0.05 mg / ml and 0.1 mg / ml injection solution 
phenylephrine

What Phenylephrine Abcur is and what it is used for

This drug belongs to a group called adrenergic or dopaminergic drugs. PhenylephrineAbcur is used to treat low blood pressure that can occur with different types of anesthesia.

Phenylephrine contained in Phenylephrine Abcur may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Phenylephrine Abcur

Do not use Phenylephrine 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 (high blood pressure )
  • if you suffer from peripheral vascular disease (poor blood circulation)
  • if you are taking medicines that cause the blood vessels to constrict ( ephedrine, pseudoephedrine, methylphenidate)
  • if you are taking medicines by mouth or nose that causes the blood vessels to constrict ( ethylphrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, thuaminoheptane, pyrazoline)

Warnings and cautions

The blood pressure in your arteries must be monitored during treatment.

Talk to your doctor or nurse before using Phenylephrine Abcur.

  • if you are older
  • if you have an overactive thyroid gland
  • if you suffer from heart problems such as low heart rate, heart block (partial), heart muscle disease, poor blood circulation in the heart
  • if you have poor blood circulation in the brain
  • if you have atherosclerosis (hardening and thickening of the walls of blood vessels)
  • if you have diabetes

Other medicines and Phenylephrine Abcur

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

Do not use Phenylephrine Abcur with:

  • drugs that constrict blood vessels ( ephedrine, pseudoephedrine, methylphenidate)
  • oral and nasal medicinal products that cause the blood vessels to constrict ( ethylphrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, thuaminoheptane, pyrazoline)

The following medicines may affect or be affected by concomitant use:

  • dihydroergotamine, ergotamine , methylergometrine, methysergide (for migraine)
  • linezolid ( antibiotics )
  • bromocriptine, cabergoline, lisuride, pergolide (for Parkinson’s disease )
  • moclobemide, toloxatone, iproniazid, nialamide (for depression)

Pregnancy, breastfeeding, 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 using 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.

Driving and using machines

This medicine may affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Phenylephrine Abcur

Your doctor or nurse will give you Phenylephrine Abcur in a vein ( intravenously ). Your doctor will decide the right dose for you and when and how to inject one.

If you use more Phenylephrine Abcur than you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Signs that you have received too much Phenylephrine Abcur are faster and irregular heartbeats.

This is unlikely to happen because you are receiving the medicine in a 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 bradycardia (slow heartbeat)
  • exhilaration
  • indignation
  • unusual arrhythmia (heart rhythm disorder)
  • high blood pressure
  • chest pain

5. How to store Phenylephrine Abcur

No special storage instructions.

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 expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is phenylephrine as phenylephrine hydrochloride.
  • The other ingredients are sodium chloride, sodium citrate, citric acid, and water for injections.

What the medicine looks like and the contents of the pack

Phenylephrine Abcur 0.05 mg/ml solution for injection is supplied in a 10 ml glass ampoule.

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

The ampoules are packed in trays of plastic or cardboard of 5, 10, 20, 50, and 100 ampoules. The vials are packaged in cartons of 1, 12, 24, or 48 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Abcur AB

Box 1452

251 14 Helsingborg

Manufacturer

Renaudin Laboratories

ZA Errobi

F-64 250 Itxassou

France

Muhammad Nadeem

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