Huberplex 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Huberplex 5 mg film-coated tablets

Chlordiazepoxide hydrochloride

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.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Huberplex is and what it is used for

Huberplex is a medicine containing chlordiazepoxide hydrochloride as the active substance. Chlordiazepoxide hydrochloride is an anxiolytic belonging to a group of medicines called benzodiazepines.

• For the short-term treatment (2-4 weeks) of anxiety, which may occur alone or in association with insomnia.
• To control muscle spasm (along with other medicines).
• In the treatment of alcohol withdrawal.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before starting to take Huberplex

Do not take Huberplex:

• if you are allergic to chlordiazepoxide hydrochloride, benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from long-term breathing difficulties with or without sleep-related breathing disorders (sleep apnea).
• if you have a condition called "myasthenia gravis," which is characterized by muscle weakness and fatigue.
• if you have severe liver problems
• if you are breastfeeding

This medicine is not recommended for the primary treatment of psychotic disorders (severe mental disorders causing abnormal thoughts and perceptions), and should not be used as the sole treatment in patients with depression, either alone or associated with anxiety. Your doctor has likely prescribed another medication for these conditions.

If you have any doubts about this, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have any liver or kidney problems
• if you notice any changes in your personality, or reactions such as restlessness, agitation, irritability, aggression, confusion, rage attacks, nightmares, hallucinations, psychosis, or inappropriate behavior. If any of these occur, you must consult your doctor and discontinue treatment.
• if you experience recent memory loss (anterograde amnesia) during treatment. To reduce this risk, take the medicine at bedtime, ensuring you will be able to sleep uninterrupted for 7–8 hours.
• after prolonged use of this medicine, a certain reduction in effect (tolerance) may occur
• after stopping the medicine, especially if treatment is abruptly discontinued, rebound symptoms and anxiety, mood changes, and restlessness may occur; therefore, it is recommended to gradually reduce the dose before stopping treatment completely.
• if you have a history of drug or alcohol abuse, you should not take this medicine unless specifically instructed by your doctor.
• lower doses are recommended in patients with chronic respiratory problems and in elderly individuals

Risk of dependence

The use of benzodiazepines may lead to dependence. This mainly occurs after long-term, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:

• benzodiazepines should only be taken under medical prescription (never because they worked for another patient) and should never be shared with others.
• do not increase the dose prescribed by your doctor, nor extend treatment beyond the recommended duration.
• consult your doctor regularly so they can determine whether continued treatment is necessary.

Children and adolescents

Huberplex should not be administered to children unless strictly necessary. Treatment duration should be as short as possible.

Taking Huberplex with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

This is extremely important because taking multiple medicines simultaneously may increase or decrease their effects.

Therefore, do not take other medicines together with this medicine unless your doctor is aware and has approved it beforehand. In particular, inform your doctor if you are taking any of the following medicines:

• Antidepressants, sleep-inducing medicines, neuroleptics, hypnotics, tranquilizers.

(may increase muscle relaxation effects; higher risk of falls in elderly patients) or other similar medicines acting on the brain and nerves

• Medicines used to relieve pain or anesthetics.
• Antihistamines (used to treat allergies) that cause drowsiness (e.g., chlorpheniramine).
• Medicines for treating epilepsy (e.g., phenytoin and phenobarbital).
• Medicines affecting the liver (e.g., the antibiotic rifampicin and cimetidine, omeprazole, macrolide antibiotics (erythromycin); medicines used to treat stomach problems, disulfiram, and contraceptives).
• Medicines used to treat viral infections (e.g., ritonavir), as these may enhance the effects of benzodiazepines.
• Medicines for treating high blood pressure (e.g., beta-blockers, anticoagulants, cardiac glycosides, moxonidine).
• Medicines known as dopaminergics (e.g., levodopa, used to treat Parkinson's disease).
• Sodium oxybate used in patients with narcolepsy. (possible increased risk of respiratory depression)
• Theophylline; a medicine to aid breathing

Concomitant use of this medicine with opioids (strong analgesics, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.

Inform your doctor about all opioid medicines you are taking and follow dosage recommendations carefully.

Taking Huberplex with alcohol

Avoid alcohol consumption during treatment. Alcohol may enhance sedation, which could affect your ability to drive or operate machinery. If you need further information on this, consult your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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. Your doctor will then decide whether or not it is appropriate to use this medicine.

Benzodiazepines pass into breast milk; therefore, you should not take this medicine during breastfeeding.

Driving and using machines

Huberplex may impair your ability to drive or operate machinery, as it may cause drowsiness, reduced attention, or slower reaction times. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Huberplex contains lactose, sucrose, and wheat starch

This medicine contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free," and it is highly unlikely to cause problems if you have celiac disease.

One tablet contains no more than 0.1 micrograms of gluten.

If you have a wheat allergy (distinct from celiac disease), you should not take this medicine.

3. How to take Huberplex

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Depending on the nature of your illness, your age and weight, your doctor will prescribe the appropriate dose.

Each dose is individual, and the patient must not exceed the indicated limits or the total daily dose, unless your doctor prescribes a higher dose. The duration of treatment should be as short as possible. In general, the total duration of treatment should not exceed 4 weeks, including gradual withdrawal.

Huberplex is a tablet taken orally. Take the medicine just before going to bed and swallow it whole with water.

Adults

Anxiety

The recommended dose for moderate anxiety in adults is 30 mg/day, divided into several doses.

In cases of severe anxiety, the maximum daily dose may be increased up to 100 mg/day, divided into several doses, according to medical judgment.

Regarding anxiety associated with insomnia, the recommended dose is 20–40 mg/day, taken before bedtime.

Treatment of sudden alcohol withdrawal

The recommended dose is 25–100 mg/day. This may be repeated if necessary 2 or 4 hours after the initial dose.

Muscle spasms

The recommended dose is 10–30 mg/day, divided into several doses throughout the day.

Under normal conditions, you should fall asleep within 20 minutes after taking this medicine, and it is advisable to ensure you can rest undisturbed for at least 7 hours. Otherwise, although this rarely occurs, you may not remember what happened while you were awake.

Never change your prescribed dose on your own. If you think the effect of the medicine is too strong or too weak, consult your doctor.

Use in elderly patients

Elderly or debilitated patients may be more affected by this medicine than younger patients. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. In elderly or debilitated patients, the dose should not exceed 5–10 mg/day, except in exceptional cases at the physician's discretion.

Use in patients with liver or kidney problems

If you have any liver or kidney problems, or suffer from muscle weakness, your doctor will decide whether you should take a lower dose of this medicine or an alternative treatment.

If you take more Huberplex than you should

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, stating the medicine and the amount ingested.

If you forget to take Huberplex

If you forget to take a dose, continue with your normal dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Huberplex

When stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Abruptly stopping the medication is generally not recommended; instead, the dose should be gradually reduced according to your doctor's instructions.

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

4. Possible adverse effects

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

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Immediately inform your doctor if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body).

The following side effects have been reported:

Very common (may affect up to 1 in 10 people):

• sedation,
• dizziness,
• somnolence,
• ataxia,
• loss of balance,
• confusion,
• fatigue.

Common (may affect up to 1 in 100 people):

• headache.

Uncommon (may affect up to 1 in 1,000 people):

• bone marrow depression,
• dizziness,
• visual disturbances,
• low blood pressure,
• gastrointestinal disorders,
• skin reaction (e.g., skin rash),
• urinary retention,
• libido disorder,
• erectile dysfunction,
• menstrual disorders.

Frequency not known (frequency cannot be estimated from available data):

• hypersensitivity,
• increased appetite,
• amnesia (memory loss), hallucinations, dependence-related depression,
• restlessness, agitation, irritability,
• depressed level of consciousness (reduced alertness),
• aggression, delirium, nightmares, psychotic disorders, abnormal behavior, emotional disorders,
• paradoxical reaction to the drug (e.g., anxiety, sleep disorders, insomnia, suicide attempt, difficulty speaking),
• gait disturbance, extrapyramidal disorder (e.g., tremor),
• respiratory depression,
• jaundice, increased blood bilirubin levels, increased transaminase levels, increased blood alkaline phosphatase levels,
• muscle weakness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Huberplex

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container 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 are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Huberplex 5 mg film-coated tablets

• The active substance is chlordiazepoxide hydrochloride. Each film-coated tablet contains 5 mg of chlordiazepoxide hydrochloride.
• The other components are: lactose, wheat starch, sucrose, talc, disodium edetate, magnesium stearate (E-572), silicon dioxide, polyvidone, crospovidone, methacrylic acid copolymer (Eudragit E), methacrylic acid copolymer (Eudragit L), titanium dioxide (E-171), aluminium hydroxide gel, Macrogol 6,000, quinoline yellow colour (E-104), beeswax, and carnauba wax.

Appearance of the product and contents of the pack

PVC/Aluminum blister packs containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) - Italy

Date of the most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/