Leaflet: Information for the user

Propranolol Kern Pharma 40 mg Film-coated Tablets

propranolol, hydrochloride

Read this 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 only. Do not give it to others even if they have similar symptoms to you, 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. See section 4.

1.What is Propranolol Kern Pharma and what it is used for

2.What you need to know before starting to take Propranolol Kern Pharma

3.How to take Propranolol Kern Pharma

4.Possible side effects

5Storage of Propranolol Kern Pharma

6.Contents of the pack and additional information

Propranolol Kern Pharma belongs to a group of medications known as beta blockers, which act at different levels within the body, including the heart.

Propranolol Kern Pharma is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of chest pain (angina).
• Treatment of certain heart abnormalities (obstructive hypertrophic cardiomyopathy).
• Control of irregular heartbeats (arrhythmias).
• Protection of the heart after a heart attack (myocardial infarction).
• Prevention of migraine (migraine).
• Treatment of tremors.
• Treatment of anxiety symptoms.
• Treatment of certain thyroid abnormalities (hyperthyroidism).
• Treatment of pheochromocytoma (high blood pressure usually caused by a tumor near the kidney) 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 Propranolol Kern Pharma

• If you are allergic (hypersensitive) to propranolol or to any of the other components of this medication (listed in section 6).
• If you have or have had asthma or wheezing or other breathing difficulties.
• If you have or have had heart problems, including heart failure or heart block, or if you have ever experienced a very slow or irregular heart rhythm, low blood pressure (hypotension), or poor blood circulation.
• If you have a feeling of painful pressure in your chest during periods of rest (Prinzmetal's angina).
• If you have untreated phaeochromocytoma (high blood pressure due to a tumor near the kidney).
• If you are following a strict fasting diet.
• If you have had a heart-related shock or a disease related to heart rhythm (sick sinus syndrome).
• If you are prone to low blood sugar levels.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

• If you are allergic to any substance.
• If you have liver, kidney, thyroid, circulation, or heart problems.
• If you have a feeling of lack of air or swollen ankles (heart failure).
• If you have a history of allergic reactions to certain substances, this medication may increase these reactions. You may also need higher doses of adrenaline than usual 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 propranolol without consulting your doctor (see "Taking Propranolol Kern Pharma with other medications").Propranolol may mask the signs of certain thyroid disorders (hyperthyroidism).

The use of propranolol in patients with high blood pressure in the liver may worsen liver function.

If you are diabetic, propranolol may alter your response to insulin or other antidiabetic treatments. Propranolol may cause low blood sugar levels even in patients who are not diabetic.

If you have muscle weakness (myasthenia gravis)

If you have conditions such as chronic obstructive pulmonary disease and bronchospasm because the use of Propranolol may worsen these conditions.

In the event of hospital admission, inform the healthcare staff, especially the anesthesiologist in the event of surgery, that you are taking propranolol.

Taking Propranolol Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

Propranolol should not be used in combination with calcium channel blockers with negative inotropic effects (e.g., verapamil, diltiazem), as it may lead to an exaggeration of these effects. This may result in severe hypotension and bradycardia.

Other medications that may cause problems when used with your medication:

• Nifedipine, nisoldipine, nicardipine, isradipine, lacidipine (used to treat hypertension or angina)
• Lidocaine (local anesthetic)
• Disopyramide, quinidine, amiodarone, propafenone, and glycosides (for heart problems)
• Adrenaline (a cardiac stimulant)
• Ibuprofen and indomethacin (for pain and inflammation)
• Ergotamine, dihydroergotamine, or rizatriptan (for migraines)
• Chlorpromazine and thioridazine (for certain psychiatric disorders)
• Cimetidine (for stomach problems)
• Rifampicin (for tuberculosis treatment)
• Theophylline (for asthma)
• Warfarin (to thin the blood) and hydralazine (for hypertension)
• Fingolimod (to treat multiple sclerosis)
• Fluvoxamine and barbiturates (to treat anxiety and insomnia)
• MAO inhibitors (to treat depression)

If you are taking clonidine (for hypertension or migraines) and Propranolol together, do not stop taking clonidine unless your doctor tells you to. If you need to stop taking clonidine, your doctor will give you detailed instructions on how to do it.

Interference with analytical tests:

If you are to undergo an analytical 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 Propranolol Kern Pharma with food, drinks, and alcohol

The consumption of alcohol may affect the effect of the tablets.

Pregnancy, breastfeeding, and fertilityIf you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

The use of this medication is not recommended during pregnancy, unless your doctor considers it essential.

Lactation:

It is not recommended to breastfeed while taking this medication.

Driving and operating machinery

It is unlikely that propranolol will affect your ability to drive or operate machinery. However, some people may feel dizzy or tired occasionally when taking Propranolol Kern Pharma. If this happens, seek advice from your doctor.

Propranolol Kern Pharma contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Propranolol Kern Pharma contains yellow orange S (E-110) and red allura AC (E-129)

This medication may cause allergic reactions because it contains yellow orange S (E-110) and red allura AC (E-129).

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 dosage and duration of your treatment with propranolol. Do not stop 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 time. Swallow the tablet whole with a glass of water.

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

Use in adults

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

*It is advisable to use other presentations of propranolol to adjust the dosage.

Use in children

In certain circumstances, propranolol may be used to treat children with arrhythmias (irregular heartbeats). The doctor will adjust the dosage according to the child's age or weight.

Use in elderly patients

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

Use in patients with liver or kidney disease

If you have liver or kidney disease, your doctor will adjust the dosage, usually starting with the lower dosage of the dosage interval.

If you take more Propranolol Kern Pharma than you should

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 forget to take Propranolol Kern Pharma

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

If you interrupt treatment with Propranolol Kern Pharma

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 medicines, this medicine may cause side effects, although not everyone will experience them. The following side effects may appear when using this medicine:

Common(may affect up to 1 in 10 people)

• hands and feet cold
• slower heart rate
• numbness and spasm in the fingers followed by heat and pain (Raynaud's phenomenon)
• altered sleep/pesadillas
• difficulty breathing
• fatigue

Uncommon(may affect up to 1 in 100 people)

• diarrhea
• nausea
• vomiting

Rare(may affect up to 1 in 1,000 people)

• worsening of breathing difficulties, which can be fatal, if you have or have had asthma
• heart failure or worsening of heart problems
• swelling of the skin that may occur on the face, tongue, larynx, abdomen, arms, and legs (angioedema)
• worsening of blood circulation, pain, weakness, and cramps in the legs if you already have circulation problems
• changes in mood
• confusion
• psychosis or hallucinations (mental disturbances)
• dizziness, particularly when getting up
• sensation of tingling in the hands
• vision disturbances
• hair loss
• skin rash, worsening of psoriasis or psoriasis-like skin reactions
• dry eyes
• easy bruising (may alter the number and types of your blood cells, such as reducing the number of platelets (thrombocytopenia))
• purple spots on the skin (purpura)

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

• muscle weakness (myasthenia gravis)
• low blood sugar levels may appear in diabetic and non-diabetic patients, including newborns, young children, and children, elderly patients, patients with artificial kidneys (hemodialysis), or patients taking diabetes medications. It may also occur in patients who are fasting or have recently fasted or have long-term liver disease.
• excessive sweating

Unknown(the frequency cannot be estimated from available data)

• headache or seizures related to low blood sugar
• inability of a man to achieve an erection (impotence)
• decreased renal blood flow
• joint pain (arthritis)
• constipation
• dry mouth
• shortness of breath or breathing difficulty (dyspnea)
• conjunctivitis (inflammation of the eye also known as "red eye")
• depression
• reduced white blood cell count and potentially life-threatening (agranulocytosis)
• worsening of angina pectoris (chest pain)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Propranolol Kern Pharma

- The active ingredient is hydrochloride of propranolol. Each tablet contains 40 mg of hydrochloride of propranolol.

- The other components are calcium carbonate, gelatin, lactose, and magnesium stearate in the tablet core and Opadry II Pink 85F240137 (containing partially hydrolyzed polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol (E-1521), talc (E-553b), carmine (E-120), yellow-orange S (E-110), and red allura AC (E-129)) in the coating.

Appearance of Propranolol Kern Pharma and content of the packaging

Coated tablets with a pink film coating, round, and scored on one face. The tablet can be divided into equal doses.

Each package contains 50 coated tablets, conditioned in PVC/PVDC/Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicine is authorized in the EEA member states under the following names:

Spain Propranolol Kern Pharma 40 mg coated tablets EFG

Last review date of this leaflet: February 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http:// www.aemps.gob.es /