Thursday, September 15, 2016

Dopacard





DOPACARD 50 mg/5 ml



Concentrate for Solution for Infusion


(Dopexamine hydrochloride as a 1% solution w/v)




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 any further questions, ask your doctor or 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 pharmacist.



In this leaflet:


  • 1. What DOPACARD is and what it is used for.

  • 2. Before you use DOPACARD.

  • 3. How to use DOPACARD.

  • 4. Possible side effects.

  • 5. How to store DOPACARD.

  • 6. Further information.




What Dopacard Is And What It Is Used For


The name of this medicine is DOPACARD 50 mg/5 ml Concentrate for Solution for Infusion. The active ingredient in this medicine is dopexamine hydrochloride which belongs to a group of medicines called sympathomimetics.


DOPACARD is used to widen your blood vessels and allow your heart to pump blood easily to your vital organs, such as kidneys or liver.


It is also used as a supportive treatment during times when your heart is not pumping blood around your body properly.




Before You Are Given Dopacard



You should not be given DOPACARD if you:


  • Are allergic (hypersensitive) to dopexamine hydrochloride or any of the other ingredients of DOPACARD.

  • Are taking, or have recently taken, medicines for depression called monoamine oxidase inhibitors (MAOI).

  • Have a disorder of the adrenal glands which causes you to have high blood pressure (phaeochromocytoma).

  • Have a blood disorder that affects the number of platelets in your blood (thrombocytopenia).

  • Have any heart problems (for example, a partially blocked artery).

DOPACARD is not suitable for use in children.




Take special care with DOPACARD if you:


  • Have very low blood pressure.

  • Have been told by your doctor you have poor blood circulation.

  • Have recently had any chest pains or if you have a history of chest pain.

  • Have ever had a heart attack.

  • Have any condition which can affect your blood sugar level e.g. diabetes

If any of the above apply to you, you should speak to your doctor before taking this medicine.




Taking other medicines


Please tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the following:


  • Water tablets (diuretics)

  • Medicines for a heart condition e.g. digoxin

  • Beta-blockers e.g. atenolol

  • Medicines for nausea and sickness e.g. prochlorperazine

  • Noradrenaline or dopamine



Pregnancy and breast-feeding


DOPACARD is not recommended for use during pregnancy and breast-feeding. If you are pregnant, think you might be pregnant, or are breast-feeding tell your doctor or pharmacist before being given DOPACARD.





How Dopacard Will Be Given


Your doctor will ensure you have sufficient fluid circulating in your body before giving DOPACARD.


The doctor or other health care professional will make up the correct dose of DOPACARD for you and it will be given as a solution by a slow injection or by a drip into a vein (infusion), for a maximum of 48 hours.


Your doctor will monitor your response to DOPACARD.



If you are given too much DOPACARD


It is unlikely you will be given too much DOPACARD, but if this happens your doctor will treat any symptoms that may occur.





Dopacard Side Effects


Like all medicines, DOPACARD can cause sides effects, although not everybody gets them. The following side effects have been reported:


  • Racing or irregular pulse.

  • Slow pulse.

  • High or low blood pressure.

  • Worsening heart failure.

  • Heart attack.

  • Chest pain (angina).

  • Nausea and vomiting.

  • Shortness of breath.

  • Sweating.

  • Headaches.

  • Shaking.

Rarely redness and soreness may occur at the site where the drip enters the vein.


More rarely, there have been reports of the following side effects being experienced by patients who have been given DOPACARD while undergoing heart surgery, although these may have been due to the condition of the patient:


  • Kidney failure.

  • Severe breathing difficulties.

  • Fluid on the lungs.

  • Blood poisoning.

  • Bleeding.

If you experience any side effects while receiving DOPACARD tell your doctor or health care professional immediately.




How To Store Dopacard


Keep all medicines out of the reach and sight of children.


Keep the ampoule in the outer carton.


DOPACARD must not be used after the expiry date printed on the ampoule.




Further Information



What DOPACARD contains


DOPACARD contains 5 ml of 1% dopexamine hydrochloride as the active substance.


It also contains disodium edetate, hydrochloric acid and water for injections as the inactive ingredients.




What DOPACARD looks like and contents of the pack


DOPACARD comes in boxes of 10 clear glass ampoules each containing 5 ml 1% w/w solution of dopexamine hydrochloride.




Marketing Authorisation Holder



Cephalon UK Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

UK




Manufacturer



Hospira S.p.A.

Via Fosse Ardeatine 2

20060 Liscate (MI)

Italy





This leaflet was last approved in March 2010


For more information please call free on 0800 783 4869 or e-mail: UKMedInfo@cephalon.com



0043/13


K172645L






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