Patient Medication Information: uses, side effects, how to take - PMS-Doxylamine-Pyridoxine
ABOUT THIS MEDICATION
What the medication is used for:
The management of nausea and vomiting of pregnancy. pms-DOXYLAMINE-PYRIDOXINE can be used during any trimester of pregnancy.
What it does:
pms-DOXYLAMINE-PYRIDOXINE provides the anti-nauseant and anti-vomiting action of two different ingredients: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
When it should not be used:
You should not be given pms-DOXYLAMINE-PYRIDOXINE if you:
- are allergic to pms-DOXYLAMINE-PYRIDOXINE or to any of the non medicinal ingredients;
- have any of the following conditions: risk of asthmatic attack, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, bladder-neck obstruction;
- are receiving a monoamine oxidase inhibitor (MAOIs) [e.g., certain antidepressants, linezolid (an antibiotic), methylene blue (a diagnostic dye)].
What the medicinal ingredients are:
Doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
What the non medicinal ingredients are:
Colloidal Anhydrous Silica, Dibasic Calcium Phosphate, FD&C Blue #1 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Glycerides, Hydroxypropyl Methylcellulose, Isopropyl Alcohol, Lecithin (Soya) FCC, Magnesium Stearate, Mannitol, Methacrylic Acid Copolymer, Methylated Silica, Methylcellulose, N-Butyl Alcohol, Polydimethylsiloxane, Polyethylene Glycol Sorbitan Tristearate, Propylene Glycol, Shellac Glaze, Simethicone, Sodium Bicarbonate, Sodium Lauryl Sulfate, Sorbic Acid, Sulfuric Acid, Talc, Titanium Dioxide, Triethyl Citrate.
What dosage forms it comes in:
Delayed-Release Tablets (Doxylamine succinate/Pyridoxine hydrochloride): 10 mg/10 mg
WARNINGS AND PRECAUTIONS
pms-DOXYLAMINE-PYRIDOXINE may cause somnolence. Caution must be exercised in activities requiring mental alertness such as driving a car or operating heavy machinery. Until you know how you will react to this medication, do not drive or operate machinery.
pms-DOXYLAMINE-PYRIDOXINE may pass into breast milk and unusual excitement, irritability or sedation (sleepiness) may occur in the infant. Nursing mothers treated with pms-DOXYLAMINE-PYRIDOXINE should not breastfeed or the use of pms-DOXYLAMINE-PYRIDOXINE during lactation should be avoided.
INTERACTIONS WITH THIS MEDICATION
Deeper somnolence could be produced if pms-DOXYLAMINE-PYRIDOXINE is taken in combination with alcohol or other drugs such as drugs for cough or colds, pain killers or sleep aids.
You should tell your doctor if you are taking or have recently taken any medications (prescription or non- prescription) or natural/herbal products, especially:
- a monoamine oxidase inhibitor (MAOIs) [e.g., linezolid (an antibiotic), methylene blue (a diagnostic dye)]
- antimuscarinic drugs (used in treating a variety of conditions such as disorders of the bowel, bladder or respiratory systems, Parkinson's disease, certain heart conditions and insomnia).
- alcohol and other central nervous system depressants, such as drugs for anxiety, seizures, mental illness, and allergies, sleeping pills, anesthetics (used for surgery), certain pain medications.
PROPER USE OF THIS MEDICATION
pms-DOXYLAMINE-PYRIDOXINE is a delayed-release formulation that works best when taken 4 to 6 hours before needed and should be taken on a daily basis. If taken with food, it may take longer to feel a relief of symptoms.
Usual dose:
pms-DOXYLAMINE-PYRIDOXINE should be taken as prescribed by your doctor or healthcare professional.
- 1. Take two pms-DOXYLAMINE-PYRIDOXINE delayed-release tablets at bedtime to control nausea and vomiting occurring in the morning
- 2. Take 1 delayed-release tablet in the morning and,
- 3. Take 1 delayed-release tablet mid-afternoon to control symptoms throughout the day.
Your doctor or healthcare professional may adjust the dosing schedule according to your condition.
Do not stop taking pms-DOXYLAMINE-PYRIDOXINE on your own. Always consult your doctor or healthcare professional. They will gradually reduce your dose when stopping pms-DOXYLAMINE-PYRIDOXINE treatment to prevent a sudden return of nausea and vomiting.
This drug is specifically prescribed for you and your actual state of health. Do not give it to others, even if they have the same symptoms, and you yourself must not use it for any other condition than the one for which it was prescribed.
Tablets should not be crushed or split.
Missed Dose:
If you forget to take a dose of pms-DOXYLAMINE-PYRIDOXINE, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not try to make up for a missed dose by taking a double dose.
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. |
If you suspect an accidental overdose, seek medical attention immediately. Do not wait for any signs or symptoms to appear before seeking medical attention, as they may not occur immediately.
Signs and symptoms of overdosage are restlessness, dryness of mouth, dilated pupils, sleepiness, dizziness, mental confusion and rapid heartbeat.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medications, pms-DOXYLAMINE-PYRIDOXINE can cause some side effects. You may not experience any of them. For most patients, these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, seek immediate emergency medical assistance.
Side effects associated with pms-DOXYLAMINE-PYRIDOXINE are: somnolence, dizziness, nervousness, stomach pain, headache, diarrhea, irritability, or insomnia.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | None | |||
| Very rare | Disorientation | |||
| Difficulty urinating | ||||
| Irregular heartbeat | ||||
| Seizures | ||||
This is not a complete list of side effects. For any unexpected effects while taking pms-DOXYLAMINE-PYRIDOXINE, contact your doctor, pharmacist or healthcare professional.
HOW TO STORE IT
Store between 15°C and 30°C.
Protect from light.
Keep out of reach and sight of children.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
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. |
MORE INFORMATION
You may need to read this package insert again. Please do not throw it away until you have finished your medicine.
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.
Pharmascience Inc.
Montréal Québec
H4P 2T4
www.pharmascience.com
Last prepared: June 03, 2016