PROPRANOLOL 40 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Propranolol Accord, 10 mg, Film-Coated Tablets
3. Propranolol Accord, 40 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
4. What is Propranolol Accord and What is it Used for
5. Important Information Before Taking Propranolol Accord
   1. When Not to Take Propranolol Accord
   2. Warnings and Precautions
   3. Propranolol Accord and Other Medications
   4. Propranolol Accord with Food, Drink, and Alcohol
   5. Surgical Procedures
   6. Driving and Operating Machinery
   7. Pregnancy, Breastfeeding, and Fertility
   8. What Propranolol Accord Contains
6. How to Take Propranolol Accord
   1. Adults
   2. Elderly Patients
   3. Renal or Hepatic Impairment
   4. Taking More Than the Recommended Dose of Propranolol Accord
   5. Missing a Dose of Propranolol Accord
   6. Stopping Treatment with Propranolol Accord
7. Possible Side Effects
   1. Common (May Affect Up to 1 in 10 People):
   2. Rare (May Affect Up to 1 in 1,000 People):
   3. Very Rare (May Affect Up to 1 in 10,000 People):
   4. Frequency Not Known (Frequency Cannot be Estimated from the Available Data):
   5. Additional Side Effects in Children and Adolescents
   6. Very Rare (May Affect Up to 1 in 10,000 People):
   7. Frequency Not Known (Frequency Cannot be Estimated from the Available Data):
   8. Reporting Side Effects
8. How to Store Propranolol Accord
9. Package Contents and Other Information
   1. What Propranolol Accord Contains:
   2. What Propranolol Accord Looks Like and Contents of the Pack:
   3. Marketing Authorization Holder:
   4. Manufacturer/Importer:
   5. 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:
   6. Date of Last Revision of the Package Leaflet: April 2025

Package Leaflet: Information for the Patient

Propranolol Accord, 10 mg, Film-Coated Tablets

Propranolol Accord, 40 mg, Film-Coated Tablets

Propranolol Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medication Has Been Prescribed Specifically for You. Do Not Pass it on to Others. It May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 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. Package Contents 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 Heart and Blood Vessels, as Well as 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 Heart Rhythm Disorders (Arrhythmias)
• to Protect the Heart After a Heart Attack (Myocardial Infarction)
• to Treat Migraines
• to Treat Essential Tremor (Involuntary, Rhythmic Tremor)
• to Treat Certain Thyroid Disorders, Such as Thyrotoxicosis and Hyperthyroidism (Caused by Excess 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 in the Esophagus Due to High Blood Pressure in the Liver.

2. Important Information Before Taking Propranolol Accord

When Not to Take Propranolol Accord

• if You are Allergic to Propranolol Hydrochloride or Any of the Other Ingredients of this Medication (Listed in Section 6),
• if You Have Untreated or Uncontrolled Heart Failure,
• if You Have Had a Heart Attack Due to a Heart Condition,
• if You Have Severe Heart Disease (Second or Third Degree Block) That May Require a Pacemaker,
• if You Have Conduction Disorders or Heart Rhythm Disorders,
• if You Have Very Slow or Irregular Heartbeats,
• if You Have Increased Blood Acidity (Metabolic Acidosis),
• if You are on a Strict Diet,
• if You Have Asthma, Wheezing, or Other Breathing Disorders,
• if You Have Untreated Pheochromocytoma (High Blood Pressure Caused by a Tumor, Usually in the Kidney Area),
• if You Have Severe Circulatory Disorders (Which May Cause Tingling, Pallor, or Cyanosis of the Fingers and Toes),
• if You Have Chest Pain at Rest (Prinzmetal's Angina),
• if You Have Very Low Blood Pressure.

If Any of the Above Warnings Apply to You, or if You are in Doubt, Consult Your Doctor Before Taking this Medication.

Warnings and Precautions

Before Starting to Take Propranolol Accord, Discuss with Your Doctor or Pharmacist if:

• You Have Allergic Reactions, Such as Insect Stings.
• You Have Diabetes, as Propranolol Accord May Change the Normal Response to Low Blood Sugar Levels, Which is Usually Associated with an Increased Heart Rate. Propranolol May Also Cause Low Blood Sugar Levels, Even in Non-Diabetic Patients.
• You Have Thyrotoxicosis (a Condition Caused by Excess Thyroid Hormones). Propranolol May Mask the Symptoms of Thyrotoxicosis.
• You Have Kidney or Liver Disease (Including Liver Cirrhosis). In Such Cases, Consult Your Doctor, as Certain Tests May be Necessary During Treatment.
• You Have Heart Disease.
• You Have Muscle Weakness (Myasthenia Gravis).
• You Have Chronic Obstructive Pulmonary Disease (COPD) or Asthma, as Propranolol May Worsen These Conditions.
• You are Taking Calcium Channel Blockers with Negative Inotropic Effects, Such as Verapamil and Diltiazem (See Propranolol Accord and Other Medications).
• You or a Family Member Have a History of Psoriasis

If You are Scheduled for Surgery, Inform the Anesthesiologist or Medical Staff that You are Taking Propranolol Accord.
If You Wear Contact Lenses, Reduced Tear Production Caused by Propranolol May Cause Discomfort.
If You Smoke, the Effect of Propranolol May be Reduced.

Propranolol Accord and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Plan to Take, as Well as Any Medications You Have Recently Taken. Propranolol Accord May Affect the Action of Certain Other Medications, and Certain Medications May Affect the Action of Propranolol Accord.
Do Not Take Propranolol Accord with Calcium Channel Blockers with Negative Inotropic Effects (Such as Verapamil and Diltiazem), as this May Increase the Risk of Severe Low Blood Pressure and Slow Heart Rate.

• Nifedipine, Nisoldipine, Nicardipine, Isradipine, Lacidipine (Used to Treat High Blood Pressure or Angina)
• Lidocaine (a Local Anesthetic)
• Disopyramide, Quinidine, Amiodarone, Propafenone, and Glycosides (Used to Treat Heart Conditions)
• Adrenaline (a Medication that Stimulates the Heart)
• Ibuprofen and Indomethacin (Used to Treat 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 High Blood Pressure)
• Fingolimod (Used to Treat Multiple Sclerosis)
• Fluvoxamine and Barbiturates (Used to Treat Anxiety and Insomnia)
• MAO Inhibitors (Used to Treat Depression)

If You are Taking Clonidine (Used to Treat High Blood Pressure or Migraines) and Propranolol, Do Not Stop Taking Clonidine Without Consulting Your Doctor. If Clonidine Needs to be Discontinued, Your Doctor Will Advise You on How to Do it.

Propranolol Accord with Food, Drink, and Alcohol

Alcohol May Affect the Action of Propranolol Accord.

Surgical Procedures

If You are Scheduled for Surgery, Inform the Anesthesiologist or Medical Staff that You are Taking Propranolol Accord.

Driving and Operating Machinery

It is Unlikely that Propranolol Accord Will Affect Your Ability to Drive or Operate Machinery.
However, Some People May Occasionally Experience Dizziness or Fatigue While Taking Propranolol. If You Experience These Symptoms, Consult Your Doctor for Advice.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant, Breastfeeding, or Think You May be Pregnant, Consult Your Doctor or Pharmacist Before Taking this Medication.
Pregnancy
Propranolol Accord is Not Recommended During Pregnancy, Unless Your Doctor Considers it Necessary.
Breastfeeding
Propranolol Accord is Not Recommended During Breastfeeding.

What Propranolol Accord Contains

Propranolol Accord Contains Lactose. If You Have Been Told that You Have an Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.

3. How to Take Propranolol Accord

Always Take this Medication Exactly as Your Doctor or Pharmacist Has Told You.
If You are in Doubt, Consult Your Doctor or Pharmacist.
Take the Tablet Before Meals, with a Small Amount of Water.
Swallow the Tablet Whole. Do Not Chew it.
Do Not Stop Taking Propranolol Accord Without Consulting Your Doctor.

Adults

The Following are the Recommended Doses for Adults:

Children and Adolescents
Propranolol May Also be Used to Treat Migraines and Heart Rhythm Disorders in Children.
In the Treatment of Migraines, the Dose for Children Under 12 Years is 20 mg, Twice or Three Times a Day, and for Children Over 12 Years, the Dose is the Same as for Adults.
In the Treatment of Heart Rhythm Disorders, the Dose Will be Adjusted by the Doctor Based on the Child's Age or Weight.

Elderly Patients

In Elderly Patients, 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 More Than the Recommended Dose of Propranolol Accord

If You Have Taken More Than the Recommended Dose of Tablets, Contact Your Doctor or Go to the Emergency Department of the Nearest Hospital Immediately.
Symptoms of Overdose Include Very Slow Heart Rate, Significant Decrease in Blood Pressure, Heart Failure, and Difficulty Breathing, with Accompanying Symptoms Such as Fatigue, Hallucinations, Tremors, Confusion, Nausea, Vomiting, Muscle Cramps, Fainting, or Coma, and Low Blood Sugar Levels. Always Bring the Remaining Tablets and Packaging with You to Allow Identification of the Medication.

Missing a Dose of Propranolol Accord

If You Forget to Take Your Medication at the Usual Time, Take it as Soon as You Remember.
If it is Almost Time for Your Next Dose, Skip the Missed Dose. Do Not Take a Double Dose to Make Up for the Missed Dose.

Stopping Treatment with Propranolol Accord

Do Not Stop Taking Propranolol Accord Without Consulting Your Doctor. In Some Cases, it May be Necessary to Gradually Discontinue the Medication.
If You Have Any Further Questions About Taking this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Propranolol Accord Can Cause Side Effects, Although Not Everybody Gets Them.
The Following Side Effects May Occur During Treatment with Propranolol Accord.

Common (May Affect Up to 1 in 10 People):

• Cold Fingers and Toes
• Slow Heart Rate, Low Blood Pressure When Standing Up, Fainting, Palpitations, Heart Rhythm Disorders, Worsening of Heart Failure
• Numbness and Tingling of the Fingers, Followed by a Feeling of Warmth and Pain (Raynaud's Syndrome)
• Sleep Disturbances/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):

• Sudden Constriction of the Airways or Worsening of Breathing Difficulties, Sometimes Fatal in Patients with Asthma or Asthmatic Conditions
• Heart Failure, Worsening of Heart Failure
• Swelling of the Skin, Which May Occur on the Face, Tongue, Throat, Abdomen, or Arms and Legs (Angioedema)
• Dizziness, Especially When Standing Up
• Worsening of Circulation in the Limbs in Patients with Existing Circulatory Disorders
• Mood Changes
• Confusion
• Psychosis or Hallucinations (After Too Rapid Discontinuation)
• Paresthesia (Abnormal Sensations, Usually Tingling or Prickling)
• Visual Disturbances
• Dry Eyes
• The Medication May Change the Number and Type of Blood Cells, Such as Decreasing the Number of Platelets (Thrombocytopenia), Which May Cause Easy Bruising and Bleeding.
• Purpura (Purple Spots on the Skin), Large Areas of Hair Loss, Skin Reactions Resembling Psoriasis (Even After Years), Exacerbation of Psoriasis
• Dry Mouth

Very Rare (May Affect Up to 1 in 10,000 People):

• Decreased or Significantly Decreased White Blood Cell Count
• Temporary Increase in Certain White Blood Cells (Transient Eosinophilia)
• Worsening of Myasthenia Gravis (Muscle Weakness), Headache, Depressed 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 Medications; it May Also Occur in Patients Who are Fasting or Have Recently Fasted, as Well as in Patients with Chronic Liver Disease
• Worsening of Diabetes, Changes in Certain Lipid Values in the Blood (Decreased HDL Cholesterol, Increased Triglycerides)
• Excessive Sweating
• Conjunctivitis
• Muscle Pain, Muscle Cramps
• In Long-Term Treatment: Arthralgia
• Worsening of Kidney Function in Severe Kidney Failure
• Libido and Erectile Dysfunction
• Increased Values of Certain Blood Parameters (ASAT, ALAT, ANA)

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• Shallow Breathing or Shortness of Breath
• Depression

Discontinuation of the Medication (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 You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Propranolol Accord

• Keep Out of the Sight and Reach of Children.
• No Special Precautions for Storage are Necessary.
• Do Not Use this Medication After the Expiration Date Stated on the Blister and Carton After EXP. The Expiration Date Refers to the Last Day of the Month Stated.
• Medicines Should Not be Disposed of via Wastewater or Household Waste.
• Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Propranolol Accord Contains:

The Active Substance is Propranolol Hydrochloride.
Each Film-Coated Tablet Contains 10 mg or 40 mg of Propranolol Hydrochloride.
The Other Ingredients are:
Core: Corn Starch, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate
Coating: Hypromellose, Microcrystalline Cellulose, Mono- and Diacetylated Monoglycerides, Titanium Dioxide (E 171)

What Propranolol Accord Looks Like and Contents of the Pack:

10 mg: White or Almost White, Round, Biconvex, Film-Coated Tablets with the Imprint "AI" on One Side and a Score Line on the Other.
40 mg: White or Almost White, Round, Biconvex, Film-Coated Tablets with the Imprint "AL" on One Side and a Score Line on the Other.
The Score Line is Only to Facilitate Breaking the Tablet for Easier Swallowing and Not to Divide it into Equal Doses.
The Medication is Packaged in PVC/PVDC/Aluminum Blisters.
The Pack 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.
Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
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 Package Leaflet: April 2025