SALBUTAMOL NEUTEC 2.5 mg SOLUTION FOR NEBULIZER INHALATION

Introduction

Package Leaflet: Information for the User

Salbutamol Neutec 2.5 mg solution for inhalation by nebulizer

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, pharmacist, or nurse.

• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Salbutamol Neutec is and what it is used for
2. What you need to know before you use Salbutamol Neutec
3. How to use Salbutamol Neutec
4. Possible side effects
1. Storage of Salbutamol Neutec

1. Contents of the pack and further information

1. What Salbutamol Neutec is and what it is used for

Salbutamol Neutec contains a medicine called salbutamol, which belongs to a group of medicines called short-acting and fast-acting bronchodilators.

• Bronchodilators help keep the airways in the lungs open, making it easier to breathe in and out.
• They help relieve chest tightness, wheezing, and coughing.

This medicine is used to treat breathing problems in people with asthma and other lung diseases that cause narrowing of the airways (such as chronic obstructive pulmonary disease). It is usually given to people who are severely affected by these diseases when other forms of treatment do not seem to work. This medicine can be used to treat adults, adolescents, and children from 4 to 11 years old.

Salbutamol Neutec is supplied in a small plastic container that contains a liquid. This liquid is placed in a device called a nebulizer, which produces a fine mist that is inhaled through a mask.

2. What you need to know before you use Salbutamol Neutec

Do not useSalbutamol Neutec

• if you are allergic to salbutamol sulfate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, nurse, or pharmacist before you start taking this medicine if:

• you have high blood pressure
• you have diabetes
• you have an overactive thyroid gland
• you have a history of heart problems, such as severe heart failure, fast or irregular heartbeats, or chest pain (angina)
• you are using another solution for inhalation by nebulizer, for example, ipratropium bromide
• you have severe acute asthma (your doctor may need to do blood tests to check the amount of potassium in your blood)

In some cases, high doses of salbutamol may cause a condition known as lactic acidosis. To minimize the risk of problems, you should be aware of the appearance of certain symptoms while taking this medicine. See possible side effects in section 4.

Sometimes, the use of salbutamol may lower the levels of potassium in the blood, especially if you are taking certain other medicines at the same time. If you are at risk of this happening, your doctor may recommend that you have more frequent blood tests to monitor your blood.

If you are using this medicine at home and notice that it is not working as well as usual, do not increase the dose or use the medicine more frequently. Instead, tell your doctor as soon as possible.

Make sure the nebulization does not get into your eyes. This can be avoided by using a mouthpiece instead of a mask or by wearing protective glasses.

If your breathing or wheezing gets worse immediately after using this medicine, stop using it immediately and tell your doctor as soon as possible.

Other medicines and Salbutamol Neutec

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription. This includes herbal medicines. If you go to the hospital, remember to take your medicine with you. In particular, tell your doctor, nurse, or pharmacist if you are taking:

• beta-blockers (medicines used for heart disease, e.g., propranolol)
• other medicines for asthma
• diuretics, corticosteroids, and xanthine derivatives (such as theophylline)

Tell your doctor that you are taking Salbutamol Neutec if you are going to have surgery, as it may interact with some anesthetics.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

This medicine can be used during pregnancy if your doctor considers it necessary.

There is not enough information to assess the risk to the baby when this medicine is used during breastfeeding.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use tools or machines.

While using the nebulizer, do not drive or use machinery.

Use in athletes

Athletes should be informed that this medicine contains a component that may produce a positive result in doping tests.

3. How to use Salbutamol Neutec

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, ask your doctor, nurse, or pharmacist again.

Salbutamol Neutec should be used as needed and not on a regular basis.

If your asthma is active (for example, you have symptoms or frequent attacks, such as difficulty breathing that makes it hard to talk, eat, or sleep, coughing, wheezing, chest tightness, or limited physical ability), you should tell your doctor immediately, who may start you on a different medicine or increase the dose of your treatment, such as an inhaled corticosteroid, to control your asthma.

Tell your doctor as soon as possible if your medicine seems to be not working as well as usual (for example, if you need higher doses to relieve your breathing problems or if your inhaler does not provide relief for at least 3 hours), as your asthma may be getting worse and you may need a different medicine.

If you use Salbutamol Neutec more than twice a week to treat your asthma symptoms, without including preventive use before exercise, this indicates poorly controlled asthma and may increase the risk of severe asthma attacks (worsening of asthma) that can have serious complications and can be life-threatening. You should contact your doctor as soon as possible to review your asthma treatment.

If you are using a medicine to reduce inflammation in your lungs, e.g., an "inhaled corticosteroid", it is important that you continue to use it regularly, even if you feel better.

Use of this medicine

• your doctor, nurse, or pharmacist should show you how to use the medicine
• use only the nebulizer recommended by your doctor and supervise your child while they are using the nebulizer
• each single-dose container holds a certain amount of liquid
• this liquid is placed in a suitable nebulizer. This produces a fine mist that is inhaled through a mask or mouthpiece
• use the nebulizer in a well-ventilated room, as some of the mist may be released into the air and may be inhaled by others
• you can use this medicine at any time of day, with or without food
• do not inject or swallow the liquid. This medicine should only be inhaled using your nebulizer
• do not let the liquid or the mist produced by the nebulizer get into your eyes. You can protect them by wearing glasses or goggles.

The recommended dose for adults and children from 4 years onwards is as follows:

• The suitable dose is 2.5 mg up to four times a day.
• This can be increased to 5 mg up to four times a day if necessary.
• The maximum recommended dose is 5 mg four times a day.

In adults, higher doses may be given for the treatment of severe airway obstruction, but only in a hospital under the direction and supervision of a doctor.

Other pharmaceutical forms may be more suitable for administration in children under 4 years of age.

Instructions for use

1. Your single-dose containers are contained in an aluminum bag. Do not open the bag until you need to use them.
2. Open the aluminum bag and remove the strip of single-dose containers.
3. Hold the strip with one hand and with the other hand, grasp the last single-dose container in the row.
4. Twist the single-dose container downwards and away from you.

1. Put the rest of the single-dose containers back in the aluminum bag. Put the opened aluminum bag back in the carton.
2. Hold the top end of the single-dose container you just removed. Twist the body of this to open it.

1. Insert the open end of the single-dose container into the nebulizer chamber and squeeze gently. Make sure to pour all the contents into the nebulizer.

1. Assemble the nebulizer and use it as indicated.

After use

• If there is any liquid left over, throw it away; do not save it for later use.
• Discard any solution left in the nebulizer chamber.
• Clean the nebulizer as recommended.

If you use more Salbutamol Neutec than you should

If you use more than you should, talk to a doctor as soon as possible.

The following effects may happen:

• your heart beats faster than usual
• feeling shaky
• hyperactivity
• build-up of acid in the body, which can speed up breathing

These effects usually go away within a few hours.

If you forget to use Salbutamol Neutec

• If you miss a dose, take the next dose as planned or if your breathing or wheezing gets worse.
• Do not take a double dose to make up for forgotten doses.

If you stop using Salbutamol Neutec

Do not stop taking this medicine without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

If your breathing or wheezing gets worse immediately after using this medicine, stop using it immediately and tell your doctor as soon as possible.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Allergic reactions(may affect up to 1 in 10,000 people)

If you have an allergic reaction, stop taking Salbutamol Neutec and see a doctor immediately. Signs of an allergic reaction include: swelling of the face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing, a rash with itching, feeling faint or dizzy, and collapse.

Tell your doctor as soon as possible if:

• you feel your heart beating irregularly or if you notice an extra heartbeat. This may affect up to 1 in 10,000 people.

If any of these happen, tell your doctor as soon as possible. Do not stop using this medicine unless your doctor tells you to.

Lactic acidosis(may affect up to 1 in 10,000 people)

An increase in the amount of lactic acid in the blood (lactic acidosis) is a very rare side effect of salbutamol, which more often affects people with severe kidney disease.

Symptoms of lactic acidosis include:

• rapid breathing or shortness of breath
• feeling cold
• stomach pain, nausea, and vomiting

Tell a doctor immediately if you get any of the symptoms listed above. Stop taking this medicine.

Other side effects

Tell your doctor if you get any of the following side effects, which may also occur with this medicine:

Common(may affect up to 1 in 10 people)

• feeling shaky
• headache

Uncommon(may affect up to 1 in 100 people)

• fast or irregular heartbeats (palpitations)
• irritation of the mouth and throat
• muscle cramps

Rare(may affect up to 1 in 1,000 people)

• low levels of potassium in the blood
• increased blood flow to the extremities (peripheral vasodilation)

Very rare(may affect up to 1 in 10,000 people)

• changes in sleep patterns and changes in behavior, such as restlessness and excitability

Very rare side effects that may occur in blood tests(may affect up to 1 in 10,000 people)

• lactic acidosis

The following side effects may also occur, but their frequency is unknown:

• chest pain, due to heart problems, such as angina. If this happens, tell your nurse, doctor, or pharmacist. Do not stop using this medicine unless your doctor tells you to.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.

If you think this medicine is not working well enough

Seek urgent medical attention if the nebulized medicine does not work, even if you get temporary relief after using the prescribed nebulized medicine. Your chest problem may be getting worse, and you may need a different medicine. Do not take Salbutamol Neutec without consulting your doctor.

5. Storage of Salbutamol Neutec

• 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, labels, and aluminum bag after 'EXP'. The expiry date is the last day of the month stated.
• Store below 30°C.
• Keep the single-dose containers in the aluminum bag and/or carton to protect them from light and moisture.
• Do not use this medicine if you notice the product is discolored.
• Once the single-dose container is opened, use it immediately.
• Any unused solution left in the nebulizer chamber should be discarded.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to the pharmacy for proper disposal. This will help protect the environment.

6. Container Content and Additional Information

Salbutamol Composition

• The active ingredient is salbutamol (salbutamol sulfate).
• Each 2.5 ml single-dose container contains 2.5 mg of salbutamol (as salbutamol sulfate), equivalent to 1 mg of salbutamol per 1 ml.
• The other ingredients are: sodium chloride, sulfuric acid (for pH adjustment), and water for injectable preparations.

Appearance of Salbutamol Neutec and Container Content

Transparent and colorless solution contained in disposable, translucent low-density polyethylene single-dose containers, arranged in strips of 5 units, and wrapped in an aluminum bag.

Salbutamol Neutec is presented in packages of 20 single-dose containers.

Marketing Authorization Holder

Neutec Inhaler Ireland Limited

22 Northumberland Road, Ballsbridge

Dublin 4, Co. Dublin

D04 ED73

Ireland

Manufacturer

Nextpharma Oy

Niittyhaankatu 20

33720 Tampere

Finland

Kymos S.L.

Ronda De Can Fatjo 7b,

Parc Tecnologic Del Valles,

Cerdanyola Del Valles,

08290

Spain

This medicinal product has been authorized in the following European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Date of Last Revision of this Leaflet:13/12/2024.

Other Sources of Information

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