Propranolol Accord - Propranolol hydrochloride uses, dose and side effects

Propranolol Accord contains propanolol hydrochloride, which belongs to a group of medicines called beta-blockers. It has effects on the heart and blood circulation but also on other parts of the body.

Propranolol Accord can be used for:

Hypertension (high blood pressure )
Angina (chest pain)
Some arrhythmias (disorders of heart rhythm)
Protection of the heart after a heart attack (heart attack)
Migraine
Essential tremor (involuntary and rhythmic shaking)
Certain thyroid diseases ( thyrotoxicosis and hyperthyroidism, caused by an overactive thyroid gland )
Hypertrophic cardiomyopathy (thickened heart muscle)
Pheochromocytoma (high blood pressure due to a tumor that is usually located near the kidneys)
Bleeding in the esophagus caused by high blood pressure in the liver

Propranolol hydrochloride contained in Propranolol Accord may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Propranolol Accord

Do not use Propranolol Accord

if you are allergic to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6)
have heart failure that is not treated or controlled
have had a shock caused by heart problems
have severe heart defects (second or third-degree heart block), a condition that may be treated with a pacemaker
have problems with heart conduction or heart rhythm
have very slow or very uneven heart rate
has increased acidity in the blood (metabolic acidosis )
follows a strict fasting diet
have asthma, wheezing or other difficulty breathing
have an untreated pheochromocytoma (high blood pressure due to a tumor near the kidney)
have severe blood circulation problems (which can make your fingers tingle or turn pale or blue)
has an urgent feeling of pain in the chest at rest (Prinzmetal’s angina)
have very low blood pressure

If you think any of these apply to you, or if you are not sure, talk to your doctor before using Propranolol Accord.

Warnings and cautions

Talk to your doctor or pharmacist before using Propranolol Accord if you:

get allergic reactions from such things as insect bites.
have diabetes because Propranolol Accord may alter your normal response to low blood sugar, which usually includes an increase in heart rate. Propranolol Accord can cause low blood sugar levels even in patients who do not have diabetes.
have thyrotoxicosis. Propranolol Accord may mask the symptoms of thyrotoxicosis.
have kidney or liver problems (including cirrhosis). If you have this, talk to your doctor as you may need to go for check-ups during treatment.
have heart problems.
suffers from muscle weakness ( myasthenia gravis ).
have conditions such as chronic obstructive pulmonary disease and bronchospasm ( bronchospasm ), as the use of Propranolol Accord may exacerbate these conditions.
use calcium channel blockers that reduce the heart rate, such as verapamil and diltiazem (see “Other medicines and Propranolol Accord”).

Other medicines and Propranolol Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Propranolol Accord may affect the effectiveness of certain other medicines and some other medicines may affect Propranolol Accord.

Propranolol Accord should not be used in combination with calcium channel blockers that reduce the heart rate (eg verapamil, diltiazem ) as it may lead to an increase in these effects. This can lead to very low blood pressure (severe hypotension ) and a slow heart rate ( bradycardia ).

Other medicines that can cause problems when taken with the medicine:

nifedipine, nisoldipine, nicardipine, israpidine, lacidipine (used to treat hypertension or angina)
lidocaine ( local anesthetic )
disopyramide, quinidine, amiodarone , propafenone, and glycosides (to treat heart problems)
adrenaline (a heart 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 the treatment of tuberculosis )
theophylline (for asthma )
warfarin (to thin the blood) and hydralazine (for hypertension )
fingolimod (for the treatment of multiple sclerosis )
fluvoxamine and barbiturates (for the treatment of anxiety and sleep problems)
MAO inhibitors (to treat depression)

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

Propranolol Accord with food, drink, and alcohol

Alcohol may affect the effectiveness of this medicine.

Operations

If you are going to the hospital to have an operation, tell your anesthetist or healthcare professional that you are taking Propranolol Accord.

Driving and using machines

It is unlikely that the medicine will affect your ability to drive or use machines. However, some people may sometimes experience dizziness or fatigue while taking Propranolol Accord. If this happens to you, talk to your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

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

Breast-feeding:

Breast-feeding is not recommended when taking this medicine.

Important information about some of the ingredients of the Propranolol Accord:

Propranolol Accord contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Propranolol Accord

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Swallow the propranolol tablet with a glass of water before eating. Swallows whole. Do not chew.

Do not stop taking this medicine unless your doctor has advised you to do so.

Adults

The following table shows the recommended dose for an adult: Show larger

	Recommended dose	Total daily dose (maximum)
Hypertension (high blood pressure )	Initially, 40 mg two or three times a day which can be increased by 80 mg per day at weekly intervals.	160 mg to 320 mg
Angina pectoris (chest pain) and tremor	Initially, 40 mg two to three times a day which can be increased by 40 mg at weekly intervals.	120 mg to 240 mg
Protection of the heart after a heart attack	Initially, 40 mg four times a day which after a few days changes to 80 mg twice a day.	160 mg
Migraine	Initially, 40 mg two to three times a day which can be increased by 40 mg in weekly intervals.	80 mg to 160 mg
Arrhythmias (irregular heartbeat), hyperthyroidism and thyrotoxicosis (certain thyroid diseases), and hypertrophic cardiomyopathy (thickened heart muscle)	10 to 40 mg three or four times a day	120 mg to 160 mg
Pheochromocytoma	Before surgery: 60 mg per day. Non-operable treatment dose: 30 mg per day.	30 mg to 60 mg
Liver disease due to high blood pressure	Initially, 40 mg twice daily which is increased to 80 mg twice daily	160 mg to 320 mg

Pediatric population

Propranolol Accord can also be used to treat children with migraines and arrhythmias:

For migraines, the dose for children under 12 years of age is 20 mg two or three times a day, and for children over 12 years of age, the dose is the same as for adults.
In case of arrhythmias, the dose should be adjusted by the doctor according to the child’s age or weight.

Older

The elderly should start with the lowest dose one. The optimal dose should be determined individually by your doctor.

Liver or kidney failure

The optimal dose should be determined individually by your doctor.

If you take more Propranolol Accord than you should

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.

Overdose causes an extremely slow heart rate, too low blood pressure, heart failure, and difficulty breathing with symptoms such as fatigue, hallucinations, fine tremor (tremors), confusion, nausea, vomiting, body spasms, fainting or coma, low blood sugar. Always take the remaining tablets, package, and label with you so that the medicine can be identified.

If you forget to take Propranolol Accord

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Propranolol Accord

Do not stop taking this medicine without talking to your doctor first. In some cases, it may be necessary to stop taking the medicine gradually.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. You can get the following side effects from this drug.

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

cold fingers and toes
slower heartbeat
numbness and spasm in the fingers followed by heat and pain (Raynaud’s phenomenon)
difficulty sleeping/nightmares
fatigue
shortness of breath.

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

nausea, vomiting, and diarrhea.

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

worsening of respiratory problems, some with fatal outcomes, if you have or have had asthma or asthmatic problems
heart failure, worsening of heart problems
swelling of the skin that may occur on the face, tongue, larynx, abdomen, or arm and leg ( angioedema )
dizziness, especially when getting up
deterioration of blood circulation, if you already have poor blood circulation
hair loss ( alopecia )
Mood swings
confusion
memory loss
psychosis or hallucinations (thought disorders)
paresthesia (abnormal sensation, usually tingling or numbness)
visual disturbances
dry eyes
rash, including worsening of psoriasis
the drug can change the number and type of blood cells, such as reducing the number of platelets ( thrombocytopenia ) in the blood which can make it easier for you to get bruises or bleeding
purple spots on the skin (purpura).

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

severe muscle weakness ( myasthenia gravis )
Low blood sugar levels can occur in patients with and without diabetes including newborns, infants, children, the elderly, patients with an artificial kidney ( hemodialysis ), or patients receiving medication for diabetes. It can also occur in patients who are fasting or have recently fasted or who have a long-term liver disease
heavy sweating.

No known frequency (can not be calculated from the available data):

headache or seizures linked to low blood sugar levels
the inability of a man to get an erection ( impotence )
decreased blood flow to the kidneys
joint pain ( arthralgia )
constipation
dry mouth
shortness of breath or shortness of breath ( dyspnoea )
conjunctivitis (eye inflammation)
Depression
severe and dangerous decrease in white blood cell count ( agranulocytosis )
worsening of angina (chest pain)

How to store Propranolol Accord

Keep out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label after ‘EXP’. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is propranolol hydrochloride. One film-coated tablet contains 10 mg or 40 mg of propranolol hydrochloride.

Other ingredients are:

corn starch

lactose monohydrate

cellulose, microcrystalline (E460)

magnesium stearate

Tablet coating:

hypromellose (E464)

cellulose, microcrystalline (E460)

acetylated monoglycerides and diglycerides

titanium dioxide (E171)

What the medicine looks like and the contents of the pack

10 mg: White to off-white, round, biconvex (rounded on both sides), film-coated tablet marked “AI” on one side and a breaker notch on the other side.

40 mg: White to off-white, round, biconvex (rounded on both sides), film-coated tablet marked “AL” on one side and a breaker notch on the other side.

The breaker is only for dividing the tablet to facilitate swallowing and not for dividing into equal doses.

Blister pack PVC / PVDC / aluminum foil with 25, 28, 30, 50, 56, 60, 100 and 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder of approval

Accord Healthcare BV

Winthontlaan 200

3526 VK Utrecht

Netherlands

Manufacturer

Accord Healthcare Polska Sp.zoo,

ul. Lutomierska 50

95-200 Pabianice

Poland