Frequently Asked Questions

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1. Does Diclectin® help to reduce impact of NVP?

• Diclectin® is indicated in cases of nausea and vomiting of pregnancy.
• Commonly, when administered at the early stage of nausea and/or vomiting, Diclectin® help to prevent the disease to progress to a more serious level called hyperemesis gravidarum (HG) that requires hospitalization to rehydrate the patient.
• In general, when administered at the early stage of nausea and/or vomiting, Diclectin® alleviates the symptoms of NVP while improving quality of life and the ability to conduct activities of daily living.

2. Is Diclectin® safe?

• Over the years, Diclectin® has been recognized as the drug of choice for NVP by the medical community: SOGC (Society of Obstetricians and Gynaecologists of Canada), MOTHERISK (Hospital for Sick Children, Toronto), Reprotox, NORD (National Organization for Rare Disorders).
• Diclectin®, a combination of doxylamine succinate (antihistamine/antiemetic) and pyridoxine hydrochloride (vitamin B₆), has been available on the Canadian market for over 25 years. This combination has been prescribed to over 33 million women.
• Diclectin® is the most studied medicine for use during pregnancy. Its vitamin B₆ and antihistamine combination has been included in 25 epidemiological studies (200,000 women) and 2 meta-analyses. All confirmed Diclectin®'s safety and efficacy in pregnancy no matter how early and for how long it is taken during pregnancy.
• Diclectin® scored the highest safety rating "A" in Briggs' Reference Guide to Fetal and Neonatal Risk.
• Diclectin® does not increase a woman's baseline risk of having a child with a major malformation.

3. How should I take Diclectin®?

• Diclectin® works optimally when given 4 to 6 hours prior to anticipated onset of symptoms.
• The delay in action may be prolonged by up to 5 more hours before Diclectin® gets effective when tablets are taken with food.

4. My prescription of Diclectin® says "as needed". What does it mean?

• Diclectin® should not be prescribed as needed (PRN).
• Diclectin® is a delayed released tablet. It normally takes between 4 to 6 hours for Diclectin® to reach its optimal effect. If taken only when needed, it will take a few hours before symptoms improve because of the delayed release action.
• It is also important to take Diclectin® on a daily basis and to take the prescribed dosing in order to reach its optimal effect. It takes 2 to 3 days of treatment with Diclectin® before blood concentration of Diclectin® reaches a certain level (steady state) that allows a control over a 24-hour period.

5. Can I crush or split Diclectin®?

Diclectin® is a delayed release tablet. If we split or alter the coating, we don't know what will happen with its stability and absorption. We can expect alteration in pharmacokinetics if this coating is destroyed. No stability data is available on crushed or split tablets. Therefore, as the manufacturer, we recommend that Diclectin® tablets be administered as whole.

6. When and how should I stop using Diclectin®?

You should not stop taking Diclectin® on your own. Always consult your doctor or healthcare professional before changing the dosage of your prescription. If he/she decides your condition requires less or no more Diclectin®, he/she will gradually reduce your dose to prevent a sudden return of your symptoms.

7. May I take Diclectin® with food?

• The delay in action may be prolonged when tablets are taken with food. It may take up to 5 more hours before it gets effective. So instead of taking 4 to 6 hours, it may take between 9 to 11 hours before it works.

8. How long does drowsiness last after Diclectin® has been started?

No specific study has been made on that topic. But we can assume that depending on the customer's metabolism rate, her body will eventually adjust to the substance. Therefore, drowsiness may last from 4 days to two weeks.

9. Is there an interaction between Diclectin® and PregVit? Does it make too much of vitamin B₆?

It would be very surprising that any reaction occurs. Vitamin B₆ is water-soluble; the excess would be eliminated through urine. Taking both products together should not be a problem.

10. I should deliver in a couple of weeks and I would like to know if it is safe to take it so close to delivery.

• In our new Diclectin® Product Monograph, we clearly state that Diclectin® is indicated to treat NVP at any trimester of pregnancy. It has been shown to be safe in all three trimesters.
• Diclectin® has been included in over 30 studies and has been shown to be safe for the baby, no matter how early and for how long a woman takes it during her pregnancy.
• Diclectin® has been rated the highest safety score (A) in Briggs' Reference Guide to Fetal and Neonatal Risk.
• No withdrawal symptoms are found with Diclectin® as would be found in newborns of moms using cocaine during pregnancy, for example.
• In our Diclectin® Product Monograph, we recommend to gradually reduce the dose of Diclectin® instead of stopping it all of a sudden. The reason for that is only because we want to prevent a sudden return of symptoms of NVP.

11. Is it ok to take Diclectin® when breastfeeding?

• Diclectin® is specifically indicated for the treatment of nausea and vomiting of pregnancy, it is therefore not indicated for lactation. There are no published reports describing the use of Diclectin® during lactation. Using Diclectin® during lactation is considered off-labeled use.
• In the seventh edition of Drugs in Pregnancy and Lactation, A Reference Guide to Fetal and Neonatal Risk written by Gerald Briggs, some information is available on the use of doxylamine succinate and pyridoxine hydrochloride during lactation:
  
  • Because of doxylamine succinate's low molecular weight, its passage into breast-milk should be expected. Effects on a nursing infant, if any, are unknown, but sedative and other antihistamine actions are a potential concern.
  • Pyridoxine is compatible with breastfeeding because it is present in low dose in the tablets so present no risk to a nursing infant.
  • The manufacturer of at least one doxylamine preparation states that doxylamine is contraindicated during lactation.
• We do not promote the use of Diclectin® during lactation, but if a physician decides to prescribe it with all this information, we believe it would be very important for the mother to monitor her baby for signs of sedation such as sleepiness. Prescribing Diclectin® for use during lactation is considered off-labelled use.

12. I kept Diclectin® tablets from a previous pregnancy. Are they still good? I don't see the expiry date on my Diclectin® prescription bottle.

• We would recommend that you consult your health professional if your have symptoms of NVP again.
• Even though you were diagnosed with NVP during a previous pregnancy and were prescribed Diclectin® at that time, it remains very important that you consult your doctor to get a new diagnosis before you begin a treatment. We do not recommend women to begin treatment with Diclectin® without a doctor's supervision. If you get a new prescription of Diclectin®, the dosage and schedule will be based on your current condition.
• Expiry date is based on established stability data. As a manufacturer, we do not recommend you to take Diclectin® tablets that are or may be expired.

13. A year ago, I was prescribed Diclectin®. I delivered and I am pregnant again. My Diclectin® tablets are expired, what should I do?

• Because the expiry date on your bottle indicates that the tablets are expired, you should not take them. The special coating might have changed and the effectiveness might be altered.
• As a manufacturer, we do not recommend you to take Diclectin® tablets that are or may be expired for a question of safety.
• Even though you were diagnosed with nausea and vomiting of pregnancy (NVP) during a previous pregnancy and were prescribed Diclectin® at that time, it remains very important that you consult your doctor to get a new diagnosis before you begin a treatment. We do not recommend women to begin treatment with Diclectin® without a doctor's supervision. If you get a new prescription of Diclectin®, the dosage and schedule will be based on your current condition.

14. Does Diclectin® contain gluten?

• No. To the best of our knowledge, Diclectin® does not contain gluten.
• We recently check with our suppliers and they all confirmed they are not using gluten in the manufacturing of our raw materials.
• A new mention will soon be added to the Diclectin® label: gluten free. We do not know when exactly.

15. Does Diclectin® contain tartrazine?

• No. To the best of our knowledge, Diclectin® does not contain tartrazine.
• A new mention will soon be added to the Diclectin® label: tartrazine free. We do not know when exactly.

16. Does Diclectin® contain sulfite?

• No. To the best of our knowledge, Diclectin® does not contain sulfite.
• A new mention will soon be added to the Diclectin® label: sulfite free. We do not know when exactly.

17. Does Diclectin® contain lactose?

• No. To the best of our knowledge, Diclectin® does not contain lactose.
• A new mention will soon be added to the Diclectin® label: lactose free. We do not know when exactly.

18. Where is Diclectin® sold?

Diclectin® is currently available only in Canada.

19. Where can I get further information on NVP?

• Every weekday, Motherisk counsellors share evidence-based information with nearly 200 women and healthcare providers who call these Motherisk Helplines:
  • Nausea and Vomiting of Pregnancy Helpline - 1-800-436-8477 - for information on "morning sickness" and how to treat it.
  • This Helpline is open Monday through Friday, 9 a.m. to 5 p.m. EST.