Package leaflet: Information for the patient

Nuperal 10mg/10mg modified-release hard capsules

Doxylamine succinate/pyridoxine hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nuperal is and what it is used for
What you need to know before taking Nuperal
How to take Nuperal
Possible side effects
How to store Nuperal
Contents of the pack and other information

1. What Nuperal is and what it is used for

This medicine belongs to a group of drugs called antiemetics and anti-nausea agents and is indicated for
the symptomatic treatment of nausea and vomiting in pregnancy, in adult subjects.
Nuperal contains two medicines (active substances) called: "doxylamine succinate" and "pyridoxine
hydrochloride". Doxylamine succinate belongs to a group of medicines called "antihistamines". Pyridoxine is also known as vitamin B6.

2. What you need to know before taking Nuperal

Do not take Nuperal:

If you are allergic to doxylamine, pyridoxine, or any of the other ingredients of this medicine (listed in section 6).
If you have hypersensitivity to antihistamines derived from ethanolamine (medicines used to treat allergies), such as diphenhydramine or carbinoxamine.
If you are taking antidepressants such as monoamine oxidase inhibitors (MAOIs), as Nuperal may intensify and prolong adverse effects on the nervous system.
If you are taking a strong inhibitor of the CYP450 isoenzyme.
If you suffer from porphyria (a very rare metabolic disorder).
If you have hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.
If you have vomiting due to other causes.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nuperal.
Before taking this medicine, consult a doctor if you suffer from:

Glaucoma (increased pressure in the eye).
Peptic ulcer (lesion of the mucosal lining of the stomach or the first part of the intestine with constriction of the digestive tract), pyloroduodenal obstruction (difficulty in food passage from stomach to intestine), or bladder neck obstruction (urinary tract dysfunction), urinary obstruction (difficulty urinating).
Thyroid dysfunction.
Heart disease and high blood pressure, as Nuperal may worsen these conditions.
Long QT syndrome (a heart condition).
Asthma and other respiratory problems such as chronic bronchitis (persistent inflammation of the bronchi), pulmonary emphysema (a lung disease making breathing difficult), or chronic obstructive pulmonary disease (COPD), as Nuperal may worsen these conditions.
Kidney and/or liver diseases.
Epilepsy, as Nuperal may worsen this condition.
Low levels of potassium in the blood or other electrolyte imbalances.

Nuperal may increase light sensitivity; therefore, sunbathing is not recommended during treatment.
Nuperal may mask symptoms related to the auditory system (such as dizziness and vertigo); therefore, it is advisable to consult your doctor if you are taking other medicines with similar effects.
Do not drink alcohol during treatment.
Nuperal may increase dehydration and cause heat stroke due to increased sweating.
Drowsiness may occur after taking Nuperal. If this happens, do not perform any activities requiring full attention unless your doctor tells you otherwise.

Children and adolescents
There are no data available on the safety and efficacy of Nuperal in individuals under 18 years of age.

Other medicines and Nuperal
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Nuperal must not be taken together with the following medicines:

Anticholinergics such as antidepressants or medicines for Parkinson’s disease, monoamine oxidase inhibitors (MAOIs) (for treatment of depression), antipsychotics (medicines for mental disorders), atropine (for treatment of spasms) or disopyramide (for treatment of certain heart problems), as they may increase their toxicity.
Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
Antihypertensive medicines (for blood pressure control) acting on the central nervous system, such as guanabenz, clonidine, or methyldopa.
Other medicines with ototoxic effects (toxic to the ear), such as carboplatin or cisplatin (for treatment of cancer), chloroquine (for malaria prevention and treatment), and certain antibiotics (medicines for infections) such as erythromycin or intravenous aminoglycosides, among others, as Nuperal may mask the toxic effects of these medicines; in such cases, periodic monitoring of auditory function is necessary.
Medicines that reduce the elimination of other active substances, such as azole or macrolide derivatives, as they may enhance the effect of Nuperal.
Certain diuretics (medicines that stimulate increased urine production).
Medicines that may affect the heart, such as those used to treat arrhythmias (irregular heartbeat), certain antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents (to reduce fats in the blood), or certain neuroleptics (medicines for mental disorders).
Medicines with photosensitizing effects (increased skin reactivity upon exposure to sunlight), such as certain antiarrhythmics (amiodarone, quinidine), certain antibiotics (tetracyclines, fluoroquinolones, azithromycin, and erythromycin, among others), certain antidepressants (imipramine, doxepine, amitriptyline), certain antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, diphenhydramine, among others), certain anti-inflammatory agents (piroxicam and naproxen, among others), certain antivirals (amantadine, ganciclovir), and certain diuretics (furosemide, chlorothiazide), as they may cause additional photosensitizing effects.
Levodopa, as the pyridoxine contained in Nuperal may reduce its effect.
Medicines for epilepsy (phenobarbital, phenytoin), as pyridoxine may reduce their blood levels.
Medicines such as hydroxyzine, isoniazid, or penicillamine, as their combination with pyridoxine may cause vitamin B6 deficiency.

Interference with diagnostic tests
This medicine may alter the following test results: skin tests using allergen extracts (allergy tests) may yield false negative results. Discontinue taking the medicine several days before undergoing such tests.

Nuperal with food, drinks, and alcohol
If capsules are taken together with food, Nuperal may have a delayed effect.
Avoid drinking alcohol while taking Nuperal, as it may increase the drug's toxicity.
See section 3 How to take Nuperal.

Pregnancy and breastfeeding
Nuperal is intended for use in pregnant women.
The use of Nuperal is not recommended during breastfeeding.

Driving and using machines
Nuperal may cause dizziness in some patients; therefore, avoid any situation requiring quick reflexes, such as driving or operating machinery, at least during the first few days of treatment, until the effect of the medicine is clearly understood.

Nuperal contains sucrose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Nuperal

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

The recommended dose is 2 capsules before bedtime if nausea and vomiting occur in the morning (Day 1). If this dose controls the symptoms, continue taking two capsules. However, if symptoms persist in the afternoon of Day 2, the patient should continue taking the usual dose of two capsules at bedtime (Day 2) and on Day 3 take three capsules (one capsule in the morning and two capsules in the evening before bedtime). If these three capsules do not adequately control symptoms on Day 3, the patient may take four capsules starting from Day 4 (one capsule in the morning, one capsule in the mid-afternoon, and two capsules in the evening before bedtime).

The maximum daily dose is 4 capsules (one in the morning, one in the mid-afternoon, and two in the evening before bedtime).

The capsules must be swallowed whole, without chewing, on an empty stomach, with a sufficient amount of liquid, preferably water.

Use in children and adolescents
There are no data on safety and efficacy in subjects under 18 years of age.

If you take more Nuperal than you should
If you take more Nuperal than prescribed, inform your doctor or pharmacist immediately.

Symptoms of possible poisoning may include neurological disturbances such as agitation, hallucinations, or intermittent seizures, which in extreme cases may lead to reduced vital signs and coma. If one or more of these symptoms occur, appropriate treatment will be provided.

If you forget to take Nuperal
If you forget to take a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
The side effects of Nuperal are generally mild and transient, and occur more frequently during the first
days of treatment.
Common side effects (may affect up to 1 in 10 people): dizziness and other side effects such as dry mouth, constipation, blurred vision, urinary retention, or increased bronchial secretion.
Uncommon side effects (may affect up to 1 in 100 people): asthenia (weakness), peripheral oedema (swelling of arms and legs), nausea, vomiting, diarrhoea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (dizziness due to postural change), diplopia (double vision), glaucoma, confusion, or photosensitivity reactions.
Rare side effects (may affect up to 1 in 1,000 people): restlessness, tremors, seizures, or blood disorders such as haemolytic anaemia.
Other side effects (frequency cannot be estimated from the available data): tachycardia (rapid heartbeat), dizziness, or dyspnoea (shortness of breath).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nuperal

Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nuperal contains

The active substances are doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg).
The other components are:
The capsules contain: sucrose, maize starch, shellac, povidone, talc, methacrylic acid-methyl methacrylate copolymer, and anhydrous colloidal silica.
The capsule shell is composed of gelatin, indigo carmine (E132), quinoline yellow (E104), and titanium dioxide (E171).

Description of the appearance of Nuperal and contents of the pack
Nuperal is supplied in packs containing 12 or 24 green capsules, in two PVC/PVdC-aluminium blisters with 12 capsules each.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milan (Italy)

Manufacturer
Laboratorios INIBSA, S.A.
Carretera de Sabadell a Granollers Km. 14.5
08185 Lliçà de Vall – Barcelona (Spain)