PROPRANOLOL ACCORD 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Propranolol Accord 10 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 Package Leaflet

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

1. What is Propranolol Accord 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 also 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 myocardial infarction (heart attack)
• Migraine
• Essential tremor (involuntary and rhythmic tremors)
• Certain types of thyroid diseases (thyrotoxicosis and hyperthyroidism, which are caused by an overactive thyroid gland)
• 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 Accord

Do not take Propranolol Accord 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 taking Propranolol.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking 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 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 (see "Other medicines and Propranolol")
• If you or a family member have (or have had) psoriasis.

If you are going to have an operation, tell the anesthesiologist 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

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, and diltiazem (used to treat high blood pressure 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 high blood pressure)
• fingolimod (to treat multiple sclerosis)
• fluvoxamine and barbiturics (to treat anxiety and insomnia);
• monoamine oxidase inhibitors (MAOIs) (to treat depression)

If you are taking clonidine (for high blood pressure or migraine) and Propranolol together, you should not stop taking clonidine unless your doctor tells you to. If stopping clonidine becomes necessary for you, your doctor will give you detailed instructions on how to do it.

Propranolol with food, drink, and alcohol

Alcohol may affect the functioning of this medicine.

Operations

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, ask your doctor or pharmacist for advice before taking 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 have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Propranolol Accord

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask your doctor or pharmacist.

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.

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.

Elderly population

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

Renal or hepatic impairment

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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. 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 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 stop taking 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 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
• Slow heart rate, decrease in blood pressure related to posture, collapse, palpitations, heart rhythm disorders, worsening of heart failure.
• Numbness and cramps in the fingers of the hands, followed by flushing and pain (Raynaud's syndrome)
• Sleep disorders/nightmares, especially at the start of treatment: dizziness, confusion
• Fatigue, and/or exhaustion (often transient)
• Allergic skin reactions: redness, itching, rash, hair loss.

Uncommon (may affect up to 1 in 100 people):

• Nausea, vomiting, and diarrhea or constipation
• Muscle weakness

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

• Constriction of the airways or worsening of breathing difficulties, sometimes with a fatal outcome, if you have or have had asthma or asthma-like complaints in the past.
• Heart failure or worsening of heart problems
• Swelling of the skin that can occur in the face, tongue, larynx, abdomen, or arms and legs (angioedema)
• Dizziness, especially when standing up
• Worsening of blood circulation in the limbs, if you already have poor circulation.
• Emotional instability
• Confusion
• Psychosis or hallucinations (after stopping the medicine too quickly).
• Paresthesia (an abnormal sensation, usually tingling or pinching ("pins and needles"))
• Visual disturbances.
• Dry eyes.

• Your medicine may alter the number and types of your blood cells, such as reducing the number of platelets (thrombocytopenia) in your blood, which can cause you to bruise and bleed more easily.
• Purple spots on the skin (purpura), large areas of hair loss, skin reactions similar to those of psoriasis (even years later), worsening of psoriasis
• Dry mouth

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

• Severe or very severe reduction in white blood cells
• Temporary increase in certain white blood cells in the blood (transient eosinophilia)
• Worsening of certain types of muscle weakness (myasthenia gravis), headache, depressive mood states.
• Low blood sugar levels may appear in diabetic and non-diabetic patients, elderly patients, patients with artificial kidneys (dialysis), or patients taking diabetes medicines. It may also occur in patients who are fasting or have recently fasted or have a long-term liver disease.
• Worsening of diabetes, modification of certain blood lipid values (reduction of HDL cholesterol, increase in triglycerides).
• Excessive sweating
• Conjunctivitis
• Muscle pain, muscle cramps
• In long-term treatment: arthropathy
• Worsening of kidney function in severe kidney failure
• Disorders of libido and erection

Increased or elevated certain blood values (GOT, GPT, ANA).

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

• Shortness of breath or difficulty breathing (dyspnea)
• Depression

Stopping the medicine (also due to the reactions mentioned) should only be done after consulting your doctor and, in general, should be gradual.

Additional side effects in children and adolescents

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

• Decrease in blood sugar levels in newborns, infants, and children.

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

• Seizures due to low blood sugar levels in newborns, infants, and children.

Reporting of side effects:

If you experience 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 Accord

• 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 which is stated on the label after ‘EXP:’. The expiry date is the last day of the month shown.
• Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Propranolol Accord

The active ingredient is propranolol hydrochloride. Each film-coated tablet contains 10 mg of propranolol hydrochloride.

The other ingredients are:

Corn starch

Lactose monohydrate

Microcrystalline cellulose (E460)

Magnesium stearate (E572)

Composition of the tablet coating:

Hypromellose (E464)

Microcrystalline cellulose (E460)

Acetylated monoglycerides and diglycerides

Titanium dioxide (E171)

Appearance of Propranolol Accord and Packaging Contents

10 mg: White or almost white, round, biconvex film-coated tablets with the inscription "AI" on one side and a score line on the other.

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

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

Only some pack 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

Manufacturer

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 pharmaceutical product is authorized in the EEA Member States under the following names:

Date of the last revision of this leaflet: April 2025