CARIBAN 10 MG / 10 MG
Modified release hard capsules
Doxylamine succinate / Pyridoxine hydrochloride
1. What is Cariban and what it is used for?
This medicine belongs to the group of anti-emetics and anti-nausea medicines and is indicated for the symptomatic treatment of nausea and vomiting during pregnancy in adults.
2. What do you need to know before you take Cariban?
Do not take Cariban:
- If you are allergic to doxylamine, pyridoxine or any of the other ingredients in this medicine listed in Section 6.
- If you are hypersensitive to antihistamines (anti-allergens) derived from ethanolamine (such as diphenhydramine or carbinoxamine)
- If you are taking antidepressants such as monoamine oxidase inhibitors (MAO) as Cariban may intensify and lengthen the side effects on the nervous system.
- If you suffer from asthma.
- If you suffer from glaucoma (increased pressure on the eyes).
- If you suffer from a peptic ulcer (erosion of the stomach walls or small intestine with stretching of the digestive tract).
- If you suffer from pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine).
- If you suffer from obstruction in the neck of the bladder (urinary tract disease).
- If you are taking strong CYP450 isoenzyme inhibitors.
- If you suffer from porphyria (a rare metabolic disorder).
- If you have hereditary problems with fructose intolerance, poor absorption of glucose-galactose or sucrase-isomaltase deficiency.
- If you are vomiting for any other reason.
Warnings and precautions
Ask your doctor or pharmacist for advice before taking Cariban.
You must consult a doctor before taking this medicine if you suffer from:
- Glaucoma (increased pressure on the eyes);
- Peptic ulcer (erosion of the stomach walls or small intestine with stretching of the digestive tract), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine) or obstruction in the neck of the bladder (urinary tract disease), urinary obstruction (difficulty urinating);
- Thyroid dysfunction.
- Heart disease and high blood pressure, as Cariban may make your disorder worse.
- Long QT syndrome (heart disease);
- Asthma and other respiratory illnesses, such as chronic bronchitis (persistent inflammation of the bronchial tubes) and pulmonary emphysema (a disease which affects the lungs, difficulty breathing) or chronic obstructive pulmonary disease (COPD), as Cariban may make your disorder worse.
- Kidney and/or liver diseases.
- Epilepsy, as it may make your disorder worse.
- Low levels of potassium in the blood or other electrolytic changes.
Cariban may cause reactions to light sensitivity, therefore it is not recommended to sunbathe during treatment.
Cariban may mask symptoms that can affect your hearing (such as vertigo), so you should consult your doctor if you are taking other medicines that might have the same effects.
You should avoid drinking alcohol during treatment.
Cariban may aggravate symptoms of dehydration and heat stroke due to decreased perspiration.
Children and adolescent
There is no data available on the safety and efficiency of Cariban in children under 18 years of age.
Taking Cariban with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might have to take any other medicines.
Cariban must not be taken in conjunction with the following medicines:
- Anticholinergics such as medicines for treating depression or Parkinson's disease, monoamine oxidase inhibitors or MAO (medicines for depression), neuroleptics (medicines for treating mental disorders), atropine medicines for the treatment of spasms or disopyramide (for the treatment of certain heart problems), as it may increase toxicity.
- Inhibitors of the central nervous system (for example barbiturates, hypnotics, sedatives, anxiolyticsopioid-type analgesics, antipsychotics or procarbazine).
- Antihypertensive drugs (medicines for treating high blood pressure) with effects on the central nervous system such as guanabenz, clonidine or alpha-methyldopa.
- If you are taking other medicines that cause toxicity to the hearing, such as carboplatin or cisplatin (medicines for treating cancer), chloroquine (medicine for treating or preventing malaria) and other antibiotics (medicines for treating infections) such as erythromycin or injected aminoglycosides, among others, suas Cariban can mask the toxic effects of these medicines, so you should have your hearing checked regularly.
- Medicines that reduce the elimination of other medicines such as derivatives of azole or macrolides, as can increase the effects of Cariban.
- Any diuretics (medicines that increase the elimination of urine).
- Medicines with an action on the heart such as those used to treat arrhythmias (problems with heart rate), some antibiotics, certain malarial drugs, certain antihistamines, certain medicines used to reduce lipids (fat) in the blood or certain neuroleptics (medicines used to treat mental disorders).
- Medicines that produce a photosensitive reaction (exaggerated reaction of the skin when exposed to sunlight) such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones, azithromycin, erythromycin, among others), some antidepressants (imipramine, doxepin, amitriptyline), some antifungal medicines (griseofulvin), antihistamines (promethazine, chlorphenamine, diphenhydramine, among others), some anti-inflammatories (piroxicam,
naproxen, among others), some anti-viral drugs (amantadine, ganciclovir), and some diuretics (furosemide, chlorothiazide), as these, can cause additional photosensitive effects.
- Levodopa, as the pyridoxine in Cariban can reduce its effectiveness.
- Medicines for treating epilepsy (phenobarbital, phenytoin) as pyridoxine can reduce their levels in the blood.
- Medicines such as hydroxyzine, isoniazid or penicillamine, when combined with pyridoxine, this can increase the need for Vitamin B6.
Interactions with diagnostics
This medicine may alter the following analytical tests: false negative in skin tests in which allergenic extracts are used (allergy tests). We recommend suspending the treatment a few days before taking the test.
Taking Cariban with food, drink, and alcohol
It is not recommended to drink alcohol while taking Cariban as this can increase the toxicity of the medicine. See Section 3 How to take Cariban.
Pregnancy, breastfeeding, and fertility
Cariban is not recommended if you are breastfeeding.
Driving and using machinery:
Cariban may cause drowsiness in some patients, so you should avoid situations that require you to be alert, such as driving vehicles or handling machinery, at least during the first few days of treatment until you know how it affects you.
Cariban contains sucrose. This medicine contains sucrose. If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine.
3. How to take Cariban?
Always take Cariban exactly as recommended by your doctor. If you have any further questions, ask your doctor.
The recommended dose is 2 capsules at bedtime if nausea and vomiting occur in the morning. If this dose helps to control your symptoms, continue taking two capsules. If nausea occurs throughout the day, take 1 capsule in the morning and another in the afternoon.
The maximum daily dose is 4 capsules (one in the morning, another in the afternoon and two 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:
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.
Possible poisoning will be recognised by neurological changes such as agitation, hallucinations, or intermittent convulsions which, in extreme cases, might lead to a
reduction in vital activity and coma. If any of these symptoms occur, appropriate treatment should be sought.
In the event of overdose or accidental ingestion, contact the Toxicological Information Service.
If you forget to take Cariban
If you forget to take a dose of Cariban, take it as soon as possible. However, if it is nearly time for the next dose, skip the forgotten dose and continue with the normal dosage. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Cariban can cause side effects, although not everybody gets them.
Cariban side effects are in general light and transient but are more common in the first few days of treatment.
Common side effects (can affect 1 in every 10 people): drowsiness and effects such as a dry mouth, constipation, blurred vision, urinary retention or increased bronchial
secretion.
Less common side effects (can affect 1 in every 100 people): asthenia (fatigue), peripheral oedema (inflammation of arms and legs), nausea, vomiting, diarrhoea, skin eruptions, tinnitus (noises in the ears), orthostatic hypotension (lowering of blood pressure due to changes in posture), diplopia (double vision), glaucoma, confusion or reactions to photosensitivity.
Rare side effects (can affect up to 1 photosensitivity reactionstion, trembling, convulsions, or blood problems such as haemolytic anaemia.
Other side effects whose frequency is not known (frequency cannot be estimated from the available data): tachycardia (faster heart rate (heartbeats)), vertigo or
dyspnoea.
Notification of side effects
If you experience any adverse effects, including any not listed in this leaflet, seek advice from your doctor or pharmacist.
5. How to store Cariban
Store below 25ºC
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month shown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any packaging and medicines you no longer require. These measures will help to protect the environment.
6. Contents of the pack and additional information
Composition of Cariban
The main active ingredients are Doxylamine succinate 10 mg and Pyridoxine hydrochloride 10 mg
The other ingredients are:
• The capsules contain: sucrose, maize starch, shellac, povidone, talc, methacrylic acid cocopolymerthyl methacrylate and anhydrous colloidal silica.
• The capsule is composed of gelatine, indigo carmine (E132), quinoline yellow (E104) and titanium dioxide (E171).
What the product looks like and the contents of the pack
Cariban comes in packs containing 24 capsules in two PVC/PVDC-aluminium blisters, with 12 capsules in each.
Licensee:
Versalya Pharma S.L. (Italfarmaco Group)
San Rafael, 3
28108 – Alcobendas (Madrid) – Spain
Manufacturer:
Laboratorios Inibsa, S.A.
Carretera de Sabadell a Granollers km 14,5 08185 Lliçà de Vall
Barcelona (Spain)
Marketing authorisation holder:
Inibsa Ginecologia, S.A.
Carretera de Sabadell a Granollers km 14,5 08185 Lliçà de Vall
Barcelona (Spain)
Most recent revision date of this leaflet: is October 2018
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