Carvedilolo Almus: detailed information

Package leaflet: Information for the patient

CARVEDILOLO ALMUS 6.25 mg tablets, 25 mg tablets

Generic medicine
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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What CARVEDILOLO ALMUS is and what it is used for
What you need to know before taking CARVEDILOLO ALMUS
How to take CARVEDILOLO ALMUS
Possible side effects
How to store CARVEDILOLO ALMUS
Contents of the pack and other information

1. What CARVEDILOLO ALMUS is and what it is used for

This medicinal product contains the active substance carvedilolo, which belongs to a class of medicines known as
"alpha and beta-adrenergic receptor blockers", medicines that relax and dilate blood vessels,
lowering blood pressure and reducing the workload of the heart.
CARVEDILOLO ALMUS is indicated for the treatment of:

essential arterial hypertension (high blood pressure); it may be used alone or in combination with other antihypertensive medicines, particularly thiazide diuretics;
angina pectoris (chest pain caused by heart problems);
heart failure (the heart's inability to supply sufficient blood to the body).

2. What you should know before taking CARVEDILOLO ALMUS

Do not take CARVEDILOLO ALMUS

if you are allergic to carvedilol or to any of the other ingredients of this medicine (listed in section 6);
if you have unstable/decompensated heart failure (reduced heart function);
if you have NYHA Class IV heart failure (classification by the 'New York Heart Association'), severe heart failure requiring intravenous administration of drugs that increase heart muscle contractility (inotropic agents);
if you have clinically evident liver dysfunction (liver problems);
if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
if you have second- or third-degree atrioventricular block (unless a permanent pacemaker has been implanted);
if you have severe bradycardia (very low heart rate);
if you have sinoatrial node disease (including sinoatrial block);
if you have severe hypotension (very low systolic blood pressure);
if you are experiencing cardiogenic shock (reduced blood flow to organs and tissues due to decreased heart function);
if you suffer from or have suffered from bronchial asthma or other respiratory diseases with a bronchospastic component;
if you have uncontrolled pheochromocytoma (a tumor affecting the adrenal medulla) not controlled with alpha-blockers;
if you have metabolic acidosis (accumulation of acids in the body);

Warnings and precautions
Talk to your doctor or pharmacist before taking CARVEDILOLO ALMUS.
In particular, be cautious and consult your doctor if:

You suffer from chronic congestive heart failure, as heart failure or fluid retention may worsen. If you have heart failure and are taking digitalis-based medications, diuretics and/or ACE inhibitors, take CARVEDILOLO ALMUS with caution, as both digitalis and carvedilol slow atrioventricular conduction. If your heart failure worsens during treatment, your doctor will recommend an alternative therapy.
You have chronic heart failure with low blood pressure, diffuse vascular disease, inadequate blood supply to the heart (ischemic heart disease), and/or pre-existing renal insufficiency. Your doctor will monitor you closely.
You have left ventricular dysfunction following acute myocardial infarction.
You have chronic obstructive pulmonary disease (COPD) with bronchospastic component and are not taking specific oral or inhaled medications. In this case, do not take carvedilol, as respiratory distress may occur. Your doctor will monitor you closely.
You suffer from diabetes mellitus, as taking CARVEDILOLO ALMUS may impair glycemic control, or the initial signs and symptoms of acute hypoglycemia may be masked or attenuated. Regular blood glucose monitoring is necessary, and antidiabetic therapy should be adjusted accordingly.
You suffer from peripheral vascular disease (blood vessel disorder), as symptoms of arterial insufficiency may worsen.
You have Raynaud's phenomenon (a condition characterized by brief episodes of narrowing of blood vessels, mainly affecting fingertips and toes, causing pain, numbness or tingling, and skin color changes).
You have thyrotoxicosis (excess thyroid hormones in the body), as taking CARVEDILOLO ALMUS may mask its symptoms.
You need to undergo general surgery requiring anesthetic agents.
You have bradycardia (reduced heart rate) with values below 55 beats per minute.
You have previously experienced a severe hypersensitivity reaction or are currently undergoing desensitization therapy, as you may develop increased sensitivity to substances causing hypersensitivity reactions and increased severity. Very rare cases of severe cutaneous adverse reactions such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) have been reported during treatment with CARVEDILOLO ALMUS (see section 4 “Possible side effects”). In such cases, treatment with CARVEDILOLO ALMUS must be discontinued.
You suffer from psoriasis (an inflammatory skin disease characterized by thickened, red patches covered with gray scales). In this case, take CARVEDILOLO ALMUS with caution.
You are taking calcium antagonists (medicines used to treat high blood pressure). In this case, careful electrocardiographic (ECG) and blood pressure monitoring will be required.
You are taking other medicines (see section “Other medicines and CARVEDILOLO ALMUS”).
You have pheochromocytoma;
You suffer from a form of angina pectoris known as Prinzmetal's angina, also called variant angina; taking CARVEDILOLO ALMUS may trigger chest pain.
You wear contact lenses. During treatment with CARVEDILOLO ALMUS, reduced tear production may occur.
You have rapidly fluctuating blood pressure (labile hypertension) or suffer from high blood pressure caused by an underlying medical condition (secondary hypertension).

Treatment with CARVEDILOLO ALMUS must be gradually discontinued (over a period of two weeks).
Children and adolescents
The safety and efficacy of CARVEDILOLO ALMUS in children and adolescents under 18 years of age have not yet been established.
Other medicines and CARVEDILOLO ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking:

Insulin or oral hypoglycemic agents (medicines for the treatment of diabetes). Signs of hypoglycemia may be masked or attenuated (especially tachycardia). If you are taking these medicines, regular blood glucose monitoring is recommended (see section “Warnings and precautions”).
Agents that reduce catecholamines (medicines such as reserpine or monoamine oxidase inhibitors): if you are taking these medicines during treatment with CARVEDILOLO ALMUS, you must be closely monitored for signs of hypotension and/or severe bradycardia.
Digoxin: The combined use of beta-blockers and digoxin may further prolong atrioventricular (AV) conduction time.
Calcium antagonists, particularly oral diltiazem or verapamil, amiodarone, and other antiarrhythmics. Monitoring of electrocardiogram (ECG) and blood pressure is recommended.
Clonidine (a medicine mainly used to treat high blood pressure): concomitant administration of clonidine and CARVEDILOLO ALMUS may enhance the blood pressure- and heart rate-lowering effects. If treatment is discontinued, gradually stop CARVEDILOLO ALMUS first, and discontinue clonidine a few days later.
Antihypertensive medicines: CARVEDILOLO ALMUS may enhance the effect of other medicines taken concomitantly for the treatment of high blood pressure.
Medicines used to induce anesthesia (see section “Warnings and precautions”).
Non-steroidal anti-inflammatory drugs (NSAIDs): concomitant use with CARVEDILOLO ALMUS may lead to increased blood pressure levels and inadequate blood pressure control.
Beta-agonist bronchodilators (used to treat chest tightness and shortness of breath caused by asthma or other lung conditions); careful monitoring is recommended (see section “Warnings and precautions”).
Cyclosporine, a medicine used to prevent transplant rejection.
Fluoxetine and paroxetine, medicines used to treat depression.
Rifampicin, a medicine used to treat tuberculosis.
Cimetidine, a medicine used to treat stomach problems. The administration of carvedilol in combination with inotropic agents has not been studied.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless your doctor has determined that the potential benefits outweigh the potential risks.
Breastfeeding
The use of this medicine is not recommended if you are breastfeeding.
Driving and using machines
There are no data available on the effect of this medicine on the ability to drive vehicles or operate machinery. However, if you experience dizziness or fatigue, avoid driving or operating machinery. This is particularly important at the beginning of treatment, after dose increases, when switching products, or if you consume alcohol.
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
CARVEDILOLO ALMUS contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take CARVEDILOLO ALMUS

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablets with a sufficient amount of liquid, regardless of meals. However, if you suffer
from heart failure, take the medicine during meals to reduce the occurrence of unwanted effects,
such as a drop in blood pressure when standing up (orthostatic hypotension).
The tablet may be divided into equal parts.

Treatment of essential arterial hypertension
The recommended initial dose is 12.5 mg once daily for the first 2 days. Subsequently, the recommended dose
is 25 mg once daily. Afterwards, the dosage may be gradually increased at intervals of no less than 2 weeks, up to
the maximum recommended dose of 50 mg daily, taken either as a single dose or in two 25 mg doses per day.

Treatment of angina pectoris
The recommended initial dose is 12.5 mg twice daily for the first 2 days. Afterwards, the dosage may be increased up to
the maximum recommended dose of 25 mg twice daily.

Treatment of heart failure
Treatment must be carried out under strict medical supervision, with the doctor adjusting the dosage according to your individual needs
until the appropriate dose is reached.
The recommended initial dose is 3.125 mg twice daily for at least 2 weeks. Afterwards, if necessary, the dosage may be gradually increased
at intervals of no less than 2 weeks: first to 6.25 mg twice daily, then to 12.5 mg twice daily, and up to a maximum of 25 mg twice daily.
If the patient has heart problems (mild or moderate heart failure) and a body weight above 85 kg, the maximum recommended dose is 50 mg twice daily.
If the patient has heart problems (mild or moderate heart failure) and a body weight below 85 kg, the maximum recommended dose is 25 mg twice daily.
The maximum recommended dose is 25 mg twice daily for all patients with severe heart failure.
Your doctor must monitor your condition and assess your health status before each dosage increase.
If your heart failure or fluid retention worsens, dosage adjustments may be required, including adjustments to diuretic therapy.
If you stop treatment with this medicine for more than two weeks, therapy should be restarted with the lowest dose of 3.125 mg twice daily,
which may then be gradually increased.

Use in the elderly
Treatment of essential arterial hypertension
The recommended initial dose is 12.5 mg once daily. Subsequently, if the response is inadequate, the dosage may be increased
at intervals of no less than 2 weeks, up to the maximum recommended dose of 50 mg daily, divided into two 25 mg doses.

Treatment of angina pectoris
The recommended initial dose for the treatment of angina pectoris is 12.5 mg twice daily. This may be increased after an interval of at least 2 days
up to the maximum dose of 25 mg twice daily (a dose not to be exceeded).

If you take more CARVEDILOLO ALMUS than you should
In case of accidental overdose, contact your doctor or the nearest hospital immediately.
If you take too much of this medicine, you may experience the following symptoms:
slowing of the heartbeat (bradycardia), low blood pressure (hypotension),
inadequate heart function (heart failure), cardiogenic shock, and cardiac arrest.
Breathing difficulties, bronchospasm, vomiting, altered consciousness, and seizures may also occur.
In addition to standard emergency procedures, your doctor will monitor and correct your vital signs as needed, possibly under intensive care conditions,
and will determine the most appropriate treatment.

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

If you stop taking CARVEDILOLO ALMUS
Do not stop treatment with this medicine without consulting your doctor.
Treatment with carvedilol must not be stopped abruptly. The discontinuation of this medicine should be gradual over a period of 2 weeks,
especially if you suffer from heart circulation disorders (ischemic heart disease).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

headache and dizziness;
heart problems (heart failure);
low blood pressure (hypotension);
feeling of fatigue (asthenia).

Dizziness, syncope, headache and asthenia are generally mild and are more likely to occur at the beginning of treatment.
Common (may affect up to 1 in 10 people)

airway infections (bronchitis), lungs (pneumonia), nose and throat (upper respiratory tract);
urinary tract infections;
decrease in the number of red blood cells (anaemia);
weight gain;
increased levels of cholesterol in the blood (hypercholesterolaemia);
changes in blood sugar levels (hyperglycaemia, hypoglycaemia) in patients with diabetes;
depression, depressed mood;
pre-syncope and syncope (feeling of fainting, fainting);
vision problems, dry eyes (reduced lacrimation) and eye irritation;
decrease in the number of heartbeats (bradycardia);
hypertension;
fluid overload;
increase in circulating blood volume (hypervolaemia);
sensation of dizziness when standing up due to a rapid drop in blood pressure (orthostatic hypotension);
fluid retention causing swelling (oedema);
circulation problems in arms and legs causing cold sensation in hands and feet and pain;
worsening of Raynaud's phenomenon (tingling, colour changes and pain in fingers);
worsening of intermittent claudication (difficulty in walking);
breathing difficulties (dyspnoea), asthma, especially in predisposed patients;
fluid accumulation in the lung (pulmonary oedema);
nausea, diarrhoea, vomiting;
abdominal pain and digestive problems;
pain in extremities;
kidney problems (renal failure, changes in kidney function in patients with widespread vascular disease and/or baseline renal failure);
pain.

Uncommon (may affect up to 1 in 100 people)

sleep disorders;
tingling in extremities (paraesthesia);
heart block (atrioventricular block);
constipation;
severe chest pain (angina pectoris);
skin reactions such as rash, dermatitis, urticaria, itching, skin lesions (psoriatic lesions, lichen planus);
hair loss (alopecia);
erectile dysfunction.

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

decrease in platelets in the blood (thrombocytopenia);
nasal congestion;
dry mouth;
urinary disorders.

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

decrease in white blood cells in the blood (leucopenia);
allergic reactions (hypersensitivity);
increased levels of liver enzymes (ALT, AST, GGT);
severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).

Carvedilol may cause urinary incontinence in women, which resolves upon discontinuation of treatment.
Carvedilol may also cause the onset of diabetes symptoms in patients with a mild form of diabetes known as 'latent diabetes'.
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 national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CARVEDILOL ALMUS

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 refers to the product in its original, undamaged packaging, correctly stored.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
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 CARVEDILOLO ALMUS contains
CARVEDILOLO ALMUS 6.25 mg tablets

The active substance is carvedilolo. Each tablet contains 6.25 mg of carvedilolo.
The other components are: sucrose, lactose monohydrate, polyvinylpyrrolidone, anhydrous colloidal silica, crospovidone, magnesium stearate, yellow iron oxide (E 172).

CARVEDILOLO ALMUS 25 mg tablets

The active substance is carvedilolo. Each tablet contains 25 mg of carvedilolo.
The other components are: sucrose, lactose monohydrate, polyvinylpyrrolidone, anhydrous colloidal silica, crospovidone, magnesium stearate.

Description of the appearance of CARVEDILOLO ALMUS and contents of the pack
Box containing 28 tablets of 6.25 mg.
Box containing 30 tablets of 25 mg.
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa – Italy
E-mail: [email protected]
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) - Italy