Patient Medication Information: uses, side effects, how to take - PMS-Diclofenac-Misoprostol
Serious Warnings and Precautions
If you have, or previously had, any of the following conditions, see your health care provider to discuss treatment options other than pms-DICLOFENAC-MISOPROSTOL:
It is important to take the lowest dose of pms-DICLOFENAC-MISOPROSTOL that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk of side effects on the heart and blood vessels as small as possible. pms-DICLOFENAC-MISOPROSTOL can result in increased blood pressure and / or worsening of congestive heart failure. NSAIDS, like pms-DICLOFENAC-MISOPROSTOL, may cause stomach and bowel problems (such as ulceration, perforation, obstruction, and bleeding). Do not take pms-DICLOFENAC-MISOPROSTOL if you are pregnant or think that you may be pregnant. pms-DICLOFENAC-MISOPROSTOL may cause uterine contractions that are associated with abortion, premature birth, birth defects and fetal death. |
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What is pms-DICLOFENAC-MISOPROSTOL used for?
- pms-DICLOFENAC-MISOPROSTOL is used for short-term and long-term relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
How does pms-DICLOFENAC-MISOPROSTOL work?
pms-DICLOFENAC-MISOPROSTOL contains two different medicines: diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) and misoprostol, a drug that helps to protect the lining of your stomach (because NSAIDs can cause damage to your stomach).
pms-DICLOFENAC-MISOPROSTOL helps to relieve joint pain, swelling, and stiffness by reducing the production of certain substances (prostaglandins) and by helping to control inflammation. pms-DICLOFENAC-MISOPROSTOL does NOT cure your illness or prevent it from getting worse. pms-DICLOFENAC-MISOPROSTOL can only relieve pain and reduce swelling as long as you continue to take it.
What are the ingredients in pms-DICLOFENAC-MISOPROSTOL?
Medicinal ingredients: diclofenac sodium and misoprostol
Non-medicinal ingredients: Colloidal Silicon Dioxide, Corn Starch, Crospovidone, Hydrogenated Castor Oil, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Methacrylic Acid Co-Polymer, Microcrystalline Cellulose, Povidone, Sodium Hydroxide, Talc, Triethyl Citrate.
pms-DICLOFENAC-MISOPROSTOL comes in the following dosage forms:
- Delayed-Release Tablets, 50 mg diclofenac sodium/200 mcg misoprostol
- Delayed-Release Tablets, 75 mg diclofenac sodium/200 mcg misoprostol
Do not use pms-DICLOFENAC-MISOPROSTOL if:
- You will be having or recently had Heart bypass surgery
You are pregnant, planning to become pregnant or are in prolonged labor during childbirth
- You are breastfeeding or planning to breastfeed
- You have severe, uncontrolled heart failure
- You are allergic to diclofenac sodium, misoprostol, other NSAIDs or any ingredient found in pms-DICLOFENAC-MISOPROSTOL
- You have gastrointestinal issues such as Ulcers, Bleeding from the stomach or gut, Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
- You have bleeding in the brain or other bleeding disorders
- You have active or severe liver disease
- You have severe or worsening kidney disease
- You have high potassium in the blood
You are taking other NSAIDs
Children and adolescents under the age of 18 should not use pms-DICLOFENAC-MISOPROSTOL.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-DICLOFENAC-MISOPROSTOL. Talk about any health conditions or problems you may have, including if you:
- Have liver disease or liver problems
- Have kidney disease or kidney problems
- Have disease of the heart or blood vessels such as uncontrolled high blood pressure, congestive heart failure, established ischemic heart disease, or peripheral arterial disease
Have high risk factors for cardiovascular disease such as high blood pressure, abnormally
- Have poor circulation to your extremities
- Previously had an ulcer or bleeding from the stomach or gut
- Previously had bleeding in the brain
- Have bleeding problems
- Have a family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, fluribiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
- Have a family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
- Have a history of a severe drug hypersensitivity reaction (drug allergy) including skin problems
- Are on any special diet, such as a low-sodium diet
- Drink alcohol
Other warnings you should know about:
Serious skin reactions:
In rare cases, serious, life-threatening skin reactions have been reported with some NSAIDs, such as pms-DICLOFENAC-MISOPROSTOL. These skin problems most often happen during the first month of treatment. STOP taking pms-DICLOFENAC-MISOPROSTOL and tell your healthcare professional immediately if you notice any changes in your skin both during and after treatment.
Driving and Operating Heavy Machinery:
pms-DICLOFENAC-MISOPROSTOL may cause visual disturbances, dizziness, vertigo or drowsiness. Do not operate heavy machinery if you experience these effects while taking pms-DICLOFENAC-MISOPROSTOL.
Light Sensitivity:
pms-DICLOFENAC-MISOPROSTOL may cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, stop taking pms-DICLOFENAC-MISOPROSTOL and talk to your healthcare professional.
SPECIAL NOTE FOR WOMEN OF CHILDBEARING AGE:
Do not take pms-DICLOFENAC-MISOPROSTOL if you are pregnant or think you are pregnant or during prolonged labour. Do not start pms-DICLOFENAC-MISOPROSTOL until you have been tested to confirm that you are not pregnant. Do not get pregnant or try to get pregnant while you are taking pms-DICLOFENAC-MISOPROSTOL and for at least one month (or through one menstrual cycle) after you stop taking it. This means using an effective form of birth control which you should discuss with your doctor. Stop taking pms-DICLOFENAC-MISOPROSTOL, and contact your doctor immediately if you do become pregnant during pms-DICLOFENAC-MISOPROSTOL therapy.
Misoprostol may cause uterine contractions (contractions of the uterus), premature birth, birth defects and abortion or may otherwise harm the unborn developing baby. Misoprostol has been reported to cause the uterus to tear when given after the eighth week of pregnancy.
Tearing of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death. Therefore, if you are pregnant, you must not take this drug.
Diclofenac can potentially prolong labor.
Abortions caused by misoprostol are likely to be incomplete. An incomplete abortion may result in very serious medical complications, resulting in hospitalization, surgery and possibly infertility, and may result in maternal death.
Do not use pms-DICLOFENAC-MISOPROSTOL if you are breastfeeding or planning to breastfeed. The body changes misoprostol to the active form of the drug, misoprostol acid, which could get into the breast milk and cause significant diarrhea in the infant.
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 pms-DICLOFENAC-MISOPROSTOL:
- Acetylsalicylic Acid (ASA) or other NSAIDs (e.g., ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen). Your healthcare provider may prescribe low dose ASA while you take pms-DICLOFENAC-MISOPROSTOL. Only take ASA as directed by your healthcare provider.
- Antacids. Do not take antacids that contain magnesium (because they can cause diarrhea) while you are taking pms-DICLOFENAC-MISOPROSTOL. Ask your pharmacist to help you select a suitable brand.
- Antidepressants
- Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., citalopram, fluoxetine, paroxetine, sertraline)
- Blood pressure medications. Using pms-DICLOFENAC-MISOPROSTOL with blood pressure drugs may increase your risk of kidney failure. This is more likely if you are elderly or dehydrated.
- Diuretics (e.g., furosemide, hydrochlorothiazide)
- ACE (Angiotensin converting enzyme) inhibitors (e.g., enalapril, lisinopril, perindopril, ramipril)
- ARBs (angiotensin II receptor blockers) (e.g., candesartan, irbesartan, losartan, valsartan)
- Beta-blockers
Blood thinners (e.g., warfarin, ASA, clopidogrel). Using pms-DICLOFENAC-MISOPROSTOL
- -thinner increases the risk of bleeding. This can occur in the stomach or anywhere.
- Corticosteroids (including glucocorticoids) (e.g., prednisone)
- Cyclosporin
- Digoxin
- Lithium
- Methotrexate
- Oral hypoglycemics (diabetes medications)
- Phenytoin (a medicine used to treat seizures)
- Tacrolimus
- Sulfinpyrazone (a medicine used to treat gout)
- Voriconazole (a medicine used to treat fungal infections)
- Drinking alcohol while taking pms-DICLOFENAC-MISOPROSTOL may increase your risk of gastrointestinal problems. Do not drink alcoholic beverages while taking this medication.
How to take pms-DICLOFENAC-MISOPROSTOL:
- pms-DICLOFENAC-MISOPROSTOL should be swallowed whole.
Take pms-DICLOFENAC-MISOPROSTOL immediately after a meal or with food or milk.
- Remain standing or sitting for 15-30 minutes after taking the medicine. This helps prevent irritation that may lead to trouble swallowing.
- This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.
- Your healthcare provider will prescribe the lowest effective dose of pms-DICLOFENAC-MISOPROSTOL to help avoid side effects. Take pms-DICLOFENAC-MISOPROSTOL exactly as directed by your healthcare provider.
Usual dose:
Adults: Take 50 mg of diclofenac twice daily. The maximum daily dose is 100 mg of diclofenac.
Overdose:
Symptoms of overdose may include stomach pain, confusion, drowsiness, low muscle tone, shaking hands that you cannot control, seizures, shortness of breath, diarrhea, fever, rapid or pounding heartbeat, slow heartbeat, dizziness or fainting.
| If you think you, or a person you are caring for, have taken too much pms-DICLOFENAC-MISOPROSTOL, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose of pms-DICLOFENAC-MISOPROSTOL, take the next dose at the regular time. Do not take a double dose to catch up for the missed dose. It is important that pms-DICLOFENAC-MISOPROSTOL be taken as prescribed. Try to remember to take pms-DICLOFENAC-MISOPROSTOL at the appropriate time. Having a regular routine associated with taking your medicine will help.
What are possible side effects from using pms-DICLOFENAC-MISOPROSTOL?
These are not all the possible side effects you may have when taking pms-DICLOFENAC-MISOPROSTOL. If you experience any side effects not listed here, tell your healthcare professional.
- pms-DICLOFENAC-MISOPROSTOL may cause some undesirable reactions especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your health care provider.
- Elderly, frail, or debilitated patients often seem to experience more frequent or more severe side effects.
- Check with your healthcare provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.
- Stomach upset is one of the common problems with NSAIDs. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your doctor.
- Because misoprostol increases mucus production some patients experience diarrhea. Keep taking your pms-DICLOFENAC-MISOPROSTOL. It is just a sign that the drug is working. Usually, the diarrhea goes away in two to three days. If it is not gone after a week, check with your doctor.
- While your body gets used to misoprostol you may feel a crampy pain in your stomach. Like the diarrhea it usually goes away in a few days. If it doesn't, check with your doctor.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Indigestion, nausea, abdominal pain or diarrhea | ✓ | ||
| COMMON | |||
| Dizziness, light headedness | ✓ | ||
| Headaches | ✓ | ||
| Insomnia | ✓ | ||
| Skin rash, itching | ✓ | ||
| Vomiting, constipation, gas, burping | ✓ | ||
| UNCOMMON | |||
| Bleeding | ✓ | ||
| Bloody or black tarry stools | ✓ | ||
| Blurred vision or any visual disturbance | ✓ | ||
| Change in heart rate or rhythm, change | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| in blood pressure, heart failure, blood clot, stroke | |||
| Malaise, fever, swelling, chills | ✓ | ||
| Menses pain, abnormal vaginal bleeding, vaginal infection | ✓ | ||
| Shortness of breath, wheezing, any trouble in breathing or tightness in the chest | ✓ | ||
| Skin bruising, hives or swelling | ✓ | ||
| Sore throat or mouth sores | ✓ | ||
| Vomiting blood | ✓ | ||
| RARE | |||
| Breast pain | ✓ | ||
| Nightmare | ✓ | ||
| Pancreatitis: abdominal pain, nausea, vomiting, loss of appetite | ✓ | ||
| Serious skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine, hives, red or dry itchy skin, purple or red spots on skin, bruising | ✓ | ||
| Swelling of the feet or lower legs | ✓ | ||
| Yellow skin or eyes, dark urine (red or brown) | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Agranulocytosis: fever, chills. Flu-like symptoms. Weakness | ✓ | ||
| Benign mass in the intestine, trouble with swallowing | ✓ | ||
| Hearing problems | ✓ | ||
| Hemolytic Anemia: Fatigue and short of breath | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Infections: Sepsis (infection of the whole body) | ✓ | ||
| Nausea, fatigue, lethargy, diarrhea, pruritus, yellow discoloration of the skin or eyes with or without itchy skin, right upper quadrant tenderness, and «flu-like» symptoms | ✓ | ||
| Seizure, stiff neck, shaking, loss of consciousness, change in mood or thoughts | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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Storage:
Store between 15°C and 25°C and protect from heat and humidity.
Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.
Keep out of reach and sight of children.
If you want more information about pms-DICLOFENAC-MISOPROSTOL:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes
- Patient Medication 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 www.pharmascience.com, or by calling 1-888-550-6060.