Patient Medication Information: uses, side effects, how to take - Teva-Doxylamine/Pyridoxine DR
ABOUT THIS MEDICATION
What the medication is used for:
The management of nausea and vomiting of pregnancy. Teva-Doxylamine/Pyridoxine DR can be used during any trimester of pregnancy.
What it does:
Teva-Doxylamine/Pyridoxine DR 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 Teva-Doxylamine/Pyridoxine DR if you:
- are allergic to doxylamine succinate and pyridoxine hydrochloride or to any of the nonmedicinal 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:
The medicinal ingredients of Teva-Doxylamine/Pyridoxine DR are doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
What the nonmedicinal ingredients are:
Nonmedicinal ingredients are as follows: colloidal silicon dioxide, croscarmellose sodium, glyceryl monostearate, glycerol triacetin, hypromellose, magnesium stearate, magnesium trisilicate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polydextrose, polysorbate, sodium lauryl sulphate, titanium dioxide, triethyl citrate.
What dosage forms it comes in:
Teva-Doxylamine/Pyridoxine DR is supplied in the form of a delayed release tablet, 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Each tablet is engraved with C over 70 on one side and blank on the other side.
WARNINGS AND PRECAUTIONS
Teva-Doxylamine/Pyridoxine DR 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.
Teva-Doxylamine/Pyridoxine DR may pass into breast milk and unusual excitement, irritability or sedation (sleepiness) may occur in the infant. Nursing mothers treated with Teva-Doxylamine/Pyridoxine DR should not breastfeed or the use of Teva-Doxylamine/Pyridoxine DR during lactation should be avoided.
INTERACTIONS WITH THIS MEDICATION
Deeper somnolence could be produced if Teva-Doxylamine/Pyridoxine DR 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
Teva-Doxylamine/Pyridoxine DR 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:
Teva-Doxylamine/Pyridoxine DR should be taken as prescribed by your doctor or healthcare professional.
- 1. Take two Teva-Doxylamine/Pyridoxine DR tablets at bedtime to control nausea and vomiting occurring in the morning.
- 2. Take 1 tablet in the morning and,
- 3. Take 1 tablet mid-afternoon to control your symptoms throughout the day.
Your doctor or healthcare professional may adjust the dosing schedule according to your condition.
Do not stop taking Teva-Doxylamine/Pyridoxine DR on your own. Always consult your doctor or healthcare professional. They will gradually reduce your dose when stopping Teva-Doxylamine/Pyridoxine DR 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 Teva-Doxylamine/Pyridoxine DR, 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:
| If you think you, or a person you are caring for, have taken too much Teva-Doxylamine/Pyridoxine DR, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or 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, Teva-Doxylamine/Pyridoxine DR 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 Teva-Doxylamine/Pyridoxine DR are: somnolence, dizziness, nervousness, stomach pain, headache, diarrhea, irritability, or insomnia.
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 | ||||||
| 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 Teva-Doxylamine/Pyridoxine DR contact your doctor, pharmacist or healthcare professional.
HOW TO STORE IT
Store at room temperature 15℃ - 30℃. Protect from light.
Keep out of reach and sight of children.
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. |
MORE INFORMATION
You may need to read this package insert again. Please do not throw it away until you have finished your medicine.
If you want more information about Teva-Doxylamine/Pyridoxine 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 Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.