Robinul Forte

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking glycopyrrolate,

• tell your doctor and pharmacist if you are allergic to glycopyrrolate or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticholinergics; antidepressants; ipratropium (Atrovent); mediations for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had glaucoma; enlargement of the prostate, ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), myasthenia gravis, gastrointestinal disease, overactive thyroid, high blood pressure, heart failure, irregular or rapid heartbeats, coronary artery disease, hiatal hernia with reflux, disorders of the nervous system, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking glycopyrrolate, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking glycopyrrolate.
• you should know that glycopyrrolate may make you drowsy or cause blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.
• you should know that glycopyrrolate reduces the body's ability to cool off by sweating. In very high temperatures, glycopyrrolate can cause fever and heat stroke.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You should not use glycopyrrolate if you are allergic to it, or if you have:

• a bladder obstruction or other urination problems;

• a blockage in your digestive tract (stomach or intestines), severe constipation;

• severe ulcerative colitis or toxic megacolon;

• eye problems;

• glaucoma; or

• myasthenia gravis.

To make sure glycopyrrolate is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• heart disease, a heart rhythm disorder;

• high blood pressure;

• a stomach disorder such as hiatal hernia, reflux disease, or slow digestion;

• a colostomy or ileostomy;

• a thyroid disorder; or

• a nerve disorder.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether glycopyrrolate passes into breast milk or if it could affect the nursing baby. This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

Do not give glycopyrrolate to a child without medical advice.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol with this medicine can cause side effects.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

In the U.S.

• Cuvposa
• Glycate
• Robinul
• Robinul Forte

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antimuscarinic

It is very important that your doctor or your child's doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check for unwanted effects.

You should not take potassium chloride tablets or other potassium supplements (in tablet or capsule forms) while is using this medicine. Using these medicines together may cause delayed movement of the potassium supplement through the esophagus and stomach.

This medicine may cause constipation or diarrhea. Constipation or diarrhea can be an early symptom of a serious bowel problem. Stop using this medicine and check with your doctor if you or your child has constipation, diarrhea, abdominal or stomach distention (swelling), pain, nausea, or vomiting.

Stop using this medicine and check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has the following symptoms while using this medicine: crying, irritability, decrease in the frequency of urine, or difficult or painful urination.

If you or your child develops a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

This medicine may make you or your child sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may make you or your child drowsy or cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

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:

• Body aches or pain
• chills
• constipation
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• difficulty with breathing
• ear congestion
• feeling of warmth
• fever
• headache
• loss of voice
• nasal congestion
• painful urination
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Abdominal or stomach discomfort or pain
• abdominal or stomach distension
• chest pain
• confusion
• convulsions
• dizziness
• dry heaves
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• pain or tenderness around the eyes and cheekbones
• rapid breathing
• shortness of breath or troubled breathing
• stuffy nose
• sunken eyes
• thirst
• tightness in the chest
• vomiting
• wheezing
• wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• low blood pressure
• muscle weakness
• trouble breathing

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:

• Altered mood
• anxiety
• attack, assault, or force
• bloated
• change in taste
• chapped lips
• crying
• dry skin
• dry tongue
• excess air or gas in the stomach or intestines
• full feeling
• hyperventilation
• irregular heartbeats
• irritability
• loss of taste
• moaning
• nervousness
• pain
• paleness of the skin
• passing gas
• rash
• restlessness
• shaking
• trouble with sleeping
• uncontrolled eye movements

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Not sweating during activities or in warm temperatures.
• Trouble passing urine.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Larger pupils.
• Change in eyesight, eye pain, or very bad eye irritation.
• Feeling confused.
• Loose stools (diarrhea).
• Bloating.
• Hard stools (constipation).
• Swelling of belly.
• Belly pain.
• Very upset stomach or throwing up.
• Change in sex ability.
• Muscle weakness.