40mg and 80mg tablets
d,l-sotalol hydrochloride
What Sotalol Mylan is and what it is used for
The active substance in Sotalol Mylan is sotalol. It belongs to a group of drugs called beta blockers. Sotalol Mylan counteracts disturbances in the heart rhythm by affecting the heart’s electrical impulses. Sotalol Mylan is used to treat disorders of the heart’s rhythm.
Sotalol hydrochloride contained in Sotalol Mylan may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Sotalol Mylan
Do not take Sotalol Mylan:
- if you are allergic to sotalol or any of the other ingredients of this medicine (listed in section 6).
- if you have certain types of disorders of the heart’s electrical impulses, untreated heart failure or shock, certain types of anesthesia, tumors that produce blood pressure-raising substances (so-called pheochromocytoma ), low blood pressure, serious disturbances in the blood circulation in the hands and feet (Raynaud’s disease ), asthma or other respiratory problems, severe renal failure, metabolic acidosis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sotalol Mylan if you:
- have diabetes, as sotalol can suppress signs of too low blood sugar and thus make it difficult to adjust the medication dose.
- have low levels of magnesium or potassium in the blood
- have reduced kidney function. A dose reduction may be necessary.
- have impaired blood circulation in the hands and feet.
- suffer from a type of chest pain (angina) called Prinzmetal’s angina because Sotalol Mylan can make your angina attacks worse.
If you suffer from dizziness or fainting attacks, contact a doctor immediately.
In rare cases, Sotalol can worsen the symptoms of psoriasis.
Before treatment with sotalol, it is important to consider that this type of medicine can worsen the symptoms of heart failure and asthmatic diseases.
Treatment with Sotalol Mylan must not be stopped suddenly
Children and young people
The safety and efficacy of Sotalol Mylan in children under 18 years of age have not been established.
Other medicines and Sotalol Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Sotalol Mylan can affect or be affected by certain other medicines.
You should talk to your doctor before taking Sotalol Mylan if you are taking any other medicine that can cause an electrical disturbance in the heart called QT prolongation. These are:
- drugs that treat irregular heartbeats (eg, disopyramide, flecainide, amiodarone, dronedarone)
- ranolazine used to treat angina
- medicines to treat depression, nervousness, or anxiety, belonging to the group of selective serotonin reuptake inhibitors ( SSRIs ) (eg citalopram, fluoxetine, sertraline ) or tricyclic antidepressants (eg clomipramine, amitriptyline, imipramine), trazodone, hydroxyzine
- medicines for the treatment of mental illness (antipsychotics) (eg chlorpromazine, thioridazine, haloperidol, fluvoxamine, amisulpride, pimozide)
- medicines to relieve nausea and vomiting (eg ondansetron, domperidone)
- certain H2-receptor blockers (eg cimetidine, famotidine), used to reduce the amount of acid in the stomach
- antihistamines used to treat allergic reactions and itchy skin rashes (eg chlorphenamine, diphenhydramine, hydroxyzine)
- antibiotics belonging to the group of fluoroquinolones (e.g. ciprofloxacin, levofloxacin, moxifloxacin) or macrolides (erythromycin, clarithromycin, azithromycin)
- fluconazole and amphotericin used to treat fungal infections
- pentamidine is used to treat a type of pneumonia and certain diseases caused by parasites
- medicines used to treat and prevent malaria (eg mefloquine, chloroquine,
- halofantrine, quinine)
- opioid er (morphine-like) medicines called methadone and hydrocodone
- donepezil, which is used to treat symptoms of dementia
- cancer medicines called protein kinase inhibitors (eg sunitinib, vandetanib, sorafenib)
- arsenic trioxide, which is used to treat leukemia
- anagrelide used to treat thrombocytopenia
It is also very important that you inform your doctor if you are taking any of the following:
- a medicine called a calcium channel blocker, used to treat or prevent angina (chest pain) or to treat high blood pressure (eg verapamil, diltiazem, lacidipine, nifedipine)
- a medicine used to treat high blood pressure by affecting the central nervous system (eg methyldopa, guanethidine)
- digoxin (for heart problems)
- floctafenine (a medicine used for short-term treatment of mild to moderate pain)
- clonidine (sometimes used to treat high blood pressure, hot flashes, or headaches). Do not stop taking clonidine unless your doctor tells you to. If you have to stop taking clonidine, your doctor will give you detailed instructions on how to do this.
- medicines for diabetes: insulin or a medicine that lowers the amount of glucose in the blood
- a bronchodilator such as a beta-2 agonist (eg, salbutamol, salmeterol, formoterol) pre-treatment of asthma and other lung diseases; these are usually in the form of an inhaler, but can also come in other forms
- medicines that can reduce the amount of potassium in the blood; this includes water tablets ( diuretics ) (eg furosemide, indapamide, bumetanide), steroids (eg prednisolone, dexamethasone),
- laxatives (eg bisacodyl, senna).
- a medicine called a proton pump inhibitor, used to reduce the amount of acid produced in the stomach (eg omeprazole, lansoprazole, esomeprazole).
Sotalol Mylan with food, drink, and alcohol
Sotalol Mylan should be taken at least 1 hour before a meal as the absorption of the medicine may be reduced if it is taken with food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is a risk that the fetus will be affected. Therefore, always consult a doctor before using Sotalol Mylan during pregnancy.
Treatment with Sotalol Mylan must be discontinued 48 – 72 hours before the expected date of delivery. If this is not possible, the newborn should be closely monitored for 48 – 72 hours after birth.
Breast-feeding
A breastfed child may be affected. Therefore, do not use Sotalol Mylan during breastfeeding, unless prescribed by a doctor.
Driving ability and use of machinery
Sotalol Mylan usually does not affect reactions and driving ability. Be aware that there is a risk of suffering from fatigue and dizziness, especially at the beginning of the treatment.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Sotalol Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. almost ‘sodium-free’.
How to take Sotalol Mylan
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor who adjusts it individually for you.
The usual starting dose is 80 mg once daily or divided into two doses. The maintenance dosage is often 160-320 mg per day, divided into two dosages. Some patients may need a higher dosage.
Sotalol Mylan should be taken at least 1 hour before a meal as the absorption of the medicine may be reduced if it is taken with food.
If you have taken too much Sotalol Mylan
If you have taken too large a dose or if e.g. a child has ingested the medicine by mistake, always contact a doctor or hospital for an assessment of the risk and advice.
In case of overdose, a lowered pulse or blood pressure, breathing difficulties, and a slow heart rhythm may occur. In the case of very large doses, other disorders of the heart function may also occur.
If you forget to take Sotalol Mylan
Do not take a double dose to make up for a missed tablet.
If you stop taking Sotalol Mylan
Treatment with Sotalol Mylan should only be terminated after consultation with a doctor and withdrawal should be done gradually over 1-2 weeks.
If you have further questions about this medicine, contact your doctor or pharmacist
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 users)
- sleep disorders
- headache, feeling faint, dizziness
- slow pulse, changes on the EKG curve, palpitations
- respiratory distress
- diarrhea, vomiting
- weakness, chest pain, fluid retention (edema)
Common side effects (may affect up to 1 in 10 users)
- depression, mood swings, anxiety
- numbness in the hands and feet, changes in taste
- visual disturbances
- hearing disorders
- disturbances in the rhythm of the heart, heart failure, fainting
- low blood pressure
- acid reflux, gas, nausea, stomach pain
- rash
- muscle cramps
- sexual disorders
- fever, fatigue
No known frequency
- decreased number of cells that help with blood clotting. This increases the risk of bleeding or bruising
- restricted blood flow to the extremities (causing cold and/or blue fingers and toes, painful leg pain when walking)
- chest pain ( angina pectoris )
- heart block (atrioventricular block)
- breathing difficulties ( bronchospasm )
- itching, hair loss, excessive sweating, psoriasis.
How to store Sotalol Mylan
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label, carton, or blister after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is d,l-sotalol hydrochloride 40 mg, and 80 mg respectively.
- Other ingredients are dibasic calcium phosphate, corn starch, talc, povidone, sodium starch glycolate, and magnesium stearate.
Appearance and package sizes of the medicine
Tablets 40 mg: 100 and 250 pcs in a plastic jar: Only for dose dispensing, 100×1 pcs in pressure packaging (single dose).
Tablets 80 mg: 30, 100, and 500 pcs in a plastic container: Only for dose dispensing, 100×1 pcs in pressure packaging (single dose).
Not all packages may be marketed.
Mylan AB
Box 23033
104 35 Stockholm