Package Insert: Information for the User

Carvedilol Cinfamed 25mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

1. What Carvedilol Cinfamed is and for what it is used

2. What you need to know before starting to takeCarvedilol Cinfamed

3. How to takeCarvedilol Cinfamed

4. Possible adverse effects

5. Storage ofCarvedilol Cinfamed

6. Contents of the package and additional information

This medication contains carvedilol as the active ingredient, which belongs to a group of medications known asalpha and beta receptor blockers. Carvedilol has antioxidant properties, antihypertensive (blood pressure reduction) properties, vasodilatory properties, and antianginal properties. It also reduces cardiac output, and has favorable effects on blood circulation at the heart level.

This medication is indicated for the treatment of:

Do not take Carvedilol Cinfamed:

• If you are allergic to carvedilol or any of the other components of this medication (listed in section 6).
• Severe heart failure (class IV) (heart's inability to pump blood during physical activity and at rest).
• Chronic obstructive pulmonary disease (COPD) with obstructed bronchi (difficulty breathing).
• If your liver does not function properly.
• Asthma.
• Heart disease consisting of 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).
• Heart disease consisting of sino-auricular node block.
• Very low blood pressure (systolic pressure of less than 85 mmHg).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

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

• If you have any lung disease.
• If you are diabetic.
• If you have 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 (increase urine production), ACE inhibitors (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 disease 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 responsible 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 beta-blocker medications, do not stop treatment 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.

Carvedilol Cinfamed with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

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

Be aware that these instructions may also apply to medications that have been used before or may be used later.

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 (medication used to prevent transplant rejection).

-Digoxin, Verapamil, Diltiazem, and anti-arrhythmic medications (medications used to treat heart problems and high blood pressure).

-Amiodarone (medication used to treat certain heart problems).

-Certain analgesics of the type of Aspirin and Ibuprofen (NSAIDs).

-Other blood pressure medications, barbiturates, phenothiazines, tricyclic antidepressants, vasodilators, and alcohol.

-Diabetes medications (including insulin and oral antidiabetic medications).

-Clonidine (medication used to control high blood pressure 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).

-MAO inhibitors (medications for depression).

-Beta-agonist bronchodilators (medications used to improve respiratory function, such as in asthma).

Carvedilol Cinfamed with food and drinks

Avoid taking alcohol during treatment with this medication, as it may modify its effects.

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 before using this medication.

This medication 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.

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 occurs especially when starting or changing treatment and when taken with alcohol.

Carvedilol Cinfamed contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. 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 once a day. If necessary, your doctor may increase the dose you receive (at intervals of at least two weeks) 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) to 100 mg once a day or in two doses of 50 mg each.

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

Treatment of symptomatic congestive heart failure

Adults and elderly:

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

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

In any case, the recommended starting dose for treatment with this medication in symptomatic congestive 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) to 6.25 mg twice a day (total 12.5 mg per day).

Your doctor may prescribe higher doses of this medication 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 (100 mg per day).

Your doctor will indicate the duration of your treatment with this medication.

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

Use in children and adolescents

This medication 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 this medication while eating, to avoid the feeling of dizziness when getting up.

Remember to take your medication.

If you take more Carvedilol Cinfamed than you should

If you take more Carvedilol Cinfamed than you should, contact your doctor immediately or go to the nearest hospital. Bring the medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Telephone 91 562.04.20.

If you forgot to take Carvedilol Cinfamed

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

If you interrupt treatment with Carvedilol CinfamedCinfamed

Treatment with this medication 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 this medication completely.

If you have any other questions about the use of this medication, 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 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), 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 that 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.

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).

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 the fingers and toes, ears, and nose), hypertension.

Respiratory, thoracic and mediastinal disorders

Common:Asthma and breathing difficulties in predisposed patients, pulmonary congestion.

Rare:Nasal congestion.

Gastrointestinal disorders

Common:Gastrointestinal discomfort with symptoms such as nausea, diarrhea, 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).

Haematological and lymphatic system disorders

Common:Anemia (decreased red blood cell count).

Rare:Thrombocytopenia (decreased platelet count).

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

Hepatobiliary disorders

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

Ocular 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 treatment).

Immune system disorders

Very rare:Allergic reactions.

Musculoskeletal and connective tissue disorders

Common:Arm and 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: Possible manifestation of latent diabetes, or worsening of existing diabetes.

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, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep out of sight and reach of children.

Do not store at a temperature above30°C. Store in the original packaging to protect it from humidity.

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 unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Carvedilol Cinfamed

• The active ingredient is carvedilol. Each tablet contains 25 mg of carvedilol.
• The other components are: Core: microcrystalline cellulose, lactose monohydrate, povidone, crospovidone, anhydrous colloidal silica, magnesium stearate (E470b); Coating: titanium dioxide (E-171), polydextrose, hypromellose, triethyl citrate, macrogol 8000.

Appearance of the product and contents of the packaging

Carvedilol Cinfamed tablets are white, oval-shaped, coated tablets with a notch on both faces and marked with “25” on one face.

This medication is presented in PVC/Aclar/Al blisters in packaging of 28 or 500 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España.

Responsible for manufacturing:

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

Alcalá de Henares

28805 (Madrid)

España

Or

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Last review date of this leaflet:June 2016

Detailed and updated information on 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 on 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/65869/P_65869.html

QR code to:https://cima.aemps.es/cima/dochtml/p/65869/P_65869.html

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