Atenolol 25mg Tablets
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Artwork No. |
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Colours Used | |
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Customer |
Accord |
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Pantone Black |
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Description |
Atenolol | ||
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Market |
UK | ||
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Language |
English | ||
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Size |
170 x 550 mm PIL | ||
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Min. Font Size |
9.5 | ||
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Version No. |
11 (Page 1 of 2) (02-14-Atenolol SPC) | ||
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Date |
28_11_14 (Atenolol (ACC-UK)02-14-SPC-PIL) |
Checked By Regulatory Affairs
Approved By Quality Assurance
Prepared By Regulatory Affairs
a :ord
PACKAGE LEAFLET: INFORMATION FOR THE USER
Atenolol 25 mg Tablets Atenolol 50 mg Tablets Atenolol 100 mg Tablets
(Atenolol)
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Atenolol Tablets are and what they are used for
2. What you need to know before you take Atenolol Tablets
3. How to take Atenolol Tablets
4. Possible side effects
5. How to store Atenolol Tablets
6. Contents of the pack and other information
1. What Atenolol Tablets are and what they are used for
Atenolol tablets contain the active ingredient
atenolol. Atenolol is one of a group of
medicines called beta blockers.
Atenolol Tablets are used
• Treat high blood pressure (hypertension).
• Treat uneven heart beats (arrhythmias).
• Help prevent chest pain characterised by a painful feeling of tightness in the chest (angina pectoris);
• Protect the heart in the early treatment after a heart attack (myocardial infarction).
It works by making your heart beat more slowly and with less force.
2. What you need to know before you take Atenolol Tablets
Do not take Atenolol Tablets:
• If you are allergic (hypersensitive) to Atenolol or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had any of the following heart problems:
-heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
-second- or third-degree heart block (a condition which may be treated by a pacemaker)
-very slow or very uneven heart beats, very low blood pressure or very poor circulation.
• If you have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. If you are being treated for phaeochromocytoma, your doctor will give you another medicine, called an alphablocker, to take as well as Atenolol Tablets.
• If you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).
This medicine is not suitable for use in children.
Do not take Atenolol Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atenolol Tablets.
Warnings and precautions
Talk to your doctor before taking Atenolol tablets if:
• You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor.
• 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 block.
• You have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster.
• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.
• You have problems with your kidneys. You may need to have some check-ups during your treatment.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Atenolol tablets.
Other medicines and Atenolol Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Atenolol Tablets can affect the way some other medicines work and some medicines can have an effect on Atenolol Tablets.
You must consult your doctor if you are planning to combine Atenolol tablets with the medicines listed below:
• Clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol tablets together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it.
• Verapamil, diltiazem and nifedipine (for high blood pressure or chest pain).
• Disopyramide, quinidine or amiodarone (for an uneven heart beat).
• Digoxin (for heart problems).
• Adrenaline, also known as epinephrine (a medicine that stimulates the heart).
• Ibuprofen or indometacin (for pain and inflammation).
• Insulin or medicines that you take by mouth for diabetes.
• Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).
Operations
If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol Tablets. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol Tablets.
If you are in any doubt, always consult your doctor or pharmacist.
Taking Atenolol tablets with food & drink
Alcohol may cause your blood pressure to drop too low. You should avoid or limit how much alcohol you drink whilst taking this medicine. Discuss this with your doctor if you have any concerns.
Pregnancy, breast-feeding and fertility
If you are pregnant, trying to become pregnant or are planning to have a baby, or are breast-feeding, talk to your doctor before taking this medicine. Always talk to your doctor before taking any medicine.
Driving and using machines
• Your medicine is not likely to affect you being able to drive or use any tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities.
• If you feel dizzy or tired when taking this medicine, do not drive or use any tools or machines.
3. How to take Atenolol Tablets
Always take Atenolol Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The general dose is for guidance only, and is as follows:
Generally, treatment is initiated at a low quantity, e.g. 25 mg. In accordance with the instructions of the doctor who is treating you, the dosage is then built up to the following quantities over the course of a few days.
Adults
• High blood pressure (hypertension)
The usual quantity for adults is 100 mg once a day, or whatever quantity your doctor advises. In some cases, e.g. in the case of older people or patients with kidney conditions, 50 mg may be enough.
• Certain types of chest pain (angina pectoris)
The usual quantity for adults is 50-100 mg once a day (possibly split into 50 mg twice a day), or whatever quantity your doctor advises.
• Certain heart rhythm disorders (arrhythmias)
The usual quantity for adults is 50-100 mg once a day, or whatever quantity your doctor advises.
Atenolol is best taken at the same time every day, with water, milk, or another fluid, preferably in the mornings.
• After a heart attack
Initial treatment will be by intravenous injection. After 15 minutes this will usually be followed by a 50mg dose of atenolol given orally (by mouth). 12hr after the intravenous dose, a further 50 mg oral dose will be given. A 100mg oral dose will be given after a further 12hrs. Treatment will then continue as a once daily 100mg dose.
Elderly people
If you are an elderly person, your doctor may decide to give you a lower dose, particularly if you have problems with your kidneys.
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Artwork No. |
- |
Colours Used | |
|
Customer |
Accord |
■ |
Pantone Black |
|
Description |
Atenolol | ||
|
Market |
UK | ||
|
Language |
English | ||
|
Size |
170 x 550 mm PIL | ||
|
Min. Font Size |
9.5 | ||
|
Version No. |
11 (Page 2 of 2) (02-14-Atenolol SPC) | ||
|
Date |
28_11_14 (Atenolol (ACC-UK)02-14-SPC-PIL) |
Checked By Regulatory Affairs
Approved By Quality Assurance
L
Prepared By Regulatory Affairs
People with severe kidney problems
If you have severe kidney problems your doctor may decide to give you a lower dose.
Children
This medicine must not be given to children.
If you take more Atenolol Tablets than you should
If you take more Atenolol Tablets than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the tablets can be identified.
Symptoms of overdose include reduced heart rate, blood pressure, a feeling of tightness in chest due to cramps in the muscles surrounding the airways or sometimes loss of consciousness.
If you forget to take Atenolol Tablets
If you forget to take a dose of the Atenolol Tablet, take it as soon as you remember, unless it is time for your next dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Atenolol Tablets
Do not stop taking Atenolol Tablets without talking to your doctor. In some cases, you may need to stop taking it gradually over 7-14 days and you will be monitored during this time.
If you have any further questions about the use of this product, then ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Atenolol Tablet can cause side effects, although not everybody gets them.
Stop taking Atenolol tablets and see a doctor or go to hospital straight away if you notice any of the following serious side effects contact your doctor immediately:
• Allergic reactions: If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat.
• An abnormal heart beat, feeling dizzy, tired or fainting. This could be signs of heart block.
• Shortness of breath or having swollen ankles. These could be signs of heart failure or your heart failure getting worse.
Other possible side effects:
Common: may affect up to 1 in 10 people)
• You may notice that your pulse rate becomes slower while you are taking the tablets. This is normal, but if you are concerned, please tell your doctor about it.
• Cold hands and feet.
• Diarrhoea.
• Feeling sick (nausea).
• Feeling tired or aching and tired muscles.
Uncommon: may affect up to 1 in 100 people)
• Disturbed sleep.
Rare:may affect up to 1 in 1,000 people)
• Heart block (which can cause dizziness, abnormal heart beat, tiredness or fainting).
• Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud's disease).
• Mood changes.
• Nightmares.
• Feeling confused, anxious or scared.
• Changes in personality (psychoses) or hallucinations.
• Headache.
• Dizziness (particularly when standing up).
• Tingling of your hands.
• Being unable to get an erection (impotence).
• Dry mouth.
• Dry eyes.
• Disturbances of vision.
• Thinning of your hair.
• Skin rash.
• Reduced numbers of platelets in your blood (this may make you bruise more easily).
• Purplish marks on your skin.
• Jaundice (causing yellowing of your skin or the whites of your eyes).
Very rare: may affect up to 1 in 10,000 people)
• Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Atenolol Tablets has had any effect on your blood.
Conditions that may get worse
If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people.
• Psoriasis (a skin condition).
• Being short of breath or having swollen ankles (if you have heart failure).
• Asthma or breathing problems.
• Poor circulation.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
r i
5. How to store Atenolol Tablets
• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in a dry place.
• Do not use your tablets after the expiry date stated on the label or carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Atenolol Tablet contains
• The active ingredient is Atenolol.
• The other ingredients are Heavy Magnesium Carbonate, Maize Starch, Sodium Lauryl Sulphate, Gelatin, Magnesium Stearate, Microcrystalline Cellulose and Purified Talc.
What Atenolol Tablets looks like and content of the pack
• Atenolol 25 mg Tablets are white, circular, flat faced, beveled edge, uncoated tablets with inscription ‘AA' on one side and scoreline on the other side.
• Atenolol 50 mg Tablets are white, circular, flat faced, beveled edge, uncoated tablets with inscription ‘AB' on one side and scoreline on the other side.
• Atenolol 100 mg Tablets are white, circular, flat faced, beveled edge, uncoated tablets with inscription ‘AC' on one side and scoreline on the other side.
Atenolol Tablets are available either in blister strips or in Amber glass bottle with LDPE closure or in securitainers.
Atenolol Tablets are available in packs of 28,100 and 250 tablets.
Not all the pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom.
This leaflet was last revised on 11/2014.