Phenilephrine Unimedic

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Phenylephrine Unimedic 0.05 mg/ml, solution for injection

Phenylephrine Unimedic 0.1 mg/ml, solution for injection

Phenylephrine

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Phenylephrine Unimedic and what is it used for
• 2. Important information before using Phenylephrine Unimedic
• 3. How to use Phenylephrine Unimedic
• 4. Possible side effects
• 5. How to store Phenylephrine Unimedic
• 6. Contents of the packaging and other information

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

This medicine belongs to the group of adrenergic and dopaminergic agents. Phenylephrine Unimedic is used to treat low blood pressure, which may occur in various types of anesthesia.

2. Important information before using Phenylephrine Unimedic

When not to use Phenylephrine Unimedic:

• if the patient is allergic (hypersensitive) to phenylephrine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has high blood pressure (hypertension),
• if the patient has peripheral vascular disease (poor blood circulation),
• if the patient is taking non-selective monoamine oxidase inhibitors (MAOIs) for depression (iproniazid, nialamide) or has stopped taking them within the last 2 weeks,
• if the patient has severe hyperthyroidism (thyrotoxicosis).

Warnings and precautions

Before starting treatment with Phenylephrine Unimedic, you should discuss it with your doctor, pharmacist, or nurse:

• if the patient is elderly,
• if the patient has hyperthyroidism,
• if the patient has heart problems such as a weak pulse, heart block (partial), heart muscle disease, poor blood circulation in the heart, mild peripheral vascular disease, arrhythmias, tachycardia (fast heart rate), bradycardia (slow heart rate), angina pectoris
• if the patient has poor blood circulation in the brain,
• if the patient has atherosclerosis (hardening and thickening of the blood vessel walls),
• if the patient has diabetes,
• if the patient is taking oxytocin, the effect on blood vessels may be enhanced and cause very high blood pressure and stroke in the postpartum period,
• if the patient has high blood pressure,
• if the patient has closed-angle glaucoma.

In patients with severe heart failure, phenylephrine may increase heart failure due to vasoconstriction. Blood pressure will be monitored during treatment. In patients with heart disease, additional monitoring of vital functions will be performed.

Children

The medicine is not recommended for use in children due to the lack of sufficient data on efficacy, safety, and dosage.

Phenylephrine Unimedic and other medicines

You should tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. You should not take Phenylephrine Unimedic with:

• iproniazid, nialamide (used for depression).

The following medicines may affect the action of Phenylephrine Unimedic or Phenylephrine Unimedic may affect their action when taken at the same time:

• dihydroergotamine, ergotamine, methylergometrine, methysergide (used for migraine),
• linezolid (antibiotic),
• bromocriptine, cabergoline, lisuride, pergolide (used for Parkinson's disease),
• desipramine, imipramine, nortriptyline, moclobemide, toloxatone, minaprine, venlafaxine (used for depression),
• inhalational anesthetics (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane),
• medicines used to treat high blood pressure (guanethidine),
• medicines used to treat heart failure and irregular heartbeat (digitalis glycosides),
• medicines used to treat arrhythmias (quinidine),
• medicines used during childbirth (oxytocin).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor, pharmacist, or nurse before taking this medicine. Pregnancy This medicine should not be used during pregnancy unless it is absolutely necessary. Breastfeeding This medicine should not be used during breastfeeding unless it is absolutely necessary. However, in the case of a single administration during childbirth, breastfeeding is possible.

Driving and using machines

Not applicable.

Phenylephrine Unimedic contains sodium

• Each 10 ml ampoule contains 1.6 mmol (36.8 mg) of sodium. This corresponds to 1.8% of the maximum recommended daily intake of sodium in the diet for adults.
• Each 5 ml ampoule contains 0.8 mmol (18.4 mg) of sodium. The medicine contains less than 1 mmol (23 mg) of sodium, which means it is considered "sodium-free".

3. How to use Phenylephrine Unimedic

The medicine is administered exclusively by healthcare professionals with the appropriate training and experience. Use in adults The doctor or nurse administers Phenylephrine Unimedic into a vein (intravenously). The doctor will determine the appropriate dose for the patient, the time of administration, and the method of administration. Use in patients with renal impairment Lower doses of phenylephrine may be necessary in patients with renal impairment. Use in patients with hepatic impairment Higher doses of phenylephrine may be necessary in patients with liver cirrhosis. Use in the elderly Treatment of the elderly should be carried out under control. Use in children The medicine is not recommended for use in children due to the lack of sufficient data on safety, efficacy, and dosage.

Overdose of Phenylephrine Unimedic

Symptoms of overdose of Phenylephrine Unimedic include: faster and irregular heartbeat, headaches, nausea, vomiting, paranoid psychosis, hallucinations, and high blood pressure. However, it is unlikely to occur, as the medicine is used in a hospital setting.

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. You should immediately inform your doctor if you experience any of the following side effects:

• chest pain or pain associated with angina,
• irregular heartbeat,
• feeling of palpitations in the chest,
• bleeding in the brain (speech disorders, dizziness, weakness on one side of the body),
• psychosis (loss of contact with reality).

Other side effects may include (frequency not known):

• hypersensitivity reactions (allergy),
• excessive dilation of the pupils,
• increased pressure in the eye (exacerbation of glaucoma),
• irritability (increased sensitivity of an organ or body part),
• agitation (restlessness),
• anxiety,
• disorientation,
• headache,
• nervousness,
• insomnia (sleep disorders),
• tremors,
• burning sensation of the skin,
• tingling sensation of the skin,
• feeling of itching or tingling of the skin (paresthesia),
• slow or fast heart rate,
• high blood pressure,
• breathing difficulties,
• fluid in the lungs,
• nausea,
• vomiting,
• sweating,
• pallor (pale skin color),
• goosebumps,
• tissue damage at the injection site,
• muscle weakness,
• difficulty urinating or urinary retention.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: + 48 22 49 21 309 website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Phenylephrine Unimedic

Store the ampoules in the outer packaging to protect them from light. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Phenylephrine Unimedic contains

• The active substance is phenylephrine in the form of phenylephrine hydrochloride at a concentration of 0.05 mg/ml or 0.1 mg/ml.
• The other ingredients are sodium chloride, sodium citrate, anhydrous citric acid, water for injections, and hydrochloric acid (to adjust pH) and sodium hydroxide (to adjust pH).

What Phenylephrine Unimedic looks like and what the pack contains

Clear, colorless 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. Ampoules on plastic trays; in cartons of 5, 10, 20, 50, or 100 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder

Unimedic Pharma AB Box 6216 102 34 Stockholm Sweden

Manufacturer

Unimedic AB Storjordenvägen 2 864 31 Matfors Sweden

Date of last revision of the leaflet: