HUBERPLEX 5 mg FILM-COATED TABLETS

2. What you need to know before taking 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 have breathing difficulties related or not to sleepfor a long time (sleep apnea).
• if you have a disease 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 that cause abnormal ideas and perceptions), nor should it be used as the only treatment in patients with depression, alone or associated with anxiety. Your doctor will probably have prescribed another medicine for these cases.

If you have any doubts, consult your doctor.

Warnings and precautions

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

• 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, outbursts of anger, nightmares, hallucinations, psychosis, and inappropriate behavior. If this happens, you should consult your doctor and stop treatment.
• if during treatment you suffer from recent memory losses (anterograde amnesia). To reduce this risk, take the medicine at bedtime to ensure that you can sleep uninterruptedly for 7-8 hours.
• after continuous use of this medicine, some loss of effect (tolerance) may be detected
• after stopping the medicine, especially if the medication is interrupted abruptly, rebound symptoms and anxiety, mood changes, and restlessness may appear, so it is recommended to gradually reduce the dose before stopping treatment.
• if you suffer from drug or alcohol dependence, you should not take this medicine unless your doctor indicates it.
• 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 uninterrupted use of the medicine for a long time. To minimize the risk of dependence, the following precautions should be taken into account:

• the use of benzodiazepines will only be done under medical prescription (never because they have worked for other patients) and will never be recommended to other people.
• do not increase the prescribed doses in any way, nor prolong the treatment for a longer time than recommended.
• consult your doctor regularly so that he can decide if the treatment should be continued.

Children and adolescents

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

Taking Huberplex with other medicines

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

This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect.

Therefore, you should not take other medicines at the same time as this medicine unless your doctor is informed and approves it beforehand. In particular, inform your doctor if you are taking any of the following medicines:

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

(may increase the effects of muscle relaxation; greater risk of falls in elderly patients) or other medicines similar to those that act on the brain and

nerves

• Pain-relieving medications or anesthetics.
• Antihistamines (used to treat allergies) that cause drowsiness (e.g., chlorphenamine)
• Medicines used to treat epilepsy (e.g., phenytoin and phenobarbital).
• Medicines that affect 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) since these medicines can enhance the action of benzodiazepines.
• Medicines used to treat high blood pressure (e.g., beta-blockers, anticoagulants,

cardiac glycosides, moxonidine)

• Medicines known as dopaminergics (e.g., levodopa, for the treatment of Parkinson's disease).
• Sodium oxybate used in patients with narcolepsy. (possible increase in respiratory depression)
• Theophylline; medicine to facilitate breathing

The concomitant use of this medicine and opioids (strong painkillers, substitution therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

Tell your doctor about all 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 enhance 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 breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

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

Driving and using machines

Huberplex can alter your ability to drive or operate machinery, as it can cause drowsiness, reduce your attention, or reduce your reaction time. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Huberplex contains lactose, sucrose, and wheat starch

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

This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free" and 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 have a wheat allergy (different from celiac disease), you should not take this medicine.

3. How to take Huberplex

Follow the administration instructions of this medicine exactly as indicated 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 should not exceed the indicated limits or the total daily dose, unless their 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 that is administered orally. Take the medicine just before bedtime and swallow it without chewing with water.

Adults

Anxiety

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

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

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

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 throughout the day.

Under normal conditions, it should not take more than 20 minutes to fall asleep after taking this medicine, and it is convenient to ensure that you can rest without being awakened for at least 7 hours. Otherwise, although this happens rarely, it is possible that you will not remember what happened while you were awake.

Never change the dose that has been prescribed for you. If you think the effect of the medicine is too strong or too weak, consult your doctor.

Use in elderly patients

Elderly people or debilitated patients may be more affected by this medicine than younger patients. If you are an elderly person, your doctor may prescribe a lower dose and check your response to treatment. In elderly or debilitated patients, the dose should not exceed 5-10 mg/day, unless in exceptional cases, according to the doctor's criteria.

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 to it.

If you take more Huberplex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Huberplex

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

If you stop taking Huberplex

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The following side effects have been reported:

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

• sedation,
• dizziness,
• drowsiness,
• ataxia,
• balance disorder,
• confusional state,
• 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., rash),
• urinary retention,
• libido disorder,
• erectile dysfunction,
• menstrual disorders.

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

• hypersensitivity,
• increased appetite,
• amnesia (memory loss), hallucinations, dependence depression,
• restlessness, agitation, irritability,
• reduced level of consciousness (reduced alertness),

-aggression, delirium, nightmares, psychotic disorders, abnormal behavior, emotional disorders,

• paradoxical drug reaction (e.g., anxiety, sleep disorders, insomnia, suicidal attempt, difficulty speaking,
• gait disturbance, extrapyramidal disorder (e.g., tremor),
• respiratory depression,
• jaundice, increased bilirubin levels in blood, increased transaminase levels, increased alkaline phosphatase levels in blood,
• muscle weakness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further 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 ingredients are: lactose, wheat starch, sucrose, talc, disodium edetate, magnesium stearate (E-572), silicon dioxide, povidone, 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), beeswax, and carnauba wax.

Appearance and packaging

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 last revision of this leaflet: May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/