Miacalcin Nasal

In the U.S.

• Fortical
• Miacalcin

In Canada

• Miacalcin Ns

Available Dosage Forms:

• Spray

Therapeutic Class: Calcium Regulator

Pharmacologic Class: Calcitonin

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. Your doctor may also want to check your nose before and during treatment with this medicine.

Your doctor might give you an allergy skin test to see if you are allergic to calcitonin before using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine. If these side effects occur, get emergency help at once.

This medicine can lower your calcium levels in the blood (hypocalcemia). Check with your doctor right away if you have abdominal or stomach cramps, confusion, convulsions, difficulty breathing, mood or mental changes, muscle cramps in hands, arms, feet, legs, or face, or numbness and tingling around the mouth, fingertips, or feet.

This medicine may cause irritation in the nose that can be painful and serious. Check with your doctor right away if you have more than one of the following symptoms: sneezing, runny or stuffy nose, shortness of breath, troubled breathing, or heavy nosebleeds.

This medicine may increase your risk of having cancer. Talk to your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Crusting, patches, or sores inside the nose
• dryness, itching, redness, swelling, tenderness, or other signs of nasal irritation not present before use of this medicine
• headaches (severe or continuing)
• nosebleeds
• runny nose
• sneezing
• stuffy nose

• Bloody or cloudy urine
• chills
• cough
• difficult, burning, or painful urination
• difficulty with breathing or wheezing (severe)
• dizziness
• fever
• frequent urge to urinate
• head congestion
• loss of sense of smell
• sore throat
• swollen glands

• Hair loss
• hives, itching, or skin rash
• increased thirst
• shakiness in the legs, arms, hands, or feet
• taste disturbances
• trembling or shaking of the hands or feet

• Abdominal or stomach cramps
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• confusion
• diarrhea
• difficulty with swallowing
• fainting
• increased sweating
• irregular heartbeats
• muscle cramps in the hands, arms, feet, legs, or face
• numbness and tingling around the mouth, fingertips, or feet
• pain or tightness in the chest
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• unusual tiredness or weakness
• unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• joint pain

• Abdominal or stomach pain
• body aches
• burning, dry, or itching eyes
• constipation
• flushing
• mental depression
• muscle pain
• nausea
• unusual tearing of the eyes
• upset stomach

• Continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss
• trouble hearing
• trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fast heartbeats; feeling lightheaded; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• severe nasal irritation; or

• low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

• bleeding from your nose;

• runny or stuffy nose;

• dryness, itching, tenderness, or general discomfort of your nose; or

• crusting, scabs, or sores inside your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

(See also How to Use section).

Runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: nasal sores, muscle cramps/spasms, numbness/tingling of the arms/legs.

Get medical help right away if you have any very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.