Prospect: information for the user

HIDROCLORURO DE FENILEFRINA ALTAN 10 mg/ml, Injectable Solution

Read this prospect carefully before starting to use the medication

1. What it isHIDROCLORURO DE FENILEFRINA ALTAN 10 mg/ml, Injectable Solutionand for what it is used

2. What you need to know before starting to useHIDROCLORURO DE FENILEFRINA ALTAN 10 mg/ml, Injectable Solution

3. How to useHIDROCLORURO DE FENILEFRINA ALTAN 10 mg/ml, Injectable Solution

4. Possible adverse effects

5. Storage ofHIDROCLORURO DE FENILEFRINA ALTAN 10 mg/ml, Injectable Solution

6. Contents of the package and additional information

HYDROCHLORIDE OF PHENYLEPHRINE ALTAN belongs to the group of agents known as sympathomimetics.

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

Do not use HYDROCHLORIDE OF PHENYLEPHRINE ALTAN

• If you are allergic (hypersensitive) to phenylephrine or to any of the other components of Hydrochloride of Phenylephrine Altan.
• If you are being treated with any medication known as monoamine oxidase inhibitors or have not passed 14 days since you stopped taking this type of medication.
• If you have high blood pressure.
• If you have excessive activity of the gland known as the thyroid.

Be especially careful with HYDROCHLORIDE OF PHENYLEPHRINE ALTAN

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

Use of other medications

Inform your doctor or pharmacist if you areusing or have usedrecently other medications, including those acquired without a prescription.

HYDROCHLORIDE OF PHENYLEPHRINE ALTANmay interact with the following medications:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

HYDROCHLORIDE OF PHENYLEPHRINE ALTANadministered in the last stages of pregnancy or during delivery may cause damage to the fetus.

Breastfeeding

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

Driving and operating machinery

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

Follow exactly the administration instructions for HYDROCHLORIDE OF PHENYLEPHRINE ALTAN as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

HYDROCHLORIDE OF PHENYLEPHRINE ALTAN must be administered always by a healthcare professional and never by yourself (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, based on 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 have passed.

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

Children:

100 micrograms per kilogram of body weight by subcutaneous or intramuscular injection.

Seniors:

No dose increase is required in seniors.

If you use more HYDROCHLORIDE OF PHENYLEPHRINE ALTAN than you should:

The symptoms of overdose include headache, vomiting, elevated blood pressure, and reflex bradycardia.

Treatment should consist of symptomatic and supportive measures. Hypertensive effects (elevated blood pressure) can be treated with medications called alpha-adrenergic receptor blockers, such as fentolamine, 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 Toxicological Information Service, Telephone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to use HYDROCHLORIDE OF PHENYLEPHRINE ALTAN:

Do not use a double dose to compensate for the missed dose.

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

Like all medications, ALTAN HYDROCHLORIDE OF PHENYLEPHRINE can cause adverse effects, although not everyone will experience them.

Adverse effects can be classified by frequency: Very frequent (affects more than 1 in 10 people); frequent (affects between 1 and 10 in 100 people); infrequent (affects between 1 and 10 in 1,000 people); rare (affects between 1 and 10 in 10,000 people); very rare (affects fewer than 1 in 10,000 people), unknown frequency (cannot be estimated from available data).

During the use of Phenylephrine, the following adverse effects have been observed, whose frequency has not been established with precision:

Cardiac disorders:

Reflex bradycardia (slow heart rate), reflex tachycardia (rapid heart rate), cardiac arrhythmias (irregular heart rate), angina pain, palpitations, cardiac arrest.

Vascular disorders

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

Central nervous system disorders:

Headache, cerebral hemorrhage, vertigo, fainting, temporary sensation 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 paresthesia, sensation of cold skin.

Metabolism and nutrition disorders:

Alterations in glucose metabolism.

General disorders and administration site conditions:

The extravasation of ALTAN HYDROCHLORIDE OF PHENYLEPHRINE can cause tissue necrosis (tissue death).

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special conservation conditions are required.

Do not use HYDROCHLORIDE FENILEPHRINE ALTAN after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of HYDROCHLORIDE OF PHENYLEPHRINE 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 contents of the package

HYDROCHLORIDE OF PHENYLEPHRINE ALTAN is presented in the form of an injectable solution, colorless and transparent.

Each package contains 10 ampoules of 1 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

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

Las Rozas, 28230 Madrid

Spain

Responsible for manufacturing

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 prospectus was approved in March 2009

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This information is intended solely for doctors or healthcare professionals:

Dosage and administration:

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

Adults:

HYDROCHLORIDE OF PHENYLEPHRINE ALTAN may be administered subcutaneously or intramuscularly at doses of2 to5 mg with additional doses of1 to10 mg if necessary, depending on the response,or at doses of100 to500 μg by slow intravenous injection as a 0.1% solution, repeating if necessary after a minimum of 15 minutes.

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 afterwards, according to the response, to 30 – 60 μg per minute.

Children:

100 μg/kg by subcutaneous or intramuscular injection.

Seniors:

No dose reduction is required in the elderly.