Document: Fenylefrin Unimedac solution for injection ENG PL change

• Fenylefrin Unimedic solution for injection PL
• Fenylefrin Unimedac solution for injection ENG PL

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Package leaflet: Information for the patient

Phenylephrine Unimedic 0.05 mg/ml, solution for injection

Phenylephrine Unimedic 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, pharmacist 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.

What is in this leaflet

1. What Phenylephrine Unimedic is and what it is used for

2. What you need to know before you use Phenylephrine Unimedic

3. How to use Phenylephrine Unimedic

4. Possible side effects

6. Contents of the pack and other information

This drug belongs to a group called adrenergic or dopaminergic agents. Phenylephrine Unimedic is used to treat low blood pressure that can occur during different types of anesthesia.

Do not use Phenylephrine Unimedic if:

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

- you suffer from hypertension (increased blood pressure)

- you are suffering from a peripheral vascular disease (poor blood circulation)

- you take a non-selective monoamine oxidase inhibitor (MAO) (or within 2 weeks of their withdrawal) for treatment of depression (iproniazide, nialamide).

- you suffer from a severe overactive thyroid gland (hyperthyroidism)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Phenylephrine Unimedic;

- if you are elderly

- if you have an overactive thyroid gland

- if you suffer from heart problems as a slow pulse, heart block (partial), heart muscle disease, poor blood circulation in the heart, severe peripher vascular insufficiency, heart rhythm disorders, tachycardia (high heart rate), bradycardia (low heart rate), angina pectoris

- if you have poor blood circulation in the brain

- if you have atherosclerosis (hardening and thickening of the blood vessel walls)

- if you have diabetes mellitus

- if you are treated with oxytocin as the effect on the blood vessels can be enhanced and cause very high blood pressure and stroke in the period immediately after childbirth

- if you suffer from arterial hypertension

- if you suffer from a closed angle glaucoma

In patients with serious heart failure phenylephrine may worsen the heart failure as a consequence of blood vessel constriction.

The blood pressure in your arteries will be monitored during treatment. If you have heart disease, additional monitoring of vital functions will be performed.

Children

The medicine 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:

- iproniazide, nialamide (for depression)

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

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

- linezolid (an antibiotic)

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

- desipramine, imipramine, nortriptyline, moclobemide, toloxatone, minalcipram, venlafaxine (for depression)

- anaesthetics that are inhaled (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane

- medicine used to treat high blood pressure (guanethidine)

- medicines used to treat heart failure and certain irregular heartbeats (cardiac glycosides)

- medicine used to treat abnormal heart rhythm (quinidine)

- medicine used during labour (oxytocin).

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, pharmacist or nurse for advice before taking this medicine.

Pregnancy
This medication should not be used during pregnancy unless absolutely necessary.

Breast-feeding

This medication should not be used during breast-feeding unless it is absolutely necessary. However, in the event of a single administration during childbirth, breast-feeding is possible.

Driving and using machines

Not relevant.

Phenylephrine Unimedic contains sodium

- Each 10 ml ampoule contains 1,6 mmol(36,8 mg)sodium per dose. This should be considered by patients on a controlled sodium diet.

- Each 5 ml ampoule contains 0,8 mmol (18,4mg) sodium per dose. This means that it contains less than
1 mmol sodium (23 mg) per dose, which means it is almost free from sodium.

The administration will be performed by a health-care professional with appropriate training and relevant experience.

Use in Adults
Your doctor or nurse will give you Phenylephrine Unimedic into a vein (intravenously). Your doctor will decide the right dose for you and when and how it should be injected.

Use in patients with impaired renal function

Lower doses of phenylephrine may be needed in patients with impaired renal function.

Use in patients with impaired liver function

Higher doses of phenylephrine may be needed in patients with cirrhosis of the liver.

Use in older people

Treatment in older people should be carried out with care.

Use in children

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

If you use more Phenylephrine Unimedic than you should

Signs that indicates that you have received too much Phenylephrine Unimedic is a faster and irregular heart beat, headache, nausea, vomiting, paranoid psychosis, hallucinations and hypertension.

It is unlikely that this will happen because you will get this medicine at a hospital.

4. Possible side effects

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

The following adverse reactions have been reported:
Some side effects may be serious. Tell your doctor straight away if you get any of the following:

- chest pain or pain due to the angina

- irregular heartbeat

- feeling the heart pumping in the chest

- bleeding in the brain (speech disorder, dizziness, paralysis of one side of the body)

- psychosis (loosing contact with reality)

Other side effects may include (frequencies are not known):

- reaction of hypersensitivity (allergy)

- excessive dilation of the pupils

- increased pressure in the eye (aggravation of glaucoma)

- excitability (excessive sensitivity of an organ or body part)

- agitation (restlessness)

- anxiety

- confusion

- headache

- nervousness,

- insomnia (difficulty falling or staying asleep)

- shaking (tremor)

- burning of the skin

- prickling of the skin

- itching or tingling skin sensation (paraesthesia)

- slow or high heart rate
- high blood pressure

- difficulty in breathing

- fluids in the lung

- nausea

- vomiting

- sweating

- pallor or skin blanching (pale colour of the skin)

- goose flesh

- tissue damage at the site of the injection

- muscle weakness

- difficulty in passing urine or urine retention

Reporting of side effects

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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Phenylephrine Unimedic

Keep the ampoules in the outer carton in order to protect from 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 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 Phenylephrine Unimedic contains

• The active substance is phenylephrine as phenylephrine hydrochloride 0.05 mg/ml respective
  0.1 mg/ml

• The other ingredients are sodium chloride, sodium citrate, citric acid, water for injection and hydrochloric acid and sodium hydroxid for pH adjustment

What Phenylephrine Unimedic looks like and contents of the pack

Clear and colourless solution.

Phenylephrine Unimedic 0.05 mg/ml, solution for injection, is available in glass ampoules of 10 ml.

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Unimedic AB

Storjordenvägen 2

SE-864 31 Matfors

Sweden

This leaflet was last revised in 10/2015