80 mg Tablets
sotalol hydrochloride
What Sotacor is and what it is used for
The active substance in Sotacor is sotalol. It belongs to a group of drugs called beta blockers.
Sotacor counteracts disturbances in the heart rhythm by affecting the heart’s electrical impulses.
Sotacor is used to treat disorders of the heart’s rhythm.
What you need to know before you take Sotacor
Do not take Sotacor
- if you are allergic (hypersensitive) to sotalol or any of the other ingredients in Sotacor (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 Sotacor if you:
- have diabetes, as Sotacor can suppress signs of too low blood sugar and thus make it difficult to adjust the dose of medicine.
- 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 Sotacor can make your angina attacks worse.
If you suffer from dizziness or fainting attacks, contact a doctor immediately.
In rare cases, Sotacor can worsen the symptoms of psoriasis.
Before treatment with Sotacor, it is important to consider that this type of medicine can worsen the symptoms of heart failure and asthmatic diseases.
Treatment with Sotacor must not be stopped suddenly.
Children and young people
The safety and efficacy of Sotacor in children under 18 years of age have not been established.
Other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Sotacor can affect or be affected by certain other medicines.
You should talk to your doctor before taking Sotacor 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 are 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 called a beta-2 agonist (eg, salbutamol, salmeterol, formoterol) for the 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).
Use of Sotacor with food and drink
Sotacor should be taken at least 1 hour before a meal as the absorption of the medicine may be reduced if taken with food.
Pregnancy and breastfeeding
Consult a doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.
There is a risk that the fetus will be affected. Therefore, always consult a doctor before using Sotacor during pregnancy.
Treatment with Sotacor must be discontinued 48 – 72 hours before the expected date of delivery. If this is not possible, the newborn should be closely monitored 48 – 72 hours after birth.
A breastfed child may be affected. Therefore, do not use Sotacor during breastfeeding other than on a specific prescription from a doctor.
Driving ability and use of machinery
Sotacor does not usually affect reactions or 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.
Sotacor contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Sotacor
Always take Sotacor 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 tablet can be divided into two equal doses. 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.
If you have taken too much Sotacor
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 heart function may also occur.
If you forget to use Sotacor
Do not take a double dose to make up for a missed tablet.
If you stop taking Sotacor
Treatment with Sotacor should only be terminated after consultation with a doctor and discontinuation should be gradual 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)
- respiratory distress
- chest pain
- diarrhea
- palpitation
- headache
- impotence
- vomiting
- slow pulse
- irregular electrocardiogram readings ( ECG abnormalities)
- sleep disorders
- fluid retention ( edema )
- dizziness.
Common side effects ( may affect up to 1 in 10 users)
- Depression
- numbness in hands and feet
- fever
- gases
- heart failure
- irregular heartbeat ( cardiac arrhythmia )
- rash
- Mood swings
- hearing disorders
- nausea
- low blood pressure
- stomach pain
- concern
- sexual disorders
- taste changes
- acid reflux
- fainting
- visual disturbances
- fatigue
- muscle cramps
Has been reported (occurring in an unknown number of users)
- 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 Sotacor
Keep this medicine out of the sight and reach of children. Use before the expiry date stated on the packaging.
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 deal with 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 sotalol hydrochloride. One tablet contains 80 mg of sotalol.
- Other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silica, stearic acid, and magnesium stearate.
Appearance and package sizes of the medicine
Sotacor tablets are white, round, and scored.
Pack sizes: 30 and 100 tablets packed in blisters (PVC/aluminum),
100 tablets in a plastic jar
Not all packages may be marketed.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
FARMEA
10 rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France