Propranolol Vzf

Leaflet attached to the packaging: patient information

PROPRANOLOL WZF 10 mg, tablets

PROPRANOLOL WZF 40 mg, tablets

Propranolol hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any further doubts, you should consult a doctor or 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or 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 using Propranolol WZF
• 3. How to use 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:

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

2. Important information before using Propranolol WZF

When not to use Propranolol WZF:

• if the patient has asthma and experiences bronchial spasms;
• if the patient is allergic to propranolol or any of the other ingredients of this medicine (listed in section 6.);
• if the patient has a very slow heart rate, called bradycardia;
• if the patient has cardiogenic shock (characterized by: cold, sweaty, pale skin; low blood pressure; rapid and weak pulse; rapid, shallow breathing; decreased urine output);
• if the patient has uncontrolled (untreated or ineffectively 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, called 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 slowing and disruption of 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, has chronic liver disease.

Warnings and precautions

Before starting to use Propranolol WZF, you should discuss it with your doctor or pharmacist,
or nurse.
You should tell your doctor if you have:

• heart failure, heart disorders called first-degree atrioventricular block;
• a pheochromocytoma and you 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 accelerated heart rate); patients with diabetes may only use 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 of 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 use Propranolol WZF".
Propranolol WZF may affect the results of some laboratory tests - this applies to bilirubin testing (performed to detect and/or monitor liver diseases) and compounds called catecholamines.

Propranolol WZF and other medicines

You should tell your doctor about all 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, conversely, some medicines may affect the action of propranolol.

While using Propranolol WZF, you should not take medicines called 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 in heart rhythm disorders);
• digoxin (a heart medicine);
• lidocaine (a medicine used for anesthesia and in heart rhythm disorders); if a patient taking propranolol is scheduled for surgery, 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 migraine);
• chlorpromazine and thioridazine (medicines used in psychiatry);
• cimetidine (a medicine used for stomach and duodenal ulcers);
• rifampicin (an antibiotic);
• theophylline (an anti-asthmatic medicine);
• warfarin (an anticoagulant medicine);
• hydralazine (a medicine for hypertension). You should consult a doctor when using propranolol and clonidine (a medicine used to treat hypertension or migraine) and when it is necessary to stop one of these medicines or when replacing clonidine with propranolol. The doctor will recommend the course of action. You should not stop 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, you should consult a doctor before using this medicine.
Propranolol WZF can be used during pregnancy only in situations where 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 using machines

It is unlikely that Propranolol WZF will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur.
In such a case, you should not perform these activities until the disorders have resolved.

Propranolol WZF contains lactose and sucrose

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

3. How to use Propranolol WZF

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor.

• The medicine should be taken orally.
• The doctor will determine the dose of the medicine individually, depending on the patient's condition and response to the medicine. Elderly patients will be advised by the doctor to start treatment with the smallest 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 from 160 mg to 320 mg per day. If further blood pressure reduction is necessary, the doctor may recommend the use of a diuretic or another antihypertensive medicine in addition.

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

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

• for migraine and essential tremor: from 80 mg to 160 mg per day;
• for angina pectoris: from 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 using the medicine, the patient should visit the doctor for a check-up.

Heart rhythm disorders (called supraventricular and ventricular), treatment of a heart muscle disease called hypertrophic cardiomyopathy, adjunctive treatment in cases of hyperthyroidism and thyrotoxic crisis

From 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 the 5th and 21st day after 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 slowing. The maximum dose is 160 mg twice a day.

Preoperative procedures in cases of 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.

Using a higher dose of Propranolol WZF than recommended

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

Missing a dose of Propranolol WZF

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

Stopping the use of Propranolol WZF

You should not suddenly stop using Propranolol WZF without consulting a doctor. The doctor will recommend gradual dose reduction and determine the time of withdrawal of the medicine (usually recommends gradual dose reduction of the medicine over 7 to 14 days). In case of patients with planned surgical procedures, you should stop using the medicine at least 24 hours before the procedure, unless the doctor recommends otherwise.
In case of any further doubts related to the use of this medicine, you should consult a doctor or 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, manifested by slow heart rate and significantly low blood pressure, the medicine should be discontinued and you should immediately consult a doctor.
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): disorders of the digestive system (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 disorders; dry eyes; worsening of heart failure; worsening of atrioventricular block; sudden blood pressure drop with fainting; in predisposed patients, exacerbation of intermittent claudication (symptoms: pain in the calf muscles 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 nodules covered with silver scales); rash.
• Very rare (less than 1 in 10,000 people): muscle weakness resembling myasthenia or worsening of myasthenia (isolated cases); increased antinuclear antibody titer (ANA) - although the clinical significance of this phenomenon has not been explained.
• Frequency not known (cannot be estimated from the available data): decreased blood glucose levels (especially in children, elderly patients, patients undergoing hemodialysis, patients treated with antidiabetic drugs, long-term fasting, patients with chronic liver disease); hyperglycemia may occur; feeling of dizziness. Hypoglycemia-related seizures may occur.

In case of worsening of side effects, you should tell your doctor, who will consider discontinuing the medicine (which should be done gradually, according to the doctor's recommendations).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help provide more information on the safety of this 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.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. You should 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 tablets with a score line on one side, allowing for division into equal doses.
Propranolol WZF, 40 mg: white, flat, beveled tablets with a score line and the inscription "P" on one side.
The 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 revision of the leaflet:December 2024