Description
How it works
Clenil Modulite contains beclometasone dipropionate, a corticosteroid medicine that you inhale directly into your lungs. It works by:
- Reducing inflammation and swelling in the airways
- Decreasing mucus production
- Making the airways less sensitive to triggers such as pollen, pollution, exercise or infections
This helps to:
- Improve day-to-day breathing
- Reduce wheezing, chest tightness and cough
- Lower the risk of asthma attacks
It must be used every day as prescribed, even when you feel well, to keep asthma under control. It will not give quick relief in an acute attack – you still need a separate reliever (blue) inhaler for sudden symptoms.
Who it may be suitable for
Clenil Modulite may be prescribed for:
- Adults and children who need a regular preventer inhaler
- People with mild asthma who need inhaled steroid to stop symptoms coming back
- People with moderate asthma whose symptoms are not well controlled with a reliever alone or with other preventer treatments
- People with severe asthma, including those who may otherwise need regular steroid tablets
It can be used in:
- Adults (including older adults)
- Children, with appropriate dose adjustment and usually with a spacer device
Who should not use Clenil Modulite
Do not use this inhaler if you:
- Are allergic to beclometasone dipropionate or any of the inhaler ingredients
Take extra care and speak to a doctor or pharmacist if:
- Your asthma is suddenly getting worse or you are needing your reliever inhaler more often
- You have a chest infection or tuberculosis (TB), or have had TB in the past
- You are being switched from steroid tablets to an inhaler
- You are on high doses of inhaled steroids for a long time
- Your child is using this inhaler long term – their growth should be checked regularly
- You have glaucoma, cataracts, osteoporosis, or are at risk of thin bones
- You take medicines that can affect steroid levels (for example some HIV medicines such as ritonavir or cobicistat)
Pregnancy and breastfeeding: the inhaler may be used if a doctor believes the benefits outweigh any risks. Always discuss if you are pregnant, planning a pregnancy or breastfeeding.
Side Effects
Like all medicines, this inhaler can cause side effects, although not everyone gets them.
Very common / common side effects:
- Oral thrush (white patches, soreness in the mouth or throat)
- Hoarseness or throat irritation
- Cough immediately after inhalation
- Headache
Oral thrush and hoarseness are more likely if:
- You use higher doses (above about 400 micrograms daily)
- You do not rinse your mouth after using the inhaler
These can often be reduced by:
- Using a spacer device
- Rinsing your mouth and spitting out after each dose
Uncommon / rare side effects:
- Rash, itching, hives (urticaria)
- Swelling of the face, lips, eyes or throat (angio-oedema – can be serious)
- Paradoxical bronchospasm – sudden wheezing, cough or shortness of breath immediately after using the inhaler
If you experience sudden worsening wheeze, breathlessness or cough straight after a puff, use your reliever inhaler immediately, stop using Clenil Modulite and seek medical help.
Very rare systemic effects with long-term high doses:
Mainly seen with high doses for long periods, particularly in children:
- Adrenal suppression (underactive adrenal glands)
- Slowed growth in children and teenagers – height should be checked regularly
- Reduced bone mineral density (thinning of the bones)
- Cataract or glaucoma
- Mood and behaviour changes, including:
- Sleep problems
- Anxiety, depression
- Irritability or aggression, particularly in children
If you notice slower growth in your child, visual changes, persistent tiredness, mood changes or any other worrying symptoms, speak to a doctor.
Patient Information Leaflet
Please see HERE for the Patient Information Leaflet
Additional Info
Key facts about Clenil Modulite 100 micrograms inhaler:
- Active ingredient: Beclometasone dipropionate 100 micrograms per puff
- Type of medicine: Inhaled corticosteroid preventer for asthma
- Use: Regular daily use to prevent symptoms – not for sudden attacks
- Device: Pressurised metered-dose inhaler with HFA-134a propellant and a dose indicator
- Contains small amounts of ethanol (alcohol) and glycerol – the amounts are too low to have noticeable effects at normal doses
- Driving and using machines: No known effect
Important points:
- Always keep a reliever inhaler (usually a blue inhaler) available for sudden breathlessness. Clenil Modulite does not relieve an acute attack.
- If you find you are needing your reliever more often, or your symptoms are getting worse, seek medical advice promptly – your preventer dose may need adjusting.
- Do not change the dose or stop your inhaler without speaking to your doctor.
Drug interactions:
- Interactions are generally unlikely, but caution is advised with strong CYP3A inhibitors (e.g. some HIV medicines such as ritonavir or cobicistat), as they may increase steroid effects – monitoring may be needed.
- There is a theoretical interaction with certain medicines used to treat alcohol dependence or infections (e.g. disulfiram or metronidazole) due to the small ethanol content, but this is unlikely to be clinically significant at normal doses.
Always let your doctor and pharmacist know about all other medicines, including over-the-counter and herbal products.
Directions
Clenil Modulite is for inhalation through the mouth only. Always use it exactly as your doctor has told you.
Typical starting doses (your own dose may be different):
- Adults (including older people)
- Usual starting dose: 200 micrograms twice daily (e.g. 2 puffs of the 100 microgram strength twice a day)
- In more severe asthma: up to 600–800 micrograms a day, split into 2–4 doses
- Children
- Usual starting dose: 100 micrograms twice daily
- May be increased up to 400 micrograms a day, split into 2–4 doses
Your doctor will aim to:
- Find the lowest dose that keeps your asthma well controlled
- Adjust the dose up or down depending on your symptoms
Using a spacer
- Children and adolescents ≤15 years: Clenil Modulite should always be used with a Volumatic™ spacer.
- Adults and adolescents ≥16 years: a Volumatic spacer must be used if your total daily dose is 1000 micrograms or more. It may also help at lower doses if you struggle to co-ordinate breathing and pressing the inhaler.
Step-by-step (general guidance)
- Sit or stand upright.
- Remove the mouthpiece cover, check that it is clean and free from objects.
- Test spray:
- If the inhaler is new or hasn’t been used for 3 days or more, press one puff into the air.
- Breathe out gently as far as comfortable.
- Place the mouthpiece in your mouth and close your lips around it (don’t bite).
- Start to breathe in slowly and deeply through your mouth.
- As you begin to breathe in, press down on the top of the inhaler once to release a puff.
- Keep breathing in steadily to fill your lungs.
- Remove the inhaler from your mouth and hold your breath for 5–10 seconds (or as long as comfortable).
- Breathe out slowly.
- If you need another puff, wait about 30 seconds and repeat.
- Replace the mouthpiece cover.
After every dose:
-
Rinse your mouth with water and spit it out, or brush your teeth – this helps reduce the risk of thrush and hoarseness.
Dose indicator
- There is a dose counter on the back of the inhaler showing approximately how many puffs remain, in steps of 20 doses.
- Consider arranging a replacement when the indicator shows 20.
- When it reaches 0, you should replace the inhaler – even if you can still hear or feel some spray.
Cleaning
- Clean the inhaler at least once a week.
- Follow the instructions in your patient leaflet – usually involves wiping the mouthpiece with a dry cloth.
- Do not wash or immerse the inhaler in water.
Missed a dose?
- If you forget a dose, take it as soon as you remember, unless it is nearly time for your next dose.
- If it is close to your next dose, skip the missed dose and take the next one at the usual time.
- Do not take extra puffs to make up for a missed dose.
It’s important to use this inhaler regularly every day. If you miss doses often or are unsure how to get back on track, speak to your doctor or pharmacist.
Do not stop using Clenil Modulite suddenly, especially if you are on a high dose or have previously used steroid tablets – your doctor will tell you how to reduce the dose gradually if needed.
FAQs
What is Clenil Modulite used for?
It is a preventer inhaler for long-term control of asthma. Used daily, it helps reduce inflammation in the lungs, control symptoms and cut the risk of asthma attacks. It does not work as a quick-relief inhaler.
How long does it take to work?
Some people notice improvement within a few days, but it can take 1–2 weeks or longer to feel the full benefit. It is important to use it every day, even if you feel well, to keep asthma under control.
Can I use this inhaler to relieve a sudden asthma attack?
No. Clenil Modulite is not a reliever. For sudden wheeze, breathlessness or chest tightness, you must use your fast-acting reliever inhaler (usually a blue inhaler) as prescribed. If you need your reliever more often than usual, see a doctor or nurse as soon as possible.
Why do I need to rinse my mouth after using it?
Rinsing your mouth and spitting out (or brushing your teeth) after each dose helps to: reduce the risk of thrush in the mouth and throat, and reduce hoarseness or soreness of the voice, which is especially important if you are on higher doses or long-term treatment.
Can children use Clenil Modulite
Yes. It is used in children with asthma, but: it should always be used with a Volumatic™ spacer in children and adolescents up to 15 years, their height should be monitored regularly during long-term treatment, and the dose should be kept to the lowest amount that controls symptoms.
Is it safe to use for a long time?
Many people use inhaled steroids for years. When used at the lowest effective dose, they are much safer than having poorly controlled asthma. At high doses for long periods, there is a small risk of systemic steroid side effects (e.g. slowed growth in children, bone thinning, eye effects), so regular asthma reviews are important.
Can I drink alcohol while using Clenil Modulite?
The inhaler contains only a tiny amount of alcohol, which is not expected to cause noticeable effects at normal doses. It is generally safe to drink alcohol in moderation unless your doctor has advised otherwise.
What should I do if my asthma gets worse while I’m using this inhaler?
Seek medical advice promptly if: you are needing your reliever inhaler more often, your reliever seems less effective, you wake at night with asthma symptoms, you notice increasing wheeze, cough or chest tightness. Your dose may need to be adjusted, or other treatments may be added, so do not just keep increasing your own dose without medical advice.
Does Clenil Modulite affect driving or using machines?
No specific effects have been reported. If you feel unwell (for example, with headache or dizziness), wait until symptoms settle before driving or using machines.
When should I get urgent help?
Seek urgent medical help or call emergency services if: you have severe breathlessness or wheeze that does not improve with your reliever inhaler, you need your reliever inhaler more than every 4 hours or repeatedly overnight, you notice swelling of the face, lips, tongue or throat, or difficulty breathing after using the inhaler, and you have sudden chest pain, coughing up blood, or severe dizziness These may be signs of a serious asthma attack or severe reaction and require immediate treatment.
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