Distraneurine 192 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Distraneurine 192mg soft capsules

Chlormethiazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

6. Contents of the pack and other information

1. What Distraneurine is and what it is used for

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

• restlessness, agitation, and certain types of confusion in elderly patients,

• severe insomnia in elderly patients, when other treatments have not been effective or are contraindicated,

• symptoms of acute alcohol withdrawal, including delirium tremens, a serious and potentially life-threatening complication of alcohol withdrawal. In these cases, careful hospital monitoring must be carried out.

2. What you need to know before taking Distraneurine

Do not take Distraneurine:

• if you are allergic to clomethiazole or to any of the other ingredients of this medicine (listed in section 6),
• if you have lung or breathing problems that have recently worsened,
• if you have respiratory problems originating in the central nervous system, including those caused by substances that have a central nervous system depressant effect (for example, alcohol, sedatives, hypnotics),
• if you suffer from a neuromuscular disease called myasthenia gravis.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Distraneurine, especially if:

• you have difficulty breathing or suffer from a condition called "sleep apnoea syndrome" (interruption of breathing during sleep),
• you suffer from hypoxia (lack of oxygen in the blood),
• you have liver or kidney problems,
• you continue to drink or abuse alcohol,
• you are taking medicines that affect the central 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 lead to withdrawal symptoms such as seizures, tremors, and organic psychosis. To avoid withdrawal syndrome, it is recommended to gradually reduce the dose according to your doctor's instructions.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist.

Children and adolescents

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

Elderly patients

Caution is recommended, as in elderly patients there may be a delayed elimination of the active ingredient of Distraneurine, resulting in higher blood levels of clomethiazole.

Other medicines and Distraneurine

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

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

• Other substances/medicines that affect the central nervous system, for example, benzodiazepines.
• Propranolol (for high blood pressure or certain heart conditions).
• Diazoxide (for high blood pressure or low blood sugar levels).
• Cimetidine (for stomach ulcers or acid reflux).
• Carbamazepine (for epilepsy, mania, alcohol withdrawal syndrome, and various 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 relapses).
• Antibiotics (to treat or prevent infection).
• Anaesthetics. If you need surgery requiring anaesthesia, inform your doctor or dentist that you are taking Distraneurine before the procedure.
• Chlorzoxazone (for muscle relaxation).

Use of Distraneurine with alcohol

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

If you are taking Distraneurine, you must inform your doctor if you have recently consumed any alcoholic beverage.

Pregnancy and breastfeeding

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

Pregnancy

Distraneurine should not be taken during pregnancy unless, in the opinion of your doctor, the expected benefit of treatment outweighs the possible 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 must be discontinued.

Driving and use of machinery

Distraneurine is a medicine that causes drowsiness. Do not drive or operate machinery if you feel sleepy or if your attention and reaction ability are reduced. Pay particular attention at the beginning of treatment or when the dose is increased.

Distraneurine contains sorbitol

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

3. How to take Distraneurine

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

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

The recommended dose is:

Treatment of restlessness, agitation, and confusional states of organic origin in elderly patients

One capsule three times a day.

Treatment of severe insomnia in elderly patients

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

Treatment of alcohol withdrawal symptoms and delirium tremens

The dose will be individually adjusted. Your doctor will initially prescribe a high dose, which will then be gradually reduced.

Your doctor may also reduce your dose if you are of Japanese origin or if you 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 mucus in the upper respiratory tract, low blood pressure, low body temperature, and even cardiorespiratory depression (slowed breathing and reduced blood pumping by the heart) and deep coma, which in some cases may be fatal. The risk increases if clomethiazole overdose is accompanied by substances that depress the central nervous system (including alcohol), especially in patients with liver problems.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 wish to stop taking Distraneurine. You may experience withdrawal symptoms such as seizures, tremors, or organic psychosis after abrupt discontinuation, 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Severe allergic reactions have been reported in rare cases. If you experience a severe allergic reaction, stop taking Distraneurine and seek immediate medical attention. You may require urgent medical treatment. Signs may 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 adverse effects are:

Frequent: may affect up to 1 in 10 people

• Tingling sensation in the nose and nasal congestion, which may occur between 15 and 20 minutes after taking the medicine.
• Inflammation in the nose.
• Conjunctivitis (inflammation of the eye's conjunctiva).

Uncommon: may affect up to 1 in 100 people

• Headaches.
• Hangover-like symptoms.
• Increased mucus production in the respiratory tract and nasopharynx.
• 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.
• Yellowish discoloration of the skin (jaundice) and liver inflammation (hepatitis).
• Blisters on the skin.

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

• Feeling overstimulated or confused.

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

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 ºC.

Do not use this medicine after the expiry date which is 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Distraneurine

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

Appearance of the product and contents of the pack

Distraneurine capsules are soft, greyish-brown capsules. They are available in amber glass bottles containing 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 most recent revision of this leaflet: April 2020