DEBRUM 150 мг/4 мг Капсулы
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Инструкция по применению DEBRUM
Содержание инструкции
Debrum 150 mg + 4 mg hard capsules
trimebutine maleate + medazepam
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 their symptoms are the same as yours, as it could 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 Debrum is and what it is used for
- 2. What you need to know before you take Debrum
- 3. How to take Debrum
- 4. Possible side effects
- 5. How to store Debrum
- 6. Contents of the pack and other information
1. What is Debrum and what is it for
Debrum contains the active ingredients trimebutine maleate and medazepam. Trimebutine maleate is a substance
that acts against muscle spasms and acts selectively on the motility of the gastro-
intestinal tract. Medazepam is a substance with anxiety-reducing activity.
Debrum is indicated in patients who suffer from manifestations characterized by painful contractions
(spasmodic-painful manifestations) of the gastro-intestinal tract that present an anxious component.
2. What you need to know before taking Debrum
Do not take Debrum
- if you are allergic to trimebutine maleate, medazepam or any of the other ingredients of this medicine (listed in section 6)
- if you are in the first three months of pregnancy (see section “Pregnancy and breastfeeding”)
- if you have a disease of the nerves and muscles, which causes muscle weakness (myasthenia gravis)
- if you have severe lung problems (severe respiratory failure)
- if you have severe liver failure
- if you suffer from sleep breathing disorders (sleep apnea syndrome)
Warnings and precautions
Talk to your doctor or pharmacist before taking Debrum.
If you take Debrum in high doses and for long periods of time, your doctor will have you undergo periodic checks
of your blood pressure, blood composition and liver function.
If you are elderly, your doctor may prescribe a lower dose of Debrum (see section 3).
Tell your doctor before taking Debrum:
- if you have chronic respiratory problems, because your doctor will prescribe a lower dose due to the risk that respiratory problems may worsen
- if you have abused drugs or alcohol, because in this case benzodiazepines must be taken with extreme caution
- if you suffer from thought disorders (psychotic illness), because in this case the use of benzodiazepines is not recommended
- if you suffer from depression or anxiety related to depression because in these cases the use of benzodiazepines is not recommended, as a marked tendency to suicide may occur.
Tell your doctor if during treatment with Debrum:
- you notice a recurrence or worsening of your condition, because Debrum may be less effective if it is used repeatedly for a few weeks.
- you experience reactions such as restlessness, agitation, irritability, aggressiveness, delusion, anger, nightmares, hallucinations, altered behavior, because the doctor will assess whether to interrupt the treatment. These reactions are more frequent in children and the elderly.
- you have episodes of short-term memory loss (anterograde amnesia), which occur mainly several hours after ingestion of this medicine. To reduce this problem, you must have uninterrupted sleep for at least 7-8 hours.
Tell your doctor if after stopping treatment with Debrum:
- you notice a worsening of your condition or the appearance of withdrawal symptoms (see the section: “If you stop taking Debrum”), because Debrum can cause dependence. This risk increases with increasing dose and duration of treatment and if you have previously abused drugs or alcohol.
Children and adolescents
The doctor will carefully assess the need for treatment before prescribing Debrum to children and
adolescents. If necessary, the duration of treatment should be as short as possible.
Other medicines and Debrum
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Tell your doctor if you are taking or need to take one or more of the medicines listed below:
- antipsychotics (neuroleptics)
- hypnotics (medicines that induce sleep) or anxiolytics/sedatives (medicines that reduce anxiety)
- antidepressants (medicines for depression)
- narcotic analgesics (medicines used to reduce pain). In case of concomitant administration with Debrum, an increase in euphoria may occur, with a consequent increase in psychic dependence
- antiepileptics (medicines for epilepsy)
- anesthetics (medicines for anesthesia)
- sedating antihistamines (medicines for the treatment of allergies, which cause drowsiness)
The concomitant use of Debrum and opioids (strong painkillers, drugs for substitution therapy and some
cough medicines) increases the risk of drowsiness, difficulty breathing, coma and can be life-threatening. For this reason, the concomitant use of Debrum and opioids should only be considered
when other treatment options are not possible.
However, if your doctor prescribes Debrum together with opioids, the dose and duration of concomitant therapy
must be established by the doctor. Therefore, inform your doctor of all opioid drugs you are
taking and carefully follow your doctor's recommendations on the doses to take. It may be
helpful to inform friends or family members to be able to recognize the signs and symptoms described above. Contact your doctor
if these symptoms occur.
Debrum with alcohol
Do not drink alcohol together with Debrum because alcohol increases its sedative effect. Drinking alcohol
together with Debrum also impairs the ability to drive and operate machinery.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are a woman of childbearing potential, you should use effective contraception during treatment and
should consult your doctor if you suspect or are planning a pregnancy to discuss together the interruption of
treatment with Debrum.
Do not take Debrum in the first three months of pregnancy.
If Debrum has been given to you for serious medical reasons during the last trimester of pregnancy or
during labor at high doses, effects on the newborn such as low body temperature, reduced muscle tone, moderate respiratory depression and withdrawal symptoms in the postnatal period may occur.
Breastfeeding
Benzodiazepines are excreted in breast milk, so do not take Debrum if you are breastfeeding.
Fertility
No clinical studies have been conducted on fertility.
Driving and using machines
Debrum can cause symptoms such as sedation, amnesia, altered concentration and muscle function that can negatively affect the ability to drive and operate machinery. If the duration
of sleep has been insufficient, the probability that your state of alertness is altered increases.
Do not drink alcohol together with Debrum because alcohol increases its sedative effect. Drinking alcohol
together with Debrum also impairs the ability to drive and operate machinery.
Debrum contains lactose (a sugar from milk)
Debrum contains lactose, if your doctor has diagnosed you with intolerance to some sugars, contact
him/her before taking this medicine.
3. How to take Debrum
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is from 2 to 4 capsules per day.
Use in elderly patients
If you are elderly, your doctor may prescribe a lower dose of Debrum and will tell you exactly how much
Debrum you should take.
Use in patients with breathing problems
Your doctor will prescribe a lower dose due to the risk of respiratory depression.
Use in children and adolescents
The doctor will carefully assess the need for treatment before prescribing Debrum to children and
adolescents. If necessary, the duration of treatment should be as short as possible.
If you take more Debrum than you should
In case of accidental ingestion of an excessive dose of Debrum, inform your doctor immediately or
go to the nearest hospital.
If you forget to take Debrum
Do not take a double dose to make up for a missed dose.
If you stop taking Debrum
Do not abruptly stop treatment with Debrum.
Debrum can cause dependence, if this occurs, when you stop treatment with Debrum the symptoms
of the disease may reappear in a more severe form or withdrawal symptoms may appear, such as
for example:
- headache
- muscle pain
- severe anxiety
- tension
- restlessness
- confusion
- irritability
In more severe cases, the following may also occur:
- distorted perception of the external world (derealization)
- distorted perception of self (depersonalization)
- excessive sensitivity and intolerance to sounds and noise
- excessive sensitivity to light and physical contact
- numbness and tingling of the extremities
- hallucinations
- seizures. If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them
Side effects with unknown frequency (frequency cannot be estimated based on available data)
- movement disorders (loss of motor coordination/difficulty performing some voluntary movements)
- headache
- drowsiness
- constipation
- diarrhoea
- dry mouth
- indigestion
- nausea
- vomiting
- itching
- fatigue
Other side effects reported in some patients, especially elderly or debilitated patients:
- drowsiness
- low blood pressure
- confusion
- movement disorders (extrapyramidal symptoms)
- skin rashes
- swelling from fluid retention (edema)
- vision disturbances
- decrease in the number of bone marrow cells, in particular granulocytes (agranulocytosis), usually reversible
- alteration of liver function
Medazepam (one of the components of Debrum), like other benzodiazepines, can cause the following effects:
- Drowsiness, inability to experience emotions (emotional blunting), reduced alertness, confusion, fatigue, muscle weakness, loss of coordination of movements, double vision, headache, dizziness. These phenomena usually occur at the beginning of therapy and usually disappear with subsequent administrations. Occasionally, gastrointestinal disorders and/or alterations in sexual desire and skin reactions have also been reported.
- AmnesiaShort-term memory loss (anterograde amnesia), behavioral changes
- DepressionDuring the use of benzodiazepines, a pre-existing depressive state may be unmasked, and restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, and behavioral changes may occur.
- Dependence.The use of benzodiazepines (even at therapeutic doses) can lead to the development of physical dependence: discontinuation of therapy can cause rebound or withdrawal symptoms (see section “Warnings and precautions”). Psychological dependence can occur. Benzodiazepine abuse has been reported.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Debrum
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 after Expiry. 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 eliminate
medicines that you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Debrum contains
- The active ingredients are trimebutine maleate and medazepam. Each hard capsule contains 150 mg of trimebutine maleate and 4 mg of medazepam.
- The other ingredients are lactose monohydrate, mannitol, macrogol 6000, magnesium stearate, corn starch.
- The hard capsule is composed of gelatin, iron oxide, titanium dioxide.
Description of the appearance of Debrum and contents of the pack
Each pack contains 30 hard capsules in blisters.
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 – 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A.- Via Pontina km. 30,400 – 00071 Pomezia (RM)
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- Страна регистрации
- Форма выпускаHard capsule, 150 MG + 4 MG
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги DEBRUMФорма выпуска: Hard capsule, 15 MG + 1,5 MGДействующее вещество: propantheline and psycholepticsПроизводитель: TEOFARMA S.R.L.Отпускается по рецептуФорма выпуска: Film-coated tablet, 40MG+2 MGДействующее вещество: otilonium bromide and psycholepticsПроизводитель: MALESCI ISTITUTO FARMACOBIOLOGICO S.P.A.Отпускается по рецептуФорма выпуска: Coated tablet, 40-30Действующее вещество: otilonium bromide and psycholepticsПроизводитель: A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.Отпускается по рецепту
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DEBRUM производится компанией ALFASIGMA S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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Вы можете купить DEBRUM в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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