Altellus 300 micrograms adults, solution for injection in pre-filled pen

Patient Information Leaflet

Introduction

Patient Information Leaflet

ALTELLUS 300 micrograms adults, pre-filled injection pen

Adrenaline

Read the entire leaflet carefully before you start using this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Altellus adults is a sterile solution in a prefilled auto-injector pen for emergency intramuscular injection.

Altellus adults auto-injectors (epinephrine) 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 of unknown cause.

Altellus adults 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 (prefilled pen) is epinephrine, an adrenergic drug.

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

2. What you need to know before using Altellus adults

Do not use Altellus adults

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

Warnings and precautions

If you have asthma, you may be at increased 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 that 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 food allergies, 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 (hyperthyroidism)
• high blood pressure
• diabetes
• increased pressure in the eye (glaucoma)
• severe kidney problems
• prostate tumor
• high levels of calcium or low levels of potassium 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 adults to a patient experiencing an allergic reaction, must be adequately trained on when administration is required.

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

Altellus adults must only be injected into the outer thigh. It should 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 reduced blood flow to the affected area. If an accidental injection occurs in these areas, seek immediate medical attention at the nearest emergency facility.

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 between 15 kg and 30 kg:

For children weighing between 15 kg and 30 kg, Altellus children, an auto-injector containing 150 micrograms of adrenaline per dose, is available.

Children weighing less than 15 kg:

The suitability of Altellus children (150 micrograms) must be individually assessed by the physician.

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

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

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

Use of Altellus adults with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

Pregnancy

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

In a life-threatening emergency, do not hesitate to use Altellus adults, 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 adults is not expected to have any effect on the breastfed infant.

Driving and using machines

Your ability to drive or operate machinery may not be affected by the administration of adrenaline, but it may be impaired by the anaphylactic reaction itself. If this occurs, do not drive.

Altellus adults 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 adults

When your doctor prescribes Altellus adults, you must ensure that you understand the reason for which it has been prescribed. You should be fully certain that you know how to use the device. Always use Altellus adults 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 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 to the leg, bent needles, or other injuries.

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

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

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

For children weighing less than 30 kg, refer to the previous section “Children and adolescents”.

Dosage

Your doctor will determine the dosage and will adjust it individually for you. The usual adult dose for allergic emergencies is 300 micrograms of adrenaline administered intramuscularly.

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

Each Altellus adults auto-injector delivers 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 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 unit of Altellus 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 must administer a second injection. For this reason, you should always carry more than one unit of Altellus adults.

How to administer Altellus adults

Altellus adults is designed to be easily used by individuals without medical training. Altellus adults is simply applied by firmly pushing it against the outer thigh, from a distance of approximately 10 cm. Precise placement is not required. When Altellus adults is firmly pushed against the thigh, a spring is activated, which drives the plunger, releasing the needle into the thigh muscle and delivering a dose of adrenaline. Altellus adults can be used, if necessary, through clothing.

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

Altellus adults MUST ONLY be injected into the outer thigh. It must NOT be injected into the buttock.

Instructions for use

Become thoroughly familiar with Altellus adults, 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 medication.

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.
• 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 adult 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 must not 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 the Altellus adult auto-injector safely in the container provided and take it with you when visiting your doctor, hospital, or pharmacy.

Altellus adult is designed as an emergency treatment. You must always seek immediate medical assistance after using Altellus adult. 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 further 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 your condition worsens again.

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

If you use more Altellus adult than you should

In case of overdose or accidental injection, contact 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 (infection at the injection site) are known. If you notice signs of infection at the injection site, such as swelling, redness, warmth, or pain, always seek immediate medical help.

Cases of accidental injection into hands and feet have been reported, which may cause loss of 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), damage to the heart muscle (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 reactions 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 through 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 adults

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 adults autoinjector to ensure the liquid remains clear and colourless. Replace the autoinjector on 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 packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Altellus adults

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

Appearance of the product and contents of the pack

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

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

Approximate length of exposed and shielded needle: 15 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

More information on this medicinal product is available upon request from 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 Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: November 2025

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