Heminevrin

Package leaflet: Information for the patient

Heminevrin, 300 mg, capsules
Clomethiazole
Please read the entire leaflet carefully before using this medicine,
as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Heminevrin is and what it is 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 Heminevrin is and what it is used for

Clomethiazole, the active substance in Heminevrin, is a short-acting hypnotic and sedative medicine which also has spasmolytic (smooth muscle relaxant) properties.
It is used in the treatment of:
delirium tremens (alcohol withdrawal delirium),
acute alcohol withdrawal states,
anxiety, agitation, and confusion in elderly patients,
sleep disorders in elderly patients.

2. Important information before taking Heminevrin

When not to take Heminevrin:

• if the patient is allergic to clemizole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute respiratory disorders (acute respiratory failure).

Warnings and precautions
Before starting Heminevrin, discuss this with your doctor or pharmacist.
This particularly applies to:

• patients with chronic respiratory failure;
• patients with sleep apnoea syndrome;
• patients taking other centrally acting depressant medicines, including benzodiazepines;
• patients with significant liver damage or impaired liver function, as the sedative effect may mask the onset of hepatic encephalopathy;
• elderly patients;
• patients with chronic impairment of kidney function;
• patients with a history of substance dependence, as clemizole may cause dependence.

Sleep medicines should be used only temporarily or intermittently to prevent withdrawal symptoms.
Consult your doctor, even if the above warnings apply to conditions that occurred in the past.

Children and adolescents
Heminevrin is not recommended for use in children and adolescents.

Heminevrin in patients with impaired kidney and/or liver function
Caution is advised when administering Heminevrin to patients with impaired kidney and/or liver function.

Heminevrin in elderly patients
Caution is advised when administering Heminevrin to elderly patients.

Heminevrin with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Cimetidine (a medicine used in peptic ulcer disease) may inhibit the metabolism of clemizole. Concomitant use of these medicines may enhance the effect of Heminevrin.
Concomitant use of clemizole and chlorzoxazone (a muscle relaxant) results in slower elimination of chlorzoxazone.
Concomitant use of clemizole and carbamazepine (used, for example, in the treatment of epilepsy) leads to faster elimination of clemizole; therefore, during concomitant use of these medicines, an increased dose of clemizole may be necessary.
Concomitant use of clemizole and propranolol (used in the treatment of hypertension and angina pectoris) should be avoided, as it may cause a significant slowing of heart function.

Heminevrin and alcohol
It is not allowed to drink alcohol while taking Heminevrin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Clemizole may be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Clemizole passes into breast milk. The effect of sedatives/sleep medicines and anticonvulsants, even when administered in small doses, on the brain of a breastfed infant has not been established. Clemizole may be used in breastfeeding women only if the expected benefit to the mother outweighs the potential risk to the infant.

Driving and operating machinery
Clemizole, like all centrally acting depressant medicines, impairs psychomotor performance. Patients should avoid driving and operating machinery while taking Heminevrin.

Heminevrin contains sorbitol
The medicine contains 7 mg of sorbitol per capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, the patient should consult a doctor before taking this medicine.

3. How to take Heminevrin

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The capsules should be swallowed whole and must not be chewed or divided.

Recommended dose

Treatment of anxiety, agitation, and confusion in elderly patients
1 capsule three times daily.

Treatment of sleep disorders in elderly patients
The initial dose is 2 capsules taken before bedtime. The dose should be reduced if early morning drowsiness occurs.

Adults

Treatment of acute alcohol withdrawal
Clometiazole does not treat alcoholism. Patients with symptoms of alcohol withdrawal should be treated in hospital or, exceptionally, on an outpatient basis in a specialized unit where medical staff can monitor the daily dose of clometiazole. Dosage should be individualized depending on the severity of symptoms and the patient's condition. During treatment, the patient should be calm but conscious. Particular care should be taken when observing patients who required deep sedation. 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 dosing schedule is recommended:
Initial dose: 2 to 4 capsules; if necessary, the dose may be repeated after several 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 dose reduction until maintenance dose is reached.
Use of the medicine is not recommended for longer than 10 days.

Treatment of delirium tremens
In most cases, oral treatment allows achievement of the desired clinical effect.
Initial dose: 2 to 4 capsules. If calming is not achieved within 1–2 hours, 1 or 2 additional capsules may be administered. Further doses may be given until the patient falls asleep. During initial symptom control, no more than 8 capsules should be taken within the first two hours. Particular care should be taken when observing patients who required deep sedation. Due to the risk of increased mucus secretion in the nasopharynx and bronchi, the patient should not be placed in a supine position.

After symptoms are controlled, the medicine should be administered according to the dosing regimen recommended for the treatment of alcohol withdrawal. The dose should be gradually reduced, and treatment should be discontinued within 10 days of initiation.

Taking more Heminevrin than recommended
If more Heminevrin has been taken than recommended, seek medical advice immediately.
Characteristic symptoms of clometiazole overdose include increased secretions, especially saliva, and constricted pupils. Other symptoms may also occur: agitation with confusion (disorientation), delirium, hallucinations, loss of reflexes, loss of consciousness progressing to deep coma, respiratory failure, respiratory arrest, pulmonary edema, vasodilation, hypovolemia (reduced circulating blood volume), decreased blood pressure due to cardiac failure, possible shock, oliguria, anuria, hypothermia, and vesicular rash.
Alcohol greatly increases the toxicity of clometiazole.

Missed dose of Heminevrin
If a dose of Heminevrin is missed, take the next dose as previously scheduled.
Do not take a double dose to make up for a missed dose.

Stopping Heminevrin treatment
After prolonged use of high doses of Heminevrin, withdrawal symptoms such as seizures, tremors, and psychosis have been reported.
Sudden discontinuation of long-term use of hypnotic medicines may sometimes lead to sleep disturbances lasting several nights.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.

Adverse reactions occurring commonly (in less than 1 in 10 treated patients)

• Nasal mucosa irritation and conjunctivitis. During treatment, these symptoms decrease in intensity or resolve completely.

Adverse reactions occurring uncommonly (in less than 1 in 100 treated patients)

• Headache
• Dyspepsia, nausea, diarrhoea
• Itching, rash, urticaria
• Transient increase in aminotransferase activity (liver enzymes)
• Increased mucus secretion in the nasopharynx and bronchi.

Adverse reactions occurring rarely (in less than 1 in 1,000 treated patients)

• Anaphylactic shock, hypersensitivity reactions
• Low blood pressure
• Skin blisters
• Jaundice, cholestatic hepatitis.

Adverse reactions occurring very rarely (in less than 1 in 10,000 treated patients)

• Paradoxical reactions such as agitation or confusion may occur in elderly patients.

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from the available data)

• Withdrawal symptoms such as seizures, tremors, and organic psychoses
• Especially in elderly patients or patients taking high doses of the medicine, a stronger sedative effect than intended may occur.

In many cases, particularly during treatment of elderly patients with dementia or patients with alcohol withdrawal symptoms, it is difficult to distinguish adverse reactions from symptoms of the underlying disease.

If any of the listed adverse reactions occur, contact a doctor immediately or go to the nearest hospital.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Heminevrin

Do not store above 25°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the packaging and other information

What Heminevrin contains

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

What Heminevrin looks like and contents of the pack
Heminevrin is a brownish-grey, soft gelatin capsule.
The medicine comes in an amber glass bottle containing 20 or 100 capsules, packed in a cardboard box.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH,
Ziegelhof 24,
17489 Greifswald, Germany
Manufacturer
CHEPLAPHARM Arzneimittel GmbH,
Ziegelhof 23-24,
17489 Greifswald, Germany
For further information, please contact:
Komtur Polska Sp. z o.o.
[email protected]