Propranolol Aurovitas

Package Leaflet: Information for the User

Propranolol Aurovitas, 10 mg, coated tablets

Propranolol Aurovitas, 40 mg, coated tablets

Propranolol hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Propranolol Aurovitas contains propranolol hydrochloride, which belongs to a group of medicines called beta-blockers. It works on the heart and blood vessels, as well as other parts of the body.
Propranolol Aurovitas can be used:

• to treat high blood pressure;
• to treat angina pectoris (chest pain);
• to treat certain heart rhythm disorders;
• to protect the heart after a heart attack;
• to treat migraines;
• to treat essential tremor (involuntary and rhythmic shaking);
• to treat certain thyroid diseases (such as thyrotoxicosis, which is caused by an excess of thyroid hormones in the blood, and hyperthyroidism);
• to treat hypertrophic cardiomyopathy (thickening of the heart muscle);
• to treat pheochromocytoma (high blood pressure caused by a tumor, usually in the kidney area);
• to treat bleeding in the esophagus due to high blood pressure in the liver.

2. Important information before taking Propranolol Aurovitas

When not to take Propranolol Aurovitas

• if you are allergic to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have untreated and/or uncontrolled heart failure,
• if you have cardiogenic shock,
• if you have severe heart disease (second- or third-degree heart block) that may require a pacemaker,
• if you have conduction disorders or heart rhythm disorders,
• if you have very slow or very irregular heart rate,
• if you have increased blood acidity (metabolic acidosis),
• if you are on a strict diet,
• if you have asthma, wheezing, or other breathing disorders,
• if you have untreated pheochromocytoma (high blood pressure caused by a tumor, usually in the kidney area),
• if you have severe circulatory disorders (which can cause tingling or paleness, or blue discoloration of fingers and toes),
• if you have squeezing chest pain at rest (Prinzmetal's angina),
• if you have very low blood pressure.

If any of the above warnings apply to you, or if you are not sure, consult your doctor before taking this medicine.

Warnings and precautions

Before starting treatment with Propranolol Aurovitas, discuss it with your doctor or pharmacist if:

• you have allergic reactions, e.g., to insect bites.
• you have diabetes, as Propranolol Aurovitas may change the normal reactions to low blood sugar levels, which usually include increased heart rate. Propranolol may cause low blood sugar levels even in patients without diabetes.
• you have thyrotoxicosis. Propranolol may mask the symptoms of thyrotoxicosis.
• you have kidney or liver disease (including liver cirrhosis). In this case, consult your doctor, as certain control tests may be necessary during treatment.
• you have heart disease.
• you have muscle weakness (myasthenia).
• you have diseases such as chronic obstructive pulmonary disease and bronchial asthma, as propranolol may worsen these conditions.
• you are taking calcium channel blockers with negative inotropic effects, e.g., verapamil and diltiazem (see "Propranolol Aurovitas and other medicines").

Propranolol Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. Propranolol Aurovitas may affect the action of some other medicines, and some medicines may affect the action of Propranolol Aurovitas.
Do not take Propranolol Aurovitas with calcium channel blockers with negative inotropic effects (e.g., verapamil, diltiazem), as this may increase their action. This may cause severe low blood pressure and bradycardia.
Other medicines that should be used with caution in combination with Propranolol Aurovitas:

• nifedipine, nisoldipine, nicardipine, isradipine, lacidipine (used to treat high blood pressure or angina);
• lidocaine (a local anesthetic);
• disopyramide, quinidine, amiodarone, propafenone, and digitalis glycosides (used to treat heart diseases);

and

• adrenaline (a medicine that stimulates the heart);
• ibuprofen and indomethacin (used for pain and inflammation);
• ergotamine, dihydroergotamine, or rizatriptan (used to treat migraines);
• chlorpromazine and thioridazine (used to treat certain mental disorders);
• cimetidine (used to treat stomach disorders);
• rifampicin (used to treat tuberculosis);
• theophylline (used to treat asthma);
• warfarin (a blood thinner) and hydralazine (used to treat high blood pressure);
• fingolimod (used to treat multiple sclerosis);
• fluvoxamine and barbiturates (used to treat anxiety and insomnia);
• monoamine oxidase inhibitors (used to treat depression).

If you are taking clonidine (used to treat high blood pressure or migraines) and propranolol, do not stop taking clonidine without your doctor's advice. If clonidine needs to be discontinued, your doctor will tell you how to do it.

Propranolol Aurovitas with food, drink, and alcohol

Alcohol may affect the action of the medicine.

Surgical procedures

If you are scheduled for surgery, inform your anesthesiologist or medical staff that you are taking Propranolol Aurovitas.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy:
This medicine should not be used during pregnancy unless your doctor considers it necessary.
Breastfeeding:
This medicine should not be used during breastfeeding.

Driving and using machines

It is unlikely that the medicine will affect your ability to drive or use machines. However, some people may occasionally experience dizziness or fatigue while taking propranolol. If you experience these symptoms, consult your doctor for advice.

Important information about some ingredients of Propranolol Aurovitas

Propranolol Aurovitas contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
Propranolol Aurovitas contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Propranolol Aurovitas

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

Regarding the 40 mg dose:

If your doctor has prescribed 1/4 (one quarter) or 1/2 (one half) of a tablet, Propranolol Aurovitas should be broken in the following way:

Figure 1 and 2

Figure 3 and 4

• Place the tablet with the dividing line facing up on a flat, rigid, and clean surface (e.g., a table or work surface).
• Place your index fingers along one of the dividing lines and press down to break the tablet (see Figure 1 and 2).
• To obtain 1/4 (one quarter) of a tablet, repeat the action from 1/2 (one half) of a tablet (see Figure 3 and
• 4).

Take the Propranolol Aurovitas tablet before a meal, with a small amount of water. Do not chew it.
Do not stop taking the medicine without your doctor's advice.

Adults

The recommended dose for an adult is as follows:

Children and adolescents

Propranolol Aurovitas can also be used to treat children with migraines and heart rhythm disorders:

• In the treatment of migraines, the dose for children under 12 years of age is 20 mg, two or three times a day, and for children over 12 years of age, the dose is the same as for adults.
• In the treatment of heart rhythm disorders, the dose of the medicine will be adjusted by your doctor depending on the child's age or weight.

Elderly

In elderly patients, treatment should be started with the lowest dose. The optimal dose will be determined by your doctor individually for each patient.

Renal or hepatic impairment

The optimal dose will be determined by your doctor individually for each patient.

Overdose of Propranolol Aurovitas

If you have accidentally taken more tablets than prescribed, go to the emergency department of the nearest hospital or immediately contact your doctor or pharmacist. Symptoms of overdose include very slow heart rate, significantly low blood pressure, heart failure, and breathing difficulties, with accompanying symptoms such as fatigue, hallucinations, tremors, disorientation, nausea, vomiting, muscle cramps, fainting, or coma. Always take the remaining tablets and packaging with you to help identify the medicine.

Missing a dose of Propranolol Aurovitas

If you forget to take the medicine at the usual time, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Propranolol Aurovitas

Do not stop taking the medicine without consulting your doctor. In some cases, it may be necessary to gradually discontinue the medicine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Propranolol Aurovitas can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with this medicine.

Common (may affect up to 1 in 10 people):

• cold fingers and toes;
• slow heart rate;
• numbness and cramps in the fingers, followed by a feeling of warmth and pain (Raynaud's syndrome);
• sleep disorders and/or nightmares;
• fatigue;
• shortness of breath.

Uncommon (may affect up to 1 in 100 people):

• nausea, vomiting, and diarrhea.

Rare (may affect up to 1 in 1,000 people):

• worsening of breathing difficulties, sometimes fatal, if you have or have had asthma or asthma-like conditions;
• heart failure, worsening of heart disease;
• swelling of the face, tongue, throat, abdomen, or hands and feet (angioedema);
• dizziness, especially when standing up;
• worsening of blood circulation in patients with existing circulatory disorders;
• hair loss (excessive hair loss);
• mood changes;
• disorientation;
• memory loss;
• psychosis or hallucinations (mental disorders);
• paresthesia (abnormal sensations, usually tingling or prickling);
• vision disturbances;
• dry eyes;
• rash, including exacerbation of psoriasis;
• blood disorders, such as decreased platelet count (thrombocytopenia), with easy bruising and bleeding;
• purpura (purple spots on the skin).

Very rare (may affect up to 1 in 10,000 people):

• severe muscle weakness (myasthenia);
• low blood sugar, which can occur in both diabetic and non-diabetic patients, including newborns, infants, and children, elderly patients, patients undergoing hemodialysis, or patients taking anti-diabetic medicines; it can also occur in patients who are fasting or have recently fasted, as well as in patients with chronic liver disease;
• excessive sweating.

Frequency not known (frequency cannot be estimated from the available data):

• headache or seizures related to low blood sugar;
• impotence (inability to achieve an erection);
• decreased blood flow to the kidneys;
• joint pain (arthralgia);
• constipation;
• dry mouth;
• shallow breathing or shortness of breath (dyspnea);
• conjunctivitis (red eye);
• depression;
• lack of white blood cells (agranulocytosis);
• worsening of angina pectoris (chest pain).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist.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, tel.: +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 Aurovitas

Keep the medicine out of the sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Propranolol Aurovitas contains

• The active substance of the medicine is propranolol hydrochloride. Each coated tablet contains 10 mg or 40 mg of propranolol hydrochloride.
• The other ingredients are: Tablet core:microcrystalline cellulose (type 101), lactose monohydrate, cornstarch, sodium carboxymethylcellulose (type A), povidone (K 30), magnesium stearate Coating:hypromellose 2910 (E 464), macrogol 6000 (E 1521), titanium dioxide (E 171)

What Propranolol Aurovitas looks like and contents of the pack

Coated tablet.
Propranolol Aurovitas, 10 mg:
White or almost white, round, biconvex coated tablets with the inscription "I" on one side and "10" on the other. The diameter of the tablet is 5.0 mm.
Propranolol Aurovitas, 40 mg:
White or almost white, round, biconvex coated tablets with the inscription "I 40" on one side and a dividing line on the other. The diameter of the tablet is 8.0 mm.
The tablet can be divided into equal doses.
The medicine is packaged in PVC/Aluminum blisters.
Package sizes: 20, 28, 30, 50, 56, 60, 90, 98, and 100 coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Propranolol AB 40 mg film-coated tablets.
France:
PROPRANOLOL ARROW 40 mg, scored film-coated tablet
Germany:
Propranolol PUREN 10 mg film-coated tablets / Propranolol PUREN 40 mg film-coated tablets
Netherlands:
Propranolol HCl Aurobindo 10 mg, film-coated tablets / Propranolol HCl Aurobindo 40 mg, film-coated tablets
Poland:
Propranolol Aurovitas
Portugal:
Propranolol Generis
Spain:
Propranolol Aurovitas 10 mg film-coated tablets EFG
Propranolol Aurovitas 40 mg film-coated tablets EFG

Date of last revision of the package leaflet: 03/2024