CARIBAN 10 mg/10 mg MODIFIED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Cariban 10 mg/10 mg Modified Release Hard Capsules

Doxylamine succinate / Pyridoxine hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• 1. If you have any doubts, 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 package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Cariban and what is it used for
2. What you need to know before taking Cariban
3. How to take Cariban
4. Possible side effects
5. Storage of Cariban
6. Package Contents and Additional Information

1. What is Cariban and what is it used for

This medication belongs to the group of antiemetic and anti-nausea medications and is indicated for the symptomatic treatment of nausea and vomiting in pregnancy in adults.

Cariban 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 Cariban

Do not take Cariban:

• If you are allergic to doxylamine, pyridoxine, or any of the other components of this medication listed in section 6.
• If you are hypersensitive to antihistamines (anti-allergic) derived from ethanolamine (such as diphenhydramine or carbinoxamine).
• If you are taking antidepressants such as monoamine oxidase inhibitors (MAOIs), as Cariban 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 insufficient sacarase-isomaltase.
• If you have vomiting due to another cause.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cariban.

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 increased blood pressure, as Cariban 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 Cariban 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 disorders.

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

Cariban 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.

Cariban contains pyridoxine hydrochloride (Vitamin B6), so it is necessary to monitor additional levels during diet or Vitamin B6 supplements.

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

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

Children and Adolescents

There are no available data on the safety and efficacy of Cariban in children under 18 years of age.

Use of Cariban with other medications

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

Cariban 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 inhibitors (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, procarbazine, or sodium oxybate).
• Antihypertensives 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 malaria treatment or prevention), and some antibiotics (medications for infection treatment) such as erythromycin or injected aminoglycosides, among others, as Cariban 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 Cariban.
• 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 antimalarial medications, certain antihistamines, certain medications used to reduce blood lipids (fats), 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), or some diuretics (furosemide, chlorothiazide), as additive photosensitizing effects may occur.
• Levodopa, as the pyridoxine contained in Cariban 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 discontinue treatment several days before performing the test.

Taking Cariban with Food, Drinks, and Alcohol

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

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

Pregnancy and Breastfeeding:

Cariban is indicated for pregnant women.

The use of Cariban is not recommended during breastfeeding.

.

Driving and Using Machines:

Cariban 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.

Cariban 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.

3. How to take Cariban

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 allows symptom control, 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 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 swallowed 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 Cariban have not been established in children under 18 years of age.

If you take more Cariban than you should

If you have taken more Cariban 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 decreased 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 Toxicological Information Service. Telephone 91 562 04 20.

If you forget to take Cariban:

If you miss a dose of Cariban, 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, Cariban can cause side effects, although not everyone will experience them.

The side effects of Cariban 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 package 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 Cariban 10 mg/10 mg Modified Release Hard Capsules

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 package. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. 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 Cariban

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

Appearance of the Product and Package Contents

Cariban is presented in packs containing 24 or 36 capsules of green color in PVC/PVdC-aluminum or PVC/PVdC/PVC-aluminum blisters, with 12 capsules each.

Marketing Authorization Holder:

Italfarmaco, S.A.

San Rafael, 3

28108 Alcobendas Madrid (Spain)

Tel: 91 657 23 23

Manufacturer:

LABORATORIOS INIBSA, S.A.

Carretera de Sabadell a Granollers, km 14.5.

08185 Lliçà de Vall - Barcelona (Spain)

or

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330 – 20126 Milan (Italy)

Date of the Last Revision of this Package Leaflet:April 2024