do so gradually (over a period of 2 weeks) and after
consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The frequency of reactions does not depend on the dose of CURCIX taken, except in the case of dizziness,
visual disturbances and decreased heart rate.
The side effects that may occur with CURCIX are:
Very common: affects more than 1 in 10 people

• dizziness, headache
• heart failure
• very low blood pressure
• feeling tired/weak

Common: affects up to 1 in 10 people

• bronchitis, pneumonia, upper respiratory tract infections (throat, tonsils, sinuses)
• urinary tract infections
• low number of red blood cells
• weight gain
• elevated cholesterol levels in the blood
• altered blood sugar levels (hyperglycemia, hypoglycemia) in patients with diabetes
• depression, depressed mood
• feeling tired
• visual disturbances, reduced tear production (dry eyes), eye irritation
• slowed heart rate
• generalized or partial swelling of the body (genitals, lower extremities)
• increased blood volume, excess fluid
• low blood pressure when standing up causing dizziness, lightheadedness or fainting
• peripheral circulatory disorders (cold hands and feet, peripheral vascular disease)
• worsening of Raynaud's disease and intermittent claudication
• shortness of breath
• fluid accumulation in the lungs
• asthma in predisposed patients
• nausea, diarrhea, vomiting, feeling of indigestion, abdominal pain, dry mouth
• pain in the extremities (e.g. legs or arms)
• kidney failure and changes in kidney function in patients with widespread vascular disease and/or underlying kidney failure
• difficulty urinating

Uncommon: affects up to 1 in 100 people

• Difficulty sleeping
• Feeling of fainting, fainting
• Tingling or numbness of hands and feet
• Disturbances of the heart's conduction system (atrioventricular block)
• Worsening of heart failure during dose increase
• Severe chest pain (angina pectoris)
• skin reactions (allergic skin reactions, skin inflammation, urticaria, itching, skin lesions similar to psoriasis or lichen)
• Hair loss or loss of body hair
• increased sweating
• erectile dysfunction

Rare: affects up to 1 in 1000 people

• reduction in the number of platelets in the blood (which causes an increased risk of bleeding or bruising)
• stuffy nose

Very rare: affects up to 1 in 10000 people

• reduction in the number of white blood cells in the blood
• severe allergic reactions
• alteration of liver function tests
• involuntary loss of urine in women (incontinence)
• severe skin lesions (for example erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Dizziness, transient loss of consciousness (syncope), headache and fatigue are generally mild
and are more likely to occur at the beginning of treatment.
If you have heart problems, in the initial phase when the doctor assesses what amount of carvedilol
is effective in improving your condition, a worsening of heart function and
increased tendency to retain fluids in the body may occur.
If you consistently experience heart problems resulting in low blood pressure, if you are affected by
conditions in which there is insufficient blood and oxygen supply to the heart, if you suffer from conditions
involving blood vessels or kidneys, with the use of carvedilol you may experience an initial
reversible worsening of kidney function. In general, all drugs that belong to the same
therapeutic class as carvedilol can cause some adverse reactions involving various
mechanisms of control of blood glucose levels.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system 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 CURCIX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after the wording EXP. and on the
blister. The expiry date refers to the last day of that month.
Store CURCIX in the original package to protect the medicine from moisture and light and at a
temperature not exceeding 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CURCIX contains
The active ingredient is carvedilol.

Curcix 6.25 mg tablets
Each tablet contains 6.25 mg of carvedilol.
The other ingredients are: sucrose; lactose monohydrate; povidone, anhydrous colloidal silica;
crospovidone; magnesium stearate; yellow iron oxide (E 172).

Curcix 25 mg tablets
Each tablet contains 25 mg of carvedilol.
The other ingredients are: sucrose; lactose monohydrate; povidone, anhydrous colloidal silica;
crospovidone; magnesium stearate.

Description of the appearance of CURCIX and contents of the pack
Film-coated, divisible tablets

Curcix 6.25 mg tablets
Blister containing 28 divisible tablets

Curcix 25 mg tablets
Blister containing 30 divisible tablets

Marketing authorisation holder and manufacturer
HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy
MANUFACTURER
Special Product’s Line S.p.A.
Strada Paduni, 240
03012 Anagni (FR)
Italy