Propranolol

• Used to treat high blood pressure, angina pectoris and heart rhythm disturbances
• Also used for tremor and prevention of migraine
• Can cause dizziness
• Avoid drinking alcohol while taking this medicine
• Available as tablets and sustained-release capsules

Propranolol belongs to a group of medicines called beta blockers. Beta blockers protect the heart against too much activity by blocking the transmission of certain nerve impulses.

Propranolol can be used for many conditions including hypertension (high blood pressure), angina pectoris (chest pain) and some arrhythmias (disorders of heart rhythm). Propranolol HCl Actavis can also be used for essential tremor (involuntary and rhythmic shaking) and the prevention of migraine if other treatments cannot be used.

This informative text is based on the official package leaflet of Propranolol HCl Actavis 10-mg, 40-mg and 80-mg tablets. Propranolol is also available as sustained-release capsules of 80 mg and 160 mg (Propranolol HCl Retard 80 – 160 PCH).

The use of Propranolol HCl Actavis is determined by a doctor depending on the nature of the symptoms and the patient's needs.

Dosage

The recommended dose in adults is:

• For hypertension (high blood pressure)

Initially 40 mg two or three times daily, which may be increased to a maximum of 320 mg in two to three doses per day.

• For angina (chest pain)

Initially 40 mg two or three times daily, which may be increased to a maximum of 320 mg in two to three doses per day.

• Arrythmias (disorders of heart rhythm)

10 to 40 mg two or three times daily.

Under some circumstances, Propranolol tablets can be used to treat children with arrythmias. For arrythmias the dosage will be adjusted by the doctor according to the child’s age or weight.

• For essential tremor

Initially 40 mg two or three times daily, which may be increased to 80-160 mg a day.

• For the prevention of migraine

Initially 40 mg two or three times daily, which may be increased to 160 mg in two to three doses per day. For migraine the dose under the age of 12 is 20 mg two or three times daily. Depending on the patient's response, the dosage can be increased at weekly intervals. Taking more than the maximum daily dose of 320 mg will not make this medicine more effective. Older people should be started with the lowest dose.
Propranolol tablets should be swallowed with a drink of water or milk, before, during or after meals.

Dosage for Propranolol sustained-release capsules

Unless otherwise prescribed by your doctor, the recommended dosage is:

• One 80-mg capsule every 24 hours, taken in the morning or evening at about the same time each day.
  The daily dose may be increased by 80 mg per day at weekly intervals.
  For migraine and essential tremor, the maximum daily dose is 160 mg. For hypertension and angina, the maximum daily dose is 320 mg.

The capsules should be swallowed whole with plenty of water, without chewing.

Alcohol/driving

Propranolol can cause dizziness. Stay out of traffic and do not operate dangerous machinery if you feel dizzy. Limit or stop drinking alcohol while taking this medicine as it is likely to trigger or worsen this side effect.

If you take more or less Propranolol than you should/stop taking Propranolol

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Overdose causes an excessively slow heart rate, too low blood pressure, heart failure and breathing difficulty, shortness of breath, decreased heart function (with symptoms such as swollen ankles). If you have accidentally taken more than the prescribed dose or are experiencing symptoms of overdose, you should urgently seek medical attention.

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.

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

See the package leaflet for more information on the use of Propranolol.

The active ingredient propranolol hydrochloride is not suitable for everyone. Do not take this medicine if:

• You are allergic (hypersensitive) to propranolol hydrochloride or any of the other ingredients of this medicine (see section 'What Propranolol contains').
• You have untreated/uncontrolled heart weakness or are not responding to digitalis therapy or diuretics.
• You have severe heart defects (second or third-degree heart blocks, sinus bradycardia, sick sinus syndrome).
• You suffer from asthma or chronic bronchitis.
• You have an increased acidity of the blood (metabolic acidosis).
• You suffer from untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney).
• You have had a shock caused by heart problems.
• You are on a strict fasting diet.

Please refer to the package leaflet of Propranolol sustained-release capsules for more situations in which the use of this medicine should be avoided.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking Propranolol if:

• You have diabetes as Propranolol may change your normal response to low blood sugar, which usually involves an increase in heart rate.
• You have thyrotoxicosis. Propranolol may hide the symptoms of thyrotoxicosis.
• You suffer from blood circulation problems (intermittent claudication or Raynaud's syndrome).
• You go into hospital to have an operation. In this case, you should tell the anaesthetist or the medical staff that you are taking Propranolol.
• Please refer to the package leaflet of Propranolol sustained-release capsules for more situations in a doctor should be consulted prior to taking Propranolol.

Pregnancy and breastfeeding

The use of this medicine is not recommended during pregnancy, unless your doctor considers it essential. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Do not breastfeed without consulting your doctor first if you are using Propranolol.

Other medicines and Propranolol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Propranolol can interfere with the action of some other medicines and some medicines can have an effect on Propranolol. This includes medicines that do not require a prescription. The doctor will have a list of medicines that you should avoid mixing Propranolol with.

Propranolol is known to interact with the following:

• Medicines for diabetes.
• Other medicines to treat heart problems.
• Clonidine (for hypertension and migraine).
• Indometacin (for pain and inflammation).
• Cimetidine (for stomach problems).
• Hydralazine (for hypertension).
• Alcohol.

Please refer to the package leaflet of Propranolol sustained-release capsules for more medicines that may modify the action of Propranolol capsules.

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

• An excessively slow heart rate (in particular in patients with a decreased function of the heart).
• Arrhythmia (in particular in patients with a decreased function of the heart).
• Drop in blood pressure (in particular in patients with a decreased function of the heart).
• Low heart pumping function (in particular in patients with a decreased function of the heart).
• Worsening of breathing difficulties (in particular in patients with asthma or asthmatic complaints).
• Cold fingers and toes.
• Fatigue.
• Dizziness.
• Sleep disturbances.
• Depression (serious dejection).
• Hallucinations (disturbances of the mind).
• Nausea and diarrhoea.
• Purple spots on the skin (purpura), severe and dangerous lowered white blood cell count (agranulocytosis) with symptoms such as fever, chills, sore throat, sores in the mouth or throat.
• Skin rash.
• Irritation of the eyes.
• Abnormal sensation of the skin (tingling, pricking, itching) with no apparent physical cause (paresthesia).
• In children: seizure linked to low levels of sugar in the blood.

Please refer to the package leaflet of Propranolol sustained-release capsules for more possible 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.

What ingredients are in this medicine?

Propranolol HCl Actavis 10, 40, 80 mg (tablets):

The active substance is propranolol hydrochloride. Each tablet contains either 10 mg, 40 mg or 80 mg of the active substance.

The other ingredients are:
Tablet core: lactose monohydrate, maize starch, soluble starch, sodium starch glycolate, cellulose microcrystalline (E460), magnesium stearate. Tablet coating: magnesium stearate, macrogol 6000, talc, hypromellose, titanium dioxide (E171), dimeticone. Propranolol HCL Retard 80-160 PCH (sustained-release capsules 80 mg and 160 mg):

The active substance per capsule is 80 mg and 160 mg propranolol hydrochloride, respectively. The other ingredients are: maize starch, glucose, sucrose, povidone, ethyl cellulose (E462), gelatine (E441), talc, titanium dioxide (E171), sulphur dioxide (E220).
The manufacturers of Propranolol HCl Actavis 10, 40, 80 mg are:

Actavis B.V.

Baarnsche Dijk 1

3741 LN Baarn

The Netherlands

Actavis Group PTC ehf

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

The manufacturers of Propranolol HCL Retard 80-160 PCH are:

Pharmachemie BV
Swensweg 5
2031 GA Haarlem
The Netherlands

Ethylpharm SA
Zone Industrielle de Saint Arnoult
28170 Chateauneuf-en-Thymerais
France

Read the package leaflet before use.