Phenylephrine Hydrochloride 10 mg Solution

PHENYLEPHRINE HYDROCHLORIDE INJECTION belongs to a group of medicines called adrenergic - and dopaminergic medicines, which raise blood pressure by constricting blood vessels. PHENYLEPHRINE HYDROCHLORIDE INJECTION is used to treat low blood pressure, which may be caused by circulatory failure, spinal anaesthesia or certain medicines.

PHENYLEPHRINE HYDROCHLORIDE INJECTION should not be administered to you:

• If you are hypersensitive (allergic) to phenylephrine hydrochloride or any of the other ingredients of PHENYLEPHRINE HYDROCHLORIDE INJECTION (listed in section 6).
• If you are a child.
• If you suffer from high blood pressure.
• If you have an overactive thyroid.
• If you are taking non-selective monoamine oxidase inhibitors (MAOIs) used to treat depression (e.g. iproniazid, nialamide, linezolid, phenelzine), or have taken them in the last 14 days.
• If you have or had heart block (slow or irregular heartbeat) within the last 3 months.
• If you have suffered from a heart attack.
• If you suffer from heart failure.
• If you have seriously impaired coronary circulation (circulation of blood in the blood vessels of the heart muscle).
• If you have bradycardia (slower than normal heart rate).

Warnings and precautions:

Talk to your doctor before being given PHENYLEPHRINE HYDROCHLORIDE INJECTION if:

• You have any heart problems or disease, including an irregular heartbeat or angina (chest pain).
• You are elderly.
• You have impaired blood flow to the brain (cerebral circulation).
• You have a disease of your blood vessels, such as arteriosclerosis or dilated blood vessels.
• You have a disease causing poor circulation in your hands and feet.
• You suffer from diabetes mellitus.
• You suffer from a nerve (autonomic) dysfunction that regulates your heart rate and blood pressure.
• You suffer from septic shock (a widespread infection causing organ failure and a dangerous drop in blood pressure).
• You have closed-angle glaucoma (increased pressure in the eye).
• You are pregnant or breastfeeding.

Children and adolescents:

PHENYLEPHRINE HYDROCHLORIDE INJECTION is not indicated for use in children.

Other medicines and PHENYLEPHRINE HYDROCHLORIDE INJECTION:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Do not use PHENYLEPHRINE HYDROCHLORIDE INJECTION with:

• Certain medicines used to treat depression (e.g. iproniazid, nialamide, linezolid, phenelzine).

You will not be expected to give yourself PHENYLEPHRINE HYDROCHLORIDE INJECTION. It will be given to you in a hospital or clinic by a person who is qualified to do so. PHENYLEPHRINE HYDROCHLORIDE INJECTION is given by slow injection or infusion (drip) into a vein. Your doctor will tell you how long your treatment with PHENYLEPHRINE HYDROCHLORIDE will last.

If you have the impression that the effect of PHENYLEPHRINE HYDROCHLORIDE is too strong or too weak, tell your doctor or pharmacist.

If you are given more PHENYLEPHRINE HYDROCHLORIDE INJECTION than you should: Since a health care provider will administer PHENYLEPHRINE HYDROCHLORIDE INJECTION, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive PHENYLEPHRINE HYDROCHLORIDE INJECTION: Since a health care provider will administer PHENYLEPHRINE HYDROCHLORIDE INJECTION, it is unlikely that the dose will be missed.

If you stop receiving PHENYLEPHRINE HYDROCHLORIDE INJECTION: When discontinuing therapy with PHENYLEPHRINE HYDROCHLORIDE INJECTION, the dose should be reduced gradually, since sudden withdrawal of therapy may result in severe low blood pressure.

PHENYLEPHRINE HYDROCHLORIDE INJECTION can have side effects. Not all side effects reported for PHENYLEPHRINE HYDROCHLORIDE INJECTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PHENYLEPHRINE HYDROCHLORIDE INJECTION, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop receiving PHENYLEPHRINE HYDROCHLORIDE INJECTION and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to PHENYLEPHRINE HYDROCHLORIDE. You may need urgent medical attention or hospitalisation.

Tell your doctor or nurse immediately if you have any of the following side effects:

• a change in your heart rate (speeding up slowing down or cessation, palpitations),
• an irregular heart beat (dysrhythmias),
• chest pain or pain due to angina,
• an increase in blood pressure with headache, nausea and vomiting,
• a decrease in blood pressure with dizziness,
• difficulty in passing urine or urine retention,
• tissue damage at the site of the injection,
• losing contact with reality and are unable to think and judge clearly (psychotic states),
• shortness of breath (dyspnoea),
• bleeding in the brain (speech disorder, dizziness, paralysis of one side of the body),
• fluids in the lung (pulmonary oedema).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Less frequent side effects:

• sweating,
• excessive production of saliva,
• a feeling of fullness in the head,
• tingling or coolness of the skin,
• anxiety,
• excessive sensitivity of an organ or body part (excitability),
• restlessness (agitation),
• confusion,
• nervousness,
• difficulty falling or staying asleep (insomnia),
• shaking (tremor),
• burning or prickling of the skin (paraesthesia),
• excessive dilation of the pupils (mydriasis),
• increased pressure in the eye (aggravation of glaucoma),
• pale colour of the skin (pallor or skin blanching),
• goose flesh (piloerection),
• muscular weakness.

If any of the side effects gets worse or you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

• Keep all medicines out of the reach of children.
• Store at or below 25 °C.
• Protect from sunlight.
• Store in the original package.
• Do not use PHENYLEPHRINE HYDROCHLORIDE INJECTION after the expiry date which is stated on the carton and ampoule.
• Keep covered in carton until time of use.
• For single use only. Discard unused portion.