Prospect: information for the user

Cariban 10 mg/10 mg hard capsules of modified release

Doxilamine succinate / Pyridoxine hydrochloride

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

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

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What is Cariban and for what it is used

2.What you need to know before starting to take Cariban

3.How to take Cariban

4.Possible adverse effects

5.Storage of Cariban

6.Contents of the package and additional 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.

Cariban contains two components (‘active substances’): ‘doxilamina succinato’ and ‘pyridoxine hydrochloride’. Doxilamina succinato belongs to the group of antihistamine medications. Pyridoxine hydrochloride is also known as Vitamin B6.

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 (antiallergics) 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 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 insufficient saccharose-isomaltose.
• 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 wall or beginning of the intestine with narrowing of the digestive tube), pyloric duodenal 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 Cariban 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 Cariban 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.

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

Cariban may mask symptoms that may affect your ears (such as dizziness), 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.

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

Cariban may worsen dehydration and heatstroke 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.

Children and adolescents:

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

Use of Cariban with other medications:

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

Cariban 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 alterations), 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 may cause ototoxicity, such as carboplatin or cisplatin (medications for cancer), chloroquine (medication for malaria treatment or prevention) and some antibiotics (medications for infections) such as erythromycin or aminoglycosides injected, as Cariban 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 Cariban.
• Some diuretics (medications that increase urine elimination).
• Medications with heart effects, such as those used for arrhythmia treatment (heart rhythm problems), some antibiotics, certain medications for malaria, certain antihistamines, certain medications for reducing lipids (fats) in the blood, or certain neuroleptics (medications for mental alterations).
• Medications that may cause photosensitization (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 Cariban may decrease its effect.
• Medications for epilepsy treatment (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 along 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.

Cariban intake with food, drinks, and alcohol:

Cariban action may be delayed when the capsules are taken with food.

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

Pregnancy and lactation:

Cariban is indicated for pregnant women.

Cariban is not recommended during breastfeeding.

.

Driving and operating machines:

Cariban may cause drowsiness in some patients, so they should avoid situations that require alertness, such as driving vehicles or operating machinery, 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 him before taking this medication.

Follow exactly the administration instructions for this medication 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 you to control the symptoms, continue taking 2 capsules. However, if symptoms persist until the afternoon of Day 2, the patient must 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 must be swallowed whole, without chewing, and on an empty stomach, with a sufficient amount of liquid, preferably water.

Use in children and adolescents

No safety and efficacy have been established in individuals 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 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 forgot to take Cariban:

If you forget a dose of Cariban, 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 normal dosing schedule continued. Do not take a double dose to make up for the missed dose.

Like all medications, Cariban can produce adverse effects, although not all people will experience them.

The adverse effects of Cariban 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 (sounds 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 the 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.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition ofCariban

• 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 container

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

Holder of the marketing authorization :

Italfarmaco, S.A.

San Rafael, 3

28108 Alcobendas Madrid (Spain)

Tel: 91 657 23 23

Responsible for manufacturing:

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)

Revision date of this prospectus:April 2024