Propranolol Accord

Leaflet accompanying the packaging: patient information

Propranolol Accord, 10 mg, coated tablets

Propranolol Accord, 40 mg, coated tablets

Propranolol hydrochloride

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Propranolol Accord contains propranolol hydrochloride, which belongs to a group of medicines called beta-blockers. It works on the cardiovascular system and other parts of the body.
Propranolol Accord can be used:

• to treat high blood pressure (hypertension)
• to treat angina pectoris (chest pain)
• to treat certain arrhythmias (heart rhythm disorders)
• to protect the heart after a heart attack (myocardial infarction)
• to treat migraines
• to treat essential tremor (involuntary and rhythmic shaking)
• to treat certain thyroid diseases, such as thyrotoxicosis and hyperthyroidism (which is caused by an excess of thyroid hormones in the blood)
• to treat hypertrophic cardiomyopathy (thickening of the heart muscle)
• to treat pheochromocytoma (high blood pressure caused by a tumor, usually in the kidney area)
• to prevent bleeding into the esophagus due to high blood pressure in the liver.

2. Important information before taking Propranolol Accord

When not to take Propranolol Accord

• if the patient is allergic to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has untreated/uncontrolled heart failure,
• if the patient has been diagnosed with cardiogenic shock,
• if the patient has severe heart disease (second- or third-degree heart block) that may require a pacemaker,
• if the patient has conduction disorders or heart rhythm disorders,
• if the patient has very slow or very irregular heart rate,
• if the patient has increased blood acidity (metabolic acidosis),
• if the patient is on a strict diet,
• if the patient has asthma, wheezing, or other breathing disorders,
• if the patient has untreated pheochromocytoma (high blood pressure caused by a tumor, usually in the kidney area),
• if the patient has severe circulatory disorders (which can cause tingling or paleness, or blue discoloration of fingers and toes),
• if the patient has squeezing chest pain at rest (Prinzmetal's angina),
• if the patient has very low blood pressure.

If any of the above warnings apply to the patient or if the patient has doubts, they should consult a doctor before taking this medicine.

Warnings and precautions

Before starting to take Propranolol Accord, the patient should discuss it with their doctor or pharmacist if:

• the patient has allergic reactions, e.g., to insect bites.
• the patient has diabetes, as Propranolol Accord may change the normal reactions to low blood sugar levels, which are usually associated with an increased heart rate. Propranolol may also cause low blood sugar levels even in patients without diabetes.
• the patient has thyrotoxicosis (a disease that occurs in people with an excess of thyroid hormones). Propranolol may mask the symptoms of thyrotoxicosis.
• the patient has kidney or liver disease (including liver cirrhosis). In such cases, the patient should consult a doctor, as some control tests may be necessary during treatment.
• the patient has heart disease.
• the patient has muscle weakness (myasthenia).
• the patient has diseases such as chronic obstructive pulmonary disease and bronchospasm, as propranolol may worsen these conditions.
• the patient is taking calcium channel blockers with negative inotropic effects, e.g., verapamil and diltiazem (see Propranolol Accord and other medicines).
• the patient or a family member has or has had psoriasis

If the patient is scheduled for surgery, they should inform the anesthesiologist about taking propranolol.
If the patient wears contact lenses, reduced tear production caused by propranolol may cause discomfort.
If the patient smokes, the effect of propranolol may be weakened.

Propranolol Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Propranolol Accord may affect the action of some other medicines, and some medicines may affect the action of Propranolol Accord.
The patient should not take Propranolol Accord in combination with calcium channel blockers with negative inotropic effects (e.g., verapamil, diltiazem), as this may enhance their effects. This may cause severe hypotension and bradycardia.
Other medicines that should be used with caution in combination with Propranolol Accord:

• nifedipine, nisoldipine, nicardipine, isradipine, lacidipine (used to treat hypertension or angina)
• lidocaine (a local anesthetic)
• disopyramide, quinidine, amiodarone, propafenone, and glycosides (used to treat heart diseases)
• adrenaline (a medicine that stimulates heart activity)
• ibuprofen and indomethacin (used for pain and inflammation)
• ergotamine, dihydroergotamine, or rizatriptan (used to treat migraines)
• chlorpromazine and thioridazine (used to treat certain mental disorders)
• cimetidine (used to treat stomach disorders)
• rifampicin (used to treat tuberculosis)
• theophylline (used to treat asthma)
• warfarin (a blood thinner) and hydralazine (used to treat hypertension)
• fingolimod (used to treat multiple sclerosis)
• fluvoxamine and barbiturates (used to treat anxiety and insomnia)
• monoamine oxidase inhibitors (used to treat depression)

If the patient is taking clonidine (used to treat hypertension or migraines) and propranolol, they should not stop taking clonidine without their doctor's advice. If it is necessary to discontinue clonidine, the doctor will inform the patient how to do it.

Propranolol Accord with food, drink, and alcohol

Alcohol may affect the action of the medicine.

Surgical procedures

If the patient is scheduled for surgery, they should inform the anesthesiologist or medical staff about taking Propranolol Accord.

Driving and using machines

It is unlikely that the medicine will affect the ability to drive or use machines. However, some people may occasionally experience dizziness or fatigue when taking propranolol. If such symptoms occur, the patient should consult their doctor for advice.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
This medicine should not be used during pregnancy unless the doctor considers it necessary.
Breastfeeding
Breastfeeding is not recommended during treatment with this medicine.

Propranolol Accord contains:

Propranolol contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Propranolol Accord

This medicine should always be taken exactly as advised by the doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be taken before a meal, with a small amount of water.
The tablet should be swallowed whole. It should not be chewed.
The patient should not stop taking the medicine without their doctor's advice.

Adults

The recommended dosage for an adult is as follows:

Children and adolescents
Propranolol may also be used to treat children with migraines and heart rhythm disorders.
In the treatment of migraines, the dose in children under 12 years of age is 20 mg, twice or three times a day, and in children over 12 years of age, the dose is the same as for adults.
In the treatment of heart rhythm disorders, the dose of the medicine will be adjusted by the doctor according to the child's age or body weight.

Elderly patients

In older people, treatment can be started with a lower 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.

Taking a higher dose of Propranolol Accord than recommended

In case of accidental ingestion of a larger amount of tablets than recommended, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital.
Symptoms of overdose are very slow heart rate, significantly lowered blood pressure, heart failure, and breathing difficulties, with accompanying symptoms such as fatigue, hallucinations, tremors, confusion, nausea, vomiting, muscle cramps, fainting, or coma, low blood sugar levels. The patient should always take the remaining tablets and packaging with them to enable the identification of the medicine.

Missing a dose of Propranolol Accord

If the patient forgets to take the medicine at the usual time, they should do so as soon as they remember.
If it is almost time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Propranolol Accord

The patient should not stop taking the medicine without consulting their doctor. In some cases, it may be necessary to gradually discontinue the medicine.
If the patient has any further doubts about taking this medicine, they should consult their 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 occur during treatment with this medicine.

Common (may affect up to 1 in 10 people):

• cold fingers and toes
• slow heart rate, low blood pressure when standing up, collapse, palpitations, heart rhythm disorders, worsening of heart failure
• numbness and cramps in the fingers, followed by a feeling of warmth and pain (Raynaud's syndrome)
• sleep disorders/nightmares, especially at the beginning of treatment, dizziness, disorientation
• fatigue and (or) exhaustion (often transient)
• skin allergic 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):

• episodic narrowing of the airways or worsening of breathing difficulties, sometimes fatal in patients with asthma or asthmatic conditions
• heart failure, worsening of heart failure
• skin swelling, which may occur on the face, tongue, throat, abdomen, or arms and legs (angioedema)
• dizziness, especially when standing up
• worsening of blood circulation in the limbs in patients with existing circulatory disorders
• mood changes
• confusion
• psychosis or hallucinations (after too rapid withdrawal)
• paresthesia (abnormal sensations, usually tingling or prickling)
• vision disturbances
• dry eyes
• the medicine may change the number and type of blood cells, for example, reduce the number of platelets (thrombocytopenia), which can cause easier bruising and bleeding.
• purplish spots on the skin (purpura), large areas of hair loss, skin reactions resembling psoriasis (even after years), worsening of psoriasis
• dryness of the mucous membrane of the mouth

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

• deficiency or significant reduction in the number of white blood cells
• temporary increase in the number of certain white blood cells (transient eosinophilia)
• worsening of pathological muscle weakness (myasthenia), headache, depressive mood
• low blood sugar levels, which may occur in both diabetic and non-diabetic patients, elderly patients, patients undergoing dialysis, or patients taking anti-diabetic medicines; it may also occur in patients who are fasting or have recently fasted and in patients with chronic liver disease
• worsening of diabetes, change in some lipid values in the blood (decrease in HDL cholesterol, increase in triglycerides)
• excessive sweating
• conjunctivitis
• muscle pain, muscle cramps
• in long-term treatment: arthropathy
• worsening of kidney function in case of severe kidney failure
• libido and erection disorders
• increase in some blood test parameters (ASpAT, ALAT, ANA)

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

• slow breathing or shortness of breath
• depression

Withdrawal of the medicine (also due to the above reactions) should only be done after consulting a doctor and should be done gradually.

Additional side effects in children and adolescents

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

• Low blood sugar levels in newborns, infants, and children

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

• Seizures caused by low blood sugar levels in newborns, infants, and children

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Propranolol Accord

• Store out of sight and reach of children.
• There are no special precautions for storing the medicine.
• Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste.
• The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Propranolol Accord contains:

The active substance of the medicine is propranolol hydrochloride.
Each coated tablet contains 10 mg or 40 mg of propranolol hydrochloride.
The other excipients are:
Core: cornstarch, lactose monohydrate, microcrystalline cellulose, magnesium stearate
Coating: hypromellose, microcrystalline cellulose, mono- and diacetylated monoglycerides, titanium dioxide (E 171)

What Propranolol Accord looks like and what the pack contains:

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.
40 mg: White or almost white, round, biconvex, film-coated tablets with the inscription "AL" on one side and a score line on the other.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
The medicine is packaged in PVC/PVDC/Aluminum blisters.
The packaging contains 25, 28, 30, 50, 56, 60, 100, and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: April 2025