Pregnancy Multivitamin Folic 5: Uses, Side Effects and Dosage

When it should not be used:

You should not be given Pregnancy Multivitamin Folic 5 if you are allergic to any of the ingredients of Pregnancy Multivitamin Folic 5 or component of the container (see list of medicinal and non-medicinal ingredients below this section).

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 Folic 5. Contact your doctor, pharmacist or healthcare professional if you have any questions about the drug.

What the medicinal ingredients are:

Each oval shaped, pink (a.m.), film-coated, immediate release tablet contains:

What the medication is used for:

Pregnancy Multivitamin Folic 5 is for use in women who are planning pregnancy or are pregnant and have any of the following conditions:

• A previous pregnancy affected by a neural tube defect, or
• A family history of neural tube defects
• Diabetes or malabsorption disorders
• Are taking medications used for seizure control or that are known to decrease folate levels, or
• Are requiring a high dose of folic acid supplement in the opinion of their doctor.

Pregnancy Multivitamin Folic 5 should be taken at least 2-3 months prior to conception, continuing up to 10-12 weeks after the last menstrual period, or throughout the pregnancy. Taking Pregnancy Multivitamin Folic 5 does not eliminate the need for balanced nutrition.

What it does:

Pregnancy Multivitamin Folic 5 provides a supplement of vitamins and minerals and 5 mg of folic acid.

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 prior history of an NTD pregnancy, the recurrence rate of another NTD pregnancy is 2-3%. Consuming 5 mg of folic acid daily has the potential of reducing the incidence of another NTD pregnancy to a recurrence rate of 1%.

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 a 5 mg tablet daily would reduce the risk by about 85%.

• * Elemental amount

^† RRR-α-tocopherol (AT)

Each oval shaped, dark blue (p.m.), film coated, immediate release tablet contains:

• * Elemental amount

What the non-medicinal ingredients are:

Pregnancy Multivitamin Folic 5 pink (a.m.) tablet contains:

Colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue No. 1, FD&C Red No. 40, glucose syrup, hydroxypropyl methylcellulose, 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 Folic 5 dark blue (p.m.) tablet contains:

Citric acid, croscarmellose sodium, D&C Red No. 27, FD&C Blue No. 1, magnesium stearate, maltodextrin, polyvinyl alcohol, pregelatinized starch, polyethylene glycol, sodium ascorbate, sodium citrate, sucrose, talcum, titanium

ABOUT THIS MEDICATION

dioxide.

This product does not contain lactose, gluten or tartrazine.

What dosage forms it comes in:

Pregnancy Multivitamin Folic 5 is supplied in a 30-day blister pack containing 30 oval, pink (a.m.) tablets and 30 oval, dark blue (p.m.) tablets.

WINGS AND PRECAUTIONS

BEFORE you use Pregnancy Multivitamin Folic 5 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.
• 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 Folic 5 pink (a.m.) tablet contains 35 mg of elemental iron. No iron is contained in the Pregnancy Multivitamin Folic 5 dark blue (p.m.) tablet.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, 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 Folic 5 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 dark blue (p.m.) tablets of Pregnancy Multivitamin Folic 5.
• 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.

PROPER USE OF THIS MEDICATION

Usual dose:

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 dark 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 Folic 5 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 Folic 5 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 Folic 5 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 Folic 5 dark blue (p.m.) tablet at least four (4) hours apart to optimize the absorption of levothyroxine hormone.

    Overdose: Do not exceed the recommended dose.

Missed dose:

When a dose has been missed, it should be taken as soon as possible and one pink (a.m.) and one dark blue (p.m.) tablet should be taken within a 24-hour period. It is recommended that Pregnancy Multivitamin Folic 5 pink (a.m.) and dark 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 Folic 5, contact your doctor, pharmacist or healthcare professional.

MORE INFORMATION

If you want more information about Pregnancy Multivitamin Folic 5:

• 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

1310rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Approved: April 25, 2023

Store at room temperature (between 15-30ºC).

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

HOW TO STORE IT