NUPERAL 10 mg/10 mg Kapsułki O Przedłużonym Uwalnianiu
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Treść ulotki
Nuperal 10mg/10mg modified-release hard capsules
Doxilamine succinate/pyridoxine hydrochloride
Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Nuperal is and what it is used for
- 2. What you need to know before you take Nuperal
- 3. How to take Nuperal
- 4. Possible side effects
- 5. How to store Nuperal
- 6. Contents of the pack and other information
1. What is Nuperal and what is it used for
This medicine belongs to a group of drugs called antiemetics and anti-nausea medications and is indicated for
the symptomatic treatment of nausea and vomiting in pregnancy, in adults.
Nuperal contains two medicines (active substances) called: “doxilamine succinate” and “pyridoxine
hydrochloride”. Doxilamine succinate belongs to a group of medicines called “antihistamines”. Pyridoxine is also known as vitamin B6.
2. What you need to know before taking Nuperal
Do not take Nuperal:
- If you are allergic to doxylamine, pyridoxine or any of the other ingredients of this medicine (listed in section 6).
- In case of hypersensitivity to antihistamines (medicines for the treatment of allergies) derived from ethanolamine (such as diphenhydramine or carbinoxamine).
- If you are taking antidepressants such as monoamine oxidase inhibitors (MAOIs) as Nuperal may intensify and extend adverse events on the nervous system.
- Ifyou are taking a potent inhibitor of the CYP450 isoenzyme.
- If you suffer from porphyria (a very rare metabolic disorder).
- If you have problems with hereditary fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency or malabsorption.
- If you suffer from vomiting for other reasons.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nuperal.
Before taking this medicine, you should consult a doctor if you suffer from:
- Glaucoma (increased pressure in the eye).
- Peptic ulcer (lesion of the mucous membrane lining the stomach or the first part of the intestine with contraction of the digestive tract), pyloroduodenal obstruction (difficulty in the passage of food from the stomach to the intestine) or bladder neck obstruction (urinary tract dysfunction), urinary obstruction (difficulty urinating).
- Thyroid dysfunction.
- Heart disease and high blood pressure as Nuperal may worsen this condition.
- Long QT syndrome (heart condition).
- Asthma and other respiratory problems such as chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (lung condition that makes breathing difficult) or chronic obstructive pulmonary disease (COPD) as Nuperal may worsen this condition.
- Kidney and/or liver diseases.
- Epilepsy, as Nuperal may worsen this condition.
- Low levels of potassium in the blood or other electrolyte imbalances.
Nuperal may increase sensitivity to light, so it is not recommended to sunbathe during the
treatment.
Nuperal may mask symptoms related to the auditory system (such as dizziness and vertigo); it is therefore recommended
to consult your doctor if you are taking other medicines with the same effects.
Do not drink alcohol during treatment.
Nuperal may increase dehydration and cause heatstroke due to increased
sweating.
After taking Nuperal you may feel drowsy. If this happens, do not perform other activities that
may require full attention, unless your doctor tells you that you can.
Children and adolescents
No data are available on the safety and efficacy of Nuperal in subjects under 18 years of
age.
Other medicines and Nuperal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Nuperal should not be taken at the same time as the following medicines:
- Anticholinergics such as antidepressants or medicines for the treatment of Parkinson's disease, monoamine oxidase inhibitors or MAOIs (for the treatment of depression), antipsychotics (medicines for the treatment of mental disorders), atropine for the treatment of spasms or disopyramide (for the treatment of some heart problems) as it may increase their toxicity.
- Central nervous system depressants (e.g. barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics or procarbazine).
- Medicines for lowering blood pressure (for controlling blood pressure) that have an effect on the central nervous system such as guanabenz, clonidine or alpha-methyldopa.
- If you are taking other medicines with a toxic effect on the auditory system such as carboplatin or cisplatin (for the treatment of tumors), chloroquine (for malaria prophylaxis and treatment), and some antibiotics (medicines for the treatment of infections) such as erythromycin or aminoglycosides administered intravenously, to name a few, as Nuperal may mask the toxic effects of these medicines; in this case, periodic checks on the auditory system are necessary.
- Medicines that reduce the elimination of other active ingredients such as azole derivatives or macrolides, as they may potentiate the effect of Nuperal.
- Some diuretics (medicines that stimulate increased urine production).
- Medicines that can have an effect on the heart such as those used for the treatment of arrhythmias (irregular heartbeat), some antibiotics, some medicines for the treatment of malaria, some antihistamines, some medicines used to reduce lipids (fats) in the blood or some neuroleptics (medicines for the treatment of mental disorders).
- Medicines with a photosensitizing effect (increased skin reactivity in case of exposure to sunlight) such as some antiarrhythmics (amiodarone, quinidine), some antibiotics (tetracyclines, fluoroquinolones azithromycin and erythromycin among others), some antidepressants (imipramine, doxepin, amitriptyline), some antifungals (griseofulvin), antihistamines (promethazine, chlorphenamine and diphenhydramine, among others), some anti-inflammatory agents (piroxicam and naproxen, among others), some antivirals (amantadine, ganciclovir), some diuretics (furosemide, chlorothiazide) as it may cause an additional photosensitizing effect.
- Levodopa as the pyridoxine contained in Nuperal may reduce its effect.
- Medicines for the treatment of epilepsy (phenobarbital, phenytoin) as pyridoxine may reduce their levels in the blood.
- Medicines such as hydroxyzine, isoniazid or penicillamine, as their combination with pyridoxine may cause vitamin B6 deficiency.
Interference with diagnostic tests
This medicine may alter the following analytical results: in skin tests where extracts
of allergens are used (tests for allergies) a false negative result may occur. Stop taking the
medicine a few days before performing the test.
Nuperal with food, drinks and alcohol
If the capsules are taken together with food, Nuperal may have an effect with longer
times.
Avoid drinking alcohol while taking Nuperal as it may increase the toxicity of the drug.
See section 3 How to take Nuperal.
Pregnancy and breastfeeding
Nuperal is intended for use by pregnant women
Taking Nuperal is not recommended during breastfeeding.
Driving and using machines
Nuperal may cause dizziness in some patients; therefore, avoid any situation that requires prompt
reflexes such as driving or using machinery, at least for the first few days of treatment, until
the type of effect caused is clear.
Nuperal contains sucrose
This medicine contains sucrose. If your doctor has diagnosed you with intolerance to some sugars,
contact him before taking this medicine.
3. How to take Nuperal
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The recommended dose is 2 capsules before bedtime if nausea and vomiting occur in the morning
(Day 1). If this dose helps to control the symptoms, continue taking two capsules. However, if the symptoms persist in the afternoon of day 2, the patient should continue to take 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 in the evening before bedtime). If these three capsules do not control
the symptoms adequately 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 in the evening before bedtime).
The maximum daily dose is 4 capsules (one in the morning, another in the mid-afternoon and two in the evening
before 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
There is no data on safety and efficacy in subjects under 18 years of age.
If you take more Nuperal than you should
In case of taking Nuperal in a quantity greater than prescribed, immediately inform your
doctor or pharmacist.
Symptoms of possible intoxication may include neurological alterations such as agitation,
hallucinations or intermittent convulsions, which in extreme cases can lead to a reduction in vital
signs and coma. If one or more of these symptoms occur, appropriate care will be provided.
If you forget to take Nuperal
If a dose is forgotten, take it as soon as possible. However, if the time for
taking the next dose is almost upon you, skip the forgotten dose and continue as normal. Do not take
a double dose to make up for forgotten doses.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of Nuperal are generally mild and transient in nature, more frequent in the first
days of treatment.
Common side effects (may affect up to 1 in 10 people):dizziness and other effects
such as dry mouth, constipation, blurred vision, urinary retention, or increased
bronchial secretion.
Uncommon side effects (may affect up to 1 in 100 people):asthenia (weakness),
peripheral edema (swelling of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the
ears), orthostatic hypotension (feeling faint due to change in posture), diplopia (double vision),
glaucoma, confusion or photosensitivity reactions.
Rare side effects (may affect up to 1 in 1000 people):restlessness, tremors,
convulsions or blood disorders such as hemolytic anemia.
Other side effects (frequency cannot be estimated based on available data):tachycardia
(fast heartbeat), dizziness or dyspnea.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store Nuperal
Store at a temperature below 25ºC.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to
the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Nuperal contains
- The active ingredients are doxylamine succinate (10 mg) and pyridoxine hydrochloride (10 mg)
- The other ingredients are:
- The capsules contain: sucrose, corn starch, shellac, povidone, talc, methacrylic acid-methyl methacrylate copolymer and anhydrous colloidal silica.
- The capsule is composed of gelatin, indigo carmine (E132), quinoline yellow (E104) and titanium dioxide (E171).
Description of the appearance of Nuperal and contents of the pack
Nuperal is supplied in packs containing 12 or 24 green capsules in two PVC/PVdC-aluminium blisters of
12 capsules each.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milan (Italy)
Manufacturer
Laboratorios INIBSA, S.A.
Carretera de Sabadell a Granollers Km. 14,5
08185 Lliçà de Vall – Barcelona (Spain)
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- Kraj rejestracji
- Postać farmaceutycznaModified-release hard capsule, 10 MG/10 MG
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki NUPERALPostać farmaceutyczna: Hard capsule, 125 MG + 80 MGSubstancja czynna: aprepitantProducent: TEVA B.V.Wymaga receptyPostać farmaceutyczna: Hard capsule, 80 MGSubstancja czynna: aprepitantProducent: SINTESY PHARMA S.R.L.Wymaga receptyPostać farmaceutyczna: Hard capsule, 80 MGSubstancja czynna: aprepitantProducent: MERCK SHARP & DOHME B.V.Wymaga recepty
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NUPERAL jest produkowany przez ITALFARMACO S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie NUPERAL jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
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