25 mg, 50 mg and 100 mg tablets
Atenolol
1. What Atenolol Accord is and what it is used for
Atenolol Accord contains the drug atenolol which is a beta-blocker.
Atenolol Accord is used to:
- treat high blood pressure ( hypertension )
- counteract chest pain due to “chronic stable angina pectoris”
- treat certain types of irregular heartbeat ( arrhythmias )
- prevent a new heart attack.
The drug works by making the heartbeat slower and with less force.
Atenolol contained in the Atenolol Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions and always follow their instructions
2. What you need to know before using Atenolol Accord
Do not use Atenolol Accord
- If you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).
- you have untreated heart failure or heart failure that has not been brought under control. Signs of this may be shortness of breath and swollen ankles.
- you have a very irregular heartbeat (such as sick sinus syndrome) or grade II or III heart block (you may have a pacemaker).
- you have a very slow heart rate (less than 50 beats per minute before treatment).
- you have very low blood pressure.
- you have very poor blood circulation.
- you have heart shock, ie if the heart is not pumping around the blood in the body well enough. Confusion, sweating, rapid heartbeat, and pallor can be signs of this.
- you have untreated pheochromocytoma (a type of tumor er). These are usually located near the kidneys and can cause high blood pressure.
- you are taking beta-adrenoceptor blockers (eg floctafenine).
- Your doctor has told you that you have an excess of acidic substances in your blood (metabolic acidosis ).
- you have asthma.
- you are taking other antihypertensive drugs such as beta-blockers, verapamil or dilatiazem.
Do not take Atenolol Accord 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, pharmacist, or nurse before taking Atenolol Accord about:
- you have problems with breathing, e.g. beep.
- you get allergic reactions to e.g. insect bites.
- you have kidney problems.
- you have such chest pain called “Prinzmetal’s angina”.
- you have poor blood circulation.
- you have a slow heart rate (50-55 beats per minute).
- you have heart block grade I (the signals between the upper and lower ventricles have slowed down).
- you have diabetes. Atenolol Accord may change the way you feel when you have low blood sugar. The tablets can hide the symptoms of low blood sugar, so that you e.g. may not notice that your heart is beating faster or harder and that you are sweating. Your blood sugar levels should be closely monitored.
- you suffer from psoriasis (skin problems).
- you have problems with the thyroid gland, e.g. thyrotoxic. Atenolol Accord may mask symptoms of thyrotoxicosis, e.g. rapid heartbeat, tremors, or excessive sweating.
- you are treated to a pheochromocytoma (a type of tumor ), you should also be treated with a type of medicine called alpha-blockers in addition to Atenolol Accord. Blood pressure should be closely monitored.
- you want to stop taking the tablets. This is especially true for patients suffering from severe reductions in oxygen supply to the heart due to inhibited blood flow (ischemic disease), these patients should not stop taking the tablets suddenly. Blood pressure can also rise quickly if you stop suddenly.
- you are going to have an operation. In such cases, it is important that the medical staff (especially the anesthesiologist) know that you are taking atenolol.
- you are older. Dose one may need to be changed.
If any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Atenolol Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because the Atenolol Accord may affect the effectiveness of other medicines. Some other medicines may also affect the effects of the Atenolol Accord.
It is especially important to tell your doctor if you are taking any of the following medicines:
DO NOT take the medicine and tell your doctor or pharmacist if:
- you take floktafenin – for pain and swelling.
- verapamil, diltiazem, or nifedipine – for high blood pressure or chest pain.
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Clonidine – for high blood pressure or migraine. 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 proceed.
- Digoxin – for heart problems.
- Lidocaine, procainamide, disopyramide, amiodarone, or quinidine – for an irregular heartbeat.
- Adrenaline and norepinephrine – cardiac stimulants.
- Ibuprofen or indomethacin – for pain and swelling.
- Baclofen – for muscle cramps.
- Insulin or other oral medicines for diabetes.
- Ampicillin – for bacterial infections.
- Barbiturate you – for sleep problems.
- Sultopride or phenothiazines – for severe mental disorders ( psychosis ).
- Antidepressants belonging to the group of tricyclic antidepressants or MAO inhibitors.
- Medicines for colds or blocked sinuses, including non-prescription ones.
- Diuretics – diuretics that work by urinating.
- Vasodilator er – vasodilator.
- Peripheral muscle relaxants (including suxamethonium halides, tubocurarine): If the agents are used concomitantly with atenolol, the relaxing effect and extent of the muscle relaxants may be increased.
If any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Surgical procedures and X-rays
Tell your doctor or healthcare professional that you are taking Atenolol Accord if any of the following apply to you:
- If you are going to have surgery. The reason is that you may get low blood pressure ( hypotension ) if you are given certain anesthetics while taking Atenolol Accord.
- If you are going to undergo an X-ray with iodine ( contrast fluid ) to take a closer look at a certain part of the body.
Pregnancy, breastfeeding, and fertility
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.
Atenolol is not recommended for women who are pregnant or breastfeeding.
Driving and using machines
Treatment with Atenolol Accord may cause dizziness and fatigue that may affect the ability to drive or use machines.
It is best to wait and see how the medicine affects you before driving or using machines.
Do not drive or use machines if you feel dizzy or tired while taking this medicine.
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.
3. How to use Atenolol Accord
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Your doctor will explain how many tablets to take each day and when to take them.
- Read the label on the package as a reminder of your doctor’s instructions.
- Try to take the tablets at the same time each day.
- Swallow the tablets whole with water.
Adults
Your doctor will decide how many Atenolol Accord you should take each day based on your condition.
High blood pressure
- The usual initial dose is 50 mg once a day.
- Then you will normally take between 50 and 100 mg once a day.
Chest pain
The usual initial dose is 50-100 mg once a day. If you are taking 100 mg, your doctor may ask you to divide the dose into two on two administrations so that you take 50 mg in the morning and 50 mg in the evening.
Irregular heartbeat
The usual initial dose is 50-100 mg once a day.
To prevent a new heart attack.
The usual dose is 100 mg once a day. Your doctor will ask you to divide the dose two occasions so that you take 50 mg in the morning and 50 mg in the evening.
Elderly patients
If you are older, your doctor may decide that you should take a lower dose, especially if you have kidney problems.
People with severe kidney problems
If you have severe kidney problems, your doctor may decide to take a lower dose of atenolol Accord or prescribe that you take them less often.
Use for children and adolescents under 18 years
Atenolol is not recommended for children or adolescents under 18 years of age.
If you forget to use Atenolol Accord
- If you forget to take a dose, take it as soon as you remember.
- However, if it is almost time for your next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose.
If you stop using Atenolol Accord
Do not stop taking Atenolol Accord 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.
Stop taking tablets and see a doctor or hospital immediately if you experience any of the following serious side effects:
Rare ( side effects occurring in less than 1 in 1,000 patients)
- Irregular heartbeat, dizziness, tiredness, or fainting. This may be a sign of heart block.
- Shortness of breath or swollen ankles. This may be a sign of heart failure or worsening heart failure .
- Breathing problems such as wheezing. This may be a sign of worsening asthma.
No known frequency (cannot be calculated from the available data):
- Swelling of the face or throat, difficulty breathing, or dizziness. This may be a sign of a severe allergic reaction.
Stop taking Atenolol Accord and see a doctor or hospital immediately if you experience any of the above side effects.
Other side effects that may occur are:
Common ( side effects occurring in less than 1 in 10 patients)
- Freezing or poor blood circulation in the hands and feet.
- Slower pulse. This is normal, but if you have any concerns, tell your doctor.
- Diarrhea.
- Constipation.
- Problems with digestion.
- Nausea or vomiting.
- A feeling of tiredness.
- Sweating.
Uncommon ( side effects occurring in less than 1 in 100 patients)
- Difficulty sleeping.
- Elevated levels of an enzyme called transaminases (shown by blood tests).
Rare ( side effects occurring in less than 1 in 1,000 patients)
- Numbness or cramps in the fingers followed by heat and pain ( Raynaud’s disease).
- Tingling or numbness in the hands and feet.
- Poor blood circulation ( intermittent claudication ) can get worse when you start taking the medicine.
- Low blood pressure.
- Headache.
- Dizziness.
- Confusion, anxiety, or fear.
- Nightmares.
- Personality changes ( psychosis ) or seeing and hearing things that do not exist (hallucinations).
- Depression.
- Dry mouth.
- Hair loss.
- Dry eyes.
- Reddening of the skin.
- Dry, scaly skin ( psoriasis ) that can get worse when you start taking the medicine.
- Visual problems.
- Easier to get bruises or dark red marks on the skin.
- The inability for men to get an erection ( impotence ).
- Yellowing of the skin or whites of the eyes (jaundice).
- Blood disorders such as blood cell changes. Your doctor may take blood tests from time to time to check if the Atenolol Accord na has had any effect on your blood.
No known frequency (cannot be calculated from the available data):
- Allergic reactions (hypersensitivity) such as itching.
- Atenolol Accord may mask the symptoms of thyrotoxicosis and low blood sugar ( diabetes ). See section 2 before taking Atenolol Accord.
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. Postal address
5. How to store Atenolol Accord
- 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. The expiry date refers to the last day of that month.
- No special storage instructions.
- The medicine 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.
Atenolol Accord contains 25 mg, 50 mg, or 100 mg of atenolol.
The other ingredients are heavy magnesium carbonate, maize starch, sodium lauryl sulfate, gelatin, magnesium stearate (E572), cellulose microcrystalline, talc.
What the medicine looks like and the contents of the pack
Atenolol Accord 25 mg tablets (white, round, flat tablets with tapered edges and the text “AA” on one side and a scoreline on the other side). The tablet can be divided into two equal doses.
Atenolol Accord 50 mg tablets (white, round, flat tablets with tapered edges and the text “AB” on one side and a scoreline on the other side). The tablet can be divided into two equal doses.
Atenolol Accord 100 mg tablets (white, round, flat tablets with tapered edges and the text “AC” on one side and a scoreline on the other side). The tablet can be divided into two equal doses .
Atenolol Accord 25 mg is packaged in PVC / PVDC / aluminum blister packs.
Pack sizes: 14, 20, 28, 30 or 90 tablets.
Atenolol Accord 50 mg is packaged in PVC / PVDC / aluminum blister packs.
Pack sizes: 14, 20, 28, 30, 90 or 100 tablets.
Atenolol Accord 100 mg is packaged in PVC / PVDC / aluminum blister packs.
Pack sizes: 14, 20, 28, 30, 50 or 90 tablets.
Atenolol Accord 25 mg tablets are also available in HDPE cans with PP screw caps.
Pack sizes: 100, 500, 1,000 or 5,000 tablets.
Atenolol Accord 50 and 100 mg tablets are also available in HDPE cans with PP screw caps.
Pack sizes: 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited,
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
This medicinal product is authorized under the European Economic Area under the names:
Netherlands: Atenolol Accord 25, 50, 100 mg tablet
France: Atenolol Accord 25, 50, 100 mg compressed
Italy: Atenolol Accord Healthcare 25, 50, 100 mg compress