Wednesday, September 21, 2016

Betaloc I.V. Injection





Betaloc IV Injection



metoprolol tartrate




Read all of this leaflet carefully before you start having this medicine.



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

  • If you have any further questions, ask your doctor or nurse.

  • 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 nurse.




In this leaflet:



  • 1. What Betaloc IV Injection is and what it is used for

  • 2. Before you have Betaloc IV Injection

  • 3. How to have Betaloc IV Injection

  • 4. Possible side effects

  • 5. How to store Betaloc IV Injection

  • 6. Further information





What Betaloc IV Injection is and what it is used for



Betaloc IV Injection contains a medicine called metoprolol tartrate. This belongs to a group of medicines called beta-blockers. Betaloc IV Injection is used:




  • To treat uneven heart beat (arrhythmia).

  • After a heart attack.

It works by making your heart beat more slowly and with less force.





Before you have Betaloc IV Injection




Do not have Betaloc IV Injection if:



  • You are allergic (hypersensitive) to metoprolol tartrate or any of the other ingredients in Betaloc IV Injection (see Section 6: Further information).

  • You are allergic to any other beta-blocker medicines (such as atenolol or propanolol).

  • You have ever had any of the following heart problems:

    • heart attack with shock

    • 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.



  • You have low blood pressure which may make you feel faint.

  • You have 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 your Betaloc IV Injection.

  • You have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).

If any of the above apply to you, do not have Betaloc IV Injection. If you are not sure, talk to your doctor or
nurse before having Betaloc IV Injection.





Take special care with Betaloc IV Injection



Check with your doctor or nurse before having Betaloc IV Injection if:



  • You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to insect stings, foods or other substances. If you have ever had asthma or wheezing, do not have 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 problems with your liver.

  • You have diabetes. Your treatment for diabetes may need to be adjusted.

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

  • You have or have ever had psoriasis (a skin condition).

If you are not sure if any of the above apply to you, talk to your doctor before having Betaloc IV Injection.





Taking other medicines



Please tell your doctor or nurse if you are taking, or have recently taken, any other medicines.



This includes medicines that you buy without a prescription and herbal medicines. This is because Betaloc IV Injection can affect the way some other medicines work and some medicines can have an effect on Betaloc IV Injection.



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



  • Clonidine (for high blood pressure or migraine). If you are taking clonidine and Betaloc IV Injection together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine or Betaloc IV Injection, your doctor will give you careful instructions about how to do it.

  • Medicines called Mono-Amine Oxidase Inhibitors (MAOIs).

  • Verapamil, diltiazem or nifedipine (for high blood pressure or chest pain).

  • Quinidine, amiodarone or digoxin (for heart problems).

  • Hydralazine (for high blood pressure).

  • Medicines for stomach ulcers (such as cimetidine).

  • Medicines for infections caused by bacteria (such as rifampicin).

  • Adrenaline, also known as epinephrine (a medicine that stimulates the heart).

  • Medicines for pain, inflammation and arthritis (such as indometacin and celecoxib).

  • Medicines for depression.

  • Medicines for mental illness (such as phenothiazine).

  • Barbiturates (a type of sedative).

  • Anti-histamines (medicines for hay fever and allergies).

  • Other beta-blocker medicines used as eye drops (such as timolol).

  • Insulin or medicines that you take by mouth for diabetes. Your doctor may need to adjust your dose of these medicines.

  • Lidocaine (a local anaesthetic).

  • Ergotamine medicines (for migraines).




Operations



If you go into hospital or to the dentist to have an operation, tell the anaesthetist, medical staff or dentist that you are having Betaloc IV Injection.



This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Betaloc IV Injection.





Pregnancy and breast-feeding



  • Talk to your doctor before having Betaloc IV Injection if you are pregnant, may become pregnant or are breast-feeding.

  • If you become pregnant while having Betaloc IV Injection, talk to your doctor as soon as possible.




Having Betaloc IV Injection with food and drink



Before having Betaloc IV Injection, inform your doctor or nurse if you have recently had alcohol. This is because alcohol can affect how the medicine works.





Driving and using machines



If you feel dizzy or tired after having this medicine, do not drive or use any tools or machines.






How to have Betaloc IV Injection




Adults



Betaloc IV Injection will be given to you by a doctor or a nurse. It will be given to you as an injection into your vein. Your doctor will decide how much to give you.



The amount depends on your illness.





Children



Your medicine must not be given to children.





If you have more Betaloc IV Injection than you should



If you think you have been given too much of this medicine, talk to your doctor or nurse straight away.





If you stop having Betaloc IV Injection



Your doctor or nurse will let you know when to stop having this medicine. You may need to stop having it gradually.






Possible side effects



Like all medicines, Betaloc IV Injection can cause side effects although not everybody gets them. The following side effects may happen with this medicine.




Very common (affects more than 1 in 10 people)



  • Feeling tired.




Common (affects less than 1 in 10 people)



  • You may notice that your pulse rate becomes slower while you are having Betaloc IV Injection. If this happens tell your doctor as soon as possible. Your doctor may need to lower your dose of Betaloc IV Injection or you may need to stop having it gradually.

  • Pounding heart beat.

  • Dizziness (particularly when standing up, may sometimes cause fainting).

  • Headache.

  • Shortness of breath on effort.

  • Feeling sick (nausea).

  • Stomach ache.

  • Diarrhoea or constipation.

  • Cold hands and feet.




Uncommon (affects less than 1 in 100 people).



  • Depression.

  • Difficulty going to sleep.

  • Nightmares.

  • Difficulty concentrating.

  • Feeling sleepy.

  • Sensation of burning, prickling or numbness.

  • Heart changes shown on an ECG.

  • Severe drop in blood pressure during a heart attack (cardiogenic shock)

  • Feeling of tightness in the airways.

  • Being sick (vomiting).

  • Skin rash.

  • Increased sweating.

  • Muscle cramps.

  • Chest pain.

  • Swelling.

  • Weight gain.




Rare (affects less than 1 in 1,000 people)



  • Feeling anxious or nervous.

  • Disturbances of vision.

  • Dry or irritated eyes.

  • Uneven heart beat.

  • Numbness and spasm in your fingers (Raynaud’s disease).

  • Allergic reactions. The signs may include runny nose and red or watery eyes.

  • Dry mouth.

  • Thinning of your hair.

  • Being unable to get an erection (impotence).

  • Liver problems (shown in a blood test).




Very rare (affects less than 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 Betaloc IV Injection has had any effect on your blood.

  • Reduced numbers of platelets in the blood. This may make you bruise more easily.

  • Confusion.

  • Hallucinations.

  • Loss of memory or problems with memory.

  • Changes to taste.

  • Ringing in the ears.

  • Inflammation of the liver (hepatitis).

  • Skin reaction due to increased sensitivity to sunlight.

  • Pain in joints.




Conditions that may get worse



If you have any of the following conditions, they may get worse when you start to take your medicine:



  • Being short of breath, feeling tired or having swollen ankles (if you have heart failure) may get worse for a while. This is uncommon affecting less than 1 in 100 people.

  • Psoriasis (a skin condition) and poor circulation may get worse. This is very rare affecting less than 1 in 10,000 people.

Do not be concerned by this list of side effects. You may not get any of them.




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 nurse.





How to store Betaloc IV Injection



  • The doctor and hospital pharmacist are responsible for storing, using and disposing of Betaloc IV Injection correctly.

  • Keep out of the reach and sight of children.

  • Do not store above 25ÂșC. Store your medicine where it is protected from light.

  • This medicine should be used immediately after opening.

  • Do not use your medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.




Further information




What Betaloc IV Injection contains



The active substance is metoprolol tartrate. Each 5 ml (millilitre) ampoule contains 5 mg (milligrams) of metoprolol tartrate (this is equal to 1 mg of metoprolol tartrate per ml).



The other ingredients are sodium chloride and water for injections.





What Betaloc IV Injection looks like and contents of the pack



Betaloc IV Injection comes in ampoules. Each ampoule contains 5 ml of a clear colourless liquid.





Marketing Authorisation Holder and Manufacturer



The Marketing Authorisation for Betaloc IV Injection is held by




AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

UK



Betaloc IV Injection is manufactured by




CENEXI

52 rue Marcel et Jacques Gaucher

94120 FONTENAY-SOUS-BOIS

France





To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:



0800 198 5000 (UK only)



Please be ready to give the following information:



Product name Betaloc IV Injection

Reference number 17901/0106



This is a service provided by the Royal National Institute of Blind People.



Leaflet prepared: May 2009.



© AstraZeneca 2009.



Betaloc is a trade mark of the AstraZeneca group of companies.



CV 09 0061








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