NAVALEM 10 mg/10 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Leaflet: information for the user

Navalem 10 mg/10 mg hard capsules of modified release EFG

Doxylamine succinate / Pyridoxine hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Navalem and what is it used for
2. What you need to know before taking Navalem
3. How to take Navalem
4. Possible side effects
5. Storage of Navalem
6. Package contents and additional information

1. What is Navalem and what is it used for

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

Navalem contains two active ingredients: 'doxylamine succinate' and 'pyridoxine hydrochloride'. Doxylamine succinate belongs to the group of antihistamine medications. Pyridoxine hydrochloride is also known as Vitamin B6.

2. What you need to know before taking Navalem

Do not take Navalem:

• If you are allergic to doxylamine, pyridoxine, or any other component 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 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 problems of fructose intolerance, glucose-galactose malabsorption, or sacarase-isomaltase insufficiency.
• 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 or duodenum wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or obstruction of the urinary bladder neck (urinary tract disease), urinary obstruction (difficulty urinating),
• Thyroid dysfunction,
• Heart disease and high blood pressure, as Navalem may worsen the disease,
• Prolongation of the QT interval (heart disease),
• Asthma and other respiratory disorders, such as chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (disease affecting the lungs, making breathing difficult), or chronic obstructive pulmonary disease (COPD), as Navalem may worsen the disease,
• Kidney and/or liver disease,
• Epilepsy, as it may worsen the disease,
• Low potassium levels in the blood or other electrolyte disturbances.

Navalem may cause light sensitivity reactions, so it is not recommended to sunbathe during treatment.

Navalem may mask symptoms that can 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 a substance use disorder (alcohol, medications, or others), talk to your doctor. Navalem contains pyridoxine hydrochloride (Vitamin B6), so it is necessary to monitor additional levels during diet or Vitamin B6 supplements.

Navalem may worsen dehydration and heat stroke symptoms due to decreased sweating.

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

Children and adolescents

There is no available data on the safety and efficacy of Navalem in individuals under 18 years of age.

Use of Navalem with other medications

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

Navalem should not be taken with the following medications:

• Anticholinergics such as medications for the treatment of depression or Parkinson's disease, monoamine oxidase inhibitors or MAOIs (medications for depression), neuroleptics (medications for the treatment of mental disorders), atropine-like medications for the treatment of spasms, or disopyramide (for the treatment of certain heart problems), as toxicity may be increased.
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, procarbazine, or sodium oxybate).
• Antihypertensives (medications for the treatment of high blood pressure) with a central nervous system effect, such as guanabenz, clonidine, or alpha-methyldopa.
• If you are taking other medications that can cause ear toxicity, such as carboplatin or cisplatin (medications for cancer treatment), chloroquine (medication for the treatment or prevention of malaria), and some antibiotics (medications for infection treatment) like erythromycin or injectable aminoglycosides, among others, as Navalem may mask the toxic effects of these medications, so you should periodically review the condition of your ears.
• Medications that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the effect of Navalem.
• Certain diuretics (medications that increase urine elimination).
• Medications with an effect on the heart, such as those used for the treatment of arrhythmias (heart rhythm problems), some antibiotics, certain medications for malaria, certain antihistamines, certain medications used to reduce lipids (fats) in the blood, or certain neuroleptics (medications for the treatment of mental disorders).
• Medications that can cause photosensitization reactions (exaggerated skin reaction when exposed to sunlight), such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, among others), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorpheniramine, diphenhydramine, among others), some anti-inflammatory medications (piroxicam, naproxen, among others), some antivirals (amantadine, ganciclovir), some diuretics (furosemide, chlorothiazide), as additive photosensitizing effects may occur.
• Levodopa, as the pyridoxine contained in Navalem may decrease its effect.
• Medications for the treatment of 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 taken 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

A delay in the action of Navalem may occur when the capsules are taken with food.

It is not advisable to consume alcoholic beverages during treatment with Navalem, as they may increase the toxicity of the medication. See section 3 How to take Navalem.

Pregnancy and breastfeeding:

Navalem is indicated for pregnant women.

The use of Navalem is not recommended during breastfeeding.

Driving and using machines:

Navalem may cause drowsiness in some patients, so situations that require a state of alertness, such as driving vehicles or operating machinery, should be avoided, at least during the first days of treatment, until you know how it affects you.

Navalem contains sucrose:

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

3. How to take Navalem

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again.

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 two capsules. However, if the symptoms persist until the afternoon of Day 2, the patient should continue with 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 at bedtime). If these three capsules do not adequately control the symptoms on Day 3, the patient may take four capsules from Day 4 onwards (one capsule in the morning, one capsule in the mid-afternoon, and two capsules at bedtime)

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

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

Use in children and adolescents

The safety and efficacy of Navalem 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 may lead to a decrease in vital activity and coma in extreme cases. If any of these symptoms occur, you will be given the appropriate treatment.

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

If you forget to take Navalem:

If you forget a dose of Navalem, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the normal dosage. Do not take a double dose to make up for the missed doses.

4. Possible side effects

Like all medications, Navalem can cause side effects, although not everyone will experience them.

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

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

Uncommon side 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 posture changes), diplopia (double vision), glaucoma, confusion, or photosensitivity reactions

Rare side effects (may affect up to 1 in 1,000 people):agitation, tremors, convulsions, or blood disorders such as hemolytic anemia.

Other side effects of unknown frequency (frequency cannot be estimated from available data):tachycardia (faster heart rate), vertigo, or dyspnea.

Reporting side effects

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

5. Storage of Navalem

Store below 25°C

Keep this medication out of the sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Navalem

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

Appearance of the product and package contents

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

Only some package sizes may be marketed

Marketing authorization holder

Inibsa Gynecology, 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

e-mail: [email protected]

Manufacturer:

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)

Date of the last revision of this leaflet:May 2020