Propranolol Aurovitas 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Propranolol Aurovitas 40 mg film-coated tablets EFG

Propranolol hydrochloride

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

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

1. What Propranolol Aurovitas is and what it is 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)
• Heart protection after myocardial infarction (heart attack)
• Migraine
• Essential tremor (involuntary, rhythmic tremors)
• Certain types of thyroid disorders (thyrotoxicosis and hyperthyroidism, caused by an overactive thyroid gland)
• Hypertrophic cardiomyopathy (thickening of the heart muscle)
• Phaeochromocytoma (high blood pressure usually due to a tumour near the kidney)
• Oesophageal bleeding caused by high blood pressure in the liver

2. What you need to know before taking Propranolol Aurovitas

Do not take Propranolol Aurovitas

• If you are allergic (hypersensitive) to propranolol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• You have untreated or uncontrolled heart failure;
• You have experienced shock caused by heart problems;
• You have severe heart defects (second- or third-degree heart blocks) requiring treatment with a cardiac pacemaker;
• You suffer from heart rhythm or conduction disorders;
• You have a very slow or irregular heartbeat;
• You have increased blood acidity (metabolic acidosis);
• You are following a strict fasting diet;
• You suffer from asthma, wheezing, or other breathing difficulties;
• You have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney);
• You have severe circulatory problems (which may cause your fingers or toes to become pale or bluish);
• You experience painful chest tightness 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, speak with your doctor before starting propranolol.

Warnings and precautions

Talk to your doctor or pharmacist before starting propranolol if you:

• Have a history of allergic reactions, for example, to insect stings;
• Have diabetes, as propranolol may alter your normal response to low blood sugar levels, which usually includes an increased heart rate. Propranolol can cause low blood sugar levels even in patients who are not diabetic.
• Have thyrotoxicosis. Propranolol may mask the symptoms of thyrotoxicosis.
• Have kidney or liver problems (including hepatic cirrhosis). If so, speak with your doctor, as you may need monitoring during treatment.
• Have heart problems.
• Suffer from muscle weakness (myasthenia gravis).
• Have conditions such as chronic obstructive pulmonary disease (COPD) or bronchospasm, as the use of propranolol may worsen these conditions.
• Are taking calcium channel blockers with negative inotropic effects such as verapamil and diltiazem (please refer to "Other medicines and propranolol").

Taking Propranolol Aurovitas with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to 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 that have negative inotropic effects (e.g., verapamil, diltiazem), as this may exaggerate these effects. This could result in severe hypotension and bradycardia.

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

• Nifedipine, nisoldipine, nicardipine, isradipine, lacidipine (used to treat hypertension or angina)
• Lidocaine (local anaesthetic)
• Disopyramide, quinidine, amiodarone, propafenone, and cardiac glycosides (used to treat 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 the treatment of tuberculosis)
• Theophylline (for asthma)
• Warfarin (to thin the blood) and hydralazine (for hypertension)
• Fingolimod (for treating multiple sclerosis)
• Fluvoxamine and barbiturates (for treating anxiety and insomnia)
• Monoamine oxidase inhibitors (MAOIs) (for treating depression)

If you are taking clonidine (for hypertension or migraine) and propranolol together, do not stop taking clonidine unless instructed by your doctor. If stopping clonidine becomes necessary, your doctor will provide you with detailed instructions on how to do so.

Propranolol Aurovitas with food, drink, and alcohol Alcohol should be avoided when taking this medicine.Surgery If you go to hospital for an operation, inform the anaesthetist 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy: The use of this medicine is not recommended during pregnancy unless your doctor considers it essential. Breastfeeding: Breastfeeding is not recommended while taking this medicine.

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

Propranolol Aurovitas contains lactose:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 result in a positive doping test.

3. How to take Propranolol Aurovitas

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

• Place the tablet, with the scored side facing upwards, on a flat, hard, clean surface (for example, a table or work surface).
• Place your index fingers along one of the break lines and press downwards to break the tablet (see figures 1 and 2).
• To obtain 1/4 (one quarter) of a tablet, repeat the procedure starting from 1/2 (half) a tablet (see figures 3 and 4).

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

Do not stop taking this medicine unless your doctor tells you to do so.

Adults

The following table shows the recommended doses for an adult:

Paediatric population

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

• For migraine, the dose is 20 mg two or three times daily for children under 12 years of age; for children aged 12 years and older, the adult dose applies.
• For arrhythmias, the dose will be adjusted by the doctor according to the child's age or body weight.

Elderly population

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

Hepatic or renal impairment

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. You will be advised to bring the medicine package and leaflet to the healthcare professional.

Overdose causes excessively slow heart rate, blood pressure too low, heart failure, and breathing difficulties, with symptoms such as fatigue, hallucinations, fine tremors, confusion, nausea, vomiting, body spasms, fainting, or coma, as well as low blood sugar levels. Always bring any remaining tablets, the packaging, and the package leaflet to enable identification of 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 your next dose, do not take the missed dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Propranolol Aurovitas

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

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

4. Possible adverse effects

Like all medicines, propranolol may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine:

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

• Cold fingers of the hands and feet
• Slower heartbeat
• Numbness and cramps in the fingers, 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 patients):

• Nausea, vomiting, and diarrhea.

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

• Worsening of breathing difficulties, sometimes fatal, 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 may 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 disturbances)
• Paresthesia (an abnormal sensation, usually tingling or prickling ("pins and needles"))
• Vision disturbances
• 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 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 occur in diabetic and non-diabetic patients, including newborns, infants, children, elderly patients, patients with artificial kidneys (hemodialysis), or patients taking medicines for diabetes. It may also occur in patients who are fasting or who have recently been fasting, or who have long-term liver disease
• Excessive sweating

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

• Headache or seizures related to low blood sugar levels
• Inability of a man to achieve an erection (impotence)
• Reduced 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
• Dangerously reduced white blood cell count (agranulocytosis)
• Worsening of angina pectoris (chest pain)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Propranolol Aurovitas

• The active substance 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) 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 pack

Film-coated tablet.

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

The tablet can be divided into equal doses.

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

Pack sizes:

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

Only certain pack 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 about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).