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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Doxylamine succinate / Pyridoxine hydrochloride

Read this entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Navalem is and what it is used for
2. What you need to know before taking Navalem
3. How to take Navalem
4. Possible side effects
5. How to store Navalem
6. Contents of the pack and other information

1. What Navalem is and what it is used for

This medicine belongs to a group of medicines called antiemetics and antinauseants, and is indicated for the symptomatic treatment of nausea and vomiting in pregnancy in adults.

Navalem contains two components ('active substances'): 'doxylamine succinate' and 'pyridoxine hydrochloride'. Doxylamine succinate belongs to the group of antihistamine medicines. 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 of the other ingredients of this medicine listed in section 6.
• If you are hypersensitive to antihistamines (antiallergic agents) derived from ethanolamine (such as diphenhydramine or carbinoxamine).
• If you are taking antidepressants such as monoamine oxidase inhibitors (MAOIs), since Navalem may intensify and prolong adverse effects on the nervous system.
• If you are taking strong inhibitors of CYP450 isoenzymes.
• If you have 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

Consult your doctor or pharmacist before starting to take Navalem.

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

• Glaucoma (increased eye pressure),
• Peptic ulcer (erosion of the stomach or beginning of the intestine with narrowing of the digestive tract), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or obstruction at the bladder neck (urinary tract disease), urinary obstruction (difficulty urinating),
• Thyroid dysfunction,
• Heart disease and high blood pressure, as Navalem may worsen the condition,
• QT interval prolongation (a heart condition),
• Asthma and other respiratory disorders, such as chronic bronchitis (persistent inflammation of the bronchi), pulmonary emphysema (a lung disease that makes 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 condition,
• Low potassium levels in the blood or other electrolyte imbalances.

Navalem may cause photosensitivity reactions; therefore, sun exposure during treatment is not recommended.

Navalem may mask symptoms affecting your ears (such as vertigo); therefore, you should consult your doctor if you are taking other medicines that may have similar effects.

Be aware of any signs of abuse or dependence on this treatment. If you have any substance use disorder (alcohol, medications, or others), speak with your doctor. Navalem contains pyridoxine hydrochloride (vitamin B6), so additional intake from diet or vitamin B6 supplements should be monitored.

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

After taking Navalem, you may feel drowsy. If this occurs, do not perform other activities requiring full attention unless your doctor tells you otherwise.

Children and adolescents

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

Taking Navalem with other medicines

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

Navalem must not be taken together with the following medicines:

• Anticholinergics such as medications for depression or Parkinson’s disease, monoamine oxidase inhibitors (MAOIs) (medications for depression), neuroleptics (medications for mental disorders), atropine-like drugs for treating spasms or disopyramide (for treating certain heart problems), as toxicity may be enhanced.
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid-type analgesics, antipsychotics, procarbazine, or sodium oxybate).
• Antihypertensives (medicines for treating high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
• Other medicines that cause ototoxicity (ear toxicity), such as carboplatin or cisplatin (medicines for treating cancer), chloroquine (medicine for treating or preventing malaria), and certain antibiotics (medicines for treating infections) such as erythromycin or injectable aminoglycosides, as Navalem could mask the toxic effects of these medicines; therefore, periodic monitoring of your ear condition is recommended.
• Medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, as they may increase the effect of Navalem.
• Any diuretic (medicines that increase urine output).
• Medicines affecting the heart, such as those used to treat arrhythmias (heart rhythm problems), certain antibiotics, certain antimalarial drugs, certain antihistamines, certain medicines used to lower blood lipids (fats), or certain neuroleptics (medicines for treating mental disorders).
• Medicines that cause photosensitization reactions (exaggerated skin reaction when exposed to sunlight), such as certain antiarrhythmics (amiodarone, quinidine), certain antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, among others), certain antidepressants (imipramine, doxepine, amitriptyline), certain antifungals (griseofulvina), antihistamines (promethazine, chlorpheniramine, diphenhydramine, among others), certain nonsteroidal anti-inflammatory drugs (piroxicam, naproxen, among others), certain antivirals (amantadine, ganciclovir), certain diuretics (furosemide, chlorothiazide), as additive photosensitizing effects may occur.
• Levodopa, as the pyridoxine contained in Navalem may reduce its effect.
• Medicines for treating epilepsy (phenobarbital, phenytoin), as pyridoxine may reduce their blood levels.
• Medicines such as hydroxyzine, isoniazid, or penicillamine, as together with pyridoxine they may increase the need for vitamin B6.

Interference with diagnostic tests

This medicine may alter the following laboratory tests: false-negative results in skin tests using allergenic extracts (allergy tests). It is advisable to discontinue treatment several days before undergoing such tests.

Taking Navalem with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding:

Navalem is indicated for use in pregnant women.

The use of Navalem during breastfeeding is not recommended.

Driving and using machines:

Navalem may cause drowsiness in some patients; therefore, situations requiring alertness—such as driving vehicles or operating machinery—should be avoided, at least during the first few days of treatment, until you know how the medicine affects you.

Navalem contains sucrose:

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Navalem

Follow exactly the instructions for administering this medicine as given by your doctor. If in 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 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 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 at bedtime).

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

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

If you take more Navalem than you should

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

A possible intoxication would be recognized by neurological disturbances such as agitation, hallucinations, or intermittent convulsions, which in extreme cases could lead to decreased vital activity and coma. If any of these symptoms occur, appropriate treatment will be initiated.

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

If you forget to take Navalem:

If you miss 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 your regular dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

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

The adverse effects of Navalem are generally mild and transient, and are more common during the first days of treatment.

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

Uncommon adverse effects (may affect 1 in 100 people): asthenia (tiredness), peripheral edema (swelling 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 haemolytic anaemia.

Other adverse effects with unknown frequency (frequency cannot be estimated from available data): tachycardia (faster heart rate), dizziness, or dyspnea.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Navalem

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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Navalem

• The active substances are doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg.
• The other components are:
  • The capsules contain: sucrose, corn 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).

Appearance of the medicine and contents of the container

Navalem is available in packs containing 12, 24 or 48 green capsules, and in multiple packs containing 48 green capsules (2 cartons of 24 capsules) in PVC/PVdC-aluminum or PVC/PVdC/PVC-aluminum blisters, with 12 capsules in each blister.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Inibsa Ginecología, S.A.

Carretera de Sabadell a Granollers Km. 14,5

08185 LLIÇA DE VALL – Barcelona (Spain)

Tel: 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)

Tel: 93 860 95 00

Fax: 93 843 96 95

OR

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milan (Italy)

OR

LACER, S.A.

C/ Boters, 5 – Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès (Barcelona) - Spain

Date of the most recent revision of this leaflet: May 2020