Patient Information Leaflet

Sumial 10 mg Film-Coated Tablets

Propranolol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

1.What is Sumial and what it is used for

2.What you need to know before you start taking Sumial

3.How to take Sumial

4.Possible side effects

5.Storage of Sumial

6.Contents of the pack and additional information

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 some heart abnormalities (obstructive hypertrophic cardiomyopathy).
• Control of irregular heartbeats.
• Protection of the heart after a heart attack.
• Prevention of migraine (migraine).
• Treatment of tremors.
• Treatment of anxiety symptoms.
• Treatment of certain thyroid abnormalities (hyperthyroidism).
• Treatment of pheochromocytoma (adrenal gland tumor) 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.

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 sounds).
• If you have or have had heart problems, including heart failure or heart block, orif you have ever experienced a very slow or irregular heart rhythm, 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 (adrenal gland tumor) that is not being treated with other medications.
• If you are undergoing or have undergone prolonged fasting.
• If you have metabolic acidosis (excessive acidity in the blood) (e.g. diabetic).
• If you are pregnant or considering becoming pregnant or are breastfeeding.
• In case of severe heart failure (cardiogenic shock) or heart rhythm-related disease (sick sinus syndrome).
• If you have a predisposition to hypoglycemia (low blood glucose levels).

Warnings and precautions

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

• If you areallergic to any substance.
• If you have liver, kidney, thyroid, circulation, or heart problems.
• If you are diabetic.
• If you have a sensation 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 larger doses of adrenaline to treat the allergic reaction.
• If you are taking a medication called clonidine for high blood pressure (hypertension) or to prevent migraines (headaches), do not stop taking either clonidine or Sumial without consulting your doctor (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 (hyperthyroidism).
• 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 antidiabetic treatments.
• Sumial may also modify the body's response to hypoglycemia (low blood glucose levels), reducing the tachycardia that occurs during this. Very rarely, blood glucose levels may decrease to such low levels that they cause seizures or coma.
• Beta-blockers may potentiate muscle weakness in patients with myasthenia (muscle weakness).
• If you have a heart condition called ischemic cardiomyopathy, do not stop treatment abruptly, but rather gradually over a period of 2 weeks.
• In case of hospital admission, inform the healthcare staff, especially the anesthesiologist in the event of surgical intervention, that you are taking Sumial.

Taking Sumial with other medications

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

Especially inform your doctor:

• If you are taking disopyramide, insulin, and other diabetes treatments, quinidine, propafenone, or amiodarone (for irregular heartbeats), blood pressure medication (hypertension) or angina treatment (in particular see verapamil, diltiazem, clonidine, nifedipine, nisoldipine, nicardipine, isradipine, lacidipine, hydralazine). Sumial may cause an increase in blood pressure when you stop taking clonidine (see "Warnings and precautions").
• If you are receiving 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 problems treatment (cimetidine), tuberculosis treatment (rifampicin), asthma treatment (theophylline) or blood clotting prevention (warfarin).
• You should also inform your doctor if you are using any nasal decongestants or other antihistamines that you may have purchased at the pharmacy.

Consider the following:

• If you are taking or have taken Sumial, do not receive lidocaine intravenous infusion.
• Sumial levels in the blood may be increased if administered with quinidine, propafenone, nicardipine, isradipine, nifedipine, nisoldipine, lacidipine, cimetidine, or alcohol.
• Sumial levels in the blood may be decreased by rifampicin.
• Sumial may increase theophylline, warfarin, thioridazine, rizatriptan, or lidocaine levels in the blood.
• Sumial may decrease lacidipine levels in the blood.
• The administration of Sumial with chlorpromazine produces an increase in the effect of both medications.
• Sumial effects may be decreased when administered with adrenaline, indomethacin, or ibuprofen.
• Sumial may prolong the effect of insulin.
• You may need larger doses of beta-2 agonist bronchodilator to overcome the bronchospasm caused by propranolol.

If you need to receive verapamil or diltiazem intravenously, you should stop taking Sumial 48 hours before.

If you need to receive verapamil or diltiazem orally, you should stop taking Sumial 7 days before and vice versa.

Interference with laboratory tests:

If you are to undergo 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 tests.

Taking Sumial with food, drinks, and alcohol

Alcohol consumption may affect the effect of the tablets.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medication. Do not takeSumialduring pregnancy and/or breastfeeding unless its use is essential. If you become pregnant during treatment withSumialcontact your doctor as soon as possible.

Driving and operating machinery

Sumial may affect your ability to drive and operate machinery to a slight or moderate extent, so try not to perform tasks that require special attention until you check how you tolerate the medication.

Sumial 10 mg contains lactose

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

Patients with diabetes mellitus should note that this medication contains 5.056g of lactose (which corresponds to 2.528 g of glucose and 2.528 g of galactose) per dose.

Use in athletes:

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

Follow exactly the administration instructions of this medication 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 suspend the treatment before your doctor tells you to. Do not take more doses than your doctor has indicated.

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

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

Use in adults

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

*It is advisable to use other Sumial presentations 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 according to the child's age or weight.

Use in elderly patients

Your doctor will adjust the dose according to the progression of your disease.

Use in patients with altered renal or hepatic function

If you have an alteration of liver or kidney function, your doctor will adjust the dose, usually starting with the lower dose of the dosing interval.

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 must seek medical attention urgently.

The overdose causes difficulty breathing, low blood pressure, drowsiness, seizures, excessively slow heartbeats, or coma.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Sumial

In case you forget a dose, wait for the next one. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with 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 doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Frequent:(affects between 1 and 10 of every 100 patients)

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

Less frequent:(affects between 1 and 10 of every 1,000 patients)

• Diarrhea.
• Nausea.
• Vomiting.

Rare:(affects between 1 and 10 of every 10,000 patients)

• Worsening of breathing difficulties if you have or have had asthma, sometimes with fatal outcome.
• Sensation of lack of air and/or swollen ankles if you also have heart problems (heart failure).
• Cardiac arrest that may 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 disturbances).
• Sensation of dizziness, particularly when getting up.
• Sensation of tingling in the hands.
• Visual disturbances.
• Hair loss.
• Skin rash, worsening of psoriasis, or psoriasis-like skin reactions.
• Dry eyes.
• Easily appearing bruises (thrombocytopenia).
• Purple spots on the skin (purpura).

Very rare:(affects fewer than 1 in every 10,000 patients)

• Muscle weakness (myasthenia gravis).

Unknown frequency:(cannot be estimated from available data)

• Seizures due to low blood sugar (hypoglycemia).
• Low blood sugar (hypoglycemia) in diabetic and non-diabetic patients, including newborns, infants, children, the elderly, patients undergoing dialysis, or patients on antidiabetic treatment. They may 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 do not appear in this prospectus.

Do not store above 86°F (30°C). Store in the original packaging, protected from light and humidity.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Sumial 10 mg

• The active ingredient is propranolol (as hydrochloride). Each tablet contains 10 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 contents of the packaging

Sumial 10 mgis presented in a package with 50 film-coated tablets. The tablets are pink, round, biconvex, film-coated, with an imprint on one face and bisected on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Atnahs Pharma Netherlands B.V.

Copenhagen Towers

Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Responsible for manufacturing

AstraZeneca Reims Production

Parc Industriel Pompelle, Chemin de Vrilly, 51100

Reims, France

Corden Pharma GmbH

Otto-Hahn-Strasse

68723 Plankstadt

Germany

Last review date of this leaflet:May 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/