PACKAGE LEAFLET: INFORMATION FOR THE USER

Atenolol 25 mg / 5 ml Sugar Free Oral Solution

Read all of this leaflet carefully before you start taking this medicine

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

In this leaflet:

1.    What Atenolol Sugar Free Oral Solution is and what it is used for.

2.    Before you take Atenolol Sugar Free Oral Solution.

3.    How to take Atenolol Sugar Free Oral Solution.

4.    Possible side effects.

5.    How to store Atenolol Sugar Free Oral Solution.

6.    Further Information.

1. What Atenolol Sugar Free Oral Solution is and what it is used for

The name of your medicine is Atenolol Sugar Free Oral Solution. Atenolol belongs to a group of drugs called beta-blockers. Atenolol is used to:

•    treat hypertension (high blood pressure) and some arrhythmias (irregular heart beats).

•    help prevent angina (chest pain).

•    protect the heart in the early treatment after a myocardial infarction (heart attack).

2.    Before you take Atenolol Sugar Free Oral Solution

Do not take Atenolol Sugar Free Oral Solution:

•    If you have ever had an allergic reaction to Atenolol or to any of the other ingredients in your medicine.

(See section 6 for a list of the ingredients).

•    If you have or have ever had any heart conditions including heart failure which is not under control, second- or third-degree heart block, or very slow or very irregular heartbeats.

•    If you have suffered from very low blood pressure, or very poor circulation.

•    If you have ever been told that you have a condition called phaeochromocytoma (high blood pressure) caused by a tumour, usually near the kidney) which is not being treated. If you are being treated for phaeochromocytoma, your doctor will give you another medicine, called an alpha-blocker, to take as well as your Atenolol.

•    If you have been told you have metabolic acidosis (abnormal levels of acid in your blood).

Do not give Atenolol to children.

If you are not sure whether to start taking Atenolol, talk to your doctor.

Tell your doctor before taking Atenolol Sugar Free Oral Solution if you have or have had any medical condition, especially the following:

•    You have asthma or you get allergic reactions, for example, to insect stings. If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the doctor who

first gave you the medicine.

•    If you suffer from allergic reactions while taking your medicine, which may include raised lumps (weals), swelling of the skin and swelling around the mouth, you may need urgent medical attention.

•    You have a type of chest pain called Prinzmetal's angina.

•    You have poor blood circulation, controlled heart failure or first-degree heart block.

•    You have diabetes. Atenolol may change your normal response to low blood sugar, which usually involves an increase in heart rate.

•    You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Atenolol may hide the symptoms of thyrotoxicosis.

•    You have kidney problems. You may need to have some check-ups during your treatment if you have problems with your kidneys.

•    You are an elderly person, especially if you have problems with your kidneys.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. Atenolol can affect the way some other medicines work and some medicines can have an effect on Atenolol.

The following medicines can cause some problems if you take them with Atenolol:

Tell your doctor if you are taking any of these:

•    Clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol together, you must 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 on how to do it.

•    Verapamil, diltiazem and nifedipine (which are used to treat high blood pressure or angina).

•    Disopyramide, quinidine or amiodarone (for irregular heartbeats).

•    Digoxin (for heart failure).

•    Adrenaline, also known as epinephrine, (a heart stimulant).

•    Ibuprofen and indometacin (for pain and inflammation).

•    Insulin and oral antidiabetic drugs (for diabetes).

•    Nasal decongestants or other cold remedies (including the ones you can buy in the pharmacy).

You may notice that your pulse rate becomes slower while you are taking the medicine. This is normal, but if you are concerned, please tell your doctor.

Operations

If you go into hospital to have an operation, tell the anaesthetist and the medical staff that you are taking Atenolol.

Pregnancy and breast-feeding

Ask your doctor for advice before taking any medicine.

There is very little information regarding the safety of Atenolol during pregnancy. Atenolol should therefore not be used during pregnancy. Tell your doctor if you are pregnant, may become pregnant or are breast feeding before taking this medicine. The use of Atenolol is not recommended during breast-feeding as significant amounts of Atenolol are excreted into breast milk. Ask your doctor for advice.

Driving and using machines

Your medicine is unlikely to have any affect on your ability to drive a car or to operate machinery. However, some patients may occasionally experience dizziness and fatigue when taking Atenolol, and you should not drive a car or operate machinery if you are affected.

Important information about some of the ingredients of Atenolol Sugar Free Oral Solution

Atenolol Sugar Free Oral Solution contains Sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Atenolol Sugar Free Oral Solution also contains methyl hydroxybenzoate (a preservative), propyl hydroxybenzoate (a preservative) that may cause allergic reactions (possibly delayed). The lemon lime (flavour) contains small amounts of ethanol (alcohol) less than 100 mg per 5ml.

3.    How to take Atenolol Sugar Free Oral Solution

Always take Atenolol Sugar Free Oral Solution exactly as your doctor has told you. Also read the label on the container. You should check with your doctor or pharmacist if you are not sure.

The usual doses are given below. Your doctor may gradually increase or decrease your dose depending on how you respond to the treatment.

Atenolol Sugar Free Oral Solution should be swallowed. Try to take your medicine at the same time each day.

Adults

Treatment of hypertension (high blood pressure)

50 mg to 100 mg (two to four 5 ml spoonfuls) a day.

Treatment of angina (chest pains)

100 mg (four 5 ml spoonfuls) once a day or 50 mg (two 5 ml spoonfuls) twice a day.

Treatment of arrhythmias (irregular heartbeat)

50 mg to 100 mg (two to four 5 ml spoonfuls) once a day.

Early treatment of myocardial infarction (heart attack)

50 mg to 100 mg (two to four 5 ml spoonfuls) once a day.

Patients with kidney problems

Patients with severe kidney problems may receive a lower dose.

Elderly

Elderly patients may get a lower dose, especially in patients with kidney problems.

Children

This medicine must not be given to children.

If you take more medicine than you should

If you have taken more medicine than you have been told to take, contact your doctor immediately or go to your nearest hospital casualty department. A number of symptoms may occur which include slow heart beat, low blood pressure or difficulty breathing. Take along any left over solution, as well as the container and label, so that the solution can be identified.

If you forget to take a dose

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

If you stop taking your medicine

Do not stop taking your medicine without talking to your doctor first. It is necessary to stop taking the medicine gradually. Your doctor will reduce your dose over a 7 - 14 days period.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atenolol Sugar Free Oral Solution can have side effects. Do not be alarmed by this list of possible effects. You may not have any of them. Most patients do not notice any side effects. However if you do and they bother you, talk to your doctor.

Allergic reactions

If you have any allergic reaction, see your doctor straight away. The signs may include hypersensitivity (allergic) reactions causing lumps on your skin (weals) or swelling of your face, mouth, lips, tongue or throat.

Common side effects (These may affect between 1 in 10 and 1 in 100 patients):

•    the heart beats more slowly    • cold fingers and toes

•    diarrhoea    • nausea

•    tiredness

Uncommon side effects (These may affect between 1 in 100 and 1 in 1,000 patients): • disturbed sleep

Very rare side effects (These may affect less than 1 in 10,000 patients):

• Very rarely there may be changes to some of the cells or other parts of your blood. It is possible that your doctor may occasionally take blood samples to check whether Atenolol Sugar Free Oral Solution 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:

•    Psoriasis (a skin condition).

•    Being short of breath or having swollen ankles (if you have heart failure).

•    Asthma or breathing problems

•    Poor circulation.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Atenolol Sugar Free Oral Solution

Store below 25°C. Keep the bottle upright.

Store in the original container.

Keep out of the reach and sight of children.

Do not use Atenolol Sugar Free Oral Solution after the expiry date which is stated on the carton and the label. The expiry date refers to the last day of that month.

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. Further Information

What Atenolol Sugar Free Oral Solution contains

The active substance is atenolol. Atenolol Sugar Free Oral Solution contains 25 mg of atenolol per 5 mililitre (5 mL).

The other ingredients are citric acid, lemon-lime flavour, methyl hydroxybenzoate,

propyl hydroxybenzoate, purified water, saccharin sodium, sodium citrate, sorbitol solution, and mono propylene glycol.

What Atenolol Sugar Free Oral Solution looks like and contents of the pack

Atenolol Sugar Free Oral Solution is a clear, colourless viscous liquid. It is available in plastic bottles containing 300ml. Marketing authorisation Holder and Manufacturer

The marketing authorisation holder and the manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.

The distributor is Chanelle Medical U.K. Ltd.

This leaflet was last revised in 01/2015.

LB7270

LB7270 156x348mm 23.01.15