Octim Injection

• Keep this leaflet, you may need to read it again
• If you have any questions, ask your doctor, 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 symptoms are the same as yours.
• If you get any side effects get serious, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What Octim Injection is and what it is used for
2. What you need to know before you use Octim Injection
3. How Octim Injection will be given
4. Possible side effects
5. How to store Octim Injection
6. Contents of the pack and other information

• if you are allergic to desmopressin acerare or any of the other ingredients of this medicine (listed in section 6)
• if you drink unusually large amount of fluids
• if you suffer from heart problems or other conditions requiring treatment with diuretics (water tablets)
• if you have low blood sodium levels (hyponatremia)
• if you suffer from syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• if you suffer from a more severe form of chest pain (unstable angina)
• if you suffer from von Willebrand’s disease type IIb

Talk to your doctor before taking Octim Injection.

Be extra careful with the use of Octim Injection:

• in children, elderly patients and patients with blood sodium levels in the lower normal range, as the risk of hyponatraemia (low blood sodium levels) may be increased
• if you suffer from a condition that causes a fluid and/or salt imbalance e.g. vomiting, diarrhoea, infections or fever
• if you are at risk of increased intracranial pressure (pressure inside the skull)
• if you have moderate to severe kidney dysfunction
• if you need to be treated for bleeding several times within two days. The effect of Octim Injection may then decrease.
• if you suffer from cardiovascular disease such as blood clots, arteriosclerosis or if you have had angioplasty (artery-opening procedure).

While using Octim Injection, your fluid intake must be limited. In this way, you will prevent fluid overload in your body and a lack of sodium in your blood.

Fluid retention (build-up of water in the body) and/or hyponatraemia (low blood sodium levels), with or without accompanying warning signs or symptoms, may occur during treatment with desmopressin (see section 4 “Possible side effects”). Contact your doctor if you notice these warning signs or symptoms; your doctor may check your weight and sodium levels.

Octim Injection does not reduce the prolonged bleeding time in thrombocytopenia (platelet deficiency).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Octim Injection may have a stronger effect if you are already taking other medications that also affect the fluid and/or salt balance in your body. As a result, your body is more likely to retain too much fluid and your blood sodium levels might decrease.

Examples include:

• medicines to treat very severe pain: opioids
• medicines to treat depression: tricyclic or SSRI antidepressants
• medicines to treat pain and/or inflammation: non-steroidal anti-inflammatory drugs, such as indomethacin, ibuprofen
• chlorpromazine (for the treatment of psychosis or schizophrenia)
• carbamazepine (for the treatment of epilepsy)
• drugs to treat diabetes: sulphonylurea derivatives, such as chlorpropamide

• you should avoid drinking large amounts of fluid while you are being treated with Octim Injection as this could lead to build up of water which dilutes the salt in the body. This is a serious problem and may lead to convulsions. You should only drink enough fluid to satisfy your thirst.
• when used to test fibrinolytic response, limit fluid intake to a maximum of 500 ml from 1 hour before until 8 hours after the dose.

If you are pregnant or planning a pregnancy, please inform your doctor before you use Octim Injection as blood pressure monitoring is recommended due to the increased risk of pre-eclampsia (a condition in pregnant women that can cause serious complications). Symptoms of pre-eclampsia include high blood pressure, oedema (swelling due to the build up of fluid) and proteinuria (protein in the urine).

Breast-feeding:

If you are breast-feeding ask your doctor or pharmacist for advice before using Octim Injection.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

The dose for adults, children and infants is 0.3 micrograms per kilogram body weight, administered just under the skin (subcutaneous) or directly into one of your veins (intravenous) over a period of 20 minutes. This dose should be given before surgery or following trauma. Further doses may be administered at 12 hourly intervals.

The dose for adults and children is 0.3 micrograms per kilogram body weight, administered just under the skin (subcutaneous) or directly into one of your veins (intravenous) over a period of 20 minutes.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too much, however, avoid drinking any more fluid and seek medical advice if you have any concerns.

Common (may affect up to 1 in 10 patients):

• headache
• nausea
• abdominal pain
• tachycardia (rapid heartbeat)¹
• flushing (reddening of the skin)¹
• hypotension (low blood pressure)¹
• tiredness

Rare (may affect up to 1 in 1,000 patients):

• dizziness

Not known (frequency cannot be estimated from the available data):

• cerebral ischemia (stroke)²
• acute myocardial infarction (heart attack)²
• blood clots in deep veins, brain or lungs³
• angina pectoris²
• itching
• hives
  1. For the treatment of bleeding (high dose) at the time of administration, transient fall in blood pressure with increased heart rate and flushing.
  2. Reported in the treatment of bleeding (high dose) and only in patients with a history of, or risk factors for blood clots, heart or blood vessel disease, or if you have had performed an angioplasty (artery-opening procedure).
  3. Reported mainly in the treatment of bleeding (high dose).

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: https://yellowcard.mhra.gov.uk. By reporting side effects you can help provide more information on the safety of this medicine.