SUMIAL 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sumial 40 mg Film-Coated Tablets

Propranolol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Contents of the Package Leaflet:

1. What Sumial is and what it is used for
2. What you need to know before taking Sumial
3. How to take Sumial
4. Possible side effects
5. Storage of Sumial
6. Package Contents and Additional Information

1. What Sumial is and what it is used for

Sumial belongs to a group of medications called beta-blockers, which act at different levels within the body, including the heart.

Sumial is indicated for:

• Treatment of high blood pressure.
• Treatment of chest pain (angina).
• Treatment of certain heart disorders (hypertrophic obstructive cardiomyopathy).
• Control of irregular heartbeats.
• Protection of the heart after a heart attack.
• Prevention of migraine (headache).
• Treatment of tremors.
• Treatment of anxiety symptoms.
• Treatment of certain thyroid disorders (thyrotoxicosis).
• Treatment of pheochromocytoma (a tumor of the adrenal gland) which will be administered along with another treatment: an alpha-adrenergic blocker.
• Prevention of bleeding in the esophagus caused by high blood pressure in the liver.

2. What you need to know before taking Sumial

Do not take Sumial

• If you are allergic (hypersensitive) to propranolol or any of the other components of Sumial (listed in section 6).
• If you have or have had asthma or wheezing (whistling).
• If you have or have had heart problems, including heart failure or heart block, or if you have ever had a very slow or irregular heartbeat, low blood pressure (hypotension), or poor blood circulation.
• If you have a specific type of chest pain called Prinzmetal's angina.
• If you have ever been diagnosed with pheochromocytoma (a tumor of the adrenal gland) that is not being treated with other medications.
• If you are undergoing prolonged fasting.
• If you have metabolic acidosis (excessive acidity in the blood) (e.g., diabetic).
• If you are pregnant or think you may be pregnant or are breastfeeding.
• In case of severe heart failure (cardiogenic shock) or heart rhythm disorder (sick sinus syndrome).
• If you have a predisposition to hypoglycemia (low blood sugar levels).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Sumial

• If you are allergic to any substance.
• If you have liver, kidney, thyroid, circulation, or heart problems.
• If you are diabetic.
• If you have a feeling of shortness of breath or swollen ankles (heart failure).

• If you have a history of allergic reactions to certain substances, Sumial may increase these reactions. You may also need higher doses of adrenaline than those usually used to treat the allergic reaction.
• If you are taking a medication called clonidine for high blood pressure (hypertension) or to prevent migraine (headache), do not stop taking clonidine or Sumial without consulting your doctor first (see "Taking Sumial with other medications").
• You may notice a decrease in pulse while taking the tablets. This is a normal reaction, but consult your doctor if you have any doubts.
• Sumial may mask the signs of certain thyroid disorders (thyrotoxicosis).
• The use of Sumial in patients with high blood pressure in the liver may worsen liver function.
• Occasionally, in non-diabetic patients, Sumial may modify the body's normal response to insulin.
• If you are diabetic, Sumial may alter your response to insulin or other anti-diabetic treatments.
• Sumial may also modify the body's response to hypoglycemia (low blood sugar levels), reducing the rapid heartbeat that occurs during this time. Very rarely, blood sugar levels can drop to levels that can cause seizures or coma.
• Beta-blockers may increase muscle weakness in patients with myasthenia (muscle weakness).
• If you have a heart condition called ischemic heart disease, do not stop treatment abruptly, but rather gradually over 2 weeks.
• In case of hospitalization, inform the healthcare staff, especially the anesthesiologist in case of surgery, that you are taking Sumial.

Taking Sumial with other medications

Tell your doctor or pharmacist that you are taking, have recently taken, or may need to take any other medication.

In particular, inform your doctor:

• If you are taking disopyramide, insulin, and other diabetes treatments, quinidine, propafenone, or amiodarone (for irregular heartbeats), high blood pressure treatment (hypertension), or angina treatment (in particular, verapamil, diltiazem, clonidine, nifedipine, nisoldipine, nicardipine, isradipine, lacidipine, hydralazine). Sumial may cause an increase in blood pressure when stopping clonidine (see "Warnings and Precautions").
• If you are being administered adrenaline, migraine treatments containing ergotamine derivatives, dihydroergotamine, or rizatriptan, chlorpromazine, or thioridazine (for certain psychiatric disorders), indomethacin, or ibuprofen (for pain relief), heart failure treatment (digoxin), or stomach problem treatment (cimetidine), tuberculosis treatment (rifampicin), asthma treatment (theophylline), or blood coagulation prevention treatment (warfarin).
• You should also inform your doctor if you are using any nasal decongestants or any other cold medication that you may have purchased at the pharmacy.

Consider that:

• If you take or have taken Sumial, you should not be administered lidocaine intravenously.
• Sumial blood levels may be increased if administered with quinidine, propafenone, nicardipine, isradipine, nifedipine, nisoldipine, lacidipine, cimetidine, hydralazine, or alcohol.
• Sumial blood levels may be decreased by rifampicin.
• Sumial may increase blood levels of theophylline, warfarin, thioridazine, rizatriptan, or lidocaine.
• Sumial may decrease blood levels of lacidipine.
• The administration of Sumial with chlorpromazine produces an increase in the effect of both medications.
• The effects of Sumial may be decreased when administered with adrenaline, indomethacin, or ibuprofen.
• Sumial may prolong the effect of insulin.
• Higher doses of beta-2 agonist bronchodilators may be required to overcome the bronchospasm produced by propranolol.

If it is necessary for you to be administered verapamil or diltiazem intravenously, you should stop your treatment with Sumial 48 hours in advance.

If it is necessary for you to be administered verapamil or diltiazem orally, you should stop your treatment with Sumial 7 days in advance and vice versa.

Interference with laboratory tests:

If you are going to have a laboratory test (including blood or urine tests), inform your doctor that you are taking this medication, as it may alter the results (bilirubin in blood or catecholamines).

In very rare cases, elevated levels of certain antibodies (ANA) have been observed in clinical analyses.

Taking Sumial with food, drinks, and alcohol

Alcohol consumption may influence the effect of the tablets.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before taking any medication. Do not take Sumial during pregnancy and/or breastfeeding unless its use is essential. If you become pregnant during treatment with Sumial, you should contact your doctor as soon as possible.

Driving and Using Machines

Sumial may mildly or moderately affect your ability to drive and use machines, so try not to perform tasks that require special attention until you know how you tolerate the medication.

Sumial 40 mg contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in Athletes:

This medication contains propranolol, which may produce a positive result in doping tests.

3. How to take Sumial

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the dose and duration of your treatment with Sumial. Do not stop treatment before your doctor tells you to. Do not take more doses than your doctor has indicated.

It is best to take the tablet every day at the same time. Swallow the tablet whole with a glass of water.

If you think the action of Sumial is too strong or too weak, inform your doctor or pharmacist.

Use in Adults

The following table shows the usual dose ranges per day for an adult according to their disease. Often, the dose is divided into several smaller doses throughout the day:

*It is considered convenient to use other presentations of Sumial to adjust the dose.

Use in Children

In certain circumstances, Sumial can be used to treat children with arrhythmias (irregular heartbeats). The doctor will adjust the dose based on the child's age or weight.

Use in Elderly Patients

Your doctor will adjust the dose based on the progression of your disease.

Use in Patients with Renal or Hepatic Impairment

If you have liver or kidney impairment, your doctor will adjust the dose, usually starting treatment with the lowest dose in the dosage range.

If you take more Sumial than you should

Propranolol is extremely toxic in case of overdose. If you have taken more than the prescribed dose accidentally or are experiencing symptoms of overdose, you should seek urgent medical attention.

Overdose causes difficulty breathing, low blood pressure, drowsiness, seizures, very slow heartbeats, or coma.

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 medication and the amount ingested.

It is recommended to bring the package and package leaflet of the medication to the healthcare staff.

If you forget to take Sumial

If you forget a dose, wait for the next one. Do not take a double dose to make up for the forgotten doses.

If you stop taking Sumial

Do not stop taking the tablets even if you feel well, unless your doctor tells you to, and in that case, stop taking them gradually.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Sumial can cause side effects, although not everyone will experience them.

Frequent:(affects 1 to 10 out of every 100 patients)

• Cold hands and feet.
• Slower heart rate.
• Numbness and spasms in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon).
• Disturbed sleep/nightmares.
• Fatigue.
• Tiredness.

Uncommon:(affects 1 to 10 out of every 1,000 patients)

• Diarrhea.
• Nausea.
• Vomiting.

Rare:(affects 1 to 10 out of every 10,000 patients)

• Worsening of breathing difficulties if you have or have had asthma, sometimes with a fatal outcome.
• Shortness of breath and/or swollen ankles if you also have heart problems (heart failure).
• Heart block that can cause an abnormal heartbeat, dizziness, fatigue, or fainting.
• Worsening of blood circulation, pain, weakness, and cramps in the legs if you already have circulation problems.
• Mood changes.
• Confusion.
• Psychosis or hallucinations (mental disorders).
• Dizziness, especially when standing up.
• Tingling sensation in the hands.
• Vision disorders.
• Hair loss.
• Skin rash, worsening of psoriasis, or psoriasis-like skin reactions.
• Dry eyes.
• Easy bruising (thrombocytopenia).
• Purple spots on the skin (purpura).

Very Rare:(affects less than 1 in every 10,000 patients)

• Muscle weakness (myasthenia gravis).

Frequency Not Known:(cannot be estimated from the available data)

• Seizures due to low blood sugar levels (hypoglycemia).
• Low blood sugar levels (hypoglycemia) in diabetic and non-diabetic patients, including newborns, infants, children, elderly patients, patients undergoing dialysis, or patients with anti-diabetic treatment. These can also occur during fasting or in patients with chronic liver disease or patients with overdose.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of Sumial 40 mg

Do not store above 30°C. Keep in the original packaging, protected from light and moisture.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Sumial 40 mg

• The active ingredient is propranolol (as hydrochloride). Each tablet contains 40 mg of propranolol (as hydrochloride).
• The other components (excipients) are: hypromellose (E 464), glycerol (E 422), titanium dioxide (E 171), carmine (E 120), lactose, calcium carboxymethylcellulose, gelatin, magnesium stearate.

Appearance of the Product and Package Contents

Sumial 40 mg is presented in a package containing 50 film-coated tablets. The tablets are pink, round, biconvex, film-coated, with a marking on one face and bisected on the other.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

AstraZeneca Reims Production

Parc Industriel Pompelle, Chemin de Vrilly, 51100

Reims, France

Corden Pharma GmbH

Otto-Hahn-Strasse

68723 Plankstadt

Germany

Date of the Last Revision of this Package Leaflet:May 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/