INDERAL 40 mg Tablet

Зміст інструкції

1. INDERAL 40 mg tablets
   1. What is Inderal and what it is used for
   2. What you need to know before taking Inderal
   3. How to take Inderal
   4. Possible side effects
   5. How to store Inderal
   6. Contents of the pack and other information

INDERAL 40 mg tablets

propranolol hydrochloride

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Inderal is and what it is used for
• 2. What you need to know before you take Inderal
• 3. How to take Inderal
• 4. Possible side effects
• 5. How to store Inderal
• 6. Contents of the pack and other information

1. What is Inderal and what it is used for

Inderal contains propranolol hydrochloride.
Inderal belongs to the class of medicines called beta-blockers.

• Inderal is indicated in adults:
• for the control of high blood pressure.
• for the treatment of chest pain caused by reduced blood flow to the heart (angina pectoris).
• to prevent further heart attacks (myocardial infarction).
• to prevent severe and frequent headaches (migraine).
• for the treatment of tremors.
• to control anxiety and increased heart rate (tachycardia) caused by anxiety.
• to treat, together with other medicines, an excess of thyroid hormones in the blood (hyperthyroidism) and the manifestations related to this disease.
• for the treatment of a hereditary disease characterized by thickening of the heart walls (obstructive hypertrophic cardiomyopathy).
• for the treatment of a tumor near the kidney (pheochromocytoma), together with a medicine for the treatment of high blood pressure caused by the tumor.
• Inderal is indicated in adults, children and adolescents:
• to control irregular heartbeat (cardiac arrhythmia).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Inderal

Do not take Inderal

• if you are allergic to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have suffered from a lung disease that makes breathing difficult (bronchial asthma or bronchospasm, chronic obstructive bronchopneumopathy);
• if you suffer from a slow heartbeat (bradycardia);
• if you suffer from a heart condition that causes reduced blood circulation, so that the tissues no longer receive enough oxygen (cardiogenic shock);
• if you suffer from low blood pressure (hypotension);
• if you suffer from increased blood acidity (metabolic acidosis);
• if you are undergoing prolonged fasting;
• if you suffer from severe circulatory disorders of the arms and legs;
• if you suffer from a kidney disease (renal insufficiency);
• if you suffer from problems with the electrical conduction or the rhythm of the heart (atrioventricular block of 2nd and 3rd degree; sinus node disease);
• if you suffer from a tumor near the kidney (pheochromocytoma) not treated with a medicine that lowers blood pressure (with an alpha blocker);
• if your heart cannot provide blood in an adequate amount in relation to the actual request of the body (heart failure);
• if you suffer from severe chest pain at rest, caused by reduced blood flow to the heart (Prinzmetal's angina);
• if you are taking verapamil and diltiazem, medicines used to treat high blood pressure (see section Other medicines and Inderal);
• if you suffer from low blood sugar levels (hypoglycemia), for example after prolonged fasting or if you have difficulty metabolizing sugars;
• if you are pregnant or if you are breastfeeding;
• if your child suffers from a disease other than cardiac arrhythmia (see section 1. What is Inderal and what it is used for).

Warnings and precautions
Talk to your doctor or pharmacist before taking Inderal.
Before starting therapy, tell your doctor:

• if you have ever had an allergic reaction (for example, from an insect sting);
• if you suffer from problems with the kidneys, liver or thyroid (a gland in the neck);
• if you suffer from diabetes;
• if you suffer from diseases of the blood circulation or the heart;
• if you suffer from problems with the electrical conduction or the rhythm of the heart (atrioventricular block of 1st degree);
• if you have difficulty breathing or swelling of the ankles;
• if you have suffered from inflammation of the bronchi (bronchitis);
• if you suffer from severe heart problems (heart failure), in this case you will be treated with appropriate therapy;
• if you have suffered from reduced or irregular heartbeats, very low blood pressure, severe circulatory disorders;
• if you suffer from mild circulatory problems in the arms and legs, as these may worsen during treatment with Inderal.

During treatment with Inderal, a reduction in heart rate may occur. This effect is
normal, but if it becomes a cause for concern, it is advisable to consult your doctor.
Inderal can occasionally cause a lowering of blood sugar levels (hypoglycemia)
even in non-diabetic patients such as newborns, children, the elderly, patients suffering from chronic liver disease (chronic hepatic insufficiency) or patients who have taken too high a dose of the drug.

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still
result in positive doping tests.

Children and adolescents
Inderal is indicated in children and adolescents in the indication of cardiac arrhythmia (see section

• 1. What is Inderal and what it is used for).

Other medicines and Inderal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• lidocaine and other anesthetic medicines (medicines that may be given to you if you are about to undergo surgery, inform the anesthesiologist of this therapy)
• clonidine (medicine used to treat high blood pressure or to prevent migraine). Treatment with clonidine or Inderal should not be stopped without first consulting your doctor
• disopyramide, quinidine or propafenone (medicines used to treat irregular heartbeats)
• chlorpromazine or thioridazine (medicines used to treat some psychiatric problems)
• analgesics such as indometacin or ibuprofen (medicines used for pain and inflammation treatment)
• medicines based on ergot derivatives or rizatriptan, (medicines used for the treatment of migraine)
• clonidine, nifedipine, nisoldipine, nicardipine, isradipine, lacidipine, hydralazine (medicines used to treat hypertension or angina)
• digoxin (medicine used to treat heart failure)
• cimetidine (medicine used to treat stomach problems)
• theophylline (medicine used to treat asthma)
• rifampicin (medicine used to treat tuberculosis)
• anticoagulants (medicines used to thin the blood)
• nasal decongestants or other drugs (containing for example pseudoephedrine) for the treatment of the cold
• insulin or other antidiabetic treatments. In diabetic patients, Inderal can occasionally alter the response to these medicines. Inderal can occasionally also alter the normal response to low blood sugar levels (hypoglycemia), which generally induces an increase in heart rate. These symptoms may be diminished by Inderal. Rarely, hypoglycemia can reach levels that cause uncontrolled body movements (convulsions) or coma.

Inderal with alcohol
The consumption of alcoholic beverages during treatment with Inderal should be avoided.

Pregnancy and breastfeeding
The use of the product is contraindicated during pregnancy and breastfeeding (see section 2. Do not
take Inderal).

Driving and using machines
It is unlikely that taking Inderal will affect your ability to drive vehicles and use
machinery. However, some patients treated with Inderal may sometimes experience dizziness and
fatigue; if you experience these symptoms, it is advisable not to engage in these activities.

Inderal contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Inderal

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.
You must follow your doctor's instructions regarding dose, method and frequency of
taking the tablets. The indicated daily dosage should be divided throughout the
day.
The tablets should be taken with some water, preferably always at the same time.

Adults

High blood pressure
The recommended starting dose is 40 mg twice a day and your doctor may increase it
at weekly intervals in relation to your response to treatment. Generally, the usual doses are
between 160 and 320 mg/day. To obtain a further reduction in blood pressure, your
doctor may also prescribe diuretics or other antihypertensive drugs (medicines used for the
treatment of high blood pressure).

Chest pain, anxiety, severe and frequent headaches, tremors
The recommended starting dose is 40 mg two or three times a day and your doctor may increase it
by the same amount at weekly intervals in relation to your response to treatment. An adequate
response in anxiety, headache and tremors is usually obtained with a dose range between 80 and
160 mg/day.
Generally, in chest pain, the dosage of 240 mg per day should not be exceeded.

Irregular heartbeat, increased heartbeats caused by anxiety, hereditary disease

characterized by thickening of the heart walls and excess thyroid hormones in the blood
The recommended dose is 10-40 mg three or four times a day.

Prevention of further heart attacks
Treatment should be started between the 5th and 21st day after a heart attack (myocardial infarction). The recommended starting
dose is 1 tablet of 40 mg 4 times a day for 2 or 3 days. The daily dose may
be administered with two doses of 80 mg daily.

Tumor near the kidney
Before surgery: the recommended dose is 60 mg/day for 3 days.
In non-operable malignant cases: the recommended dose is 30 mg/day.
(To be used exclusively in association with a drug for the treatment of high blood pressure).

Patients with liver or kidney disease
Particular attention must be paid to choosing the initial dose when starting treatment.

Elderly
In the elderly, the optimal dose must be determined individually based on clinical results.

Paediatric population

Arrhythmias
In some conditions Inderal can be used to treat arrhythmias in children (heart rhythm
disorders). The dose will be adjusted by the doctor in accordance with the age and weight of your child.
The dose must be determined individually, and the following scheme is only a guide:
0.25-0.5 mg/kg 3-4 times a day, adjusted according to response. Maximum dose 1 mg/kg 4 times a
day, the total daily dose should not exceed 160 mg per day.

If you take more Inderal than you should
Propranolol is seriously toxic if used in case of overdose. If you have accidentally taken
a larger quantity than the prescribed dose or overdose symptoms occur, you should
urgently consult a doctor.
Overdose causes difficulty breathing, low blood pressure, drowsiness, convulsions, high
levels of potassium in the blood, an excessively slowed heartbeat and other heart problems or
coma.

If you forget to take Inderal
Do not take a double dose to make up for a missed tablet.
If you forget to take a dose, it is advisable to take it as soon as possible.

If you stop taking Inderal
Improvement in health status should not lead to discontinuation of treatment unless
requested by your doctor.
Discontinuation of treatment must take place gradually.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Inderal, as with any medicine, the following side effects may occur with the following frequency:

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

• feeling of coldness in the fingers of the hands and feet
• slowed heartbeat
• numbness and cramping of the fingers followed by a sensation of heat and pain (Raynaud's phenomenon)
• sleep disturbances/nightmares
• fatigue and/or weakness (often transient).

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 if you suffer from asthma (lung disease that makes breathing difficult)
• feeling of breathlessness and/or swelling of the ankles if you suffer from heart disease (heart failure)
• heart block (a condition that can cause an abnormal heartbeat, dizziness, fatigue or fainting)
• dizziness, especially when standing up, tingling in the hands, worsening of blood circulation, if you already have circulatory problems
• hair loss
• mood changes, confusion, psychosis (mental disorders) and hallucinations (seeing inexplicable things)
• vision disturbances, dry eyes
• skin rash including worsening of psoriasis (skin disease characterized by scaling)
• easy bruising (decrease in the number of platelets in the blood, thrombocytopenia), purplish spots on the skin (purpura).

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

• severe muscle weakness (myasthenia gravis).

Frequency not known(the frequency cannot be estimated from the available data):

• lowering of blood sugar levels (hypoglycemia) in diabetic and non-diabetic patients including newborns, children, the elderly, dialysis patients or patients undergoing antidiabetic therapy. Hypoglycemia can also be observed in patients who are fasting or in patients with severe liver disease (chronic hepatic insufficiency)
• uncontrolled body movements (convulsions) related to hypoglycemia
• changes in certain blood cells or other blood components. Your doctor may occasionally ask you to have tests to check if Inderal has had any effect on your blood cells
• headache
• skin rashes characterized by redness and blisters (erythematous)
• depression.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Inderal

Store at a temperature below 25°C.
Store in the original package.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Inderal contains

• The active ingredient is propranolol hydrochloride 40 mg
• The other ingredients are lactose monohydrate(see section 2. Inderal contains lactose), gelatin, stearic acid, magnesium stearate.

Description of the appearance of Inderal and contents of the pack
Inderal 40 mg tablets is available in packs of 30 and 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Atnahs Pharma Netherlands B.V.
Copenhagen Towers,
Ørestands Boulevard 108,

• 5.tv, DK-2300, København S, Denmark

Manufacturer
AstraZeneca Dunkerque Production,
AstraZeneca Reims Production
Parc Industriel de la Pompelle
Chemin de Vrilly
51100 Reims, France