25 mg, 50 mg film-coated tablets
atenolol
1. What Atenolol Mylan is and what it is used for
Atenolol Mylan contains the medicine atenolol. It belongs to a group of medicines called beta-blockers. It works by making the heartbeat slower and with less force.
Atenolol Mylan is used to:
– treat high blood pressure ( hypertension )
– treat certain types of irregular heartbeat ( arrhythmias )
– counteract chest pain (angina)
– protect the heart in the early treatment after a heart attack.
Atenolol contained in Atenolol Mylan 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.
What you need to know before taking Atenolol Mylan
Do not take Atenolol Mylan
- if you are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).
- if you have or have had any of the following heart problems:- if you have uncontrolled heart failure (this often causes shortness of breath and swollen ankles).- if you have grade II or III heart block (a condition that can be treated with a pacemaker).- if you have had a collapse caused by severe heart problems (a condition called cardiogenic shock where the heart can not pump enough blood around the body) .- if you have a special condition with irregular heart function called sick sinus syndrome.- if you have a very slow heart rate (less than 45-50 beats per minute) or a very irregular heartbeat.- if you have very low blood pressure .- if you have very poor blood circulation in the arms and legs (which can lead to tingling in the fingers and toes or whitening or a bluish tone). if you have a tumor called pheochromocytoma that is not being treated. It is often located near the kidneys and can lead to high blood pressure.
- if your doctor has told you that you have too high levels of acidic substances in your blood (metabolic acidosis ).
Do not take Atenolol Mylan if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atenolol Mylan.
Warnings and cautions
Talk to your doctor or pharmacist before taking Atenolol Mylan
- if you have asthma, wheezing, or similar breathing problems. If you have previously had asthma or wheezing, do not take this medicine without first consulting a doctor.
- if you get allergic reactions from, for example, insect bites, foods, or other substances. Allergic reactions can occur more quickly and become more severe. Atenolol may reduce the effect of adrenaline (used to treat severe allergic reactions).
- if you have a type of chest pain (angina) called Prinzmetal’s angina.
- if you have poor blood circulation in your arms and legs.
- if you have a mild heart rhythm disorder (first-degree heart block).
- if you have diabetes. Your medicine may hide signs of low blood sugar, such as rapid heartbeat and tremors.
- if you have hyperthyroidism (a condition caused by an overactive thyroid gland ). Your medicine may mask the symptoms of hyperthyroidism.
- if you have kidney problems. You may then need to go for check-ups during the treatment.
- if you are to be anesthetized. Tell your anesthetist that you are taking atenolol.
- if you have heart failure.
Talk to your doctor or pharmacist before taking Atenolol Mylan if you are not sure if any of the above applies to you.
Other medicines and Atenolol Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:
- verapamil or diltiazem (used to treat heart problems) (see “Do not take Atenolol Mylan” in this section).
- clonidine (for high blood pressure or migraine ). If you take clonidine and Atenolol Mylan together, do not stop taking clonidine without your doctor’s approval. If you have to stop taking clonidine, your doctor will give you detailed instructions on how to do this.
- nifedipine (for high blood pressure or chest pain).
- drugs for fast or organ-bound heart rhythm (eg beta-blockers such as labelatol or antiarrhythmics such as disopyramide ).
- digoxin (for heart problems).
- cardiac stimulants such as adrenaline.
- medicines that relieve pain and inflammation (eg ibuprofen, indomethacin, aspirin, or diclofenac ).
- Insulin or diabetes medicine.
- ergotamine (for migraines ).
- phenylpropanolamine (decongestant).
Operations
If you are going to have surgery, tell your anesthetist or healthcare professional that you are taking Atenolol Mylan. This is because your blood pressure may drop if you are given certain anesthetics while taking Atenolol Mylan.
Pregnancy, breastfeeding, and fertility
Pregnancy
There is a possibility that the fetus is affected. Therefore, always consult a doctor before using Atenolol Mylan during pregnancy.
Breast-feeding:
Atenolol Mylan passes into breast milk but is unlikely to affect breast-fed infants. However, consult a physician if you use Atenolol Mylan more than temporarily during breastfeeding.
There is a risk that newborns to mothers who received Atenolol Mylan during childbirth or breastfeeding may have low blood sugar. Caution should be exercised. Talk to your doctor or nurse if you are worried
Driving and using machines
Your medicine probably does not affect your ability to drive or use tools or machines. However, it is best to wait and see how you are affected by the medicine before doing any of these.
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.
How to take Atenolol Mylan
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 tell you how many tablets to take each day and when to take them.
Read the label on the box as a reminder of your doctor’s instructions.
Try to take the tablets at the same time each day.
Adults
Dosage one should be adjusted individually so that too slow a heart rhythm is avoided.
High blood pressure ( hypertension )
The usual dose is 50 mg per day.
Preventive treatment after myocardial infarction:
When you are in the hospital, the doctors decide what dose you should receive. After discharge, 100 mg is usually given orally daily, in 1-2 doses. If the treatment is stopped, this should be done gradually.
Chest pain (angina)
The usual dose is 50 mg to 100 mg daily.
Irregular fast heartbeats ( arrhythmias )
When the heart rate is normalized, the normal dose is 50 mg to 100 mg per day.
Patients with severe kidney problems
If you have severe kidney problems, your doctor may decide to give you a lower dose.
Symptoms of an overdose of Atenolol Mylan may include:
very slow heartbeat, very low blood pressure, and shortness of breath.
If you forget to take Atenolol Mylan
If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Atenolol Mylan
Do not stop taking Atenolol Mylan without consulting your doctor. In some cases, you may need to stop gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions:
If you get an allergic reaction, see a doctor immediately. Symptoms of this can be a rash or swelling of the face, lips, mouth, tongue, or throat.
Other possible side effects:
Common (may affect up to 1 in 10 people):
- Fatigue and muscle weakness can go away after a period of treatment.
- Cold hands and feet
- Slow pulse
- Stomach upset such as diarrhea and nausea.
Uncommon (may affect up to 1 in 100 people):
- Sleep disorders
- Liver problems (observed as elevated transaminase levels in blood tests).
Rare (may affect up to 1 in 1,000 people):
- Lack of platelets which can manifest itself as small hemorrhages in the skin and mucous membranes
- Deterioration of heart function, disturbances in heart rhythm, deterioration of heart failure.
- Impairment of blood circulation,
- Numbness or cramps in the fingers followed by feeling hot or in pain
- Dizziness or fainting due to a drop in blood pressure
- Ant crawls
- Nightmares
- Headache
- Depression
- Confusion
- Hallucinations or disturbed perception of reality
- Dry mouth (careful oral hygiene is therefore important),
- Dry eyes and visual disturbances,
- Hair loss
- Rash
- Exacerbation of psoriasis.
- Spasm of the trachea in asthmatics,
- Erectile dysfunction.
- Hepatic effects (which may lead to itching during pregnancy)
- Sweating
Has been reported (occurs in an unknown number of users)
– Lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints).
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 Mylan
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, bottle, and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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. An Atenolol Mylan 25 mg film-coated tablet contains 25 mg of atenolol. An Atenolol Mylan 50 mg film-coated tablet contains 50 mg of atenolol. The other ingredients are Tablet core: Anhydrous calcium hydrogen phosphate, heavy magnesium subcarbonate, sodium starch glycollate (Type A), maize starch, anhydrous colloidal silica, and magnesium stearate.Film coating: Hypromellose, macrogol and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Atenolol Mylan 25 mg: white, film-coated tablet, diameter 7 mm, marked “AT 25” and “G”.
Atenolol Mylan 50 mg: white, film-coated tablet, diameter 8 mm, marked “AT 50” and “G”.
Pack sizes
28 pcs, 98 pcs and 100×1 pcs in print packaging.
100 pcs and 250 pcs in a plastic jar.
Marketing Authorisation Holder
Mylan AB,
Box 23033
10435 Stockholm
Manufacturer
McDermott Laboratories to Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland