Sumial 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sumial 10 mg film-coated tablets

Propranolol

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if the effects are not listed in this leaflet.

Leaflet contents:

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. How to store Sumial
6. Contents of the pack and other information

1. What Sumial is and what it is used for

Sumial belongs to a group of medicines called beta-blockers, which act at various 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 conditions (obstructive hypertrophic cardiomyopathy).
• Control of irregular heartbeats.
• Protection of the heart after heart attack.
• Prevention of migraine.
• Treatment of tremor.
• Treatment of symptoms of anxiety.
• Treatment of certain thyroid disorders (thyrotoxicosis).
• Treatment of phaeochromocytoma (a tumor of the adrenal gland), which will be administered together with another treatment: an alpha-adrenergic blocker.
• Prevention of bleeding in the oesophagus caused by high blood pressure in the liver.

2. What you need to know before starting to take Sumial

Do not take Sumial

• If you are allergic (hypersensitive) to propranolol or any of the other ingredients 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, 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 phaeochromocytoma (a tumor of the adrenal gland) that is not being treated with other medicines.
• If you are undergoing or have been subjected to prolonged fasting.
• If you have metabolic acidosis (excessive acidity in the blood) (e.g., diabetic acidosis).
• If you are pregnant or think you may be pregnant, or if you are breastfeeding.
• In case of severe failure of the heart's pumping function (cardiogenic shock) or a condition related to heart rhythm (sick sinus syndrome).
• If you are prone to hypoglycemia (low blood glucose levels).

Warnings and precautions

Talk to 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 have diabetes.

• If you experience shortness of breath or swollen ankles (heart failure).

• If you have a history of allergic reactions to certain substances, Sumial may increase these reactions. Higher doses of adrenaline than normally used may also be required to treat an allergic reaction.

• If you are taking a medicine called clonidine for high blood pressure (hypertension) or to prevent migraine (headache), do not stop taking either clonidine or Sumial without first consulting your doctor (see “Taking Sumial with other medicines”).

• A decrease in pulse rate may be observed while taking the tablets. This is a normal reaction, but consult your doctor if you have any concerns.

• 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 alter the body's normal response to insulin.

• If you have diabetes, Sumial may alter your response to insulin or other antidiabetic treatments.

• Sumial may also alter the body's response to hypoglycemia (low blood glucose levels), reducing the tachycardia that normally occurs during hypoglycemia. Very rarely, glucose levels may drop so low as to cause seizures or coma.

• Beta-blockers may worsen muscle weakness in patients with myasthenia gravis (muscle weakness).

• If you have a heart condition called ischemic heart disease, treatment should not be stopped abruptly but gradually tapered over 2 weeks.

• If you are admitted to hospital, inform healthcare staff, especially the anaesthetist if undergoing surgery, that you are taking Sumial.

Taking Sumial with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor:

• If you are taking disopyramide, insulin and other treatments for diabetes, quinidine, propafenone, or amiodarone (for irregular heartbeat), treatment for high blood pressure (hypertension) or angina (especially verapamil, diltiazem, clonidine, nifedipine, nisoldipine, nicardipino, isradipino, lacidipino, hydralazine). Sumial may cause an increase in blood pressure when clonidine is discontinued (see “Warnings and precautions”).
• If you are receiving adrenaline, migraine treatments containing ergotamine derivatives, dihydroergotamine or rizatriptan, chlorpromazine or thioridazine (for certain psychiatric disorders), indometacin or ibuprofen (for pain relief), treatment for heart failure (digoxin), treatment for stomach problems (cimetidine), treatment for tuberculosis (rifampicin), asthma (theophylline), or treatment to prevent blood clotting (warfarin).
• You should also inform your doctor if you are using any nasal decongestant or other over-the-counter cold remedy.

Please note that:

• If you are taking or have taken Sumial, intravenous lidocaine infusion must not be administered.
• Blood levels of Sumial may be increased when taken concomitantly with quinidine, propafenone, nicardipino, isradipino, nifedipine, nisoldipine, lacidipino, cimetidine, hydralazine, or alcohol.
• Blood levels of Sumial may be reduced by rifampicin.
• Sumial may increase blood levels of theophylline, warfarin, thioridazine, rizatriptan, or lidocaine.
• Sumial may decrease blood levels of lacidipino.
• Co-administration of Sumial with chlorpromazine increases the effect of both medicines.
• The effects of Sumial may be reduced when taken with adrenaline, indometacin, or ibuprofen.
• Sumial may prolong the effect of insulin.
• Higher doses of beta-2 agonist bronchodilators may be required to overcome bronchospasm caused by propranolol.

If intravenous verapamil or diltiazem is required, you must stop your treatment with Sumial 48 hours beforehand.

If oral verapamil or diltiazem is required, you must stop your treatment with Sumial 7 days beforehand, and vice versa.

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may affect test results (e.g., blood bilirubin or catecholamines).

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

Taking Sumial with food, drinks, and alcohol

Alcohol intake may affect the action of the tablets.

Pregnancy and breastfeeding

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

Driving and using machines

Sumial may have a minor or moderate effect on your ability to drive and use machines. Therefore, avoid performing tasks requiring special attention until you know how you tolerate the medicine.

Sumial 10 mg contains lactose

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

Patients with diabetes mellitus should be aware that this medicine contains 5.056 g of lactose (equivalent to 2.528 g of glucose and 2.528 g of galactose) per dose.

Use in athletes:

This medicine contains propranolol, which may result in a positive doping test.

3. How to take Sumial

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you the dose and duration of your treatment with Sumial. Do not stop treatment before your doctor tells you to do so. Do not take more than the dose your doctor has prescribed.

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

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

Use in adults

The following table shows the usual daily dose ranges for an adult depending on their condition. Often, the dose is divided into several smaller doses taken throughout the day:

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

Use in children

Under certain circumstances, Sumial may 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 based on the progression of your condition.

Use in patients with impaired renal or hepatic function

If you have impaired liver or kidney function, your doctor will adjust the dose, usually starting treatment with the lowest dose within the recommended dosage range.

If you take more Sumial than you should

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

Overdose causes difficulty breathing, low blood pressure, drowsiness, seizures, excessively slow heartbeat, or coma.

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 medication and the amount ingested.

It is recommended to bring the medicine's packaging and leaflet to healthcare personnel.

If you forget to take Sumial

If you miss a dose, wait until the next scheduled dose. Do not take a double dose to make up for a missed dose.

If you stop taking Sumial

Do not stop taking the tablets even if you feel well, unless your doctor advises you to do so. In such case, stop taking them gradually.

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

4. Possible adverse effects

Like all medicines, Sumial may cause adverse effects, although not everyone experiences them.

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

• coldness in the fingers of the hands and feet.
• slowed heart rate.
• numbness and spasms in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon).
• disturbed sleep / nightmares.
• tiredness.
• fatigue.

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

• diarrhea.
• nausea.
• vomiting.

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

• worsening of breathing difficulties if you have or have had asthma, sometimes with fatal outcome.
• sensation of breathlessness and/or swollen ankles if you also have heart problems (heart failure).
• heart block, which may cause an irregular heartbeat, dizziness, tiredness, 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).
• dizziness, particularly when standing up.
• tingling sensation in the hands.
• vision disorders.
• hair loss.
• skin rash, worsening of psoriasis, or psoriasis-like skin reactions.
• dry eyes.
• increased tendency to bruise (thrombocytopenia).
• purple spots on the skin (purpura).

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

• muscle weakness (myasthenia gravis).

Frequency not known: (cannot be estimated from 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 undergoing dialysis, or patients on antidiabetic therapy. These may also occur during fasting, in patients with chronic liver disease, or in cases of overdose.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet.

5. Storage of Sumial 10 mg

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

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, 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 Sumial 10 mg

• The active substance 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 container

Sumial 10 mg is supplied in a container with 50 film-coated tablets. The tablets are pink, round, biconvex, film-coated, with an imprint on one side and a bisect 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 most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/