ALTELLUS 300 micrograms for adults, pre-filled pen injector solution

Introduction

Package Leaflet: Information for the User

ALTELLUS 300 micrograms for adults, solution for injection in a 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 the pack

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

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

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

The Altellus for adults 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 caused by exercise or unknown causes.

The Altellus for adults 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 for adults acts directly on the cardiovascular system (heart and blood circulation) and respiratory system (lungs), countering the potentially fatal 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 you use Altellus for adults

Do not use Altellus for adults

There are no known reasons why Altellus for adults 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 eat (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 tumor in the prostate
• 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 for adults 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 for adults should only be injected into the outer part of the thigh .It should not be injected into the buttock due to the risk of accidental injection into a vein.

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, you should immediately go to the nearest emergency room for treatment.

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. Carefully follow the instructions for use given in section 3.

Children and adolescents

Children between 15 kg and 30 kg in weight:

For children between 15 kg and 30 kg in weight, Altellus for children is available, an auto-injector that contains 150 micrograms of adrenaline per dose.

Children under 15 kg in weight:

The suitability of Altellus for children (150 micrograms) must be assessed on an individual basis 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.

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 inhibitors (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 chlorphenamine (antihistamines).
• Medicines that act on the nervous system (parasympatholytics).

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

Using Altellus for adults with food, drinks, and alcohol

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

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In a life-threatening situation, do not hesitate to use Altellus for adults, as your life and that of your child may be in danger. Experience with the use of adrenaline during pregnancy is limited.

Breastfeeding

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

Driving and using machines

Your ability to drive and use machines will not be affected by the administration of an adrenaline injection, but it may be affected by the anaphylactic reaction. If this happens, do not drive.

Altellus for adults 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 considered essentially "sodium-free".

3. How to use Altellus for adults

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. Always use Altellus for adults 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 for adults 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 for Altellus (without medicine and without a 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 medicine should not be carried together to avoid confusion in an emergency situation.

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

For children who weigh less than 30 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 dose in adults for allergic emergencies is 300 micrograms of adrenaline by intramuscular injection.

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

Each Altellus for 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 should 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 for adults. 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 for adults.

How to apply Altellus for adults

Altellus for adults is designed to be easily used by people without medical training. Altellus for adults should simply be thrust firmly into the outer part of the thigh, from a distance of about 10 cm. There is no need for exact placement. When you thrust Altellus for adults firmly into the thigh, a spring is activated that triggers the plunger, the needle is released towards the thigh muscle, and a dose of adrenaline is released .Altellus for adults can be used, if necessary, through clothing.

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

Altellus for adults should only be injected into the outer part of the thigh. Do not inject into the buttock.

Instructions for use

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

Blue safety cap Visibility window Orange end

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

Hold the auto-injector by the center, never by the ends. For correct administration, observe the drawings 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.
• Never remove the blue safety cap until the product is to be used.

A small bubble may appear in the Altellus for adults 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 darkens. After use, dispose of Altellus for adults safely in the tube provided and take it with you when you go to your doctor, hospital, or pharmacy.

Altellus for adults has been designed as a treatment for emergency situations. You should always seek medical help immediately after using Altellus for adults. 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 additional treatment if necessary. This is because the reaction may 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 for adults 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 described, which can cause loss of blood flow in the affected area. In case of accidental injection, always 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), stress cardiomyopathies have been observed in patients treated with adrenaline.

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

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. Storing Altellus for adults

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 for adults 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. Dispose of the container and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Altellus for Adults

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

Appearance of the Product and Packaging Content

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 0.3 mg of adrenaline.

Length of exposed and protected needle approx.: 15 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

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 Member States of the European Economic Area under the following names:

Date of 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/