LEXIL 15 mg /1.5 Mg Kapsułki Twarde
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Jak stosować LEXIL
Treść ulotki
Lexil 15 mg + 1.5 mg hard capsules
propanteline bromide + bromazepam
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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Lexil is and what it is used for
- 2. What you need to know before you take Lexil
- 3. How to take Lexil
- 4. Possible side effects
- 5. How to store Lexil
- 6. Contents of the pack and other information
1. What is Lexil and what is it used for
Lexil contains the active ingredients propanteline bromide and bromazepam.
Propanteline reduces excessive secretion and motility of the gastrointestinal tract and relaxes the muscles
of the intestine (spasmolytic activity).
Bromazepam acts on the brain to correct emotional imbalances, e.g. states of tension, anxiety, associated or
not associated with depression.
Lexil is indicated in patients suffering from painful contractions (spasmodic-painful manifestations) of the
stomach and intestines associated with anxiety.
2. What you need to know before taking Lexil
DO NOT take Lexil
- if you are allergic to propanteline bromide or to bromazepam or to any of the other ingredients of this medicine (listed in section 6);
- if you have increased pressure inside the eye (glaucoma);
- if you have an enlarged prostate (prostatic hypertrophy);
- if you have difficulty urinating (urinary retention);
- if you suffer from intestinal obstruction;
- if you have a disease that causes muscle weakness (myasthenia gravis);
- if you have severe heart problems (heart failure);
- if you have severe kidney problems (renal failure);
- if you have severe liver problems (hepatic failure);
- if you are in the first trimester of pregnancy
- if you are breastfeeding. Warnings and precautionsTalk to your doctor or pharmacist before taking Lexil. Pay particular attention:
- if you are taking other medicines that act on the brain (psychotropic drugs) to avoid the appearance of unexpected side effects due to the interaction between medicines (see section “Other medicines and Lexil”);
- if you are taking the product at high doses and for a long period, because in predisposed individuals treatment with bromazepam at high doses and for long periods of time can cause dependence, as occurs with other medicines that have a similar activity. In case of prolonged treatment, your doctor may prescribe blood tests and checks of liver function. ChildrenThe administration of benzodiazepines, including bromazepam, in children should be avoided and requires in any case a careful evaluation by the doctor. When the administration of benzodiazepines in children is necessary, the duration of treatment should be as short as possible. Other medicines and LexilTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
- If you take Lexil together with the following medicines, the depressive effect on the brain may increase: o antipsychotics or neuroleptics (medicines used for the treatment of severe mental problems); o hypnotics (medicines that induce sleep); o anxiolytics/sedatives (medicines that reduce anxiety/relax); o antidepressants (medicines for the treatment of depression); o antiepileptics (for the treatment of epilepsy); o anesthetics (for pain relief); o sedative antihistamines (medicines for the treatment of allergies, which cause drowsiness); o narcotic analgesics (used to reduce pain). Taking Lexil with narcotic analgesics can also cause an increase in euphoria, resulting in increased psychic dependence.
- The concomitant use of Lexil and opioid derivatives (potent painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Lexil together with another opioid derivative, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about all opioid-derived medicines you are taking and strictly follow the dosage instructions provided by your doctor. It may be helpful to inform relatives and friends to be aware of the signs and symptoms mentioned above. Contact your doctor if these symptoms occur.
- If you take Lexil together with medicines that inhibit certain liver enzymes (in particular cytochrome P450), the activity of benzodiazepines, such as bromazepam contained in Lexil, may increase.
- If you take Lexil together with cimetidine (anti-ulcer medicine), the time it takes to eliminate bromazepam (contained in Lexil) from the body may be prolonged. Lexil with drinks and alcoholDo not drink alcohol while taking Lexil. Alcohol can increase the sedative effect of Lexil. See also “Driving and using machines” Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Lexil should not be used during the first trimester of pregnancy. After the first trimester, the medicine should only be administered if absolutely necessary and under the direct control of the doctor.
Women of childbearing potential should use effective contraception during treatment.
If this medicine is administered, for serious medical reasons, during the last period of pregnancy or
during labor at high doses, there may be effects on the newborn due to the action of the medicine, including
low body temperature (hypothermia), poor muscle tone (hypotonia) and moderate respiratory
depression.
Newborns born to mothers who have taken benzodiazepines continuously during the advanced stages of
pregnancy may develop physical dependence and may experience withdrawal symptoms in the
period after birth.
Benzodiazepines should not be used during breastfeeding because they pass into breast
milk.
Driving and using machines
Lexil, like other medicines that act with the same mechanism, can alter the ability to drive
vehicles or use machinery.
Taking alcohol with Lexil can increase the sedative effect of this medicine. This negatively affects the ability to drive vehicles and use machinery.
Lexil contains lactose
Lexil capsules contain lactose: if your doctor has diagnosed you with intolerance to certain sugars,
contact him before taking this medicine.
3. How to take Lexil
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 one Lexil capsule 3-4 times a day. Lexil should preferably be taken with
main meals and before bedtime.
If the symptoms are particularly severe, the daily dose of Lexil may be increased to 6 capsules, to be
taken in 3-4 times during the day.
The treatment should be as short as possible.
Have regular check-ups with your doctor who will tell you how long to continue the treatment in
function of your symptoms.
Use in elderly patients
If you are elderly or debilitated, start with 1-2 Lexil capsules per day; the doctor will determine whether to increase the
dose later up to the optimal daily dosage.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.
Use in children
Experience with the use of Lexil in children is limited, see section 2.
If you take more Lexil than you should
In case of accidental intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
If you experience symptoms such as constipation, dry mouth, visual disturbances, dizziness, difficulty urinating,
breathing or heart problems, or drowsiness and confusion up to coma, immediately consult your doctor or go to the emergency room.
If you forget to take Lexil
Do not take a double dose to make up for a missed dose.
If you stop taking Lexil
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.
With the use of Lexil, the following side effects may occur:
- Dependence
The use of benzodiazepines (even at the doses used for treatment) can cause physical dependence. Discontinuation of therapy may worsen symptoms (rebound phenomena) or cause withdrawal symptoms. Psychological dependence may occur.
Benzodiazepine abuse has been reported.
- Depression During the use of benzodiazepines, a depressive state present before the start of therapy may emerge.
- Amnesia Memory loss (anterograde amnesia) may occur even at commonly used dosages for treatment, and the risk may increase at higher doses.
- Allergic reactions in predisposed individuals.
- Quite seriousreactionsthat may be caused by benzodiazepines or benzodiazepine-like compounds and are more likely in children and the elderly: o restlessness o agitation o irritability o aggressiveness o disillusionment o anger o nightmares o hallucinations o severe mental disorders (psychosis) o behavioral changes.
- Adverse reactionsreported occasionally: o stomach and intestinal (gastrointestinal) problems o changes in sexual desire o skin reactions o dry mouth o difficulty urinating o difficulty seeing nearby objects clearly (accommodation disorders) o low blood pressure (hypotension).
- Other side effects that occur mainly at the beginning of therapy and usually disappear with subsequent administrations o drowsiness o emotional blunting o reduced attention o confusion o fatigue o headache o dizziness o decreased muscle tone o loss of coordination of movements (ataxia) o double vision.
Reporting of side effects
If you get any side effects, even if 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 Lexil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. 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 Lexil contains
- The active ingredients are propanteline bromide and bromazepam. Each capsule contains 15 mg of propanteline bromide and 1.5 mg of bromazepam.
- The other ingredients are talc, magnesium stearate, lactose monohydrate, gelatin, titanium dioxide, E
- 172. Description of the appearance of Lexil and contents of the packEach pack of Lexil contains a glass bottle containing 20 hard capsules for oral use. Marketing Authorisation HolderTEOFARMA S.r.l. Via F.lli Cervi, 8 27010 Valle Salimbene (PV) Manufacturer and release for final dispositionTEOFARMA S.r.l. Viale Certosa, 8/A 27100 Pavia
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 15 MG + 1,5 MG
- Kod ATCA03CA34
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LEXILPostać farmaceutyczna: Film-coated tablet, 40MG+2 MGSubstancja czynna: otilonium bromide and psycholepticsProducent: MALESCI ISTITUTO FARMACOBIOLOGICO S.P.A.Wymaga receptyPostać farmaceutyczna: Coated tablet, 40-30Substancja czynna: otilonium bromide and psycholepticsWymaga receptyPostać farmaceutyczna: Coated tablet, 5 MG + 5 MGSubstancja czynna: isopropamide and psycholepticsProducent: NEOPHARMED GENTILI S.P.A.Bez recepty
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LEXIL wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w LEXIL jest propantheline and psycholeptics. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LEXIL jest produkowany przez TEOFARMA S.R.L.. 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 LEXIL 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.
Możesz kupić LEXIL w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (propantheline and psycholeptics) to m.in. OBISPAX, SPASMOMEN SOMATIKO, VALTRAX. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
