Leaflet: information for the user

Propranolol Accord 40 mg film-coated tablets EFG

Propranolol hydrochloride

Read this 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 you must not give it to others even if they have the same symptoms of illness as 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. See section 4.

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

2. What you need to know before you start taking Propranolol Accord

3. How to take Propranolol Accord

4. Possible side effects

5. Storage of Propranolol Accord

6. Contents of the pack and additional information

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

Propranolol may be used for:

• Hypertension (high 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 type of thyroid diseases (hyperthyroidism and thyrotoxicosis, caused by an overactive thyroid gland)
• )
• Hypertrrophic cardiomyopathy (thickening of the heart muscle)
• Phaeochromocytoma (high blood pressure usually caused by a tumor near the kidney)
• Oesophageal hemorrhage caused by high blood pressure in the liver

Do not take Propranolol Accord if:

·You are allergic to hydrochloride propranolol or 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 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 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 feeling of painful pressure in your chest 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, pharmacist, or nurse before starting to take Propranolol Accord 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 involves an increase in heart rate. Propranolol may cause low blood sugar levels 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 medicines and Propranolol")
• If you or a family member has (or has had) psoriasis.

If you are to undergo surgery, inform the anesthetist that you are taking Propranolol.

If you wear contact lenses, the reduction of tear production by Propranolol may make them uncomfortable.

If you are a smoker, the effect of Propranolol may be reduced.

Other medicines and Propranolol Accord

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.Propranolol mayinteract 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 (for example, verapamil, diltiazem), as this may lead to severe hypotension and bradycardia.

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

• nifedipine, nisoldipine, nicardipine, isradipine, lacidipine, and diltiazem (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)
• fingerolimod (for multiple sclerosis)
• fluvoxamine and barbiturates(for anxiety and insomnia);
• monoamine oxidase inhibitors (MAOIs) (for depression)

If you are taking clonidine (for hypertension or migraine) and Propranolol together, you should stop taking clonidin 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 with food, drink, and alcohol
Alcohol may affect the functioning of this medicine.

Operations
If you are to undergo surgery, tell the anesthetist or medical staff that you are taking Propranolol.

Driving and operating machinery
It is unlikely that your medicine 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.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend 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:
It is not recommended to breastfeed while taking this medicine.

Propranolol Accord contains

Propranolol Accord contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are unsure, consult your doctor or pharmacist again.Consult your doctor or pharmacist again if you are unsure.

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.

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 the adult dose for children 12 years or older.
- 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 Accord than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.Overdose causes 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, low blood sugar level.Always bring the remaining tablets, the packaging, and the leaflet to identify the medicine.

If you forget to take Propranolol Accord

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 interrupt treatment with Propranolol Accord

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 doubts about the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.The following side effects may appear when using this medicine:

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 swelling and pain (Raynaud's syndrome)
• Sleep disturbances/pesadillas
• Fatigue
• Difficulty breathing

Infrequent (may affect up to 1 in 100 patients):

• Nausea, vomiting, and diarrhea.

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

• Worsening of respiratory difficulty, sometimes with a fatal outcome, if you have or have had asthma or asthma-like symptoms in the past.
• 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 poor circulation.
• Hair loss (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 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 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 long-term liver disease.
• Excessive sweating

Unknown (frequency cannot be estimated from available data):

• Headache or seizures related to low blood sugar
• Impotence in men
• Decreased renal blood flow
• Joint pain (arthritis)
• Constipation
• Dry mouth
• Lack of breath or breathing difficulty (dyspnea)
• Conjunctivitis
• Depression
• Reduced and dangerous white blood cell count (agranulocytosis)
• Worsening of angina pectoris (chest pain) in patients with angina pectoris

Reporting of side effects:

If you experience side effects, consult your doctor, pharmacist, or nurse. This includes possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• This medication does not require any special storage conditions.
• Do not use this medication after the expiration date that appears on the label after ‘CAD:’. The expiration date is the last day of the month indicated.
• Do not dispose of medications through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Propranolol Accord

The active ingredient is propranolol hydrochloride. Each film-coated tablet contains 40 mg of propranolol hydrochloride.

The other components are:

Maize starch

Lactose monohydrate

Microcrystalline cellulose (E460)

Magnesium stearate (E572)

Composition of the tablet coating:

Hydroxypropyl methylcellulose (E464)

Microcrystalline cellulose (E460)

Acetylated monoglycerides and diglycerides

Titanium dioxide (E171)

Appearance of Propranolol Accord and packaging contents

40 mg: Round, biconvex film-coated tablets, white or off-white in color, with the inscription "AI" on one face and a groove on the other.

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

PVC-PVdC/ALU blister pack in sizes of 25, 28, 30, 50, 56, 60, 100, and 250 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible Person

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

This medicinal product is authorized in the Member States of the EEA under the following names:

Last reviewed date of this leaflet: June 2024