Diazepam Normon 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Normon 10 mg tablets EFG

Diazepam

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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

Doctors prescribe diazepam for people experiencing symptoms of anxiety, agitation, and psychological 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 functioning 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.

Diazepam helps relieve muscle pain caused by muscle or joint spasms or 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.

Diazepam may be used as an adjunctive treatment (a treatment administered in addition to the primary treatment to increase the likelihood of recovery) for seizure disorders (such as epilepsy, seizures), although it has not been shown to be effective as monotherapy. In such cases, your doctor will periodically assess the usefulness of the medicine for your condition.

2. What you need to know before starting to take Diazepam Normon

Do not take Diazepam Normon

• If you are allergic to diazepam or to any of the other components of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other medicines in the benzodiazepine group.
• If you have long-term breathing difficulties related or unrelated to sleep.
• If you suffer from 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 diazepam unless your doctor has formally instructed you to do so.

This medicine is not recommended for the primary treatment of psychotic disorders (severe mental disorders causing abnormal thoughts and perceptions), nor should it 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

Consult your doctor or pharmacist before starting to take Diazepam Normon:

• If you have any heart, 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 a history of, or problems with, drug dependence or central nervous system depressants, including alcohol.
• If you are taking other medicines.

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

In patients with depression, diazepam acts only on the anxious component and therefore does not constitute treatment for depression itself; it may even unmask certain signs of depression.

If you are epileptic and are undergoing long-term treatment with diazepam, the use of the benzodiazepine antagonist flumazenil to reverse the effect of diazepam is not recommended, as seizures may occur.

Your doctor will pay special attention due to the high associated risk if you are elderly or severely debilitated.

Children

The duration of treatment should be as short as possible.

Elderly patients

Elderly patients may require lower doses of diazepam than younger patients. The pharmacological effects of benzodiazepines appear to be greater in elderly patients than in younger populations. If you are elderly, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor’s instructions carefully.

Patients with hepatic impairment

The sedative effect of diazepam is increased in patients with alcoholic cirrhosis.

Other medicines and Diazepam Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is extremely important because taking more than one medicine simultaneously may increase or decrease their effects. For example, tranquilizers, sleep-inducing medicines, and similar drugs act on the brain and nerves and may enhance the effect of diazepam.

Cisapride, cimetidine, ketoconazole, fluconazole, voriconazole, fluvoxamine, fluoxetine, hormonal contraceptives, disulfiram, isoniazid, diltiazem, idelalisib, modafinil, armodafinil, esomeprazole, and omeprazole temporarily increase the sedative effect of diazepam, thereby increasing the risk of drowsiness. The same applies to grapefruit juice.

Conversely, medicines such as rifampicin and carbamazepine reduce the effects of diazepam.

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

The sedative effect and cardiorespiratory depression may be increased when diazepam is combined with other central nervous system depressants, potentially leading to coma or death.

Xanthines such as theophylline and caffeine counteract the sedative effects of diazepam.

Therefore, you should not use diazepam with any other medicine unless your doctor has specifically authorized it.

If you need further information on this, consult your doctor or pharmacist.

Taking Diazepam Normon with food, drinks, and alcohol

Alcoholic beverages increase the sedative effects of diazepam; therefore, avoid consuming alcoholic drinks during treatment. If you need further information, consult your doctor.

Diazepam should not be taken in combination with grapefruit juice, as it may increase diazepam levels in your body.

Food and antacids may slow down, but not reduce, the absorption of diazepam; this may result in milder effects after a single dose, but does not affect treatment with multiple doses.

Prokinetic medicines (medicines to improve intestinal transit) increase the absorption of diazepam.

Risk of dependence

The use of benzodiazepines and benzodiazepine-like drugs may lead to physical and psychological dependence. This occurs mainly after prolonged, uninterrupted use of the medicine. To minimize the risk of dependence, the following precautions should be observed:

• Benzodiazepines should only be taken on medical prescription (never because they worked for someone else), 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 treatment should continue.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you take diazepam before or during childbirth due to strict medical necessity, the newborn may experience hypothermia (abnormally low body temperature), weakness, hypotension, and breathing difficulties. Cases of withdrawal syndrome in newborns have also been reported.

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

Driving and using machines

Do not drive or operate tools or machinery, as this medicine may cause sedation, amnesia, difficulty concentrating, and muscle weakness, all of which may negatively affect your ability to drive vehicles or operate machinery. Your doctor must decide when you can resume these activities. This effect is increased if you have also consumed alcohol.

Diazepam Normon contains lactose

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

3. How to take Diazepam Normon

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, 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 diazepam. The tablet can be divided into equal doses.

Remember to take your medicine.

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

Use in adults

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

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.

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

Adjuvant in anticonvulsant therapy: 2 to 10 mg, 2 or 4 times daily.

Dosage in special populations

Use in children

2 to 2.5 mg, 1 or 2 times daily, gradually increased according to need and tolerance; as a general rule, 0.1–0.3 mg/kg per day. Due to the wide variability in children's response to medicines acting on the CNS, treatment should be started at the lowest dose and increased as required. Do not use in children under 6 months of age.

Use in elderly patients or in the presence of debilitating diseases

2 to 2.5 mg, 1 or 2 times daily, then gradually increased as needed and tolerated.

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

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

In elderly patients or those with liver or kidney disorders, muscle weakness, children, 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 limits indicated, nor must the total daily dose, unless your doctor prescribes a higher dose.

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

The tablet can be divided into two equal doses.

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

Treatment duration should be as short as possible and never longer than 2–3 months. Consult your doctor regularly so they can decide whether treatment should continue.

Do not prolong treatment beyond the recommended time.

To avoid withdrawal symptoms, diazepam must not be stopped abruptly, especially if it has been taken for a long time.

If you take more Diazepam Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Diazepam Normon

Do not take a double dose to make up for missed doses. Instead, continue with your normal dose.

If you stop taking Diazepam Normon

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 can 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 listed in this leaflet, inform your doctor or pharmacist.

Most patients tolerate diazepam well, but the most frequent adverse effects, which occur especially at the beginning of treatment, are fatigue, muscle weakness, and drowsiness.

Occasionally, other adverse effects have been reported, such as confusion, decreased level of alertness, loss of sensation, dizziness, affective disorders, emotional and mood disturbances, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating speech, gastrointestinal disturbances, changes in heart rhythm, headache, hypotension, circulatory disturbances, changes in libido (sexual drive), nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or urinary retention, skin rashes, stammering, tremor, vertigo, and blurred vision. The most common skin reactions are rash (skin inflammation), urticaria (reddish 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).

Heart failure and respiratory depression, including respiratory failure, may occur.

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

In addition, the use of benzodiazepines may lead to dependence, primarily when the medicine is taken continuously over a long period. Abrupt discontinuation of the medication is generally not recommended and should always follow your doctor's instructions.

Anterograde amnesia (difficulty in remembering recent events) may occur at normal doses; the risk increases with higher doses. Amnesic effects may be associated with behavioural 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Normon

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.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Diazepam Normon

• The active substance is diazepam. Each tablet contains 10 mg of diazepam.
• The other components are monohydrate lactose, corn starch, magnesium stearate, hydroxypropylcellulose (low substituted), indigo carmine lake (E-132).

Appearance of the product and contents of the pack

The tablets are blue, round, biconvex, with a break line and printed with “D 10” on one side and smooth on the other.

Diazepam Normon 10 mg tablets are available in blister packs (Aluminum/PVC) containing 25, 30, and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent review of this leaflet: March 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85969/P_85969.html