PATIENT INFORMATION LEAFLET Pitressin® 20PU/ml Solution for Injection ARGIPRESSIN

IN THIS LEAFLET:

1.    What Pitressin® 20PU/ml Solution for Injection is and what it is used for

2.    Before you are given Pitressin® 20PU/ml Solution for Injection

3.    How Pitressin® 20PU/ml Solution for Injection is given to you

4.    Possible side effects

5.    How to store Pitressin® 20PU/ml Solution for Injection

6.    Further information

1.    WHAT PITRESSIN® 20PU/ML SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR

Pitressin® 20PU/ml Solution for Injection contains argipressin which is similar to a naturally occurring hormone in your body. It is an 'antidiuretic' which helps to prevent excess loss of water in your urine and also narrows some blood vessels in the body.

Pitressin® 20PU/ml Solution for Injection is used to treat:

•    diabetes insipidus. This is a rare form of diabetes causing production of large quantities of urine. Pitressin® 20PU/ml Solution for Injection increases the amount of water absorbed back into your kidneys

•    bleeding from enlarged veins in the oesophagus (food pipe).

2.    BEFORE YOU ARE GIVEN PITRESSIN® 20PU/ML SOLUTION FOR INJECTION

You should not be given Pitressin 20PU/ml Solution for Injection if:

•    You know that you are allergic to argipressin or any of the other ingredients (see section 6 of this leaflet)

•    You suffer from a certain type of kidney disease called chronic nephritis with nitrogen retention (your doctor will advise you).

•    You suffer from any types of diseases or conditions of your blood vessels, especially the blood vessel of your heart.

•    You are intended to receive halogenated anaesthetic agents during surgical procedures.

Speak to your doctor if one of these applies to you before you are given this medicine.

Before you are given Pitressin 20PU/ml Solution for Injection, your doctor will take special care if any of the following situations apply to you. Make sure your doctor is aware of these situations if it is not already obvious:

•    You suffer from asthma or other allergic conditions

•    You suffer from migraine

•    You suffer from epilepsy (fits)

•    You suffer from high blood pressure, heart or kidney disease

•    You suffer from obstruction of the blood vessels of the heart (e.g. coronary artery disease).

•    You have undergone removal of pituitary gland (dosage will depend on urine concentration). Speak to your doctor if one of these applies to you before you are given this medicine.

Taking other medicines:

Tell your doctor before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is extremely important because some medicines can strengthen or weaken the effects of others.

In particular, tell your doctor if you are taking any of the following:

-    medicine which control seizures (carbamazepine)

-    medicine to treat diabetes (chloropropamine)

-    medicine used in corticosteroid replacement therapy (fludrocortisone)

-    medicines to treat depression (e.g. amitriptyline, imipramine etc.)

-    lipid lowering agent (clofibrate)

-    medicines containing urea (in some skin and ear preparations)

-    antibiotics (demeclocycline)

-    medicine used for severe low blood pressure or cardiac arrest (noradrenaline)

-    medicine used to treat mania (lithium)

-    medicine which prevents blood clotting (heparin).

Pregnancy and breast-feeding

Tell your doctor before you are given this medicine if you are or think you may be pregnant or are planning to become pregnant, or are breast-feeding.

As with all drugs, Pitressin® 20PU/ml Solution for Injection should only be given in pregnancy and when breast feeding if absolutely necessary. Your doctor will guide you.

Driving and using machines:

Pitressin® 20PU/ml Solution for Injection can affect your ability to drive and use machinery safely, as you may feel dizzy after receiving your injection. Speak to your doctor for further advice.

3. HOW PITRESSIN® 20PU/ML SOLUTION FOR INJECTION IS GIVEN TO YOU

It is most likely that you will be in hospital when you are given Pitressin® 20PU/ml Solution for Injection.

For the treatment of diabetes insipidus: the dose is usually 0.25ml to 1ml injected under the skin or into a muscle every four hours.

For the treatment of bleeding in the oesophagus: the dose is usually 1ml diluted in a sugar solution and slowly dripped through a needle into a vein. This will usually take about 15 minutes.

Your doctor will decide on the most suitable dose and way to give it to you depending on your symptoms.

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

If you think you have been given more Pitressin 20PU/ml Solution for Injection than you should have

As the injection will be administered by a doctor, it is unlikely that you will be given more than is necessary. However, if you think that you have been given too much, tell your doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pitressin® 20PU/ml Solution for Injection can sometimes cause side effects, although not everyone gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare.

Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately. Pitressin® 20PU/ml Solution for Injection can cause ‘water intoxication’. Signs of drowsiness, being uninterested in anything (listless) and headaches. If you notice any signs, tell the nurse or your doctor straightaway. If it is not corrected, water intoxication to fits or even coma.

Other side effects sometimes seen are:

•    Dizziness

•    Pounding in the head

•    Feeling sick or being sick

•    Stomach ache

•    Repeated desire to pass stools.

•    Abnormal collection of fluid in the body or 'bloating

•    Wind

•    ‘Nettle rash’ or hives - itchy red bumps on the skin

•    Paleness of the lips

•    Wheezing

•    Gangrene which causes dead black areas of skin like fingers or toes (very rare).

•    Sweating

•    Shakiness

In patients with disease of the heart or circulation, Pitressin® 20PU/ml Solution for Injection may give rise to angina (chest pain).

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

5.    HOW TO STORE PITRESSIN® 20PU/ML SOLUTION FOR INJECTION

The storage of Pitressin® 20PU/ml Solution for Injection will not be your responsibility.

Store between 2°C and 8°C. Keep the ampoules in the outer carton in order to protect from light. Do not freeze.

For single use only.

If only part used, discard the remaining solution.

Do not use after the last day of the month shown in the expiry date.

6.    FURTHER INFORMATION

The active substance is argipressin.

The other ingredients are glacial acetic acid and sufficient water for injections is used to make the final volume of 1ml.

What Pitressin 20PU/ml Solution for Injection looks like and contents of pack

Pitressin® 20PU/ml Solution for Injection is a clear, sterile solution. It is a solution for injection which comes in a small glass bottle (ampoule), containing 20 international pressor units of the active ingredient, argipressin. It is available in packs of ten 1ml ampoules.

Marketing authorization holder

Mercury Pharmaceuticals Ltd., No. 1 Croydon, 12 - 16 Addiscombe Road, Croydon, CR0 0XT, UK.

Manufacturer

Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR This leaflet was last revised in July 2012.

Mercury Pharma Group Limited is licensed to use the registered trademark Pitressin.