25 mg, 50 mg tablets of
atenolol
1. What Atenolol Sandoz is and what it is used for
Atenolol Sandoz contains an active substance called atenolol, which belongs to a group of medicines called beta-blockers.
Atenolol Sandoz is used for:
- treatment of high blood pressure ( hypertension )
- treatment of chest pain due to chronic stable angina
- treatment of certain forms of irregular heartbeat ( arrhythmia )
- prevention of further myocardial infarction
The drug works by lowering the speed and force with which the heart beats ( pulse one).
Atenolol contained in Atenolol Sandoz may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you use Atenolol Sandoz
Do not take Atenolol Sandoz:
- if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).
- if you have had any of the following heart problems:
- heart failure that is not under control (this usually leads to shortness of breath and swelling of the ankles).
- second or third-degree heart block (a condition that can be treated with a pacemaker)
- very slow or irregular heartbeat, very low blood pressure, or very poor circulation
- cardiogenic shock. This means that the heart does not pump around the blood in the body well enough. Signs of this may include confusion, sweating, rapid heartbeat, and pale skin
- if you have a tumor called pheochromocytoma that you are not being treated for. Tumor one usually sits next to the kidneys and can lead to high blood pressure. If you are being treated for pheochromocytoma, your doctor will give you another medicine, an alpha-blocker, which you should take with Atenolol Sandoz. Blood pressure should be closely monitored.
- if you have been told that you have elevated acid levels in your blood (metabolic acidosis ).
Do not take Atenolol Sandoz if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before taking Atenolol Sandoz if:
- you have asthma, wheezing or similar breathing problems, or if you get allergic reactions, e.g. of insect bites. If you have had asthma or wheezing, do not take this medicine without talking to a doctor first.
- you have a type of chest pain (angina) called Prinzmetal’s angina.
- you have poor blood circulation or controlled heart failure.
- you have first-degree heart blocks.
- you have diabetes. Your medicine may change the way you react to low blood sugar. You may feel your heart beating faster or stronger and you may feel sweaty. Your blood sugar levels should be closely monitored.
- you have thyrotoxicosis (a condition caused by an overactive thyroid gland ). It may mask the symptoms of thyrotoxicosis.
- you have kidney problems. You may need to go for check-ups during treatment.
- You have a skin condition called psoriasis.
- you have a low heart rate (50-55 beats per minute).
- If you have a tumor called pheochromocytoma, you should also be treated with a type of medicine called alpha-blocker in addition to Atenolol Sandoz. Blood pressure should be closely monitored.
- you are an older person.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Other medicines and Atenolol Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also includes over-the-counter medicines such as natural preparations. The reason for this is that Atenolol Sandoz may affect or be affected by other medicines.
In particular, tell your doctor if you are taking any of the following medicines:
- Clonidine (for high blood pressure or migraine ). If you are taking clonidine and Atenolol Sandoz together, do not stop taking clonidine unless your doctor tells you to. If you have to stop taking clonidine, you will be given detailed instructions by your doctor on how to do it.
- Verapamil, diltiazem, and nifedipine (for high blood pressure or chest pain).
- Disopyramide, quinidine, or amiodarone (for irregular heartbeats).
- Digoxin (for heart problems).
- Adrenaline, also called epinephrine (a drug that stimulates the heart).
- Ibuprofen or indomethacin (for pain and inflammation ).
- Insulin or medicines for diabetes that you take by mouth.
- Ampicillin against bacterial infection.
- Barbiturate is for sleep problems or epilepsy.
- Sultopride and phenothiazines for more serious mental health problems ( psychosis ).
- Drugs for depression from the groups called “tricyclic antidepressants” or “MAO inhibitors”.
- Medicines to treat stuffy nose or stuffy sinuses or cold medicines (including those you can buy at the pharmacy)
- Medicines to reduce the pressure in the eye due to glaucoma or other eye problems.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Operations
If you are going to be hospitalized for an operation, tell your anesthetist or healthcare professional that you are taking Atenolol Sandoz. The reason for this is that you may get low blood pressure ( hypotension ) if you are given certain anesthetics or anesthetics or substances that contain iodine (called contrast media) for x-rays when you take Atenolol Sandoz.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
- This medicine is not likely to affect your ability to drive or use tools or machines, but it is best to wait and see how the medicine affects you before performing any of these activities.
- If you feel dizzy or tired while taking this medicine, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Atenolol Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use Atenolol Sandoz
Always use Atenolol Sandoz exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Your doctor will tell you how many tablets to take daily and when to take them.
- Read the label on the package to remind yourself of what the doctor said.
- Strive to take the tablets at the same time each day.
- Swallow the tablets whole with water. The breaker is only available to help you split the tablet if you have difficulty swallowing it whole.
Adults
Your doctor will decide how much Atenolol Sandoz to take each day depending on your condition.
High blood pressure
- The usual starting dose is 25 mg once a day.
- Thereafter, one generally takes between 50 mg and 100 mg once daily.
Chest pain
The usual dose is between 50 mg and 100 mg once a day. If you are taking 100 mg, your doctor may ask you to take this dose in two different doses, ie 50 mg in the morning and 50 mg in the evening.
Irregular heartbeat
The usual dose is between 50 mg and 100 mg once a day.
Prevention of further myocardial infarction
The usual dose is 100 mg once a day. Your doctor may ask you to take this dose in two different doses, ie 50 mg in the morning and 50 mg in the evening.
Elderly
If you are older, your doctor may prescribe a lower dose, especially if you have kidney failure.
People with severe kidney failure
If you have severe kidney problems, your doctor may prescribe a lower dose of Atenolol Sandoz or ask you to take the medicine less often.
Children
This medicine must not be given to children.
If you forget to take Atenolol Sandoz
- If you miss a dose, take it as soon as you remember.
- However, if it is almost time to take the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Atenolol Sandoz
Do not stop taking Atenolol Sandoz without talking to your doctor first. Your doctor may need to reduce the dose slowly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. You should not worry about this list of side effects. You may not experience a single one of them. The following side effects may occur in users of this medicine:
Stop taking Atenolol Sandoz and see a doctor or hospital immediately if you experience any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people) :
- Abnormal heart rhythm, feeling dizzy, tired, or fainting. This may be a sign of heart block.
- Shortness of breath or swollen ankles. This could be a sign of heart failure or worsening of existing heart failure.
- Respiratory problems, e.g. wheezing or wheezing. This may be a sign of worsening asthma.
- Numb or cold toes and fingers.
Has been reported (occurs in an unknown number of users):
- Swelling of the face or throat, difficulty breathing, or dizziness. This may be a sign of a severe allergic reaction.
Stop taking Atenolol Sandoz and see a doctor or hospital immediately if you experience any of the side effects mentioned above.
Other side effects:
Common (may affect up to 1 in 10 people) :
- cold feet and hands or poor blood circulation in them
- slow pulse. This is normal, but if you are worried, talk to your doctor.
- diarrhea
- constipation
- indigestion
- nausea or vomiting
- fatigue
- sweating.
Uncommon (may affect up to 1 in 100 people) :
- difficulty sleeping
- high values for an enzyme called transaminase (seen in blood samples).
Rare (may affect up to 1 in 1,000 people) :
- purple spots on the skin
- tingling and tingling in the hands and feet
- poor blood circulation which causes window disease (intermittent lameness) and which may become more difficult when you start using this medicine
- low blood pressure that can cause dizziness, dizziness or fainting
- headache
- dizziness
- confusion, anxiety, or fear
- nightmares
- personality changes ( psychosis ) or seeing or hearing something that does not exist in reality (hallucinations)
- Depression
- dry mouth
- hair thinning
- dry eyes
- rash
- dry, flaky skin ( psoriasis ) which may get worse when you start using this medicine
- vision problem
- easier to get bruises or violet spots on the skin
- erection problem ( impotence )
- yellow skin or yellow whites of the eyes (jaundice)
- blood problems, e.g. changes in blood cells. Your doctor may take blood tests from time to time to check if Atenolol Sandoz has affected your blood.
Has been reported (occurs in the unknown number of users):
- allergic reactions ( hypersensitivity reactions ), e.g. itchy rash
- Atenolol Sandoz can mask the symptoms of hypothyroidism and low blood sugar ( diabetes ) (see section 2 “What you need to know before you use Atenolol Sandoz”).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Atenolol Sandoz
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 carton after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is atenolol.
One tablet contains 25 mg of atenolol.
One tablet contains 50 mg of atenolol.
Other ingredients are:
Povidone K25, corn starch, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and anhydrous colloidal silica.
What the medicine looks like and the contents of the pack
25 mg tablets:
White, round biconvex tablets. One side is marked with “25” and the opposite side has a notch. Diameter: 7 mm.
50 mg tablets:
White, round biconvex tablets. One side is marked with “50” and the opposite side has a notch. Diameter: 8 mm.
The tablets are packaged in aluminum / PVC blisters in a carton.
25 mg tablets:
Pack sizes:
Blisters: 28, 30, 56, 100, 100×1 and 250 tablets.
50 mg tablets:
Pack sizes:
Blisters: 14, 20, 28, 30, 50, 56, 60, 98, 100, 100×1, 300 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia