Octostim 1.5 mg/ml nasal spray solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Octostim 1.5 mg/ml nasal spray solution
Desmopressin acetate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Octostim is and what it is used for
- What you need to know before using Octostim
- How to use Octostim
- Possible side effects
- How to store Octostim
- Contents of the pack and other information
1. What Octostim is and what it is used for
Octostim contains desmopressin, an analogue of the natural pituitary hormone arginine-vasopressin, which, when administered at appropriate doses, causes changes in the factors involved in blood coagulation, thereby shortening or normalizing prolonged bleeding time caused by various conditions.
It is indicated for:
- the therapeutic treatment and prevention of bleeding in patients with mild Hemophilia A and von Willebrand disease (disorders of blood coagulation) who respond positively to a test dose. In exceptional cases, moderate forms of these diseases may also be treated.
- decreasing and normalizing prolonged bleeding time due to platelet function disorders in patients who respond positively to a test dose.
2. What you need to know before using Octostim
Do not use Octostim if you have wounds or irritation in the nasal mucosa, as you may not achieve the desired effect.
Do not use Octostim:
- if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6),
- if you have prolonged excessive thirst or thirst due to a mental disorder,
- if you suffer from heart failure or other conditions requiring treatment with diuretic medicines (those that increase urine production),
- in von Willebrand disease Type IIB (a blood coagulation disorder), hemophilia A and von Willebrand disease Type I with factor VIII coagulant activity below 5%, hemophilia B and hemophiliacs with anti-factor VIII antibodies,
- if you have low sodium levels in the blood (known hyponatremia),
- if you suffer from syndrome of inappropriate ADH secretion (antidiuretic hormone),
- if you have uncontrolled high blood pressure.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Octostim.
Take special care with Octostim to avoid fluid accumulation in the following cases:
- children or elderly patients,
- treatment with diuretic medicines (those that increase urine production) (see section "Use with other medicines"),
- coronary heart disease, hypertension,
- conditions characterized by disturbances in the balance of water and electrolytes (calcium, magnesium, etc.) in the blood,
- patients at risk of increased intracranial pressure (pressure inside the skull),
- patients with kidney problems.
Due to the possibility of excessive fluid retention, monitor for headache, nausea, weight gain, and blood pressure during treatment. Treatment must be discontinued if weight gain or signs of fluid retention/hyponatremia (low blood sodium) occur.
Consult your doctor if you belong to any of the patient groups mentioned above.
Interaction of Octostim with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This medicine may interact with drugs that can enhance the antidiuretic effect (reduction in urine volume) of desmopressin, thereby increasing the risk of water retention and hyponatremia (low blood sodium): tricyclic antidepressants, chlorpromazine (a medicine used to treat psychiatric disorders), carbamazepine (a medicine used to prevent seizures), chlorpropamide (a medicine used to treat diabetes mellitus), and non-steroidal anti-inflammatory drugs.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will assess the risks and benefits of treatment.
Desmopressin passes into breast milk, although in small amounts; therefore, if you are breastfeeding, natural breastfeeding is not recommended.
Driving and using machines
The effect of Octostim on the ability to drive and use machines is none or negligible.
Warnings about excipients:
This medicine may cause bronchospasm (sudden sensation of suffocation) because it contains benzalkonium chloride.
3. How to use Octostim
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Octostim is administered intranasally.
Therapeutic control of bleeding or prevention of bleeding:
300 micrograms (1 spray into each nostril) are administered during bleeding. The dose may be repeated every 12 hours for up to 2–3 days. In the case of surgical procedures, desmopressin is recommended to be administered intravenously.
It is important that you read and follow the instructions below on how to use Octostim
Before using Octostim for the first time, prime the pump by pressing it 6 times, or until a spray appears. If you have not used Octostim for 3 days, the pump must be re-primed by pressing it twice, or until a spray appears.
INSTRUCTIONS FOR USE:
Blow your nose before using the spray.
- Remove the protective cap from the applicator.
- Check that the end of the tube inside the bottle is submerged in the liquid.
- Re-prime the pump if the spray has not been used within the last 3 days.
- Once primed, the pump delivers one dose each time pressure is applied.
- Insert the applicator directly into the nostril and spray once. Breathe normally through your nose without inhaling forcefully.
- If a higher dose is needed, spray alternately into each nostril.
- Replace the protective cap after use and store the bottle in an upright position.
The bottle must be stored in an upright position.
If you are unsure whether the dose was correctly administered, do not re-administer the spray until the next scheduled dose.
Use in children:
In young children, administration must be performed under strict adult supervision to ensure the correct dose.
If you use more Octostim than you should
If you have used more Octostim than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915 620 420, indicating the medicine and amount used.
If you use more Octostim than recommended or accidentally, symptoms may include those associated with water retention and/or decreased sodium in the blood, such as headache, nausea, vomiting, weight gain, and in severe cases, seizures.
Treatment should be discontinued, fluid intake should be restricted, and symptomatic treatment should be provided if necessary.
If you forget to take Octostim
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.
If you stop using Octostim
Your doctor will advise you on the duration of your treatment with Octostim. Do not stop treatment early, as it may not have the intended effect.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Octostim may cause adverse effects, although not everyone experiences them.
The following frequent adverse effects may affect up to 1 in 10 people:
- headache
- stomach pain
- nausea
- nasal congestion/rhinitis
- nosebleed
- transient tachycardia
- facial flushing
- eye redness
The following very rare adverse effects may affect up to 1 in 10,000 people:
- low sodium levels in the blood (hyponatremia)
Other adverse effects for which frequency is unknown:
- weight gain, vomiting, muscle spasms, swelling, fatigue, confusion, dizziness, and in severe cases, seizures and allergic reactions to benzalkonium chloride (preservative)
- redness and itching.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Octostim
Keep this medicine out of the sight and reach of children.
Do not use Octostim after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
The shelf life after first opening the container is 6 months.
Do not store above 25°C.
Store in an upright position.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Octostim:
The active substance is desmopressin acetate. 1 millilitre of nasal spray solution contains 1.5 milligrams of desmopresin acetate, equivalent to 1.34 milligrams of desmopressin.
The other components are:
Benzalkonium chloride,
Monohydrate citric acid,
Sodium chloride,
Disodium phosphate dihydrate,
Purified water.
Appearance of the product and contents of the container
Octostim is supplied in brown glass bottles of 10 millilitres containing 2.5 millilitres of solution, equipped with pre-compression spray pumps with an applicator and a protective cap, designed to deliver 150 micrograms per spray actuation.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
FERRING S.A.U.
C/ Arquitecto Sánchez Arcas 3, 1º.
28040 Madrid
SPAIN
Manufacturer
FERRING GmbH
Wittland, 11
24109 Kiel
Germany
Date of the most recent revision of this leaflet: September 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/