Leaflet: information for the user

Diazepan Leo 5 mg tablets

Diazepam

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains diazepam as its active ingredient, which belongs to a group of medications known as benzodiazepines.

Diazepam has tranquilizing, sedating, muscle relaxing, and anticonvulsant effects.

Doctors prescribe this medication to people who exhibit symptoms of anxiety, agitation, and psychological 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 individual to significant stress.

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

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

This medication may be used as an adjunctive treatment (treatment administered after the primary treatment to increase the chances of a cure) for convulsive disorders (such as epilepsy, seizures), but it has not been proven useful as a single treatment. In these cases, your doctor will periodically evaluate the usefulness of the medication for your case.

Do not take Diazepan Leo

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to other medications in the benzodiazepine group.
• If you have breathing difficultiesrelated or unrelated to sleepfor a long time.
• If you have a condition called “myasthenia gravis”, characterized by muscle weakness and fatigue.
• If you have severe respiratory problems (Severe respiratory insufficiency).
• If you have severe liver problems (Severe hepatic insufficiency).
• If you suffer from drug or alcohol dependence, do not take this medication unless your doctor has formally indicated it.

This medication 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 sole treatment for patients with depression, alone or associated with anxiety. Your doctor has probably prescribed another medication for these cases.

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

Warnings and precautions

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

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

• If you have allergies

• If you have drug or alcohol dependence problems
• If you are taking other medications

Your doctor will decide whether you should take a lower dose of this medication or not take it at all.

If you are epilepticand are following a long-term treatment with this medication, do not use the benzodiazepine antagonist Anexate (flumazenil) to reverse the effect of this medication, as seizures may occur.

Taking Diazepan Leo 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 this medication with other medications unless your doctor is informed and approves it in advance. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can reinforce the effect of this medication.

Cisapride, cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole temporarily increase the sedative effect of this medication, increasing the risk of drowsiness.

Similarly, the metabolism of phenytoin may be affected if you are taking this medication, so if you are taking this medication, your doctor will adjust the doses accordingly.

The concomitant use of diazepam and opioids (potent analgesics, substitution therapy medications, and some cough medications) increases the risk of drowsiness, breathing difficulty (respiratory depression), coma, and may 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 should limit the dose and duration of concomitant treatment.

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

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

Taking Diazepan Leo with food and drinks

Alcoholic beverages increase the sedative effects of this medication, so avoid the use of 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 taking the medication continuously for a long time. To minimize the risk of dependence, the following precautions should be taken:

• Benzodiazepines should only be taken under medical prescription (never because they have worked for other patients), and never advise others.
• Do not increase the doses prescribed by your doctor, nor prolong the treatment longer than recommended.
• Consult your doctor regularly so that they can decide whether you should continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Benzodiazepines pass into breast milk, so you should consult your doctor about taking or not taking this medication while breastfeeding.

Driving and operating machinery

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

Use in the elderly

Elderly patients may need lower doses of this medication than young patients. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 medication.

Remember to take your medication.

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.

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

Adjunct for relief of muscle skeletal spasm:‑2 to 10 mg, 3 or 4 times a day.

Adjunct 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, increasing gradually as needed and tolerated; as a general rule, 0.1‑0.3 mg/kg per day. Due to the variety of responses of children to medications acting on the CNS, treatment should begin with the lowest dose and increase 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, increasing gradually as needed and tolerated.

The treatment should begin with the lowest dose. Do not exceed the maximum dose.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

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

Guidelines for correct administration

Do not increase, in any way, the doses prescribed by your doctor.

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 beverage.

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

Never change the dose that has been prescribed for you.

Treatment duration

The duration of treatment should be as short as possible and never exceed 2-3 months. Consult your doctor regularly to decide if treatment should continue.

Do not prolong treatment beyond the recommended time.

To avoid withdrawal symptoms, do not stop taking this medication 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 medication, callimmediatelyyour doctor, pharmacist or the nearest hospital.

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

If you forgot to take Diazepan Leo

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

If you interrupt treatment with Diazepan Leo

Upon cessation of administration, restlessness, anxiety, insomnia, lack of concentration, headache and hot flashes may appear. It is not generally recommended to stop medication 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 may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform 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 such as confusion, deterioration of alertness, loss of sensitivity, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive alterations, alteration of heart rhythm, headache, hypotension, circulatory alterations, increase or decrease in libido (sexual appetite), nausea, dry mouth or hypersalivation (excessive salivation), incontinence or urinary retention, skin eruptions, stuttering, tremor, vertigo, and blurred vision have been described.The most common skin reactions are inflammation of the skin, urticaria (red rashes), and pruritus (uncomfortable itching that causes the desire to scratch the affected area).

Very rarely, an increase in transaminases and alkaline phosphatase, jaundice (yellowish discoloration of the skin and eyes), and cardiac arrest have been reported.

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

It is known that when benzodiazepines are used, side effects on behavior such as restlessness, agitation, irritability, delirium (incoherence of ideas), outbursts of anger, aggression, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior may occur. These reactions are more frequent in the elderly and in children. If you experience these side effects, you should discontinue treatment and contact your doctor immediately.

On the other hand, the use of benzodiazepines can lead to dependence, mainly when the medicine is taken continuously for a long time. It is generally not recommended to stop treatment abruptly, always following the doctor's instructions.

Amnesia (difficulty remembering recent events) may appear at normal doses, and the risk increases with increased doses. The amnestic effects may be associated with behavioral alterations.

If any other reaction not described in this leaflet is observed, 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 mentioned in this leaflet. You can also report them directly through the Spanish System for the 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.

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.

No special storage conditions are required.

Store in the original packaging.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Diazepan Leo Composition

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

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

Appearance of the product and content of the packaging

The tablets are round, biconvex, and white in color

Diazepan Leo 5 mg tablets are available in packaging with 30 and 100 tablets.

Only some sizes of the packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

TEOFARMA, S.r.l.

Via F.lli Cervi, 8

Valle Salimbene (Pavia) - 27010 – Italy

Responsible manufacturer

TEOFARMA S.r.l.

Viale Certosa, 8/A

Pavia – 27100 Italy

Last review date of this leaflet: February 2022

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