Document: Adenosin Life Medical solu for inj and inf ENG PL change

• Adenosin Life Medical solution for injection or infusion PL
• Adenosin Life Medical solu for inj and inf ENG PL

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Package leaflet: information for the user

Adenosin Life Medical 5 mg/ml, solution for injection/infusion
(Adenosine)

Read all of this leaflet carefully before you start using this medicinebecause it contains important information for you.

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

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

• 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 inthis leaflet:

Adenosin Life Medical is an antiarrhythmic drug. It is used to diagnose and treat abnormal heart rhythms. It is also used as a diagnostic tool to widen the blood vessels in the heart in connection with a stress test (photographingthe heart).

2. What you need to know beforeyou use Adenosin Life Medical.

You will be given Adenosin Life Medical either as an injection or as an infusion (drip). Before you are given Adenosin Life Medical, your doctor will ask you some questions about your medical history.

Do not use Adenosin Life Medical:

• If you are hypersensitive (allergic) to adenosine or mannitol.

• If you have suffered with serious heart disturbances.

• If you have intermittent rapid and slow heart rhythms, and are not fitted with a functional pacemaker.

• If you have low blood pressure.

• If you ever feel suffocating pain in the centre of the chest.

• If you have had heart failure.

Do not use Adenosin Life Medical as an infusionif:

• you have raised intracranial pressure.

• you have decreased blood volume (hypovolaemia).

• you are taking dipyridamole (used to prevent the formation of blood clots)

Tell your doctor if any of the above conditions apply to you.

Warnings and precautions:

Because of the way this medicine works, it can affect the function of your heart. Your doctor will monitor the response of your heart during treatment with this medicine.

Tell your doctor:

• If you have had a heart transplant, as you may be more sensitive to the effects of this medicine.

• If you have had any heart problems, including a heart attack

• If you suffer from breathlessness, wheezing or any illness which affects your lungs.

• If you are taking theophylline (used for asthma or bronchitis).

• If you are taking any other medicines that affect the rhythm of your heart.

Othermedicines and Adenosin Life Medical:

Please inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Adenosin Life Medical with food and drink:

Tell your doctor if you have consumed food or drinks containing caffeine in the past 12 hours.

Pregnancyand breast-feeding

Tell your doctor if you think you may be pregnant.There is limited information about the use of Adenosin Life Medical duringpregnancy.

Adenosin Life Medical can be used during breast-feeding.

Driving and using machines:

No special precautions are needed.

Adenosin Life Medical will be given to you directly into a vein by a specialist physician.

When Adenosin Life Medical is used to diagnose and treat abnormal heart rhythm it is given as a quick injection and the usual dose is:

Adults: the initial dose is usually 5 mg, if this doesn’t work 10 mg may be given and then 15 mg.

Infants, children and adolescents: The dose is related to body weight with an initial dose of 50 µg/kg per body weight.

When Adenosin Life Medical is used as a diagnostic tool (stress test) it is given as an infusion (drip) and the normal infusion rate is 140 µg/kg/min given during 4-6 minutes.

Your heart rate will be monitored whilst you are receiving Adenosin Life Medical. If you have the impression that the effect of Adenosin Life Medical is too strong or too weak, talk to your doctor.

Like all medicines, this medicine can causeside-effects although not everybody gets them. Most side effects are mild and disappear rapidly.

When Adenosin Life Medical is given by injection, symptoms usually disappear within 30 seconds.

Common (may affect up to 1 in10 people):breathing difficulties, flushing, chest discomfort, headache, dizziness, chest pains, fast heartbeat, nausea (feeling sick), abnormal tingling sensations.

Uncommon (may affect up to 1 in 100 people):increased perspiration, palpitations (feeling your heart beat), low blood pressure, metallic taste in the mouth, pressure in the groin, increased rate of breathing, agitation, blurred vision.

Rare (may affect up to 1 in 1000 people): bronchial asthma may be aggravated, and changes in the functioning of the heart may occur.

When the medicine is given by intravenous infusion, side-effects occur more frequently, but are still mild in nature and disappear after a few minutes. Side-effects can be reduced by combining the infusion with low intensity exercise.

Common (may affect up to 1 in 10 people):headache, pain in the chest and jaw, dizziness, flush, a change in the rhythm of your heart like missed or extra beats, irregular heart beat or a slow heart beat, nausea (feeling sick), stomach ache, breathing difficulties.

Uncommon (may affect up to 1 in100 people):palpitations (feeling your heart beat), low blood pressure, increased rate of breathing.

Rare (may affect up to 1 in1000 people): bronchospasm, even in patients not suffering from bronchial asthma or obstructive pulmonary disease.

Reporting of side effects

If you getany side effects, talk to your doctor. This includes any possible side effectsnot listedin this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

Keep this medicine out of the sight and reach of children.

Do not usethis medicine after the expiry date which is stated on the label.

Do not refrigerate or freeze.

Any portion of the medicine not used immediately should be thrown away.

What Adenosin Life Medical contains

What Adenosin Life Medical looks like and contents of the pack

Adenosin Life Medical is a solution of adenosine for injection or infusion (drip).

It is supplied as a clear and colourless solution in glass vials (10 or 50 ml) and in glass ampoules (2 ml).

Pack sizes: 10x2 ml, 1x10 ml, 10x10 ml, 1x50 ml, 10x 50 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Life Medical Sweden AB

Brahegatan 29

114 37 Stockholm

Sweden

Manufacturer: ApotekProduktion & Laboratorier AB (APL), Formvägen 5 B; Box 3076,
SE-903 03 UMEÅ, Sweden.

This leaflet does not contain all the information about your medicine. If you are unsure about anything, ask your doctor.

This leaflet was last revisedin: 2015-10-21