Diazepan Leo 2 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diazepan Leo 2 mg tablets

Diazepam

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Diazepam has calming, sedative, muscle-relaxant, and anticonvulsant effects.

Doctors prescribe this medicine for people experiencing symptoms of anxiety, agitation, and mental tension caused by psychoneurotic conditions and transient situational disorders. Benzodiazepines are only indicated for the treatment of severe disorders that significantly impair a person's activity or subject them to considerable stress.

It may also be useful in relieving symptoms of acute agitation, tremor, and hallucinations in patients experiencing alcohol withdrawal syndrome.

This medicine helps relieve muscle pain caused by muscle or joint spasms, inflammation, trauma, etc. It may also be used to treat spasms resulting from conditions such as cerebral palsy (a group of disorders affecting a person's ability to move, maintain balance and posture), paraplegia (paralysis of the lower half of the body, affecting both legs), as well as in athetosis (continuous, involuntary, slow, and writhing movements of fingers and hands) and generalized stiffness syndrome.

This medicine may be used as an adjunctive treatment (treatment administered following primary treatment to increase the chances of recovery) for convulsive disorders (such as epilepsy, seizures), but it has not been shown effective as monotherapy. In such cases, your doctor will periodically evaluate the usefulness of this medicine for your condition.

2. What you need to know before taking Diazepan Leo

Do not take Diazepan Leo

• If you are allergic to the active substance or to 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 suffer from long-term breathing difficulties with or without sleep-related symptoms.
• If you have a disease called "myasthenia gravis", which is 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, you should not take this medicine unless your doctor specifically instructs you to do so.

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 will likely have prescribed another medicine for these conditions.

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 liver or kidney disease

• If you have breathing difficulties

• If you suffer from severe muscle weakness

• If you have other illnesses

• If you have allergies

• If you have problems with drug or alcohol dependence

• If you are taking other medicines

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

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

Taking Diazepan Leo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is extremely important because taking more than one medicine at the same time may increase or decrease their effects.

Therefore, you should not take this medicine together with other medicines unless your doctor is aware and has approved it beforehand. For example, tranquilizers, sleeping aids, and similar medicines act on the brain and nerves and may enhance the effect of this medicine.

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

In addition, the metabolism of phenytoin may be affected if you are taking this medicine; therefore, your doctor will adjust the doses accordingly.

Concomitant use of diazepam and opioids (strong analgesics, medications for substitution therapy, and some cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are available.

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

Inform your doctor about all opioid medicines you are taking and strictly follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor if you experience such 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; therefore, avoid consuming alcoholic drinks during treatment. If you need further information, consult your doctor.

Risk of dependence

The use of benzodiazepines may lead to dependence. This mainly occurs after taking the medicine continuously for a long time. 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 other patients), and you should never recommend them to others.
• Do not increase the doses prescribed by your doctor, nor extend the treatment beyond the recommended duration.
• Consult your doctor regularly so they can decide whether you should continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Before starting treatment, your doctor must know if you are or suspect you are pregnant, or if you are planning to become pregnant. Your doctor will then decide whether or not you should take this medicine.

Benzodiazepines pass into breast milk; therefore, you should consult your doctor about whether or not to take this medicine during breastfeeding.

Driving and using machines

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

Use in elderly patients

Elderly patients may require lower doses of this medicine than younger 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.

3. How to take Diazepan Leo

Follow exactly the administration instructions for this medicine as given by your doctor. 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 most appropriate 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 ones:

Adults:

Anxiety symptoms: 2 to 10 mg, 2 to 4 times daily, depending on symptom severity.

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

Adjunctive treatment for relief of musculoskeletal spasm: 2 to 10 mg, 3 or 4 times daily.

Adjunctive treatment in anticonvulsant therapy: 2 to 10 mg, 2 to 4 times daily.

Special dosing

Use in children: 2 to 2.5 mg, 1 or 2 times daily, gradually increased according to needs and tolerance; as a general rule, 0.1–0.3 mg/kg daily. Due to the variable response of children to medicines acting on the CNS, treatment should be initiated with the lowest dose and increased as required. Do not use in children under 6 months of age.

In elderly patients or in the presence of debilitating diseases: 2 to 2.5 mg, 1 or 2 times daily, gradually increased as needed and tolerated.

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

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

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

Instructions for correct administration

Do not increase the doses prescribed by your doctor under any circumstances.

Each individual dose must not exceed the indicated limits, nor must the total daily dose, 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 should be taken at the times when they are most needed, usually in the afternoon or evening.

Never change the prescribed dose on your own.

Duration of treatment

The treatment duration should be as short as possible and never longer than 2–3 months. Consult your doctor regularly to determine whether treatment should continue.

Do not extend the treatment beyond the recommended period.

To avoid withdrawal symptoms, you must 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 taken an overdose of this medicine, contact your doctor, pharmacist, or nearest hospital immediately.

In case of overdose or accidental ingestion, contact 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 missed doses. Instead, continue with your normal dose.

If you stop taking Diazepan Leo

When stopping treatment, symptoms such as restlessness, anxiety, insomnia, difficulty concentrating, headache, and hot flushes may occur. Abrupt discontinuation of 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 may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

Occasionally, other adverse effects have been reported such as confusion, impaired alertness, loss of sensation, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, gastrointestinal disturbances, changes in heart rhythm, headache, hypotension, circulatory disturbances, increased or decreased libido (sexual desire), nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or urinary retention, skin rashes, stammering, tremor, dizziness, and blurred vision. The most frequent skin reactions are rash (skin inflammation), urticaria (reddish itchy welts), and pruritus (tingling or uncomfortable skin irritation causing an urge to scratch the affected area).

Very rarely, elevated transaminase and alkaline phosphatase levels, jaundice (yellowing 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 sedative medicines simultaneously (including alcoholic beverages).

It is known that when benzodiazepines are used, adverse behavioral effects may occur, such as restlessness, agitation, irritability, delirium (incoherent thinking), rage attacks, aggressiveness, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior. These reactions are more frequent in elderly patients and in children. If you experience any of these effects, you must stop treatment and contact your doctor immediately.

Furthermore, the use of benzodiazepines may lead to dependence, particularly when the medicine is taken continuously over a long period. Abrupt discontinuation of the medication is generally not recommended and should always be done in accordance with your doctor's instructions.

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

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

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 Medicines: www.notificaRAM.es/. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Diazepan Leo

The active substance is diazepam. Each tablet contains 2 mg of diazepam.

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

Appearance of the product and contents of the pack

The tablets are white, round, biconvex tablets.

Diazepan Leo 2 mg tablets are available in packs containing 30 and 100 tablets.

Only some 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 the most recent revision of this leaflet: February 2022

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/