PITRESSIN 20PU/ML SOLUTION FOR INJECTION
Active substance: ARGIPRESSIN
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PATIENT INFORMATION LEAFLET Pitressin 20PU/ml Solution for Injection ARGIPRESSIN Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. 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. 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. 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).
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. 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 sideeffects, 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 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 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 Wind body or 'bloating Nettle rash or hives - itchy red Paleness of the lips
bumps on the skin Gangrene which causes dead black areas of skin like fingers or toes (very rare).
Wheezing 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 2C and 8C. 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 March 2012.
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. 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 sideeffects, 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 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 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 Wind body or 'bloating Nettle rash or hives - itchy red Paleness of the lips
bumps on the skin Gangrene which causes dead black areas of skin like fingers or toes (very rare).
Wheezing 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 2C and 8C. 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 March 2012.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
