Patient Medication Information: uses, side effects, how to take - Pregnancy Multivitamin
ABOUT THIS MEDICATION
PART III: CONSUMER INFORMATION
Pr Pregnancy Multivitamin
Vitamin-Mineral Supplement Tablets
for Prenatal/Postpartum Use
Oral, Blue Tablet (evening) contains 1.1 mg of Folic Acid
This leaflet is part III of a three-part Product Monograph document designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Pregnancy Multivitamin.
Contact your doctor, pharmacist or healthcare professional if you have any questions about the drug.
What the medication is used for:
Pregnancy Multivitamin is a vitamin-mineral supplement specially formulated for use in women at least 2-3 months prior to conception, throughout pregnancy, and during the postnatal period. Taking Pregnancy Multivitamin does not eliminate the need for balanced nutrition.
What it does:
Pregnancy Multivitamin provides a supplement of vitamins and minerals.
There is strong evidence that preventative treatment with folic acid, prior to and during pregnancy, can reduce the risk of fetal neural tube defects (NTDs). NTDs result from improper development and closure of the neural tube during the third and fourth week of development. Pregnancies affected by an NTD may result in a miscarriage or stillbirth, and children born with an NTD may have mild to severe disability or die in early childhood.
Although the use of a folic acid supplement from before conception to early pregnancy reduces the number of NTDs, they cannot be completely avoided through folate supplementation because of their various origins. For women who had a prior history of an NTD pregnancy, the recurrence rate of another NTD pregnancy is 2-3%.
There is evidence that supplementing the diet with an additional
0.4 mg/day of folic acid would reduce the risk of neural tube defects for all women planning a pregnancy by about 36%,
1 mg per day would reduce the risk by about 57% and the use of 1.1 mg daily would reduce the risk by about 59%.
When it should not be used:
You should not take Pregnancy Multivitamin if you are allergic to any of the ingredients of Pregnancy Multivitamin or component of the container (see list of medicinal and nonmedicinal ingredients below this section).
What the medicinal ingredients are:
Each oval shaped, pink (a.m.), film-coated, immediate release tablet contains:
| Beta-Carotene | 1.6 mg |
|---|---|
| Vitamin B1 (thiamine mononitrate) | 3 mg |
| Vitamin B2 (riboflavin) | 3.4 mg |
| Niacinamide | 20 mg |
|---|---|
| Pantothenic Acid (calcium pantothenate) | 5 mg |
| Vitamin B6 (pyridoxine HCl) | 10 mg |
| Vitamin C (ascorbic acid) | 120 mg |
| Vitamin E (dl-alpha tocopheryl acetate) | 13.8 mg AT† |
| Copper (copper gluconate) | 2 mg |
| Iodine (potassium iodide) | 0.15 mg |
| Iron (ferrous fumarate)* | 35 mg |
| Magnesium (magnesium oxide) | 50 mg |
| Zinc (zinc oxide) | 15 mg |
- * Elemental amount
† RRR-α-tocopherol (AT)
Each oval shaped, blue (p.m.), film coated, immediate release tablet contains:
| Folic Acid | 1.1 mg |
|---|---|
| Vitamin B12 (cyanocobalamin) | 12 mcg |
| Vitamin D3 (cholecalciferol) | 600 IU |
| Calcium (calcium carbonate)* | 300 mg |
- * Elemental amount
What the nonmedicinal ingredients are:
Pregnancy Multivitamin pink (a.m.) tablet contains:
Colloidal silicon dioxide, croscarmellose sodium, corn starch, FD&C Blue No. 1, FD&C Red No. 40, glucose syrup, hydroxy propyl methyl cellulose, microcrystalline cellulose, modified food starch, polyvinyl alcohol, povidone, polyethylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talcum, titanium dioxide.
Pregnancy Multivitamin blue (p.m.) tablet contains:
Citric acid, croscarmellose sodium, FD&C Red No. 40, FD&C Blue No. 2, magnesium stearate, maltodextrin, pregelatinised starch, polyvinyl alcohol, sodium ascorbate, sodium citrate, sucrose, talcum, titanium dioxide, triacetin.
What dosage forms it comes in:
Pregnancy Multivitamin is supplied in a 30-day blister pack containing 30 oval, pink (a.m.) tablets and 30 oval, blue (p.m.) tablets. Each pink tablets are engraved with “D” on both sides and blue tablets are engraved with “N” on both sides.
WARNINGS AND PRECAUTIONS
BEFORE you use Pregnancy Multivitamin talk to your doctor or healthcare professional if:
- You have a vitamin B12 deficiency. Folic acid should be taken with vitamin B12 in order to avoid potential problems of the nervous system. Any dose of folic acid over 1 mg per day may require monitoring for vitamin B12 by a doctor or healthcare professional.
PROPER USE OF THIS MEDICATION
Usual dose:
INTERACTIONS WITH THIS MEDICATION
- You have seizure disorders controlled with anticonvulsant medications (e.g. carbamazepine, phenobarbital, phenytoin, primidone, valproic acid). You may have an increase in seizures when folic acid is taken.
Keep this product out of the reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Each Pregnancy Multivitamin pink (a.m.) tablet contains 35 mg of elemental iron. No iron is contained in the Pregnancy Multivitamin blue (p.m.) tablet.
As with most medications, interaction with other drugs is possible.
Tell your doctor, pharmacist or healthcare professional if you are taking any other medications, including prescription, non- prescription or natural health products, or vitamin-mineral supplements.
In particular, the drugs that may interact with Pregnancy Multivitamin include:
- Thyroid hormone medications: Absorption of thyroid medications could be reduced if taken at the same time as iron or calcium supplements. Thyroid medications should be taken four hours before or after the pink (a.m.) and the blue (p.m.) tablets of Pregnancy Multivitamin .
- Dihydrofolate reductase inhibitors: Dihydrofolate reductase inhibitors (including sulphasalazine, trimethoprim, triamterene) inhibit the absorption and metabolism of folic acid.
- Antiepileptic drugs: Antiepileptic drugs reduce folic acid absorption. Folic acid supplements have worsened seizure control in some people with epilepsy.
Take one pink (a.m.) tablet every morning on an empty stomach, one hour before breakfast, with a glass of water. Do not take any food for one hour after taking the pink (a.m.) tablet to help the iron absorption. If you suffer from nausea and/or vomiting in the morning (morning sickness), take the pink (a.m.) tablet two hours or more after breakfast. Take one blue (p.m.) tablet with a glass of water close to the evening meal (before or after), i.e. within one hour of the evening meal, to help calcium absorption.
This product is specifically prescribed for you based on your current state of health. Do not give it to others, even if you think they could benefit from taking it, and you yourself must not use it for any other condition than the one for which it was prescribed.
Tablets are not intended to be crushed, chewed or split. If you have difficulty swallowing tablets, let your doctor or healthcare
professional know.
Special cases:
- For women taking calcium rich food for breakfast, the Pregnancy Multivitamin pink (a.m.) tablet may be taken two (2) hours or more after breakfast. Following administration of the pink (a.m.) tablet a wait of one (1) additional hour is recommended before eating in order to optimize the absorption of iron.
- For women suffering from nausea and/or vomiting in the morning where it is difficult to take vitamin-mineral supplements on an empty stomach, the Pregnancy Multivitamin pink (a.m.) tablet may be taken two (2) hours or more after breakfast. Following administration of the pink (a.m.) tablet a wait of one (1) additional hour is recommended before eating in order to optimize the absorption of iron.
- For women taking levothyroxine hormone in the morning, it is recommended to take the Pregnancy Multivitamin pink (a.m.) tablet at least four (4) hours apart to optimize the absorption of levothyroxine hormone. For women taking levothyroxine hormone at bedtime, it is recommended to take the Pregnancy Multivitamin blue (p.m.) tablet at least four (4) hours apart to optimize the absorption of levothyroxine hormone.
Overdose:
Do not exceed the recommended dose.
| If you think you, or a person you are caring for, have taken too much Pregnancy Multivitamin, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
|---|
Missed dose:
When a dose has been missed, it should be taken as soon as possible and one pink (a.m.) and one blue (p.m.) tablet should be taken within a 24-hour period. It is recommended that Pregnancy Multivitamin pink (a.m.) and blue (p.m.) tablets be taken at least four (4) hours apart in order to optimize the absorption of nutrients.
The prescribed dosing schedule should then continue as directed by doctor or healthcare professional.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects: The most common adverse reactions associated with vitamin-mineral supplements are gastrointestinal symptoms such as constipation, diarrhea, nausea and gastric irritation.
This is not a complete list of side effects.
For any unexpected effects while taking Pregnancy Multivitamin, contact your doctor, pharmacist or healthcare professional.
Store at room temperature (15 to 30ºC).
Protect from moisture. Contact with moisture may produce surface discoloration or erosion of the tablet.
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. |
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If you want more information about Pregnancy Multivitamin:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.jamppharma.com), or by calling 1-866-399-9091
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada