Carvedilol Sandoz

Package leaflet: Information for the patient

Carvedilolo Sandoz 6.25 mg tablets, 25 mg tablets

carvedilol
Generic medicine
Read this entire 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Carvedilolo Sandoz is and what it is used for

Carvedilolo Sandoz is used to treat:

• high blood pressure;
• chronic stable angina pectoris, a condition characterized by chest pain;
• stable moderate to severe heart failure, in addition to regular therapy (such as ACE inhibitors and diuretics, with or without digitalis).

Note on use in chronic heart failure:
Treatment with Carvedilolo may only be initiated if the patient has been stabilized with conventional heart failure therapy; that is, the dose of this existing standard therapy must have remained stable for at least four weeks before starting treatment with Carvedilolo.
Carvedilolo Sandoz, which belongs to a group of medicines called beta-blockers, dilates blood vessels and prevents excessive acceleration of the heartbeat.

2. What you should know before taking Carvedilolo Sandoz

Do not take Carvedilolo Sandoz:

• if you are allergic to carvedilol or to any of the other ingredients of this medicine listed in section 6;
• if you have severe heart failure requiring treatment with specific intravenous medications or causing cardiogenic shock;
• if you suffer from respiratory disorders with narrowing of the airways requiring medical treatment, such as asthma or chronic obstructive pulmonary disease;
• if you have severe liver problems;
• if you have cardiac conduction disorders, known as "sick sinus syndrome", "sinoatrial block", or "second- or third-degree atrioventricular (AV) block";
• if you have a very slow heart rate (less than 50 beats per minute);
• if you have very low blood pressure (systolic blood pressure below 85 mm Hg: this is the first value obtained when measuring blood pressure);
• if you have a condition called "Prinzmetal's angina";
• if you have an untreated tumour of the adrenal gland's medulla called "pheochromocytoma", which causes high blood pressure;
• if you have excess acid in the blood due to metabolic disorders (metabolic acidosis);
• if you have circulatory problems in the arms or legs (Raynaud's disease, intermittent claudication);
• if you are being treated with verapamil or intravenous diltiazem (see section “Other medicines and Carvedilolo Sandoz”);
• if you are taking any of the following medicines: Monoamine Oxidase Inhibitors (MAO inhibitors) (for depression); antiarrhythmics such as disopyramide for treating abnormal heart rhythms;
• if you have a blood clot in the lungs causing chest pain and shortness of breath (acute pulmonary embolism);
• if you are breastfeeding.

Do not take Carvedilolo Sandoz if any of the above conditions apply to you. If you have any doubts, consult your
doctor or pharmacist before taking Carvedilolo Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Carvedilolo Sandoz
At the beginning of treatment or when increasing the dose, your doctor will monitor you for 2 hours in the
following cases:

• if you have severe heart failure;
• if you have salt or fluid depletion;
• if you are over 65 years old;
• if you already had low blood pressure before starting treatment.

Your doctor will monitor your kidney function at each dose increase if you are being treated for heart
failure and if you have:

• low blood pressure;
• reduced blood flow to the heart;
• generalised arteriosclerosis;
• kidney problems.

Be especially careful:

• if you have diabetes: Carvedilolo Sandoz may mask signs of low blood sugar, such as rapid heartbeat and tremor;
• if you have respiratory disorders with narrowing of the airways: dose adjustment may be necessary;
• if you have overactive thyroid: Carvedilolo Sandoz may mask signs of hyperactivity (such as tremors and rapid heartbeat);
• if your heart rate drops below 55 beats per minute: Carvedilolo Sandoz may slow it further;
• if you have a mild cardiac conduction disorder known as "first-degree atrioventricular block": Carvedilolo Sandoz may worsen the condition;
• if you have poor circulation in the arms and legs: Carvedilolo Sandoz may worsen symptoms;
• if you have a circulation disorder affecting the arms and legs (called Raynaud’s phenomenon): Carvedilolo Sandoz may worsen symptoms;
• if you have or have previously had psoriasis: Carvedilolo Sandoz may worsen skin reactions;
• if you have or have previously had severe allergies or are undergoing desensitisation treatment: Carvedilolo Sandoz may intensify reactions to substances you are allergic to;
• if you wear contact lenses: Carvedilolo Sandoz may alter tear fluid secretion, causing dry eyes;
• if you are scheduled for general anaesthesia: inform the anaesthetist that you are taking Carvedilolo Sandoz, as the risk of hypotension may increase;
• if you suffer from sudden changes in blood pressure. Experience with Carvedilolo Sandoz in patients with this condition is limited;
• if you have high blood pressure due to another disease. Experience with Carvedilolo Sandoz in patients with this condition is limited;
• if you suffer from drops in blood pressure upon standing. Experience with Carvedilolo Sandoz in patients with this condition is limited;
• if you have acute inflammation of the heart. Experience with Carvedilolo Sandoz in patients with this condition is limited;
• if you have narrowing of heart valves or outflow tracts. Experience with Carvedilolo Sandoz in patients with this condition is limited.
• If you think you may have a type of angina called “Prinzmetal’s variant angina”
• If you have blood vessel problems (peripheral vascular disease)
• If you have a growth in one of the adrenal glands (pheochromocytoma)
• If you have ever had a very serious illness with blisters on the skin, mouth, eyes, and genitals (toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS)) while taking carvedilol.

Do not stop treatment with Carvedilolo Sandoz suddenly or without first consulting your
doctor.
If any of the above situations apply to you or if you are unsure, inform your doctor or
pharmacist before taking Carvedilolo Sandoz.
Particular caution is required when Carvedilolo is administered concomitantly with certain drugs such as adrenaline (also known as epinephrine) used to treat allergic (anaphylactic) reactions.
These patients may respond less effectively to treatment. Inform your doctor immediately if you have these conditions or if such circumstances are present, as they must be considered before or during treatment.
Withdrawal symptoms (withdrawal syndrome)
Treatment with Carvedilolo should not be stopped abruptly. This is particularly important in patients with heart disease due to reduced coronary artery perfusion. Instead, the dose should be gradually reduced over a period of two weeks.
Use as a doping agent
The use of carvedilol may lead to positive results in anti-doping tests. The use of carvedilol as a doping agent may be dangerous to health.
Children and adolescents
Carvedilolo Sandoz is not recommended in this patient group due to lack of data on safety and efficacy.
Elderly
Elderly patients may be more sensitive to Carvedilolo and should be monitored more closely.
Other medicines and Carvedilolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Carvedilolo Sandoz.
In particular, inform your doctor if you are taking any of the following medicines:

• other medicines for the heart or blood pressure, including diuretics
• calcium channel blockers, such as verapamil, diltiazem, amlodipine, felodipine, lacidipina, nifedipine, nicardipine, nimodipine, nitrendipine (medicines used to treat irregular heartbeats);
• nitrates (medicines used to treat heart conditions);
• clonidine, reserpine, guanethidine, methyldopa, guanfacine (medicines used to treat heart conditions). Before stopping clonidine treatment, consult your doctor;
• alpha-blockers, such as prazosin, terazosin, doxazosin, alfuzosin, urapidil, and tamsulosin (medicines used to treat high blood pressure and/or an enlarged prostate);
• amiodarone, quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone (medicines used to treat heart rhythm disorders);
• digoxin and digitoxin (medicines to treat heart weakness);
• barbiturates (for treating epileptic seizures or sleep disorders);
• phenothiazines (for treating mental disorders);
• tricyclic antidepressants (e.g. amitriptyline and imipramine), monoamine oxidase inhibitors (such as tranylcypromine and moclobemide), fluoxetine and paroxetine (used to treat depression);
• insulin or oral diabetes medications: Carvedilolo Sandoz may reduce the effect of these medicines;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, ketoprofen, or acetylsalicylic acid (medicines used to treat pain and inflammation);
• cyclosporine and tacrolimus (used to prevent rejection after organ transplantation);
• medicines used in anaesthesia, such as inhaled anaesthetics or drugs used to relax skeletal muscles;
• sympathomimetics, medicines used to treat asthma, nasal congestion, eye disorders (e.g. increased intraocular pressure), and severe acute allergic reactions;
• rifampicin (used to treat tuberculosis);
• cimetidine (used to reduce stomach acidity);
• ketoconazole (used to treat fungal infections);
• haloperidol (used to treat mental disorders);
• erythromycin (an antibiotic used to treat bacterial infections).

Carvedilolo Sandoz with food, drinks and alcohol
Carvedilol should not be taken together with grapefruit or grapefruit juice.
Grapefruit and grapefruit juice can increase blood levels of the active ingredient carvedilol, leading to unpredictable side effects.
You should also avoid excessive alcohol consumption at the same time as or close to taking the medicine, as alcohol may affect the action of carvedilol.
Surgical procedures
If you are about to undergo surgery, inform your doctor that you are taking Carvedilolo. This is because some anaesthetics can lower blood pressure, which could become dangerously low.
Pregnancy and breastfeeding
Do not take Carvedilolo Sandoz if you are pregnant, planning a pregnancy, or breastfeeding, unless your doctor has instructed you to do so. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Dizziness may occur while taking Carvedilolo Sandoz. This is more likely at the beginning of or when changing treatment, and when consuming alcohol. If this occurs, do not drive and do not operate tools or machinery.
Consult your doctor if you notice any other problems that may affect driving or the use of tools or machinery during treatment with Carvedilolo Sandoz.
Carvedilolo Sandoz contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Carvedilolo Sandoz

Always take Carvedilolo Sandoz exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
6.25/25 mg: tablets with higher or lower amounts of active substance are available.

Treatment of high blood pressure
Adults

• Initial dose: 12.5 mg once daily for the first 2 days. Treatment is then continued with 25 mg once daily.
• Maximum dose: 25 mg twice daily.

Elderly

• Initial dose: 12.5 mg once daily. This dose may be gradually increased, depending on individual needs.
• Maximum dose: 25 mg twice daily.

Treatment of angina pectoris

• Initial dose: 12.5 mg twice daily for the first 2 days. Treatment is then continued with 25 mg twice daily.
• Maximum dose: 50 mg twice daily. Elderly patients must not exceed the maximum dose of 25 mg twice daily.

Treatment of heart failure

• Initial dose: 3.125 mg twice daily. Depending on the response to treatment, this dose may be gradually increased after two weeks or more to 6.25 mg twice daily, then to 12.5 mg twice daily, and finally to 25 mg twice daily.
• Maximum dose: 25 mg twice daily. The maximum dose for patients with body weight over 85 kg and mild heart failure is 50 mg twice daily.

Your doctor will closely monitor you at the beginning of treatment and whenever the dose is increased.

Hepatic and renal impairment
The dosage will be determined by your doctor and adjusted on an individual basis.

Method of administration
Take the tablets with a glass of water, during a meal.

Duration of treatment
The duration of treatment will be determined by your doctor.

If you take more Carvedilolo Sandoz than you should
If you take more Carvedilolo Sandoz than prescribed, or if someone else takes your tablets, inform your doctor or go to hospital immediately. Bring the medicine package with you.
Symptoms of overdose include:

• excessively slow pulse;
• very low blood pressure;
• difficulty breathing;
• heart failure, which may lead to a shock-like state;
• cardiac arrest;
• decreased level of consciousness and rapid body tremors due to uncontrolled seizures.

If you forget to take Carvedilolo Sandoz
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Carvedilolo Sandoz
Do not stop taking this medicine without consulting your doctor. Your doctor may decide to discontinue treatment with Carvedilolo Sandoz gradually over 1 or 2 weeks.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carvedilolo Sandoz may cause side effects, although not everybody will experience them.
Contact your doctor immediately if you experience any of the following side effects:
Signs of severe allergic reactions, which may include sudden swelling of the throat, face, lips and mouth. This may make breathing or swallowing difficult.
Chest pain accompanied by shortness of breath, sweating and feeling unwell.
Reduced urine output, sometimes with swelling of the legs, indicating kidney problems.
Severe skin reactions, e.g. rash, redness of the skin, blistering on lips, eyes or mouth, peeling of the skin (symptoms of erythema multiforme), mouth, lip and skin ulcers (signs of Stevens-Johnson syndrome), detachment of the outer layer of skin from the underlying layers of skin over the entire body (signs of toxic epidermal necrolysis).
Very low blood sugar level (hypoglycaemia), which could cause seizures and unconsciousness.

Other side effects may occur with the following frequencies:

Very common, may affect more than 1 in 10 people :

• dizziness
• headache
• heart problems. Signs include chest pain, fatigue, shortness of breath, and swelling of arms and legs
• drop in blood pressure
• weakness
• tiredness

Common, may affect up to 1 in 10 people :

• fluid retention. Signs include: generalised swelling of the body, swelling of body parts, e.g. hands, feet, ankles and legs, and an increase in the amount of blood in the body.
• bronchitis
• pneumonia
• pain in extremities
• upper respiratory tract infection
• diarrhoea
• increase or decrease in blood sugar levels in diabetic patients
• slowing of the heartbeat
• urinary tract infection
• decrease in red blood cells, which may lead to pale skin, weakness or shortness of breath
• weight gain
• increase in cholesterol levels
• depression
• eye irritation
• vision disorders
• dry eyes
• dizziness or light-headedness when standing up
• reduced blood circulation in the upper or lower limbs
• stomach discomfort after eating
• abdominal pain
• breathing problems
• feeling unwell
• altered kidney function
• pain
• increase in blood pressure
• fluid accumulation in the lungs
• bronchial asthma in predisposed patients
• fainting (syncope)

Uncommon, may affect up to 1 in 100 people :

• sleep disorders
• tingling sensation (paraesthesia)
• constipation
• various skin reactions such as allergic rash, itching and inflammation
• psoriasiform skin reactions or worsening of existing psoriasis
• inability to achieve an erection (erectile dysfunction)
• nightmares
• hallucinations, confusion
• disturbances in conduction of electrical impulses between the upper and lower chambers of the heart (atrioventricular block)
• chest pain due to narrowing of the blood vessels of the heart

Rare, may affect up to 1 in 1,000 people :

• reduced number of platelets. Signs include easy bruising and nosebleeds
• nasal congestion
• dry mouth

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

• abnormal liver function test results
• reduced number of white blood cells. Signs include mouth, gum, throat and lung infections
• allergic reactions (hypersensitivity). Signs may include difficulty breathing or swallowing due to sudden swelling of the throat or face, or swelling of the hands, feet and ankles
• urinary incontinence in women
• certain types of psychiatric disorders (psychosis)

Not known: frequency cannot be estimated from the available data

• hair loss
• excessive sweating (hyperhidrosis)

Carvedilolo Sandoz may also cause the development of signs of diabetes in people who have a very mild form of diabetes called "latent diabetes".
Carvedilolo may also cause sinus node arrest (the heart's natural 'pacemaker' which controls heart contractions and regulates heart rate) in predisposed patients (e.g. elderly patients or patients with pre-existing slow heart rate (bradycardia), sinus node dysfunction or heart rhythm disorders).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging or container after "Exp". The expiry date refers to the last day of the month.
Store in the original packaging.
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 Sandoz contains

• The active substance is carvedilolo.
• Each tablet contains 6.25 mg of carvedilolo.
• Each tablet contains 25 mg of carvedilolo.
• The other components are: monohydrate lactose, crospovidone, povidone (K25), anhydrous colloidal silica, magnesium stearate, sucrose.

Description of the appearance of Carvedilolo Sandoz and package contents
6.25 mg tablets:
white, oval, slightly biconvex tablet, marked with the code "S2" on one side and a break line on the opposite side.
25 mg tablets:
white, round, slightly biconvex tablet with bevelled edges and a break line on one side.
The tablets are packaged in laminated foil blisters (OPA/Al/PVC/Al), which are placed into cardboard cartons or HDPE bottles with PP caps and a PE desiccant insert filled with silica gel.
Pack sizes:
Blister packs: 7, 10, 14, 28, 30, 32, 50, 56, 60, 98, 100, 100x1, 120 and 250 tablets.
HDPE containers: 7, 10, 14, 28, 30, 32, 50, 56, 60, 98, 100, 100x1, 120 and 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Salutas Pharma GmbH – Otto-Von-Guericke – Alle 1 – 39179 – Barleben – Germany
Lek Pharmaceuticals d.d, - Verovškova 57 – 1526 Ljubljana - Slovenia

This medicinal product has been authorised in the EEA Member States under the following names:
Italy: Carvedilolo Sandoz