Phenylephrine Solution

Phenylephrine 50 μg/mL PS Equity contains phenylephrine hydrochloride, which raises blood pressure by constricting blood vessels. Phenylephrine 50 μg/mL PS Equity is used to treat low blood pressure.

Phenylephrine 50 μg/mL PS Equity should not be administered to you:

• if you are hypersensitive (allergic) to phenylephrine hydrochloride or any of the other ingredients of Phenylephrine 50 μg/mL PS Equity (listed in section 6);
• if you suffer from high blood pressure, or peripheral vascular disease (poor blood circulation, particularly in the limbs);
• if you are taking a Monoamine Oxydase inhibitor (MAO) (or within 2 weeks of their withdrawal), that is used to treat depression (such as iproniazide, nialamide);
• if you suffer from severe overactive thyroid gland (hyperthyroidism);
• if you have one of the following serious heart conditions: heart - block, uncontrolled heart failure, poor blood circulation in the heart;
• if you have a very slow heartbeat (called bradycardia);
• if you are taking medicines causing narrowing of the blood vessels (ephedrine, pseudoephedrine, methylphenidate);
• if you are taking medicines given by mouth or via the nose causing narrowing of the blood vessels (etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline).

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection:

• if you have diabetes;
• if you suffer from arterial hypertension (high blood pressure);
• if you have an overactive thyroid gland (uncontrolled hyperthyroidism);
• if you have blood vessel disease, such as arteriosclerosis (hardening and thickening of the walls of the blood vessels), or aneurysms;
• if you suffer from heart disease including chronic heart conditions, peripheral vascular insufficiency, heart rhythm disorders, tachycardia (high heart rate), bradycardia (low heart rate), partial heart block, angina pectoris;
• if you have poor blood circulation in the brain, heart, hands or feet;
• if you are elderly;
• if you suffer from closed angle glaucoma (increased pressure in the eye);
• if you suffer from a sulphite allergy.

In patients with serious heart failure, Phenylephrine 50 μg/mL PS Equity 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

Phenylephrine 50 μg/mL PS Equity is not recommended for use in children due to insufficient data on efficacy, safety and dose recommendations.

Other medicines and Phenylephrine 50 μg/mL PS Equity

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Phenylephrine 50 μg/mL PS Equity is not to be used in combination with (see section 2):

• non - selective monoamine oxidase inhibitors (MAOIs) (iproniazid, nialamide, phenylzine) used to treat depression;
• medicines causing narrowing of the blood vessels (ephedrine, pseudoephedrine, methylphenidate);
• medicines given by mouth or via the nose causing narrowing of the blood vessels (etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline).

Interactions are possible with the following medicines:

• certain antidepressants (iproniazid, nialamide, desipramine, imipramine, nortriptyline, milnacipran, moclobemide, pargyline, selegiline, toloxatone, venlafaxine);
• medicine to treat infection (linezolid);
• certain medicines used to treat migraine (dihydroergotamine, ergotamine, methylergotamine, methylsergide);
• certain medicines used to treat Parkinson’s disease (bromocriptine, lisuride, pergolide);
• medicines used to treat high blood pressure (guanethidine, labetalol, prazosin, reserpine and related products);
• medicines used to treat heart failure, certain irregular or abnormal heartbeats and abnormal heart beat (quinidine, digoxin);
• medicine used as an appetite suppressant (sibutramine);
• anaesthetics that are inhaled (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane);
• medicine used to inhibit the production of a hormone responsible of lactation (cabergoline);
• medicine used to induce labour (oxytocin);
• medicine used to treat enlarged prostates in men (doxazosin);
• medicines used to treat certain mental conditions (haloperidol, phenothiazine).

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself Phenylephrine 50 μg/mL PS Equity injection. It will be given to you by a person who is qualified to do so.

Use in adults

Your doctor will determine the dose to be administered and may repeat or adjust it until the desired effect is attained.

Use in patients with impaired renal function

Lower doses of Phenylephrine 50 μg/mL PS Equity may be needed if you have impaired renal function.

Use in patients with impaired liver function

Higher doses of Phenylephrine 50 μg/mL PS Equity may be needed if you have cirrhosis of the liver.

Use in older people

Treatment in older people should be carried out with care.

Use in children

Phenylephrine 50 μg/mL PS Equity is not recommended for use in children due to insufficient data on efficacy, safety and dose recommendations.

Your doctor will tell you how long your treatment with Phenylephrine 50 μg/mL PS Equity will last. If you have the impression that the effect of Phenylephrine 50 μg/mL PS Equity is too strong or too weak, tell your doctor or pharmacist.

If you have been given more Phenylephrine 50 μg/mL PS Equity than you should

Since a healthcare provider will administer Phenylephrine 50 μg/mL PS Equity, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. You may have the following symptoms: palpitations, cardiac rhythm disorders (tachycardia, cardiac dysrhythmias).

If you forget to use Phenylephrine 50 μg/mL PS Equity

Since a healthcare provider will administer Phenylephrine 50 μg/mL PS Equity, it is unlikely that the dose will be missed.

Phenylephrine 50 μg/mL PS Equity can have side effects. Not all side effects reported for Phenylephrine 50 μg/mL PS Equity are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Phenylephrine 50 μg/mL PS Equity, please consult your healthcare provider for advice.

Some side effects may be serious. Tell your doctor straightaway of you get any of the following:

• chest pain or pain due to the angina,
• an 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).

These are all very serious side effects. If you have them, you may have had a serious reaction to Phenylephrine 50 μg/mL PS Equity. You may need urgent medical attention or hospitalisation.

Other side effects include:

Frequent side effect:

• headache.

Less frequent side effects:

• reaction of hypersensitivity (allergy),
• excessive dilation of the pupils,
• increased pressure in the eye (aggravation of glaucoma),
• excitability,
• agitation (restlessness),
• anxiety,
• confusion,
• nervousness,
• insomnia (difficulty falling or staying asleep),
• shaking (tremor),
• feeling of fullness in the head,
• prickling of the skin,
• itching or tingling skin sensation (paraesthesia),
• slow or high heart rate,
• high blood pressure,
• low blood pressure with dizziness,
• difficulty in breathing,
• fluids in the lung,
• nausea,
• vomiting,
• sweating,
• pallor or skin blanching (pale colour of the skin),
• goose bumps,
• tissue damage at the site of the injection,
• muscle weakness,
• difficulty in passing urine or urine retention.

Side effects with unknown frequencies:

• change in the metabolism of glucose (sugar),
• loss of heart function or blood flow to the heart,
• severe pain in the chest,
• fainting,
• flushing,
• cold skin,
• excessive production of saliva,
• excessive sweating.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of Phenylephrine 50 μg/mL PS Equity.

Store all medicines out of reach of children. Store at or below 30 °C. Store the syringe in the unopened blister until use. Keep the blister in the outer carton in order to protect from light. The pre - filled syringe is for single patient only. Discard syringe after use. Do not reuse. Only clear colourless solution free from particles or precipitates should be used. Any syringe, even partially used, should be discarded appropriately after use.

Do not use after the expiry date, which is stated on the carton and ampoule. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).