Propranolol Accord 10 mg film-coated tablets EFG

Package leaflet: Information for the user

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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Propranolol Accord 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 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)
• Heart protection after myocardial infarction (heart attack)
• Migraine
• Essential tremor (involuntary, rhythmic shaking)
• 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)
• Bleeding in the oesophagus caused by high blood pressure in the liver (portal hypertension)

2. What you need to know before taking Propranolol Accord

Do not take Propranolol Accord 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 had 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 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 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 Accord 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 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");
• if you or a family member has (or has had) psoriasis.

If you are undergoing surgery, inform the anaesthetist that you are taking Propranolol.

If you wear contact lenses, the reduction in tear production caused 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 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 should 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, isradipine, lacidipine, and diltiazem (used to treat hypertension or angina);
• lidocaine (a local anaesthetic);
• disopyramide, quinidine, amiodarone, propafenone, and glycosides (for treating 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 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 admitted to hospital for surgery, tell the anaesthetist or medical staff that you are taking Propranolol.

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.

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.

Propranolol Accord contains:

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

3. How to take Propranolol Accord

Always take this medicine exactly as your doctor, pharmacist, or nurse has instructed you. 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.

Adults

The following table shows the recommended doses for an adult:

Paediatric population

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

• For migraine, the dose for children under 12 years of age is 20 mg two or three times daily, and the adult dose applies for children aged 12 years or older.
• 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 Accord 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 medicine and the amount ingested. Overdose may cause 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 the remaining tablets, the packaging, and the leaflet so that the medicine can be identified.

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 your next dose, do not take the missed dose.

If you stop taking Propranolol Accord

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 will experience them. The following adverse effects may occur when using this medicine:

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

• Cold fingers and toes
• Slow heart rate, drop in blood pressure related to posture, collapse, palpitations, disturbances in heart rhythm, worsening of heart failure
• Numbness and cramps in the fingers, followed by swelling and pain (Raynaud's syndrome)
• Sleep disorders/nightmares, particularly at the beginning of treatment: dizziness, confusion
• Fatigue and/or exhaustion (often transient)
• Skin allergic reactions: redness, itching, rash, hair loss

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

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

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

• Attacks of airway constriction or worsening of breathing difficulties, sometimes fatal, if you have or have had asthma or asthmatic complaints in the past

• Heart failure or worsening of heart problems

• Swelling of the skin which may occur in the face, tongue, larynx, abdomen, or arms and legs (angioedema)

• Dizziness, especially when getting 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 pricking ("pins and needles"))

• Vision 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 may make you bruise and bleed more easily

• Purple-colored spots on the skin (purpura), large areas of hair loss, skin reactions similar to psoriasis (even years later), worsening of psoriasis

• Dry mouth

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

• Deficiency or very severe reduction of white blood cells
• Temporary increase in certain white blood cells (transient eosinophilia)
• Worsening of a certain type of muscle weakness (myasthenia gravis), headache, depressive mood states
• Low blood sugar levels may occur in diabetic and non-diabetic patients, elderly patients, patients with artificial kidneys (dialysis), 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
• Worsening of diabetes, changes in 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 renal failure
• Disorders of libido and erection

Increase or elevation of certain blood values (GOT, GPT, ANA).

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

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

Discontinuation of the medicine (also due to the reactions mentioned) should only occur 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 available data):

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

Reporting of adverse effects:

If you experience adverse effects, consult your doctor, pharmacist, or nurse. This includes possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 stated on the label 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. If you are unsure, ask your pharmacist how to 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 Accord

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

The other components 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 contents of the pack

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

The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not guarantee equal division of the dose.

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

Only certain 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, Spain

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,

The Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

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

Date of the most recent review of this leaflet: April 2025