Octostim 1,5 mg/ml soluciÓn para pulverizaciÓn nasal

Leaflet: information for the user

Octostim 1.5 mg/ml nasal spray solution

Desmopressin acetate

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Octostim and what it is used for

2. What you need to know before you start using Octostim

3. How to use Octostim

4. Possible side effects

5. Storage of Octostim

6. Contents of the pack and additional information

Octostim contains desmopressin, a natural arginine-vasopressin hormone analog, which, when administered at adequate doses, causes a modification in the factors involved in blood coagulation and as a consequence shortens or normalizes prolonged bleeding time (hemorrhage), caused by various reasons.

It is indicated for:

• therapeutic treatment and prevention of bleeding (hemorrhage) in patients with mild Hemophilia A and von Willebrand disease (blood coagulation alterations) who respond positively to the test dose. In exceptional cases, it may also be used to treat moderate cases of these diseases.
• in patients who respond positively to the test dose, it decreases and normalizes prolonged bleeding time (hemorrhage) due to thrombocytopenia (platelet alteration).

Do not use Octostim if you have wounds or irritation in the nasal mucosa, as you may not obtain the desired effect.

The desired effect may not be obtained.

Do not use Octostim:

• if you are allergic to desmopressin or any of the other components of this medication (listed in section 6),
• if you have prolonged excessive thirst or thirst due to a mental disorder
• if you have heart failure and other diseases that require treatment with diuretic medications (those that increase urine production),
• in von Willebrand disease Type IIB (blood clotting disorders), hemophilia A, and von Willebrand disease type I with a factor VII coagulant activity less than 5%, hemophilia B, and hemophiliacs with anti-factor VIII antibodies
• if you have sodium deficiency in the blood (known hypnatremia)
• if you have inappropriate secretion of ADH (antidiuretic hormone) syndrome
• if you have uncontrolled high blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Octostim.

Be especially careful with Octostim to avoid fluid accumulation in the following cases:

• children or elderly patients
• diuretic medications (those that increase urine production) (see section “Use of other medications”).
• coronary heart disease, hypertension
• diseases characterized by alterations in the proportion of water and electrolytes (calcium, magnesium...) in the blood
• patients at risk of increased intracranial pressure (pressure inside the skull)
• patients with kidney problems.

Considering the possibility of excessive fluid retention, you should monitor that you do not have headaches, nausea, weight gain, and your blood pressure during treatment.The treatment should be interrupted in the case of weight gain and signs of fluid retention/ hypnatremia (decreased sodium in the blood).

Consult your doctor if you are in any of the patient groups mentioned above.

Interaction of Octostim with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

This medication may interact with drugs that can increase the antidiuretic effect (reduction of urine production) of desmopressin and, therefore, increase the risk of water retention and hypnatremia (decreased sodium in the blood):tricyclic antidepressants, clopromacina (medication for the treatment of psychiatric problems), carbamazepine (medication to prevent seizures), andchlorpropamide(medication for the treatment of diabetes mellitus) and nonsteroidal anti-inflammatory drugs.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

If you are pregnant, your doctor will evaluate the risk versus the benefit of treatment

Desmopressin, although in small amounts, passes into breast milk, so in the case of breastfeeding, it is recommended to substitute natural breastfeeding.

Driving and operating machinery

The influence of Octostim on the ability to drive and operate machinery is negligible or insignificant.

Warnings about excipients:

This medication may cause bronchospasm (sudden sensation of choking) because it contains benzalkonium chloride.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Octostim is administered via intranasal route.

Therapeutic control of bleeding or prevention of bleeding:

300 micrograms (1 spray in each nasal orifice) are administered during bleeding (bleeding). The dose can be repeated every 12 hours for a maximum of 2-3 days. In the case of surgery, it is recommended to administer desmopressin via intravenous route.

It is essential that you read and follow the following instructions on how to use Octostim

Before using Octostim for the first time, you must prepare the pump by pressing it 4 times, or until a spray appears. If you have not used Octostim in the past week, it is necessary to prepare the pump again by pressing it once, or until a spray appears.

!IMPORTANT! When using Octostim theend of the tube must always be submerged in the liquid.

USAGE INSTRUCTIONS:

1. Remove the protective cap from the applicator.
2. Hold the bottle with your thumb, index, and middle fingers as indicated in figure 2.
3. Incline your head slightly backward while inserting the applicator directly into the nasal orifice as indicated in figure 3. Start the nebulization by covering, simultaneously, the other nasal orifice. Inhale gently the product in each dosage.
4. Repeat the administration in the other nasal orifice
5. Replace the protective cap. Store the bottle always in an upright position.

If you use more Octostim than you should

If you have used more Octostim than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915 620 420 indicating the medication and the amount used.

If you use Octostim more than you should or accidentally, the symptoms would be the consequent of water retention and/or sodium decrease in the blood such as headache, nausea, vomiting, weight gain, and in severe cases, convulsions.

It is recommended to interrupt the treatment and restrict fluid intake and symptomatic treatment if necessary.

If you forgot to take Octostim

If you miss a dose, apply the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Octostim

Your doctor will indicate the duration of your treatment with Octostim. Do not suspend the treatment before, as it may not have the expected effect.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Octostim can produce adverse effects, although not everyone will experience them.

The following adverse effects, which are frequent, may affect up to 1 in 10 people:

• Headache
• Abdominal pain
• Nausea
• Nasal congestion/rhinitis
• Nosebleed
• Transient tachycardia
• Facial flushing
• Eye redness

The following are adverse effects that are very rareand may affect up to 1 in 10,000 people:

• Hypontremia (sodium deficiency in the blood)

Other adverse effects for which the frequency is unknown:

• Weight gain, vomiting, muscle spasms, swelling, fatigue, disorientation, dizziness, and in severe cases, seizures and comaAllergic reactions to benzalkonium chloride (preservative)
• Redness and itching.

.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Octostim after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

The shelf life after the first opening of the packaging is 6 months.

Do not store at a temperature above 25°C.

Store the bottle always in an upright position.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Octostim:

The active ingredient is desmopressin acetate. 1 milliliter of nasal spray solution contains 1.5 milligrams of desmopressin acetate, equivalent to 1.34 milligrams of desmopressin.

The other components are:

Benzalkonium chloride

Citric acid monohydrate,

Sodium chloride,

Dihydrated disodium phosphate,

Purified water.

Appearance of the product and contents of the packaging

Octostim is presented in 10 milliliter brown glass bottles containing 2.5 milliliters of solution, which are equipped with pre-compressed aerosol pumps with an applicator and a protective cap, and are designed to release 150 micrograms each time they are pressed.

Holder of the Marketing Authorization and Responsible Manufacturer

Holder of the Marketing Authorization

FERRING S.A.U.

C/ Arquitecto Sánchez Arcas 3, 1º.

28040 Madrid

SPAIN

Responsible Manufacturer

FERRING GmbH

Wittland, 11

24109 Kiel

Germany

Date of the last review of this prospectus: July 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/