Patient Medication Information: uses, side effects, how to take - PMSC-Esomeprazole DR
What is pmsc-ESOMEPRAZOLE DR used for:
pmsc-ESOMEPRAZOLE DR is used in adults to treat problems caused by too much acid in the stomach such as:
- reflux esophagitis (tissue damage caused by the stomach acid and juices moving up the food tube)
- symptoms of reflux disease (e.g. heartburn, backup of stomach content to the throat)
symptoms of nonerosive reflux disease (NERD) not related to tissue damage of the food pipe, such as:
- a burning feeling that moves up the food pipe (heartburn)
- a sour or bitter taste moving up to the mouth
- ulcers caused by nonsteroidal anti-inflammatory drugs (drugs for pain and sore joints)
pmsc-ESOMEPRAZOLE DR is used in children 12-17 years old to treat:
- reflux esophagitis (tissue damage caused by the stomach acids and juices moving up the food tube)
- symptoms of reflux disease (e.g. heartburn, backup of stomach contents to the throat)
the symptoms of nonerosive reflux disease (NERD), not related to tissue damage of the food pipe, such as:
- a burning feeling that moves up the food pipe (heartburn)
- a sour or bitter taste moving up to the mouth
How does pmsc-ESOMEPRAZOLE DR work?
pmsc-ESOMEPRAZOLE DR is a medicine called a proton pump inhibitor (PPI). pmsc-ESOMEPRAZOLE DR works by causing less acid to be made in your stomach.
What are the ingredients in pmsc-ESOMEPRAZOLE DR?
Medicinal ingredients: esomeprazole magnesium dihydrate
Non-medicinal ingredients: crospovidone, hypromellose, hydroxypropyl cellulose, glyceryl monostearate, macrogol, magnesium stearate, methacrylic acid – ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, povidone K30, sodium stearyl fumarate, sugar spheres, talc and triethyl citrate. In addition, the tablet film coating contains: hypromellose, iron oxide red, iron oxide yellow, macrogol and titanium dioxide, The tablet imprinting contains: iron oxide black, propylene glycol and shellac glaze.
pmsc-ESOMEPRAZOLE DR comes in the following dosage forms:
Tablets (delayed release): 20 mg and 40 mg
Do not use pmsc-ESOMEPRAZOLE DR if you:
- you are allergic to esomeprazole, substituted benzimidazoles or any of the other ingredients of pmsc-ESOMEPRAZOLE DR (see What are the ingredients in pmsc-ESOMEPRAZOLE DR?).
- you are taking rilpivirine, a medicine used to treat HIV infection.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pmsc-ESOMEPRAZOLE DR. Talk about any health conditions or problems you may have, including if you:
- have had any health problems in the past
- are breastfeeding or planning to breastfeed
- are due to have a specific blood test (Chromogranin A)
Other warnings you should know about:
pmsc-ESOMEPRAZOLE DR is not recommended for use in patients under 12 years of age
This medicine should be used at the lowest dose and for the shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.
Serious Side Effects: pmsc-ESOMEPRAZOLE DR can cause serious side effects, including:
Serious Skin Reactions: In very rare cases, serious or life-threatening skin reactions have been reported with PPIs, such as pmsc-ESOMEPRAZOLE DR.
o Drug reaction with eosinophilia and systemic symptoms (DRESS),
o Stevens-Johnson Syndrome (SJS),
o toxic epidermal necrosis (TEN)
o erythema multiforme
o acute generalized exanthematous pustulosis (AGEP)
Serious Stomach and Intestine Problems: pmsc-ESOMEPRAZOLE DR can cause serious stomach and intestine problems. Tell your healthcare professional about symptoms that may be a sign of a more serious problem in your stomach or intestine such as:
o trouble swallowing.
o unplanned weight loss.
o vomiting blood or food.
o black (blood-stained) stools.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Antibiotics: While taking pmsc-ESOMEPRAZOLE DR you may:
experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever,
abdominal pain or tenderness. These are symptoms of bowel inflammation caused by a bacterial infection (Clostridium difficile).
If this happens, stop taking the drug tell your healthcare professional immediately.
Pregnancy: Tell your healthcare professional if you are pregnant or planning to become pregnant. There are specific risks you must discuss with your healthcare
professional.
Long term use of pmsc-ESOMEPRAZOLE DR: Long-term use of pmsc-ESOMEPRAZOLE DR may:
- interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your healthcare professional about this risk.
- lead to low blood magnesium in some people. When blood magnesium is lower than normal, it may also lead to low blood calcium and low blood potassium.
- increase risks of broken bones of the hip, wrist or spine. This is more likely to happen if you use pmsc-ESOMEPRAZOLE DR every day for a year or longer. Talk to your healthcare professional about this risk.
- cause a growth in your stomach (polyp) especially after one year.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with pmsc-ESOMEPRAZOLE DR:
- Medications that prevent blood clots such as warfarin, acetylsalicylic acid and clopidogrel. Use of pmsc-ESOMEPRAZOLE DR with clopidogrel should be avoided as it may decrease the effectiveness of clopidogrel.
Medicines used to treat HIV such as atazanavir, nelfinavir and saquinavir. pmsc-
ESOMEPRAZOLE DR may decrease the effectiveness or increase side effects of some medicines used to treat HIV.
pmsc-ESOMEPRAZOLE DR should not be used with atazanavir, nelfinavir or saquinavir.
- Methotrexate, used in high doses to treat cancer. Your healthcare professional may tell you to stop taking pmsc-ESOMEPRAZOLE DR temporarily while you are taking methotrexate.
- Medicines used to treat fungal infections such as itraconazole, ketoconazole, and voriconazole
- Diazepam, used to treat anxiety
- Phenytoin, used to treat epilepsy
- Cisapride (not available in Canada), used to help empty the stomach
- Tacrolimus, used to lower the risk of organ rejection
- Cilostazol (not available in Canada), used to treat poor circulation in the legs
- Digoxin, used to treat heart disorders
- Medicines used to treat tuberculosis such as rifampin
- Herbal medicines such as St John’s Wort
- Medicines used in cancer therapy such as erlotinib
Drug interactions can be different if you take pmsc-ESOMEPRAZOLE DR for short periods of time than if you take it every day.
How to take pmsc-ESOMEPRAZOLE DR:
Follow your doctor’s directions carefully. They may be different from the information contained in this leaflet.
- Take all doses of pmsc-ESOMEPRAZOLE DR that your doctor prescribes even when you or your child feel well. In some cases, doses every day are needed to control pain and symptoms, to correct acid problems and to help damaged areas heal.
- Take pmsc-ESOMEPRAZOLE DR until your doctor tells you to stop. Even if you start to feel better in a few days, your symptoms may return if pmsc-ESOMEPRAZOLE DR is stopped too soon. pmsc-ESOMEPRAZOLE DR needs to be taken for the full treatment duration to help correct acid problems.
pmsc-ESOMEPRAZOLE DR may be taken with food or on an empty stomach.
Tablets (delayed release):
- The tablet may be swallowed whole with water.
- Do not disperse, divide, crush or chew the tablets.
Usual dose:
Adults
Your healthcare professional may tell you to take pmsc-ESOMEPRAZOLE DR:
- 20 to 40 mg once a day for 2 to 8 weeks
- Continue taking pmsc-ESOMEPRAZOLE DR 20 mg each day. This is to keep your symptoms from coming back.
Maintenance Treatment of NERD (on-demand) dose
After first treatment of NERD, your doctor may suggest that you take pmsc-ESOMEPRAZOLE DR 20 mg once daily, as needed, if symptoms of heartburn and regurgitation return once in a while. Contact your doctor if your symptoms get worse, won’t go away, or if new symptoms arise.
Children (12 – 17 years of age)
The suggested dose for treating acute disease is 20 or 40 mg once a day for 2 to 8 weeks.
Overdose:
Missed Dose:
If you/your child miss a dose of pmsc-ESOMEPRAZOLE DR, and remember within 12 hours, take the tablet as soon as possible. Then go back to the regular schedule. If more than 12 hours have passed, do not take the missed dose. Do not double the dose. Just take the next dose on time.
What are possible side effects from using pmsc-ESOMEPRAZOLE DR?
These are not all the possible side effects you may feel when taking pmsc-ESOMEPRAZOLE DR. If you experience any side effects not listed here, contact your healthcare professional.
If these side effects become bothersome (or last longer than 1-2 days), discuss with your healthcare professional: Common side effects include:
- Nausea
- Stomach upset
- Diarrhea
- Headache
If you think you, or a person you are caring for, have taken too much pmsc-ESOMEPRAZOLE DR, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even i f there are no symptoms.
Uncommon side effects include:
- Dry mouth
- Dizziness
- Insomnia
- Feeling of burning/prickliness/numbing
- Swelling of extremities
- Feeling sleepy
- Feeling like you or your surroundings are moving (vertigo)
Rare side effects include:
- Taste disorders
- Nervousness
- Hair loss
- Increased sweating
Stopping your PPI therapy after taking it for a long time, may cause your symptoms to get worse and your stomach may increase acid production. Carefully follow your doctor’s instructions when stopping pmsc-ESOMEPRAZOLE DR therapy.
| Serious side effects and what to do | |||
| about them | |||
| Talk to your healthcare professional | |||
| Symptom / effect | Only if severe | In all cases | Stop taking drug and |
| get immediate medical | |||
| help | |||
| Blood disorders (low white and/or red blood cell count): feeling tired or weak, pale skin, bruising or bleeding for longer than usual if you hurt yourself, fever, chills | |||
| Blurred vision | |||
| Confusion | |||
| Depression | |||
| Feeling ill | |||
Gastrointestinal fungal infection: diarrhea, vomiting, melena, hemorrhage, abdominal pain, and fever | |||
Hepatitis (inflammation of liver): skin and eyes appear yellow | |||
| Myalgia (muscle pain): aching muscles, tenderness or weakness | |||
| Photosensitivity (sensitivity to sunlight): itchy, red skin when exposed to sunlight | |||
Severe allergic reaction: shortness of breath, chest pain or discomfort, feeling thirsty, urinating less of ten, less urine or dark urine, swelling or anaphylactic reaction/shock | |||
| Shortness of breath | |||
| Skin reactions: rash, dermatitis, itching and/or hives | |||
| Sore joints | |||
| Stomatitis (mouth sores, redness and swelling of the lining of the mouth): inflammation in the mouth | |||
| Very Rare | |||
| Aggressive behaviour | |||
Clostridium difficile colitis (bowel inflammation): severe or persistent diarrhea, abdominal pain, nausea and vomiting, fever | |||
| Decreased consciousness | |||
| Gynecomastia: breast enlargement in men (and /or women) | |||
| Hallucinations: seeing or hearing things that are not there | |||
| Hypomagnesemia (low level of magnesium in the blood): abnormal eye movements, fatigue, muscle spasms or cramps, muscle weakness, numbness | |||
Liver failure (serious disturbance of liver function, hepatic failure): yellow colour to skin, whites of the eyes (jaundice), bleeding easily, swollen | |||
abdomen, mental disorientation or confusion, sleepiness, coma | |||
| Muscular weakness | |||
| Nephritis (inflammation of the kidney): decreased appetite, difficulty breathing, fatigue, frequent urination, itchiness, nausea, vomiting | |||
Serious skin reactions:
| |||
| UNKNOWN | |||
| Subacute cutaneous lupus erythematosus: new or worsening joint pain, rash on your cheeks or arms that gets worse in the sun |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Keep all tablets sealed in the blister strips until it is time for a dose. If you do not, moisture from the air may damage the drug.
- Store pmsc-ESOMEPRAZOLE DR at controlled room temperature (15°C – 25°C).
- Do not keep pmsc-ESOMEPRAZOLE DR in the bathroom medicine cabinet or other warm, moist places.
- Do not use pmsc-ESOMEPRAZOLE DR after the expiry date marked on the pack.
- Keep pmsc-ESOMEPRAZOLE DR well out of the reach and sight of children.
If you want more information about pmsc-ESOMEPRAZOLE DR:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health- canada/services/drugs- health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.pharmascience.com; or by calling 1-888-550-6060;
Pharmascience Inc.
Montréal, Quebec
Canada H4P 2T4