Package Leaflet: Information for the User

Navalem 10 mg/10 mg Modified Release Hard Capsules

Doxilamine succinate / Pyridoxine hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as 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 pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Navalem is and what it is used for

2.What you need to know before you start taking Navalem

3.How to take Navalem

4.Possible side effects

5.Storage of Navalem

6.Contents of the pack and other information

This medication belongs to the group of substances known as antiemetics and antinauseants and is indicated for the symptomatic treatment of nausea and vomiting during pregnancy in adults.

Navalem contains two active components: 'doxilamina succinato' and 'piridoxina hidrocloruro'. Doxilamina succinato belongs to the group of antihistamine medications. Piridoxina hidrocloruro is also known as Vitamin B6.

Do not take Navalem:

• If you are allergic to doxilamine, pyridoxine, or any of the other components of this medication listed in section 6.
• If you are hypersensitive to antihistamines (antiallergics) derived from ethanolamine (such as diphenhydramine or carbinoxamine).
• If you are taking antidepressants such as monoamine oxidase inhibitors (MAOIs) as Navalem may intensify and prolong the adverse effects on the nervous system.
• If you are taking potent inhibitors of CYP450 isoenzymes.
• If you have porphyria (a very rare metabolic disorder).
• If you have hereditary fructose intolerance, glucose-galactose malabsorption, or saccharase-isomaltase deficiency.
• If you have vomiting due to another cause.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Navalem.

You should consult a doctor before taking this medication if you have:

• Glaucoma (increased eye pressure),
• Peptic ulcer (erosion of the stomach wall or beginning of the intestine with narrowing of the digestive tube), pyloric obstruction (difficulty passing food from the stomach to the intestine), or bladder neck obstruction (urinary tract disease), urinary obstruction (difficulty urinating),
• Thyroid dysfunction,
• Heart disease and high blood pressure as Navalem may worsen the disease,
• Prolonged QT interval (heart disease),
• Asthma and other respiratory alterations, such as chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (disease affecting the lungs and making breathing difficult) or chronic obstructive pulmonary disease (COPD), as Navalem may worsen the disease,
• Kidney and/or liver diseases,
• Epilepsy, as it may worsen the disease,
• Low potassium levels in the blood or other electrolyte imbalances.

Navalem may cause light sensitivity, so it is not recommended to take the sun during treatment.

Navalem may mask symptoms that may affect your ears (such as vertigo), so you should consult your doctor if you are taking other medications that may have the same effects.

Be aware of any signs of abuse or dependence on this treatment. If you have any substance use disorder (alcohol, medications, or others), talk to your doctor.

Navalem contains pyridoxine hydrochloride (vitamin B6), so it is necessary to control additional levels during diet or vitamin B6 supplements.

Navalem may worsen dehydration and heatstroke symptoms due to decreased sweating.

After taking Navalem, you may feel drowsy. If this happens, do not perform other activities that require full attention, unless your doctor tells you that you can.

Children and adolescents:

No data is available on the safety and efficacy of Navalem in children under 18 years.

Use of Navalem with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Navalem should not be taken together with the following medications:

• Anticholinergics such as medications for depression or Parkinson's disease, monoamine oxidase inhibitors (MAOIs) or IMAO (medications for depression), neuroleptics (medications for mental disorders), atropinic medications for spasms or disopyramide (for certain heart problems) as it may potentiate toxicity.
• Central nervous system inhibitors (e.g. barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, procarbazine, or oxibato of sodium).
• Antihypertensives (medications for high blood pressure) with central nervous system effects such as guanabenz, clonidine, or alpha-methyldopa.
• If you are taking other medications that produce ototoxicity, such as carboplatin or cisplatin (cancer medications), chloroquine (malaria medication), and some antibiotics (infection medications) such as erythromycin or aminoglycosides, as Navalem may mask the toxic effects of these medications, so you should review your ear status periodically.
• Medications that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the effect of Navalem.
• Some diuretics (medications that increase urine elimination).
• Medications with heart effects, such as those used to treat arrhythmias (heart rhythm problems), some antibiotics, certain malaria medications, certain antihistamines, certain medications used to reduce blood lipids (fats), or certain neuroleptics (medications for mental disorders).
• Medications that produce photosensitization reactions (exaggerated skin reaction when exposed to sunlight) such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, etc.), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, diphenhydramine, etc.), some anti-inflammatory medications (piroxicam, naproxen, etc.), some antivirals (amantadine, ganciclovir), some diuretics (furosemide, chlorothiazide) as they may cause additive photosensitization effects.
• Levodopa as the pyridoxine in Navalem may decrease its effect.
• Medications for epilepsy (phenobarbital, phenytoin) as pyridoxine may decrease their blood levels.
• Medications such as hydroxyzine, isoniazid, or penicillamine as they may increase the need for vitamin B6 when combined with pyridoxine.

Interference with diagnostic tests:

This medication may alter the following analytical determinations: false negative skin tests using allergenic extracts (allergy tests). It is recommended to suspend treatment several days before performing the test.

Taking Navalem with food, drinks, and alcohol:

There may be a delay in the action of Navalem when the capsules are taken with food.

It is not recommended to consume alcoholic beverages during Navalem treatment as they may potentiate the medication's toxicity. See section 3How to take Navalem.

Pregnancy and lactation:

Navalem is indicated for pregnant women.

It is not recommended to use Navalem during breastfeeding.

Driving and operating machinery:

Navalem may cause drowsiness in some patients, so they should avoid situations that require full attention, such as driving vehicles or operating machinery, at least during the first few days of treatment until you know how it affects you.

Navalem contains saccharose:

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationindicated by your doctor.Consult your doctor again if you are unsure.

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

The maximum daily dose is 4 capsules (1 in the morning, 1 in the afternoon, and 2 at bedtime).

The capsules should be swallowedwhole, without chewingand on an empty stomach, with a sufficient amount of liquid, preferably water.

Use inchildren and adolescents

The safety and efficacy have not been established in individuals under 18 years of age.

If you take more Navalem than you should

If you have taken more Navalem than you should, consult your doctor or pharmacist immediately.

A possible overdose would be recognized by neurological alterations such as agitation, hallucinations, or intermittent convulsions, which could lead in extreme cases to a decrease in vital activity and coma. In the event of any of these symptoms, appropriate treatment will be initiated.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Navalem:

If you forget a dose of Navalem,it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule continued. Do not take a double dose to make up for the missed dose.

Like all medications, Navalem may produce adverse effects, although not everyone will experience them.

The adverse effects of Navalem are generally mild and transient, being more frequent in the first days of treatment.

Frequent Adverse Effects (may affect 1 in 10 people):drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, or increased bronchial secretion.

Less Frequent Adverse Effects (may affect 1 in 100 people):asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to changes in posture), diplopia (double vision), glaucoma, confusion, or photosensitivity reactions

Rare Adverse Effects (may affect up to 1 in 1,000 people):agitation, tremor, seizures, or blood disorders such as hemolytic anemia.

Other Adverse Effects of Unknown Frequency (frequency cannot be estimated from available data):tachycardia (faster heart rate), vertigo, or dyspnea.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store below 25°C

Keepthis medicationout of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Navalem

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

Appearance of the product and content of the packaging

Navalem is presented in packaging containing 12, 24, or 48 green capsules, and in multiple packaging containing 48 green capsules (2 boxes of 24 capsules) in PVC/PVdC-aluminum blisters or PVC/PVdC/PVC-aluminum blisters, with 12 capsules each.

Only some sizes of packaging may be commercially available

Holder of the marketing authorization

Inibsa Ginecología, S.A.

Carretera de Sabadell a Granollers Km. 14,5

08185 LLIÇA DE VALL – Barcelona (Spain)

Phone: 93 860 95 00

Fax: 93 843 96 95

Email: [email protected]

Responsible for manufacturing:

Laboratorios INIBSA, S.A.

Carretera de Sabadell a Granollers Km. 14,5

08185 LLIÇA DE VALL – Barcelona (Spain)

Phone: 93 860 95 00

Fax: 93 843 96 95

Or

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan (Italy)

Last review date of this prospectus: May 2020