SOTALOLO 80 mg Коированные Таблетки

Содержание инструкции

1. Sotalolo Mylan Generics 80 mg tablets
   1. What you need to know before taking Sotalol Mylan Generics
   2. How to take Sotalol Mylan Generics
   3. Possible side effects
   4. How to store Sotalolo Mylan Generics
   5. Contents of the pack and other information

Sotalolo Mylan Generics 80 mg tablets

(sotalol hydrochloride)

Generic medicine
Read this leaflet carefully before taking this medicine as 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 because it could 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 Sotalolo Mylan Generics is and what it is used for

2. What you need to know before you take Sotalolo Mylan Generics

3. How to take Sotalolo Mylan Generics

4. Possible side effects

5. How to store Sotalolo Mylan Generics

6. Contents of the pack and other information

1. What Sotalolo Mylan Generics is and what it is used for

The name of this medicine is Sotalolo Mylan Generics. Each tablet contains the active ingredient sotalol hydrochloride.
Sotalolo Mylan Generics belongs to a group of medicines called beta-blockers or beta-adrenergic receptor antagonists.
Sotalolo Mylan Generics is used to treat irregular heartbeats.

2. What you need to know before taking Sotalol Mylan Generics

Do not take Sotalol Mylan Generics:

• if you are allergic to sotalol or 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 a very slow heartbeat or low blood pressure
• if you suffer from a condition that causes discoloration (white or purple) of your hands and feet (Raynaud's syndrome)
• if you suffer from severe circulatory disorders
• if you have suffered from some heart diseases (such as untreated heart failure, heart block, sick sinus syndrome) or cardiogenic shock
• if you suffer from a condition called metabolic acidosis
• if you suffer from an untreated tumor of the adrenal gland (see section “Warnings and precautions for use”)
• if you suffer from kidney failure
• if you are planning to have surgery or need an anesthetic, inform your anesthesiologist or dentist that you are taking Sotalol Mylan Generics
• if you are taking verapamil or diltiazem intravenously (medicines for the treatment of irregular heartbeat).

If you are affected by any of the conditions listed above, talk to your doctor before taking this
medicine.

Warnings and precautions for use
Talk to your doctor or pharmacist before taking Sotalol Mylan Generics.
The doctor may want to check the level of potassium and magnesium in the blood before you begin to
take Sotalol Mylan Generics. Patients with low levels should not take Sotalol Mylan
Generics.
Regular blood tests may be required during treatment with Sotalol Mylan Generics.
You must talk to your doctor or pharmacist before taking Sotalol Mylan Generics.

• if you are pregnant, planning a pregnancy or breastfeeding
• if you suffer from a heart disease, have an enlarged heart or are being treated for heart failure or if you have recently had a heart attack
• if you suffer from abnormal heart rhythm (seen on an electrical recording of the heart (ECG), such as prolonged QT interval). In such cases, the doctor will be very careful before increasing the dose.
• if you have kidney problems, as the dose of Sotalol Mylan Generics may require adjustment
• if you suffer from diabetes, as it may be necessary to adjust the dose of insulin or other medicines you are taking to treat diabetes. Sotalol Mylan Generics can also mask or reduce the warning signs of low blood sugar levels (hypoglycemia)
• if you suffer from an overactive thyroid, as Sotalol Mylan Generics tablets can mask the symptoms or worsen them if treatment with sotalol is stopped abruptly
• if you suffer from, or have recently suffered from diarrhea, or if you have recently had severe diarrhea, or an attack that has lasted a long time. This is because it can affect potassium and magnesium levels in the body, and you may not be able to take Sotalol Mylan Generics
• if you suffer from psoriasis (a skin disease that causes itching, red and painful patches of skin)
• if you are allergic to a variety of allergens. While taking this medicine you may have a more severe reaction to repeated exposure. Sotalol Mylan Generics can also reduce the effectiveness of medicines used to treat severe allergic reactions, such as adrenaline
• if you suffer from liver problems
• if you have a tumor of the adrenal gland (pheochromocytoma, see section “Do not take this medicine”), alpha receptors must be blocked simultaneously with another medicine.

If you are to be subjected to surgery
You must inform your doctor or anesthesiologist that you are taking Sotalol Mylan Generics in
as it can affect the effect of anesthetics or drugs used to relax the muscles
during surgery. You may need to stop taking Sotalol Mylan
Generics before surgery and must be gradually discontinued for a period of one
week. Your doctor will tell you if this is necessary.
If you need to have laboratory tests, such as urine tests, tell your doctor that you are
taking Sotalol Mylan Generics.

Children
Sotalol Mylan Generics is not recommended in children and adolescents under the age of 18
years.

Other medicines andSotalol Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take other
medicines, even those available without a prescription. Some medicines can have an effect
on the effectiveness of each other medicine.

Do not take Sotalol Mylan Genericsin combination with:

• other medicines for the treatment of heart rhythm disturbances (e.g. verapamil, quinidine, diltiazem, disopyramide, procainamide, flecainide, amiodarone, bepridil)
• other beta-blockers (medicines that can be used for angina, high blood pressure or to prevent migraine)

It is particularly important that you inform your doctor if you are taking any of the following
medicines:

• medicines used to treat diabetes (e.g. metformin or insulin)
• medicines used to treat asthma and other lung diseases (e.g. salbutamol terbutaline or isoprenaline by inhalation)
• medicines used to treat depression (e.g. imipramine, maprotiline), anxiety, nervous disorders and mental disorders (e.g. haloperidol)
• medicines used to treat allergies such as hay fever (some antihistamines such as astemizole and terfenadine)
• diuretics
• medicines used for high blood pressure or as an aid in the treatment of Raynaud's syndrome (e.g. amlodipine, nifedipine)
• methyldopa, reserpine, or guanethidine (medicines used to keep blood pressure under control)
• medicines used to treat heart failure (e.g. digoxin)
• a medicine called halofantrine (used to treat malaria)
• some antibiotics (e.g. pentamidine and “floxacin” antibiotics such as ciprofloxacin)

Or, if you are taking:

• a medicine called clonidine (sometimes used to treat hot flashes or headaches). If you are taking clonidine and sotalol at the same time and treatment with clonidine needs to be stopped, you must stop taking sotalol, slowly reducing the amount you are taking, before stopping clonidine.
• steroids
• laxatives
• a medicine called floctafenine (used to relieve pain and inflammation)
• a medicine called amphotericin B (used to treat fungal infections)
• medicines used to treat psychiatric disorders (phenothiazines, some antidepressants), barbiturates, opioids, drugs to lower blood pressure, diuretics or vasodilators can lead to an excessive drop in blood pressure.

Sotalol Mylan Generics with alcohol
Moderate amounts of alcohol do not affect Sotalol Mylan Generics, however you should consult
your doctor before seeing if consumption is advisable for you.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to have a baby, seek
advice from your doctor or pharmacist before taking this medicine.
During pregnancy, Sotalol Mylan Generics should not be given to you unless your doctor
thinks it is essential. If taken during pregnancy, sotalol must be stopped 48-72 hours before
the expected date of delivery. If this is not possible, the newborn must be kept under close observation
for 48-72 hours after birth.
You should not breastfeed during treatment with Sotalol Mylan Generics.

Driving and using machines
Sotalol Mylan Generics generally does not affect the ability to drive. However, if you feel tired or
lightheaded or dizzy, do not drive or use machinery.

3. How to take Sotalol Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Do not stop taking Sotalol Mylan Generics without telling your doctor.

Adults
The recommended initial dose is 80 mg administered as a single dose or divided into two doses. The dose will be gradually adjusted every 2-3 days. Most patients will take from 160 mg to 320 mg each day. Some patients may need doses up to 640 mg per day. Lower doses are often used in elderly patients or those with kidney disease.
The tablet can be divided into equal doses. The tablets or doses (half tablet) must not be chewed or crushed and must be swallowed whole, with a glass of water and can be taken before, during or after meals, but always in the same way each day as your doctor has told you.
The dose must be taken divided into two doses approximately 12 hours apart. Always take this medicine as described in this leaflet or as indicated by your doctor, pharmacist or nurse.
Check with your doctor or pharmacist or nurse if you are not sure.
During the first few weeks after starting treatment with sotalol, your doctor will need to see you regularly to check the response and it may be necessary to adjust the dose to what suits you best.

Use in children and adolescents
Sotalol Mylan Generics is not recommended in children and adolescents under the age of 18 years.

If you take more Sotalol Mylan Generics than you should
If you take too many tablets, contact your doctor immediately or go to the Accident and Emergency department of the nearest hospital.
Depending on the extent of the overdose, the following symptoms may occur: a marked drop in blood pressure, slow pulse, heart rhythm disturbances, heart failure, difficulty breathing, narrowing/spasms of the airways and symptoms of hypoglycemia (feeling hungry, sweating, dizziness, fatigue, blurred vision, tremor or agitation, anxiety or irritability, paleness, rapid pulse or palpitations)

If you forget to take Sotalol Mylan Generics
Do not take a double dose to make up for a missed dose.
If you forget to take a dose, do not worry, take it as soon as you remember, unless it is almost time to take the next dose, and in this case do not take the missed dose and continue as before.

If you stop taking Sotalol Mylan Generics
Treatment with beta-blockers must not be stopped abruptly.If you have to stop treatment, the dose must always be reduced gradually over a period of at least 1 or 2 weeks.
Sudden discontinuation of beta-blockers may increase the risk of having a heart attack or an irregular heartbeat. It can also cause an increase in symptoms of poor blood flow to the heart (angina), resulting in chest pain that occurs especially with movement or during physical activity, or an increase in blood pressure.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist or nurse.

For those who play sports
The use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects
Immediately inform your doctor or go to the nearest hospital emergency roomif you have 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 should be
stopped.
Not known (frequency cannot be estimated based on available data):

• Cardiac arrest (causing sudden collapse, absence of heartbeat, no breathing and loss of consciousness)

Other possible side effects
Common (that can affect up to 1 in 10 people):

• irregular heartbeat, slow heartbeat, chest pain, low blood pressure, difficulty breathing, swelling, fainting and palpitations, heart rhythm changes (Torsades de Pointes, QT prolongation, AV conduction disturbance, ventricular tachycardia), worsening of angina pectoris (causing chest pain)
• worsening of peripheral occlusive disease, cold extremities.
• nausea and vomiting, indigestion, abdominal pain, flatulence, diarrhea, cramps
• anxiety, depression, confusion, mood swings, headache, dizziness, vertigo, general weakness, fatigue, sleep problems, tingling in feet and hands (pins and needles)
• sexual dysfunction, impotence, fever, skin rashes, skin reactions, hearing problems, vision problems, altered taste

Not known (frequency cannot be estimated based on available data):

• hallucinations, abnormal dreams
• blurred vision, conjunctivitis, inflammation of the cornea (keratoconjunctivitis), reduced tear production (especially when wearing contact lenses)
• dry mouth
• activation or worsening of psoriasis (skin disease)
• increased fats and decreased sugar (glucose) concentration in the blood

Patients taking this type of medicine have experienced cold and/or blue fingers and toes of the hands and
feet, worsening of leg pain when walking, skin rashes or dry eyes.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 Sotalolo Mylan Generics

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date stated on the packaging after the wording
“Expiry”. The expiry date refers to the last day of that month.
Blisters
Store in the original packaging to protect from light.
Safety bottles
Keep the container tightly closed to protect from light
Do not dispose of any medicine in wastewater 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 Mylan Generics contains

• The active ingredient is sotalol hydrochloride. The 80 mg tablet contains 80 mg of sotalol hydrochloride.
• The other excipients are: calcium hydrogen phosphate, corn starch, povidone, sodium glycolate starch, talc, magnesium stearate.

What Sotalolo Mylan Generics looks like and contents of the pack
The medicine is presented in the form of white tablets with beveled edges. The Sotalolo
Mylan Generics 80 mg tablets have “SL | 80” imprinted on one side and nothing on the other.
Sotalolo Mylan Generics is available in safety bottles of 20, 28, 30, 40, 50, 60, 100 and 300
tablets.
Sotalolo Mylan Generics is available in blisters of 20, 28, 30, 40, 50, 60, 90, 100 and 300 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.a.
Via Vittor Pisani, 20
20124 Milan.

Manufacturer
Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan B.V., Dieselweg 26, 3752 LB Bunschoten, Netherlands
This medicine is authorised in the Member States of the European Economic Area under the following
names:
Denmark Sotalol Mylan Tabletter 80 mg, 160 mg
Greece Sotalol/Mylan TAB 80mg/TAB, 160 mg/TAB
Ireland Sotoger Tablets 80 mg, 160 mg
Italy Sotalolo Mylan Generics 80 mg Compresse
Netherlands Sotalol HCl Mylan 80 mg, 180 mg Tabletten
Belgium Sotalol Mylan 160 mg tabletten