Package Insert: Information for the Patient

Huberplex 5 mg Film-Coated Tablets

Clordiazepoxide Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Huberplex and what it is used for

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

3. How to take Huberplex

4. Possible side effects

5. Storage of Huberplex

6. Contents of the pack and additional information

Huberplex is a medication that contains clordiazepoxide hydrochloride as its active ingredient. Clordiazepoxide hydrochloride is an anxiolytic that belongs to the group of medications known as benzodiazepines.

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

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

Do not take Huberplex:

• if you are allergic to clordiazepóxido hidrocloruro, benzodiazepines, or any of the other components of this medication (listed in section 6).
• if you have respiratory difficulties related or unrelated to sleep (sleep apnea) for a long time.
• if you have a condition called "myasthenia gravis," characterized by muscle weakness and fatigue.
• if you have severe liver disease.
• if you are breastfeeding.

This medication is not recommended for the primary treatment of psychotic disorders (serious mental disorders that cause abnormal ideas and perceptions), nor should it be used as the sole treatment for depression, alone or associated with anxiety. Your doctor has probably prescribed another medication for these cases.

If you have any doubts, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have any liver or kidney problems.
• if you notice any change in your personality, or reactions such as restlessness, agitation, irritability, aggression, confusion, anger attacks, nightmares, hallucinations, psychosis, and inappropriate behavior. If this occurs, you should consult your doctor and discontinue treatment.
• if during treatment you experience recent memory loss (anterograde amnesia). To reduce this risk, take the medication at bedtime to ensure you can sleep uninterrupted for 7-8 hours.
• after prolonged use of this medication, some loss of effect (tolerance) may be detected.
• after stopping the medication, especially if it is stopped abruptly, rebound symptoms and anxiety, mood changes, and restlessness may appear. Therefore, it is recommended to gradually reduce the dose before discontinuing treatment.
• if you are dependent on substance abuse or alcohol, do not take this medication unless your doctor advises you to.
• it is recommended to use lower doses in patients with chronic respiratory problems and in elderly people.

Risk of dependence

The use of benzodiazepines can lead to dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• benezodiazepines should be taken only under medical prescription (never because they have worked for other patients) and should not be recommended to others.
• do not increase the doses prescribed by your doctor, nor prolong the treatment longer than recommended.
• consult your doctor regularly to decide if treatment should continue.

Children and adolescents

Huberplex should not be administered to children unless it is strictly necessary. The duration of treatment should be the minimum possible.

Taking Huberplex with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is extremely important because the simultaneous use of multiple medications can increase or decrease its effect.

Therefore, do not take other medications at the same time as this medication unless your doctor is informed and approves it in advance. In particular, inform your doctor if you are taking any of the following medications:

- Antidepressants, sleep-inducing medications, neuroleptics, hypnotics, tranquilizers.

(may increase muscle relaxation effects; increased risk of falls in elderly patients) or other similar medications that act on the brain and nerves

- Pain-relieving medications or anesthetics.

- Antihistamines (used to treat allergies) that cause drowsiness (e.g., clorfenamina).

- Medications used to treat epilepsy (e.g., phenitoína and phenobarbital).

- Medications that affect the liver (e.g., the antibiotic rifampicina and cimetidina, omeprazol, macrolide antibiotics (erythromycin); medications used to treat stomach problems, disulfuro, and anticonceptives).

- Medications used to treat viral infections (e.g., ritonavir) as these medications can potentiate the action of benzodiazepines.

- Medications used to treat high blood pressure (e.g., beta-blockers, anticoagulants, cardiac glycosides, moxonidina).

- Medications known as dopaminérgicos (e.g., Levodopa, for Parkinson's disease).

- Sodium oxibate used in patients with narcolepsy. (possible increase in respiratory depression)

- Theophylline; medication to facilitate breathing

The concomitant use of this medication and opioids (strong pain-relieving medications, medication for substance abuse treatment, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can put your life in danger. Therefore, concomitant use should only be considered when other treatment options are not possible.

Inform your doctor about all the opioid medications you are taking and follow the dosage recommendation carefully.

Taking Huberplex with alcohol

Avoid consuming alcohol during treatment. The effect of alcohol can potentiate sedation, and this can affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.The doctor will then decide whether or not to use this medication.

Benzodiazepines pass into breast milk, so do not take this medication during breastfeeding.

Driving and operating machinery

Huberplex may affect your ability to drive or operate machinery, as it can cause drowsiness, decrease attention, or decrease reaction time. The appearance of these effects is 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 medication contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

One tablet does not contain more than 0.1 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of 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 should not exceed the indicated limits or the total daily dose, unless your doctor prescribes a higher dose. The treatment duration should be the shortest possible. In general, the total treatment duration should not exceed 4 weeks, including gradual withdrawal.

Huberplex is an oral tablet. Take the medication just before going to bed and swallow it without chewing 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 to 100 mg/day, divided into several doses, at the discretion of the doctor.

Regarding anxiety associated with insomnia, the recommended dose is 20-40 mg/day, before going to bed.

Treatment of sudden alcohol withdrawal

The recommended dose is 25-100 mg/day. It can be repeated if necessary at 2 or 4 hours after the initial dose.

Muscle spasms

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

In normal conditions, it will not take more than 20 minutes to fall asleep after taking this medication, and it is advisable to ensure that you can rest without being woken up for at least 7 hours. Otherwise, although this occurs in rare cases, it is possible that you will not remember what happened while you were awake.

Never change the dose prescribed by your doctor yourself. If you think the medication's effect is too strong or too weak, consult your doctor.

Use in elderly patients

Elderly patients or debilitated patients may be more affected by this medication than young patients. If you are an elderly patient, your doctor may prescribe a lower dose and monitor your response to treatment. In elderly patients or debilitated patients, the dose should not exceed 5-10 mg/day, unless in exceptional cases at the discretion of your doctor.

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 medication or take an alternative.

If you take more Huberplex than you should

In case of overdose or accidental ingestion, consultimmediately your doctor or pharmacist or callthe Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Huberplex

If you forgot to take a dose, continue with the normal dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Huberplex

When stopping administration, symptoms of restlessness, anxiety, insomnia, lack of concentration, headache and hot flashes may appear. It is not generally recommended to interrupt treatment abruptly, but rather to gradually reduce the dose, in accordance with the doctor's instructions..

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

The following side effects have been reported:

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

- drowsiness,

- dizziness,

- drowsiness,

- ataxia,

- balance disorder,

- confusion,

- fatigue.

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

- headache,

Rare (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.

Unknown frequency (frequency cannot be estimated from available data):

- hypersensitivity,

- increased appetite,

- amnesia (memory loss), hallucinations, dependence 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, attempted suicide, difficulty speaking,

- gait disturbance, extrapyramidal disorder (e.g., tremor),

- respiratory depression,

- jaundice, increased bilirubin levels in blood, increased levels of transaminases, increased levels of alkaline phosphatase in blood,

- muscle weakness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for 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.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Huberplex 5 mg film-coated tablets

• The active ingredient is clorazepate hydrochloride. Each film-coated tablet contains 5 mg of clorazepate hydrochloride.
• The other components are: lactose, wheat starch, sucrose, talc, disodium edetate, magnesium stearate (E-572), silicon dioxide, polyvinylpyrrolidone, crospovidone, methacrylic acid copolymer (Eudragit E), methacrylic acid copolymer (Eudragit L), titanium dioxide (E-171), aluminum hydroxide gel, Macrogol 6.000, quinoline yellow (E-104) colorant, beeswax, and carnauba wax.

Appearance of the product and content of the packaging

PVC/Aluminum blister packs containing 30 film-coated tablets

Holder of the marketing authorization and responsible manufacturer

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) - Italy

Last review date of this leaflet: May 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/