Label: information for theuser

ALTELLUS 150 micrograms children, preloaded injectable solution in pen

Adrenaline

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

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

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

• This medication has been prescribed to you alone and should not be given 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 label. See section 4.

Label content

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

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

3. How to use Altellus children

4. Possible adverse effects

5. Storage of Altellus children

6. Contents of the package and additional information

Altellus for childrenis a sterile pre-filled syringe for intramuscular injection in emergency cases.

Altellus for children (adrenaline) auto-injectors 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 for children auto-injectors are intended for immediate administration in patients at high risk of anaphylaxis, including individuals with a history of anaphylactic reactions.

The symptoms that indicate the onset of anaphylactic reaction include: itching skin, rash (like 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 auto-injector (pre-filled syringe) is adrenaline, which is an adrenergic drug.

Altellus for children acts directly on the cardiovascular (heart and blood circulation) and respiratory (lungs) systems, countering the possible fatal effects of anaphylaxis by rapidly constricting blood vessels, relaxing lung muscles to improve breathing, reducing swelling, and stimulating heart rhythm.

No use Altellus niños

No hay razones conocidas por las cuales no se deba utilizarAltellus niñosdurante 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 niñosa 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 niñossolo 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 con peso menor de 15 kg:

La idoneidad de Altellus 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.

Niños y adolescentes por encima de 30 kg de peso:

Para estos pacientes se dispone de Altellus 300 microgramos autoinyector, que contiene 300 microgramos de adrenalina por dosis.

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 niñosya 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 niños con los alimentos, bebidas y alcohol

Los alimentos y bebidas no afectan al uso deAltellus niños.

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 niños, 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 niños tenga ningún efecto sobre el lactante.

Conducción y uso de máquinas

No procede.

Altellus niños 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 children, 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 exactly as instructed by your doctor or pharmacist at all times. 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 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 auto-injector. The simulator and the Altellus auto-injector with medication should not be carried together to avoid confusion in an emergency situation.

Altellus is intended for children with a body weight ranging from 15-30 kg.

For adults, adolescents, and children with a body weight above 30 kg, Altellus 300 micrograms for adults, auto-injector containing 300 micrograms of adrenaline per dose is available.

For children weighing less than 15 kg, see the previous section "Children and adolescents".

Dose

The dose will be decided by your doctor, who will adjust it individually for you. The pediatric dose (15 – 30 kg) for allergic emergencies is 150 micrograms of adrenaline administered intramuscularly.

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

Each Altellus auto-injector releases a single dose of 0.3 ml of liquid, equivalent to 150 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. 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.

How to apply Altellus

Altellus is designed to be easily used by people without medical training. Altellus simply needs to be firmly pressed into the outer part of the thigh, about 10 cm away. There is no need for exact placement. When Altellus is pressed firmly into the thigh, a spring is activated, the needle is released towards the thigh muscle, and a dose of adrenaline is released.Altellus can be used, if necessary, through clothing.

The usage instructions for Altellus must be followed carefully.

Altellus must only be injected into the outer part of the thigh.It must not be injected into the buttocks.

Usage instructions

Familiarize yourself well with Altellus, 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 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 needle cover extends and the visibility window darkens. After use, dispose ofAltellussafely in the container provided and take it with you when you visit your doctor, hospital, or pharmacy.

Altellus has beendesigned as a treatment in emergency situations. You must always seek medical help immediately after using Altellus.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 mustremain lying down withyourfeet elevatedunless you are short of breath, in which caseyou mustsit up.Ask someone tostay with youuntil the ambulance arrivesif you do not feel wellagain.

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

If you use more Altellus 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 produce adverse effects, although not all people may experience them.

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

Cases of accidental injection in hands and feet have been described, which may cause loss of blood flow in the affected area. If an accidental injection occurs, seek medical help immediately.

Allergic reactions may occur in patients sensitive to sodium metabisulfite.In rare cases (may affect 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, breathing 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 of 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 25ºC. 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 Children 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 point of 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 children

• The active principle is adrenaline. Each dose contains 150 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 packaging

Transparent and colourless solution in a preloaded pen (auto-injector).

The auto-injector contains 2 ml of injection solution. Each auto-injector releases a single dose (0.3 ml) of 0.15 mg of adrenaline.

Approximate length of exposed and protected needle: 13 mm

Presentation:

1 Auto-injector

2 x 1 Auto-injector.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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