Clenil Modulite Inhaler

What is Clenil Modulite?

Clenil Modulite is a preventer inhaler used in the management of asthma. Its active ingredient, beclometasone dipropionate, belongs to a class of medicines called corticosteroids (often referred to as steroids). Unlike anabolic steroids used for muscle building, corticosteroids like beclometasone work by reducing inflammation in the body.

Mechanism of Action

Clenil Modulite works by delivering beclometasone directly to the lungs, where it exerts a local anti-inflammatory effect. Think of asthma as having "angry" or inflamed airways that overreact to triggers like pollen, cold air, or exercise. Clenil Modulite acts like a soothing balm that calms this inflammation, reducing swelling and irritation in the walls of the small air passages in the lungs.

This anti-inflammatory action makes the airways less sensitive to triggers, preventing asthma symptoms before they start and making breathing easier over time. The medication works on specific cells in the immune system, inhibiting the release of inflammatory substances that cause airway narrowing and mucus production.

What is Clenil Modulite Used For?

Clenil Modulite is used to help prevent the symptoms of mild, moderate or severe asthma. It is specifically indicated for:

• Regular prevention of asthma symptoms
• Reducing the frequency and severity of asthma attacks
• Controlling chronic inflammation in the airways
• Improving overall lung function in asthmatic patients

Clenil Modulite is suitable for adults, adolescents, and children whose asthma requires regular preventive treatment. The appropriate strength and dosage will depend on the severity of your asthma and your individual response to treatment.

Before Using Clenil Modulite

Before starting treatment with Clenil Modulite, it's important to discuss your medical history with your doctor. Special consideration is needed if any of the following apply to you:

Medical History Assessment Checklist

• Current or previous treatment for tuberculosis (TB)
• Any allergies to medicines or other substances
• Liver problems
• Osteoporosis or family history of bone mineral density issues
• Eye problems such as cataracts or glaucoma
• Current or recent infections

Required Baseline Evaluations

Before and during treatment with Clenil Modulite, your doctor may:

• Perform breathing tests to assess your lung function
• Monitor your height regularly if you are a child or adolescent
• Check your bone mineral density if you are on long-term high-dose treatment
• Conduct eye examinations periodically

If your asthma seems to be getting worse (increased wheezing, shortness of breath, decreased effectiveness of your reliever inhaler), contact your doctor immediately as your treatment may need adjustment.

Clenil Modulite Contraindications

Absolute Contraindications

Do not use Clenil Modulite if you:

• Are allergic to beclometasone dipropionate or any other ingredients of this medicine
• Have a known allergy to any other medicines used to treat asthma

Relative Contraindications (Use with Caution)

Special caution is required if you have:

• Active or quiescent tuberculosis infection of the respiratory tract
• Untreated fungal, bacterial, or viral infections
• Severe liver impairment
• Osteoporosis (especially in postmenopausal women)

Special Population Considerations

Elderly Patients

No specific dosage adjustment is generally required for elderly patients, but special attention should be paid to patients with pre-existing osteoporosis or increased risk of fractures.

Children and Adolescents

Clenil Modulite can be used in children, but:

• Clenil Modulite 200 and 250 micrograms are not suitable for children
• Regular monitoring of height is essential as prolonged treatment may affect growth
• Using a Volumatic spacer device is recommended for all children and adolescents aged 15 years and under
• Young children may need assistance with inhaler technique

Renal or Hepatic Impairment

No specific studies have been conducted in patients with renal or hepatic impairment. Since beclometasone is predominantly cleared by hepatic metabolism, caution should be exercised in patients with severe liver disease.

Clenil Modulite and Other Medicines

Before starting Clenil Modulite, inform your doctor about all medicines you are taking, including prescription, over-the-counter, and herbal products.

Potential Drug Interactions

• HIV medications such as ritonavir and cobicistat may increase the effects of Clenil Modulite. Your doctor may need to monitor you carefully if you are taking these medicines.
• Other corticosteroids (oral, injectable, or other inhaled forms) may increase the risk of systemic side effects.
• Ketoconazole and other potent CYP3A4 inhibitors may increase plasma concentrations of beclometasone.

Timing Recommendations

If you use both a preventer (Clenil Modulite) and a reliever inhaler, use the reliever first to open up the airways, wait a few minutes, then use your Clenil Modulite. This allows the preventer medication to penetrate deeper into the lungs.

Pregnancy & Breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using Clenil Modulite. The benefits of treating asthma during pregnancy should be weighed against potential risks to the fetus.

Breastfeeding

Beclometasone dipropionate may pass into breast milk in small amounts. Consult your doctor before using Clenil Modulite while breastfeeding. The benefits of asthma control during breastfeeding should be considered against potential risks to the infant.

Driving & Machine Operation

Clenil Modulite is unlikely to affect your ability to drive or use machines. However, if you experience side effects such as dizziness, blurred vision, or other symptoms that could impair your alertness, avoid these activities until you feel normal again.

Warning signs to watch for: dizziness, blurred vision, fatigue. If you experience any of these, do not drive or operate machinery until the symptoms resolve.

Clenil Modulite Ingredients

Active Ingredient

• Beclometasone dipropionate (50, 100, 200, or 250 micrograms per actuation)

Other Ingredients (Excipients)

Allergen Warnings

This product contains alcohol (ethanol) but in very small amounts - less than 9 mg per actuation, which is equivalent to less than 2 ml of wine or beer per dose. This small amount is unlikely to have any noticeable effects.

The product also contains fluorinated greenhouse gases (norflurane) as part of the propellant system.

How to Use Clenil Modulite

Proper inhaler technique is essential for Clenil Modulite to work effectively. Your doctor, nurse or pharmacist should show you how to use your inhaler correctly.

1. Remove the mouthpiece cover by holding between thumb and forefinger, squeezing gently and pulling apart.
2. Check the mouthpiece to ensure it's clean with no foreign objects.
3. Test your inhaler if new or unused for 3+ days by releasing one puff into the air.
4. Hold the inhaler upright with your thumb on the base, below the mouthpiece.
5. Breathe out as far as comfortable (away from the inhaler).
6. Place mouthpiece in mouth between teeth and close lips around it (don't bite).
7. Start breathing in slowly and press down on the inhaler to release a puff.
8. Continue breathing in steadily and deeply.
9. Hold your breath for a few seconds or as long as comfortable.
10. Breathe out slowly.
11. If taking another puff, wait about 30 seconds before repeating steps 4-10.
12. After use, replace the mouthpiece cover firmly.

Important: Don't rush steps 2-5. Practice in front of a mirror initially to ensure proper technique.

Clenil Modulite Dosage Guidelines

The starting dose depends on your asthma severity and will be determined by your doctor. It may be higher than the common starting doses listed below. Your doctor will prescribe the lowest effective dose to control your symptoms.

Clenil Modulite 50 micrograms

Clenil Modulite 100 micrograms

Clenil Modulite 200 micrograms

Not suitable for children

Clenil Modulite 250 micrograms

Not suitable for children

The total daily dose may be divided into 2, 3 or 4 doses per day depending on your individual needs.

When to Use a Volumatic Spacer

A Volumatic spacer device should always be used when:

• Adults, elderly and adolescents (16+) are taking total daily doses of 1,000 micrograms or more
• Clenil Modulite is used in children and adolescents aged 15 years and under, regardless of dose

Administration Instructions

Inhaler Technique Tips

• Shake the inhaler well before each use
• Breathe out fully before placing the inhaler in your mouth
• Start breathing in slowly just before pressing the canister
• Press the canister firmly and continue to breathe in deeply
• Hold your breath for 5-10 seconds after inhalation
• Wait 30-60 seconds between puffs if taking more than one

Using with a Spacer Device

For those who have difficulty coordinating inhalation with actuation, or when high doses are prescribed, using a Volumatic spacer is recommended:

1. Attach the inhaler to the spacer
2. Shake the inhaler and place in spacer
3. Press the canister to release one puff into the spacer
4. Breathe in and out normally through the spacer mouthpiece 4-5 times
5. For children under 5, a face mask attachment may be used with the spacer

Cleaning Your Inhaler

Clean your inhaler once a week:

1. Remove the mouthpiece cover
2. Do not remove the canister from the actuator
3. Do not use water or other liquids
4. Use a clean cotton swab to gently clean the small circular opening where medicine sprays out
5. Replace the mouthpiece cover

Missed Dose Management

If you forget to take your Clenil Modulite:

• Skip the forgotten dose and take the next dose at the usual time
• Do not take a double dose to make up for a forgotten one
• Try to establish a routine to help remember regular doses

If you frequently forget doses, your asthma may not be as well controlled. Discuss this with your doctor who may suggest strategies to improve adherence.

Overdose Information

If you use more Clenil Modulite than prescribed:

• Contact your doctor as soon as possible
• Your doctor may want to check cortisol levels in your blood
• Acute overdose is unlikely to cause serious problems due to the local action in the lungs
• Chronic excessive use may lead to systemic steroid effects

Never increase or decrease your dose without medical advice. Always use Clenil Modulite exactly as prescribed by your doctor.

Symptom Management

If excessive use occurs, watch for symptoms of systemic corticosteroid effects including:

• Weight gain, especially in the face and upper back
• Acne, thinning skin
• Mood changes, difficulty sleeping
• Increased blood pressure
• High blood sugar

Report any such symptoms to your doctor immediately.

Clenil Modulite Side Effects

Like all medicines, Clenil Modulite can cause side effects, although not everybody gets them. If you experience any side effects, talk to your doctor, pharmacist or nurse.

Very Common (may affect more than 1 in 10 people)

• Thrush (oral candidiasis) in the mouth and throat - more likely with daily doses over 400 micrograms. To prevent this, rinse your mouth with water or brush your teeth after each use.

Common (may affect up to 1 in 10 people)

• Hoarse voice or sore throat or tongue - rinsing your mouth with water after use or using a spacer device may help prevent this

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions including skin rashes, hives, itching or redness

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

• Swelling of the face, eyes, lips and throat (angioedema)
• Changes to normal steroid production in the body, particularly after long-term high-dose treatment
• Slowed growth in children and adolescents - regular height monitoring is important
• Decreased bone mineral density (thinning and weakening of bones)
• Eye problems including cataracts and glaucoma (increased pressure in the eye)
• Adrenal suppression symptoms - if you become unwell with loss of appetite, abdominal pain, weight loss, tiredness, nausea, vomiting, feeling faint, sweating or convulsions, especially during stress such as surgery, infection or asthma attack

Unknown Frequency (cannot be estimated from available data)

• Sleeping problems, depression, anxiety, restlessness, nervousness, over-excitement or irritability (more likely in children)
• Headaches
• Nausea (feeling sick)
• Blurred vision

Reporting 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 at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to Store Clenil Modulite

• Keep out of sight and reach of children
• Do not use after the expiry date printed on the carton and label
• Store below 30°C - protect from frost and direct sunlight
• If the inhaler gets very cold, take the metal canister out and warm in your hands for a few minutes before use
• Never use anything else to warm the canister
• Do not dispose of via wastewater or household waste - ask your pharmacist how to dispose of medicines no longer required

Clenil Modulite Pack Information

What Clenil Modulite Contains

• Active substance: beclometasone dipropionate (50, 100, 200 or 250 micrograms per puff)
• Other ingredients: glycerol, ethanol, and the propellant norflurane (HFC-134a)

What Clenil Modulite Looks Like

Clenil Modulite is a pressurised inhalation solution contained in an aluminium can with plastic actuator and protective cap. Each canister contains 200 puffs and has a dose indicator on the back that shows how many puffs remain.

When to Replace Your Inhaler

When the indicator shows 20 doses left, request a new inhaler from your doctor. When '0' appears in the window, discard the inhaler even if it feels like there is content remaining, as remaining puffs may not contain enough medicine.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Manufacturer: Chiesi Farmaceutici S.p.A., 96 via S. Leonardo, 43122 Parma, Italy or Chiesi S.A.S., 2 rue des Docteurs Alberto et Paolo Chiesi, 41260 La Chaussee Saint Victor, France

Where Can I Buy Clenil Modulite Online in the UK