PROPRANOLOL KERN PHARMA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Propranolol Kern Pharma 40 mg film-coated tablets EFG

propranolol, hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Propranolol Kern Pharma and what is it used for
2. What you need to know before you take Propranolol Kern Pharma
3. How to take Propranolol Kern Pharma
4. Possible side effects

5 Storage of Propranolol Kern Pharma

1. Contents of the pack and further information

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

Propranolol Kern Pharma belongs to a group of medicines called 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 disorders (hypertrophic obstructive cardiomyopathy).
• Control of irregular heartbeats (arrhythmias).
• 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 (high blood pressure usually due to 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.

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

Do not take Propranolol Kern Pharma

• If you are allergic (hypersensitive) to propranolol or any of the other ingredients of this medicine (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 had a very slow or irregular heartbeat, low blood pressure (hypotension), or poor blood circulation.
• If you have a feeling of oppressive pain in the chest at rest (Prinzmetal's angina).
• If you have untreated pheochromocytoma (high blood pressure due to a tumor near the kidney).
• If you are on a strict fasting diet.
• If you have had a shock due to heart problems or a disease related to heart rhythm (sick sinus syndrome).
• If you are prone to low blood sugar levels.
• If you are pregnant or think you may be pregnant or are breastfeeding.

Warnings and precautions

Consult 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 have a feeling of shortness of breath or swollen ankles (heart failure).
• If you have a history of allergic reactions to certain substances, this medicine may increase such reactions. Also, larger doses of adrenaline than those usually used to treat allergic reactions may be needed.

If you are taking a medicine called clonidine for high blood pressure (hypertension) or to prevent migraine (headache), do not stop taking clonidine or propranolol without consulting your doctor first (see "Taking Propranolol Kern Pharma with other medicines").

Propranolol may mask the 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 anti-diabetic treatments. Propranolol may cause low blood sugar levels even in non-diabetic patients.
• 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 case of hospitalization, inform the healthcare staff, especially the anesthesiologist in case of surgery, that you are taking propranolol.

Taking Propranolol Kern Pharma with other medicines

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

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 medicines that may cause problems when used with your medicine:

• 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 heart 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 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 migraine) and Propranolol together, do not stop taking clonidine unless your doctor tells you to. If stopping clonidine becomes necessary for you, your doctor will give you detailed instructions on how to do it.

Interference with laboratory tests:

If you are going to have a laboratory test (including blood or urine tests), tell your doctor that you are taking this medicine, 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 Propranolol Kern Pharma with food, drinks, and alcohol

Consumption of alcohol may influence the effect of the tablets.

Pregnancy, breastfeeding, and fertilityIf you are pregnant or breastfeeding, think you may be pregnant, or plan 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 during treatment with this medicine.

Driving and using machines

It is unlikely that propranolol will affect your ability to drive or use machines. However, some people may feel dizzy or tired when taking Propranolol Kern Pharma. If this happens, ask your doctor for advice.

Propranolol Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

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

Use in athletes:

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

3. How to take Propranolol Kern Pharma

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

Remember to take your medicine.

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

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 this medicine is too strong or too weak, tell 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 propranolol to adjust the dose.

Use in children

In certain circumstances, propranolol 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 liver or kidney disease

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

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to take the package and leaflet of the medicine to the healthcare staff.

If you forget to take Propranolol Kern Pharma

If you miss a dose, wait for the next one. Do not take a double dose to make up for the 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, and in that case, stop taking them gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may appear when using this medicine:

Common(may affect up to 1 in 10 people)

• cold hands and feet
• slower heart rate
• numbness and spasm in the fingers followed by heat and pain (Raynaud's phenomenon)
• disturbed sleep/nightmares
• breathing difficulties
• 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, sometimes with fatal outcome, if you have or have had asthma
• 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 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 (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 (severe myasthenia)
• low blood sugar levels may appear in diabetic and non-diabetic patients, including newborns, small children, and children, 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 a long-term liver disease.
• excessive sweating

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

• headache or convulsions related to low blood sugar levels
• impotence (inability of a man to achieve an erection)
• decreased renal blood flow
• joint pain (arthralgia)
• constipation
• dry mouth
• shortness of breath or breathing difficulties (dyspnea)
• conjunctivitis (inflammation of the eye, also called "red eye")
• depression
• reduced white blood cell count and dangerous (agranulocytosis)
• worsening of angina pectoris (chest pain)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Propranolol Kern Pharma

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

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Propranolol Kern Pharma

• The active substance is propranolol hydrochloride. Each tablet contains 40 mg of propranolol hydrochloride.
• The other ingredients are calcium carbonate, gelatin, lactose, and magnesium stearate in the tablet core and Opadry II Pink 85F240137 (containing polyvinyl alcohol, partially hydrolyzed (E-1203), titanium dioxide (E-171), macrogol (E-1521), talc (E-553b), carmine (E-120), orange yellow S (E-110), and allura red AC (E-129)) in the coating.

Appearance of Propranolol Kern Pharma and contents of the pack

Film-coated tablets are pink, round, and scored on one side. The tablet can be divided into two equal doses.

Each pack contains 50 film-coated tablets, packaged 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 medicine is authorized in the EEA member states under the following names:

Spain Propranolol Kern Pharma 40 mg film-coated tablets EFG

Date of last revision of this leaflet: February 2023

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