DIAZEPAN LEO 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diazepan Leo 5 mg Tablets

Diazepam

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Diazepan Leo and what is it used for

This medicine contains the active substance diazepam, which belongs to a group of medicines called benzodiazepines.

Diazepam has a calming effect, sedative, muscle relaxant, and anticonvulsant effects.

Doctors prescribe this medicine to people who have symptoms of anxiety, agitation, and mental tension caused by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of intense disorders that limit activity or subject the person to significant stress.

It may also be useful for relieving symptoms of acute agitation, tremors, and hallucinations in patients with alcohol withdrawal syndrome.

This medicine helps to relieve muscle pain caused by muscle spasms or inflammation of muscles or joints, trauma, etc. It can also be used to combat spasms caused by diseases such as cerebral palsy (a group of disorders that affect a person's ability to move, balance, and posture) and paraplegia (paralysis of the lower half of the body, affecting both legs), as well as in athetosis (continuous, involuntary, slow, and extravagant movements of fingers and hands) and in the stiff person syndrome.

This medicine may be used as an adjunctive treatment (treatment given after the main treatment to increase the chances of a cure) for convulsive disorders (such as epilepsy, convulsions), but it has not been shown to be useful as a single treatment. In these cases, your doctor will periodically assess the usefulness of the medicine for your case.

2. What you need to know before taking Diazepan Leo

Do not take Diazepan Leo

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other medicines in the benzodiazepine group.
• If you have breathing difficulties related or not to sleepfor a long time.
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue
• If you have severe respiratory problems (severe respiratory failure).
• If you have severe liver problems (severe liver failure).
• If you are addicted to drugs or alcohol, you should not take this medicine, unless your doctor formally indicates it.

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.

Do not use this medicine in children under 6 months of age.

Warnings and precautions

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

• If you have any liver or kidney disease
• If you have breathing difficulties
• If you have severe muscle weakness
• If you have other diseases

• If you have allergies

• If you have a history of drug or alcohol dependence
• If you are taking other medicines

Your doctor will decide whether it is convenient for you to take a lower dose of this medicine or not to take it at all.

If you are an epileptic and are undergoing long-term treatment with this medicine, it is not recommended to use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of this medicine, as convulsions may occur.

Taking Diazepan Leo 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 this medicine with other medicines unless your doctor is informed and approves it beforehand. For example, tranquilizers, sleep inducers, and similar medicines act on the brain and nerves and can enhance the effect of this medicine.

Cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of this medicine, which increases the risk of drowsiness.

Also, the metabolism of phenytoin may be affected if you are taking this medicine, so if you are taking this medicine, your doctor will adjust the doses of the same.

The concomitant use of diazepam and opioids (potent analgesics, medication for substitution therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes diazepam along with opioids, your doctor must limit the dose and duration of concomitant treatment.

Tell your doctor about all opioid medications you are taking and strictly follow your doctor's recommendation regarding the dose. It may be helpful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

If you need more information about this, consult your doctor or pharmacist.

Taking Diazepan Leo with food and drinks

Alcoholic beverages increase the sedative effects of this medicine, so avoid using alcoholic beverages during treatment. If you need additional information, consult your doctor.

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:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients), and never advise them to other people.
• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.
• Consult your doctor regularly so that he can decide whether to continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Before starting treatment, your doctor should know if you are or suspect you may be pregnant or if you want to become pregnant. The doctor will then decide whether or not it is convenient for you to take this medicine.

Benzodiazepines pass into breast milk, so you should consult your doctor about taking this medicine while breastfeeding.

Driving and using machines

Do not drive or operate tools or machines because this medicine can cause sedation, amnesia, difficulty concentrating, and muscle weakness, which can negatively affect the ability to drive vehicles or operate machinery. This effect is increased if you have also ingested alcohol.

Use in the elderly

The elderly may need lower doses of this medicine than younger patients. If you are elderly, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.

3. How to take Diazepan Leo

Follow the administration instructions of this medicine indicated by your doctor exactly. 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 most suitable dose and indicate the duration of your treatment with this medicine.

Remember to take your medicine.

Follow these instructions unless your doctor has given you different instructions:

Adults:

Anxiety symptoms:2 to 10 mg, 2 to 4 times a day, depending on the severity of the symptoms.

Symptomatic relief in acute alcohol withdrawal:10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg 3 or 4 times a day, as needed.

Adjunctive therapy for muscle spasms:2 to 10 mg, 3 or 4 times a day.

Adjunctive therapy in anticonvulsant therapy:2 to 10 mg, 2 or 4 times a day.

Special dosages

Use in children: 2 to 2.5 mg, 1 or 2 times a day, gradually increasing as needed and tolerated; as a general rule, 0.1-0.3 mg/kg per day. Due to the varied response of children to medicines that act on the central nervous system, treatment should be started with the lowest dose and increased as required. Do not use in children under 6 months of age.

In the elderly or in the presence of debilitating diseases: 2 to 2.5 mg, 1 or 2 times a day, gradually increasing as needed and tolerated.

Treatment should be started with the lowest dose. The maximum dose should not be exceeded.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

In elderly patients or those with liver or kidney disorders, or muscle weakness, in children, in debilitated patients, or those with low serum albumin levels, the doctor will prescribe a lower dose.

Rules for correct administration

Do not increase the prescribed doses in any way.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

The tablets should be taken without chewing, with a little water or a non-alcoholic drink.

The tablets will be taken at the times that are most necessary, normally in the afternoon or evening.

Never change the dose that has been prescribed for you.

Duration of treatment

The duration of treatment should be as short as possible and never more than 2-3 months. Consult your doctor regularly so that he can decide whether to continue treatment.

Do not prolong treatment for longer than recommended.

To avoid withdrawal symptoms, you should not stop taking this medicine abruptly, especially if you have been taking it for a long time.

If you take more Diazepan Leo than you should

If you or someone else has ingested an overdose of this medicine, call your doctor, pharmacist, or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, Telephone (91) 562.04.20.

If you forget to take Diazepan Leo

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

If you stop treatment with Diazepan Leo

When stopping the administration, 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 questions 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 everyone gets them.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

Most patients tolerate this medicine well, but the most common side effects, which occur especially at the beginning of treatment, are fatigue and drowsiness.

Occasionally, other side effects of the type of confusion, impaired alertness, loss of sensitivity, constipation, depression, double vision, ataxia, difficulty articulating words, digestive changes, changes in heart rhythm, headache, hypotension, circulatory changes, increased or decreased libido, nausea, dry mouth or hypersalivation, incontinence or urinary retention, skin rashes, stuttering, tremors, dizziness, and blurred vision have been described. The most common skin reactions are rash, urticaria, and pruritus.

Very rarely, increased transaminases and alkaline phosphatase, jaundice, and cardiac arrest have been reported.

An increased risk of falls and fractures has been observed in elderly patients and in patients who are taking other sedative medicines (including alcoholic beverages) at the same time.

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, agitation, irritability, delirium, rage, aggression, nightmares, hallucinations, psychosis, or inappropriate behavior may occur. These reactions are more frequent in the elderly and in children. If you experience these effects, you should stop treatment and contact your doctor immediately.

Furthermore, the use of benzodiazepines can lead to dependence, mainly when the medicine is taken uninterrupted for a long time. It is not recommended to interrupt the medication abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

Anterograde amnesia (difficulty remembering recent events) may occur at normal doses, and the risk increases when the dose is increased. Amnestic effects may be associated with behavioral changes.

If you notice any other reaction not described in this package leaflet, consult your doctor or pharmacist.

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 not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepan Leo

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

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

No special storage conditions are required.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. 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 Diazepan Leo

The active substance is diazepam. Each tablet contains 5 mg of diazepam.

The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate, sodium starch glycolate (Type A), magnesium stearate, and white talc.

Appearance of the product and contents of the pack

The tablets are white, biconvex, and round

Diazepan Leo 5 mg tablets are available in packs of 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

TEOFARMA, S.r.l.

Via F. lli Cervi, 8

Valle Salimbene (Pavia) - 27010 – Italy

Manufacturer

TEOFARMA S.r.l.

Viale Certosa, 8/A

Pavia – 27100 Italy

Date of last revision of this package leaflet: February 2022

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/