25 micrograms/dose inhalation spray, salmeterol suspension
What Serevent Evohaler is and what it is used for
| • | Serevent Evohaler contains the drug salmeterol, which is a ‘long-acting tracheal dilator’. Salmeterol has a dilating effect on the airways in the lungs and makes it easier to breathe. The effect is usually felt within 10-20 minutes and lasts for 12 hours or more. |
| • | Your doctor has prescribed this medicine to prevent breathing problems, which can be caused by asthma. Taking Serevent Evohaler regularly prevents asthma attacks. This also applies to asthma that is caused by exertion or if the asthma symptoms only happen at night. |
| • | Taking Serevent Evohaler regularly also prevents breathing problems due to other lung diseases such as chronic obstructive pulmonary disease (COPD). |
| • | Serevent Evohaler prevents sudden breathing problems (shortness of breath/wheezing) but does not have an immediate effect on acute problems. Then you should use a short-acting bronchodilator medication that gives a quick effect (eg salbutamol ). |
| • | Serevent Evohaler is an inhalation spray. The drug is inhaled directly into the lungs. |
| • | Serevent Evohaler contains norflurane, which has less of an impact on the environment than previous sprays. These sprays may have tasted different from what Serevent Evohaler does. This does not affect the effectiveness of the medicine. |
If you are being treated for asthma, you should always have both Serevent and an inhaled cortisone to take with you.
Salmeterol contained in Serevent Evohaler may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Serevent Evohaler
Do not take Serevent Evohaler
- if you are allergic (hypersensitive) to salmeterol or the other ingredient, norflurane (HFA 134a).
Take special care with Serevent Evohaler
| • | If your asthma or breathing worsens, contact a doctor immediately. If you feel that your breathing becomes more wheezing/wheezing or that the feeling of tightness in your chest increases and you need to take more of your fast-acting bronchodilator medication, do not take more inhalations of Serevent. Your condition may worsen and you may become seriously ill. Contact your doctor as your asthma treatment may need to be changed. |
| • | Once your asthma is under control, your doctor may decide to gradually reduce the dose of one of Serevent. |
| • | If you have been prescribed Serevent for your asthma, continue to take the other asthma medications that you are already using. These can be inhaled cortisone or cortisone tablets. Continue to take the same dose as before unless your doctor tells you otherwise. Continue even if you feel much better. Do not stop using your inhaled cortisone (or cortisone tablets) when you start using Serevent. |
| • | Your doctor may want to monitor your treatment more regularly if you have increased thyroid function ( hyperthyroidism ), diabetes (Serevent may increase blood sugar), or cardiovascular disease including rapid and irregular heartbeat. |
Other medicines and Serevent Evohaler
Tell your doctor if you are taking or have recently taken any other medicines. This also applies to those for asthma or any over-the-counter medicine. The effect of the treatment can be affected if Serevent and certain other medicines are taken at the same time.
- Before you start using Serevent, tell your doctor if you are being treated for fungal infection with medicines containing ketoconazole or itraconazole, or if you are being treated for ritonavir HIV. These medicines may increase the risk of side effects with Serevent, including irregular heartbeat, or aggravate the side effects.
- Avoid taking beta-blockers while taking Serevent, unless your doctor tells you to. Beta-blockers such as atenolol, propranolol, and sotalol are often used to treat high blood pressure or other heart conditions. Tell your doctor if you are taking beta-blockers or have recently been prescribed beta-blockers, as these may reduce or prevent the effects of salmeterol.
- Serevent can reduce the amount of potassium in the blood. Symptoms of this may be that the heart beats irregularly, muscle weakness, or cramping. This is more likely to happen if you are taking Serevent with medicines to treat high blood pressure such as diuretics, or if you are taking other medicines for breathing problems such as theophyllines or cortisone. You may be asked to provide a blood test to check your potassium levels. If you have any further questions, ask your doctor.
Pregnancy and breastfeeding
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 taking this medicine.
Driving and using machines
The effects or possible side effects of Serevent are unlikely to affect your ability to drive or use machines. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Serevent Evohaler
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
| • | If you are being treated for asthma, you should always have both Serevent and an inhaled cortisone to take with you. |
| • | Use Serevent every day until your doctor advises you to stop. |
| • | You will feel that the medicine starts working after the first day. |
Serevent is for inhalation use only.
| Adults and adolescents 12 years and older with asthma | |
| • | A standard starting dose is 2 doses twice daily. |
| • | For more severe asthma symptoms, your doctor may increase your dose one to 4 times twice daily. |
| Children with asthma | |
| • | For children 4 to 12 years, the usual dose is 2 doses twice daily. |
| • | Serevent is not recommended for children under 4 years. |
| Adults with chronic obstructive pulmonary disease (COPD, including bronchitis and emphysema ) | |
| • | A standard starting dose is 2 doses twice daily. |
| • | Not applicable to children and adolescents. |
Instructions
for use, A doctor, nurse, or pharmacist should show you how to use an inhalation spray. From time to time, they should also check how you use it. It is important that Serevent Evohaler inhalation spray is used correctly and as prescribed so that you have the intended effect on your asthma or COPD.
The metal container, in the plastic inhaler with the nozzle, contains the medicine.
How to check inhalation spray one
Check the technology in front of a mirror the first few times. If it squeaks from the top of the spray or out through the sides of the mouth, you should start again.
If you or your child finds it difficult to use an inhalation spray, a respirator can facilitate treatment. Talk to your doctor, nurse, or pharmacist.
Cleaning
To prevent the inhaler from “plugging in”, it is important that the inhaler is cleaned at least once a week.
| Do this: | |
| • | Remove the protective cap. |
| • | Never remove the metal container from the plastic inhaler. |
| • | Wipe the inside and outside of the nozzle and plastic inhaler with a dry cloth or paper towel. |
| • | Replace the protective cap. |
Do not immerse the metal container in water.
If you take more Serevent Evohaler than you should
Your heart may beat faster than usual and you may feel shaky and/or dizzy. You may also have headaches, muscle weakness, or joint pain. You must follow your doctor’s dosing recommendation. If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.
If you forget to take Serevent Evohaler
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the risk of side effects, your doctor will prescribe the lowest dose needed for you to be free of your asthma or COPD. The following side effects have been reported from people who have used Serevent.
Allergic reactions: if you suddenly notice difficulty breathing after taking Serevent. The breathing becomes wheezing or you get a cough, itching, or swelling (usually on the face, lips, tongue, or throat). Contact a doctor immediately if you notice any of this or if it happens suddenly after taking Serevent. Allergic reactions are very rare (affect less than 1 in 10,000 people).
Other side effects:
| Common (affects more than 1 in 10 people): | |
| • | Muscle cramps |
| • | You feel shaky, have fast or irregular heartbeats (palpitations), headaches, and hands tremble ( tremor ). Tremors (tremors) are more common if you take more than 2 inhalations twice daily. These side effects are usually reduced after a period of use. |
| Uncommon (affects less than 1 in 100 people): | |
| • | Rash |
| • | Very fast heart rate ( tachycardia ). This is more common if you take more than 2 inhalations twice daily |
| • | Nervousness. |
| Rare (affects less than 1 in 1,000 people): | |
| • | Dizziness |
| • | Difficult to fall asleep / sleep |
| • | Decreased potassium levels in the blood (which can cause symptoms such as irregular heartbeat, muscle weakness, and cramps). |
| Very rare (affects less than 1 in 10,000 people): | |
| • | Difficulty breathing/wheezing that worsens shortly after taking Serevent Evohaler. Stop taking Serevent Evohaler. Use the inhaler with the fast-acting tracheal dilator medicine and consult a doctor |
| • | Irregular heartbeat or extra heartbeat ( arrhythmia ). Tell your doctor but do not stop taking Serevent Evohaler |
| • | Elevated blood sugar levels ( glucose ) (hyperglycemia). If you have diabetes, more frequent blood sugar measurements and any adjustments to your usual diabetes treatment may be needed |
| • | Elevated blood sugar levels ( glucose ) (hyperglycemia). If you have diabetes, more frequent blood sugar measurements and any adjustments to your usual diabetes treatment may be needed |
| • | Mouth and throat irritation |
| • | Nausea |
| • | Painful, swollen joints, or chest pain. |
How to store Serevent Evohaler
| • | Keep out of sight and reach of children. |
| • | Always replace the protective cap immediately after use. Gently push the protective cap into place until a snap is heard. You do not need to use much force. |
| • | Do not store above 30 ° C. |
| • | The contents of the metal container are under pressure. Do not expose it to temperatures above 50 o C. Do not puncture, burn or otherwise injure even if the container appears to be empty. |
| • | Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month. |
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- Each spray dose contains 25 micrograms of the active substance salmeterol
- Each metal container contains 120 doses.
- The other ingredient is norflurane (HFA 134a).
What the medicine looks like and the contents of the pack
Inhalation spray, suspension. The metal container contains an off-white suspension for inhalation.
Marketing Authorization Holder and Manufacturer
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00
E-mail: info.produkt@gsk.com
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Austria | Serevent Evohaler |
| Belgium | Serevent Evohaler |
| Denmark | Serevent |
| Estonia | Serevent |
| Hungary | Serevent Evohaler |
| Iceland | Serevent |
| Ireland | Serevent Evohaler |
| Lithuania | Serevent |
| Luxembourg | Serevent Evohaler |
| Malta | Serevent Evohaler |
| Netherlands | Serevent 25 Inhaler CFK free, suspension 25 micrograms/dose |
| Norway | Serevent |
| Poland | Serevent |
| Slovakia | Serevent Inhaler N |
| Slovenia | Serevent 25 /g / via inhalation suspension undercover |
| Sweden | Serevent Evohaler |
| UK(Northern Ireland) | Serevent Evohaler |