PROPRANOLOL TARBIS 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Propranolol Tarbis 10 mg film-coated tablets EFG

Propranolol Tarbis 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. See section 4.

Contents of the pack

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

1. What is Propranolol Tarbis 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 may be used 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, caused by an overactive thyroid gland, and hyperthyroidism)
• Hypertrophic cardiomyopathy (thickening of the heart muscle)
• Pheochromocytoma (high blood pressure usually due to a tumor near the kidney)
• Bleeding in the esophagus caused by high blood pressure in the liver

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

Do not take Propranolol Tarbis if:

• you are allergic 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 your fingers and toes to turn pale or blue);
• you have a feeling of painful oppression 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 are not sure, talk to your doctor before starting to use propranolol.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse 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")

Other medicines and Propranolol Tarbis

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 have an effect on 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)
• disopyramide, quinidine (for heart problems)
• lidocaine
• amiodarone, propafenone (for irregular heartbeats)
• digoxin (for heart failure)
• adrenaline (a heart stimulant)
• 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)
• barbiturics (to treat anxiety and insomnia);
• propafenone (to treat heart problems)
• monoamine oxidase inhibitors (MAOIs) (to treat depression)

If you are taking clonidine (for hypertension or migraine) and propranolol together, you should stop taking clonidine unless your doctor tells you to do so. If stopping clonidine becomes necessary for you, your doctor will give you detailed instructions on how to do so.

Propranolol with food, drink, and alcohol

Alcohol may affect the functioning of this medicine.

Surgery

If you are going to the hospital for an operation, tell the anesthesiologist or medical staff that you are taking propranolol.

Driving and using machines

It is unlikely that your medicine will affect your ability to drive or use machines. However, some people may feel dizzy or tired when taking propranolol. If this happens to you, ask your doctor for advice.

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 medicine.

Pregnancy:

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

Breastfeeding:

Breastfeeding is not recommended during treatment with this medicine.

Important information about some of the ingredients of Propranolol Tarbis:

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

3. How to take Propranolol Tarbis

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

Swallow the propranolol tablet with water before meals. It should be swallowed whole. Do not chew.

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

The following table shows the recommended doses for an adult:

*In some circumstances, propranolol may be used to treat children with these conditions. The dose will be adjusted by the doctor according to the child's age or weight.

Elderly people may start with a lower dose.

If you take more Propranolol Tarbis than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. 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 be able to identify the medicine.

If you forget to take Propranolol Tarbis

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.

If you stop taking Propranolol Tarbis

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may appear when using 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
• Breathing difficulties

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, if you have or have had asthma.
• Shortness of breath and/or swelling in the ankles, if you also have heart failure.
• Heart block that can cause irregular heartbeat, dizziness, tiredness, or fainting
• Dizziness, especially when standing up
• Worsening of blood circulation, if you already have poor circulation.
• Hair loss (alopecia)
• Emotional instability
• Confusion
• Memory loss
• Psychosis or hallucinations (mental disorders).
• Abnormal sensation, usually tingling or pinching ("pins and needles")
• Visual disturbances.
• Dry eyes.
• Skin rash, including worsening of psoriasis·
• Swelling of blood vessels under the skin, which can be painful and accompanied by redness (thrombocytopenia)
• 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 long-term liver disease.
• Excessive sweating

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

• Seizures related to low blood sugar levels
• Impotence (inability of a man to achieve an erection)
• Decreased renal blood flow
• Joint pain
• Constipation
• Dry mouth
• Conjunctivitis
• Depression
• Reduced white blood cell count
• Worsening effects in patients with angina pectoris

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Tarbis

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

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Propranolol Tarbis

The active substance is propranolol hydrochloride.

Each film-coated tablet contains 10 mg of propranolol hydrochloride.

Each film-coated tablet contains 40 mg of propranolol hydrochloride.

The other ingredients are:

Core of the tablet: Cornstarch, lactose monohydrate, microcrystalline cellulose (E460), magnesium stearate

Coating: Hypromellose Type 2910 6 cPs (E464), glycerol (E422), titanium dioxide (E171)

Appearance of Propranolol Tarbis and contents of the pack

Film-coated tablet.

Propranolol Tarbis 10 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, white to off-white in color, with a diameter of approximately 5.1 mm and engraved with "HP" on one side and "score line" on the other side.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Propranolol Tarbis 40 mg film-coated tablets EFG

Film-coated tablets, biconvex, round, white to off-white in color, with a diameter of approximately 8.6 mm and engraved with "HP1" on one side and "score line" on the other side.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Blister pack containing 30, 50, 100, 200, and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Propranolol Amarox 10 mg/40 mg/80 mg film-coated tablets

Netherlands: Propranolol HCL Amarox 10 mg/40 mg/80 mg, film-coated tablets

Spain: Propranolol Tarbis 10 mg/40 mg film-coated tablets EFG

Date of the last revision of this leaflet: April 2024

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