Propranolol Tarbis 40 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Propranolol Tarbis 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 may be used 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 trembling)
• Certain types of thyroid diseases (thyrotoxicosis, caused by an overactive thyroid gland, and hyperthyroidism)
• Hypertrophic cardiomyopathy (thickening of the heart muscle)
• Phaeochromocytoma (high blood pressure usually caused by a tumour near the kidney)
• Bleeding in the oesophagus caused by high blood pressure in the liver

2. What you need to know before taking Propranolol Tarbis

Do not take Propranolol Tarbis if:

• you are allergic 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) that require treatment with a cardiac pacemaker;
• you suffer from heart rhythm or conduction disorders;
• you have a very slow or irregular heartbeat;
• you have increased acidity in the blood (metabolic acidosis);
• you are following a strict fasting diet;
• you have asthma, wheezing, or other breathing difficulties;
• you have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney);
• you have severe blood circulation 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 applies to you, or if you have any doubts, speak with 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 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").

Other medicines and Propranolol Tarbis

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines. Propranolol may interfere with the action of other medicines, and other medicines may affect propranolol.

Propranolol must not be used in combination with calcium channel blockers that have 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 together with your medicine include:

• nifedipine, nisoldipine, nicardipine, isradipino, lacidipino (used to treat hypertension or angina);
• disopyramide, quinidine (to treat heart problems);
• lidocaine;
• amiodarone, propafenone (for irregular heartbeats);
• digoxin (for heart failure);
• adrenaline (a cardiac stimulant);
• cimetidine (for stomach problems);
• rifampicin (for the treatment of tuberculosis);
• theophylline (for asthma);
• warfarin (to thin the blood) and hydralazine (for hypertension);
• fingolimod (to treat multiple sclerosis);
• barbiturates (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 must not stop taking clonidine unless your doctor tells you to. If stopping clonidine becomes necessary, your doctor will give you detailed instructions on how to do so.

Propranolol with food, drink and alcohol

Alcohol may affect how this medicine works.

Surgery

If you are going into hospital for surgery, tell the anaesthetist 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 operate machinery. However, some people may occasionally feel dizzy or tired when taking propranolol. If this happens to you, seek advice from your doctor.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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.

Breast-feeding:

Breast-feeding is not recommended while taking this medicine.

Important information about some of the ingredients of Propranolol Tarbis:

Propranolol Tarbis contains lactose: If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Propanolol Tarbis

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

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

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

The following table shows the recommended doses for an adult:

*In certain 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 Poison Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested. Overdose causes excessively slow heart rate, blood pressure that is too low, heart failure, and difficulty breathing, 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 container, and the package leaflet so that the medication can be identified.

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 your next dose, do not take the missed dose.

If you stop taking Propranolol Tarbis

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, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur when using this medicine:

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

• Cold fingers of the feet and hands
• 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 difficulty, if you have or have had asthma.
• Dyspnea and/or swelling in the ankles, if you also have heart failure.
• Heart block that may 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 disturbances)
• Abnormal sensation, usually tingling or pricking ("pins and needles")
• Vision disturbances
• Dry eyes
• Skin rash, including worsening of psoriasis
• Swelling of blood vessels under the skin, which may be painful and accompanied by redness (thrombocytopenia)
• Purple-colored 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 medications 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

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

• Seizures related to low blood sugar levels
• Inability of a man to achieve an erection (impotence)
• 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 adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Tarbis

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

Do not use this medicine after the expiry date stated on the packaging and blister pack/bottle, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This will help 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 components are:

Tablet core: Corn starch, monohydrate lactose, 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, biconvex, round tablets, white to off-white in colour, with an approximate diameter of 5.1 mm, marked with "HP" on one side and a "scored line" on the other.

The tablet is scored to allow splitting and facilitate swallowing, but not for dividing into equal doses.

Propranolol Tarbis 40 mg film-coated tablets EFG

Film-coated, biconvex, round tablets, white to off-white in colour, with an approximate diameter of 8.6 mm, marked with "HP1" on one side and a "scored line" on the other.

The tablet is scored to allow splitting and facilitate swallowing, but not for dividing into equal doses.

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

Only certain 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

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Propranolol Amarox 10 mg/40 mg/80 mg Filmtabletten

The Netherlands: Propranolol HCL Amarox 10 mg/40 mg/80 mg, filmomhulde tabletten

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

Date of the most recent revision of this leaflet: April 2024

Detailed and up-to-date 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/