Leaflet NUPERAL 10mg / 10mg modified release capsules

Indicated for: nausea and vomiting of pregnancy

Route of administration: oral

Substance: doxylamine + pyridoxine (antihistamine + vitamin B6)

ATC: R06AA59 (Respiratory system | Antihistamines for systemic use | Aminoalkyl ethers)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Anticholinergic effects
Anticholinergic effects

May cause dry mouth, constipation, urinary retention, or blurred vision.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Doxylamine + pyridoxine is used for nausea and vomiting in pregnancy when simple measures, such as small meals, avoiding triggers and dietary changes, have not helped enough. Doxylamine is a sedating antihistamine, while pyridoxine is vitamin B6. It can reduce symptoms and help maintain fluids, nutrition and daily functioning.

It is taken by mouth, usually starting at bedtime, and the dose may be increased gradually if symptoms remain troublesome. Gastro-resistant tablets should be swallowed whole with water and not crushed, chewed or split, because this can affect release. Do not take more than prescribed. Severe vomiting, weight loss, dehydration or inability to keep fluids down needs prompt medical advice.

The most common side effect is sleepiness. Dizziness, tiredness, dry mouth, constipation, blurred vision and difficulty passing urine may also occur. Avoid driving, cycling, machinery and tasks requiring full attention until you know how it affects you. Alcohol, sleeping tablets, some cold medicines, strong pain medicines and other sedatives can increase drowsiness.

Do not use this medicine if you are allergic to doxylamine, similar antihistamines, pyridoxine or any ingredient, and do not take it with monoamine oxidase inhibitors. Tell your doctor if you have asthma, narrow-angle glaucoma, stomach ulcer, bowel or bladder blockage, or if you take extra vitamin B6. Do not stop suddenly unless advised, because symptoms may return.

General data about NUPERAL 10mg / 10mg

  • Substance: doxylamine + pyridoxine
  • Date of latest medicines list: 01-02-2026
  • Product code: W71613001
  • Concentration: 10mg / 10mg
  • Pharmaceutical form: modified release capsules
  • Quantity: 12
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: LABORATORIOS INIBSA S.A. - SPANIA
  • Holder: ITALFARMACO S.P.A. - ITALIA
  • Number: 16368/2025/01
  • Shelf life: 3 years