Propranolol Kern Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Propranolol Kern Pharma 10 mg film-coated tablets EFG

propranolol, hydrochloride

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 only, 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 side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

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

2. What you need to know before taking Propranolol Kern Pharma

3. How to take Propranolol Kern Pharma

4. Possible side effects

5. How to store Propranolol Kern Pharma

6. Contents of the pack and other information

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

Propranolol Kern Pharma belongs to a group of medicines called beta-blockers, which act at various 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 disorders (obstructive hypertrophic cardiomyopathy).
• Control of irregular heartbeats (arrhythmias).
• Protection of the heart after myocardial infarction.
• Prevention of migraine.
• Treatment of tremor.
• Treatment of symptoms of anxiety.
• Treatment of certain thyroid disorders (thyrotoxicosis).
• Treatment of phaeochromocytoma (high blood pressure usually caused by a tumour near the kidney), 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 taking Propranolol Kern Pharma

Do not take Propranolol Kern Pharma

• If you are allergic (hypersensitive) to propranolol or to any of the other ingredients of this medicine (listed in section 6).
• If you have asthma, wheezing, or other breathing difficulties.
• 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 experience painful chest tightness at rest (Prinzmetal's angina).
• If you have untreated pheochromocytoma (high blood pressure due to a tumour near the kidney).
• If you are following a strict fasting diet.
• If you have had cardiogenic shock or a rhythm-related heart condition (sick sinus syndrome).
• If you are prone to low blood sugar levels.

If you are pregnant or think you may be pregnant, or if you are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take this medicine.

• If you are allergic to any substance.
• If you have liver, kidney, thyroid, circulation, or heart problems.
• If you feel short of breath or have swollen ankles (heart failure).
• If you have a history of allergic reactions to certain substances, this medicine may increase such reactions. Higher than usual doses of adrenaline may also be needed 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 propranolol without first consulting your doctor (see “Taking Propranolol Kern Pharma with other medicines”). – Propranolol may mask signs of certain thyroid disorders (thyrotoxicosis).

• 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 (COPD) or bronchospasm, because the use of Propranolol may worsen these conditions.
• If you are admitted to hospital, inform healthcare staff, especially the anaesthetist if undergoing surgery, that you are taking propranolol.

Taking Propranolol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

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

Other medicines that may cause problems when used together with your medicine:

• Nifedipine, nisoldipine, nicardipine, isradipine, lacidipino (used to treat hypertension or angina)
• Lidocaine (local anaesthetic)
• 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 migraine)
• Chlorpromazine and thioridazine (for certain psychiatric disorders)
• Cimetidine (for stomach problems)
• Rifampicin (for the treatment of tuberculosis)
• 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 migraine) and propranolol together, you must not stop taking clonidine unless your doctor tells you to. If stopping clonidine becomes necessary, your doctor will give you detailed instructions on how to do so.

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 alter test results (e.g., blood bilirubin or catecholamines).

Very rarely, elevated levels of certain antibodies (ANA) have been observed in clinical laboratory tests.

Taking Propranolol Kern Pharma with food, drinks, and alcohol

Alcohol intake may affect the action of the tablets.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

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

Breastfeeding:

Breastfeeding is not recommended while taking this medicine.

Driving and using machines

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

Propranolol Kern Pharma contains lactose

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

Propranolol Kern Pharma contains sunset yellow FCF (E-110) and allura red AC (E-129)

This medicine may cause allergic reactions as it contains sunset yellow FCF (E-110) and allura red AC (E-129).

Use in athletes:

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

3. How to take Propranolol Kern Pharma

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 propranolol. 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 each day. Swallow the tablet whole with a glass of water.

If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Use in adults

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

*Other presentations of propranolol are considered advisable for dose adjustment.

Use in children

In certain circumstances, propranolol 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 according to the progression of your condition.

Use in patients with liver or kidney disease

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

If you take more Propranolol Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the medicine packaging and leaflet to healthcare personnel.

If you forget to take Propranolol Kern Pharma

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

If you stop taking Propranolol Kern Pharma

Do not stop taking the tablets even if you feel well, unless your doctor tells 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, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur when using this medicine:

Common* (may affect up to 1 in 10 people)*

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

Uncommon* (may affect up to 1 in 100 people)*

• diarrhoea
• nausea
• vomiting

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

• worsening of breathing difficulties, sometimes leading to fatal outcome, if you have or have had asthma or asthmatic symptoms in the past
• heart failure or worsening of heart problems
• swelling of the skin that may occur in the face, tongue, larynx, abdomen, or arms and legs (angioedema)
• 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 (may affect 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 occur in diabetic and non-diabetic patients, including newborns, infants, children, elderly patients, patients with artificial kidneys (haemodialysis), or patients taking medicines for diabetes. It may also occur in patients who are fasting or who have recently been fasting, or who have long-term liver disease.
• excessive sweating

Not known* (frequency cannot be estimated from available data)*

• headache or seizures related to low blood sugar levels
• inability of a man to achieve an erection (impotence)
• reduced renal blood flow
• joint pain (arthralgia)
• constipation
• dry mouth
• shortness of breath (dyspnoea)
• conjunctivitis (eye inflammation also known as “red eye”)
• depression
• dangerously reduced white blood cell count (agranulocytosis)
• worsening of angina pectoris (chest pain)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Propranolol Kern Pharma

No special storage conditions required.

Keep this medicine out of the 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 containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Propranolol Kern Pharma

• The active substance is propranolol hydrochloride. Each tablet contains 10 mg of propranolol hydrochloride.
• The other components are calcium carmellose, 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), sunset yellow FCF (E-110), and allura red AC (E-129)) in the film coating.

Appearance of Propranolol Kern Pharma and contents of the pack

Pink, round, film-coated tablets, scored on one side. The score is intended only to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

Each pack contains 50 film-coated tablets, packed in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This medicinal product is authorized in the EEA Member States under the following names:

Spain: Propranolol Kern Pharma 10 mg film-coated tablets EFG

Date of the most recent review of this leaflet: February 2023.

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