Propranolol aurovitas

Package leaflet: Information for the user

Propranolol Aurovitas, 10 mg, film-coated tablets
Propranolol Aurovitas, 40 mg, film-coated tablets
Propranololi hydrochloridum
Please read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Propranolol Aurovitas is and what it is used for

Propranolol Aurovitas contains propranolol hydrochloride, which belongs to a group of medicines called beta-blockers. It acts on the cardiovascular system and also on other parts of the body.
Propranolol Aurovitas may be used:

• to treat hypertension (high blood pressure);
• to treat angina pectoris (chest pain);
• to treat certain arrhythmias (heart rhythm disorders);
• to protect the heart after myocardial infarction (heart attack);
• to prevent migraine;
• to treat essential tremor (involuntary, rhythmic trembling);
• to treat certain thyroid disorders (such as thyrotoxicosis, caused by excess thyroid hormones in the blood, and hyperthyroidism);
• to treat hypertrophic cardiomyopathy (thickening of the heart muscle);
• to treat phaeochromocytoma (high blood pressure caused by a tumour, usually near the kidney);
• to treat bleeding from oesophageal varices due to high blood pressure in the liver.

2. Important information before using Propranolol Aurovitas

When not to use Propranolol Aurovitas

• if the patient is allergic to propranolol hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has untreated and/or uncontrolled heart failure,
• if the patient has cardiogenic shock,
• if the patient has severe heart disease (second or third-degree heart block), which may require treatment with a cardiac pacemaker,
• if the patient has heart conduction or rhythm disorders,
• if the patient has very slow or very irregular heartbeat,
• if the patient has increased blood acidity (metabolic acidosis),
• if the patient is on a strict diet,
• if the patient has asthma, wheezing, or other breathing problems,
• if the patient has untreated phaeochromocytoma (high blood pressure caused by a tumour, usually in the area of the kidney),
• if the patient has severe circulatory disorders (which may cause tingling, paleness, or bluish discoloration of fingers and toes),
• if the patient has constricting chest pain at rest (Prinzmetal's angina),
• if the patient has very low blood pressure.

If any of the above warnings apply to the patient or if the patient has any doubts,
the patient should consult a doctor before taking this medicine.
Warnings and precautions
Before starting treatment with Propranolol Aurovitas, discuss with a doctor or
pharmacist if:

• the patient has allergic reactions, e.g. to insect stings.
• the patient has diabetes, because Propranolol Aurovitas may alter the normal response to low blood sugar levels, which usually include increased heart rate. Propranolol may also cause decreased blood sugar levels even in patients without diabetes.
• the patient has thyrotoxicosis. Propranolol may mask symptoms of thyrotoxicosis.
• if the patient has kidney or liver disease (including liver cirrhosis). In such cases, consultation with a doctor is necessary, as certain control tests may be required during treatment.
• if the patient has heart disease.
• if the patient has muscle weakness (myasthenia gravis).
• if the patient has conditions such as chronic obstructive pulmonary disease and bronchospasm, as propranolol may worsen these conditions.
• if the patient is taking calcium antagonists with negative inotropic effects, e.g. verapamil and diltiazem (see "Propranolol Aurovitas with other medicines").

Propranolol Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Propranolol Aurovitas may affect the action of certain other medicines, and some medicines may affect the action of Propranolol Aurovitas.
Do not use Propranolol Aurovitas in combination with calcium antagonists with negative inotropic effects (e.g. verapamil, diltiazem), as this may enhance their effects. This may lead to severe hypotension and bradycardia.
Other medicines that should be used with caution in combination with Propranolol Aurovitas:

• nifedipine, nilvadipine, nicardipine, isradipine, lacidipine (used in the treatment of hypertension or angina pectoris);
• lidocaine (local anaesthetic);
• disopyramide, quinidine, amiodarone, propafenone and digitalis glycosides (used in the treatment of
  heart conditions);
• adrenaline (a drug that stimulates heart function);
• ibuprofen and indomethacin (used for pain and inflammatory conditions);
• ergotamine, dihydroergotamine or rizatriptan (used in the treatment of migraine);
• chlorpromazine and thioridazine (used in the treatment of certain psychiatric disorders);
• cimetidine (used in the treatment of gastrointestinal disorders);
• rifampicin (used in the treatment of tuberculosis);
• theophylline (used in the treatment of asthma);
• warfarin (used to thin the blood) and hydralazine (used in the treatment of hypertension);
• fingolimod (used in the treatment of multiple sclerosis);
• fluvoxamine and barbiturates (used in the treatment of anxiety and insomnia);
• MAO inhibitors (used in the treatment of depression).

If the patient is taking clonidine (used in the treatment of hypertension or migraine) and
propranolol simultaneously, do not discontinue clonidine without medical advice. If clonidine needs to be discontinued, the doctor will inform the patient how to do so.
Propranolol Aurovitas with food, drink and alcohol
Alcohol may affect the action of this medicine.
Surgical procedures
If the patient is scheduled for surgery, the patient should inform the anaesthetist or medical staff about taking Propranolol Aurovitas.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy:
Use of this medicine during pregnancy is not recommended unless considered necessary by the doctor.
Breastfeeding:
Breastfeeding is not recommended while taking this medicine.
Driving and operating machinery
It is unlikely that this medicine affects the ability to drive or operate machinery. However, some individuals may occasionally experience dizziness or fatigue while taking propranolol. If such symptoms occur, the patient should consult a doctor for advice.
Important information about certain ingredients of Propranolol Aurovitas
Propranolol Aurovitas contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Propranolol Aurovitas contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Propranolol Aurovitas

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
For the 40 mg dose:
If your doctor has prescribed 1/4 (one quarter) of a tablet or 1/2 (half) of a tablet, the Propranolol Aurovitas tablet should
be broken as shown below:

Figure 1 and 2
Figure 3 and 4

• Place the tablet on a flat, firm, and clean surface (e.g. a table or worktop), with the side containing the break line facing upwards.
• Place your index fingers along one of the break lines, then press downwards to break the tablet (see Figure 1 and 2).
• To obtain 1/4 (one quarter) of a tablet, repeat the procedure with the 1/2 (half) tablet (see Figure 3 and 4).

The Propranolol Aurovitas tablet should be taken before a meal, swallowed with a small amount
of water. Do not chew the tablet.
Do not stop taking this medicine without consulting your doctor.
Adults
The recommended dosage for adults is given below:

Children and adolescents
Propranolol Aurovitas may also be used in the treatment of children with migraine and cardiac
arrhythmias:

• In the treatment of migraine, the dose for children under 12 years of age is 20 mg twice or three times daily; for children over 12 years of age, the dose is the same as for adults.
• In the treatment of cardiac arrhythmias, the dose will be adjusted by the physician according to the child's age or body weight.

Elderly patients
In elderly patients, treatment should be initiated with the lowest dose. The optimal dose will be individually determined by the physician for each patient.
Hepatic or renal impairment
The optimal dose will be individually determined by the physician for each patient.
Use of a higher than recommended dose of Propranolol Aurovitas
If an overdose is accidentally taken, seek immediate medical attention at the nearest hospital emergency department or contact a physician or pharmacist without delay. Symptoms of overdose may include very slow heart rate, marked decrease in blood pressure, heart failure, and breathing difficulties, accompanied by symptoms such as fatigue, hallucinations, tremor, disorientation, nausea, vomiting, muscle cramps, fainting or coma, and low blood sugar levels. Always bring any remaining tablets and the packaging to enable identification of the medicinal product.
Missed dose of Propranolol Aurovitas
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.
Stopping Propranolol Aurovitas
Do not discontinue treatment without consulting a physician. In some cases, gradual withdrawal of the medicinal product may be necessary.
If you have any further questions regarding the use of this medicinal product, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine.

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

• cold fingers and toes;
• slowed heart rate;
• numbness and cramps in fingers, followed by a sensation of warmth and pain (Raynaud's syndrome);
• sleep disturbances and (or) nightmares;
• fatigue;
• shortness of breath.

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

• nausea, vomiting, and diarrhoea.

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

• worsening of breathing difficulties, sometimes fatal, if the patient has or has had asthma or asthma-like conditions;
• heart failure, worsening of heart disease;
• swelling of the face, tongue, larynx, abdomen, or hands and feet (angioedema);
• dizziness, especially when standing up;
• worsening of blood circulation in patients with existing circulatory disorders;
• hair loss (excessive hair shedding);
• mood changes;
• disorientation;
• memory loss;
• psychosis or hallucinations (mental disturbances);
• paraesthesia (abnormal sensations, usually tingling or pricking);
• visual disturbances;
• dry eyes;
• skin rash, including worsening of psoriasis;
• blood cell disorders, such as reduced platelet count (thrombocytopenia), leading to easy bruising and bleeding;
• purple spots on the skin (purpura).

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

• severe muscle weakness (myasthenia);
• low blood sugar levels, which may occur in both diabetic and non-diabetic patients, including newborns, infants and children, elderly patients, patients undergoing haemodialysis, or patients taking antidiabetic medicines; it may also occur in patients currently or recently fasting, or in patients with chronic liver disease;
• excessive sweating.

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

• headache or seizures associated with low blood sugar;
• inability to achieve erection (impotence);
• reduced blood flow through the kidneys;
• joint pain (arthralgia);
• constipation;
• dryness of the oral mucosa;
• shallow breathing or dyspnoea (shortness of breath);
• conjunctivitis ("red eye");
• depression;
• absence of white blood cells in blood (agranulocytosis);
• worsening of angina pectoris (chest pain).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Propranolol Aurovitas

Keep this medicine out of sight and reach of children.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Propranolol Aurovitas contains

• The active substance is propranolol hydrochloride. Each film-coated tablet contains 10 mg or 40 mg of propranolol hydrochloride.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (type 101), lactose monohydrate, maize starch, sodium carboxymethyl starch (type A), povidone (K 30), magnesium stearate
  Coating: hypromellose 2910 (E 464), macrogol 6000 (E 1521), titanium dioxide (E 171)

What Propranolol Aurovitas looks like and contents of the pack
Film-coated tablet.
Propranolol Aurovitas, 10 mg:
White or almost white, round, biconvex film-coated tablets, marked with
“I” on one side and “10” on the other. The tablet diameter is 5.0 mm.
Propranolol Aurovitas, 40 mg:
White or almost white, round, biconvex film-coated tablets, marked with
“I 40” on one side and a breakline on the other. The tablet diameter is 8.0 mm.
The tablet can be divided into equal doses.
The medicine is packed in PVC/Aluminium blisters.
Pack sizes: 20, 28, 30, 50, 56, 60, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Propranolol AB 40 mg filmomhulde tabletten.
France: PROPRANOLOL ARROW 40 mg, comprimé pelliculé sécable
Germany: Propranolol PUREN 10 mg Filmtabletten / Propranolol PUREN 40 mg Filmtabletten
Netherlands: Propranolol HCl Aurobindo 10 mg, filmomhulde tabletten / Propranolol HCl Aurobindo 40 mg, filmomhulde tabletten
Poland: Propranolol Aurovitas
Portugal: Propranolol Generis
Spain: Propranolol Aurovitas 10 mg comprimidos recubiertos con película EFG / Propranolol Aurovitas 40 mg comprimidos recubiertos con película EFG