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Atenolol Oral Solution 25mg/5ml

Active Ingredient:
atenolol
Company:  
Rosemont Pharmaceuticals Limited See contact details
ATC code: 
C07AB03
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 24 Apr 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 00427/0280.

Atenolol Oral Solution 25mg/5ml

Package leaflet: Information for the user

Atenolol 25 mg/5 ml Sugar Free Oral Solution

atenolol

(referred to as “Atenolol Solution” throughout the text)

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 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.

What is in this leaflet:

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

1. What Atenolol Solution is and what it is used for

Atenolol Solution contains atenolol which is a beta-blocker.

It is used to:

  • treat high blood pressure (hypertension)
  • treat heart rhythm changes (arrhythmias)
  • prevent chest pain (angina)
  • protect the heart in the early treatment after a heart attack (myocardial infarction).

2. What you need to know before you take Atenolol Solution
Do not take Atenolol Solution:
  • if you are allergic to atenolol or to 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 well controlled (this usually makes you breathless and causes your ankles to swell)
    • second or third-degree heart block (this is usually corrected with a pacemaker)
    • irregular or slow heartbeat
    • very low blood pressure
    • very poor blood circulation
  • if you have an untreated tumour in your adrenal glands (phaeochromocytoma). This tumour lies near your kidneys and can cause high blood pressure
  • if you have higher than normal levels of acid in your blood (metabolic acidosis)
  • if you have severe problems with blood circulation in your limbs.
  • Do not take this medicine if you have wheezing or asthma.

If any of the above apply to you, speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Atenolol Solution, if you have:

  • or have ever had asthma, wheezing or any other similar breathing problems (reversible obstructive airways disease). Do not take this medicine without first checking with your doctor
  • severe allergic reactions to some allergens, for example to insect stings, animal fur as the usual dose of adrenaline may not work
  • well-controlled heart failure
  • a type of angina (chest pain) called Prinzmetal's angina
  • poor blood circulation or any problems with circulation in your limbs
  • first-degree heart block
  • diabetes. Atenolol Solution may mask the symptoms of low blood sugar such as an increase in heartbeat
  • thyrotoxicosis (a condition caused by an overactive thyroid gland). Atenolol Solution may hide the symptoms of thyrotoxicosis
  • kidney problems
    or if you are
  • elderly - you may need to start on a lower dose.

Other medicines and Atenolol Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may be affected by Atenolol Solution or they may affect how well Atenolol Solution will work. Tell your doctor or pharmacist if you are taking:

  • clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol Solution 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
  • medicines for high blood pressure or chest pain (calcium channel blockers) e.g. verapamil, diltiazem and nifedipine, as this may result in severe low blood pressure, slow heartbeat or heart failure
  • digoxin (for heart conditions)
  • medicines for irregular heartbeat (e.g. disopyramide, quinidine, amiodarone)
  • adrenaline, also known as epinephrine (a medicine that stimulates the heart)
  • medicines for diabetes, including insulin
  • anti-inflammatory medicines (e.g. ibuprofen, indometacin)
  • medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in a pharmacy).

If you go into hospital or to the dentist to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol Solution. You may need to stop taking Atenolol Solution the day before. Your doctor will advise you as you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol Solution.

Pregnancy and breast-feeding

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 Solution can be passed to your unborn or breast-fed baby.

DO NOT take Atenolol Solution if you are pregnant, planning to become pregnant or if you are breast-feeding unless advised to by your doctor, especially if you are less than 28 weeks pregnant.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Atenolol Solution may cause dizziness or tiredness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.

Atenolol Solution contains sorbitol, propylene glycol, methyl hydroxybenzoate and propyl hydroxybenzoate, sodium and ethanol (alcohol)

  • sorbitol
    This medicine contains 5.32 g sorbitol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 266 mg/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.
  • propylene glycol
    This medicine contains 1 g propylene glycol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 50 mg/ml.
    If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
  • methyl hydroxybenzoate and propyl hydroxybenzoate
    These may cause allergic reactions (possibly delayed).
  • sodium
    This medicine contains 32.8 mg sodium (main component of cooking/table salt) in each 20 ml (four 5 ml spoonfuls) solution.
    This is equivalent to 1.64% of the recommended daily intake of sodium for an adult.
  • ethanol (alcohol)
    This medicine contains 2.25 mg of alcohol (ethanol) in each 5ml, which is equivalent to 0.45 mg/ml.The amount in 5ml dose of this medicine is equivalent to less than 1 ml beer or 1 ml wine.The small amount of alcohol in this medicine will not have any noticeable effects.

3. How to take Atenolol Solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

  • Take the solution with or without food, whichever you prefer.
  • Drinking alcohol while taking this medicine may cause your blood pressure to drop.

The recommended dose is

Adults:

  • High blood pressure (hypertension): the usual dose is 10 ml to 20 ml (two to four 5 ml spoonfuls) once a day.
  • Chest pain (angina): the usual dose is 20 ml (four 5 ml spoonfuls) once a day or 10 ml (two 5 ml spoonfuls) twice a day.
  • Irregular heartbeats (arrhythmias): the usual dose is 10 ml to 20 ml (two to four 5 ml spoonfuls) once a day.
  • Early treatment of a heart attack (myocardial infarction): following initial treatment by a doctor, the usual dose is 20 ml (four 5 ml spoonfuls) once a day.
    Your doctor will monitor you regularly for low heart rate (pulse 50-55 beats per minute at rest) and may reduce the dose.
    Elderly: your doctor may lower the dose, particularly if you have kidney problems.
    Children: this medicine is NOT suitable for children.
    Patients with severe kidney problems: if your kidneys are not working properly, your doctor may lower the dose.

If you take more Atenolol Solution than you should

If you take more solution than you should you may get wheezy and feel very tired, dizzy or become unconscious.

1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the bottle and any remaining solution with you so that people can see what you have taken.
3. Do this even if you feel well.

If you forget to take Atenolol Solution

If you forget to take a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the forgotten dose and continue as usual.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Atenolol Solution

Stopping this medicine suddenly may cause:

  • chest pain
  • fast or irregular heartbeat
  • general feeling of discomfort or illness or weakness
  • headache
  • shortness of breath (sudden)
  • sweating
  • trembling.

Do NOT stop taking this medicine suddenly. Talk to your doctor if you want to stop taking Atenolol Solution. Your doctor will explain how to reduce your dose slowly over 1 to 2 weeks.

Do not let yourself run out of medicine especially over the weekend or on holidays.

If you have any further questions on the use of this medicine, 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 the solution and seek medical help immediately if you have any of the following allergic reactions:

  • difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
  • severe itching of the skin, with a red rash or raised lumps.

Seek immediate medical attention if you have any of the following symptoms:

Rare (may affect less than 1 in 1000 people)

  • signs of heart block (dizziness, abnormal heartbeat, tiredness or fainting)
  • fainting, especially when standing up from a sitting or lying position
  • pinpoint red spots on the skin, unusual purple bruise like rash on the skin or in the mouth, unusual or heavy bleeding
  • changes in personality (psychoses).

Tell your doctor if you get any of the following side effects:

Common side effects (may affect less than 1 in 10 people)

  • cold hands and feet
  • slow or irregular heartbeat
  • problems with digestion or bowels
  • feeling tired

Uncommon side effects (may affect less than 1 in 100 people)

  • disturbed sleep

Rare side effects (may affect less than 1 in 1000 people)

  • dry mouth
  • mood changes
  • dry eyes, problems with vision
  • headache
  • nightmares, hallucinations
  • dizziness
  • confusion
  • shortness of breath and swollen ankles
  • tingling or numbness in arms and legs
  • hair loss
  • rash which looks like psoriasis (red or silver-white scaly patches of skin)
  • light-headedness or dizziness when standing up from a sitting or lying position
  • sore leg muscles which may cause you to 'limp' when walking
  • numbness and spasm in your fingers which is followed by warmth and pain (Raynaud's disease)
  • yellowing of your skin or eyes
  • asthma
  • difficulty getting an erection.

Not known

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

Conditions that may get worse

If you have the following conditions they may get worse when you start taking Atenolol Solution:

  • asthma or breathing problems
  • psoriasis (red or silver-white scaly patches of skin)
  • poor blood circulation
  • heart failure (shortness of breath, swollen ankles).

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 via the Yellow Card Scheme at: 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.

5. How to store Atenolol Solution
  • 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 bottle label and on the carton. The expiry date refers to the last day of that month.
  • Do not use after 30 days from the date of first opening.
  • Do not store above 25ºC. Store in the original container. Do not refrigerate or freeze.
  • 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 Solution contains
  • The active substance is atenolol (25 mg per 5 ml).
  • The other ingredients are:
    sorbitol (E420), propylene glycol (E1520), saccharin sodium, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), citric acid monohydrate, trisodium citrate dihydrate, lemon and lime flavour (containing ethanol), and purified water.
    (See end of Section 2 for further information on sorbitol, sodium, ethanol, propylene glycol, methyl hydroxybenzoate and propyl hydroxybenzoate).

What Atenolol Solution looks like and contents of the pack

Atenolol Solution is a clear, colourless solution with an odour of lemon and lime.

It is available in amber glass bottles of 300 ml.

Marketing Authorisation Holder
Rosemont Pharmaceuticals Ltd
Leeds
LS11 9XE
UK

Manufacturer
Delpharm Bladel BV
Industrieweg 1
5531 AD Bladel
The Netherlands

This leaflet was last revised in April 2023

Rosemont Pharmaceuticals Limited
Company image
Address
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone
+44 (0)113 244 1400
Fax
+44 (0)113 245 3567
Customer Care direct line
+44 (0)800 919 312
Out of Hours Telephone
+44 (0)795 762 3515
Out of Hours contact
[email protected]