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

Introduction

Package Leaflet: Information for theuser

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

Adrenaline

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

1. What is Altellus children and what is it used for
2. What you need to know before you use Altellus children
3. How to use Altellus children
4. Possible side effects
5. Storage of Altellus children
6. Package contents and further information

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

Altellus children is a sterile solution in a pre-filled pen for injection, for emergency use, into the muscle (intramuscular).

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

The Altellus children auto-injectors 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 start of an anaphylactic reaction include: itching of the skin, rash (like 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 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 potential fatal effects of anaphylaxis through rapid constriction of blood vessels, relaxing lung muscle to improve breathing, reducing swelling, and stimulating heart rate.

2. What you need to know before you use 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 greater risk of a severe allergic reaction.

Anyone who has had an anaphylactic episode should consult their doctor about testing for substances they may be allergic to, so that these can be strictly avoided in the future. It is essential to be aware that an allergy to one substance can lead to allergies to another series of related substances. If you have a food allergy, it is crucial that you check the ingredients of everything you consume (including medicines), as even small amounts can cause severe reactions.

Tell your doctor if you have:

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

Despite these cases, adrenaline is essential for the treatment of anaphylaxis. Patients who suffer from any of the conditions mentioned, or anyone who is in a situation where they need to administer Altellus children to a patient having an allergic reaction, should be properly instructed on the situations in which it should be administered.

The instructions for use must be followed carefully to avoid accidental injection.

Altellus children should only be injected into the outer thigh. Do not inject into the buttock.

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

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 given in section 3.

Children and adolescents

Children weighing less than 15 kg:

The suitability of Altellus must be assessed individually by the doctor.

The use in children who weigh less than 7.5 kg is not recommended unless the situation is life-threatening and under medical supervision.

Children and adolescents over 30 kg in weight:

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

Other medicines and Altellus

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially if you are taking any of the following medicines:

• Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), as the effects of adrenaline may be increased.
• Medicines for Parkinson's disease, such as catechol-O-methyltransferase (COMT) inhibitors and levodopa, as the effect of adrenaline may be increased.
• Medicines that can make the heart sensitive to irregular beats (arrhythmias), such as digitalis and quinidine.
• Beta-blocker medicines for heart disease or medicines for nervous system disorders, 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 that act on the nervous system (parasympatholytics).

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

Using Altellus children with food, drinks, and alcohol

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

Tell your doctor if you drink 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

In a life-threatening situation, do not hesitate to use Altellus children, as your life and that of your child 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 baby.

Driving and using machines

Not applicable.

Altellus children contains sodium metabisulfite (E-223) and sodium chloride.

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

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is essentially "sodium-free".

3. How to use Altellus children

When your doctor prescribes Altellus 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. Always use Altellus children exactly as your doctor or pharmacist has told you. If you are not sure 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 children auto-injector.

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

Never reuse a used needle.

A simulator of Altellus children (without medicine and without a needle) is available to teach and demonstrate how to use the Altellus children auto-injector. The simulator and the auto-injector with Altellus children medicine 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 over 30 kg, Altellus 300 micrograms auto-injector is available, which contains 300 micrograms of adrenaline per dose.

For children who weigh 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 normal pediatric dose (15-30 kg) for allergic emergencies is 150 micrograms of adrenaline by intramuscular injection.

If you detect 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 enough to completely counteract the effects of a severe allergic reaction. For this reason, your doctor may prescribe more than one unit of Altellus children. If your symptoms have not improved or have worsened 5-15 minutes after the first injection, either you or the person with you should administer a second injection. For this reason, you should always carry more than one unit of Altellus children.

How to apply Altellus children

Altellus children is designed to be used easily by people without medical training. Altellus children should simply be thrust firmly into the outer thigh, from a distance of about 10 cm. There is no need for precise placement. When you thrust Altellus children firmly into the thigh, a spring is triggered that activates the plunger, the needle is released towards the thigh muscle, and a dose of adrenaline is delivered.

Altellus children can be used, if necessary, through clothing.

The instructions for use of Altellus children must be followed carefully.

Altellus children should ONLY be injected into the outer thigh. Do not inject into the buttock.

Instructions for use

Familiarize yourself with Altellus children, when and how it should be used.

Blue safety cap Visibility 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, observe the diagrams and follow these steps:

• Never put your thumb, fingers, or hand over the orange end. Never press or push the orange end with your thumb, fingers, or hand.
• The needle comes out of 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 effectiveness.

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

Altellus children has been designed as a treatment in emergency situations. You should always seek medical help immediately after using Altellus children.Call 112, ask for an ambulance, and indicate that you are suffering from anaphylaxis, even if your symptoms seem to be improving.You will need to go to the hospital for observation and further treatment if necessary. This is because the reaction can occur again sometime later.

While waiting for the ambulance, you should remain lying down with your feet elevated, unless you are having trouble breathing, in which case you should sit up. Ask someone to stay with you until the ambulance arrives in case you do not feel well 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, phone 91 562 04 20.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare cases of severe 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, heat, or pain, always seek medical help immediately.

Cases of accidental injection into hands and feet have been reported, which can cause loss of blood flow in the affected area. If an accidental injection occurs, always 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), stress cardiomyopathy has been observed in patients treated with adrenaline.

Unknown: (frequency cannot be estimated from the available data): cardiac arrhythmias, sometimes severe, severe chest pain, high blood pressure, breathing difficulties, pallor, sweating, nausea, vomiting, headache, dizziness, weakness, tremors, and nervousness or anxiety, injection site injuries such as hematoma, bleeding, or erythema.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Altellus children

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

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date is the last day of the month shown.

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

Keep the container in the outer packaging to protect it from light. When exposed to air or light, adrenaline degrades rapidly and turns pink or brown. Remember to periodically check the contents of the glass cartridge in the Altellus children auto-injector to ensure that the liquid remains transparent and colorless.Replace the auto-injector on its expiry date or before if the solution has changed color or contains a precipitate (solid particles).

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for safe disposal. If you are unsure, ask your pharmacist for advice on how to dispose of unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Altellus Children

• The active ingredient 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 Packaging Contents

Transparent and colorless solution in a pre-loaded pen (auto-injector).

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

Length of exposed and protected needle approx.: 13 mm

Presentation:

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

Further information on this medicinal product can be obtained 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 2021

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