The dosage of SYMBICORT INHALER is individual. It should be taken regularly (every day), even when you have no symptoms.

Follow your doctor's instructions carefully. Asthma and COPD treatment will differ from person to person. Therefore, your prescribed treatment may be different from the information in this leaflet.

Patients with Asthma:

Treatment with SYMBICORT should not be initiated to treat an asthma attack.

For the treatment of asthma, your doctor will instruct you to use SYMBICORT INHALERin one of two ways:

1. SYMBICORT maintenance therapy; or
2. SYMBICORT maintenance and reliever therapy.

Each of these treatment plans is described below.

1. SYMBICORT Maintenance Therapy for Asthma:

You take a regular daily dose from SYMBICORT TURBUHALER. In addition, you use a separate inhaler, containing a fast-acting bronchodilator (airway-widening medicine) for relief of asthma symptoms. This means that you need two separate inhalers.

Adults and adolescents (12 years and older):

• 1-2 inhalations SYMBICORT 100 INHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.
• or
• 1-2 inhalations SYMBICORT 200 INHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.
• or
• 1 inhalation SYMBICORT FORTE INHALER once or twice daily. The maximum recommended daily maintenance dose is 4 inhalations.

Always carry your fast-acting bronchodilator (rescue medication) with you for relief of symptoms.

During periods of worsening of asthma, the dose may temporarily be increased up to a maximum of 4 inhalations of SYMBICORT 100 INLAER or SYMBICORT 200 INHALER twice daily or 2 inhalations of SYMBICORT FORTE INAHLER twice daily.

Do NOT exceed the dose prescribed by your doctor.

2. SYMBICORT Maintenance and Reliever Therapy (SYMBICORT SMART) for Asthma:

You take a regular daily maintenance dose of SYMBICORT TURBUHALER. You also use SYMBICORT TURBUHALER if you need extra doses for relief of asthma symptoms. This means that you use one inhaler (SYMBICORT TURBUHALER) for both daily maintenance AND symptom relief.

Adults and adolescents (12 years and older):

• 1-2 inhalations SYMBICORT 100 TURBUHALER twice daily or 2 inhalations once daily. You should take 1 additional inhalation as-needed if you feel symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. The maximum recommended daily dose is 8 inhalations.
• or
• 1-2 inhalations SYMBICORT 200 TURBUHALER twice daily or 2 inhalations once daily. You should take 1 additional inhalation as-needed if you feel symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. The maximum recommended daily dose is 8 inhalations.

Always carry SYMBICORT TURBUHALER with you. You should use extra doses as needed to relieve your asthma symptoms, including periods when your asthma gets worse.

Do not exceed the maximum total number of daily inhalations (8 inhalations/day). If you exceed 8 inhalations/day please seek medical attention.

Patients with COPD:

Adults (18 years and older):

• 2 inhalations SYMBICORT 200 TURBUHALER twice daily. The maximum recommended daily dose is 4 inhalations.
• or
• 1 inhalation SYMBICORT FORTE TURBUHALER twice daily. The maximum recommended daily dose is 2 inhalations.

Treatment with SYMBICORT should not be initiated to treat a COPD attack.

How to prepare a new inhaler for use:

Before you start using SYMBICORT TURBUHALER for the first time it is important that you read the instructions below and follow them carefully.

TURBUHALER is an inhaler from which very small amounts of powder are administered. When you breathe in through the TURBUHALER, powder is delivered to the lungs. It is therefore important that you inhale as deeply and strongly as you can through the mouthpiece.

SYMBICORT TURBUHALER is simple to use.

A. Preparation before first use of a NEW (never been used) inhaler:

Before using your inhaler for the first time you need to prepare the inhaler for use. The preparation does not need to be repeated even if your inhaler is not used regularly.

STEP 1: Unscrew and lift off the cover. You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.

STEP 2: Holding the inhaler upright, turn the red grip as far as it will go in one direction (clockwise or counter-clockwise, it does not matter which way you turn it first); then you must turn it back again as far as it will go in the opposite direction. Do not hold the mouthpiece when turning the grip. The click you hear is part of the loading process.Once you perform this step twice, the inhaler is ready to use.

B. Using the inhaler:

To use your TURBUHALER properly, follow these 4 steps:

STEP 1: Unscrew and lift off the cover. You may hear a rattling sound. This is normal; it is the sound of the drying agent, not the medication.

STEP 2: Holding the inhaler upright, turn the red grip as far as it will go in one direction (clockwise or counter-clockwise, it does not matter which way you turn it first); then you must turn it back again as far as it will go in the opposite direction. Do not hold the mouthpiece when turning the grip. The click you hear is part of the loading process. The inhaler is now ready to use.

If you are not sure you heard the click, and you turn and click the inhaler a second time, you will not end up taking 2 doses by mistake. The TURBUHALER is designed to load only one dose at a time.

STEP 3: Breathe out, with your mouth away from the mouthpiece. Then, place the mouthpiece gently between your teeth.

STEP 4: Now close your lips over the mouthpiece. Inhale as deeply and strongly as you can. Before you exhale, remember to remove the inhaler from your mouth. Repeat this process from Step 1 if more than one dose has been prescribed. When you have taken the prescribed amount of maintenance doses, rinse your mouth with water, and do not swallow. Once you perform these steps, you have completed using SYMBICORT TURBUHALER.

You may not feel or taste the medication when inhaling. This is common.

Do not bite or chew the mouthpiece.

If you accidentally drop, shake or breathe out into SYMBICORT TURBUHALER after it is loaded, you will lose your dose. If this happens, you should load a new dose and inhale it.

Note: Always replace the cover properly after use. Do not try to remove the mouthpiece or to twist it unnecessarily; it is fixed to the inhaler and must not be taken off.

Stopping SYMBICORT TURBUHALER:

Talk to your doctor about how to gradually stop your medication if necessary. It is important that you do not suddenly stop taking SYMBICORT TURBUHALER as it may cause unwanted side effects.

Cleaning:

Clean the outside of the mouthpiece once a week with a dry tissue. Never use water or any other fluid when cleaning the mouthpiece. If fluid enters the inhaler it may not work properly.

When to Start a New Inhaler:

SYMBICORT TURBUHALER has a dose indicator. The dose indicator tells you approximately how many doses are left in the inhaler. The dose indicator moves slowly each time you load a dose. Every 20th dose is marked with a number and every 10th dose is marked with a dash (Figure 5). When the "0" on the red background has reached the middle of the window you should discard your inhaler. The sound you hear when you shake the inhaler is produced by a drying agent, not the medication. SYMBICORT TURBUHALER cannot be re-filled with drug and should be discarded.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

The most common signs and symptoms that may occur after overdosage are trembling, headache and rapid heartbeat.

Missed dose:

If you miss a dose, take it as soon as you remember and then go back to your regular schedule.

Never take a double dose to make up for missed doses. If you are still unsure, check with your doctor or pharmacist to see what you should do.

Common side effects are:

• Headache;
• Trembling;
• Sensation of heart beat;
• Cough;
• Irritation of mouth and/or throat;
• Hoarseness.

Less common side effects are:

• Nausea;
• Sleep difficulties;
• Agitation;
• Restlessness or nervousness;
• Dizziness;
• Muscle cramps.

If any of these side effects worry you, do not stop treatment, but tell your doctor about them.

Rare side effects are:

• Skin rash and bruising;
• Itching;
• Facial swelling;
• Increase in chest tightness, chest pain;
• Depression or behavioural disturbances;
• High blood sugar levels.

If you had been taking oral corticosteroids to treat your asthma and you suddenly have a severe asthma attack when starting SYMBICORT TURBUHALER, contact your doctor right away.

In patients with asthma, you should TELL YOUR DOCTOR if:

The relief of your asthma is not as good as usual or does not last as long as usual. A change from “usual” includes more wheezing, coughing, tightness or shortness of breath;

• You exceed the maximum total number of daily inhalations (8 inhalations/day);
• There is a constant increase in your use of fast-acting reliever medication;
• Your symptoms are waking you up at night;
• Measurement from your peak flow meter indicates a value between 60% and 80% of predicted or personal best.

These may be signs that your asthma is getting worse. Your doctor may adjust your treatment.

You should TELL YOUR DOCTOR RIGHT AWAY or go to the nearest hospital if you notice the following warning signs:

• A sudden worsening of your shortness of breath and wheezing shortly after using your fast-acting medication;
• You do not feel relief from additional doses of your fast-acting reliever medication;
• Measurement from your peak flow meter indicates a value less than 60 percent of predicted or personal best;
• You are breathless at rest;
• Your pulse is more than 120 beats per minute.

In patients with COPD, you should TELL YOUR DOCTOR RIGHT AWAY if you notice the following warning signs, which indicate your condition is worsening:

• Unusual increase in the severity of the breathlessness, cough, tiredness or wheeze;
• Unusual colour, level, consistency or stickiness of phlegm;
• Symptoms of a chest cold and/or chest tightness (e.g. indicating a chest infection);
• Unexplained swelling;
• Unexplained fever.

Serious Warnings for Asthma Patients

Formoterol, one of the medicines in SYMBICORT TURBUHALER, may increase the risk of asthma-related death. It may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Therefore,

• Your doctor will assess your asthma control at regular intervals. SYMBICORT TURBUHALER should only be used when your doctor decides that other asthma medications (e.g. inhaled glucocorticosteroids along with an as needed relief medication) are not helping you enough, or that you need two maintenance medications to control your asthma.
• SYMBICORT TURBUHALER should not be the first medication you use, unless advised by your doctor.

For any concerns regarding the use of SYMBICORT TURBUHALER, consult your doctor.

BEFORE you use SYMBICORT TURBUHALER talk to your doctor or pharmacist if you:

• Have health problems now or have had in the past;
• Have heart problems;
• Have high blood sugar (diabetes);
• Have low blood potassium or any problems with your thyroid gland;
• Have seizures (epilepsy);
• Have severe liver problems (e.g. cirrhosis);
• Take, or have taken steroid medicines within the past several months;
• Have ever had a bad, unusual or allergic reaction to budesonide, formoterol or lactose or to other medicines for breathing problems;
• Are pregnant or planning to become pregnant;
• Are breast feeding;
• Have weak bones (osteoporosis).

Drugs like SYMBICORT can cause eye disorders:

• Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
• Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.

You should therefore have regular eye exams.

You should avoid coming into contact with people who have measles or chicken pox while taking SYMBICORT TURBUHALER. If you are exposed, tell your doctor right away.

Special attention should be paid if you are an adolescent with asthma. Your growth should be monitored regularly by a doctor when being treated with corticosteroids. Studies have also shown that children whose asthma is not controlled do not grow as quickly as other children.

COPD:

Patients with COPD have a higher chance of getting pneumonia (a lung infection). Drugs like SYMBICORT TURBUHALER may increase the chance of getting pneumonia. It is very important that you tell your doctor immediately if you suspect an infection as even mild chest infections should be treated right away.

You should avoid close contact with people who have colds or the flu (influenza). Your doctor may also recommend that you receive a flu shot each year.

If you are using SYMBICORT TURBUHALER for COPD, tell your doctor if you have any of the following symptoms:

• Fever or chills;
• Increased mucus production or change in mucus colour;
• Increased cough;
• Increased breathing difficulties.

These all may be signs of pneumonia.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

Drugs that may interact with SYMBICORT TURBUHALER are:

• Beta-blockers used to lower blood pressure (propranolol) or for other heart or eye problems (e.g. atenolol, timolol);
• Ketoconazole, itraconazole used to treat fungal infections;
• Ritonavir used to treat HIV or AIDS.

If you are allergic to TRICOR or an inactive ingredient that the medication contains, you should not use it.

Before you take TRICOR, you should talk with your doctor if any of the following applies to you:

• Sensitivity to the drug TRICOR or its inactive ingredients
• Poor liver function
• Increased levels of liver enzymes, known as LFTs, on your most recent lab report
• Impaired kidney function
• Damaged bile ducts or a condition called primary biliary cirrhosis
• Gallbladder disease
• Underactive thyroid
• Diabetes mellitus
• You are age 65 or older
• You are using a medication that is considered harmful to the kidneys

Before taking TRICOR, let your doctor know if you:

• Are allergic to TRICOR or any of its ingredients
• Are taking blood thinners, such as like warfarin (Coumadin), dabigatran (Pradaxa), or enoxaparin (Lovenox), because TRICOR may increase their effects
• Are taking a type of cholesterol drug called a statin, such as rosuvastatin (Crestor), atorvastatin (Lipitor), simvastatin (Zocor), lovastatin (Mevacor), or others.

Pregnancy and TRICOR

Benzonatate falls under the FDA’s Pregnancy Category C, which means that it is unknown whether this medication will cause harm to an unborn baby or fetus.

TRICOR should not be taken while breastfeeding. Talk to your doctor first if you are taking TRICOR and planning to breastfeed.

Common Side Effects of TRICOR

If you have any of the following common side effects of TRICOR and they do not go away or become severe, call your doctor or get emergency medical care:

• Mild headache
• Nausea
• Constipation
• Runny nose

TRICOR may actually lower levels of a type of good cholesterol called HDL-C.

Serious Side Effects and Reactions

Tell your doctor right away or get emergency medical help if you have any of the following symptoms:

• Shortness of breath or trouble breathing
• Pain in the chest
• Discomfort in your jaw, neck, upper back, or arms
• Tongue swelling or other mouth and throat problems
• Yellow appearance of the skin, nails, or whites of the eyes (this could be jaundice, a sign of serious effects on the liver)
• Pain in the upper area your back
• Stomach or digestion problems, such as pain, bloating, heartburn, nausea, more gas than usual, or vomiting
• Skin that feels clammy
• Rapid heartbeat
• Swelling, weakness, or pain in your muscles or lower legs
• Red urine
• Allergic reactions, such as rash, swelling, or other skin problems
• Blisters or swelling in your lips, mouth, eyes, ears, nose, or genital areas
• Signs of abnormal bleeding caused by low blood-clotting cells (thrombocytopenia), such as: easy bruising, red pin-prick spots on the skin, gums bleeding when you brush your teeth

It is always important to tell your doctor and pharmacist about all of your treatments, including over-the-counter (OTC) medications; vitamins, nutritional shakes, protein powders, and other supplements; herbal treatments or other alternative medicines; and any illegal or recreational drugs.

The following drugs may interact with TRICOR:

• Acyclovir (Zovirax)
• Adefovir dipivoxil (Hepsera)
• A group of antibiotics called aminoglycosides, such as: amikacin, gentamicin, kanamycin, neomycin, and streptomycin
• Amphotericin
• Blood pressure medications, such as the beta blockers: betaxolol (Betoptic, Kerlone), bisoprolol (Zebeta), atenolol (Tenormin), esmolol (Brevibloc), metoprolol (Lopressor, Toprol XL), and propranolol (Inderal, Inderal LA )
• Diabetes medications, such as chlorpropamide (Diabinese), glimepiride, glipizide, glyburide, and nateglinide (Starlix)
• Cholestyramine
• Certain drugs for cancer, such ascisplatin and pemetrexed

TRICOR and Alcohol

Drinking alcohol while taking TRICOR can make your TRICOR treatment less effective — especially when drinking for long periods of time.

TRICOR and Grapefruit Juice

The liver breaks down TRICOR and grapefruit juice in different ways, so the possibility of a drug interaction may be unlikely.

However, you should still limit or avoid grapefruit juice while taking TRICOR.

TRICOR and Other Interactions

You should avoid taking cholesterol-lowering drugs known as statins, such asrosuvastatin, (Crestor), atorvastatin (Lipitor), simvastatin (Zocor), lovastatin (Mevacor), and others.

If you are taking statins while on TRICOR, it can increase your risk of having a reaction that damages your muscles and kidneys.

Also, talk to your doctor before taking TRICOR if you are taking ezetimibe (Zetia).

TRICOR can increase the effects of blood-thinning medications.

You should not take TRICOR while on any of the following drugs:

• Colchicine (Colcrys)
• Telbivudine (Tybexa)
• Ursodiol (Actigall)
• Contraceptives and hormone replacement medications containing: conjugated estrogens, estradiol, estropipate, ethinyl estradiol, or mestranol
• Water or fluid pills such as: bendroflumethiazide (sold in combination with nadalol as Corzide), cholorthiazide (Diurel), hydrochlorothiazide, also known as HCTZ for short (Esidrix, Microzide), indapamide (Lozol), chlothalidone (Thalitone), or metolazone (Zaroxylin)

The brand Tricor is available in strengths of 54 milligrams (mg) and 160 mg. Generic fenofibrate is available in 48 mg and 154 mg tablets. You should not take more than the highest dose prescribed by your doctor in one day.

Always take TRICOR with a full glass of water regardless of whether you eat. Eating may delay TRICOR’s effect.

TRICOR Overdose

If you suspect an overdose, you should contact a poison-control center or emergency room immediately.

Missed Dose of TRICOR

If you miss a dose of TRICOR, try to take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of the medication at the same time.

Serious Warnings and Precautions

You should not take PRINIVIL while you are pregnant. Taking it while you are pregnant can cause injury and even death to your baby. If you become pregnant while taking this drug, stop taking it and get in touch with your doctor as soon as possible.

DO NOT USE PRINIVIL IF:

• you are allergic to lisinopril or to any of the other ingredients in PRINIVIL.
• you have had an allergic reaction (angioedema):
  • to any other ACE inhibitor. You can tell you are taking or have taken an ACE inhibitor because these types of drugs have ingredients that end with “-PRIL” (such as enalapril and captopril) or
  • have been diagnosed with hereditary angioedema. This is an increased risk of getting an allergic reaction that is passed down through your family, or
  • where the reason for it is not known
• Signs of an allergic reaction include:
  • swelling of the hands, feet, ankles, face, lips, tongue and throat
  • suddenly having trouble breathing or swallowing
• Make sure that you tell your doctor, nurse or pharmacist that this has happened to you before.
• have diabetes or kidney disease and are already taking:
  • a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) or
  • an angiotensin receptor blocker (drugs that have ingredients that end in “-SARTAN”).
• Taking these drugs at the same time as PRINIVIL is not recommended.

Low Blood Pressure:

You may feel dizzy or light headed:

• particularly in the first few days after you start taking PRINIVIL. You should lie down if this happens. You should avoid driving or doing any tasks that require special attention.
• when you exercise or when the weather is hot.

If you faint, stop taking the drug and talk to your doctor.

Blood tests:

While you are taking PRINIVIL your doctor may do blood tests to check:

• the level of white blood cells in your blood.
• the potassium levels in your blood.
• that your kidneys are working properly.

Cough:

You may develop a cough while taking PRINIVIL. This usually goes away once you stop taking it or when the dose is lowered.

Black patients:

you are at a higher risk for having an allergic reaction (angioedema).

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

These are not all the possible side effects you may feel when taking PRINIVIL. If you experience any side effects not listed here, contact your healthcare professional.

• Dry cough
• Sore throat
• Stuffy or runny nose
• Unusual tiredness and/or weakness
• Headache
• Pain in the abdomen
• Hair loss
• Changes in your mood or confusion
• Changes in taste
• Impotence (not able to have an erection)

THE FOLLOWING MAY INTERACT WITH PRINIVIL:

• Drugs that lower your blood pressure. These include:
  • diuretics (“water pills”)
  • aliskiren-containing drugs (such as Rasilez)
  • angiotensin receptor blockers (ARBs)
  • other drugs that are used to lower blood pressure
• Drugs that can increase the levels of potassium in your blood. These include:
  • potassium-sparing drugs (such as spironolactone, triamterene or amiloride)
  • potassium supplements
  • salt substitutes that contain potassium
• Drugs used to treat diabetes (including oral drugs and insulin)
• Lithium (used to treat a certain kind of depression)
• Injectable gold (in the form of gold sodium aurothiomalate) used to treat arthritis
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) used to reduce pain and swelling (such as naproxen, ibuprofen and celecoxib)
• Drugs used for mTOR inhibitor therapy (such as temsirolimus, sirolimus, everolimus). These drugs are used to lower the body’s ability to reject a transplant or to treat certain cancers. Taking these drugs together with PRINIVIL could increase the risk for an allergic reaction called angioedema.
• Indomethacin (used to treat pain and swelling)
• Certain drugs that you can buy without a prescription are known to cause your blood pressure to go up. These include drugs:
  • to control your hunger
  • for asthma
  • to treat colds and coughs
  • to treat allergies (such as hayfever)
  • to treat sinus problems

You should not take these types of medicines unless you have talked it over with your doctor first.

Swallow the tablet whole. You should not split or break the tablets.

If your doctor has given you specific instructions to follow, for example to eat a low salt diet or to lose weight, you should follow them.

Take PRINIVIL:

• exactly as your doctor has told you how to take it
• once a day at about the same time every day
• with or without food

Usual dose:

Your doctor has decided on the best dose for you based on your needs.

Even if you feel better, you should not stop taking this medicine unless your doctor tells you to.

Overdose:

If you think you have taken too much PRINIVIL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Symptoms of an overdose include:

• feeling light headed or dizzy. This can happen because of a sudden or extreme drop in blood pressure.

Missed dose:

• If it has been less than 6 hours since you missed taking it, take your dose as soon as possible and then go back to your regular schedule.
• If it has been more than 6 hours since you missed taking it, skip the missed dose. Take the next dose at your usual time.

Do not take two doses at the same time.