PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER FORMAXA AXAHALER 12 micrograms/dose, inhalation powder, hard capsule (formoterol fumarate) Read all of this leaflet carefully before you start using this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Formaxa Axahaler 12 micrograms/dose is and what it is used for 2. Before you use Formaxa Axahaler 12 micrograms/dose 3. How to use Formaxa Axahaler 12 micrograms/dose 4. Possible side effects 5. How to store Formaxa Axahaler 12 micrograms/dose 6. Further information Ingredients: Formaxa comes as capsules containing a dry powder. The dry powder is inhaled into the lungs using the inhaler provided in the pack. Each capsule contains 12 micrograms of formoterol fumarate. This is one of a group of medicines called bronchodilators. Formaxa capsules come in HDPE tablet container of 60 capsules closed with a polypropylene screwcap which contains desiccant (silica gel). The active substance is formoterol fumarate dihydrate 12 micrograms/dose. The excipients are lactose monohydrate and lactose. The Shell of the capsule is composed of hypromellose. Marketing Authorisation Holder Laboratoires SMB S.A., rue de la Pastorale 26-28, B-1080 Brussels, Belgium Manufactured by: SMB Technology S.A., 39, rue du parc industriel, 6900 Marche en Famene, Belgium

2 1. What FORMAXA AXAHALER is and what it is used for How does FORMAXA work? FORMAXA selectively stimulates beta 2 -receptors in the bronchi. This blocks the contraction of the bronchi and already contracted bronchi dilate which relieves dyspnea. The effect starts in 1 to 3 minutes and lasts at least 12 hours after inhalation. What this medicine is used for Formaxa is used to treat the wheezing and breathlessness of asthma in patients already receiving inhaled corticosteroids. It makes breathing easier by relaxing muscle spasms in the air passages of the lungs. Regular use of Formaxa with inhaled corticosteroids will help to prevent breathing problems. Formaxa is also used to treat reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD). 2. Before you use Formaxa Axahaler Have you ever had an unusual or allergic reaction to formoterol or lactose? Do you suffer from any heart problems? Do you have an overactive thyroid gland? Are you diabetic? Are you pregnant or breast feeding? If the answer to either of these questions is YES, do not use your medicine without talking to your doctor again. Using other medicines Please tell your doctorpharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Are you taking any of the following: Medicines for heart conditions including irregular heart beats and angina Medicines for high blood pressure Beta blockers (either as tablets or eye drops) Water tablets (diuretics) Medicines for depression, for example, monoamine oxidase inhibitors (MAOIs) or tricyclics Anti-histamines or cold remedies (including any bought from the chemist) Theophylline or aminophylline? If the answer to any of these questions is YES, tell your doctor or pharmacist. Driving and using machines FORMAXA has no or negligible influence on the ability to drive and use machines

3 Other special warnings Your doctor may have given you other medicines for your breathing problems, for example, inhaled steroids. It is very important to keep using these regularly. DO NOT stop using them or change the dose when you start using Formaxa. Formaxa is not suitable for children under the age of 12 years. Do not swallow the capsules - they must only be used with the inhaler. 3. How to use Formaxa Axahaler Always use Formaxa exactly as your doctor has told you. You should check with your doctor if you are not sure. Your doctor will tell you how much Formaxa to use and when to use it. Follow his/her instructions carefully. If the person taking the medicine is an adolescent, he or she should be shown how to use the inhaler correctly and should only use the inhaler with the help of an adult. Adults and adolescents Asthma: The usual dose is 1 or 2 puffs (1 capsule = 1 puff) morning and evening. Chronic obstructive pulmonary disease: The usual dose is 1 puff in the morning and evening. Normally the effects of this medicine will last for 12 hours. However, if you do get attacks of wheezing between doses, do not take extra doses of Formaxa. Your doctor will have prescribed another medicine for this purpose. If you are not sure about this, check with your doctor. If you use more Formaxa than you should Do not increase your dose of FORMAXA without talking to your doctor first. If you forget to useformaxa If you miss a dose, take it as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten dose. If you stop using Formaxa Do not stop or reduce the dose of Formaxa or any other medicine for your breathing just because you feel better, without talking to your doctor first. It is very important to use these medicines regularly. If you feel sick or very shaky or if you have an unusually fast heart beat, your Formaxa dose may be too high. Tell your doctor as soon as possible. How to use the capsules with your inhaler Follow carefully the instructions for use to be able to use (inhale) FORMAXA appropriately.

4 Take the capsule from the container before inhalation. The capsule will be conserved inside the inhaler during 3 days without problems. 1. Remove the protector. 2. Hold the inhalator body with your clean hands and turn the mouth-piece in the direction of the arrow. 3. Put the capsule into the capsule chamber located in the inhalator body. 4. Turn the mouth-piece to the starting position. 5. Keep the inhalator upright and forcefully press the red buttons on the sides of the device ONLY ONCE. Release the buttons. You will hear a click when the capsule is penetrated. Please note: The capsule may break at this stage, and small pieces of hypromellose can end up in your mouth or throat when inhaling. Hypromellose can be ingested and is therefore not harmful. Breaking of the capsule can be avoided by not pressing the puncturing buttons more than once and by following the directions for storage of the capsules. Take the capsule from the container only just before inhalation. 6. a) Exhale forcefully. 6. b) Put the mouthpiece in your mouth and tilt your head slightly backwards. Close your lips tightly around the mouthpiece and inhale as deeply as you can. You should hear a buzzing sound when the capsule rotates in the capsule chamber and the inhalation powder is released. If you cannot hear a buzzing sound the capsule might have been stuck in the capsule chamber. If this happens, open the inhalator and release the capsule by lifting it out of the capsule chamber. DO NOT attempt to release the capsule by pushing repeatedly on the puncture buttons. 6. c) If you heard a buzzing sound, hold your breath as long as you can before you take the inhalator out of your mouth. Exhale. Open the inhalator and check if there is there is any inhalation powder left in the capsule. If any powder remains, repeat steps 6 a to c.

5 After use Open the inhalator, remove the empty capsule, turn the mouthpiece back to starting position and replace the protector. Inhalator care The inhalator should be cleaned from residual drugs by wiping the mouthpiece and the capsule chamber with a DRY cloth. Alternatively, it can be cleaned using a clean, soft brush. Please note: Formaxa capsules must only be used with the inhaler provided. You must not try to inhale them using another inhaler. Also, do not put other types of capsules into the inhaler supplied with Formaxa. If you have any further questions on the use of this product, ask your doctor. 4. Possible side effects Like all medicines, Formaxa can cause side effects, although not everybody gets them. Formaxa does not usually cause unwanted effects. However, it can do so sometimes in some people. If you get any of the following tell your doctor: A sudden increase in breathlessness or wheezing. Unusually fast heart beat or palpitations. Feeling nervous or anxious. Other effects which may occur include: Headache or dizziness Muscle cramps Shakiness of the hands Mouth or throat irritation Sleeplessness These effects are often mild and may wear off after a few days treatment. If they are severe or last for more than a few days, tell your doctor. Also, if your medicine upsets you in any other way, tell your doctor. In isolated cases allergic reactions with a large drop in blood pressure and swelling of the face, eyelids, or lips have been reported. If you suffer from any of these problems you should tell your doctor. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

6 5. How to store FORMAXA AXAHALER Keep out of the reach and sight of children. Do not use FORMAXA AXAHALER after the expiry date which is stated on the carton and on the bottle.the expiry date refers to the last day of that month. Do not use the medicine after this date. Always discard the old inhalator and use a new inhalator included in each package. Medicines 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. Keep your medicine at room temperature in a dry place (do not store above 25 C), out of the reach and sight of children. Return any unused medicine to your pharmacist. REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if they have the same symptoms as you. 6. Further information The information in this leaflet applies only to Formaxa. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. Inhaler CE The device conforms with Directive 93/42/EEC. For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Laboratoires SMB SA Rue de la Pastorale B-1080 Brussels - Belgium This leaflet was last approved in 09/2005 Copyright Laboratoires SMB SA