Package Leaflet: Information for the User

Carvedilol cinfa 25 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Carvedilol cinfacontains carvedilol as the active ingredient, whichbelongs to a group of medicationsknown asalpha and beta blockers. Carvedilol has antioxidant, antihypertensive (blood pressure reduction), vasodilatory, and antianginal properties. It also reduces cardiac output, and has favorable effects on blood circulation at the heart level.

Carvedilol is indicated for the treatment of:

• Symptomatic congestive heart failure (the heart has lost some of its ability to pump blood) of moderate to severe origin, ischemic or non-ischemic.
• Essential hypertension (elevated blood pressure).
• Ischemic cardiopathy (insufficient blood and oxygen supply to the heart).

Do not take Carvedilol cinfa

• If you are allergic to carvedilol or any of the other ingredients of this medication (listed in section 6).
• If you have a type of heart failure that is decompensated (class IV), which means your heart is unable to pump blood effectively at rest and during physical activity.
• If you have chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• If your liver does not function properly.
• If you have asthma.
• If you have a heart condition that consists of a second- and third-degree atrioventricular (A-V) block (unless a permanent pacemaker has been implanted).
• If your heart beats slowly (less than 50 beats per minute).
• Heart failure (or shock, a state in which the heart has been so damaged that it is unable to supply enough blood to the body's organs).
• If you have a heart condition that consists of a sino-atrial node block.
• In case of very low blood pressure (systolic pressure less than 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carvedilol cinfa.

Inform your doctor if you have any of the following conditions:

• If you have any lung disease.
• If you are diabetic.
• If you have any heart disease.
• If you are taking other heart medications, especially if you are taking any of the following medications, inform your doctor: digitalis (increases the force of the heart's beat), diuretics (increases urine production), beta-blockers (anti-hypertensive medication), calcium channel blockers (anti-hypertensive medication), and anti-arrhythmics (act on the heart's rhythm).
• If you have any thyroid problems.
• If you are allergic and receiving allergy treatment.
• If you have circulation problems or Raynaud's phenomenon.
• If you are scheduled for surgery, inform your doctor that you are being treated with carvedilol.
• If you have a condition called pheochromocytoma.
• If you have psoriasis (skin disease).
• If you have Prinzmetal's angina (chest pain that begins during rest without obvious causes).
• If you are undergoing anesthesia. Inform your anesthesiologist.
• If you wear contact lenses. Carvedilol may reduce tear production.
• If you have severe skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome).
• As with all medications with beta-blocking activity, do not stop treatment with carvedilol abruptly. The dose should be gradually reduced according to your doctor's instructions.

Use in athletes

This medication contains carvedilol, which may produce a positive result in doping control tests.

Children and adolescents

Carvedilol is not recommended for children and adolescents under 18 years due to insufficient safety and efficacy data.

Carvedilol cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is very important, as taking multiple medications at the same time may increase or decrease their effect.

Do not take carvedilol with any other medication unless your doctor has allowed it.

These instructions may also apply to medications that have been used before or may be used afterwards.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Fluoxetine and paroxetine (depression medications).
• Ciclosporin and tacrolimus (medications used to prevent transplant rejection).
• Digoxin, verapamil, diltiazem, and anti-arrhythmic medications (medications used to treat heart problems and hypertension).
• Amiodarone (medication used to treat certain heart conditions).
• Certain analgesics, such as aspirin and ibuprofen (NSAIDs).
• Other medications for hypertension, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.
• Diabetes medications (including insulin and oral antidiabetic medications).
• Clonidine (medication used to control hypertension or migraine).
• Rifampicin (medication used to treat infections).
• Cimetidine (medication used to treat gastrointestinal problems).
• Inducers or inhibitors of hepatic metabolism (medications that modify the elimination of other medications from the body).
• Monamine oxidase inhibitors (medications used to treat depression).
• Bronchodilator β-agonists (medications used to improve respiratory function, such as in asthma).
• Adrenaline/epinephrine (used to treat severe allergic reactions).

Carvedilol cinfa with food, drinks, and alcohol

Avoid taking Carvedilol cinfa simultaneously or immediately after taking grapefruit or grapefruit juice. Grapefruit or grapefruit juice may cause an increase in the active ingredient carvedilol in the blood and lead to unpredictable adverse effects.

Avoid excessive and simultaneous or occasional consumption of alcohol, as alcohol may affect the effect of Carvedilol cinfa.

Your doctor or pharmacist will inform you about the foods with which it is recommended to take the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Carvedilol is not recommended during pregnancy and breastfeeding.

Carvedilol may cause fetal death in the womb, as well as premature birth. Additionally, adverse effects may occur in the fetus and newborn. After birth, the newborn has a higher risk of heart and lung problems.

Breastfeeding

Carvedilol passes into breast milk, so it is not recommended to use it during breastfeeding.

Driving and operating machinery

In some cases, this medication may impair your ability to drive or operate machinery. This may occur when starting or changing treatment and when taking it with alcohol.

This medication contains saccharose and lactose.If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Essential Hypertension

Adults

Oral route. The recommended starting dose is 12.5 mg once a day for the first two days. Subsequently, the recommended dose is 25 mg of carvedilol once a day. If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks), up to 50 mg once a day or in two doses of 25 mg each.

Older Patients

Oral route. The recommended starting dose is 12.5 mg once a day, which is usually sufficient. If the response is not adequate, your doctor will adjust the dose (at intervals of at least two weeks).

Ischemic Cardiopathy

Adults

Oral route. The recommended starting dose is 12.5 mg twice a day (total 25 mg per day) for the first two days. Subsequently, the recommended dose is 25 mg twice a day (total 50 mg per day). If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks), up to 50 mg twice a day (total 100 mg per day).

Older Patients

Oral route. The maximum recommended dose for older patients is 50 mg administered in divided doses (twice a day).

Chronic Heart Failure Treatment

Adults and Older Patients

Oral route

Your doctor will tell you individually the dose you should take, closely monitoring you during the adjustment to higher doses.

In case you are using heart disease medications (digitalis) or blood pressure control medications (diuretics and/or ACE inhibitors) and before starting carvedilol treatment, your doctor will adjust the amount of these types of medications you should take.

In any case, the recommended starting dose for carvedilol treatment in chronic heart failure is 3.12 mg twice a day (total 6.25 mg per day) for two weeks. If you tolerate this dose well, it can be increased later (at intervals of at least two weeks) up to 6.25 mg twice a day (total 12.5 mg per day).

Your doctor may prescribe higher doses of carvedilol later (at least two weeks after).

If you weigh less than85 kg, the maximum recommended dose is 25 mg twice a day (total 50 mg per day). If your weight is greater than85 kg, the maximum recommended dose is 50 mg twice a day (total 100 mg per day).

Your doctor will indicate the duration of your carvedilol treatment.

As a general rule, regardless of your disease, carvedilol withdrawal should be done gradually over a few days, or reduce the dose by half every three days.

Use in Children and Adolescents

Carvedilol is not recommended for use in children and adolescents under 18 years due to the lack of sufficient data on safety and efficacy.

Guidelines for Correct Administration

Take the tablets with a sufficient amount of liquid, a glass of water.

If you have congestive heart failure (your heart has lost a little of its ability to pump blood and may cause difficulty breathing, weakness, and fluid accumulation), you should take carvedilol while eating, to avoid dizziness when standing up.

Remember to take your medication.

The tablet can be split into equal doses.

If You Take More Carvedilol Cinfa Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If You Forget to Take Carvedilol Cinfa

Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Carvedilol Cinfa

Carvedilol treatment should not be interrupted abruptly, especially if you have ischemic cardiopathy, a disease that causes the heart not to pump blood well. Your doctor will gradually reduce the dose over a few days until you stop taking carvedilol completely.

If you have any other doubts about the use of thismedication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects are classified as: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).

Infections and infestations

Common:Bronchitis, pneumonia, upper respiratory tract infections, urinary tract infections.

Nervous system disorders

Very common:Headache, dizziness, and weakness, which are usually mild and occur mainly at the beginning of treatment.

Common:Presyncope, syncope (fainting), especially at the beginning of treatment.

Uncommon:Paresthesias (tingling sensation).

Mental and behavioural disorders

Common:Depressed mood, depression.

Uncommon:Sleep disorders.

Unknown frequency:Hallucinations.

Cardiac disorders

Very common:Worsening of heart failure (the heart has lost some of its ability to pump blood).

Common:Bradycardia (decreased heart rate), fluid overload, increased blood volume in the body.

Uncommon:Atrioventricular (AV) block (heart problems), and angina pectoris (chest pain).

Unknown frequency:Sinus arrest (a condition that makes heartbeats very slow or stop), especially in elderly patients or patients with other heart rhythm problems.

Vascular disorders

Very common:Low blood pressure.

Common:Postural hypotension (dizziness when standing up or changing body position), peripheral circulation disorders (cold hands and feet), worsening of symptoms in patients with intermittent claudication (increased pain in the legs when walking) or Raynaud's phenomenon (decreased blood flow to fingers and toes, ears, and nose), hypertension.

Respiratory, thoracic and mediastinal disorders

Common:Asthma and breathing difficulties in predisposed patients, fluid accumulation in the lungs.

Rare:Nasal congestion.

Gastrointestinal disorders

Common:Gastrointestinal disturbances with symptoms such as nausea, diarrhea, and abdominal pain, indigestion, vomiting.

Uncommon:Constipation.

Rare:Dry mouth.

Skin and subcutaneous tissue disorders

Uncommon:Cutaneous reactions (e.g. allergic exanthema, dermatitis, urticaria, pruritus, psoriasis, lichen planus-like skin lesions).

Unknown frequency:Hair loss, severe cutaneous adverse reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome), excessive sweating (hyperhidrosis).

Haematological and lymphatic system disorders

Common:Anemia (decreased red blood cell count in the blood).

Rare:Thrombocytopenia (decreased platelet count in the blood).

Very rare:Leucopenia (decreased white blood cell count in the blood).

Hepatobiliary disorders

Very rare:Alterations in serum transaminases (changes in the amount of certain liver enzymes in the blood).

Eye disorders

Common:Decreased tear production (dry eye), eye irritation, visual disturbances.

Renal and urinary disorders

Common:Acute renal failure (kidney not functioning properly) and renal function disorders in patients with diffuse vascular disease and/or altered renal function.

Rare:Urination problems.

Unknown frequency:Urinary incontinence in women (disappears when stopping medication).

Immune system disorders

Very rare:Allergic reactions.

Musculoskeletal and connective tissue disorders

Common:Arm or leg pain.

Reproductive and breast disorders

Uncommon:Impotence.

Metabolism and nutrition disorders

Common:Worsening of blood sugar control in diabetic patients (hyperglycemia, hypoglycemia), weight gain, increased blood cholesterol.

Unknown frequency:It is possible that latent diabetes mellitus may be manifested, or that existing diabetes may worsen.

General disorders and administration site conditions

Very common:Fatigue.

Common:Pain, edema (fluid retention, swelling of legs, ankles, and feet).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Carvedilol cinfa

• The active ingredient is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other components are: anhydrous colloidal silica, povidone (E-1201), sucrose, lactose, crospovidone, microcrystalline cellulose (E-460) and magnesium stearate.

Appearance of the product and contents of the packaging

Carvedilol cinfa 25 mg is presented in the form of white, cylindrical, biconvex, scored and marked with the code “CV25” tablets.

Each package contains 28 or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:September 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68328/P_68328.html

QR code to:https://cima.aemps.es/cima/dochtml/p/68328/P_68328.html