Document: Fenylefrin Abcur solution for injection ENG PL change

• Fenylefrin Abcur solution for injection PL
• Fenylefrin Abcur solution for injection ENG PL

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Package leaflet: Information for the patient

Fenylefrin Abcur 0.05 mg/ml, solution for injection

Fenylefrin Abcur 0.1 mg/ml, solution for injection

phenylephrine

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

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

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

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

• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Fenylefrin Abcur is and what it is used for

2. What you need to know before you use Fenylefrin Abcur

3. How to use Fenylefrin Abcur

4. Possible side effects

6. Contents of the pack and other information

This medicine belongs to a class of medicines called adrenergic and dopaminergic agents. Fenylefrin Abcur is used to treat low blood pressure that can occur during different types of anaesthesia.

Do not use Fenylefrin Abcur:

- if you are allergic to phenylephrine or any of the other ingredients of this medicine (listed in section 6).

- if you suffer from hypertension (elevated blood pressure)

- if you suffer from peripheral vascular failure (bad blood circulation)

- if you are taking medicines causing narrowing of the blood vessels (ephedrine, pseudoephedrine, methylphenidate)

- if you are taking medicines given by mouth and by the nose causing narrowing of the blood vessels (etilefrine, midodrie, naphtazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline).

Warnings and precautions

It is important that the blood pressure in your arteries is monitored during treatment.

Talk to your doctor or nurse before using Fenylerin Abcur:

- if you are elderly

- if you have an overactive thyroid gland

- if you suffer from heart problems, such as slow heart beats, heart block (partial), heart muscle disease, poor blood circulation in the heart

- if you have poor blood circulation in the brain

- if you have arteriosclerosis (hardening and thickening of the walls of the blood vessels)

- if you have diabetes

Other medicines and Fenylefrin Abcur

Tell your doctor if you are using, have recently used or might use any other medicines.

Do not use Fenylefrin Abcur in combination with:

- medicines causing narrowing of the blood vessels (ephedrine, pseudoephedrine, methylphenidate)

- medicines given by mouth and by the nose causing narrowing of the blood vessels (etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline).

Interactions are possible with the following medicines:

- dihydroergotamine, ergotamine, methylergometrine, methysergide (against migraine)

- linezolide (an antibiotic)

- bromocriptine, cabergoline, lisuride, pergolide (against Parkinson's disease)

- moclobemid, toloxatone, iproniazide, nialamide (against depression)

Pregnancy, breast-feeding and fertility

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.

Pregnancy

This medicine should not be used during pregnancy unless clearly necessary.

Breast-feeding

This medicine should not be used during breast-feeding unless clearly necessary.

Your doctor or nurse will give Fenylefrin Abcur to you into a vein (intravenous route). Your doctor will decide the correct dosage for you and when and how the injection should be given.

If you use more Fenylefrin Abcur than you should

Signs of getting too much Fenylefrin Abcur are faster and irregular heartbeats.

This is not likely to happen since you are getting the medicine at hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

• headache

• reflex bradychardia (slow heart rate)

• excitement

• agitation

• rare arythmia (heart rhythm disorder)

• high blood pressure

• pain in the chest

If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet.

5. How to store Fenylefrin Abcur

This medicinal product does not require any special storage conditions

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

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fenylefrin Abcur contains

- The other ingredients are sodium chloride, sodium citrate, citric acid and water for injections.

What Fenylefrin Abcur looks like and contents of the pack

Fenylefrin Abcur 0.05 mg/ml, solution for injection is supplied as glass ampoules of 10 ml.

Fenylefrin Abcur 0.1 mg/ml, solution for injection is supplied as glass ampoules of 5 ml, 10 ml or 20 ml and glass vials of 50 ml.

The ampoules are arranged on plastic or cardboard trays contained in cardboard cartons of 5, 10, 20, 50 or 100 ampoules.

The vials are arranged in cardboard cartons of 1, 12, 24 or 48 vials.

Marketing Authorisation Holder

Abcur AB

P.O Box 1452

251 14 Helsingborg

Sweden

Manufacturer

[To be completed nationally]

This leaflet was last revised in 2016-05-19