Patient Information Leaflet

Propranolol Aurovitas 40 mg Film-Coated Tablets

Propranolol Hydrochloride

Read this leaflet carefully before you start to take 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, pharmacist or nurse.
• This medicine has been prescribed for you and you should not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

Propranolol contains hydrochloride of propranolol that belongs to a group of medications 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 (elevated blood pressure)
• Angina pectoris (chest pain)
• Some type of arrhythmias (heart rhythm disorders)
• Heart protection after a myocardial infarction (heart attack)
• Migraine
• Essential tremor (involuntary and rhythmic tremors)
• Certain types of thyroid diseases (hyperthyroidism and thyrotoxicosis, caused by an overactive thyroid gland)
• Hypertrophic cardiomyopathy (thickening of the heart muscle)
• Phaeochromocytoma (high blood pressure usually caused by a tumor near the kidney)
• Oesophageal bleeding caused by elevated blood pressure in the liver

Do not take Propranolol Aurovitas

• If you are allergic (hypersensitive) to propranolol hydrochloride or to any of the other components of this medication (listed in section 6).
• You have untreated or uncontrolled heart failure;
• You have had a heart-related shock;
• You have severe heart defects (second- or third-degree heart block) that require treatment 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, bronchitis, or other breathing difficulties;
• You have untreated phaeochromocytoma (high blood pressure due to a tumor near the kidney);
• You have severe blood circulation problems (which may cause your hands and feet to become pale or blue);
• You have a painful chest sensation during periods of rest (Prinzmetal's angina);
• You have very low blood pressure

If you think any of these situations apply to you, or if you are unsure, 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, which usually means an increase in heart rate. Propranolol may cause low blood sugar even in non-diabetic patients.
• Have thyrotoxicosis. Propranolol may mask 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, as the use of propranolol may worsen these conditions.
• Use calcium channel blockers with negative inotropic effects, such as verapamil and diltiazem (please see "other medications and propranolol")

Propranolol Aurovitas with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.Propranolol mayinterfere with the action of other medications and other medications 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 medications that may cause problems when taken with your medication:

• 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 heart 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 (for multiple sclerosis)
• Fluvoxamine and barbiturates (for anxiety and insomnia);
• Monamine oxidase inhibitors (MAOIs) (for 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 you need to stop taking clonidine, your doctor will give you detailed instructions on how to do so.

Propranolol Aurovitas with food, drink, and alcohol
Alcohol should be avoided when taking this medication.

Operations
If 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:
The use of this medication is not recommended during pregnancy, unless your doctor considers it essential.

Breastfeeding:
It is not recommended to breastfeed while taking this medication.

Driving and operating machinery
It is unlikely that this medication will affect your ability to drive or operate machinery. However, some people may feel dizzy or tired occasionally when taking Propranolol. If this happens, seek advice from your doctor.

Propranolol Aurovitas contains lactose:

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Propranolol Aurovitas contains sodium:

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

Use in athletes

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

Follow exactly the administration instructions of this medication as indicated 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, Propanolol Aurovitas can be broken as shown below:

• Place the tablet, with the face marked with lines upwards, on a flat, rigid, and clean surface (for example, a table or a work surface).
• Place your index fingers along one of the scoring 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 medication 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, the dose for children under 12 years is 20 mg two or three times a day, and for children 12 years or older, the adult dose is used.

- For arrhythmias, the dose will be adjusted by the doctor according to the child's age or weight.

Geriatric population

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

Liver or renal insufficiency

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

The overdose causes an excessively slow heart rate, too low blood pressure, heart failure, and difficulty breathing with symptoms such as fatigue, hallucinations, fine tremors, confusion, nausea, vomiting, muscle spasms, fainting, or coma. Always bring the remaining tablets, packaging, and medication leaflet to identify the medication.

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 compensate for the missed dose.

If you interrupt the treatment with Propranolol Aurovitas

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

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

Like all medications, propranolol may cause side effects, although not everyone will experience them. The following side effects may occur with this medication:

Frequent: (may affect up to 1 in 10 patients):

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

Less frequent (may affect up to 1 in 100 patients):

• Nausea, vomiting, and diarrhea.

Rare (may affect up to 1 in 1000 patients):

• Worsening of breathing difficulty, sometimes with fatal outcome, if you have or have had asthmaor past asthma symptoms.
• Heart failure or worsening of heart problems
• Swelling of the skin that may occur on 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.
• Loss of hair (Alopecia)
• Emotional instability
• Confusion
• Memory loss
• Psychosis or hallucinations (mental alterations).
• Paresthesia (an abnormal sensation, usually tingling or pins and needles)
• Vision disturbances.
• Dry eyes.
• Skin rash, including worsening of psoriasis.
• Your medication may alter the number and types of your blood cells, such as reducing the number of platelets (thrombocytopenia) in your blood, which may cause you to bruise and bleed more easily.
• Purple spots on the skin (purpura).

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

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

Unknown (frequency cannot be estimated from available data):

• Headache or seizures related to low blood sugar levels
• Impotence in men
• Decreased renal blood flow
• Joint pain (arthralgia)
• Constipation
• Dry mouth
• Shortness of breath or breathing difficulty (dyspnea)
• Conjunctivitis (inflammation of the eye, also known as "red eye")
• Depression
• Reduced white blood cell count and risk (agranulocytosis)
• Worsening of angina pectoris (chest pain)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

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, Cornstarch, Sodium starch glycolate (Type A) from potato, Povidone (K-30) and Magnesium stearate.

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

Appearance of the product and contents of the package

Coated tablet.

White to off-white, round, biconvex coated tablets, engraved on one face 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 PVC white opaque - aluminum blister packs

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmaceutica, S.A.

Rua Joao de Deus, n° 19,

Venda Nova, Amadora

2700-487, Portugal

O

Arrow Génériques- Lyon

26 avenue Tony Garnier, Lyon,

69007, France

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

Last review date of this leaflet:March 2024

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).