Altellus 150 micrograms children, solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ALTELLUS 150 micrograms children, solution for injection in a pre-filled pen

Adrenaline

Read this 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 you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Altellus children is and what it is used for
2. What you need to know before using Altellus children
3. How to use Altellus children
4. Possible side effects
5. How to store Altellus children
6. Contents of the pack and other information

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

Altellus children is a sterile solution in a pre-filled pen for emergency intramuscular injection.

Altellus children auto-injectors (adrenaline) are indicated for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens such as, for example, foods, medications, insect bites or stings, as well as severe allergic reactions triggered by exercise or unknown causes.

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

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

The medicine contained in the auto-injector (pre-filled pen) is adrenaline, which is an adrenergic drug.

Altellus children acts directly on the cardiovascular system (heart and blood circulation) and respiratory system (lungs), counteracting the potentially life-threatening effects of anaphylaxis by rapidly constricting blood vessels, relaxing lung muscles to improve breathing, reducing swelling, and stimulating heart rate.

2. What you need to know before using Altellus children

Do not use Altellus children

There are no known reasons why Altellus children should not be used during an allergic emergency.

Warnings and precautions

If you have asthma, you may be at higher risk of a severe allergic reaction.

Any person who has experienced an episode of anaphylaxis should consult their doctor about testing for substances to which they may be allergic, so these can be strictly avoided in the future. It is important to be aware that an allergy to one substance may lead to allergies to other related substances. If you have a food allergy, it is important to check the ingredients of everything you consume (including medications), as even small amounts can cause serious reactions.

Inform your doctor if you have:

• heart disease
• overactive thyroid
• high blood pressure
• diabetes
• increased pressure in the eye (glaucoma)
• severe kidney problems
• prostate tumor
• high calcium levels or low potassium levels in the blood
• Parkinson's disease

Despite these conditions, adrenaline is essential for the treatment of anaphylaxis. Patients with any of the conditions listed above, or anyone who may need to administer Altellus children to a patient experiencing an allergic reaction, must be properly instructed on when administration is required.

Instructions for use must be followed carefully to avoid accidental injection.

Altellus children should only be injected into the outer thigh. It must not be injected into the buttock due to the risk of accidental intravenous injection.

Precautions: Accidental injection into the hands or fingers may result in loss of blood flow to the affected area. If an accidental injection occurs in these areas, seek immediate medical attention at the nearest emergency department.

If you have a thick layer of subcutaneous fat, there is a risk that a single dose of Altellus may not be sufficient. A second injection may be necessary. Follow the instructions for use carefully as described in section 3.

Children and adolescents

Children weighing less than 15 kg:

The suitability of Altellus must be individually assessed by a physician.

Use in children weighing less than 7.5 kg is not recommended unless the situation is life-threatening and under medical supervision.

Children and adolescents weighing over 30 kg:

For these patients, Altellus 300 micrograms auto-injector is available, containing 300 micrograms of adrenaline per dose.

Other medicines and Altellus

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors), as the effects of adrenaline may be increased.
• Medicines for Parkinson's disease, such as catechol-O-methyltransferase inhibitors (COMT inhibitors) and levodopa, as the effect of adrenaline may be increased.
• Medicines that may make the heart sensitive to irregular heartbeats (arrhythmias), such as digitalis and quinidine.
• Beta-blockers for heart conditions or medications for nervous system disorders called alpha- or beta-blockers, as they may reduce the effect of adrenaline.
• Medicines for thyroid disorders.
• Medicines that help you breathe more easily, used for asthma (theophylline).
• Medicines used during childbirth (oxytocin).
• Medicines used to treat allergies such as diphenhydramine or chlorpheniramine (antihistamines).
• Medicines acting on the nervous system (anticholinergics).

Diabetic patients should carefully monitor their glucose levels after using Altellus children, as adrenaline may affect the amount of insulin produced by the body, thereby increasing blood glucose levels.

Use of Altellus children with food, drinks, and alcohol

Food and drinks do not affect the use of Altellus children.

Inform your doctor if you consume alcohol, as it may increase the effect of adrenaline.

Pregnancy and breastfeeding

Pregnancy

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.

In a life-threatening emergency, do not hesitate to use Altellus children, as both your life and your baby's life may be at risk. Experience with the use of adrenaline during pregnancy is limited.

Breastfeeding

Altellus children is not expected to have any effect on the breastfed infant.

Driving and use of machines

Not applicable.

Altellus children contains sodium metabisulfite (E-223)

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.

This medicine contains less than 1 mmol (23 mg) of sodium per dose and is therefore considered essentially "sodium-free."

3. How to use Altellus children

When your doctor prescribes Altellus children, you must ensure that you understand the reason for which it has been prescribed. You must be fully certain that you know how to use the device. Always use Altellus children exactly as instructed by your doctor or pharmacist. If you are unsure about how to use it, ask your doctor, nurse, or pharmacist to repeat the instructions.

It is recommended that family members, caregivers, or teachers also be trained in the correct use of the Altellus children 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 to the leg, bent needles, or other injuries.

The product is for single use only. Do not reuse a used auto-injector.

A training simulator for Altellus children (without medication and without needle) is available for teaching and demonstrating how to use the Altellus children auto-injector. The simulator and the medication-containing Altellus children auto-injector should not be carried together to avoid confusion in an emergency situation.

Altellus children is intended for children with a body weight between 15–30 kg.

For adults, adolescents, and children weighing over 30 kg, Altellus 300 micrograms for adults is available—an auto-injector containing 300 micrograms of adrenaline per dose.

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

Dosage

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

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

Each Altellus children auto-injector delivers 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 must not be reused.

Sometimes, a single dose of adrenaline may not be sufficient to completely reverse the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one Altellus children unit. If your symptoms have not improved or have worsened within 5–15 minutes after the first injection, you or the person accompanying you must administer a second injection. For this reason, you should always carry more than one Altellus children unit.

How to administer Altellus children

Altellus children is designed to be easily used by people without medical training. Altellus children is simply administered by firmly jabbing it into the outer thigh, from a distance of about 10 cm. Precise placement is not required. When Altellus children is firmly jabbed into the thigh, a spring is activated, driving the plunger forward; the needle is released toward the thigh muscle and delivers a dose of adrenaline. Altellus children can be used, if necessary, through clothing.

The instructions for use of Altellus children must be followed carefully. It is recommended that family members, caregivers, or teachers also receive instruction on the correct use of Altellus.

Altellus children MUST ONLY be injected into the outer thigh. It must not be injected into the buttock.

Instructions for use

Become thoroughly familiar with Altellus children, when and how it should be used.

Blue safety cap Viewing window Orange end

Follow these instructions only when you are about to use the medicine.

Hold the auto-injector by the center—never by the ends. For correct administration, refer to the illustrations and follow these steps:

• Never place your thumb, fingers, or hand over the orange end. Never press or push the orange end with your thumb, fingers, or hand.

• The needle emerges from the orange end.

• DO NOT remove the blue safety cap until the product is to be used.

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

Although most of the liquid (approximately 90%) remains in the auto-injector after use, it cannot be reused. However, you have received the correct dose of medication if the orange needle cap extends and the viewing window darkens. After use, dispose of Altellus children safely in the container provided and take it with you when you go to your doctor, hospital, or pharmacy.

Altellus children is designed as a treatment for emergency situations. You must always seek immediate medical help after using Altellus children. Call 112, request an ambulance, and state that you are experiencing anaphylaxis, even if symptoms appear to be improving. You will need to go to the hospital for observation and additional treatment if necessary. This is because the reaction may recur some time later.

While waiting for the ambulance, you should remain lying down with your legs elevated, unless you have difficulty breathing, in which case you should sit up. Ask someone to stay with you until the ambulance arrives, in case you feel unwell again.

Unconscious patients should be placed on their side in the recovery position.

If you use more Altellus children than you should

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Rare cases of serious skin and soft tissue infections (injection site infection) have been reported. If you notice signs of infection at the injection site, such as swelling, redness, warmth, or pain, always seek immediate medical attention.

Cases of accidental injection into the hands or feet have been described, which may cause impaired blood flow to the affected area, resulting in paleness, coldness, or numbness. In case of accidental injection, always seek immediate medical help.

Allergic reactions may occur in patients sensitive to sodium metabisulfite. In rare cases (may affect up to 1 in 1,000 people), myocardial injury (stress cardiomyopathy) has been observed in patients treated with adrenaline.

Not known: (frequency cannot be estimated from available data): disturbances in heart rhythm, sometimes severe, irregular and uncoordinated contractions of the lower chamber of the heart (ventricular fibrillation), severe chest pain, high blood pressure, breathing difficulties, pallor, sweating, nausea, vomiting, headache, dizziness, weakness, tremor, and nervousness or anxiety; injection site injuries such as bruising, bleeding, or skin erythema; and skeletal injuries.

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Altellus niños

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

Do not use this medicine after the expiry date stated on the carton and label after CAD. or EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze.

Keep the container in the outer packaging to protect it from light. Adrenaline degrades rapidly when exposed to air or light, turning pink or brown. Remember to periodically inspect the contents of the glass cartridge in the Altellus niños auto-injector to ensure that the liquid remains clear and colourless. Replace the auto-injector by its expiry date, or earlier if the solution has changed colour or contains a precipitate (solid particles).

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Altellus niños

• The active substance is adrenaline. Each dose contains 150 micrograms of adrenaline.
• The other components are: sodium chloride, sodium metabisulfite (E-223), hydrochloric acid, water for injection.

Appearance of the product and contents of the container

Clear, colourless solution in a pre-filled pen (auto-injector).

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

Approximate length of exposed and shielded needle: 13 mm

Pack sizes:

1 Auto-injector

2 x 1 Auto-injector

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Meda Pharma GmbH & Co. KG.

Benzstrasse 1

61352 Bad Homburg

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the last review of this leaflet: November 2025

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