DIAZEPAM NORMOGEN 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diazepam Normogen 5 mg Tablets EFG

Diazepam

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Diazepam has a calming effect, sedative, muscle relaxant, and anticonvulsant effects.

Doctors prescribe diazepam to people who have symptoms of anxiety, agitation, and mental tension caused by psychoneurotic states and transient situational disorders. Benzodiazepines are only indicated for the treatment of intense disorders that limit activity or subject to significant stress.

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

Diazepam contributes to the relief of muscle pain caused by muscle spasms or inflammation of muscles or joints, trauma, etc. It can also be used to combat spasms caused by 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 (continuous, involuntary, slow, and extravagant movements of fingers and hands) and in the stiff person syndrome.

Diazepam may be used as an adjunctive treatment (treatment given after the main treatment to increase the chances of a cure) for convulsive disorders (such as epilepsy, convulsions), but it has not been shown to be useful as a single treatment. In these cases, your doctor will periodically assess the usefulness of the medicine for your case.

2. What you need to know before you take Diazepam Normogen

Do not take Diazepam Normogen

• If you are allergic to diazepam or 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 have breathing difficulties related or not to sleepfor a long time.
• If you have a disease called "myasthenia gravis", which is characterized by muscle weakness and fatigue.
• If you have severe respiratory problems (severe respiratory failure).
• If you have severe liver problems (severe liver failure).
• If you are addicted to drugs or alcohol, you should not take diazepam, unless your doctor has formally indicated it.

This medicine 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 only treatment in patients with depression, alone or associated with anxiety. Your doctor will probably have prescribed another medicine for these cases.

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 Normogen:

• 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 of or problems with dependence on drugs or central nervous system depressants, including alcohol.
• If you are taking other medicines.

Your doctor will decide whether it is convenient for you to take a lower dose of diazepam or not to take it at all.

In patients with depression, diazepam only acts on the anxious component, so it does not constitute a treatment for depression in itself and may eventually unmask some signs of it.

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

Your doctor will pay special attention to the high risk associated if you are an elderly patient or are very 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 seem 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 disorders

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

Other medicines and Diazepam Normogen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is extremely important because the simultaneous use of more than one medicine can increase or decrease its effect. For example, tranquilizers, sleep inducers, and similar medicines act on the brain and nerves and can reinforce 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, increasing the risk of drowsiness. The same happens with grapefruit juice.

On the other hand, medicines such as rifampicin and carbamazepine produce a decrease in the effects of diazepam.

Also, the metabolism of phenytoin may be affected if you are taking diazepam, so if you are taking this medicine, your doctor will adjust the doses of the same.

The sedative effect and cardiorespiratory depression can be increased when combining diazepam with other central nervous system depressants, which can cause 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 allowed it.

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

Taking Diazepam Normogen with food, drinks, and alcohol

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

You should not take diazepam in combination with grapefruit juice, as it can increase the levels of diazepam in your body.

Food and antacids can decrease the speed, but not the absorption of diazepam; this can lead to milder effects after a single dose, but it 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 can lead to physical and psychological dependence. This occurs mainly after uninterrupted use of the medicine for a long time. To minimize the risk of dependence, the following precautions should be taken into account:

• The use of benzodiazepines will only be done under medical prescription (never because they have been effective in other patients), and never advise them to other people.
• Do not increase the prescribed doses in any way, nor prolong treatment for longer than recommended.
• Consult your doctor regularly so that he can decide if you should continue treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

If, for strict medical necessity, you take diazepam before or during delivery, hypothermia (abnormally low body temperature), weakness, hypotension, and breathing difficulties may appear in the newborn. There have also been cases of withdrawal syndrome in newborns.

Benzodiazepines pass into breast milk, so you should consult your doctor about taking diazepam while breastfeeding.

Driving and using machines

Do not drive or operate tools or machines because this medicine 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 Normogen contains lactose

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

3. How to take Diazepam Normogen

Follow the administration instructions of this medicine exactly 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 two equal doses.

Remember to take your medicine.

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.

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

Adjunctive treatment for muscle spasms:2 to 10 mg, 3 or 4 times a day.

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

Posology in special populations

Use in children

From 2 to 2.5 mg, 1 or 2 times a day, gradually increasing as needed and tolerated; as a general rule, 0.1-0.3 mg/kg per day. Due to the variety of response of children to medicines that act on the central nervous system, treatment should be started with the lowest dose and increased as required. Do not use in children under 6 months of age.

Use in elderly or debilitated patients

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

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

If you think the effect of diazepam is too strong or too weak, tell your doctor or pharmacist.

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

Rules for correct administration

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

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

.

Never change the dose that has been prescribed for you yourself.

Duration of treatment

The duration of treatment should be as short as possible and never more than 2-3 months. Consult your doctor regularly so that he can decide if treatment should be continued.

Do not prolong treatment for longer than recommended.

To avoid withdrawal symptoms, you should not stop taking diazepam abruptly, especially if you have been taking it for a long time.

If you take more Diazepam Normogen than you should

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 medicine and the amount ingested.

If you forget to take Diazepam Normogen

Do not take a double dose to make up for forgotten doses. On the contrary, you should continue with the normal dose.

If you stop treatment with Diazepam Normogen

When stopping administration, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended, in general, to interrupt treatment abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this package leaflet, tell your doctor or pharmacist.

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

Occasionally, other side effects of the type of confusion, decreased alertness, loss of sensitivity, dizziness, affective disorders, emotional and mood changes, constipation, depression, diplopia (double vision), ataxia (inability to coordinate voluntary muscle movements), difficulty articulating words, digestive changes, changes in heart rhythm, headache, hypotension, circulatory changes, changes in libido (sexual appetite), nausea, dry mouth or hypersalivation (exaggerated salivary secretion), incontinence or urinary retention, skin rashes, stuttering, tremors, vertigo, and blurred vision. The most frequent skin reactions are rash (skin inflammation), urticaria (red patches), and pruritus (uncomfortable itching or irritation of the skin that causes the desire to scratch the affected area).

Very rarely, increased transaminases and alkaline phosphatase, jaundice (yellowish appearance of the skin and eyes), as well as cardiac arrest, have been reported.

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

Cardiac failure, respiratory depression, including respiratory failure, may occur.

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, disorientation, agitation, irritability, delirium (incoherence of ideas), fits of rage, aggression, nervousness, hostility, anxiety, nightmares, abnormal dreams, hallucinations, psychosis (loss of contact with reality), hyperactivity, or inappropriate behavior may occur. These reactions are more frequent in the elderly and in children. If you experience these effects, you should stop treatment and contact your doctor immediately.

On the other hand, the use of benzodiazepines can lead to dependence, mainly when the medicine is taken uninterrupted for a long time. It is not recommended, in general, to interrupt treatment abruptly, but rather to gradually reduce the dose, according to the doctor's instructions.

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

If you notice any other reaction not described in this package 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 that does not appear in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Diazepam Normogen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Diazepam Normogen

• The active ingredient is diazepam. Each tablet contains 5 mg of diazepam.
• The other components are lactose monohydrate, cornstarch, magnesium stearate, hydroxypropylcellulose (low substituted) and yellow iron oxide (E-172).

Appearance of the Product and Packaging Content

The tablets are pale yellow, round, biconvex, with a break line and serigraphed with "D 5" on one face and smooth on the other.

Diazepam Normogen 5 mg tablets are available in blister packs (Aluminum/PVC) of 30, 40 and 500 tablets.

Only some 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 Last Revision of this Leaflet:March 2022

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85979/P_85979.html