Patient Information Leaflet

Carvedilolo Hexal 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, ask 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 side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

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

Carvedilolo Hexal belongs to a group of medicines called beta-blockers. These relax and widen blood vessels and prevent the heart from beating too fast.
Carvedilolo Hexal is used to treat:
high blood pressure
chronic stable angina pectoris, a condition characterized by chest pain due to inadequate blood supply to the heart muscle
moderate to severe chronic stable heart failure in combination with other medicines (such as ACE inhibitors and diuretics, with or without digitalis).
The symptoms of this persistent reduced heart function are swollen ankles and shortness of breath.
Note on use in chronic heart failure:
Treatment with Carvedilolo may only be initiated if the patient has been stabilized with conventional therapy for heart failure; that is, the dose of this existing standard therapy must have remained stable for at least four weeks before starting treatment with Carvedilolo.

2. What you should know before taking Carvedilolo Hexal

Do not take Carvedilolo Hexal if you are/have

allergic to carvedilolo or to any of the other ingredients of this medicine (listed in section 6)
severe heart failure requiring intravenous administration of medications
cardiogenic shock
a history of airway narrowing in the lungs, or asthma
severe liver disease
a cardiac conduction disorder, known as
second- or third-degree AV block
sick sinus syndrome including sinoatrial block
a pulse rate of less than 50 beats per minute
severe heart failure with severe circulatory problems
blood pressure systolic/upper lower than 85 mm Hg
excess acid in the body due to a metabolic disorder (a condition called metabolic acidosis)
treatment with verapamil or intravenous diltiazem; both are medicines used to treat blood pressure and heart conditions
a blood clot in the lungs causing chest pain and shortness of breath (acute pulmonary embolism)
a specific type of chest pain (Prinzmetal's angina)
been told you have high blood pressure due to a tumor near the kidney (pheochromocytoma)
are taking any of the following medicines: Monoamine Oxidase (MAO) Inhibitors (for depression) or antiarrhythmics such as disopyramide for treating abnormal heart rhythms
are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Carvedilolo Hexal if you have or have ever had any of the following conditions:

heart failure See the second bullet list in the previous section “Do not take Carvedilolo Hexal” if you suffer from severe heart failure
reduced kidney function
recent heart attack and heart failure due to this
breathing difficulties called chronic obstructive pulmonary disease (COPD) with airway narrowing in the lungs
diabetes Monitoring of blood glucose levels is advised and, if necessary, treatment should be adjusted. Carvedilolo Hexal may mask the symptoms of low blood sugar
circulation problems in arms and legs Symptoms include cold fingers and toes, increased numbness, aching in fingers or toes turning pale, then bluish, and finally reddish
overactivity of the thyroid gland
need to undergo anesthesia or general surgery Inform your doctor if you are taking Carvedilolo Hexal
reduced heart rate Your doctor will adjust the dose if your pulse is below 55 beats per minute. Also, refer to the seventh bullet point in the section "Do not take Carvedilolo Hexal" if your pulse is below 50 beats per minute
previous severe hypersensitivity reactions or undergoing desensitization therapy for pollen or other allergens
psoriasis or have ever suffered from this skin condition
tumor of the adrenal medulla – the inner parts of the two glands located above the kidneys – affecting blood pressure
mild first-degree heart block
wearing contact lenses Carvedilolo Hexal may reduce tear fluid secretion, causing dry eyes
fluctuating high blood pressure or caused by an underlying disease
drop in blood pressure when standing up quickly, causing dizziness or fainting
an inflammatory heart disease
obstruction of heart valves or outflow tract
artery disorders in arms and/or legs
if you think you have a type of angina called “Prinzmetal’s variant angina”
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 carvedilolo

When Carvedilolo is administered simultaneously with certain drugs such as adrenaline (also known as epinephrine) for treating allergic (anaphylactic) reactions, particular caution is required. 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 must not be stopped abruptly. This is especially 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.

Children and adolescents
Carvedilolo is not recommended for children and adolescents under 18 years of age due to lack/insufficiency 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 Hexal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Inform your doctor if you are taking any of the following medicines:

other medicines for your heart or blood pressure, including diuretics
amiodarone or other medicines for treating irregular heartbeat
digoxin, digitoxin: medicines for treating heart failure
diltiazem, verapamil: medicines for treating hypertension and heart problems Refer to the last bullet list under “Do not take Carvedilolo Hexal” if you are taking diltiazem or verapamil intravenously
amlodipine, felodipine, nifedipine or any other medicine for treating high blood pressure
insulin or oral medicines for treating diabetes
rifampicin, erythromycin, clarithromycin, telithromycin: medicines for treating bacterial infections
cimetidine: a medicine to reduce stomach acidity
ketoconazole: a medicine for treating fungal infections
fluoxetine and paroxetine: medicines for treating depression
haloperidol: a medicine for treating mental disorders
reserpine, guanethidine, methyldopa, guanfacine: medicines for treating high blood pressure and heart failure
clonidine: a medicine for treating high blood pressure and eye pressure
moclobemide, phenelzine: medicines for treating depression
cyclosporine or tacrolimus: a medicine to suppress the immune system, used to treat severe skin diseases and severe eye or joint inflammation. Careful monitoring of cyclosporine blood levels is recommended after starting treatment with Carvedilolo Hexal.
ergotamine: a medicine for treating migraine
nitrates: medicines for treating chest pain caused by narrowing of blood vessels
medicines for treating mental disorders, nausea or vomiting whose active ingredient names mostly end in "azine"
certain medicines for treating depression, mental disorders or anxiety, called tricyclic antidepressants, such as imipramine, doxepin, amitriptyline, opipramol
medicines for treating epilepsy or for sedation, whose active ingredient names mostly end in "tal"
medicines for treating pain, inflammation or rheumatism called non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac
adrenaline: a medicine for treating cardiac and vascular collapse, severe allergic reactions, and used in local anesthesia
beta-agonists: medicines to widen airways such as salbutamol, terbutaline
anesthetics
muscle-relaxing medicines (neuromuscular blocking agents)
dihydropyridines (medicines used to treat high blood pressure or angina pectoris)

Use as a doping agent
The use of carvedilolo may lead to positive results in anti-doping tests. The use of carvedilolo as a doping agent may be dangerous to health.

Carvedilolo Hexal with food, drinks and alcohol
Carvedilolo should not be taken together with grapefruit or grapefruit juice.
Grapefruit and grapefruit juice can increase levels of the active substance Carvedilolo in the blood, leading to unpredictable side effects.

Carvedilolo Hexal with alcohol
Avoid consuming alcohol during treatment with Carvedilolo Hexal, as it may enhance the effects of alcohol.

Surgery
If you are about to undergo surgery, inform your doctor that you are taking carvedilolo. This is because some anesthetics can lower blood pressure, which could become excessively low.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Carvedilolo Hexal is not recommended during pregnancy unless your doctor considers it strictly necessary.
If treatment during pregnancy is essential, treatment with Carvedilolo Hexal should be discontinued 2 or 3 days before the expected delivery. If this is not possible, the newborn must be monitored during the first 2 or 3 days of life.

Breastfeeding
Breastfeeding is not recommended during treatment with Carvedilolo Hexal.

Driving and using machines
Carvedilolo Hexal may cause undesirable effects such as dizziness, fainting, or feeling weak, especially at the beginning of treatment or after dose increases.
Do not drive or operate machinery if you experience side effects that impair your reaction ability. Consult your doctor if you notice any other problems that may affect driving, use of tools, or machinery during treatment with Carvedilolo Hexal.

Carvedilolo Hexal contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Carvedilolo Hexal

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tablets with a higher amount of active substance are also available.

The recommended dose is:

High blood pressure

Adults
- Initial dose: 1 tablet of Carvedilolo Hexal 12.5 mg once daily for the first two days. Treatment should continue with 1 tablet of Carvedilolo Hexal 25 mg once daily. If necessary, your doctor may increase the dose at intervals of no less than 2 weeks. The maximum single recommended dose is 1 tablet of Carvedilolo Hexal 25 mg.
- Maximum dose: 1 tablet of Carvedilolo Hexal 25 mg twice daily
Patients over 65 years
- Initial dose: 1 tablet of Carvedilolo Hexal 12.5 mg once daily. This dose may be sufficient to control blood pressure. If necessary, your doctor may increase the dose at intervals of no less than 2 weeks.

Chronic stable angina pectoris

Adults
- Initial dose: 1 tablet of Carvedilolo Hexal 12.5 mg twice daily for the first two days. Treatment should continue with 1 tablet of Carvedilolo Hexal 25 mg twice daily. If necessary, your doctor may increase the dose at intervals of no less than 2 weeks.
- Maximum dose: 1 tablet of Carvedilolo Hexal 50 mg twice daily
Patients over 65 years
- Initial dose: 1 tablet of Carvedilolo Hexal 12.5 mg twice daily for the first two days. Treatment should continue with 1 tablet of Carvedilolo Hexal 25 mg twice daily.
- Maximum dose: 1 tablet of Carvedilolo Hexal 25 mg twice daily

Heart failure

Initial dose: 1 tablet of Carvedilolo Hexal 3.125 mg twice daily for two weeks. If this dose is tolerated for at least two weeks, the dose will be increased to 1 tablet of Carvedilolo Hexal 6.25 mg twice daily. Further increases will be made at intervals of at least two weeks, depending on tolerance to the medicine.
Maximum dose according to body weight:
- Patients weighing less than 85 kg: 1 tablet of Carvedilolo Hexal 25 mg twice daily
- Patients weighing 85 kg or more: 1 tablet of Carvedilolo Hexal 50 mg twice daily

Your symptoms of heart failure may temporarily worsen at the beginning of treatment or during dose escalation. This is especially likely if you have severe heart failure and are taking high-dose diuretics. This does not mean you should stop treatment. If this occurs, your doctor may adjust the dose of your other medicines.
Refer to point two under "Do not take Carvedilolo Hexal" in section 2 if you have severe heart failure as described in that section.
Inform your doctor if you notice a marked slowing of your heartbeat. Refer to point seven under "Do not take Carvedilolo Hexal" in section 2 if your heart rate is below 50 beats per minute.

Reduced kidney or liver function
Your doctor may adjust the dose according to your individual needs.

Use in children and adolescents
Carvedilolo Hexal is not recommended for this age group due to lack of experience in these patients.

Patients over 65 years
Your doctor will monitor your health more closely, as you may be more sensitive to the effects of Carvedilolo Hexal.

Instructions for use
Swallow the tablets with a glass of water during meals. Do not chew the tablets.

Instructions for tablet splitting
To split the tablet, place it on a flat, hard surface with the score line facing upwards. Press evenly with your finger at the center of the tablet until it breaks into two parts. The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

Duration of treatment
This should be determined by your doctor.

If you take more Carvedilolo Hexal than you should
Contact your doctor or the nearest emergency department immediately. Take the package, this leaflet, and any remaining tablets with you.
Symptoms of overdose may include:
marked lowering of blood pressure
very slow heartbeat
heart failure
difficulty breathing
loss of consciousness
vomiting
seizures

If you forget to take Carvedilolo Hexal
Do not take a double dose to make up for the forgotten dose. Simply take the next dose at your usual time.

If you stop taking Carvedilolo Hexal
Do not stop taking Carvedilolo Hexal suddenly and without your doctor's approval. Normally, your doctor will gradually reduce the dose; otherwise, your symptoms may worsen.

If you have any doubts about using 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.
Contact your doctor immediately if you experience any of the following side effects:

Severe allergic reactions Signs of severe allergic reactions include sudden swelling of the throat, face, lips and mouth, difficulty breathing or swallowing.
Chest pain accompanied by shortness of breath, sweating and feeling unwell.
Reduced urine output less frequently, with swelling of the legs, indicating kidney problems.
Severe skin reactions such as
- erythema multiforme: skin rash with fever and blisters
- Stevens-Johnson syndrome: severe skin rash with fever and blisters
- toxic epidermal necrolysis: peeling off of the upper layer of skin over the entire body.
Very low blood sugar level which could cause seizures and unconsciousness.

Side effects may occur with the frequencies described below:
Very common: may affect more than 1 in 10 people

dizziness
headache
worsening of heart failure manifested as shortness of breath, swollen ankles
low blood pressure
fatigue.

Common: may affect up to 1 in 10 people

bronchitis, lung inflammation, respiratory infections
urinary tract infections which may cause problems with passing urine
low red blood cell levels
weight gain
increased cholesterol levels
increase or decrease in blood sugar levels in patients with diabetes
depression, depressed mood
visual disturbances
dry eyes, eye irritation
slow heartbeat
swelling of tissues due to excess fluid, fluid overload
drop in blood pressure when standing up quickly
impaired blood circulation to arms and legs, manifested as
- cold hands or feet
- muscle pain or
- pain in fingers or toes, numbness, fingers or toes turning white, then blue, and finally red
difficulty breathing
fluid accumulation in the lungs, worsening of asthma symptoms
feeling unwell (nausea) or discomfort (vomiting)
diarrhoea
heartburn, stomach ache
pain in arms and legs, generalised pain
reduced and other alterations in kidney function
urinary disorders
fainting
high blood pressure

Uncommon: may affect up to 1 in 100 people

sleep disorders
nightmares
hallucinations, confusion
abnormal sensations such as tingling and itching
altered conduction of electrical impulses between the upper and lower chambers of the heart
chest pain due to narrowing of blood vessels
skin reactions, such as allergic rash, skin inflammation, hives, itching
psoriasis, psoriasis appearing as a skin reaction
inability to achieve an erection (impotence disorders)
constipation

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

reduced platelet count which may lead to increased tendency to bruise or nosebleeds
nasal congestion
dry mouth

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

reduced white blood cell count which may cause symptoms of infection, unexplained fever, sore throat
allergic reactions. Signs may include difficulty breathing or swallowing due to sudden swelling of the throat or face, or swelling of the hands, feet and ankles
liver problems (increased levels of liver enzymes – ALT, AST, GGT)
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 Hexal may also cause the development of signs of diabetes in people with latent diabetes.
Carvedilol may also cause sinus node arrest (the heart's natural 'pacemaker' that controls heartbeats and regulates heart rate) in predisposed patients (e.g. in 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Carvedilolo Hexal

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 blister and on the packaging or container after "Exp.". The expiry date refers to the last day of the month.
High-density polyethylene (HD-PE) container:
Do not store above 30°C. Store in the original container to protect the medicine from light.
Blister:
Do not store above 25°C. Store in the original packaging to protect the medicine from light.
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 Hexal 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, microcrystalline cellulose, crospovidone, povidone K30, anhydrous colloidal silica, magnesium stearate, yellow iron oxide (E172) (only in 6.25 mg tablets).

Description of the appearance of Carvedilolo Hexal and package contents
6.25 mg:
Yellow, round, biconvex, scored tablet with code C2 on one side.
25 mg:
White, round, biconvex, scored tablet with code C4 on one side.
Pack sizes:
Containers and closures made of polyethylene (PE/HD): 28, 30, 60, 100, 250 and 500 tablets
Blister packs (Al/PVC): 14, 20, 28, 30, 50, 50x1, 56, 60, 98, 98x1 and 100 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-Allee 1
D-39179 Barleben (Germany)
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana (Slovenia)

This medicinal product has been authorised in EEA Member States under the following names:
Finland: Carvedilol HEXAL 3.125 mg tablets
Carvedilol HEXAL 6.25 mg tablets
Carvedilol HEXAL 12.5 mg tablets
Carvedilol HEXAL 25 mg tablets
Carvedilol HEXAL 50 mg tablets
Italy: Carvedilolo HEXAL