Patient Information Leaflet

Carvedilol Teva-ratiopharm 6.25 mg Tablets

carvedilol

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.

1. What Carvedilol Teva-ratiopharm is and what it is used for

2. What you need to know before you start taking Carvedilol Teva-ratiopharm

3. How to take Carvedilol Teva-ratiopharm

4. Possible side effects

5. Storage of Carvedilol Teva-ratiopharm

6. Contents of the pack and additional information

Carvedilol Teva-ratiopharm belongs to the group of alpha and beta-blockers. Carvedilol is used in the treatment of high blood pressure and in the treatment of angina pectoris. Carvedilol is also used as a complementary treatment in heart failure.

No take Carvedilol Teva-ratiopharm

• If you are allergic to carvedilol or any of the other ingredients of this medication (listed in section 6),
• If you haveunstable or decompensated heart failureor certain types ofheart conduction disorders(type II and III AV block, unless you have a pacemaker, or sick sinus syndrome),
• If you have aliver diseasethat causes problems,
• If you have avery slow heart rate (less than 50 beats per minute)orvery low blood pressure,
• If you haveseverely compromised cardiac function(cardiogenic shock),
• If you have asevere acid-base imbalancein the body (metabolic acidosis, acidemia),
• If you haveasthmaor otherrespiratory diseaseswith a tendency to cause throat constriction (e.g., chronic obstructive pulmonary disease),
• If you havesevere respiratory problems(acute pulmonary embolism),
• If you have an unusual type of chest pain (Prinzmetal's angina),
• If you have heart failure due to respiratory disease (cor pulmonale),
• If you havepheochromocytomaand are not being treated with medication,
• If you are takingMAO inhibitors(e.g., moclobemide) (except MAO-B inhibitors),
• If you are receiving intravenous treatment withverapamil, diltiazemor other medications used to treat heart rhythm disorders (antiarrhythmics),
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Carvedilol Teva-ratiopharm

• If you haveheart failureaccompanied by

• low blood pressure,
• reduced blood flow and oxygen supply to the heart(ischemic cardiopathy) andarterial hardening(atherosclerosis)
• and/orrenal problems,

Your kidney function should then be monitored. You may need to reduce your dose.

• If you have had aheart attack.This should be treated before taking carvedilol,
• If you have a certain type ofheart conduction disorder(type I AV block),
• If you havehypertensiondue to an organic cause,
• If you havediabetes. Treatment with Carvedilol Teva-ratiopharm may mask the signs of low blood sugar. Therefore, your blood sugar should be monitored regularly,

• If you haveseverely reduced blood flow to the hands and feet,
• Simultaneous treatment with medications used to treat heart failure (digitalis glycosides) or heart rhythm disorders (e.g., verapamil, diltiazem)
• Low blood pressure (orthostatic hypotension),
• Acute inflammatory cardiopathy,
• Stenosis of the heart valves or outflow tract,
• Terminal peripheral artery disease,
• Lability or secondary hypertension,
• Simultaneous treatment with other hypotensive medications (alpha-1 receptor antagonists or alpha-2 receptor agonists),
• If you haveRaynaud's phenomenon(the fingers of the hands or feet turn blue, then white, and then red with pain). Carvedilol Teva-ratiopharm may worsen the symptoms,
• If you havehyperthyroidism, with high production of thyroid hormone, Carvedilol Teva-ratiopharm may mask the symptoms,
• If you are using Carvedilol Teva-ratiopharm and are to undergosurgerywith an anesthetic. You should consult with the responsible anesthesiologist well in advance,
• If you have avery slow heart rate (less than 55 beats per minute),
• If you have asevere allergic reaction(e.g., to an insect bite or food) or if you are undergoing or will undergoallergen desensitizationbecause Carvedilol Teva-ratiopharm may weaken the effectiveness of medications used to treat such allergic reactions,
• If you havepsoriasis,
• Severe skin reactions (e.g., toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome [SJS]),
• If you usecontact lenses. Carvedilol may reduce tear production.

Children and adolescents

There is insufficient data on the efficacy and safety of carvedilol in children and adolescents under 18 years of age. Therefore, carvedilol should not be used in this patient group.

Older patients

Older patients may be more sensitive to carvedilol and should be monitored more closely.

Other medications and Carvedilol Teva-ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Other concomitant treatment may affect or be affected by carvedilol.

It isespecially importantthat your doctor knows if you are already being treated with:

• Digoxinor digitoxin(for treating heart failure).
• Insulinororal antidiabetic drugs(medications that reduce blood sugar) as the reduction in blood sugar may be increased and the symptoms of hypoglycemia may be masked.
• Rifampicin(antibiotic used in the treatment of tuberculosis).
• Carbamazepine(medication for treating epilepsy).
• Fluconazole(medication for treating fungal infections).
• Paroxetine, fluoxetine, bupropion(medications for treating depression).
• Medications containingreserpine, guanitidine, methyldopa, guanfacine, or monoamine oxidase inhibitors (MAOIs)(medications for treating depression and Parkinson's disease), as they may lead to a greater reduction in heart rate.

• Ciclosporin or tacrolimus(medication for inhibiting the immune system, for preventing rejection after organ transplantation, also used for certain rheumatic or dermatological problems).
• Medications for treating irregular heartbeats(e.g., verapamil, diltiazem, quinidine, amiodarone).
• Clonidine(medication for reducing blood pressure).
• Sympathomimetics(medications that increase the function of the sympathetic nervous system).
• Medications used to treat respiratory problems (e.g.,salbutamol, formoterol).
• Dihydropyridines(medications for treating high blood pressure and heart disease).
• Other medications that reduce blood pressure. Carvedilol may potentiate the effect of other medications that reduce blood pressure taken concomitantly (e.g.,alpha-1 receptor antagonists, nitrates) and medications in which blood pressure reduction occurs as an adverse effect, for examplebarbiturates(in the treatment of epilepsy),phenothiazines(for treating psychosis),tricyclic antidepressants(for treating depression),vasodilators(medications that widen blood vessels).
• Neuromuscular blockers(medications that reduce muscle tension).
• Ergotamine(medication for migraines).

• Anesthetics(medications used in anesthesia).

• Determined analgesic tablets(NSAIDs),estrogens(hormones), andcorticosteroids(adrenal hormone), as they may reduce blood pressure, reducing the effect of Carvedilol Teva-ratiopharm.

• Cinacalcet(medication used for treating parathyroid gland problems).

Carvedilol Teva-ratiopharm with food, drinks, and alcohol

Carvedilol should be avoided when taken at the same time or near grapefruit or grapefruit juice during the initiation of treatment. Grapefruit and grapefruit juice may cause an increase in the amount of carvedilol in the blood and, possibly, unpredictable side effects. During treatment with carvedilol, the consumption of alcohol should be limited, as alcohol may affect how carvedilol works.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using any medication.

There is a risk of fetal damage. Carvedilol Teva-ratiopharm should only be used during pregnancy if your doctor considers it necessary. Therefore, always consult your doctor before using Carvedilol Teva-ratiopharm tablets during pregnancy.

It is not known whether Carvedilol Teva-ratiopharm passes into human breast milk, and therefore it should not be used during lactation.

Driving and operating machinery

Dizziness and fatigue may occur at the beginning of treatment, after increasing the dose, when changing treatment, or in combination with alcohol. At therapeutic doses, it is not known whether carvedilol reduces the ability to drive or operate machinery. If you feel dizzy or weak when taking the tablets, you should avoid driving or work that requires great attention.

Carvedilol Teva-ratiopharm contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. If you feel that the effects of Carvedilol Teva-ratiopharm are too strong or too weak, speak with your doctor or pharmacist.

You should swallow the tablets with at least half a glass of water. You can take the tablets with or without food. Patients with heart failure should, however, take the tablets with food to reduce the risk of dizziness when standing up suddenly.

The tablets can be divided into equal doses.

Carvedilol Teva-ratiopharm tablets are available in the following concentrations: 6.25 mg, and 25 mg

Hypertension

Adults

The usual dose is 1 tablet of Carvedilol 12.5 mg (which corresponds to 12.5 mg of carvedilol) for the first two days and 2 tablets of Carvedilol 12.5 mg (which corresponds to 25 mg of carvedilol) once a day thereafter. For this dosing, other concentrations of carvedilol are also available.

If necessary, the dose can be increased gradually at intervals of at least two weeks. The maximum recommended daily dose is 50 mg.

Older patients

The recommended dose is 1 tablet of Carvedilol 12.5 mg (which corresponds to 12.5 mg of carvedilol) once a day.

If necessary, the dose can be increased further gradually at intervals of at least two weeks up to a maximum daily dose of 50 mg.

Angina pectoris

Adults

The usual dose is 1 tablet of Carvedilol 12.5 mg (which corresponds to 12.5 mg of carvedilol) twice a day for the first two days and 2 tablets of Carvedilol 12.5 mg (which corresponds to 25 mg of carvedilol) twice a day thereafter. For this dosing, other concentrations of Carvedilol Teva-ratiopharm are also available.

If necessary, the dose can be increased gradually at intervals of at least two weeks. The maximum recommended daily dose is 100 mg.

Older patients

The usual dose is 1 tablet of Carvedilol 12.5 mg (which corresponds to 12.5 mg of carvedilol) twice a day for the first two days and 2 tablets of Carvedilol 12.5 mg (which corresponds to 25 mg of carvedilol) twice a day thereafter. The maximum recommended daily dose is 50 mg.

Heart failure

The usual initial dose is 3.125 mg of carvedilol twice a day for two weeks. The dose can be increased incrementally, usually at intervals of two weeks.

However, it may be necessary to increase or decrease the dose. Your doctor will advise accordingly.

The maximum recommended dose is 25 mg administered twice a day in patients weighing less than 85 kg, and 50 mg twice a day in patients weighing more than 85 kg, provided that the heart failure is not severe. The dose should be increased to 50 mg twice a day carefully with close medical supervision.

If you take more Carvedilol Teva-ratiopharm than you should

If you take more Carvedilol Teva-ratiopharm than you should, or if children have taken the medication by accident, contact your doctor, the hospital, or call emergency services to obtain an assessment of the risk and advice on the action to be taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

The symptoms of overdose may include a feeling of faintness due to excessively low blood pressure, low heart rate, and in severe cases, pauses in heartbeats. Respiratory difficulties, narrowed airways, discomfort, decreased level of consciousness, and seizures may also occur.

If you forget to take Carvedilol Teva-ratiopharm

If you forget a dose (or more doses), take the next dose at the usual time.

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

If you interrupt treatment with Carvedilol Teva-ratiopharm

Do not stop your treatment suddenly or change the dose unless your doctor tells you to. Your treatment should be withdrawn gradually over a period of two weeks. Sudden interruption may worsen your symptoms.

If you have any other doubts 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.

Most side effects are related to the dose and disappear when the dose is reduced or treatment is stopped. Some side effects may occur at the beginning of treatment and resolve spontaneously as treatment continues.

Contact your doctor immediately if you experience any of the following side effects

• Chest pain with simultaneous difficulty breathing, sweating, and nausea (can affect up to 1 in 100 people).
• Severe skin reactions, such as skin rash, redness, blisters on the lips, around the eyes or mouth, scaly skin (symptoms of erythema multiforme), mouth sores, lips, and skin (signs of Stevens-Johnson syndrome), peeling of the top layer of the skin of the lower layers of the skin of the entire body (signs of toxic epidermal necrolysis) (very rare frequency).

Very common (can affect more than 1 in 10 people)

• Dizziness,
• Headache,
• Heart failure,
• Low blood pressure,
• Weakness.

Common (can affect up to 1 in 10 people)

• Bronchitis, pneumonia, upper respiratory tract infection,
• Urinary tract infections,
• Reduction in the number of red blood cells in the blood,

• Weight gain,
• Elevated cholesterol levels,
• Loss of blood sugar control in people with diabetes,
• Depression, depressive mood,
• Visual disturbances,
• Decreased tear production, eye irritation,
• Low heart rate,
• Edema (inflammation of the body or parts of the body), fluid overload, increased blood volume in the body,
• Dizziness when standing up suddenly,
• Fainting,
• Problems with blood circulation (the signs include cold hands and feet), hardening of the arteries (atherosclerosis), worsening of symptoms in patients with Raynaud's disease (the fingers of the hands and feet first turn blue, then white, and then red with pain) or claudication (pain in the legs that worsens when walking),
• Asthma and respiratory problems,
• Fluid accumulation in the lungs,
• Diarrhea,
• Discomfort, nausea, vomiting, stomach pain, indigestion,
• Pain (e.g. in arms and legs),
• Acute kidney failure and renal function disorders in patients with hardening of the arteries and/or altered renal function,
• Difficulty urinating.

Uncommon (can affect up to 1 in 100 people)

• Sleep disturbance,
• Confusion, hallucinations,
• Nightmares,
• Abnormal sensation,
• Heart conduction system disorders, angina pectoris (including chest pain),
• Determined skin reactions (e.g. allergic dermatitis, urticaria, itching, and inflammation of the skin, increased sweating, psoriatic or lichen planus skin lesions),
• Constipation,
• Impotence.

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

• Decreased platelet count (thrombocytopenia),
• Nasal congestion,
• Dry mouth,

Very rare (can affect up to 1 in 10,000 people, including isolated cases)

• Decreased white blood cell count,
• Psychosis,
• Allergic reactions,
• Liver function test alteration,
• Involuntary loss of urine in women (urinary incontinence).

Frequency not known (cannot be estimated from available data)

• Hair loss.

The pharmacological class of beta receptor blockers can trigger hidden diabetes.

Bradycardia (lack of impulse from the sinoatrial node, the "pacemaker" of the heart that controls heart contractions and regulates heart rate) in predisposed patients (e.g. elderly patients or patients with pre-existing bradycardia, sinoatrial node dysfunction, or AV block).

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use http://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..

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date refers to the last day of that month.

PVC/PVdC/Aluminum blisters

Do not store at a temperature above 30?°C.

Store in the original packaging to protect it from light.

OPA/Aluminum/PVC/Aluminum blisters

Store in the original packaging to protect it from light.

This medication does not require special temperature storage conditions.

Medications should not be disposed of through drains or trash. Deposit the packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Carvedilol Teva-ratiopharm 6.25 mg tablets

• Theactive ingredientis: Carvedilol

Each tablet contains 6.25 mg of carvedilol

• Theother componentsare:

- microcrystalline cellulose

- lactose monohydrate

- crospovidone

- povidone

- anhydrous colloidal silica

- magnesium stearate

Appearance of the product and contents of the packaging

Tablets, white, biconvex, capsule-shaped, engraved with “C” with a notch and “2” on one side and smooth on the other.

The tablets can be divided into equal doses.

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98, 100, and 105 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder andresponsible manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer:

Merckle GmbH

Ludwig Merckle Strasse 3

89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp. z o.o.

Mogilska 80 Str.

31-546 Krakow

Poland

Or

Teva Pharmaceutical Works Privated Limited

Pallagi út 13

Debrecen H-4042

Hungary

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany, Austria:Carvedilol-ratiopharm 6.25 mg Tablets

Finland, Sweden:Carveratio

Spain:Carvedilol Teva-ratiopharm 6.25 mg tablets EFG

Poland, Portugal:Carvedilol-ratiopharm

Last review date of this leaflet: April 2024