Trimbow uses, dose and side effects

88 micrograms/5 micrograms/9 micrograms Inhalation powder
beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium (beclometasone dipropionase/formoterol fumarase dihydricus/glycopyrronium)

What Trimbow is and what it is used for

Tombow is a medicine to make breathing easier that contains three active substances:

beclomethasone dipropionate
formoterol fumarate dihydrate and
glycopyrronium.

Beclomethasone dipropionate belongs to a group of medicines called corticosteroids that work by reducing swelling and irritation in the lungs.

Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They work in different ways to relax the muscles in the airways, helping to widen the airways so you can breathe more easily.

Regular treatment with these three active substances helps relieve and prevent symptoms such as shortness of breath, wheezing, and cough in adult patients with chronic obstructive pulmonary disease (COPD). Tombow can reduce exacerbations (flare-ups) of COPD symptoms. COPD is a serious, long-term disease that means that the airways are blocked and the alveoli in the lungs are damaged, leading to breathing difficulties.

What you need to know before using Trimbow

Do not use Trimbow

If you are allergic to beclomethasone dipropionate, formoterol fumarate dihydrate, and/or glycopyrronium, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tombow is used as a maintenance treatment for obstructive lung disease. Do not use this medicine to treat a sudden attack of shortness of breath or wheezing.

If your breathing worsens

If your shortness of breath or wheezing (breathing with a whistling sound) worsens immediately after inhaling the medicine, stop using the Trimbow inhaler and use your rapid-acting emergency inhaler immediately. You should contact a doctor immediately. The doctor will evaluate your symptoms and can start another treatment for you if necessary.

See also section 4, “Possible side effects”.

If your lung disease worsens

See your doctor immediately if your symptoms get worse or are difficult to manage (eg if you use a separate as-needed inhaler more often) or if your as-needed inhaler does not improve your symptoms. Your lung disease may have worsened and the doctor may need to prescribe another treatment.

Talk to your doctor or pharmacist before using Trimbow:

if you have heart problems, e.g. angina (pain in the heart or chest), recently had a heart attack (myocardial infarction), heart failure, narrowing of the arteries around the heart (coronary artery disease), heart valve disease, or another heart defect, or a condition called hypertrophic obstructive cardiomyopathy ( a condition where the heart muscle is abnormal).
if you have heart rhythm disturbances such as irregular heartbeats, high pulse or palpitations, or if you have found out that you have an abnormal heart rhythm ( ECG ).
if you have narrowing of the arteries (“arteriosclerosis”, high blood pressure, or if you know you have an aneurysm (an abnormal bulge in the vessel wall).
if you have an overactive thyroid gland.
if you have a low level of potassium in your blood ( hypokalaemia ). Tombow in combination with certain other medicines for the lungs or medicines such as diuretics (water-reducing medicines to treat heart disease or high blood pressure ) can cause a rapid drop in potassium levels in the blood. Therefore, the doctor may need to measure the potassium level in your blood from time to time.
if you have liver or kidney disease.
if you have diabetes. High doses of formoterol can raise your blood sugar and therefore you may need to take extra blood sugar measurements when you start using this medicine and also from time to time during treatment.
if you have a tumor in the adrenal gland (so-called pheochromocytoma ).
if you are going to have anesthesia. Depending on the type of anesthetic, it may be necessary to stop treatment with Trimbow at least 12 hours before the anesthetic.
if you are being treated or have ever been treated for tuberculosis (TB) or if you have a respiratory infection.
if you have an eye disease called narrow-angle glaucoma.
if you have difficulty urinating.
if you have an infection in your mouth or throat.

If any of the above apply to you, talk to your doctor before using Trimbow. If you have or have had any medical problems or allergies, or if you are not sure if you can use Trimbow, you should contact your doctor or pharmacist before using the inhaler.

If you already use Trimbow

If you use Trimbow or high doses of other inhaled cortisone preparations for long periods and in case of stress (eg hospitalization after an accident, after a serious injury, or before surgery) you may need more of this medicine. In such a situation, the doctor can increase the dose of cortisone to overcome the stress and can prescribe these in the form of tablets or injections.

Contact a doctor if you experience blurred vision or other visual disturbances.

Children and young people

This medicine should not be given to children under the age of 18.

Other medicines and Trimbow

Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This includes medicines that, like Trimbow, are used for lung disease.

Some medicines can increase the effects of Trimbow and your doctor may want to monitor you closely if you are taking these medicines (eg some anti-HIV medicines: ritonavir, cobicistat).

Do not use this medicine together with a beta-blocker (used to treat certain heart problems such as angina pectoris or to lower blood pressure, etc.) unless your doctor has chosen a beta blocker that does not affect your breathing. Beta-blockers (including beta-blocker eye drops ) can reduce the effect of formoterol or cancel it completely. On the other hand, the use of other beta2-agonists ( medicines that act in the same way as formoterol) may increase the effect of formoterol.

Use of Trimbow together with:

drugs for the treatment of
- abnormal heart rhythm ( quinidine, disopyramide, procainamide )
- allergic reactions ( antihistamines )
- symptoms of depression or mental disorders such as MAOIs (eg phenelzine and isocarboxazid), tricyclic antidepressants (eg amitriptyline and imipramine), or phenothiazines

can cause changes in the ECG ( electrocardiogram ). They can also increase the risk of heart rhythm disturbances ( ventricular arrhythmias ).

drugs for the treatment of Parkinson’s disease ( levodopa ), for the treatment of underactive thyroid gland (levothyroxine), drugs containing oxytocin (which causes uterine contraction), and alcohol may increase the risk of cardiac side effects of formoterol.
MAO inhibitors, including drugs with a similar effect such as furazolidone and procarbazine (in mental disorders), can cause increased blood pressure.
medicines for the treatment of heart disease ( digoxin ) can cause a lowered level of potassium in the blood. This can increase the risk of abnormal heart rhythms.
other drugs for the treatment of obstructive pulmonary disease (theophylline, aminophylline, or corticosteroids ) and diuretics can also cause a decrease in potassium levels in the blood.
some anesthetics can increase the risk of abnormal heart rhythms.

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 using this medicine.

You should only use Trimbow during pregnancy if your doctor advises you to do so. Use of Trimbow during labor should preferably be avoided due to formoterol’s inhibitory effects on uterine contractions.

You should not use Trimbow while breastfeeding. You and the doctor must decide whether to stop breastfeeding or to stop/abstain from treatment with Trimbow, taking into account the benefit of breastfeeding for the baby and the benefit of treatment for you.

Driving ability and use of machinery

Tombow is unlikely to affect the ability to drive or use machines.

Trimbow contains lactose

Lactose contains small amounts of milk protein, which can cause allergic reactions.

How to use Trimbow

Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

The recommended dose is two inhalations in the morning and two inhalations in the evening.

If you feel that the medicine is not having a sufficient effect, you should contact the doctor.

If you have previously used another inhaler containing beclomethasone dipropionate, consult your doctor, as the effective dose of beclomethasone dipropionate in Trimbow to treat your obstructive pulmonary disease may be lower than for some other inhalers.

Mode of administration

Tombow is intended for inhalation.

You must inhale the medicine through the mouth so that the medicine is taken directly into the lungs.

Instructions for use

Information about the contents of the package can be found in section 6.

If the contents of the package do not match what is described in section 6, return the inhaler to the person who supplied it and exchange it for a new one.

Do not remove the inhaler from the protective bag unless you intend to use it immediately.
Only use the inhaler as directed.
Keep the protective cap closed until you need to take a dose from the inhaler.
Store the inhaler in a clean, dry place when not in use.
Never attempt to disassemble the inhaler.

A. The main parts of the inhaler

It takes three steps to take a dose from the inhaler: open, inhale, and close.

B. Before using a new inhaler

1. Open the protective bag and take out the inhaler.

Do not use the inhaler if the protective bag seal is broken or if the protective bag is damaged – return it to the person who supplied it and exchange it for a new one.
Use the label on the carton to record the date you opened the protective bag.

2. Examine the inhaler.

If the inhaler shows signs of damage or is broken, return it to the person who provided it and exchange it for a new one.

3. Check the dose counter. If the inhaler is new, the dose counter will show “120”.

Do not use a new inhaler that shows a number below ‘120’ – return it to the person who supplied it and exchange it for a new one.

C. How to use the inhaler

C.1. Open

1. Hold the inhaler firmly and hold it upright.

2. Check the number of remaining doses: a number between “1” and “120” indicates that there are doses left.

If the dose counter shows “0”, there are no doses left. Throw away the inhaler and get a new one.

3. Open the protective cover completely.

4. Exhale as much as feels comfortable before inhaling.

Do not exhale through the inhaler.

C.2. Inhale

If possible, stand or sit upright when inhaling.

1. Pick up the inhaler, bring it to your mouth and close your lips around the mouthpiece.

Do not cover the air hole when holding the inhaler.
Do not inhale through the vent.

2. Inhale forcefully and deeply through the mouth.

You may feel a certain taste when you take dose one.
You may hear or feel a click when you take dose one.
Do not inhale through the nose.
Keep your lips around the inhaler during inhalation a.

3. Remove the inhaler from the mouth.

4. Hold your breath for 5 to 10 seconds or as long as feels good.

5. Exhale slowly.

Do not exhale through the inhaler.
If you are unsure that you are taking the correct dose, contact a pharmacist or doctor.

D.3. Close

1. Turn the inhaler back to the upright position and close the protective cap completely.

2. Check that the dose counter has counted down by one dose.

If you are unsure whether the dose counter has counted down by a dose after an inhalation, wait until the next dosing occasion and take dose one as usual. Do not take an extra dose.

3. If you need to take another dose, repeat steps C.1 to C.3.

D. Cleaning

The inhaler usually does not need to be cleaned.
If necessary, the inhaler can be wiped with a dry cloth or paper towel.
- Do not use water or other liquids to clean the inhaler. Keep it dry.

If you have used too much Trimbow

You must take the dose as directed by your doctor. Do not exceed the prescribed dose without talking to a doctor.

If you take too much Trimbow, side effects, as described in section 4, may occur.

Tell your doctor if you have used too much Trimbow and if you get any of these symptoms. Your doctor may want to do some blood tests.

If you forget to use Trimbow

Take the next dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and instead just take the next dose at the correct time. Do not take a double dose to make up for a missed dose.

If you stop using Trimbow

You must use Trimbow every day. Do not stop using Trimbow or reduce the dose, even if you feel better or are symptom-free. If you want to do that, you should contact a doctor.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

There is a risk of worsening shortness of breath or wheezing immediately after using Trimbow and this is called paradoxical bronchospasm (which may affect up to 1 in 1,000 people). If this happens, you should stop using Trimbow and instead immediately use your rapid-acting as-needed inhaler to treat shortness of breath and wheezing. Contact a doctor immediately.

Tell a doctor immediately

if you get allergic reactions such as skin allergy, hives, itching, rash (may affect up to 1 in 100 users), redness of the skin, swelling of the skin or mucous membranes, especially the eyes, face, lips, and throat (may affect up to 1 in 1 000 users).
if you experience pain or discomfort in the eyes, temporary blurred vision, light rings, or color impressions in the field of vision together with red eyes. These may be signs of an acute attack of narrow-angle glaucoma (which may affect up to 1 in 10,000 users).

Tell your doctor if you have any of the following symptoms while using Trimbow as they may be symptoms of pneumonia (which may affect up to 1 in 10 people):

fever or chills
increased mucus production changed the color of the mucus
increased coughing or increased breathing difficulties.

Possible side effects are listed below according to frequency.

Common (may affect up to 1 in 10 users)

sore throat
runny or stuffy nose and sneezing
fungal infections in the mouth. Reduce the risk of these side effects by rinsing your mouth, gargling with water, or brushing your teeth immediately after inhalation
huskiness
headache
urinary tract infection.

Uncommon (may affect up to 1 in 100 users)

flu-like symptomssinusitisitchy, runny or stuffy nosefungal infections of the throat or gullet (esophagus)vaginal yeast infectionrestlessnesstremorsdizzinesstaste changes or reduced tastenumbnessotitisirregular heartbeats changes on electrocardiogram ( ECG )unusually fast heartbeats and heart rhythm disturbancespalpitations (abnormal heartbeats)facial flushing increased blood flow to certain tissues in the body asthma attack cough and phlegm

throat irritationnosebleedredness in the throat dry mouthdiarrheadifficulty swallowing malaise upset stomach discomfort in the stomach after a meal burning sensation in the lipscariesskin rash, hives, itching inflammation of the oral mucosa, with or without ulcers increased sweating muscle cramps and muscle pain pain in arms or legs pain in muscles, bones or joints in the chestfatiguehigh blood pressure reduction of levels of certain substances in the blood: of certain white blood cells called granulocytes, of potassium or cortisol increase in certain components of the blood: glucose, C-reactive protein, the number of blood platelets, insulin, free fatty acids or ketones.

Rare (may affect up to 1 in 1,000 users)

fungal infections in the chest decreased appetite sleep disorders (too little or too much sleep)feeling of tightness over the chest feeling of skipped heartbeats or extra heartbeats, usually slow heartbeatsworsening of asthma

leakage of blood from a vessel into surrounding tissuelowered blood pressureweaknesspain in the back of the mouth and throat inflammation of the throat dryness throw frequent and painful urination difficulty and pain when urinatingkidney inflammation.

Very rare (may affect up to 1 in 10,000 users)

low level of certain blood cells called platelets
respiratory distress
swollen hands and feet
growth retardation in children and adolescents.

Has been reported (occurring in an unknown number of users)

blurred vision

Use of high doses of inhaled cortisone preparations for a long time can in very rare cases cause effects in the body:

impaired functioning of the adrenal glands (adrenal suppression)
decreased bone density
clouding of the lens of the eye (cataract or cataract ).

Tombow does not contain a high dose of inhaled corticosteroid but the doctor may want to measure cortisol levels in the blood from time to time.

The following side effects may also occur with long-term use of high doses of inhaled cortisone preparations but the frequency is currently unknown (cannot be estimated from available data):

Depression
worries, nervousness, feeling rushed or irritable.

It is more likely that these side effects occur in children.

How Trimbow should be stored

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Store at a maximum of 25 °C.

Store the inhaler in the original packaging. Moisture sensitive. Do not remove the inhaler from the protective bag until just before the first use.

After opening the protective bag, the medicine must be stored dry and used within 6 weeks. Use the self-adhesive label on the outer carton to record the date you opened the protective pouch and attach the label to the underside of the inhaler.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

The active substances are beclomethasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium.

Each delivered dose ( dose one leaving the mouthpiece) contains 88 micrograms of beclomethasone dipropionate, 5 micrograms of formoterol fumarate dihydrate, and 9 micrograms of glycopyrronium (as 11 micrograms of glycopyrronium bromide).

Each metered dose contains 100 micrograms of beclomethasone dipropionate, 6 micrograms of formoterol fumarate dihydrate, and 10 micrograms of glycopyrronium (as 12.5 micrograms of glycopyrronium bromide).

Other ingredients are lactose monohydrate (see section 2) and magnesium stearate.

Appearance and package sizes of the medicine

Tombow is a white to almost white inhalation powder.

It is supplied in a white plastic inhaler called NEXThaler fitted with a gray protective cap over the mouthpiece and a counter for the inhalations.

Each inhaler is packed in a sealed protective bag.

Tombow is supplied in packs containing one inhaler and in multipacks of two or three inhalers, which provide 120 inhalations each (120, 240, or 360 inhalations).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chiesi Farmaceutici SpA

Via Palermo 26/A

43122 Parma

Italy

Manufacturer