Diazepam Grindex 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diazepam Grindeks 5 mg tablets EFG

Read the entire leaflet carefully before you start using 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1 What Diazepam Grindeks is and what it is used for

2 What you need to know before taking Diazepam Grindeks

3 How to take Diazepam Grindeks

4 Possible side effects

5 How to store Diazepam Grindeks

6 Contents of the pack and other information

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

Diazepam Grindeks 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 diazepam for individuals experiencing symptoms of anxiety, agitation, and psychic 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 helpful in relieving symptoms of acute agitation, tremor, and hallucinations in patients with alcohol withdrawal syndrome.

Diazepam helps relieve muscle pain caused by muscle or joint spasms, inflammation, trauma, etc. It may also be used to control spasms occurring in 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 rigidity syndrome.

Diazepam may be used as an adjunctive treatment (a treatment given following primary therapy to increase the chances of recovery) for seizure disorders (such as epilepsy, convulsions), although it has not been shown to be effective as monotherapy. In such cases, your doctor will periodically assess the continued usefulness of the medicine for your condition.

2. What you need to know before taking Diazepam Grindeks

Do not take Diazepam Grindeks

• If you are allergic to diazepam or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines in the benzodiazepine group.
• If you have long-term breathing difficulties with or without sleep-related symptoms.
• 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 have drug or alcohol dependence, you should not take diazepam unless formally instructed by your doctor.

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

Consult your doctor or pharmacist before starting to take this medicine.

• If you have any 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 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 should not take it at all.

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

Other medicines and Diazepam Grindeks

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 at the same time may increase or decrease their effects.

Therefore, you should not take diazepam with other medicines unless your doctor is aware and has approved it beforehand. For example, tranquilizers, sleep-inducing medicines, and similar drugs 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 diazepam, increasing the risk of drowsiness.

Likewise, 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.

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

Taking Diazepam Grindeks with food, drinks, and alcohol

Alcoholic beverages increase the sedative effects of diazepam; therefore, avoid consuming alcohol 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 on a doctor's prescription (never because they have 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

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. 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 diazepam during breastfeeding.

Driving and using machines

Diazepam may impair your ability to drive or operate machinery, as it may cause drowsiness, reduce your attention, or slow your reaction time. These effects are more likely at the beginning of treatment or when the dose is increased. Do not drive or operate machinery if you experience any of these effects.

Use in elderly people

Elderly people may require lower doses of diazepam 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.

Diazepam Grindeks 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 Grindeks

Follow exactly the dosing instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Depending on the nature of your condition, your age and weight, your doctor will prescribe the most appropriate dose and indicate the duration of your treatment with Diazepam Grindeks.

Remember to take your medication.

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.

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

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

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 drugs acting on the CNS, treatment should be started at the lowest dose and increased as required. Not to be used 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, gradually increased as needed and tolerated.

Treatment should be initiated 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 with 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 proper administration

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

Each individual dose must not exceed the limits indicated, nor should 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 exceed 2–3 months. Consult your doctor regularly to determine whether treatment should continue.

Do not prolong the treatment beyond the recommended period.

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

If you take more Diazepam Grindeks than you should

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

If you forget to take Diazepam Grindeks

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

If you stop taking Diazepam Grindeks

When stopping administration, 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 will experience them.

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

Most patients tolerate diazepam well, but the most common adverse effects, which occur especially at the beginning of treatment, are tiredness 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 rate, headache, hypotension, circulatory disturbances, increased or decreased libido (sexual desire), nausea, dry mouth or hypersalivation (excessive salivary secretion), urinary incontinence or retention, skin rashes, stammering, tremor, dizziness, and blurred vision. The most frequent 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 transaminases and alkaline phosphatase, 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, aggression, nightmares, hallucinations, psychosis (loss of contact with reality), or inappropriate behavior. These reactions are more frequent in elderly individuals and in children. If you experience any of these effects, you must stop treatment immediately and contact your doctor without delay.

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 follow your doctor's instructions.

Anterograde amnesia (difficulty remembering recent events) may occur at normal doses, and the risk increases with higher doses. 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diazepam Grindeks

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

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, 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 Grindeks

The active substance is diazepam. Each tablet contains 5 mg of diazepam.

The other components are monohydrate lactose, hydroxypropyl potato starch, microcrystalline cellulose, silicon dioxide (E-551), talc, magnesium stearate.

Appearance of the product and contents of the pack

Round, flat white tablets with bevelled edges, scored on one side. Tablet dimensions: diameter 6.6–7.4 mm; height 2.5–2.7 mm.

Blister pack of 10 tablets.

Diazepam Grindeks 5 mg tablets are available in packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

AS GRINDEKS
Krustpils iela 53, Riga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

Manufacturer:

AS GRINDEKS
Krustpils iela 53, Riga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

Further information about this medicine can be requested from the local representative of the Marketing Authorisation Holder

Grindeks Kalceks España, S.L.,
C/ José Abascal, 58 – 2º Dcha.,
28003, Madrid, Spain

Date of the most recent revision of this leaflet: October 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/