ARGIPRESSIN 20 INTERNATIONAL UNITS /ML SOLUTION FOR INJECTION
Active substance(s): ARGIPRESSIN / ARGIPRESSIN / ARGIPRESSIN
Argipressin 20 International Units/ml
Solution for Injection
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
This product is known by the above name but will be referred to as Argipressin Injection throughout
the rest of this leaflet.
What is in this leaflet:
1. What Argipressin Injection is and what it is used for
2. What you need to know before you use Argipressin Injection
3. How to use Argipressin Injection
4. Possible side effects
5. How to store Argipressin Injection
6. Contents of the pack and other information
1. WHAT ARGIPRESSIN INJECTION IS AND WHAT IT IS USED FOR
Argipressin 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.
Argipressin is used to treat:
• diabetes insipidus. This is a rare form of diabetes causing production of large quantities of urine.
Argipressin increases the amount of water absorbed back into your kidneys
• bleeding from enlarged veins in the oesophagus (food pipe).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARGIPRESSIN INJECTION
Do not use Argipressin Injection if:
• you are allergic to argipressin or any of the other ingredients of this medicine (listed in section 6)
• you suffer from a severe allergic reaction (anaphylactic shock) to argipressin or any of the other
ingredients of this medicine (listed in section 6)
• you suffer from any diseases or conditions associated with your blood vessels, especially the blood
vessels of your heart
• you are intended to receive halogenated anaesthetic agents during surgical procedures
• you suffer from a certain type of kidney disease called chronic nephritis with nitrogen retention (your
doctor will advise you).
Speak to your doctor if one of these applies to you before you are given this medicine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Argipressin Injection
• 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)
• you have undergone removal of pituitary gland (dosage will depend on urine concentration).
Other medicines and Argipressin Injection
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
This is extremely important because some medicines can strengthen or weaken the effects of
In particular, tell your doctor if you are taking any of the following:
• medicines which control seizures (carbamezepine)
• other medicines to treat diabetes (chloropropamide)
• medicines used in corticosteroid replacement therapy (fludrocortisone)
• medicines to treat depression (e.g. amitriptyline, imipramine etc.)
• antibiotics (demeclocycline)
• medicines which prevent blood clotting (heparin)
• medicines used to treat mania (lithium)
• medicines used for severe low blood pressure or cardiac arrest (noradrenaline)
• medicines containing urea (in some skin and ear preparations)
• lipid lowering agent (clofibrate).
Argipressin Injection with food and drink
• Do not drink alcohol before you are given Argipressin Injection.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor, pharmacist or nurse before taking this medicine. As with all drugs, Argipressin should only
be given in pregnancy and when breast feeding if absolutely necessary. Your doctor will guide you.
Driving and using machines
Argipressin 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 TO USE ARGIPRESSIN INJECTION
It is most likely that you will be in hospital when you are given Argipressin.
For the treatment of diabetes insipidus: Injected under the skin or into a muscle every four hours. Your
doctor will decide on the most suitable dose and way to give it you depending on your symptoms.
For the treatment of bleeding in the oesophagus: The dose is diluted in a sugar solution and slowly
dripped through a needle into a vein. 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.
Use in children and adolescents
Argipressin is not recommended in children below 18 years.
No dose change, give as per adults.
If you think you have been given more Argipressin 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. If
you experience chest pain after receiving this medicine, inform your doctor immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 as this can also result in a heart
attack if not treated straight away.
Argipressin can cause ‘water intoxication’. Signs of this are drowsiness, being uninterested in anything
(listless) and headaches. If you notice any of these signs, tell the nurse or your doctor straightaway. If
it is not corrected, water intoxication can lead to fits or even coma.
Other side effects include:
Not known: frequency cannot be estimated from the available data
• Gangrene – with symptoms of redness, swelling, loss of sensation/severe pain which can cause dead,
black areas of skin- in areas such as fingers or toes
• Decreased oxygen in a tissue – with symptoms of pain, pale skin, tingling skin ( usually because of
decreased blood flow)
• Nettle rash or hives – Itchy red bumps on the skin
• Repeated desire to pass stools (diarrhoea)
• Abnormal collection of fluid in the body or ‘bloating’
• Paleness of the lips
• Feeling sick or being sick
• Passing wind
• Pounding in the head or a headache
• Stomach ache
• Excessive sweating
In patients with disease of the heart or circulation, Argipressin may give rise to angina (chest pain).
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ARGIPRESSIN INJECTION
Keep this medicine out of the sight and reach of children.
The storage of Argipressin 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
For single use only.
The white and blue rings above the blue OPC are for product identification and should not be taken as
break rings. The ampoules should be open cut at the OPC.
If only part used, discard the remaining solution.
Do not use after the last day of the month shown in the expiry date.
6. CONTENTS OF THE PACK AND OTHER 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 Argipressin Injection looks like and contents of pack
Argipressin Injection is a clear, sterile solution. It is a solution for injection which comes in a small glass
bottle (ampoule), containing 20 international units of the active ingredient, argipressin. It is available in
packs of ten 1ml ampoules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mercury Pharmaceutical Ltd, Capital House, 85 King William Street,
London EC4N 7BL, UK
Haupt Pharma Wülfing GmbH, Bethelner Landstraße 18, D-31028 Gronau, Germany
This leaflet was last revised in August 2016.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.