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Details for: PREGVIT / PREGVIT FOLIC 5

Company: DUCHESNAY INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02451573PREGVITBETA-CAROTENE; VITAMIN E (DL-ALPHA TOCOPHERYL ACETATE); ASCORBIC ACID (ASCORBIC ACID); VITAMIN B1 (THIAMINE MONONITRATE); VITAMIN B2 (RIBOFLAVIN); NICOTINAMIDE; VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE); D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE); MAGNESIUM (MAGNESIUM OXIDE); IODINE (POTASSIUM IODIDE); IRON (FERROUS FUMARATE); COPPER (CUPRIC OXIDE); ZINC (ZINC OXIDE); FOLIC ACID; VITAMIN B12 (CYANOCOBALAMIN); VITAMIN D3 (CHOLECALCIFEROL); CALCIUM (CALCIUM CARBONATE)1.6 MG; 13.8 MG; 120 MG; 3 MG; 3.4 MG; 20 MG; 10 MG; 5 MG; 50 MG; 0.15 MG; 35 MG; 2 MG; 15 MG; 1.1 MG; 12 MCG; 600 UNIT; 300 MGTABLETORAL
02451581PREGVIT FOLIC 5BETA-CAROTENE; FOLIC ACID; VITAMIN E (DL-ALPHA TOCOPHERYL ACETATE); ASCORBIC ACID (ASCORBIC ACID); VITAMIN B1 (THIAMINE MONONITRATE); VITAMIN B2 (RIBOFLAVIN); NICOTINAMIDE; VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE); D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE); MAGNESIUM (MAGNESIUM OXIDE); IODINE (POTASSIUM IODIDE); IRON (FERROUS FUMARATE); COPPER (CUPRIC OXIDE); ZINC (ZINC OXIDE); VITAMIN B12 (CYANOCOBALAMIN); VITAMIN D3 (CHOLECALCIFEROL); CALCIUM (CALCIUM CARBONATE)1.6 MG; 5 MG; 13.8 MG; 120 MG; 3 MG; 3.4 MG; 20 MG; 10 MG; 5 MG; 50 MG; 0.15 MG; 35 MG; 2 MG; 15 MG; 12 MCG; 600 UNIT; 300 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Pregvit®

Pregvit® 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 Pregvit® does not eliminate the need for balanced nutrition.

Pregvit® folic 5

Pregvit® 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.
Pregvit® 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 Pregvit® folic 5 does not eliminate the need for balanced nutrition.
What it does

Pregvit®

Pregvit® 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%.

Pregvit® folic 5

Pregvit® 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%.

When it should not be used

Pregvit®

You should not take Pregvit® if you are allergic to any of the ingredients of Pregvit® or component of the container (see list of medicinal and nonmedicinal ingredients below this section).

Pregvit® folic 5

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

What the medicinal ingredient is

Pregvit®

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 (cupric oxide) 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 µg
Vitamin D3 (cholecalciferol) 250 or 600 IU
Calcium (calcium carbonate)* 300 mg

* Elemental amount

Pregvit® folic 5

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 (cupric oxide) 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, dark blue (p.m.), film coated, immediate release tablet contains:

Folic Acid 5 mg
Vitamin B12 (cyanocobalamin) 12 µg
Vitamin D3 (cholecalciferol) 250 or 600 IU
Calcium (calcium carbonate)* 300 mg

* Elemental amount

What the non-medicinal ingredients are

Pregvit®

Pregvit® pink (a.m.) tablet contains:
ammonium hydroxide, N-butyl alcohol, carnauba wax, D&C Red #27, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, FD&C Yellow #6, isopropyl alcohol, macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, propylene glycol, shellac glaze, simethicone, sodium croscarmellose, sodium lauryl sulfate, starch (corn starch), talc, titanium dioxide.

Pregvit® blue (p.m.) tablet contains:
ammonium hydroxide, N-butyl alcohol, carnauba wax, D&C Red #27, FD&C Blue #2, FD&C Red #40, FD&C Yellow #6, isopropyl alcohol, macrogol/PEG 3350, magnesium stearate, polyvinyl alcohol, propylene glycol, shellac glaze, simethicone, sodium croscarmellose, sodium lauryl sulfate, talc, titanium dioxide.

This product does not contain lactose, gluten or tartrazine.

Pregvit® folic 5

Pregvit® folic 5 pink (a.m.) tablet contains:
ammonium hydroxide, N-butyl alcohol, carnauba wax, D&C Red #27, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, FD&C Yellow #6, isopropyl alcohol, macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, propylene glycol, shellac glaze, simethicone, sodium croscarmellose, sodium lauryl sulfate, starch (corn starch), talc, titanium dioxide.

Pregvit® folic 5 dark blue (p.m.) tablet contains:
ammonium hydroxide, N-butyl alcohol, carnauba wax, D&C Red #27, FD&C Blue #1, FD&C Blue #2, isopropyl alcohol, macrogol/PEG 3350, magnesium stearate, polyvinyl alcohol, propylene glycol, shellac glaze, simethicone, sodium croscarmellose, sodium lauryl sulfate, talc, titanium dioxide. This product does not contain lactose, gluten or tartrazine.

This product does not contain lactose, gluten or tartrazine.

What dosage form it comes in

Pregvit®

Pregvit® is supplied in a 30-day blister pack containing 30 oval, pink (a.m.) tablets and 30 oval, blue (p.m.) tablets. Each tablet is imprinted with a pink image of a pregnant woman.

Pregvit® folic 5

Pregvit® 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. Each tablet is imprinted with a pink image of a pregnant woman.

Warnings and precautions
Pregvit®
Pregvit® folic 5

Pregvit®

BEFORE you use Pregvit® 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 Pregvit® pink (a.m.) tablet contains 35 mg of elemental iron. No iron is contained in the Pregvit® blue (p.m.) tablet.

Pregvit® folic 5

BEFORE you use Pregvit® 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 Pregvit® folic 5 pink (a.m.) tablet contains 35 mg of elemental iron. No iron is contained in the Pregvit® folic 5 dark blue (p.m.) tablet.
Interactions with this medication
Pregvit®
Pregvit® folic 5

Pregvit®

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, nonprescription or natural health products, or vitamin-mineral supplements.

In particular, the drugs that may interact with Pregvit® 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 Pregvit® .
  • 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.

Pregvit® folic 5

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, nonprescription or natural health products, or vitamin-mineral supplements.

In particular, the drugs that may interact with Pregvit® 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 Pregvit® 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
Pregvit®
Pregvit® folic 5

Pregvit®

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 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 Pregvit® 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 Pregvit® 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 Pregvit® 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 Pregvit® blue (a.m.) tablet at least four (4) hours apart to optimize the absorption of levothyroxine hormone.

Overdose

Do not exceed the recommended dose.

In case of drug overdose, contact a healthcare practitioner, 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 Pregvit® 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.

Pregvit® folic 5

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 Pregvit® 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 Pregvit® 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 Pregvit® 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 Pregvit® folic 5 dark blue (a.m.) tablet at least four (4) hours apart to optimize the absorption of levothyroxine hormone.

Overdose

Do not exceed the recommended dose.

In case of drug overdose, contact a healthcare practitioner, 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 dark blue (p.m.) tablet should be taken within a 24-hour period. It is recommended that Pregvit® 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

Pregvit®

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 Pregvit® , contact your doctor, pharmacist or healthcare professional.

Pregvit® folic 5

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 Pregvit® folic 5, contact your doctor, pharmacist or healthcare professional

How to store

Pregvit®

Store at room temperature (15 to 30ºC).

Protect from moisture. Contact with moisture may produce surface discoloration or erosion of the tablet.

Keep in a safe place out of reach of children.

Pregvit® folic 5

Store at room temperature (15 to 30ºC).

Protect from moisture. Contact with moisture may produce surface discoloration or erosion of the tablet.

Keep in a safe place out of reach of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

    Report online at www.healthcanada.gc.ca/medeffect
    Call toll-free at 1-866-234-2345
    Complete a Canada Vigilance Reporting Form and:
      Fax toll-free to 1-866-678-6789, or
      Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full Product Monograph, prepared for healthcare professionals, can be obtained by contacting the sponsor, Duchesnay Inc., at:
950 boul. Michèle-Bohec
Blainville, Québec, Canada
J7C 5E2
Tel: 1-888-666-0611
Fax: 1-888-588-8508
E-mail: medicalinfo@duchesnay.com
www.duchesnay.com

This leaflet was prepared by Duchesnay Inc.

Last revised: January 26, 2016.

Date modified: