PHENYLEPHRINE HYDROCHLORIDE ALTAN 10 mg/ml INJECTABLE SOLUTION

1. What PHENYLEPHRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injectable Solution is and what it is used for

PHENYLEPHRINE HYDROCHLORIDE ALTAN belongs to the group of so-called sympathomimetic agents.

PHENYLEPHRINE HYDROCHLORIDE ALTAN is used in the treatment of hypotension (low blood pressure) that may occur during surgical operations.

2. What you need to know before starting to use PHENYLEPHRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injectable Solution

Do not use PHENYLEPHRINE HYDROCHLORIDE ALTAN

• If you are allergic (hypersensitive) to phenylephrine or any of the other components of Phenylephrine Hydrochloride Altan.
• If you are being treated with certain medications called monoamine oxidase inhibitors or if it has not been 14 days since you stopped taking this type of medication.
• If you have high blood pressure.
• If you have an overactive thyroid gland.

Be careful with PHENYLEPHRINE HYDROCHLORIDE ALTAN

• If you have any heart disease.
• If you have angina pectoris, as it may cause you pain.
• If you have diabetes mellitus.
• If you have closed-angle glaucoma (an eye disease characterized by increased pressure inside the eye).

Using other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

PHENYLEPHRINE HYDROCHLORIDE ALTAN may interact with the following medications:

• Inhaled halogenated anesthetics (cyclopropane, halothane, etc.).
• Cardiac glycosides (heart medications)
• Quinidine
• Tricyclic antidepressants.
• Antihypertensive medications (high blood pressure medications)

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

PHENYLEPHRINE HYDROCHLORIDE ALTAN administered in the late stages of pregnancy or during childbirth may harm the fetus.

Breastfeeding

The amount of phenylephrine that passes into breast milk appears to be small.

Driving and using machines

No data are available on how PHENYLEPHRINE HYDROCHLORIDE ALTAN affects driving or operating machinery.

3. How to use PHENYLEPHRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injectable Solution

Follow the administration instructions for Phenylephrine Hydrochloride Altan exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

PHENYLEPHRINE HYDROCHLORIDE ALTAN should always be administered by a healthcare professional and never by oneself (see section 6).

The normal dose is:

Adults:

• Subcutaneous or intramuscular injection: in doses of 2 to 5 mg with additional doses of 1 to 10 mg if necessary, depending on the response.
• Slow intravenous injection: in doses of 100 to 500 micrograms as a 0.1% solution, repeating if necessary after a minimum of 15 minutes has passed.

• Intravenous infusion: dilute one 10 mg ampoule in 500 ml of 5% glucose injectable solution or 0.9% sodium chloride injectable solution and infuse intravenously, initially at a maximum rate of 180 micrograms per minute, reducing to 30-60 micrograms per minute according to the response.

Children:

100 micrograms per kilogram of weight by subcutaneous or intramuscular route.

Elderly:

No dose increase is required in the elderly.

If you use more PHENYLEPHRINE HYDROCHLORIDE ALTAN than you should

Overdose symptoms include headache, vomiting, high blood pressure, and reflex bradycardia.

Treatment should consist of symptomatic and supportive measures. Hypertensive effects (high blood pressure) can be treated with medications called alpha-adrenergic receptor blockers, such as phentolamine, 5-60 mg intravenously over 10-30 minutes, repeating if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use PHENYLEPHRINE HYDROCHLORIDE ALTAN

Do not use a double dose to make up for the forgotten dose.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, PHENYLEPHRINE HYDROCHLORIDE ALTAN can cause side effects, although not everyone gets them.

Side effects can be classified according to frequency as: Very common (affects more than 1 in 10 people); common (affects between 1 and 10 in 100 people); uncommon (affects between 1 and 10 in 1,000 people); rare (affects between 1 and 10 in 10,000 people); very rare (affects less than 1 in 10,000 people), frequency not known (cannot be estimated from available data).

During the use of Phenylephrine, the following side effects have been observed, whose frequency cannot be established with precision:

Cardiac disorders:

Reflex bradycardia (slow heart rate), reflex tachycardia (fast heart rate), cardiac arrhythmias (irregular heart rhythm), angina pectoris, palpitations, cardiac arrest.

Vascular disorders

Hypertension (high blood pressure), hypotension (low blood pressure), flushing (redness).

Nervous system disorders:

Headache, cerebral hemorrhage, vertigo, fainting, temporary feeling of having a heavy head.

Phenylephrine has no significant stimulating effects on the central nervous system at usual doses.

Respiratory, thoracic, and mediastinal disorders:

Dyspnea (difficulty breathing), pulmonary edema (inflammation of the lung).

Gastrointestinal disorders:

Vomiting, increased salivation.

Renal and urinary disorders:

Difficulty urinating, urinary retention.

Skin and subcutaneous tissue disorders:

Sweating, transient tingling, feeling of cold in the skin.

Metabolic and nutritional disorders:

Alterations in glucose metabolism.

General disorders and administration site conditions:

Extravasation of PHENYLEPHRINE HYDROCHLORIDE ALTAN can cause tissue necrosis (tissue death).

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of PHENYLEPHRINE HYDROCHLORIDE ALTAN 10 mg/ml, Injectable Solution

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use PHENYLEPHRINE HYDROCHLORIDE ALTAN after the expiration date stated on the package. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of PHENYLEPHRINE HYDROCHLORIDE ALTAN

The active ingredient is phenylephrine (hydrochloride). Each ampoule contains 10 mg of phenylephrine (hydrochloride).

The other components are: Hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and package contents

PHENYLEPHRINE HYDROCHLORIDE ALTAN is presented as a colorless and transparent injectable solution.

Each package contains 10 ampoules of 1 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma

Las Rozas, 28230 Madrid

Spain

Manufacturer

Avda. de la Constitución, 198-199,

Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo

Spain

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n

01118 (Alava)

Spain

This package leaflet was approved in March 2009

-------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Dosage and Administration:

Administer by subcutaneous, intramuscular, slow intravenous, or intravenous infusion.

Adults:

PHENYLEPHRINE HYDROCHLORIDE ALTAN can be administered subcutaneously or intramuscularly in doses of 2 to 5 mg with additional doses of 1 to 10 mg if necessary, depending on the response, or in doses of 100 to 500 μg by slow intravenous injection as a 0.1% solution, repeating if necessary after a minimum of 15 minutes has passed.

Alternatively, dilute one 10 mg ampoule in 500 ml of 5% glucose injectable solution or 0.9% sodium chloride injectable solution and infuse intravenously, initially at a maximum rate of 180 μg per minute, reducing to 30-60 μg per minute according to the response.

Children:

100 μg/kg by subcutaneous or intramuscular route.

Elderly:

No dose reduction is required in the elderly.