Propranolol Vzf

Leaflet attached to the packaging: patient information

PROPRANOLOL WZF 10 mg, tablets

PROPRANOLOL WZF 40 mg, tablets

Propranolol hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Propranolol WZF and what is it used for
• 2. Important information before taking Propranolol WZF
• 3. How to take Propranolol WZF
• 4. Possible side effects
• 5. How to store Propranolol WZF
• 6. Contents of the packaging and other information

1. What is Propranolol WZF and what is it used for

Propranolol WZF is classified as a beta-adrenergic blocker.
Propranolol WZF is used:

• for hypertension;
• for the treatment of angina pectoris (also known as coronary artery disease), except for the so-called vasospastic form (Prinzmetal's angina);
• to prevent myocardial infarction in patients with coronary artery disease and to prevent repeated myocardial infarction;
• for arrhythmias (supraventricular and ventricular);
• for migraine prophylaxis;
• for the treatment of essential tremor;
• to reduce anxiety (situational and generalized, which is accompanied by, for example, rapid heart rate, increased blood pressure, sweating, and facial flushing);
• to prevent bleeding from the upper gastrointestinal tract in patients with so-called portal hypertension and esophageal varices;
• as adjunctive treatment for hyperthyroidism and thyrotoxic crisis (severe multi-organ disorders occurring as a complication of hyperthyroidism);
• for the treatment of hypertrophic cardiomyopathy;
• in preoperative procedures for pheochromocytoma (a tumor located in the adrenal glands) in combination with an alpha-adrenergic blocker.

2. Important information before taking Propranolol WZF

When not to take Propranolol WZF:

• if the patient has asthma and experiences bronchospastic conditions;
• if the patient is allergic to propranolol or any other component of this medicine (listed in section 6);
• if the patient has very slow heart rate, known as bradycardia;
• if the patient has cardiogenic shock (characterized by: cold, sweaty, pale skin; decreased blood pressure; rapid, weak pulse; rapid, shallow breathing; decreased urine output);
• if the patient has uncontrolled (untreated or inadequately treated) heart failure;
• if the patient has low blood pressure;
• if the patient has metabolic acidosis (increased concentration of acidic metabolic products in the blood);
• if the patient has been fasting for a long time;
• if the patient has severe peripheral circulation disorders;
• if the patient has serious heart rhythm disorders, known as second- or third-degree atrioventricular block;
• if the patient has a particular type of angina pectoris called Prinzmetal's angina;
• if the patient has sick sinus syndrome (characterized by slowed and disturbed heart rhythm and conduction disorders in the heart);
• if the patient has a pheochromocytoma that is not being treated;
• if the patient is at risk of decreased blood glucose levels (hypoglycemia), e.g., is malnourished, emaciated, or has chronic liver disease.

Warnings and precautions

Before starting treatment with Propranolol WZF, discuss it with your doctor, pharmacist, or nurse.
Tell your doctor if you have:

• heart failure, heart disorders known as first-degree atrioventricular block;
• a pheochromocytoma and are taking alpha-adrenergic blockers (e.g., prazosin);
• peripheral circulation disorders;
• diabetes - Propranolol WZF may mask or modify the symptoms of low blood glucose levels (especially rapid heart rate); patients with diabetes may only take the medicine after consulting a doctor. In patients who do not have diabetes, the medicine may decrease blood glucose levels;
• hyperthyroidism - the medicine may mask the symptoms of hyperthyroidism;
• allergy to beta-adrenergic blockers (to which Propranolol WZF belongs), as severe allergic reactions to the medicine may occur;
• kidney or liver function disorders, especially liver cirrhosis or portal hypertension, as these patients may experience worsening liver function.

Propranolol WZF may exacerbate slow heart rate, especially in patients with this condition.
Elderly patients should strictly follow the doctor's recommendations regarding the dosage of the medicine - see also section 3, "How to take Propranolol WZF".
Propranolol WZF may affect the results of some laboratory tests - this includes bilirubin testing (performed to detect and/or monitor liver diseases) and catecholamine testing.

Propranolol WZF and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Propranolol WZF may affect the action of some medicines, and some medicines may affect the action of propranolol.

While taking Propranolol WZF, do not take calcium channel blockers, such as verapamil, diltiazem, nifedipine, nisoldipine, nicardipine,

isradipine, lacidipine(medicines used to treat hypertension or angina pectoris),
as their concurrent use may cause dangerous blood pressure lowering, slow heart rate, and heart failure.
Medicines that affect the action of Propranolol WZF include:

• disopyramide, quinidine, propafenone (medicines used to treat heart rhythm disorders);
• digoxin (a heart medicine);
• lidocaine (a medicine used for anesthesia and heart rhythm disorders); if a surgical procedure is planned for a patient taking propranolol, the patient should inform the anesthesiologist about taking Propranolol WZF;
• adrenaline (a medicine that stimulates heart activity);
• ibuprofen and indomethacin (anti-inflammatory and analgesic medicines);
• ergotamine and dihydroergotamine (medicines used for migraines);
• chlorpromazine and thioridazine (medicines used in psychiatry);
• cimetidine (a medicine used for stomach ulcers and duodenal ulcers);
• rifampicin (an antibiotic);
• theophylline (an anti-asthmatic medicine);
• warfarin (an anticoagulant medicine);
• hydralazine (a medicine for hypertension). Consult a doctor when taking propranolol and clonidine (a medicine used to treat hypertension or migraines) and when stopping one of these medicines or replacing clonidine with propranolol. The doctor will advise on the course of action. Do not stop taking these medicines without prior consultation with a doctor.

Propranolol WZF and alcohol

Alcohol may reduce the effectiveness of Propranolol WZF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Propranolol WZF can be used during pregnancy only when the doctor considers it necessary. Like other beta-adrenergic blockers, the medicine may cause complications in the fetus, miscarriage, or premature birth. Side effects may also occur, especially decreased blood glucose levels and slow heart rate in the fetus or newborn. The risk of cardiopulmonary complications in newborns after birth increases.
Propranolol WZF passes into breast milk. Breastfeeding is not recommended during treatment with the medicine.

Driving and operating machinery

It is unlikely that Propranolol WZF will affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur.
In such cases, do not perform these activities until the disturbances have resolved.

Propranolol WZF contains lactose and sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Propranolol WZF

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

• Take the medicine orally.
• The doctor will determine the dose of the medicine individually, depending on the patient's condition and response to the medicine. Elderly patients should start treatment with the lowest dose.

ADULTS

Hypertension

The initial dose is 80 mg twice a day. It may be increased at weekly intervals, depending on the patient's response to the medicine.
The target dose is 160 mg to 320 mg per day. If further blood pressure reduction is necessary, the doctor may recommend additional use of a diuretic or another antihypertensive medicine.

Treatment of angina pectoris, migraine prophylaxis, treatment of essential tremor

The initial dose is 40 mg two or three times a day, which may be increased by the same dose at weekly intervals, depending on the patient's response to the medicine. The usual target dose is:

• for migraine and essential tremor: 80 mg to 160 mg per day;
• for angina pectoris: 120 mg to 240 mg per day.

Reduction of situational and generalized anxiety

• situational anxiety: 40 mg per day.
• generalized anxiety requiring chronic treatment: usually 40 mg twice a day. The dose can be increased to 40 mg three times a day. Treatment should be continued depending on the patient's response to the medicine. After 6-12 months of treatment, the patient should visit the doctor for a follow-up examination.

Arrhythmias (supraventricular and ventricular), treatment of hypertrophic cardiomyopathy, adjunctive treatment for hyperthyroidism and thyrotoxic crisis

10 mg to 40 mg three times a day.

Prevention of myocardial infarction in patients with coronary artery disease and prevention of repeated myocardial infarction

Treatment should be started between 5 and 21 days after the myocardial infarction.
The initial dose is 40 mg four times a day for 2 to 3 days. To increase the likelihood that the patient will take the medicine, the total daily dose can be given twice a day at 80 mg.

Prevention of bleeding from the upper gastrointestinal tract in patients with portal hypertension and esophageal varices

Initially, 40 mg twice a day, then the dose can be increased to 80 mg twice a day, depending on the achieved heart rate reduction. The maximum dose is 160 mg twice a day.

Preoperative procedures for pheochromocytoma (in combination with an alpha-adrenergic blocker)

Propranolol WZF should only be used in combination with an alpha-adrenergic blocker.

• Before surgery: 60 mg per day for 3 days.
• Non-surgical, malignant tumors: 30 mg per day.

CHILDREN

In some cases, Propranolol WZF may be used in children to treat arrhythmias (heart rhythm disorders). The doctor will adjust the dosage depending on the child's age and body weight.

Taking a higher dose of Propranolol WZF than recommended

After taking a higher dose of the medicine than recommended, symptoms such as slow heart rate, significantly low blood pressure (hypotension), acute heart failure, and bronchospasm (breathing difficulties, shortness of breath) may occur. In case of these symptoms, consult a doctor or go to the nearest hospital.

Missing a dose of Propranolol WZF

If you miss a dose of Propranolol WZF, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next one according to the established schedule. Do not take a double dose of the medicine to make up for the missed dose.

Stopping treatment with Propranolol WZF

Do not suddenly stop taking Propranolol WZF without consulting your doctor. The doctor will recommend gradual dose reduction and determine the time of withdrawal from the medicine (usually recommends gradual dose reduction over 7 to 14 days). In patients with planned surgical procedures, stop taking the medicine at least 24 hours before the procedure, unless the doctor recommends otherwise.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Propranolol WZF is usually well-tolerated. In rare cases of intolerance to the medicine, which manifests as slow heart rate and significantly low blood pressure, the medicine should be discontinued and a doctor consulted immediately.
The following may occur:

• Common (in 1 to 10 out of 100 people): sleep disorders; nightmares; slow heart rate; coldness and cyanosis of the limbs, mainly fingers; feeling of fatigue (transient).
• Uncommon (in 1 to 10 out of 1,000 people): gastrointestinal disorders (diarrhea, nausea, vomiting).
• Rare (in 1 to 10 out of 10,000 people): decreased platelet count; hallucinations; psychosis; mood changes; dizziness; paresthesia (tingling, prickling, burning); vision disturbances; dry eyes; worsening heart failure; worsening atrioventricular block; sudden blood pressure drop with fainting; in predisposed patients, exacerbation of intermittent claudication (symptoms: muscle pain in the calves occurring after exertion); bronchospasm (asthma attacks, wheezing, coughing) in patients with asthma or asthmatic symptoms; hair loss; purpura (petechiae on the skin); psoriasis-like skin reactions; worsening of psoriasis symptoms (elevated, red-brown patches covered with silver scales); rash.
• Very rare (less than 1 in 10,000 people): muscle weakness resembling myasthenia or worsening myasthenia (isolated cases); increased antinuclear antibody titers (ANA) have been observed - although the clinical significance of this phenomenon has not been explained.
• Frequency not known (cannot be estimated from available data): decreased blood glucose levels (especially in children, elderly patients, those undergoing hemodialysis, those treated with antidiabetic medicines, those who have been fasting for a long time, or those with chronic liver disease); increased blood glucose levels (hyperglycemia) may occur; feeling of dizziness. Seizures related to decreased blood glucose levels may occur.

If side effects worsen, tell your doctor, who will consider discontinuing the medicine (which should be done gradually, according to the doctor's instructions).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Propranolol WZF

Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Propranolol WZF contains

• The active substance of the medicine is propranolol hydrochloride. One tablet contains 10 mg or 40 mg of propranolol hydrochloride.
• The other ingredients are: lactose monohydrate, sucrose, potato starch, talc, magnesium stearate, povidone K-25.

What Propranolol WZF looks like and what the packaging contains

Propranolol WZF, 10 mg: white, flat, beveled-edge tablets with a score line on one side, allowing for division into equal doses.
Propranolol WZF, 40 mg: white, flat, beveled-edge tablets with a score line and the inscription "P" on one side.
A carton contains 50 tablets (2 blisters of 25 tablets each).

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2; 39-460 Nowa Dęba
Date of last update of the leaflet:December 2024