Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion. It will be referred to as “Dopamine Concentrate” for ease of use hereafter.

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

• if you are allergic to dopamine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have been told by your doctor that you have a tumour of the adrenal gland (phaeochromocytoma).
• if you have abnormal heartbeats and uncoordinated contraction of the heart muscles.
• if you have an overactive thyroid gland
• if you are being given certain anaesthetics, such as halothane and cyclopropane.

Talk to your doctor or nurse before you are given Dopamine Concentrate

• if you have any heart related problems
• if you have recently used monoamine oxidase inhibitors (known as MAOIs which are used for the treatment of depression; see section “Taking other medicines” for further information)
• if you are sensitive to sulphite
• if you have a weaker pulse in your wrists than normal on examination
• if you have a blood disorder in which the volume of circulating blood is decreased (hypovolaemia)
• if you know that you are suffering or have suffered from problems related to circulation of blood in your hands and feet (peripheral vascular disease)
• if you have any kidney or liver diseases
• if you are pregnant or breast feeding
• if you have diabetes.

Speak to your doctor before you are given this injection if this applies to you.

Your doctor will monitor you for any side-effects affecting the heart or kidneys while you are receiving dopamine.

Dopamine infusion should be withdrawn gradually, to avoid low blood pressure.

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

Some medicines can interact with Dopamine Concentrate, which can significantly alter their effects. If you are already taking one of the following medicines, speak to your doctor before you receive this medicine:

• Monoamine oxidase inhibitors (used for the treatment of depression) or if you have taken them in the last 14 days, e.g. phenelzine, moclobemide, rasagiline, selegiline, entacapone.
• Water tablets (diuretics), e.g. furosemide, amiloride or triamterene.
• Medicines which are often used for treating blood pressure and heart disorders (alpha and beta blockers e.g. propranolol, tolazoline).
• Medicines used to treat epilepsy (phenytoin).
• Medicines used to treat migraine (e.g. ergotamine derived from ergot alkaloids, methysergide).
• Medicines used to treat depression such as Tricyclic antidepressants (e.g. amitriptyline).
• Medicines used to reduce high blood pressure like guanethidine.
• Medicine used to help your breathing (doxapram).
• Medicines used to treat psychological problems like schizophrenia (e.g. haloperidol, clozapine).

Tell your doctor before you are given Dopamine Concentrate if you have recently received any anaesthetic agent such as halothane, isoflurane or cyclopropane.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

As with all drugs, this medicine should only be given in pregnancy and when breast feeding if absolutely necessary. Your doctor will be able to advise you.

Not applicable

Sodium metabisulfite may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm (breathing difficulties).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

As the injection will be administered under the supervision of a doctor, it is unlikely that you will be given more than is necessary. However, if you have any concerns about the dose of your medicine discuss them with your doctor.

If you develop symptoms like narrowing of the blood vessels, tissue death around blood vessels, restriction in blood supply due to tissue damage due to over use of this product your doctor will stop giving you this medicine and give you other medications for treatment.

• serious allergic reactions- any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips, rash or itching (especially affecting your whole body)
• pain in your fingers or toes (at higher doses, especially in people who have had problems with their circulation, gangrene can occur)
• severe irregular heartbeat.

Common: may affect up to 1 in 10 people

• headache
• a rapid or slow heart beat, chest pain, irregular heart beat and awareness of a rapid or irregular pulse
• difficulty in breathing
• low blood pressure (which may cause symptoms such as faintness or dizziness)
• narrowing of blood vessels (which may cause the skin to become cold and to turn pale or to have a bluish colour)
• nausea and vomiting.

Uncommon: may affect up to 1 in 100 people

• dilation of the pupil of the eye which may cause difficulty with bright lights
• goose pimples or hair 'standing at ends'
• irregular transfer (aberrant conduction), slow heartbeat (bradycardia)
• abnormalities in the ECG (a tracing of electrical currents in the heart)
• high blood pressure
• an excess of urea or other waste products in the blood (which may make you feel generally unwell and is identified by blood tests).

If dopamine hydrochloride escapes from the vein into the surrounding tissues during administration, it may cause damage of the surrounding tissues; tell your doctor if you notice any pain or swelling at the injection site so that the appropriate treatment may be given.

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 Website: 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.

• The active substance is dopamine hydrochloride.
• The other ingredients are sodium metabisulfite (E 223) in water for injections.

Dopamine Concentrate is a clear, colourless or pale yellow solution presented in 5ml clear glass ampoules (small glass bottles).

Each 5ml ampoule contains 200mg dopamine hydrochloride.

There are ten 5ml ampoules packed in to one cardboard box.