DIAZEPAM GRINDEKS 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

DiazepamGrindeks5 mg EFG tablets

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

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1 What is Diazepam Grindeks and what is it used for

1. What you need to know before you take Diazepam Grindeks
2. How to take Diazepam Grindeks
3. Possible side effects
4. Storage of Diazepam Grindeks
5. Contents of the pack and further information

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

Diazepam Grindeks 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 the person 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 may 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, 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 Grindeks

Do not take Diazepam Grindeks

• If you are allergic to diazepam or 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 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 drug or alcohol dependent, you should not take diazepam unless your doctor formally indicates 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 this medicine.

• If you have 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 drug or alcohol dependence problems
• If you are taking other medicines

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

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

Other medicines and Diazepam Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is extremely important because taking more than one medicine at the same time can increase or decrease its effect.

Therefore, you should not take diazepam with other medicines unless your doctor is informed and approves it beforehand. For example, tranquilizers, sleep inducers, and similar medicines act on the brain and nerves and can enhance the effect of this medicine.

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

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.

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

Taking Diazepam Grindeks 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 can lead to 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 worked for other patients), and never advise them to other people.

• Do not increase the prescribed doses in any way, nor prolong the treatment for longer than recommended.

• Consult your doctor regularly so that he can decide if you should continue treatment.

Pregnancy and breastfeeding

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. The doctor will then decide whether it is convenient for you to take this medicine.

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

Driving and using machines

Diazepam can alter your ability to drive or operate machinery, as it can cause drowsiness, decrease your attention, or decrease your reaction capacity. The appearance of these effects is more likely at the start of treatment or when the dose is increased. Do not drive or use machines if you experience any of these effects.

Use in elderly people

Elderly people may need lower doses of diazepam than younger 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 Grindeks contains lactose

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

3. How to take Diazepam Grindeks

Follow exactly the administration instructions of the medicine 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 treatment with Diazepam Grindeks.

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.

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 people or in the presence of debilitating diseases

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 action of this medicine 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 the prescribed doses in any way.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, 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 will be taken at the times that are most necessary, normally in the afternoon or evening. Never change the dose that has been prescribed for you.

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 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20 indicating the medicine and the amount used.

If you forget to take Diazepam Grindeks

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

If you stop treatment with Diazepam Grindeks

When stopping the administration, restlessness, anxiety, insomnia, lack of concentration, headache, and hot flashes may appear. It is not recommended to interrupt the medication 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 effect not mentioned in this leaflet, tell your doctor or pharmacist.

Most patients tolerate diazepam well, but the most common side effects, which occur especially at the start of treatment, are fatigue and drowsiness.

Occasionally, other side effects have been described, such as confusion, impaired alertness, loss of sensitivity, constipation, depression, double vision, ataxia, difficulty articulating words, digestive changes, changes in heart rhythm, headache, hypotension, circulatory changes, increased or decreased libido, nausea, dry mouth or hypersalivation, incontinence or urinary retention, skin rashes, stuttering, tremors, dizziness, and blurred vision. The most common skin reactions are rash, urticaria, and pruritus.

Very rarely, increased transaminases and alkaline phosphatase, jaundice, 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 (including alcoholic beverages) at the same time.

It is known that when benzodiazepines are used, behavioral side effects such as restlessness, agitation, irritability, delirium, rage, aggression, nightmares, hallucinations, psychosis, or inappropriate behavior may occur. These reactions are more frequent in elderly people and children. If you experience these effects, you should stop treatment and contact your doctor immediately.

Furthermore, the use of benzodiazepines can lead to dependence, mainly when the medicine is taken uninterrupted for a long time. It is not recommended to interrupt the medication 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, 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 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 listed in this 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 Grindeks

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

Store in the original package to protect it from light.

This medicine does not require any special storage temperature.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Diazepam Grindeks

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

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

Appearance of the product and contents of the pack

Round, flat, white tablets with beveled edges and scored on one face. 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 authorization holder and manufacturer

Marketing authorization holder:

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

Tel.: +371 67083205

Fax: +371 67083505

E-mail: grindeks@grindeks.lv

Manufacturer:

AS GRINDEKS.

Krustpils iela 53, Riga, LV-1057, Latvia

Tel.: +371 67083205

Fax: +371 67083505

E-mail: grindeks@grindeks.com

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.,

C/ José Abascal, 58 – 2º Dcha.,

28003, Madrid, Spain

Date of the last revision of this leaflet:October 2021

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