5 mg tablets 
diazepam

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Diazepam Pilum is and what it is used for 
2. What you need to know before you use Diazepam Pilum 
3. How to use Diazepam Pilum 
4. Possible side effects 
5. How to store Diazepam Pilum 
6. Contents of the pack and other information 

What Diazepam Pilum is and what it is used for

Diazepam Pilum belongs to a group of medicines called benzodiazepines. It works by enhancing the effect of a suppressant substance ( GABA ) in the brain. As a result, it has a calming, anti-anxiety, antispasmodic, and muscle-relaxing effect. The effect of Diazepam Pilum tablets often comes already after 15-30 minutes, which means that in case of temporary discomfort you can wait with the medication until it is needed and thus avoid routine use.

Diazepam Pilum is used for anxiety, anxiety, restlessness. Difficulty falling asleep is often caused by anxiety and tension, which makes it difficult to relax, which is why Diazepam Pilum can facilitate falling asleep. Diazepam Pilum is also used as a sedative before surgeries, examinations, and sampling which may cause concern. Also, Diazepam Pilum is used for muscle spasms and epileptic seizures as well as for alcohol detoxification.

Diazepam contained in Diazepam Pilum may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Diazepam Pilum

Do not use Diazepam Pilum

  • if you are allergic to diazepam or any of the other ingredients of this medicine (listed in section 6).
  • in sleep apnea (respiratory arrest during sleep).
  • has a disease called myasthenia gravis which causes the muscles to weaken and quickly become tired
  • have a serious liver disease
  • have acute respiratory depression (slow and/or shallow breathing).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Diazepam Pilum if you:

  • have impaired liver or kidney function
  • have previously had or are in the process of abusing drugs, alcohol, or drugs
  • is older. Diazepam Pilum can confuse and affect the muscles, which can lead to falls and fall injuries
  • have difficulty breathing
  • suffering from depression
  • have suicidal thoughts
  • have epilepsy or have previously had seizures.

Other important aspects:

  • Mental side effects – contact your doctor if you experience side effects such as agitation, restlessness, aggression, nightmares, or hallucinations. Such side effects are more common in children or the elderly (see section 4 Possible side effects ).
  • Memory loss – during treatment you may experience memory loss which occurs more often during treatment with high doses of Diazepam Pilum. The symptoms often occur several hours after the medicine has been swallowed and therefore you should make sure that you can have an uninterrupted sleep period of 7-8 hours to reduce the risks.
  • Addiction – when treated with this medicine there is a risk of addiction. The risk increases with dose one and the treatment time and also in patients who have previously had alcohol and drug problems. You should therefore take DiazepamPilum for as short a time as possible.
  • Tolerance – if after a few weeks you notice that the effect of the medicine is not as strong as at the beginning of the treatment, talk to your doctor.
  • Abstinence – withdrawal symptoms such as relapse into sleep problems and anxiety can occur even at normal doses during a short treatment period and to reduce the risk of withdrawal symptoms, treatment should be phased out (see section 3 If you stop taking Diazepam Pilum).

There is a risk of addiction. The prescribed dose must not be exceeded.

Other medicines and Diazepam Pilum

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking the following medicines in combination with Diazepam Pilum may affect your mental health, make you very drowsy and impair your breathing and blood pressure:

  • antidepressants (eg fluvoxamine, fluoxetine )
  • medicines for mental illness (clozapine)
  • antihistamines (for the treatment of allergies )
  • anesthetics
  • sedative (used for sedative effect)
  • sleeping pills (for sleep problems)
  • muscle relaxants (eg suxamethonium, tubocurarine)
  • certain strong painkillers such as morphine ( opioids )
  • phenobarbital (for the treatment of eg epilepsy ).


Concomitant use of Diazepam Pilum with opioids (strong painkillers, opioid dependence drugs, and certain cough medicines) increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.


If your doctor prescribes Diazepam Pilum at the same time as opioid medicines, your dose and treatment time should be limited by your doctor.


Tell your doctor if you are taking any opioid medication and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Diazepam Pilum may affect or be affected by the following medicines:

  • drugs against alcohol abuse ( disulfiram )
  • theophylline (for the treatment of asthma and other respiratory problems)
  • drugs that reduce the production of stomach acid (cimetidine, omeprazole, esomeprazole)
  • medicines for epilepsy such as phenytoin and carbamazepine
  • rifampicin ( antibiotic for tuberculosis)
  • atazanavir, ritonavir, delavirdine, efavirenz, indinavir, nelfinavir, or saquinavir (antiviral medicines)
  • fluconazole, itraconazole, ketoconazole, or voriconazole (antifungal medicines)
  • isoniazid (for the treatment of tuberculosis )
  • oral contraceptives ( birth control pills ), as they can cause diazepam to leave the body more slowly and increase its effect. Breakthrough bleeding may occur during concomitant treatment with diazepam and oral contraceptives, but the preventive effect remains
  • cisapride (for the treatment of stomach problems)
  • corticosteroids (anti-inflammatory drugs)
  • levodopa (for the treatment of Parkinson’s disease )
  • valproic acid (for the treatment of epilepsy and mental illness)
  • drugs used under anesthesia (ketamine).

Diazepam Pilum with food, drink, and alcohol

Avoid concomitant use of alcohol during treatment with Diazepam Pilum, as alcohol may intensify the effects of the medicine and may make you very drowsy and affect your respiratory and cardiovascular function. 

Grapefruit and grapefruit juice should be avoided while taking Diazepam Pilum. Grapefruit can increase the effect of Diazepam Pilum.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a risk that the fetus is affected. If you take Diazepam Pilum late in pregnancy, during childbirth, or continuously for a long period of pregnancy, your baby may have low body temperature, muscle weakness, difficulty breathing, irregular heartbeat, difficulty eating (breastfeeding problems), or withdrawal symptoms. Therefore, always consult a doctor before using Diazepam Pilum during pregnancy.

Diazepam Pilum passes into breast milk. There is therefore a risk that a breastfed baby may be affected. Therefore, do not use Diazepam Pilum while breast-feeding.  

Driving and using machines

Diazepam Pilum may make you feel sleepy and may impair your ability to concentrate and react. It can also affect the muscles. These side effects may persist for several days even after diazepam treatment is stopped. You should not drive or use any tools or machines if you experience such side effects.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Diazepam Pilum contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Diazepam Pilum

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one and the treatment time should be determined by the doctor who adapts it individually for you. The treatment time should be as short as possible and generally not last for more than 8-12 weeks. The treatment should be phased out gradually.

Dose one may vary depending on the indication and individual sensitivity. Elderly patients are more sensitive. When used regularly, doctors and patients should work together to find the lowest effective dose.

Elderly patients

If you are older or fragile, you are more likely to be sensitive to the side effects of Diazepam Pilum and your dose may therefore need to be reduced. Your doctor will decide which dose of Diazepam Pilum is right for you and how often you should take the tablets.

Hepatic impairment

If you have liver disease ( liver cirrhosis ) or impaired liver function, the dose must be reduced.

Use for children and adolescents

Before an operation or examination, the usual dose for children over 12 kg is 10 mg.

For children under 12 kg: 5 mg.

The tablet can be divided into two equal doses.

If you take more Diazepam Pilum then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Signs that you have taken too much Diazepam Pilum may be difficulty coordinating movements, drowsiness, fatigue, confusion, difficulty speaking, muscle weakness, and low blood pressure.

Severe overdose can lead to coma (unconscious unconsciousness), cardiac arrest, and severe difficulty breathing.

If you forget to take Diazepam Pilum

Do not take a double dose to make up for a forgotten dose.

If you forget to take a dose, you should take it as soon as you remember that you have previously forgotten to take the medicine. If it is soon time for your next dose, skip the missed dose.

If you stop taking Diazepam Pilum

Do not stop treatment with Diazepam Pilum without consulting your doctor. The number of tablets or the strength of the tablets should be gradually reduced before stopping treatment completely. This reduces the risk of withdrawal symptoms.

Sudden discontinuation of treatment may cause withdrawal symptoms such as headache, anxiety, panic, palpitations, sweating, tremors, stomach problems, irritation, aggression, sensory disturbances, muscle spasms, general malaise, loss of appetite, insomnia, mental side effects such as severe confusion, seizures. The probability of abstinence and its severity depends on the duration of treatment, dose strength, and degree of dependence.

If you have epilepsy or have previously had seizures and discontinue treatment with Diazepam Pilum, there is a risk of seizures or prolonged epileptic seizures. There is also a risk of seizures if you have alcohol or drug problems and suddenly stop taking Diazepam Pilum.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Contact your doctor immediately or go to the nearest emergency room if any of the following occur:

Uncommon may affect up to 1 in 100 people):

  • respiratory depression (very slow and/or shallow breathing).

Rare (may affect up to 1 in 1,000 people):

  • respiratory arrest (respiratory arrest)
  • unconsciousness.

Very rare (may affect up to 1 in 10,000 people):

  • anaphylactic reaction (severe allergic reaction ) with symptoms such as sudden wheezing, swelling of the lips, tongue, and throat or the rest of the body, rash, fainting, or difficulty swallowing.

Other side effects that may occur:

Very common (may affect more than 1 user in 10):

  • drowsiness.

Common (may affect up to 1 in 10 people):

  • fatigue
  • withdrawal symptoms (for symptoms see section 3 If you stop taking DiazepamPilum )
  • confusion
  • difficulty coordinating muscle movements and other movement disorders, tremors.

Uncommon (may affect up to 1 in 100 people):

  • muscle weakness ( Myasthenia gravis )
  • memory slots
  • concentration difficulties
  • balance disorders
  • dizziness
  • headache
  • slurred speech
  • gastrointestinal problems such as nausea, vomiting, constipation, diarrhea
  • increased saliva production
  • allergic skin reactions in the form of itching, redness and swelling, and rash.

Rare may affect up to 1 in  1,000 people):

  • Mental side effects include: agitation, agitation, restlessness, irritation, aroused mood with aggression, memory loss, imagination, outbursts of rage, psychosis, nightmares, inappropriate behavior, or hallucinations. Can get serious. Children and the elderly are at higher risk of being affected. Talk to your doctor if this happens.
  • decreased alertness
  • Depression
  • emotional emptiness
  • insomnia
  • heart problems such as slow heart rate ( bradycardia ), heart failure, and cardiac arrest
  • low blood pressure, fainting
  • the increased amount of mucus in the trachea
  • dry mouth
  • increased appetite
  • yellow eyes and skin (jaundice). Contact a doctor.
  • changes in liver enzymes that appear in blood test results
  • inability to empty the bladder, poor control of bladder (urinary incontinence)
  • enlargement of the mammary glands in men
  • impotence, altered sex drive.

Very rare (may affect up to 1 in 10,000 people):

  • low white blood cell count ( leukopenia )
  • high levels of certain enzymes in the blood ( transaminases ).

Has been reported (occurs in an unknown number of users):

  • blurred vision, double vision, and involuntary eye movements (these side effects disappear after stopping treatment with diazepam ).

5. How to store Diazepam Pilum

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

Do not store above 25 ° C.

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is diazepam. One tablet contains 5 mg of diazepam.
  • The other ingredients are: lactose monohydrate (see section 2 “Diazepam Pilum contains lactose” for further information), hydroxypropyl starch, microcrystalline cellulose, silica, talc, and magnesium stearate

What the medicine looks like and the contents of the pack

Appearance

Diazepam Pilum is a white, round, flat tablet with a notch on one side. 
The height of the tablet is 2.5-2.7 mm and the diameter is 7 mm.

Pack sizes

Blister: 25, 50, and 100 tablets. 
Plastic jar: 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pilum Pharma A / S, Energivej 15, 5260 Odense S, Denmark

Manufacturer

AS GRINDEKS, Krustpils iela 53, LV-1057 Riga, Latvia

Local representative

Orifarm Generics AB, Box 56048, 102 17 Stockholm, info@orifarm.com

Muhammad Nadeem

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