Prospecto: information for the user

ALTELLUS 300 micrograms adults, pre-filled syringe solution

Adrenaline

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

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

1.What is Altellus adults and for what it is used

2.What you need to know before starting to use Altellus adults

3.How to use Altellus adults

4.Possible adverse effects

5.Storage of Altellus adults

6.Contents of the package and additional information

Altellus adultsis a sterile preloaded pen for injection, in cases of emergency, in the muscle (intramuscular).

Altellus adults autoinjectors (adrenaline) are indicated for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens in, for example, foods, medications, insect bites or stings, as well as severe allergic reactions caused by exercise or unknown causes.

Altellus adults autoinjectors are intended for immediate administration in patients with a high risk of anaphylaxis, including individuals with a history of anaphylactic reactions.

The symptoms that signal the onset of anaphylactic reaction include: itching skin, rash (such as urticaria); flushing; swelling of the lips, throat, tongue, hands, and feet; wheezing; hoarseness; nausea; vomiting; abdominal cramps and, in some cases, loss of consciousness.

The medication in the autoinjector (preloaded pen) is adrenaline, which is an adrenergic drug.

Altellus adultsactsdirectly on the cardiovascular system (heart and blood circulation) and respiratory system (lungs), countering the possible fatal effects of anaphylaxis by rapidly constricting blood vessels, relaxing the pulmonary muscles to improve breathing, reducing swelling, and stimulating heart rhythm.

No use Altellus adultos

No hay razones conocidas por las cuales no se deba utilizarAltellus adultosdurante una emergencia de tipo alérgico.

Advertencias y precauciones

Si tiene asma,puede presentar mayor riesgo deuna reacciónalérgica grave.

Cualquier persona que tengaun episodio deanafilaxiadebeconsultar a su médicosobre las pruebasde las sustanciasa lasque puedeser alérgico, para que éstas puedan serestrictamenteevitadasen el futuro.Es importanteser consciente de queuna alergia auna sustanciapuededar lugar a alergiasa otra serie desustanciasrelacionadas.

Si usted tienealergia a los alimentos, es importante quecompruebelos ingredientes detodo lo queingiere(incluidos los medicamentos),ya que inclusopequeñas cantidadespueden causarreacciones graves.

Informe a su médico si padece:

• una enfermedad cardíaca
• una hiperfunción del tiroides
• tensión arterial alta
• diabetes

• un aumento de presión en el ojo (glaucoma)
• problemas de riñón graves
• un tumor en la próstata
• niveles altos de calcio o niveles bajos de potasio en la sangre
• enfermedad de Parkinson

A pesar de estos casos, la adrenalina es esencial para el tratamiento de la anafilaxia. Los pacientes que sufren cualquiera de las condiciones señaladas, o cualquier persona que esté en situación de aplicarAltellus adultosa un paciente que sufre una reacción alérgica, deben ser instruidos adecuadamente sobre las situaciones en las que debe administrarse.

Las instrucciones de uso deben seguirse cuidadosamente a fin de evitar la inyección accidental.

Altellus adultossolo debe inyectarse en la parte externa del muslo.No se debe inyectar en la nalga debido al riesgo de inyección accidental en vena.

Precauciones:la inyecciónaccidental en las manos o dedos puede dar lugar a la pérdida de riego sanguíneo en la zona afectada. Si se produce una inyección accidental en estas zonas, debe acudir inmediatamente al servicio de urgencias más cercano para ser tratado.

Si tiene una gruesa capa de grasa subcutánea, existe el riesgo de que una sola dosis de Altellus no sea suficiente. Puede ser necesaria una segunda inyección. Siga cuidadosamente las instrucciones de uso que se dan en la sección 3

Niños y adolescentes

Niños entre 15 kg y 30 kg de peso:

Para niños entre 15 kg y 30 kg de peso está disponible Altellus niños, autoinyector que contiene 150 microgramos de adrenalina por dosis.

Niños con peso inferior a 15 kg:

La idoneidad de Altellus niños (150 microgramos) ha de ser valorada de modo individual por el médico.

El uso en niños que pesen menos de 7,5 kg no se recomienda a menos que la situación sea de amenaza para la vida y bajo supervisión médica

.Otros medicamentos y Altellus

Comunique a su médico o farmacéutico si está utilizando, ha utilizado recientemente o podría tener que utilizar cualquier otro medicamento, especialmente si toma cualquiera de los siguientes medicamentos:

• Antidepresivos como los antidepresivos tricíclicos o los inhibidores de la monoaminooxidasa (inhibidores de la MAO), ya que los efectos de la adrenalina se pueden aumentar.
• Medicamentos para tratar la enfermedad de Parkinson, tales como los inhibidores de la catecol-O-metil transferasa (inhibidores de la COMT) y levodopa, ya que se puede aumentar el efecto de la adrenalina.
• Medicamentos que pueden hacer sensible al corazón a latidos irregulares (arritmias), como la digital y la quinidina.
• Medicamentos beta bloqueantes para enfermedades cardíacas o medicamentos para alteraciones del sistema nervioso, ya que pueden reducir el efecto de la adrenalina.
• Medicamentos para trastornos del tiroides.
• Medicamentos que le permiten respirar más fácilmente, utilizados para el asma (teofilina).
• Medicamentos utilizados durante el parto (oxitocina).
• Medicamentos utilizados para tratar alergias como difenhidramina o clorfenamina (antihistamínicos).
• Medicamentos que actúan sobre el sistema nervioso (parasimpaticolíticos).

Los pacientes diabéticos deben controlar cuidadosamente sus niveles de glucosa tras el uso deAltellus adultosya que la adrenalina puede afectar a la cantidad de insulina producida por el organismo, aumentando así el nivel de glucosa en sangre.

Uso de Altellus adultos con los alimentos, bebidas y alcohol

Los alimentos y bebidas no afectan al uso deAltellus adultos.

Informe a su médico si toma alcohol, ya que puede aumentar el efecto de la adrenalina.

Embarazo y lactancia

Embarazo

Si está embarazada o en período de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

En una situación crítica de amenaza para su vida, no dude en utilizar Altellus adultos, ya que su vida y la de su hijo pueden estar en peligro. La experiencia del uso de adrenalina durante el embarazo es limitada.

Lactancia

No se espera que Altellus adultos tenga ningún efecto sobre el lactante.

Conducción y uso de máquinas

La capacidad para conducir y usar máquinas no se verá afectada por la administración de una inyección de adrenalina, pero podría verse afectada por la reacción anafiláctica. Si esto ocurre, no conduzca.

Altellus adultos contiene metabisulfito de sodio (E-223) y cloruro de sodio

Este medicamento puede producir reacciones alérgicas graves y broncoespasmo (sensación repentina de ahogo) porque contiene metabisulfito de sodio.

Este medicamento contiene menos de 23 mg (1 mmol) de sodio por dosis, por lo que se considera esencialmente “exento de sodio”.

When your doctor prescribes Altellus for adults, you must ensure that you understand the reason why it has been prescribed. You must be completely sure that you know how to use the device. Use Altellus for adults exactly as your doctor or pharmacist has instructed. If you are unsure of how to use it, ask your doctor, nurse, or pharmacist to repeat the instructions.

It is recommended that family members, caregivers, or teachers are also trained in the correct use of the Altellus for adults auto-injector.

In the case of an injection administered by a caregiver, the patient's leg must be immobilized during the injection to minimize the risk of laceration at the injection site.

Under no circumstances should the used needle be reused.

A simulator of Altellus (without medication and without needle) is available to teach and demonstrate how to use the Altellus for adults auto-injector. The simulator and the Altellus for adults auto-injector with medication should not be carried together to avoid confusion in an emergency situation.

Altellus for adults is intended for individuals with a body weight above 30 kg.

For children weighing less than 30 kg, see the previous section "Children and adolescents".

Dose

The dose will be determined by your doctor, who will adjust it individually for you. The normal dose in adults for allergic emergencies is 300 micrograms of adrenaline administered intramuscularly.

If you detect signs of an acute allergic reaction, use Altellus for adults immediately.

Each Altellus for adults auto-injector releases a single dose of 0.3 ml of liquid, equivalent to 300 micrograms of adrenaline. After use, a small volume remains in the auto-injector, but it should not be reused.

At times, a single dose of adrenaline may not be sufficient to completely neutralize the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one unit of Altellus for adults. If your symptoms have not improved or have worsened within 5-15 minutes after the first injection, either you or the person with you should administer a second injection.For this reason, you must always carry more than one unit of Altellus for adults.

How to use Altellus for adults

Altellus for adults is designed to be easily used by individuals without medical training.Altellus for adults simply needs to be firmly pushed into the outer part of the thigh, from a distance of about 10 cm. There is no need for an exact placement in the same location. By firmly pushing Altellus for adults into the thigh, a spring is activated, the plunger is released in the direction of the thigh muscle, and a dose of adrenaline is released.Altellus for adults can be used, if necessary, through clothing.

The usage instructions for Altellus for adults must be followed carefully.

Altellus for adults MUST ONLY be injected into the outer part of the thigh.Do not inject into the buttocks.

Usage instructions

Familiarize yourself well with Altellus for adults, when and how it should be used.

Blue safety cap Visibility window Orange tip

Follow these instructionsonlywhen you are going to use the medication.

Hold the auto-injector by the center, never by the ends. For correct administration, observe the drawings and follow these steps:

- Never place your finger, fingers, or hand on the orange tip. Never press or push the orange tip with your finger, fingers, or hand.

- The needle comes out through the orange tip.

- NEVER remove the blue safety cap until the product is about to be used.

A small bubble may appear in the Altellus for adults auto-injector.This does not affect the product's efficacy.

Although most of the liquid (about 90%) remains in the auto-injectorafter use, it cannot be reused. However, you have received the correct dose of medication if the orange tip of the needle extends and the visibility window darkens. After use, dispose ofAltellus for adultssafely in the container provided and take it with you when you visit your doctor, hospital, or pharmacy.

Altellus for adults has beendesigned as a treatment in emergency situations. You must always seek medical help immediately after using Altellus for adults.Call 112, request an ambulance, and indicate that you are experiencing anaphylaxis,evenif your symptomsappear to be improving.You will need to go to the hospital for observation and additional treatment if necessary.This is because the reaction canappear againsome time later.

While waitingfor the ambulance,you shouldremain lying down withyourfeet elevatedunless you are short of breath, in which caseyou shouldsit up.Ask someone tostay with youuntil the ambulance arrivesif you do not feel wellagain.

Unconscious patients should be placedon their side,in the recovery position.

If you use more Altellus for adults than you should

In the event of an overdose or accidental injection, consult your doctor or pharmacist immediately or call the toxicology information service, phone 91 562 04 20.

Like all medications, this medicationmay cause adverse effects, although not all people will experience them.

Rare cases of severe skin and soft tissue infections (infection at the injection site) have been reported. If you experience signs of infection at the injection site, such as swelling, redness, heat, or pain, seek medical help immediately.

Accidental injections in hands and feet have been described, which may cause loss of blood flow to the affected area. If you experience an accidental injection, seek medical help immediately.

Allergic reactions may occur in patients sensitive to sodium metabisulfite.In rare cases (affecting up to 1 in 1,000 people), cardiomyopathies due to stress have been observed in patients treated with adrenaline.

Not known: (frequency cannot be estimated from available data): severe heart rhythm disturbances, intense chest pain, high blood pressure, respiratory difficulties, pallor, sweating, nausea, vomiting, headache, dizziness, weakness, tremors, and nervousness or anxiety, lesions at the injection site such as hematomas, bleeding, or erythema.

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 Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medicationafter the expiration date that appears on the box and label after CAD. or EXP. The expiration date is the last day of the month indicated.

Do not storeat a temperature above 25°C. Do not refrigerate or freeze.

Store the container in the outer packaging to protect it from light. When exposed to air or light, adrenaline degrades quickly and turns pink or brown.Remember to check the contents of the glass cartridge in the Altellus adult autoinjector periodically, to ensure that the liquid remains transparent and colorless.Replace the autoinjector on its expiration date or earlier if the solution has changed color or contains a precipitate (solid particles).

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment

Composition of Altellus adults

• The active principle is adrenaline. Each dose contains 300 micrograms of adrenaline.
• The other components are: sodium chloride, sodium metabisulphite (E-223), hydrochloric acid, water for injection.

Appearance of the product and contents of the container

Transparent and colourless solution in a preloaded pen (autoinjector).

The autoinjector contains 2 ml of injection solution. Each autoinjector releases a single dose (0.3 ml) of 0.3 mg of adrenaline.

Approximate length of exposed and protected needle: 15 mm.

Presentations:

1 Autoinjector

2 x 1 Autoinjector.

Not all container sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:November 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/