Heminevrin

Package Leaflet: Information for the Patient

Heminevrin, 300 mg, Capsules

Clomethiazole

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Heminevrin and what is it used for
• 2. Important information before taking Heminevrin
• 3. How to take Heminevrin
• 4. Possible side effects
• 5. How to store Heminevrin
• 6. Contents of the pack and other information

1. What is Heminevrin and what is it used for

Clomethiazole, the active substance of Heminevrin, is a short-acting sedative and hypnotic, also exhibiting spasmolytic (smooth muscle relaxing) effects.
It is used in the treatment of:
delirium tremens(alcoholic hallucinations),
acute alcohol withdrawal syndrome,
states of anxiety, agitation, and confusion in elderly patients,
sleep disorders in elderly patients.

2. Important information before taking Heminevrin

When not to take Heminevrin:

Warnings and precautions

Before starting to take Heminevrin, discuss it with your doctor or pharmacist.
This is especially important for

• patients with chronic respiratory failure,
• patients with sleep apnea syndrome,
• patients taking other central nervous system depressants, including benzodiazepines,
• patients with significant liver damage and reduced liver function, as the sedative effect may mask the onset of hepatic coma,
• elderly patients,
• patients with chronic kidney function disorders,
• patients with a tendency to addiction, as clomethiazole may cause dependence.

The use of sedatives should be temporary or intermittent to prevent withdrawal symptoms.
You should consult your doctor, even if the above warnings refer to past situations.

Children and adolescents

Heminevrin is not recommended for use in children and adolescents.

Heminevrin in patients with kidney and/or liver function disorders

Caution should be exercised when using Heminevrin in patients with kidney and/or liver function disorders.

Heminevrin in elderly patients

Caution should be exercised when using Heminevrin in elderly patients.

Heminevrin and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
Cimetidine (a medication used to treat stomach ulcers) may inhibit the metabolism of clomethiazole.
Concomitant use of these medications may enhance the effect of Heminevrin.
Concomitant use of clomethiazole and chlorzoxazone (a muscle relaxant) results in slower elimination of chlorzoxazone.
Concomitant use of clomethiazole and carbamazepine (used, for example, in the treatment of epilepsy) results in faster elimination of clomethiazole, so it may be necessary to increase the dose of clomethiazole during concomitant use of these medications.
Avoid concomitant use of clomethiazole and propranolol (used in the treatment of high blood pressure and angina pectoris), as it may cause significant slowing of heart rate.

Heminevrin and alcohol

Do not drink alcohol while taking Heminevrin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
Clomethiazole can be used during pregnancy only if the expected benefits to the mother outweigh the risk to the fetus.
Clomethiazole passes into breast milk. The effect of sedatives and anticonvulsants, even at low doses, on the brain of a breastfed child has not been established. Clomethiazole can be used in breastfeeding women only if the expected benefits to the mother outweigh the risk to the child.

Driving and using machines

Clomethiazole, like all central nervous system depressants, impairs psychomotor performance.
Avoid driving and operating machinery while taking Heminevrin.

Heminevrin contains sorbitol

The medication contains 7 mg of sorbitol per capsule. Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or hereditary fructose intolerance, consult your doctor before taking the medication.

3. How to take Heminevrin

Always take this medication exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.
Swallow the capsules whole, do not chew or divide them.
Recommended dose

Treatment of anxiety, agitation, and confusion in elderly patients

1 capsule three times a day.

Treatment of sleep disorders in elderly patients

Initial dose is 2 capsules before bedtime. The dose should be reduced if morning drowsiness occurs.

Adults

Acute alcohol withdrawal syndrome.

Clomethiazole does not treat alcoholism. Patients with symptoms of alcohol withdrawal should be treated in a hospital or, exceptionally, in an outpatient setting, where medical staff will monitor the daily dose of clomethiazole. The dosage should be determined individually, depending on the severity of symptoms and the patient's condition. During treatment, the patient should be calm but conscious. Patients who require deep sedation should be closely monitored. Due to the risk of increased mucus secretion in the nasopharynx and bronchi, the patient should not be placed in a supine position.
The following dosage regimen is recommended:
Initial dose is 2 to 4 capsules, if necessary, the dose can be repeated after a few hours.
Day 1: (first 24 hours): 9 to 12 capsules in 3 or 4 divided doses.
Day 2: 6 to 8 capsules in 3 or 4 divided doses.
Day 3: 4 to 6 capsules in 3 or 4 divided doses.
Days 4 to 6: gradual reduction of dosage to a maintenance dose.
The medication should not be used for more than 10 days.

Treatment of delirium tremens.

In most cases, oral treatment allows for the achievement of the expected clinical effect.
Initial dose is 2 to 4 capsules. If sedation is not achieved within 1-2 hours, 1 or 2 capsules can be administered again. Further doses of the medication can be given until the patient falls asleep. During the initial control of symptoms, no more than 8 capsules should be taken within the first two hours. Patients who require deep sedation should be closely monitored. Due to the risk of increased mucus secretion in the nasopharynx and bronchi, the patient should not be placed in a supine position.
After controlling the symptoms, the medication should be administered according to the dosage recommended for the treatment of alcohol withdrawal syndrome. The dose should be gradually reduced, and the use of the medication should be discontinued within 10 days of starting treatment.

Overdose of Heminevrin

If you have taken more than the recommended dose of the medication, seek medical attention immediately.
Characteristic symptoms of clomethiazole overdose include: increased secretion, especially saliva, and miosis (pupillary constriction). Other symptoms may also occur: agitation with confusion (disorientation), hallucinations, and illusions, loss of reflexes, loss of consciousness, leading to deep coma, respiratory failure, apnea, pulmonary edema, vasodilation, hypovolemia (decreased blood volume), and decreased blood pressure due to heart failure, possible shock, oliguria, anuria, hypothermia, and vesicular rash. Alcohol significantly increases the toxicity of clomethiazole.

Missed dose of Heminevrin

If you miss a dose, take the next dose as previously scheduled.
Do not take a double dose to make up for the missed dose.

Stopping the use of Heminevrin

After long-term use of high doses of Heminevrin, withdrawal symptoms such as seizures, tremors, and psychoses have been reported.
Sudden cessation of long-term use of sedatives may sometimes lead to sleep disturbances lasting several nights.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Heminevrin can cause side effects, although not everybody gets them.

Common side effects (affecting less than 1 in 10 people)

• irritation of the nasal mucosa and conjunctivitis. During treatment, the severity of these symptoms decreases or they disappear completely.

Uncommon side effects (affecting less than 1 in 100 people)

• headache
• nausea, vomiting, diarrhea
• pruritus, rash, urticaria
• transient increase in liver enzymes (aminotransferases)
• increased mucus secretion in the nasopharynx and bronchi.

Rare side effects (affecting less than 1 in 1,000 people)

• anaphylactic shock, hypersensitivity reactions
• hypotension
• vesicles on the skin
• jaundice, congestive hepatitis.

Very rare side effects (affecting less than 1 in 10,000 people)

• paradoxical reactions in the form of agitation or confusion may occur in elderly patients

Side effects with unknown frequency (frequency cannot be estimated from available data)

• withdrawal symptoms, such as seizures, tremors, and organic psychoses
• especially in elderly patients or patients taking high doses of the medication, a stronger sedative effect than intended may occur

In many cases, especially during the treatment of elderly patients with dementia or patients with symptoms of alcohol withdrawal, it is difficult to distinguish between side effects and symptoms of the underlying disease.
If you experience any of these side effects, contact your doctor or pharmacist as soon as possible.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Heminevrin

Do not store above 25°C.
Keep the medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Heminevrin contains

• The active substance is clomethiazole. Each capsule contains 192 mg of clomethiazole (equivalent to 300 mg of clomethiazole ethanedisulfonate).
• The other ingredients are: Miglyol 812 (medium-chain triglycerides), gelatin, glycerol 85%, Karion 83 70% (mannitol, sorbitol, hydrogenated starch hydrolysate), titanium dioxide (E 171), iron oxide brown (E 172).

What Heminevrin looks like and contents of the pack

Heminevrin is a gray-brown, flexible, gelatin capsule.
A brown glass bottle containing 20 or 100 capsules, in a cardboard box.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH,
Ziegelhof 24,
17489 Greifswald, Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH,
Ziegelhof 23-24,
17489 Greifswald, Germany
To obtain more detailed information, please contact:
Komtur Polska Sp. z o.o.
[email protected]

Date of last revision of the leaflet: