PROPRANOLOL AUROVITAS 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Propranolol Aurovitas 40 mg Film-Coated Tablets EFG

Propranolol Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Propranolol Aurovitas and what is it used for
2. What you need to know before you take Propranolol Aurovitas
3. How to take Propranolol Aurovitas
4. Possible side effects
5. Storage of Propranolol Aurovitas
6. Contents of the pack and other information

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

Propranolol contains propranolol hydrochloride, which belongs to a group of medicines called beta-blockers. It has effects on the heart and circulation, as well as on other parts of the body.

Propranolol is indicated for:

• Hypertension (high blood pressure)
• Angina pectoris (chest pain)
• Certain types of arrhythmias (heart rhythm disorders)
• Protection of the heart after a heart attack (myocardial infarction)
• Migraine
• Essential tremor (involuntary and rhythmic tremors)
• Certain types of thyroid diseases (thyrotoxicosis and hyperthyroidism, which are caused by an overactive thyroid gland)
• Hypertrophic cardiomyopathy (thickening of the heart muscle)
• Pheochromocytoma (high blood pressure usually due to a tumor near the kidney)
• Esophageal bleeding caused by high blood pressure in the liver

2. What you need to know before you take Propranolol Aurovitas

Do not take Propranolol Aurovitas

• If you are allergic (hypersensitive) to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• You have untreated or uncontrolled heart failure;
• You have had a shock caused by heart problems;
• You have severe heart defects (second or third degree heart block) that need to be treated with a pacemaker;
• You have heart rhythm or conduction problems;
• You have a very slow or irregular heart rate;
• You have an increase in blood acidity (metabolic acidosis);
• You are on a strict fasting diet;
• You have asthma, wheezing, or other breathing difficulties;
• You have untreated pheochromocytoma (high blood pressure due to a tumor near the kidney);
• You have severe blood circulation problems (which can cause fingers and toes to turn pale or blue);
• You have a feeling of painful pressure in the chest at rest (Prinzmetal's angina);
• You have very low blood pressure

If you think any of these situations apply to you, or if you have any doubts, talk to your doctor before starting to use propranolol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take propranolol if you:

• Have a history of allergic reactions, for example, to insect bites;
• Have diabetes, as propranolol may change your normal response to low blood sugar levels, which usually means an increase in heart rate. Propranolol may cause low blood sugar levels even in non-diabetic patients.
• Have thyrotoxicosis. Propranolol may hide the symptoms of thyrotoxicosis.
• Have kidney or liver problems (including liver cirrhosis). If so, talk to your doctor, as you may need to have some checks during your treatment.
• Have heart problems.
• Suffer from muscle weakness (myasthenia gravis)
• Have conditions such as chronic obstructive pulmonary disease and bronchospasm because the use of propranolol may worsen these conditions.
• Use channel blockers with negative inotropic effects such as verapamil and diltiazem (please consult "Other medicines and propranolol")

Taking Propranolol Aurovitas with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Propranolol may interfere with the action of other medicines, and other medicines may affect propranolol.

Propranolol should not be used in combination with calcium channel blockers with negative inotropic effects (e.g., verapamil, diltiazem), as this may lead to an exaggeration of these effects. This could result in severe hypotension and bradycardia.

Other medicines that may cause problems when taken with your medicine:

• Nifedipine, nisoldipine, nicardipine, isradipine, lacidipine (used to treat hypertension or angina)
• Lidocaine (local anesthetic)
• Disopyramide, quinidine, amiodarone, propafenone, and glycosides (for heart problems)
• Adrenaline (a cardiac stimulant)
• Ibuprofen and indomethacin (for pain and inflammation)
• Ergotamine, dihydroergotamine, or rizatriptan (for migraine)
• Chlorpromazine and thioridazine (for certain psychiatric disorders)
• Cimetidine (for stomach problems)
• Rifampicin (for tuberculosis treatment)
• Theophylline (for asthma)
• Warfarin (to thin the blood) and hydralazine (for hypertension)
• Fingolimod (to treat multiple sclerosis)
• Fluvoxamine and barbiturics (to treat anxiety and insomnia);
• Monoamine oxidase inhibitors (MAOIs) (to treat depression)

If you are taking clonidine (for hypertension or migraine) and propranolol together, do not stop taking clonidine unless your doctor tells you to. If stopping clonidine becomes necessary for you, your doctor will give you detailed instructions on how to do it.

Propranolol Aurovitas with food, drink, and alcoholAlcohol should be avoided when taking this medicine. SurgeryIf you are going to the hospital for an operation, tell the anesthetist or medical staff that you are taking propranolol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: The use of this medicine is not recommended during pregnancy, unless your doctor considers it essential. Breastfeeding: It is not recommended to breastfeed during treatment with this medicine.

Driving and using machinesIt is unlikely that this medicine will affect your ability to drive or use machines. However, some people may feel dizzy or tired occasionally when taking Propranolol. If this happens, ask your doctor for advice.

Propranolol Aurovitas contains lactose:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Propranolol Aurovitas contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Use in athletes

This medicine contains propranolol, which may produce a positive result in doping tests.

3. How to take Propranolol Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

If your doctor has prescribed 1/4 (one quarter) of a tablet or 1/2 (half) of a tablet, Propranolol Aurovitas can be broken as shown below:

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

Swallow the propranolol tablet with water before meals. Do not chew.

Do not stop taking the medicine unless your doctor tells you to.

Adults

The following table shows the recommended doses for an adult:

Pediatric population

Propranolol can also be used to treat children with migraine and arrhythmias:

• For migraine, for children under 12 years, the dose is 20 mg two or three times a day, and for children 12 years or older, the dose is the same as for adults.
• For arrhythmias, the dose will be adjusted by the doctor according to the child's age or weight.

Elderly population

Elderly patients should start with the lowest dose. The optimal dose will be determined individually by the doctor.

Liver or kidney failure

The optimal dose will be determined individually by the doctor.

If you take more Propranolol Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

Overdose causes an excessively slow heart rate, very low blood pressure, heart failure, and difficulty breathing, with symptoms such as fatigue, hallucinations, fine tremors, confusion, nausea, vomiting, body spasms, fainting, or coma, low blood sugar levels. Always bring the remaining tablets, packaging, and leaflet, to identify the medicine.

If you forget to take Propranolol Aurovitas

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

If you stop taking Propranolol Aurovitas

Do not stop treatment without consulting your doctor first. In some cases, it may be necessary to stop treatment gradually.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, propranolol can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

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

• Cold fingers and toes
• Slower heart rate
• Numbness and cramps in the fingers of the hands, followed by a sensation of heat and pain (Raynaud's syndrome)
• Sleep disorders/nightmares
• Fatigue
• Difficulty breathing

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 with a fatal outcome, if you have or have had asthma or asthmatic symptoms in the past.
• Heart failure or worsening of heart problems
• Swelling of the skin that can occur in the face, tongue, larynx, abdomen, or arms and legs (angioedema)
• Dizziness, especially when standing up
• Worsening of blood circulation, if you already have circulation problems.
• Hair loss (alopecia)
• Emotional instability
• Confusion
• Memory loss
• Psychosis or hallucinations (mental disorders).
• Paresthesia (an abnormal sensation, usually tingling or pinching ("pins and needles"))
• Vision changes.
• Dry eyes.
• Skin rash, including worsening of psoriasis·
• Your medicine may alter the number and types of your blood cells, such as reducing the number of platelets (thrombocytopenia) in your blood, which can cause you to bruise and bleed more easily.
• Purple spots on the skin (purpura).

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

• Severe muscle weakness (myasthenia gravis)
• Low blood sugar levels can occur in diabetic and non-diabetic patients, including newborns, young children, and children, elderly patients, patients with artificial kidneys (hemodialysis), or patients taking diabetes medications. It can also occur in patients who are fasting or have recently fasted or have a long-term liver disease.
• Excessive sweating

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

• Headache or seizures related to low blood sugar levels
• Inability of a man to achieve an erection (impotence)
• Decreased renal blood flow
• Joint pain (arthralgia)
• Constipation
• Dry mouth
• Shortness of breath or breathing (dyspnea)
• Conjunctivitis (eye inflammation, also known as "red eye")
• Depression
• Reduced and dangerous white blood cell count (agranulocytosis)
• Worsening of angina pectoris (chest pain)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Propranolol Aurovitas

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Propranolol Aurovitas

• The active ingredient is propranolol hydrochloride. Each tablet contains 40 mg of propranolol (as hydrochloride).

• The other components (excipients) are:

Core: Microcrystalline cellulose (Grade 101), Lactose monohydrate, Corn starch, Sodium starch glycolate (Type A) of potato, Povidone (K-30), and Magnesium stearate.

Coating: Hypromellose 2910 (E464), Macrogol 6000 (E1521), Titanium dioxide (E171)

Appearance of the Product and Container Content

Film-coated tablet.

White to off-white, round, biconvex film-coated tablets, engraved on one side with “I 40” and on the other divided into four sections. The size is 8 mm.

The tablet can be divided into equal doses.

Propranolol Aurovitas is available in white opaque PVC-aluminum blister packs.

Container Sizes:

Blister: 20, 28, 30, 50, 56, 60, 90, 98, 100 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmaceutica, S.A.

Rua Joao de Deus, n° 19,

Venda Nova, Amadora

2700-487, Portugal

Or

Arrow Génériques- Lyon

26 avenue Tony Garnier, Lyon,

69007, France

This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names:

Date of the Last Revision of this Leaflet:March 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).