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

What Phenylephrine Unimedic is and what it is used for

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

Phenylephrine contained in Phenylephrine Unimedic 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 Fenylefrin Unimedic

Do not use Phenylephrine Unimedic

  • 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 a non-selective monoxide inhibitor (MAO) for the treatment of depression (iproniazid, nialamide), or within 2 weeks after stopping that treatment
  • if you suffer from severe toxic goiter (overactive thyroid gland )

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Fenylefrin Unimedic.

  • 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, impaired blood circulation in the legs, unregulated heart rhythm, tachycardia (fast heartbeat), bradycardia (slow heartbeat), angina
  • 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 mellitus
  • if you are being treated with oxytocin as the effect on vessels can be exacerbated and cause greatly increased blood pressure and stroke during the period immediately after delivery
  • if you suffer from high blood pressure in the artery are
  • if you have narrow-angle glaucoma ( glaucoma )

Patients with severe heart failure may be worsened by treatment with phenylephrinedue to narrowing of blood vessels.

The blood pressure in your arteries will be during treatment. If you have heart disease, the function of important organs will also be monitored.

Children and young people

It is not recommended for use in children due to insufficient data on efficacy, safety, and dosage recommendations. 

Other medicines and Phenylephrine Unimedic

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

Do not use Phenylephrine Unimedic with:

  • iproniazid, nialamide (for depression)

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 )
  • desipramine, imipramine, nortriptyline, moclobemide, toloxatone, venlafaxine (for depression)
  • inhaled anesthetics (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane)
  • drug for the treatment of high blood pressure (guanethidine)
  • drugs for the treatment of heart failure and certain irregular heartbeats (cardiac glycosides)
  • drugs for the treatment of abnormal heart rhythm ( quinidine )
  • medicines used in childbirth ( oxytocin )

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 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. However, if you receive this only once during childbirth, breastfeeding is possible.

Driving and using machines

Not relevant.

Phenylephrine Unimedic contains excipients

  • One 10 ml ampoule of Phenylephrine Unimedic contains 1.6 mmol (36.8 mg) sodium per dose. This should be considered by patients on a low-salt diet.
  • One 5 ml contains 0.8 mmol (18.4 mg) sodium per dose, ie it contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially ‘sodium-free’.

3. How to use Phenylephrine Unimedic

The drug will be given by healthcare professionals with appropriate training and experience.

Adults

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

Patients with renal impairment

Patients with renal impairment may need lower doses of phenylephrine.

Patients with hepatic impairment

Patients with hepatic impairment may need higher doses of phenylephrine.

Elderly Elderly 
people should be treated with caution.

Children

It is not recommended for use in children due to insufficient data on efficacy, safety, and dosage recommendations. 

If you use more Phenylefrin Unimedic then you should 

If you have ingested too much medicine, contact your doctor, hospital, or the Poison Information Center for risk assessment and advice.

Signs that you have been given too much Phenylephrine Unimedic are faster and irregular heartbeats, headaches, nausea, vomiting, psychosis, hallucinations, and high blood pressure.

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:

Some side effects can be serious. Tell your doctor immediately if you get any of the following:

  • chest pain or pain due to angina
  • irregular heartbeats
  • a feeling that the heart is beating hard in the chest
  • cerebral hemorrhage (speech difficulties, dizziness, paralysis on one side of the body)
  • psychosis (loses contact with reality)

Other side effects that have been reported (unknown frequency)

  • hypersensitivity reaction
  • excessive pupil s
  • increased pressure in the eye (worsening of glaucoma )
  • anxiety (restlessness)
  • anxiety
  • confusion
  • headache
  • nervousness
  • difficulty sleeping (difficulty falling asleep or sleeping)
  • shaking ( tremor )
  • burning sensation on the skin
  • an ant crawls in the skin
  • itching or tingling on the skin (paresthesia)
  • slow or fast heartbeats
  • high blood pressure
  • difficulty breathing
  • fluid in the lung (s)
  • nausea
  • vomiting
  • sweating
  • pallor, pale color of the skin
  • goosebumps
  • tissue damage at the injection site
  • muscle weakness
  • difficulty urinating or total urinary retention

5. How to store Phenylephrine Unimedic

Store in the original package. Sensitive to light.

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 0.05 mg / ml and 0.1 mg / ml respectively.
  • The other ingredients are sodium chloride, sodium citrate, citric acid, water for injections, hydrochloric acid, and sodium hydroxide for pH adjustment.

What the medicine looks like and the contents of the pack

Clear, colorless solution.

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

Phenylephrine Unimedic 0.1 mg/ml, solution for injection is supplied in 5 ml and 10 ml glass ampoules.

The ampoules are packed in plastic trays in cartons of 5, 10, 20, 50, and 100 ampoules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Unimedic Pharma AB

Box 6216,

102 34

Stockholm

Email: medinfo@unimedicpharma.se

Tel: +46 (0) 10 130 99 50

For any information about this medicine, please see the Marketing Authorization Holder.

Manufacturer

Unimedic AB

Storjordenvägen 2

SE ‑ 864 31 Matfors

Muhammad Nadeem

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