SPASMOMEN 40-30 Coated tablet
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Инструкция по применению SPASMOMEN SOMATIKO
Содержание инструкции
SPASMOMEN SOMATICO 40 mg + 2 mg coated tablets
otilonium bromide + diazepam
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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What SPASMOMEN SOMATICO is and what it is used for
- 2. What you need to know before you take SPASMOMEN SOMATICO
- 3. How to take SPASMOMEN SOMATICO
- 4. Possible side effects
- 5. How to store SPASMOMEN SOMATICO
- 6. Contents of the pack and other information
1. What is SPASMOMEN SOMATICO and what is it for
SPASMOMEN SOMATICO contains the active ingredients otilonium bromide, a substance with spasmolytic action (i.e., induces relaxation) at the level of the smooth musculature of the digestive tract, and diazepam, a benzodiazepine with anxiolytic action (reduces anxiety).
SPASMOMEN SOMATICO is used in adults in the treatment of spasmodic-painful manifestations (strong contractions of the musculature associated with pain) with an anxious component of the gastrointestinal tract.
2. What you need to know before taking SPASMOMEN SOMATICO
Do not take SPASMOMEN SOMATICO
- If you are allergic to the active ingredients (otilonium bromide, diazepam) or to any of the other ingredients of this medicine (listed in section 6);
- if you suffer from glaucoma (increased pressure inside the eye);
- in case of prostatic hypertrophy (enlargement of the prostate);
- in case of syndromes of intestinal occlusion (stopping of the progression of intestinal contents due to the presence of an obstacle or obstruction) or urinary retention (inability to expel urine from the bladder);
- in case of myasthenia gravis (a disease characterized by muscle weakness).
Taking SPASMOMEN SOMATICO is contraindicated during the first trimester of
pregnancy (see “Pregnancy and breastfeeding”).
Furthermore, it is not recommended in early childhood (see “Children and adolescents”).
Warnings and precautions
Consult your doctor or pharmacist before taking SPASMOMEN SOMATICO.
If you take SPASMOMEN SOMATICO for a prolonged period of time, it is advisable to
undergo checks of the blood count (blood tests) and liver function (liver).
In predisposed subjects, treatment with benzodiazepines at high doses and for prolonged periods can
lead to dependence, as can happen with other medicines with hypnotic (sleep-inducing), sedative (calming) and ataraxic (with a tranquillizing effect) activity.
Because individual reactivity (personal response to the drug) is very variable, if you are elderly or
debilitated, the dose of SPASMOMEN SOMATICO must be established with caution (see
section 3 “How to take SPASMOMEN SOMATICO”).
Children and adolescents
SPASMOMEN SOMATICO contains otilonium bromide and diazepam, a benzodiazepine with anxiolytic action.
The use of benzodiazepines in early childhood is not normally recommended
(see “Do not take SPASMOMEN SOMATICO”).
Other medicines and SPASMOMEN SOMATICO
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The simultaneous use of SPASMOMEN SOMATICO and other psychotropic drugs requires
particular caution and vigilance on the part of the doctor to avoid unexpected adverse effects from
interaction.
Take SPASMOMEN SOMATICO with caution in association with medicines with central activity
(that act at the level of the central nervous system), such as neuroleptics (antipsychotic drugs
used for the treatment of some psychiatric pathologies, such as schizophrenia, bipolar disorder and some forms of depression), antidepressants, hypnotics (drugs that induce sleep),
analgesics (reduce pain) and anaesthetics (drugs capable of inducing temporary loss of
pain sensitivity), as this association can increase the sedative action.
The concomitant use of Spasmomen Somatico and opioids (substances used as strong painkillers,
for substitute therapy in drug-dependent patients and present in some cough medicines) increases the risk of drowsiness, difficulty in 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 Spasmomen Somatico together with opioids, the dose and duration
of concomitant therapy must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow
your doctor's recommendations on dosage. It may be helpful to inform family and friends how
to recognize the signs and symptoms described above. If you experience these symptoms, see your doctor.
SPASMOMEN SOMATICO with alcohol
Do not drink alcoholic beverages during treatment with SPASMOMEN SOMATICO because, as
with any other psychotropic medicine (that acts on the mental state), individual reactions are
unpredictable.
Pregnancy and breastfeeding
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
Do not take SPASMOMEN SOMATICO in the first trimester of pregnancy (see “Do not take
SPASMOMEN SOMATICO”).
In the second and third trimesters of pregnancy, take SPASMOMEN SOMATICO only if
absolutely necessary when, in the doctor's opinion, the possible benefits outweigh the possible risks.
Breastfeeding
If you are breastfeeding, take SPASMOMEN SOMATICO only if absolutely necessary when,
in the doctor's opinion, the possible benefits outweigh the possible risks.
Driving and operating machinery
SPASMOMEN SOMATICO, like other drugs in the same therapeutic class, depending on
the method of use, the dose and individual sensitivity, can affect the ability to react
(e.g. in the aptitude to drive a vehicle, in behaviour during road traffic,
in operating machinery requiring particular attention).
3. How to take SPASMOMEN SOMATICO
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is 1-3 tablets per day, according to the doctor's judgement, to be taken
preferably after meals.
However, the choice of the most appropriate dosage should be guided by the characteristics
of the pharmacological association (otilonium bromide + diazepam) and not by those of the individual
components.
In elderly patients, the dosage must be carefully established by the doctor who must evaluate
a possible reduction of the dosages mentioned above (see “Warnings and precautions”).
If you take more SPASMOMEN SOMATICO than you should
In animals, otilonium bromide has proven to be practically non-toxic. Consequently,
even in humans, particular problems due to overdose should not arise.
Manifestations of diazepam overdose include drowsiness, confusion, coma, reduced reflexes.
Although these effects are generally minimal, breathing, the
pulse (heart rate), blood pressure must be monitored and general support measures associated with immediate gastric lavage (stomach emptying) must be adopted.
If you forget to take SPASMOMEN SOMATICO
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 SPASMOMEN SOMATICO, the following side effects may occur:
Rare side effects:
- ataxia (alteration of muscle coordination that makes it difficult to perform certain movements);
- headache;
- nausea, vomiting, diarrhea, constipation, abdominal pain;
- palpitations (increased awareness of your heartbeat);
- visual disturbances;
- hypotension (low blood pressure);
- dry mouth;
- pruritus, skin rashes (appearance on the skin of more or less raised red spots);
- sialorrhea (excessive production of saliva);
- depression, confusion, hallucinations;
- cases of granulocytopenia (decrease in the concentration of granulocytes, a type of white blood cells, in the blood);
- changes in blood levels (of the concentration in the blood) of transaminases (enzymes whose concentration in the blood indicates the presence of liver diseases), of phosphatase (an enzyme that provides indications on the possible presence of diseases of the bones, liver, pancreas and intestine), of bilirubin (a colored substance present in bile derived from the degradation of hemoglobin);
- irritability.
Side effects with unknown frequency (frequency cannot be estimated on the basis
of available data):
- drowsiness;
- dizziness.
These side effects are more frequent in elderly or debilitated patients.
If these are signs of relative overdose (a situation in which the drug is taken respecting
the indicated dosages but, due to the presence, for example, of liver or kidney diseases, there is
an increase in its concentrations in the blood), they disappear spontaneously within a few days
or after a dosage adjustment.
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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store SPASMOMEN SOMATICO
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 and the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
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 SPASMOMEN SOMATICO contains
Each coated tablet contains:
Active ingredients: otilonium bromide 40 mg, diazepam 2 mg.
Other ingredients: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, precipitated silica, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol, iron oxides.
Description of the appearance of SPASMOMEN SOMATICO and contents of the pack
Coated tablets, oblong, pink in colour.
Blister containing 30 coated tablets in a cardboard box.
Marketing Authorisation Holder
- A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence.
Manufacturer
A.Menarini Manufacturing Logistics and Services s.r.l. -Via Sette Santi, 3 - Florence.
Berlin Chemie AG – Glienicker Weg, 125 - Berlin (Germany).
A.Menarini Manufacturing Logistics and Services s.r.l. – Campo di Pile – L’Aquila.
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- Страна регистрации
- Форма выпускаCoated tablet, 40-30
- Код АТХA03CA04
- Действующее вещество
- 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 SPASMOMEN SOMATIKOФорма выпуска: Film-coated tablet, 40MG+2 MGДействующее вещество: otilonium bromide and psycholepticsПроизводитель: MALESCI ISTITUTO FARMACOBIOLOGICO S.P.A.Отпускается по рецептуФорма выпуска: Hard capsule, 15 MG + 1,5 MGДействующее вещество: propantheline and psycholepticsПроизводитель: TEOFARMA S.R.L.Отпускается по рецептуФорма выпуска: Coated tablet, 5 MG + 5 MGДействующее вещество: isopropamide and psycholepticsПроизводитель: NEOPHARMED GENTILI S.P.A.Отпускается без рецепта
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SPASMOMEN SOMATIKO требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SPASMOMEN SOMATIKO — otilonium bromide and psycholeptics. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SPASMOMEN SOMATIKO производится компанией A. MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения SPASMOMEN SOMATIKO с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить SPASMOMEN SOMATIKO в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (otilonium bromide and psycholeptics) включают OBISPAX, LEXIL, VALTRAX. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
