Package Leaflet: Information for the User

Diazepam Normon 10 mg Tablets EFG

Diazepam

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, 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.

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

Diazepam has tranquilizing, sedative, muscle relaxant and anticonvulsant effects.

Doctors prescribe diazepam to people who exhibit symptoms of anxiety, agitation and mental tension produced 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 situation of significant stress.

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 athetosis (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) for convulsive disorders (such as epilepsy, seizures), but it has not been shown to be useful as a single treatment. In these cases, your doctor will periodically evaluate the usefulness of the medication for your case.

Do not take DiazepamNormon

• If you are allergic to diazepam 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 are dependent on drugs or alcohol, do not take diazepam, unless your doctor has formally instructed you to do so.

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 Diazepam Normon:

• If you have any heart, 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 or problems with dependence on drugs or central nervous system depressants, including alcohol.
• 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.

In patients with depression, diazepam only acts on the anxious component, so it is not a treatment for depression itself and may eventually unmask some of its symptoms.

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

Your doctor will pay special attention to the high risk associated with you being an elderly patient or severely debilitated.

Children

The duration of treatment should be as short as possible.

Elderly patients

Elderly patients may need lower doses of diazepam than younger patients. The pharmacological effects of benzodiazepines in elderly patients appear to be greater than in the younger population. If you are an elderly patient, your doctor may prescribe a lower dose and check your response to treatment. Please follow your doctor's instructions carefully.

Patients with liver dysfunction

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

Other medications and Diazepam Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is extremely important because the simultaneous use of multiple medications can increase or decrease their effect. For example, tranquilizers, sleep inducers, and similar medications act on the brain and nerves and can enhance the effect of diazepam.

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

On the other hand, medications such as rifampicin and carbamazepine reduce the effects of diazepam.

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.

Combining diazepam with other central nervous system depressants can increase the sedative and cardiopulmonary depressive effects, potentially causing coma or death.

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

Therefore, do not use diazepam with any other medication, unless your doctor has allowed it.

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

Taking Diazepam Normon 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.

Do not take diazepam in combination with grapefruit juice, as this can increase the levels of diazepam in your body.

Foods and antacids can slow down the absorption of diazepam, but will not decrease it; this may lead to milder effects after a single dose, but does not affect treatment with multiple doses.

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

Risk of dependence

The use of benzodiazepines and benzodiazepine-like medications can lead to physical and psychological dependence. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, follow these precautions:

• Take benzodiazepines only under medical prescription (never because they have worked for other patients), and never advise others to take them.
• Do not increase the prescribed doses, nor prolong the treatment longer than recommended.
• Consult your doctor regularly to decide whether to continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

If you take diazepam before or during delivery, your newborn may experience hypothermia (abnormally low body temperature), weakness, hypotension, and breathing difficulties. Additionally, cases of withdrawal syndrome in newborns have been reported.

Benzodiazepines pass into breast milk, so you should consult your doctor about taking diazepam 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. Your doctor will decide when you can resume these activities. This effect is increased if you have also consumed alcohol.

Diazepam Normon contains lactose

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

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 diazepam. The tablet can be divided into equal doses.

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.

Posology in special populations

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 needed. Do not use in children under 6 months of age.

Use in 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.

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.

The tablet can be divided into two equal doses.

Diazepam tablets should 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 diazepam abruptly, especially if you have been taking it for a long time.

If you take more Diazepam Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Diazepam Normon

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

If you interrupt treatment with Diazepam Normon

Upon cessation of administration, anxiety, insomnia, lack of concentration, headaches, and hot flashes may appear. It is generally not recommended to stop medication abruptly, but rather to gradually reduce the dose, according to 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 can 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, muscle weakness, and drowsiness.

Occasionally, other side effects such as confusion, decreased alertness, loss of sensation, dizziness, emotional and mood disturbances, constipation, depression, double vision, ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive disturbances, heart rhythm alterations, headache, hypotension, circulatory disturbances, changes in libido (sexual desire), nausea, dry mouth or excessive salivation, urinary incontinence or retention, skin eruptions, stuttering, tremors, vertigo, 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.

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

It is known that when benzodiazepines are used, side effects on behavior such as restlessness, disorientation, agitation, irritability, delirium (incoherent ideas), outbursts of anger, aggression, nervousness, hostility, anxiety, nightmares, abnormal dreams, hallucinations, psychosis (loss of contact with reality), hyperactivity, 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 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 appearing in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and themedications that you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist howto dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

Diazepam Normon Composition

• The active ingredient is diazepam. Each tablet contains 10 mg of diazepam.
• The other components are lactose monohydrate, cornstarch, magnesium stearate, hydroxypropylcellulose (partially substituted), and indigotin lake (E-132).

Appearance of the product and contents of the packaging

The tablets are blue, round, biconvex, with a breaking bar and printed with “D 10” on one face and smooth on the other.

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet:March 2022

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/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

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