Carvipress

Package leaflet: Information for the patient

CARVIPRESS 3.125 mg tablets, 6.25 mg tablets, 12.5 mg tablets, 25 mg tablets, 50 mg tablets

Carvedilol
Please read this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

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

1. What CARVIPRESS is and what it is used for
CARVIPRESS contains the active substance carvedilol, which belongs to a group of medicines called alpha and beta blockers.
It is indicated for the treatment of:

• High blood pressure. It may be used alone or in combination with other antihypertensive medicines, especially thiazide diuretics, which are drugs that help eliminate fluids from the body.
• Angina pectoris, a condition characterized by chest pain.
• Heart failure, which occurs when the heart is no longer able to pump blood adequately throughout the body.

2. What you should know before taking CARVIPRESS

Do not take CARVIPRESS

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe heart failure (NYHA Class IV, classification by the "New York Heart Association") unresponsive to standard therapy requiring intravenous inotropic agents
  (medicines affecting cardiac muscle contractility) administered intravenously to support heart function
• if you have cardiac conduction disorders, known as: second- or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block
• if you currently have or have had asthma
• if you have previously experienced bronchial narrowing (bronchospasm) or suffer from chronic obstructive bronchial disease (chronic obstructive pulmonary disease, COPD), causing airway narrowing and breathing difficulties
• if you have severe liver problems
• if your heart rate is below 50 beats per minute (severe bradycardia)
• if you are experiencing reduced blood flow to organs and tissues due to decreased heart activity (cardiogenic shock)
• if you have very low blood pressure (severe hypotension, defined as systolic blood pressure below 85 mmHg)

Warnings and precautions
Talk to your doctor or pharmacist before taking CARVIPRESS, especially:

• if you have heart failure
• if you have diabetes mellitus
• if you have heart failure and low blood pressure (systolic blood pressure below 100 mmHg)
• if you have ischemic heart disease
• if you have circulatory disorders involving inflammation and narrowing of arteries and veins (systemic vasculopathies)
• if you have kidney failure
• if you have chronic obstructive bronchial disease (COPD) with a bronchospastic component and are not taking other specific medications for this condition
• if you have peripheral vasculopathy (circulatory impairment to extremities due to inflammation and narrowing of arteries and veins)
• if you have Raynaud's syndrome, a rare disease affecting arteries characterized by numbness in fingers or toes, with skin turning pale white and cyanotic
• if you have overactivity of the thyroid gland (thyrotoxicosis)
• if you are scheduled for anesthesia or general surgery requiring anesthetics. In this case, inform the anesthesiologist that you are taking Carvedilol
• if you have a slow heart rate (bradycardia) with fewer than 55 beats per minute
• if you have previously experienced severe allergic reactions or are undergoing desensitization therapy for severe allergies, as beta-blockers may increase both sensitivity to allergens and the severity of allergic reactions
• if you have psoriasis, an inflammatory skin disease characterized by thickened, red patches covered with gray scales
• if you are taking diltiazem, verapamil (calcium channel blockers), or other medicines to control heart rhythm (see also section "Other medicines and CARVIPRESS"). Your doctor should carefully monitor your ECG and blood pressure
• if you have labile blood pressure (fluctuating hypertension) or secondary hypertension due to an underlying disease
• if you have pheochromocytoma (a tumor causing sudden spikes in blood pressure)
• if you suffer from a type of angina pectoris causing spontaneous chest pain, known as "Prinzmetal's angina"
• if you wear contact lenses, as the medicine may reduce tear production

Children and adolescents
The safety and efficacy of CARVIPRESS have not been established in patients under 18 years of age.

Other medicines and CARVIPRESS
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Pay special attention and inform your doctor if you are taking:

• antihypertensive medicines taken concurrently (e.g., alpha-1 receptor antagonists), or medicines that list low blood pressure as a possible side effect
• verapamil, diltiazem, amiodarone, or other medicines used to treat heart rhythm disorders (arrhythmias)
• digoxin, a medicine used to treat heart weakness, known as a cardioactive glycoside
• clonidine (a medicine used to lower blood pressure or treat migraine)
• insulin or oral antidiabetic medicines (agents that lower blood sugar), as their blood sugar-lowering effect may be enhanced, and symptoms of low blood sugar (especially tachycardia, rapid heartbeat) may be masked
• rifampicin (an antibiotic used to treat tuberculosis), as it may reduce carvedilol concentration
• cimetidine (a medicine used to treat heartburn), as it may increase plasma levels of carvedilol
• reserpine, a substance used to treat high blood pressure and some forms of psychosis
• monoamine oxidase inhibitors (MAOIs), medicines used to treat depression
• cyclosporine, a substance that suppresses and reduces immune system functions
• fluoxetine, used to treat depression
• non-steroidal anti-inflammatory drugs (NSAIDs), as they may increase blood pressure
• anesthetics, as the effects of carvedilol may add to those of anesthetics

The concomitant use of carvedilol with inotropic agents (medicines affecting heart contractility) has not been studied.

For athletes:
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take CARVIPRESS during pregnancy unless your doctor has determined that the potential benefits outweigh the potential risks.
Breastfeeding while taking CARVIPRESS is not recommended.

Driving and using machines
Individual variations in attention levels and reaction times have been observed when driving or operating machinery, particularly at the beginning of treatment, when dosage is changed, when switching to another medicine, or when consuming alcohol.
Exercise particular caution when driving or using machinery, as dizziness or related symptoms may occur.

CARVIPRESS tablets contain lactose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take CARVIPRESS

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You should take the tablets with a sufficient amount of water. You may take the tablets with or without food. However, if you have heart failure, take the tablets with food to slow down the absorption of the medicine and reduce the risk of dizziness when standing up suddenly (orthostatic hypotension).

Recommended dose:

Treatment of high blood pressure (Essential arterial hypertension)

Adults
The recommended starting dose is 1 tablet of 12.5 mg once daily for the first two days, followed by 2 tablets (equivalent to 25 mg of Carvedilol) once daily.
If necessary, the dose may be gradually increased at intervals of no less than two weeks, up to the maximum recommended daily dose of 50 mg, taken as a single dose or divided into two doses of 25 mg twice daily.

Elderly
The recommended starting dose is 1 tablet of 12.5 mg once daily. This dosage has provided adequate blood pressure control in some patients. If the response is inadequate, your doctor may increase the dose at intervals of no less than two weeks, up to the maximum recommended dose of 50 mg, divided into 25 mg twice daily.

Angina pectoris

Adults
The recommended starting dose is 12.5 mg twice daily for the first two days. Subsequently, the recommended dose is 25 mg twice daily. Do not exceed the recommended dose.

Elderly
The recommended starting dose is 12.5 mg twice daily. The dose may then be increased, after an interval of at least two days, to 25 mg twice daily, which is the maximum recommended dose.

Heart failure
THE DOSAGE MUST BE INDIVIDUALIZED AND YOUR DOCTOR MUST MONITOR YOU CLOSELY THROUGHOUT THE PERIOD REQUIRED TO REACH THE APPROPRIATE DOSE.
Before starting treatment with Carvedilol, the patient should be clinically stable. If you are already being treated with medicines to control heart rhythm (digitalis, diuretics, and ACE inhibitors), the dosage of these drugs should be stabilized.
The recommended starting dose is 3.125 mg twice daily for at least two weeks. If you tolerate this dose well, your doctor may subsequently increase it at intervals of no less than two weeks: first to 6.25 mg twice daily, then to 12.5 mg twice daily, and finally to 25 mg twice daily. The dose should be increased up to the highest dose tolerated by the patient.
The maximum recommended dose is 25 mg twice daily:

• if you have severe heart failure
• if you have mild or moderate heart failure and body weight below 85 kg
  The maximum recommended dose is 50 mg twice daily:
• if you have mild or moderate heart failure and body weight above 85 kg
  Before each dose increase, your doctor should examine you to check for any signs of worsening heart failure or vasodilation.

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

If you take more CARVIPRESS than you should
If you accidentally ingest or take an excessive dose of CARVIPRESS, contact your doctor immediately or go to the nearest hospital.
In case of overdose, severe lowering of blood pressure (hypotension), slowed heart rate (bradycardia), heart failure, a condition similar to fainting (cardiogenic shock), and cardiac arrest may occur. Additionally, breathing difficulties, airway constriction (bronchospasm), vomiting, disturbances of consciousness, and generalized seizures may occur.

Treatment in case of accidental ingestion of an excessive dose of CARVIPRESS
If you accidentally ingest or take an excessive dose of CARVIPRESS, you will receive standard emergency procedures and the most appropriate treatment in hospital, depending on the overdose effects and symptoms you experience.

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

If you stop taking CARVIPRESS
If you have any questions about using this medicine, consult your doctor or pharmacist.
CARVIPRESS must be discontinued gradually over a period of two weeks and under medical supervision.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have been observed with the use of Carvipress:

Very common (may affect more than 1 in 10 people)

• Dizziness, headache (cephalalgia);
• Reduced heart activity (heart failure);
• Low blood pressure (hypotension);
• Fatigue (asthenia).

Common (may affect up to 1 in 10 people)

• Inflammation of the bronchi and lungs (bronchitis and pneumonitis), infections of the upper respiratory tract (external nose and oral cavity; nasal cavities and paranasal sinuses; pharynx, larynx, cartilaginous tissue);
• Urinary tract infections;
• Decreased red blood cell levels in the blood (anaemia);
• Weight gain, increased blood cholesterol levels (hypercholesterolaemia), increased or decreased blood glucose levels (hyperglycaemia and hypoglycaemia) in patients with diabetes;
• Depression, depressed mood;
• Vision problems, reduced tear production (dry eyes), eye irritation;
• Reduced heart rate (bradycardia), fluid accumulation (oedema) affecting the whole body, arms and legs, genitals, increased circulating blood volume (hypervolaemia), increased fluid levels;
• Posture-related low blood pressure (orthostatic hypotension), poor blood circulation in peripheral areas of the body (cold hands and feet, peripheral vascular problems, worsening leg pain during physical activity (intermittent claudication), and worsening of Raynaud's disease);
• Breathing difficulties (dyspnoea), fluid accumulation in the lungs (pulmonary oedema), asthma (in patients predisposed to this condition);
• Nausea, diarrhoea, vomiting, indigestion (dyspepsia), abdominal pain;
• Pain in hands and feet;
• Reduced kidney function (renal failure) and kidney problems (in patients with widespread blood vessel disorders and/or pre-existing renal failure), urinary problems;
• Pain.

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders;
• Sensation of fainting, loss of consciousness (syncope), numbness or tingling in limbs, arms and legs (paraesthesia);
• Impaired conduction of the cardiac impulse between atrium and ventricle (atrioventricular block), severe chest pain (angina pectoris);
• Skin reactions (such as: pustular, blistering and bullous rash (exanthema) of allergic nature, skin inflammation (dermatitis), skin rash (urticaria), itching, thickened red patches covered with grey scales (psoriasiform skin lesions), mucosal and skin lesions due to lichen planus), hair loss (alopecia);
• Inability to achieve an erection (erectile dysfunction).

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

• Decreased platelet levels in the blood (thrombocytopenia);
• Nasal congestion (nasal congestion);
• Dry mouth.

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

• Decreased white blood cell levels in the blood (leucopenia);
• Allergic reaction (hypersensitivity);
• Increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT);
• Severe skin adverse reactions such as skin rash characterised by lesions with erythema and oedema, sometimes with blisters (erythema multiforme), severe forms of skin shedding (Stevens-Johnson syndrome), and skin decomposition (toxic epidermal necrolysis);
• Difficulty in retaining urine in women.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website www.agenziafarmaco.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CARVIPRESS

The tablets must be stored in a dry place at temperatures not exceeding 30°C.
Since they may discolour when exposed to light, it is recommended to store them in the closed packaging.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package contents and other information

What CARVIPRESS contains
The active substance is carvedilol.
Each 3.125 mg scored tablet contains 3.125 mg of carvedilol.
The other ingredients are: sucrose, monohydrate lactose, polyvinylpyrrolidone,
anhydrous colloidal silica, crospovidone, magnesium stearate, red iron oxide.
Each 6.25 mg scored tablet contains 6.25 mg of carvedilol.
The other ingredients are: sucrose, monohydrate lactose, polyvinylpyrrolidone,
anhydrous colloidal silica, crospovidone, magnesium stearate, yellow iron oxide.
Each 12.5 mg scored tablet contains 12.5 mg of carvedilol.
The other ingredients are: sucrose, monohydrate lactose, polyvinylpyrrolidone,
anhydrous colloidal silica, crospovidone, magnesium stearate, yellow iron oxide,
red iron oxide.
Each 25 mg scored tablet contains 25 mg of carvedilol.
The other ingredients are: sucrose, monohydrate lactose, polyvinylpyrrolidone,
anhydrous colloidal silica, crospovidone, magnesium stearate.
Each 50 mg scored tablet contains 50 mg of carvedilol.
The other ingredients are: sucrose, monohydrate lactose, polyvinylpyrrolidone,
anhydrous colloidal silica, crospovidone, magnesium stearate.

Description of the appearance of CARVIPRESS and contents of the pack
Box containing 28 scored tablets of 3.125 mg.
Box containing 14 scored tablets of 6.25 mg.
Box containing 28 scored tablets of 6.25 mg.
Box containing 56 scored tablets of 6.25 mg.
Box containing 28 scored tablets of 12.5 mg.
Box containing 56 scored tablets of 12.5 mg.
Box containing 30 scored tablets of 25 mg.
Box containing 56 scored tablets of 25 mg.
Box containing 15 scored tablets of 50 mg.

Marketing Authorization Holder
VISUFARMA S.p.A.
Via Canino, 21
Rome
Italy

Responsible person for batch release
I.B.N. Savio S.r.l.
Via del Mare, 36 - Pomezia (Rm) 00040