DISTRANEURINE 192 mg SOFT GEL CAPSULES

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.

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.

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