Atenolol 5mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness 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.

The name of the medicine is Atenolol 5mg/ml Oral Solution but it will be referred as Atenolol throughout this leaflet.

1. What Atenolol is and what it is used for
2. What you need to know before you take Atenolol
3. How to take Atenolol
4. Possible side effects
5. How to store Atenolol
6. Contents of the pack and other information

• You are allergic to Atenolol or any of the other ingredients of this medicine (listed in Section 6).
• 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.
• 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 alpha-blocker, to take as well as Atenolol.
• You have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).

Do not take Atenolol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Atenolol.

Talk to your doctor or pharmacist before taking Atenolol 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.

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 herb medicines. This is because Atenolol can affect the way some other medicines work and some medicines can have an effect on Atenolol.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol 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).

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol.

Atenolol should not be taken with the food.

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.

• 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.

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).

Sorbitol (E420): This medicine contains 280mg sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Sodium: This medicine contains 2.79mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.14% of the recommended maximum daily dietary intake of sodium for an adult.

Propylene glycol (E1520): This medicine contains 3.03mg propylene glycol in each ml.

• High blood pressure (hypertension): The usual initial dose is 5ml (25mg) per day. The usual maintenance dose is once daily 10 to 20ml (50 to 100mg).
• Chest pain (angina): The usual dose is 10 to 20ml (50 to 100mg) per day. The dose of 20ml (100mg) per day can be divided over two doses per day.
• Uneven heart beats (arrhythmias): The usual dose is 10ml (50mg) to 20ml (100mg) once daily.
• The early treatment of a heart attack (myocardial infarction): The usual dose is 10ml (50mg) to 20ml (100mg) a day.

If you are an elderly person, your doctor may decide to give you a lower dose, particularly if you have problems with your kidneys.

If you have severe kidney problems your doctor may decide to give you a lower dose.

Your medicine must not be given to children.

This medicinal product must be taken orally.

Use the double ended plastic spoon (as shown below) to measure the required dose. The smaller end measures 2.5ml and larger end measures 5ml.

If you take more Atenolol 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 medicine can be identified.

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

Do not stop taking Atenolol without talking to your doctor. In some cases, you may need to stop taking it gradually.

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.

• Jaundice (causing yellowing of your skin or the whites of your eyes).
• You may become more prone to bruising or bleeding or have purplish marks on your skin – this could be a sign of changes to some of the cells or other parts of your blood and your doctor may want to take blood samples every so often to check this.

Common (affects less than 1 in 10 people)

• You may notice that your pulse rate becomes slower while you are taking the medicine. This is normal, but if you are concerned please tells your doctor about it.
• Cold hands and feet.
• Diarrhoea.
• Feeling sick (nausea).
• Feeling tired.

Uncommon (affects less than 1 in 100 people)

• Disturbed sleep.

Rare (affects less than 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.
• Changes in personality (psychoses).
• 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.

Not known (frequency cannot be estimated from the available data)

• Lupus-like syndrome (a disease where the immune system produces antibodies that attacks mainly skin and joints).

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is Atenolol.

Each ml of oral solution contains 5mg Atenolol.

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate (E330), sodium citrate (E331), sorbitol liquid (non-crystallising) (E420), saccharin sodium (E954), orange flavor [containing propylene glycol (E1520)] and purified water.

Atenolol is clear colourless oral solution with orange flavour supplied in an amber PET bottle with tamper-evident child resistant plastic cap and a double-ended plastic spoon for measuring and administering the dose.

Atenolol is supplied in bottles containing 100ml, 150ml and 300ml solution.

Not all pack sizes may be marketed.