Leaflet: information for the user

Diazepam Stada 10 mg tablets EFG

Read this leaflet carefully before you start taking 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 and should not be given to others, even if they have the same symptoms, 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.

1.What is Diazepam Stada and what it is used for

2.What you need to knowbefore starting to takeDiazepam Stada

3.How to take Diazepam Stada

4.Possible side effects

5.Storage of Diazepam Stada

6.Contents of the pack and additional informationl

Diazepam Stada contains as active ingredient diazepam, which belongs to a group of medicines called benzodiazepines.

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

Doctors prescribe diazepam to people who experience symptoms of anxiety, agitation and mental tension caused by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of a severe disorder that limits their activity or subjects them to a significant stressful situation.

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

Diazepam 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 (slow, involuntary, continuous and extravagant movements of fingers and hands) and in generalized rigidity syndrome.

Diazepam may be used as an adjunctive treatment (treatment administered after the primary treatment to increase the chances of a cure) of 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 Diazepam Stada

• If you are allergic to diazepam or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications in the benzodiazepine group.
• If you have respiratory difficulties (related or unrelated to sleep) for 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 diazepam unless your doctor instructs you to do so formally.

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, either alone or associated with anxiety. Your doctor has probably prescribed another medication for these cases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diazepam Stada.

• If you have any liver or kidney disease
• If you have respiratory 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 diazepam or not take it at all.

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

Children

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

Taking Diazepam Stada with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take other medications. This is extremely important because the simultaneous use of multiple medications may increase or decrease their effect.

Therefore, do not take diazepam 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 may enhance the effect of diazepam.

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

Similarly, the metabolism of phenytoin may be affected if you are taking diazepam, 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, 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 instructions 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 about this, consult your doctor or pharmacist.

Taking Diazepam Stada with food, drinks, and alcohol

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

Risk of dependence

The use of benzodiazepines may 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:

•The use of benzodiazepines should only be under medical prescription (never because they have worked in other patients), and never advise others to take them.

•Do not increase the prescribed doses or prolong the treatment longer than recommended.

•Consult your doctor regularly to decide whether to continue treatment.

Pregnancy and breastfeeding

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 advisable or not to take diazepam.

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

Driving and operating machinery

Do not drive or operate tools or machinery because this medication 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 people

Elderly people may need lower doses of diazepam than young patients. If you are an elderly person, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.

Diazepam Stada contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions 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 most suitable dose and indicate the duration of your diazepam treatment.

Remember to take your medication.

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

Use in 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.

Muscle skeletal spasm relief:2 to 10 mg, 3 or 4 times a day.

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

Use in children

From 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.

Use in elderly or in the presence of debilitating diseases

From 2 to 2.5 mg, 1 or 2 times a day, increasing gradually as needed and tolerated.

Treatment should begin with the lowest dose. Do not exceed the maximum dose.

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

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

Guidelines for correct administration

Do not increase the doses prescribed by your doctor at all.

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

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

Diazepam tablets should be taken at the hours when they are most needed, 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 diazepam abruptly, especially if you have been taking it for a long time.

If you take more Diazepam Stada than you should

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

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 medication and the amount used.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Diazepam Stada

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

If you interrupt treatment with Diazepam Stada

Upon cessation of administration, anxiety, insomnia, lack of concentration, headache and hot flashes may appear. It is not generally recommended to interrupt 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 diazepam 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, impaired alertness, numbness, constipation, depression, double vision, ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive disturbances, heart rhythm alterations, headache, hypotension, circulatory disturbances, increased or decreased libido (sexual appetite), nausea, dry mouth or hypersalivation (excessive salivation), incontinence or urinary retention, skin eruptions, stuttering, tremors, dizziness, and blurred vision have been described. The most common skin reactions are inflammation (skin inflammation), urticaria (red itchy patches), and pruritus (uncomfortable skin 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 (incoherent ideas), outbursts of anger, aggression, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior may occur. These reactions are more common 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 medication 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. Amnestic effects may be associated with behavioral alterations.

If you observe any other reaction not described in this 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 appearing 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.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the 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.

Composition of Diazepam Stada

• The active ingredient is diazepam. Each tablet contains 10 mg of diazepam.
• The other components are lactose monohydrate, cornstarch and magnesium stearate.

Appearance of the product and contents of the packaging

Diazepam Stada 10 mg tablets: round, flat, and bisected tablets, white or almost white in color, with the inscription E1 on one face.

Diazepam Stada 10 mg tablets are available in packaging of 25 and 30 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet:July 2018

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/