SOTALOLO 80 mg Film-Coated Tablets

Зміст інструкції

1. Sotalol Teva 80 mg tablets
   1. What is Sotalolo Teva and what is it used for
   2. What you need to know before you take Sotalolo Teva
   3. How to take Sotalolo Teva
   4. Possible side effects
   5. How to store Sotalolo Teva
   6. Contents of the pack and other information

Sotalol Teva 80 mg tablets

Sotalol

Generic medicine

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

1. What is Sotalolo Teva and what is it used for

• Sotalolo Teva belongs to a group of medicines called beta-blockers, which slow down the heartbeat, making the heart beat more efficiently.
• Sotalolo Teva is used to prevent the recurrence of serious heart rhythm problems.

2. What you need to know before you take Sotalolo Teva

Do not take Sotalolo Teva:

• if you are allergic to sotalol, sulfonamides (e.g. cotrimoxazole, sulfadiazine) or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from heart problems other than those for which the medicine has been prescribed to you, in particular:
• abnormal heart rhythm, known as “long QT syndrome”,
• torsades de pointes (a life-threatening irregular heartbeat),
• atrioventricular block or sick sinus syndrome (without a pacemaker) (some types of heart rhythm disorders),
• your heart beats less than 50 times per minute,
• uncontrolled heart failure,
• shock due to heart problems (a condition that may be associated with low blood pressure, cold skin, weak pulse, confusion and anxiety).
• if you suffer from any of the following conditions:
• asthma or any other breathing difficulty,
• Prinzmetal's angina (chest pain and palpitations at rest, usually during sleep),
• circulatory problems (for example Raynaud's phenomenon or leg muscle pain during walking),
• untreated pheochromocytoma (a benign adrenal tumor),
• low blood pressure (not due to an irregular heartbeat),
• severe kidney problems,
• metabolic acidosis (acidification of the blood).
• if you are planning to undergo general anesthesia.
• if you are also taking other medicines to correct an abnormal heart rhythm, for example quinidine, hydroquinidine or disopyramide (so-called “Class I antiarrhythmic agents”), or amiodarone, dofetilide or ibutilide (so-called “Class III antiarrhythmic agents”).
• if you are also taking medicines used to treat schizophrenia and other serious mental disorders, for example sulpiride, sultopride, amisulpride, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamezazine, tiapride, pimozide, haloperidol, droperidol (so-called “neuroleptics”).
• If you are also receiving injections of erythromycin (an antibiotic) or vincamine (which may be used in the treatment of some forms of brain disease, such as dementia), or if you are taking bepridil (used to treat angina), cisapride (used to treat some gastrointestinal problems), difenamil (which may be used to treat a slow heartbeat), mizolastine (used to treat hay fever), moxifloxacin (an antibiotic) or floctafenine (used to treat pain).

If you are elderly, it is particularly important that you do not take Sotalolo Teva if one or more of the
situations listed above applies to your case.

Warnings and precautions
Sotalolo Teva can sometimes worsen an already altered heartbeat or cause new heart problems.

Talk to your doctor or pharmacist before taking Sotalolo Teva if you suffer from:

• slow heartbeat (less than 50-55 beats per minute).
• heart failure treated or a heart rhythm disorder called “first-degree atrioventricular block” or if you have recently had a heart attack.
• an imbalance of electrolytes (low levels of potassium and magnesium in the blood).
• severe or prolonged diarrhea.
• frequent allergic reactions.
• hyperthyroidism.
• psoriasis (thickened and painful skin patches).
• diabetes, treated with insulin or sulfonamides, as the warning signs of low blood sugar may be less noticeable than usual.
• kidney disease.

Other precautions to take:

• Tell hospital staff or your dentist that you are taking Sotalolo Teva if you are to undergo surgery requiring anesthesia or if you need X-rays that require iodinated contrast agents.
• Do not suddenly stop taking Sotalolo Teva (see section 3 “How to take Sotalolo Teva”).

Athletes should be aware that Sotalolo Teva may result in positive doping tests.

Other medicines and Sotalolo Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Some medicines must not be taken at the same time as Sotalolo Teva. These medicines are

listed above, in the sub-section “Do not take Sotalolo Teva”.

Also tell your doctor if you are using one or more of the medicines listed below.
Sotalolo Teva generally should not be taken at the same time as the following medicines, because of the risk of further heart problems:

• Alofantrine (used to treat malaria).
• Pentamidine (used to treat pneumonia).
• Sparfloxacin (an antibiotic).
• Methadone (which can be used to treat cough, pain and heroin addiction).
• Diltiazem or verapamil (so-called “calcium channel blockers/antagonists”, used to treat an abnormal heartbeat).
• Medicines that can raise blood pressure, such as monoamine oxidase inhibitors (MAOIs), for example moclobemide, phenelzine, isocarboxazide.

You also need to be careful if you are taking:

• Diuretics (water tablets)
• Laxatives (used to treat constipation)
• Glucocorticoids (used to treat inflammation and skin allergic reactions)
• Tetracosactide (used mainly to diagnose or treat disorders of the adrenal glands)
• Amphotericin B (given intravenously) (used to treat fungal infections)
• Guanfacine (used to treat attention deficit hyperactivity disorder [ADHD])
• Digitalis glycosides including digoxin (used to treat irregular heartbeats or impaired heart function)
• Class Ic antiarrhythmic agents (such as propafenone or flecainide) or lidocaine given intravenously (used to control irregular heartbeats)
• Mefloquine (used to prevent or cure malaria)
• Cholinergic inhibitors such as donepezil, rivastigmine, tacrine, galantamine, neostigmine, pyridostigmine or ambenonium (used to treat Alzheimer's disease)
• Pilocarpine (used to treat dry mouth or high pressure in the eyes)
• Other beta-blockers, clonidine, dihydropyridines or alpha-methyldopa (used to treat high blood pressure)
• Volatile halogenated anesthetics (used in surgery)
• Insulin and hypoglycemic sulfonamides (used to treat diabetes)
• Baclofen (used in the treatment of muscle spasm)
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac (used to treat pain, fever or inflammation)
• Tricyclic antidepressants (e.g. imipramine), phenothiazine neuroleptics (used to treat psychiatric disorders)
• Amifostine (used during chemotherapy or radiotherapy)
• Dipiridamol (given intravenously) (used to prevent blood clot formation).

Interactions with laboratory tests:
If you have a blood test, tell your doctor if you are taking sotalol, as this may
affect the results of some blood tests.

Athletes
Athletes should be informed that this medicine contains an active ingredient that may
lead to a positive result in “doping tests”.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor may prescribe Sotalolo Teva only if absolutely necessary. Do not take
Sotalolo Teva unless otherwise directed by your doctor and always strictly following the
prescription.
Breastfeeding during therapy with Sotalolo Teva is not recommended.

Driving and using machines
Sotalolo Teva can affect your vision or cause dizziness.
Do not drive or use machines or tools if you experience these symptoms.

Sotalolo Teva contains lactose
Sotalolo Teva tablets contain lactose. If you have been diagnosed with lactose
intolerance, contact your doctor before taking this medicine.

3. How to take Sotalolo Teva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:
Adults (including the elderly):
The initial dose is 80 mg of sotalol, to be taken once a day or in two divided doses at
intervals of 12 hours. The doctor will gradually increase the dosage according to your needs.
The recommended dose is between 160 mg and 320 mg of sotalol per day, to be taken in 2 or 3
separate doses.
For some patients with an irregular heartbeat that threatens survival, the dosage may
be increased to 480 mg or 640 mg of sotalol per day.
Patients with kidney problems may require a lower dosage.

Use in children:
Due to the lack of data in this regard, Sotalolo Teva is not recommended for children. Consult your
doctor.
Method of administration
Sotalolo Teva tablets should be swallowed whole with a full glass of water.
The tablet can be divided into equal doses.

If you take more Sotalolo Teva than you should
If you (or someone else) have swallowed many tablets together or if you believe that a child has swallowed
some tablets, contact the nearest hospital emergency department or your
doctor immediately. Bring this leaflet, the remaining tablets and the container with you to show them at the hospital or to
the doctor, so they know which tablets were taken.

If you forget to take Sotalolo Teva
If you have forgotten to take a dose, take it as soon as you remember, unless it is already the
time to take the next tablet. Do not take a double dose to make up for the
forgotten tablet. Take the next doses at the scheduled time.

If you stop taking Sotalolo Teva
You should not suddenly stop taking Sotalolo Teva, as serious heart problems, including heart attack and death, may occur.
Your doctor will decide when and how to stop therapy with Sotalolo Teva. Follow your
doctor's instructions.
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.
manifest.

Immediately inform your doctor if you experience any of the following symptoms:

• swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing. These may be signs of an allergic reaction, and the tablets will be discontinued.

Other side effects:

• Blood disorders (such as changes in the number of white blood cells or red blood cells or platelets) which may be characterised by unusual bleeding or unexplained bruising, fever or chills, sore throat, mouth or throat ulcers. If these symptoms occur, contact your doctor.
• Low blood sugar levels.
• Cold hands and/or feet.
• Vision problems.
• Slow heartbeat, shortness of breath, wheezing, chest pain, palpitations, swelling of the ankles, abnormalities on the electrocardiogram, low blood pressure, worsening of irregular heartbeat, fainting, heart failure.
• Skin rashes, itching, sweating, sensitivity to light.
• Nausea, vomiting, diarrhoea, indigestion, abdominal pain and flatulence.
• Cramps, muscle or joint pain.
• Sexual problems, including impotence.
• Fatigue, dizziness, feeling weak, headache, depression, difficulty sleeping, tingling, anxiety, fever.

In exceptional cases, inflammation of joints and connective tissue (for example tendons) with skin rashes has been reported. These symptoms usually disappear with discontinuation of therapy.
If you have psoriasis or intermittent claudication (leg pain similar to cramps, caused by
walking), your symptoms may worsen.
If any of these side effects get worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, speak to your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Sotalolo Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp.. The expiry
date refers to the last day of that month.
Store the blister in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in waste water 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 Sotalolo Teva contains

• The active substance is sotalol hydrochloride.
• Each tablet contains 80 mg of sotalol hydrochloride.
• The other ingredients are lactose monohydrate, corn starch, magnesium stearate, povidone and indigo carmine (E132).

Description of the appearance of Sotalolo Teva and contents of the pack

• Sotalolo Teva 80 mg: blue, oval-shaped tablet; one side is divided by a score line and bears the numbers 93 and 61 imprinted above and below this line; the other side is smooth.
• Sotalolo Teva 80 mg is available in packs of 20, 28, 30, 40, 50, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano
Manufacturer
Teva UK Ltd. - Brampton Road - Hampden Park – BN22 9AG Eastbourne – East Sussex (United
Kingdom)
Pharmachemie B.V. - Swensweg 5, P.O. 552, 2003 RN Haarlem (Netherlands)
Teva Operations Poland Sp. z o.o ul. Mogilska 80, 31-546 Kraków, Poland