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DISTRANEURINE 192 mg SOFT GEL CAPSULES

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About the medicine

How to use DISTRANEURINE 192 mg SOFT GEL CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Leaflet: information for the user

Distraneurine 192mg soft capsules

Clometiazol

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
    1. If you have any doubts, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
    • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Distraneurine is and what it is used for
  2. What you need to know before taking Distraneurine
  3. How to take Distraneurine
  4. Possible side effects

5 Storage of Distraneurine

  1. Contents of the pack and further information

1. What Distraneurine is and what it is used for

Distraneurine contains the active substance clometiazol, which belongs to the group of hypnotics and sedatives. Distraneurine is used for the treatment of:

  • restlessness, agitation, and some types of confusion in elderly patients,
  • severe insomnia in elderly patients, when the use of other treatments has not been effective or is contraindicated,
  • symptoms of acute alcohol withdrawal, including delirium tremens, a serious and potentially life-threatening complication of alcohol withdrawal. In these cases, close hospital monitoring should be performed.
Doctor consultation

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Discuss your symptoms and treatment with a doctor online.

2. What you need to know before taking Distraneurine

Do not take Distraneurine:

  • if you are allergic to clometiazol or any of the other components of this medicine (listed in section 6),
  • if you have lung or respiratory problems that have worsened recently,
  • if you have respiratory problems originating from the central nervous system, including those caused by substances that have an inhibitory effect on your central nervous system (e.g., alcohol, sedatives, hypnotics),
  • if you suffer from a neuromuscular disease called myasthenia gravis.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Distraneurine, especially if:

  • you have difficulty breathing or suffer from a condition called "sleep apnea syndrome" (interruption of breathing while sleeping),
  • you suffer from hypoxia (oxygen deficiency in the blood)
  • you have liver or kidney problems,
  • you continue to drink or abuse alcohol,
  • you take medications that affect the nervous system, such as benzodiazepines,
  • you have a history of addiction.

Risk of psychological and/or physical dependence: this may occur after prolonged administration of high doses. Abrupt discontinuation of treatment may cause withdrawal symptoms such as convulsions, tremors, and organic psychosis. To avoid the onset of withdrawal syndrome, it is recommended to gradually reduce the dose, according to your doctor's instructions.

If you are not sure if the above applies to you, consult your doctor or pharmacist.

Children and adolescents

Distraneurine is not recommended for children and adolescents under 18 years of age, as there is not enough information about its use in this age group.

Elderly patients

Caution is recommended, as in elderly patients, there may be a delay in the elimination of the active substance of Distraneurine, resulting in higher levels of clometiazol in the blood.

Other medicines and Distraneurine

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine. This is because Distraneurine may affect how some medicines work, and some medicines may have an effect on Distraneurine.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Other substances/medicines that affect the central nervous system, such as benzodiazepines.
  • Propranolol (for high blood pressure or certain heart problems).
  • Diazoxide (for high blood pressure or low blood sugar levels).
  • Cimetidine (for stomach ulcers or acidity).
  • Carbamazepine (for epilepsy, mania, alcohol withdrawal syndrome, and different types of painful conditions called neuralgias).
  • Other medicines used to treat epilepsy.
  • Sedatives (to help you relax or sleep).
  • Analgesics (to relieve pain).
  • Antidepressants (to treat depression or prevent relapse).
  • Antibiotics (to treat or prevent infection).
  • Anesthetics. If you need an operation that requires anesthesia, tell your doctor or dentist that you are taking Distraneurine before undergoing the operation.
  • Chlorzoxazone (for muscle relaxation).

Use of Distraneurine with alcohol

Do not drink alcohol while taking Distraneurine, as it may cause difficulty breathing that can be severe. This can have fatal consequences.

If you are taking Distraneurine, tell your doctor if you have recently consumed any alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Distraneurine should not be taken during pregnancy, unless, in your doctor's judgment, the expected benefit of treatment outweighs the potential risk.

Breastfeeding

This medicine should not be used during breastfeeding, as it passes into breast milk and the effects on infants are unknown. If treatment with this medicine is necessary, breastfeeding should be discontinued.

Driving and using machines

Distraneurine is a medicine that causes sleepiness. Do not drive or use machines if you feel drowsy or if you notice that your attention and reaction are reduced. Pay special attention when starting treatment or if the dose is increased.

Distraneurine contains sorbitol

This medicine contains 7 mg of sorbitol (E420) per capsule.

3. How to take Distraneurine

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will prescribe the minimum number of doses necessary, review the treatment periodically, and discontinue it gradually as soon as possible. The maximum recommended treatment duration is 10 consecutive days.

The soft capsules should be swallowed whole with a sufficient amount of water and should not be chewed or crushed.

The recommended dose is:

Treatment of restlessness, agitation, and organic confusion in elderly patients

One capsule three times a day.

Treatment of severe insomnia in elderly patients

Two capsules before bedtime. Your doctor may reduce the dose if you experience morning drowsiness.

Treatment of symptoms of alcohol withdrawal and delirium tremens

The dose will be adjusted individually. Your doctor will initially prescribe a high dose to reduce it gradually afterwards.

Your doctor may also reduce your dose if you are of Japanese origin or have liver problems.

If you take more Distraneurine than you should

If you take more Distraneurine than prescribed by your doctor, you may experience the following effects: drowsiness, confusion, unconsciousness, increased mucous formation in the upper respiratory tract, low blood pressure, low body temperature, and even cardiopulmonary depression (slowing of breathing and heart pumping) and deep coma, in some cases with a fatal outcome. The risk increases if the overdose of clometiazol is accompanied by substances that decrease the function of the central nervous system (including alcohol), especially in patients with liver problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Distraneurine

Do not take a double dose to make up for forgotten doses.

If you stop taking Distraneurine

Talk to your doctor if you want to stop taking Distraneurine. You may experience withdrawal symptoms, such as convulsions, tremors, or organic psychosis, after abrupt cessation, especially after taking high doses. The dose of Distraneurine should be gradually reduced over several days, according to your doctor's instructions.

If you have any other doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In rare cases, serious allergic reactions have been reported. If you have a serious allergic reaction, stop taking Distraneurine and seek medical attention immediately. You may need urgent medical treatment. The signs can include:

  • Sudden onset of skin rash, itching, or hives.
  • Blisters on the skin.
  • Swelling of the face, lips, tongue, or other parts of the body.
  • Shortness of breath, wheezing, or difficulty breathing.

Other possible side effects are:

Common: may affect up to 1 in 10 people

  • Feeling of tingling in the nose and nasal congestion, which can appear between 15 and 20 minutes after taking the medicine.
  • Nasal inflammation.
  • Conjunctivitis (inflammation of the eye conjunctiva).

Uncommon: may affect up to 1 in 100 people

  • Headaches.
  • Hangover symptoms.
  • Increased mucous formation in the respiratory and nasopharyngeal tract.
  • Nausea, vomiting, abdominal pain, diarrhea.

Rare: may affect up to 1 in 1,000 people

  • Facial swelling, allergic reaction up to anaphylactic shock.
  • Low blood pressure.
  • Yellowing of the skin (jaundice) and liver inflammation (hepatitis).
  • Blisters on the skin.

Very rare: may affect up to 1 in 10,000 people

  • Feeling of overexcitement or confusion.

Frequency not known: frequency cannot be estimated from the available data

  • Abuse, psychological dependence, and/or physical dependence, and withdrawal symptoms.
  • Feeling very drowsy, which is more likely if you are taking a high dose of the medicine or if you are an elderly patient and are taking the medicine during the day.
  • Drowsiness.
  • Tingling, numbness, or burning sensation in the skin.
  • Cardiac arrest and respiratory problems, especially after taking Distraneurine in high doses and in combination with other central nervous system inhibitors.
  • Increased saliva production.
  • Changes in liver function (observed in blood tests).
  • Skin rash, itching, or hives.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Distraneurine

Keep this medicine out of the sight and reach of children.

Store below 30 °C.

Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Distraneurine

  • The active substance is clometiazol. Each capsule contains 192 mg of clometiazol.
  • The other ingredients are medium-chain triglycerides, gelatin, glycerol (85%), Karion 83 (containing mannitol, sorbitol (E420), hydrogenated corn starch hydrolyzate), titanium dioxide (E171), and brown iron oxide (E172).

Appearance of the product and pack contents

Distraneurine capsules are soft capsules of a grayish-brown color. They are available in amber glass bottles with 30 capsules, closed with a white screw cap.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24, 17489 Greifswald, Germany

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the last revision of this leaflet:April 2020

Online doctors for DISTRANEURINE 192 mg SOFT GEL CAPSULES

Discuss questions about DISTRANEURINE 192 mg SOFT GEL CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (4)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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€80
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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
Camera Book a video appointment
€60

Frequently Asked Questions

Is a prescription required for DISTRANEURINE 192 mg SOFT GEL CAPSULES?
DISTRANEURINE 192 mg SOFT GEL CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in DISTRANEURINE 192 mg SOFT GEL CAPSULES?
The active ingredient in DISTRANEURINE 192 mg SOFT GEL CAPSULES is clomethiazole. This information helps identify medicines with the same composition but different brand names.
How much does DISTRANEURINE 192 mg SOFT GEL CAPSULES cost in pharmacies?
The average pharmacy price for DISTRANEURINE 192 mg SOFT GEL CAPSULES is around 8.27 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures DISTRANEURINE 192 mg SOFT GEL CAPSULES?
DISTRANEURINE 192 mg SOFT GEL CAPSULES is manufactured by Cheplapharm Arzneimittel Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DISTRANEURINE 192 mg SOFT GEL CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DISTRANEURINE 192 mg SOFT GEL CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to DISTRANEURINE 192 mg SOFT GEL CAPSULES?
Other medicines with the same active substance (clomethiazole) include DEXDOR 100 micrograms/ml concentrate for infusion solution (25x2 ml), DEXDOR 100 micrograms/ml concentrate for infusion solution, DEXDOR 100 micrograms/ml concentrate for infusion solution. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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