Prospecto:information for the user

Distraneurine 192mg soft capsules

Clometiazol

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor, pharmacist, or nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenifthey are not listed in this prospectus. See section 4.

1.What is Distraneurine and what is it used for

2.What you need to knowbeforestarting totake Distraneurine

3.How to take Distraneurine

4.Possible adverse effects

5Storage of Distraneurine

6.Contents of the package and additional information

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

- anxiety, 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,

- acute symptoms of alcohol withdrawal, includingdelirium tremens, a severe and potentially life-threatening complication of alcohol withdrawal. In these cases, meticulous hospital monitoring should be performed.

Do not take Distraneurine:

• if you are allergic to clometiazol or any of the other components of this medication (listed in section 6),
• if you have respiratory or breathing problems that have worsened recently,
• if you have respiratory problems originating from the central nervous system, including those caused by substances that inhibit your central nervous system (for example, alcohol, sedatives, hypnotics),
• if you have 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 have a condition called "sleep apnea" (interruption of breathing while sleeping),
• you suffer from hypoxia (deficit of oxygen in the blood)
• you have problems with your liver or kidneys,
• you continue drinking or abusing alcohol,
• you are taking medications that affect the nervous system, such as benzodiazepines,
• you have a history of addiction.

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

If you are unsure whether 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 available about its use in this age group.

Older patients

Caution is recommended, as older patients may have a delay in the elimination of the active principle of Distraneurine, resulting in higher levels of clometiazol in the blood.

Other medications and Distraneurine

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication. This is because Distraneurine may affect the way some medications work, and some medications may have an effect on Distraneurine.

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

• Other substances/medications that affect the central nervous system, for example, benzodiazepines.
• Propranolol (for high blood pressure or some heart problems).
• Diazoxide (for high blood pressure or low sugar levels).
• Cimetidine (for stomach ulcers or acid reflux).
• Carbamazepine (for epilepsy, mania, alcohol withdrawal syndrome, and various types of painful conditions called neuralgias).
• Other medications 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 an infection).
• Anesthetics. If you need surgery that requires the administration of anesthesia, inform your doctor or dentist that you are taking Distraneurine before undergoing the procedure.
• Clorazoxazone (for muscle relaxation).

Use of Distraneurine with alcohol

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Lactation

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

Driving and operating machinery

Distraneurine is a medication that causes drowsiness. Do not drive or operate machinery if you feel drowsy or notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Distraneurine contains sorbitol

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationas indicated by your doctor.If you are unsure, consult your doctor or pharmacist again. Your doctor will prescribe the minimum number of doses possible, regularly review the treatment, and discontinue it as soon as possible in a gradual manner. The maximum recommended administration time is 10 consecutive days.

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

Recommended dose:

Treatment of anxiety, agitation, and organic origin confusion states 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 morning drowsiness appears.

Treatment of alcohol withdrawal symptoms and delirium tremens

The dose will be adjusted individually. Your doctor will initially prescribe a high dose to be gradually reduced.

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 indicated 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 severe cardiorespiratory depression (slowing of breathing and heart pumping) and deep coma, in some cases with fatal outcome. The risk increases if the clometiazol overdose 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Distraneurine

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Distraneurine

Consult your doctor if you want to stop taking Distraneurine. You may experience withdrawal symptoms, such as seizures, tremors, or organic psychosis, after a sudden stop, especially after taking high doses. You should gradually reduce the dose of Distraneurine over several days, according to your doctor's instructions.

If you have any other questions about the use of thismedication, ask your doctor,pharmacistor nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In rare cases, severe allergic reactions have been reported. If you have a severe allergic reaction, stop taking Distraneurine and seek medical attention immediately. You may need to receive urgent medical treatment. The signs may include a sudden appearance of:

•Skin rash, itching, or hives on the skin.

•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:

Frequent: may affect up to 1 in 10 peoplepeople

• Tingling sensation in the nose and nasal congestion, which may appear between15 and 20minutes after taking the medicine.

• Inflammation in the nose.

• Conjunctivitis (inflammation of the conjunctiva of the eye).

Infrequent: may affect up to 1 in 100people

• Headaches.

• Hangover symptoms.

•Increased mucus formation in the respiratory and nasopharyngeal tracts.

•Nausea, vomiting, abdominal pain, diarrhea.

Rare: may affect up to 1 in 1000people

•Swelling of the face, allergic reaction up to anaphylactic shock.

• Low blood pressure.

• Yellow discoloration of the skin(jaundice) and inflammation of the liver(hepatitis).

•Blisters on the skin.

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

•Sensation of overexcitement or confusion.

Unknown frequency: its frequency cannot be estimated from the available data

•Abuse, psychological and/or physical dependence, and withdrawal symptoms.

•Feeling extremely drowsy, which is more likely if you are taking a high dose of the medicine or if you are an elderly patient and taking the medicine during the day.

•Drowsiness.

•Prickling, 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 the way your liver functions (observed in blood tests).

• Skin rash, itching, or hives on the skin.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Store below 30°C.

Do not usethis medicationafter the expiration date that appears onthe bottleafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Distraneurine

- The active ingredient isclometiazol. Each capsule contains 192 mg of clometiazol.

- The other components are medium-chain triglycerides, gelatin, glycerol (85%), Karion 83 (containing mannitol, sorbitol (E420),hydrolyzed hydrogenated cornstarch), titanium dioxide (E171) and iron brown oxide (E172).

Appearance of the product and contents of the packaging

Thecapsules of Distraneurine are brown-gray soft capsules. It is available in amber-colored glass bottles with 30 capsules, closed with a white screw cap.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Germany

Responsible for Manufacturing

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

Last review date of this leaflet:April 2020