Patient leaflet - Vivaire 200/6 micrograms per actuation pressurised inhalation solution
1. What VIVAIRE is and what it is used for
VIVAIRE is a pressurised inhalation solution containing two active substances which are inhaled through your
mouth and delivered directly into your lungs.
The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone
dipropionate belongs to a group of medicines called corticosteroids which have an anti-inflammatory action
reducing the swelling and irritation in your lungs.
Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax
the muscles in your airways and helps you to breathe more easily.
Together these two active substances make breathing easier, by providing relief from symptoms such as
shortness of breath, wheezing and cough in patients with asthma.
VIVAIRE is used to treat asthma in adults.
If you are prescribed VIVAIRE it is likely that either:
your asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting
bronchodilators or
- your asthma responds well to both corticosteroids and long-acting bronchodilators
2. What you need to know before you use VIVAIRE
Do not use VIVAIRE:
if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using VIVAIRE:
If you have any heart problems, such as angina (heart pain, pain in the chest), heart failure, narrowing of the
arteries, valvular heart disease or any other known abnormalities of your heart
if you have high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the
blood vessel wall).
If you have disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or
palpitations or if you have been told that your heart trace is abnormal.
- If you have an overactive thyroid gland.
- If you have low blood levels of potassium.
- If you have any disease of your liver or kidneys.
If you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore
you may need to have some additional blood tests to check your blood sugar when you start using this
inhaler and from time to time during treatment).
- If you have a tumour of the adrenal gland (known as a phaeochromocytoma).
If you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop
taking VIVAIRE at least 12 hours before the anaesthesia.
If you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal
infection of your chest.
If you must avoid alcohol for any reason
If any of the above applies to you, always inform your doctor before you use VIVAIRE. If you have or
had any medical problems or any allergies or if you are not sure as to whether you can use VIVAIRE talk to
your doctor, asthma nurse or pharmacist before using this medicine.
Your doctor may wish to measure the potassium levels in your blood from time to time especially if your
asthma is severe. Like many bronchodilators VIVAIRE can cause a sharp fall in your serum potassium level
(hypokalaemia). This is because a lack of oxygen in the blood combined with some other treatments you may
be taking together with this medicine can make the fall in potassium level worse.
If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need
for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an
accident, having a serious injury or before an operation. In this case, the doctor treating you will decide
whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or
a steroid injection.
Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including
VIVAIRE and any medicines or tablets bought without a prescription, in their original package, if possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
VIVAIRE should not be used in children and adolescent less than 18 years old, until further data
become available.
Other medicines and VIVAIRE
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines including
medicines obtained without a prescription. This is because this medicine may affect the way some other
medicines work. Also, some medicines may affect the way VIVAIRE works.
In particular, tell your doctor, pharmacist or nurse if you are using any of the following medicines:
Some medicines may increase the effects of this medicine and your doctor may wish to monitor you
carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Beta-blocker medicines. Beta blockers are medicines used to treat many conditions including heart
problems, high blood pressure and glaucoma (increased pressure in the eyes). If you need to use beta
blockers including eye drops, the effect of formoterol may be reduced or formoterol may not work at all.
Beta adrenergic drugs (drugs which work in the same way as formoterol) may increase the effects
of formoterol.
- Medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide).
- Medicines used to treat allergic reactions (antihistamines).
Medicines to treat symptoms of depression or mental disorders such as monoaminoxidase inhibitors
(for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitryptiline and
imipramine), phenothiazines.
- Medicines to treat Parkinson’s Disease (L-dopa).
- Medicines to treat an underactive thyroid gland (L-thyroxine).
- Medicines containing oxytocin (which causes uterine contraction).
Medicines to treat mental disorders such as monoaminoxidase inhibitors (MAOIs), including drugs with
similar properties like furazolidone and procarbazine.
- Medicines to treat heart disease (digoxin).
- Other medicines used to treat asthma (theophylline, aminophylline or steroids).
- Diuretics (water tablets).
Also tell your doctor if you are going to have a general anaesthetic for an operation or for dental work.
Pregnancy and breastfeeding
There are no clinical data on the use of VIVAIRE during pregnancy
VIVAIRE must not be used 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.
Driving and using machines
VIVAIRE is unlikely to affect your ability to drive and use machines.
VIVAIRE contains alcohol
This medicine contains 9 mg of alcohol (ethanol) in each actuation which is equivalent to 0.25 mg/kg per dose of two actuations. The amount in two actuations of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not have any noticeable effects.
3. How to use VIVAIRE
VIVAIRE is for inhalation use. VIVAIRE should be inhaled via your mouth into your lungs.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The pharmacist’s label will tell you how many puffs to take and how often they must be taken.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of VIVAIRE. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Dosage:
Adults and the elderly:
The recommended dose is two actuations twice daily.
The maximum daily dose is 4 actuations.
Remember: You should always have your quick-acting “reliever” inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.
At-risk patients:
There is no need for dose adjustment if you are older. No information is available regarding the use of this medicine in people with liver or kidney problems.
Use in children and adolescents less than 18 years of age:
Children and adolescents aged less than 18 years must NOT take this medicine.
VIVAIRE is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing this substance. If you have been using a different inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of this medicine you should take for your asthma.
Do not increase the dose
If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.
If your asthma gets worse:
If your symptoms get worse or are difficult to control (e.g., if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need to change your dose of VIVAIRE or prescribe alternative treatment.
Method of administration
VIVAIRE is for inhalation use
This medicine is contained in a pressurised canister in a plastic casing with a mouthpiece. There is a counter on the back of the inhaler, which tells you how many doses are left. Each time you press the canister, a puff of medicine is released and the counter will count down by one. Take care not to drop the inhaler as this may cause the counter to count down.
Testing your inhaler
Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, you should test your inhaler to make sure that it is working properly.
- 1. Remove the protective cap from the mouthpiece
- 2. Hold your inhaler upright with the mouthpiece at the bottom
- 3. Direct the mouthpiece away from yourself and firmly depress the canister to release one puff
- 4. Check the dose counter. If you are testing your inhaler for the first time, the counter should read 120.
How to use your inhaler
Whenever possible, stand or sit in an upright position when inhaling.
Before you start inhaling, check the dose counter: any number between “1” and “120” shows that there are doses left. If the dose counter shows “0” there are no doses left – dispose of your inhaler and get a new one.
3
4
DOSE
COUNTER
2
1
5
- 1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
3
4
DOSE
COUNTER
2
1
5
- 2. Breathe out as slowly and deeply as possible.
3
4
DOSE
COUNTER
2
1
5
- 3. Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the mouthpiece. 3
4
DOSE
COUNTER
2
1
5
- 4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down firmly on the top of the inhaler to release one puff.
3
4
DOSE
COUNTER
2
1
5 5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not Breathe into the inhaler.
If you need to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5.
Important: Do not perform steps 2 to 5 too quickly.
After use, close with the protective cap and check the dose counter.
You should get a replacement when the counter shows the number 20. Stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to give you a full dose.
If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, this means that VIVAIRE will not be getting into your lungs as it should. Take another puff, following the instruction starting again from step 2.
If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.
To lower the risk of a fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush your teeth each time you use your inhaler.
If you think the effect of VIVAIRE is too much or not enough, tell your doctor or pharmacist.
If you find it difficult to operate the inhaler while starting to breathe in you may use the AeroChamber Plus™ spacer device. Ask your doctor, pharmacist or a nurse about this device.
It is important that you read the package leaflet which is supplied with your AeroChamber Plus™ spacer device and that you follow the instructions on how to use the AeroChamber Plus™ spacer device and how to clean it, carefully.
Cleaning
You should clean your inhaler once a week.
When cleaning, do not remove the canister from the actuator and do not use water or other liquids to clean your inhaler.
To clean your inhaler:
- 1. Remove the protective cap from the mouthpiece by pulling it away from your inhaler.
- 2. Wipe inside and outside of the mouthpiece and the actuator with a clean, dry cloth or tissue.
- 3.
Replace the mouthpiece cover
3
4
DOSE
COUNTER
2
1
5
If you use more VIVAIRE than you should
- Taking more formoterol than you should have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels.
Taking too much beclometasone dipropionate can lead to short-term problems with your adrenal glands. This will get better within a few days however your doctor may need to carry out some blood tests to check your serum cortisol levels.
Tell your doctor if you have any of these symptoms.
If you forget to use VIVAIRE
Do not take a double dose to make up for a forgotten dose. Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time.
If you stop using VIVAIRE
Do not lower the dose or stop using the medication. Even if you are feeling better, do not stop taking VIVAIRE or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use this medicine regularly even though you may have no symptoms
If you have any further questions on the use of this medicine, ask your doctor or, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using this medicine and this is known as paradoxical bronchospasm. If this occurs you should STOP using VIVAIRE immediately and use your quick-acting “reliever” inhaler straightaway to treat the symptoms of shortness of breath and wheezing. You should contact your doctor immediately.
Tell your doctor immediately if you experience any hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat.
Other possible side effects are listed below according to their frequency.
Common (may affect up to 1 in 10 people):
- fungal infections (of the mouth and throat)
- headache
- hoarseness
- sore throat
Uncommon (may affect up to 1 in 100 people)
- palpitations
- unusually fast heartbeat and heart rhythm disorders
- some changes in the electrocardiogram (ECG)
- increase in blood pressure
- flu like symptoms
- sinus inflammation
- rhinitis
- inflammation of the ear
- throat irritation
- cough and productive cough
- asthma attack
- fungal infections of the vagina
- nausea
- abnormal or impaired sense of taste
- burning of the lips
- dry mouth
- swallowing difficulties
- indigestion
- upset stomach
- diarrhoea
- pain in muscle and muscle cramps
- reddening of the face and throat
- increased blood flow to some tissues in the body
- excessive sweating
- trembling
- restlessness
- dizziness
- nettle rash or hives
alterations of some constituents of the blood:
° fall in the number of white blood cells
° increase in the number of blood platelets
° fall in the level of potassium in the blood
° increase in blood sugar level
° increase in the blood level of insulin, free fatty acid and ketones
The following side effects have also been reported as “uncommon” in patients with chronic obstructive pulmonary disease:
- pneumonia; tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, increasing cough, increased breathing problems
- reduction of the amount of cortisol in the blood; this is caused by the effect of corticosteroids on your adrenal gland
- irregular heart beat
Rare (may affect up to 1 in 1,000 people)
- tightness in the chest
- sensation of a missed heartbeat (caused by premature contraction of the heart’s ventricles)
- decrease in blood pressure
- inflammation of the kidney
- swelling of skin and mucous membrane persisting for several days
Very rare (may affect up to 1 in 10,000 people)
- worsening of asthma
- shortness of breath
- a fall in the number of blood platelets
- swelling of the hands and feet
- rounded face (full moon) (cushing’s syndrome)
Using high dose inhaled corticosteroids over a long time can cause, in very rare cases, systemic effects. These include:
- problems with how your adrenal glands work (adrenosuppression)
- increased pressure in your eyes (glaucoma)
- cataracts
- growth retardation (slowing of growth in children and adolescents)
- decrease in bone mineral density (thinning of the bones)
Not known (frequency cannot be estimated from the available data)
- sleeping problems
- depression or feeling worried
- nervousness
- over-excited or irritable
These events are more likely to occur in children.
- Blurred vision
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 Yellow Card Scheme, Website: https://yellowcard.mhra.gov.uk, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store VIVAIRE
- Keep this medicine out of the sight and reach of children.
- Before use: store the inhaler in a refrigerator (at 2-8°C).
- After first use: do not store the inhaler above 25 °C for a maximum of three months.
- Do not use this medicine beyond 3 months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label.
- Do not freeze.
If the inhaler has been exposed to severe cold, warm it with your hands for a few minutes before using. Never warm it by artificial means.
Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50 °C. Do not pierce the canister.
- Medicines should not be disposed of via wastewater or household waste. Return all used, partially used and unused inhalers to your pharmacist to be disposed of. These measures will help to protect the environment.
6. Contents of the pack and other information
What VIVAIRE contains
- The active substances are beclometasone dipropionate, formoterol fumarate dihydrate. Each actuation/ metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 10.24 g of HFC-134a (Norflurane) corresponding to 0.015 tonne CO2 equivalent (global warming potential GWP = 1430).
The other ingredients are ethanol anhydrous and hydrochloric acid. To help protect the environment, the inhaler contains the CFC-free propellant, HFC-134a, which replaces completely the chlorofluorocarbon (CFC) propellants present in some other inhalers and appears to have a less damaging effect on the ozone layer. This medicine does not contain CFCs.
What VIVAIRE looks like and contents of the pack
VIVAIRE is a pressurised solution contained in an aluminium canister with a metering valve, fitted into a plastic actuator (white) incorporating a mouthpiece and fitted with a dose counter, with a dust cap (green).
Each pack contains:
1 pressurised container which provides 120 actuations or
2 pressurised containers which provide 120 actuations each
Not all pack size may be marketed.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Cipla (EU) Limited
Dixcart House, Addlestone Road,
Bourne Business Park, Addlestone,
KT15 2LE, United Kingdom
Distributed by
Zentiva Pharma UK Limited
12 New Fetter Lane,
London, EC4A 1JP,
United Kingdom
Manufacturer
Cipla (EU) Limited
Dixcart House, Addlestone Road,
Bourne Business Park, Addlestone,
KT15 2LE, United Kingdom
This leaflet was last revised in October 2024
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