SOTALEX 80 mg Таблетка

Содержание инструкции

1. SOTALEX 80 mg tablets
   1. What is Sotalex and what is it used for
   2. What you need to know before taking Sotalex
   3. How to take Sotalex
   4. Possible side effects
   5. How to store Sotalex
   6. Package Contents and Other

SOTALEX 80 mg tablets

Sotalol hydrochloride

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 their symptoms are the same as yours, 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 Sotalex is and what it is used for
• 2. What you need to know before you take Sotalex
• 3. How to take Sotalex
• 4. Possible side effects
• 5. How to store Sotalex
• 6. Contents of the pack and other information

1. What is Sotalex and what is it used for

Sotalex contains the active ingredient “sotalol hydrochloride” which belongs to a group of
medicines known as beta-blockers. These medicines slow down the heartbeat, making
the heart beat more efficiently in adults.

Sotalex is used for:

• preventing the occurrence of some serious heart rhythm irregularities
• treating an irregular heartbeat
• maintaining a regular heartbeat after a procedure performed to normalize an irregular heartbeat

2. What you need to know before taking Sotalex

DO NOT take Sotalex

• If you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from asthma, wheezing attacks or any other lung disease.
• If you suffer from low blood pressure.
• If you suffer from pain in the fingers of your hands and feet that first become white, then bluish and finally reddish (Raynaud's syndrome).
• If you are planning to undergo general anesthesia.
• If you suffer from severe kidney problems.
• If you suffer from a condition called metabolic acidosis (build-up of acid in the blood).
• If you suffer from a benign tumor of the adrenal gland (pheochromocytoma) that has not been treated.
• If you suffer from a very slow heartbeat.
• If you have suffered from some heart diseases (such as uncontrolled heart failure, heart block, sick sinus syndrome unless a pacemaker has been implanted).

controlled, heart block, sick sinus syndrome unless a pacemaker has been installed).

• If you suffer from an abnormal heart rhythm, known as “long QT syndrome”.
• If you are in a state of shock due to heart problems (a condition that can manifest with low blood pressure, cold skin, weak pulse, mental confusion and anxiety).
• If you suffer from Prinzmetal's Angina (chest pain and palpitations at rest, usually during sleep) as sotalol may increase the risk of angina pectoris.
• If you are taking other medicines to correct an abnormal heart rhythm, the so-called “class I antiarrhythmic agents” (e.g. quinidine, disopyramide and procainamide) or the so-called “class III antiarrhythmic agents” (e.g. amiodarone) (see section “Other medicines and Sotalex”).
• If you are also taking medicines used to treat schizophrenia and other serious mental disorders, for example sulpiride, amisulpride, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamezazine, tiapride, pimozide, haloperidol, droperidol (the so-called “neuroleptics”).
• If you are taking antidepressants (e.g. citalopram, escitalopram, clomipramine, amitriptyline, desipramine, imipramine and nortriptyline).
• If you are taking antipsychotics (e.g.: phenothiazine: mesoridazine, thioridazine, levomepromazine, chlorpromazine; butyrophenones: droperidol; others: pimozide, sultopride).
• If you are taking medicines to treat malaria (e.g. alofantrine and chloroquine).
• If you are taking antihistamines (e.g. terfenadine, promethazine, astemizole).
• If you are taking medicines to prevent vomiting or nausea (e.g. cisapride domperidone, ondansetron) (see section “Other medicines and Sotalex”).
• If you are taking medicines that act as kinase inhibitors for the treatment of some types of advanced or progressive cancers (e.g. vandetanib) (see section “Other medicines and Sotalex”).
• If you are also receiving injections of erythromycin (an antibiotic) or vincamine (which can 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), difemanil (which can be used to treat a slow heartbeat), mizolastine (used to treat hay fever), moxifloxacin (an antibiotic) or floctafenine (used for pain relief)
• if you are taking methadone (for the treatment of withdrawal syndrome), arsenic trioxide, donepezil, propofol, trazodone, probucol, fluconazole, papaverine or anagrelide .

Warnings and precautions
Talk to your doctor or pharmacist before taking Sotalex:

• If you suffer from diabetes, as sotalol may also mask or reduce the warning signs of low blood sugar levels (hypoglycemia).
• If you suffer from thyroid problems with an excess of thyroid hormones in the circulation (thyrotoxicosis), as sotalol may mask the symptoms or worsen them if treatment with sotalol is stopped abruptly.
• If you have kidney problems, as the dose of Sotalex may require adjustment

(see section “How to take Sotalex”).

• If you suffer from psoriasis (a skin disease that causes itching, red and painful patches of skin), as sotalol may worsen the symptoms.
• If you have recently had a heart attack, as sotalol may worsen an already altered heartbeat or cause new heart rhythm problems.
• If you have some abnormalities on the electrocardiogram (prolonged QT interval), a history of enlargement of the heart muscle (cardiomegaly) or heart failure (decompensated heart failure).
• If you suffer from an electrolyte imbalance (low levels of potassium and magnesium in the blood) (see “Other medicines and Sotalex).
• If you suffer from frequent episodes of allergic reactions.

Other precautions to take:

• Tell your doctor or anesthesiologist that you are taking Sotalex as it may affect the effect of anesthetics.
• Do not stop taking Sotalex suddenly (see section “How to take Sotalex”).
• The presence of sotalol in the urine may alter the result of the measurement of urinary metanephrines (an indicator of the presence of a benign tumor of the adrenal gland, pheochromocytoma).

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test.

Children and adolescents
The efficacy and safety of Sotalex in patients under 18 years of age has not been
adequately established.

Other medicines and Sotalex
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can interact with Sotalex. These medicines are
listed above, in the sub-paragraph “Do not take Sotalex”. In these cases it may
be necessary to adjust the dosage or stop treatment with some of them. It is
important to tell your doctor if you are taking any of the following medicines:

• Floctafenine
• other medicines for the treatment of heart rhythm disturbances (e.g. disopyramide, hydroquinidine, quinidine, procainamide, flecainide, amiodarone, dofetilide, ibutilide, propafenone)
• medicines that can alter the electrocardiogram (prolongation of the QT interval) or induce Torsades de Pointes:
• medicines for depression and mental disorders (e.g. neuroleptics such as thioridazine, chlorpromazine, levomepromazine; antidepressants such as citalopram, escitalopram, clomipramine and amitriptyline; phenothiazines such as mesoridazine, levomepromazine, chlorpromazine)
• medicines for the treatment of an infection (antibiotics) such as fluoroquinolones (e.g. moxifloxacin, levofloxacin) and macrolides (e.g. azithromycin, clarithromycin, erythromycin) and pentamidine
• medicines that are used to prevent and treat malaria (alofantrine, chloroquine, artenimol)
• medicines for allergies (antihistamines, e.g. terfenadine, astemizole)
• medicines that increase the movements or contractions of the stomach and intestines and are used to treat nausea and vomiting (cisapride, domperidone, ondansetron)
• medicines that act as kinase inhibitors for the treatment of some types of advanced or progressive cancers, for example in the stomach, intestine or kidneys (vandetanib, sunitinib, sorafenib)
• medicines that are used to reduce stomach acid, for the treatment of gastroesophageal reflux disease and peptic ulcer disease (proton pump inhibitors) as hypomagnesemia may occur increasing the potential for torsades de pointes
• medicines for the treatment of addiction (methadone)
• others (bepridil, difemanil, erythromycin, mizolastine, vincamine, moxifloxacin, trioxide of arsenic, donepezil, propofol, trazodone, probucol, fluconazole, papaverine, anagrelide)
• medicines that serve to increase urine production (diuretics) that reduce the amount of potassium and magnesium in the blood (see “Warnings and precautions”)
• medicines that reduce the amount of potassium in the blood: amphotericin B (an antibiotic), laxatives, corticosteroids (medicines to treat inflammation)
• medicines used to treat high blood pressure: calcium channel blockers (such as verapamil and diltiazem)

It is also necessary to be careful if you are taking:

• medicines to lower blood sugar levels (e.g. antidiabetics and insulin)
• digoxin a medicine used to treat some heart diseases
• medicines used to treat high blood pressure: for example clonidine, beta-blockers, reserpine, guanethidine
• medicines for asthma and other lung diseases (e.g. salbutamol, terbutaline, isoprenaline)
• medicines for anesthesia in case of surgical interventions (e.g. lidocaine)
• baclofen a medicine for the treatment of muscle spasms and multiple sclerosis
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, diclofenac (used for the treatment of pain, fever or inflammation)
• amifostine (used during chemotherapy or radiotherapy)
• dipiridamol (administered intravenously) (used to prevent blood clot formation)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
You should tell your doctor if you think you are pregnant (or if there is a possibility
of becoming pregnant). Sotalex should not be used during pregnancy,
therefore the doctor will carefully assess the benefits of therapy for you and the risks to the
fetus.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. The doctor
will assess whether to stop breastfeeding or treatment with Sotalex.

Driving and using machines
Possible side effects such as vision problems and dizziness may impair the
ability to drive and operate machinery.

Sotalex contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor
before taking this medicine .

3. How to take Sotalex

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended initial dose is 80 mg of Sotalex 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 every 2-3 days
up to a maximum dose of 320 mg per day.
For some patients with an irregular heartbeat that threatens survival, the
dosage may be increased up to 480 mg or 640 mg of sotalol per day.
During the first few weeks after starting treatment with Sotalex and whenever your
dosage is changed, the doctor will monitor your response to treatment.
Patients with impaired kidney function
If your kidney function is impaired, your doctor will take this into account when
prescribing the dose to be administered to you.

How to take the tablets
The tablets must be swallowed whole, with a glass of water, preferably
1-2 hours before meals.

If you take more Sotalex than you should
If you have taken too many tablets, contact your doctor or go to hospital
immediately. The symptoms of overdose may consist of:

• slowed heartbeat (bradycardia)
• heart failure (decompensated heart failure)
• low blood pressure (hypotension)
• severe difficulty breathing (bronchospasm)
• low blood sugar levels (hypoglycemia)
• seizures (including seizures caused by low blood sugar levels)

Therapeutic measures
Sotalol can be removed from the circulation via hemodialysis (a method of
blood filtration). The doctor may control the symptoms with specific
therapies.

If you forget to take Sotalex
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, take it as soon as you remember unless it is
almost time to take the next dose; in this case, simply wait for the
time of the next dose and continue treatment as usual.

If you stop taking Sotalex
Do not stop or interrupt treatment with Sotalex without first consulting your
treating doctor as serious heart problems, including heart attack and
death, may occur.
Your doctor will decide when and how to stop therapy with Sotalex. Follow the
instructions of your doctor.
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 everyone will experience them.
If you experience the following side effects at the beginning of treatment with Sotalex, contact

immediatelyyour doctor who will STOPthe treatment:

• slow heartbeat (bradycardia),
• very low blood pressure (severe hypotension).

The following side effects have been observed and reported during treatment with Sotalex:

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

• slow heartbeat (bradycardia), difficulty breathing (dyspnea), chest pain, feeling of heartbeat in the chest (palpitations), swelling, abnormalities on the electrocardiogram (a test to see how the heart's electrical system is working), low blood pressure (hypotension), irregular heartbeat (proarrhythmia), fainting (syncope), weak heart (heart failure), “feeling faint” (presyncope)
• Skin rashes (rash)
• Nausea, vomiting, diarrhea, abdominal pain, excessive production of intestinal gas (flatulence), pain and/or persistent or recurrent discomfort localized to the stomach (dyspepsia)
• Muscle cramps
• Fatigue, dizziness, weakness (asthenia), lightheadedness, headache (cephalalgia),

sleep disturbances, depression, changes in sensation (paresthesia), changes
in mood, anxiety

• Sexual problems
• Problems with vision and hearing
• Changes in the sense of taste
• Fever

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

• reduced number of cells that help with blood clotting - this increases the risk of bleeding or bruising
• low blood sugar levels
• limited blood flow to the extremities causing cold and/or blue fingers and toes, leg pain when walking (Raynaud's syndrome)
• bronchospasm
• serious change in heart rhythm (atrioventricular block)
• angina pectoris
• itching, hair loss, excessive sweating, psoriasis

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 Sotalex

This medicine does not require special storage conditions. 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.
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 to
protect the environment.

6. Package Contents and Other

Information What Sotalex Contains

• The active ingredient is sotalol hydrochloride 80 mg
• The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, anhydrous colloidal silica, stearic acid, magnesium stearate

Description of the appearance of Sotalex 80 mg tablets and package contents
White, round, biconvex tablets with a fracture line on both sides, packaged in blisters of 40 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 24, 17489 - Greifswald (Germany)

Manufacturer:
FARMEA
10 rue Bouché Thomas
ZAC d’Orgemont, 49000 Angers, France