Nomefren

Leaflet accompanying the packaging: patient information

Nomefren, 5 mg, tablets

Nitrazepam

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in the leaflet, you should consult a doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Nomefren and what is it used for
• 2. Important information before taking Nomefren
• 3. How to take Nomefren
• 4. Possible side effects
• 5. How to store Nomefren
• 6. Contents of the packaging and other information

1. What is Nomefren and what is it used for

Nomefren belongs to a group of medicines called benzodiazepines, which are sedatives.
Nomefren shortens the time it takes to fall asleep and prolongs the duration of sleep.
Nomefren is used for the short-term treatment of severe insomnia.
Nomefren helps you fall asleep, but it does not cure the cause of insomnia, which you should discuss with your doctor.

2. Important information before taking Nomefren

When not to take Nomefren:

• if you are allergic (hypersensitive) to nitrazepam or any of the other ingredients of this medicine (listed in section 6 "Contents of the packaging and other information"),
• if you are allergic (hypersensitive) to any benzodiazepine medicine (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam),
• if you have a lung disease,
• if you have breathing difficulties when you wake up or during sleep,
• if you have myasthenia (a disease characterized by muscle weakness and easy fatigue),
• if you have a mental illness or personality disorders (serious mental problems),
• if you have severe liver disease.

Nomefren is not intended for people under 18 years of age.

Warnings and precautions

Before taking the medicine, you should inform your doctor:

• if you have a long-term lung, liver or kidney disease,
• if you have depression or have recently experienced the death of a loved one or relative,
• if you have or have had a mental illness,
• if you have abused alcohol or drugs. You should not drink alcohol or take drugs while taking Nomefren.
• if you are pregnant or breastfeeding.

Because Nomefren causes muscle relaxation, elderly patients should be particularly careful when getting up at night, as there is a risk of falls and consequent injuries, including hip fractures.

Nomefren and other medicines

You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription. This is extremely important, as the medicines taken at the same time may enhance or weaken each other's effects. In particular, you should inform your doctor if you are taking any of the following medicines:

• antidepressants, other sedatives and sleeping pills or other medicines that affect the brain and nerves,
• medicines used to relieve pain or anesthesia,
• antihistamines (used to treat allergies) that cause drowsiness (e.g. chlorphenamine).
• medicines used to treat epilepsy (e.g. phenytoin and phenobarbital),
• medicines that affect the liver (e.g. the antibiotic rifampicin).

Taking Nomefren and opioid medicines (strong painkillers, substitution therapy medicines and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, taking them at the same time should only be considered when other treatment options are not possible.
If, however, your doctor has prescribed Nomefren and opioid medicines at the same time, they should limit the dose and duration of concurrent treatment.
You should inform your doctor about all the opioid medicines you are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform your friends or relatives so that they are aware of the above symptoms. If such symptoms occur, you should contact your doctor.

Nomefren with food and drink

While taking Nomefren, you should not drink alcohol. Alcohol enhances the sedative effect of the medicine, which can be dangerous.

Pregnancy, breastfeeding and fertility

Before taking Nomefren, you should inform your doctor if you are pregnant, think you may be pregnant or plan to have a child. Your doctor will decide whether you should take this medicine.
Before taking Nomefren, you should inform your doctor if you are breastfeeding.
If you are breastfeeding, you should avoid taking Nomefren, as the medicine passes into breast milk.
If your doctor decides that you should take this medicine during late pregnancy or during childbirth, your baby may have a low body temperature, be floppy and have breathing and feeding difficulties. The unborn baby is at risk of becoming dependent on this medicine, and after birth, there may be a risk of withdrawal symptoms in the newborn.

Driving and using machines

Nomefren may cause side effects such as reduced alertness, confusion, fatigue, dizziness, poor muscle coordination and double vision. This may affect your ability to drive and use machines. You should not drive or operate machinery if you experience any of these side effects.
The medicine may affect your ability to drive. You should not drive while taking this medicine until you know how it affects you.
If your ability to drive safely is impaired, driving a vehicle may be an offense.
However, you will not commit an offense if:

• this medicine has been prescribed to treat a medical or dental problem and
• you have taken the medicine in accordance with the instructions given by your doctor or contained in the information provided with the medicine and
• the medicine has not affected your ability to drive safely.

You should talk to your doctor or pharmacist if you are unsure whether it is safe to drive while taking this medicine.

Important information about some ingredients of Nomefren

Nomefren contains lactose. Therefore, if you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.
Sodium
Nomefren contains less than 1 mmol (23 mg) of sodium per dose unit, which means the medicine is considered "sodium-free".

3. How to take Nomefren

Your doctor will determine the smallest dose necessary to control your symptoms.
The dose recommended by your doctor depends on the nature of your illness, your response to the medicine, your age and weight.
You should always take this medicine exactly as your doctor has told you. Do not change the prescribed dose yourself. You should contact your doctor or pharmacist if you are unsure how to take this medicine.
If you think the effect of the medicine is too strong or too weak, you should consult your doctor.
Nomefren is not intended for use in children.
The usual starting dose is 5 mg (one tablet). However, if you are elderly or have a lung, liver or kidney disease, or are feeling unwell, the starting dose is usually not more than 2.5 mg (half a tablet).
You may not need to take the medicine every night.
The tablet should be swallowed whole, with a glass of water or other non-alcoholic drink.
The medicine should be taken just before going to bed. You should make sure that after taking the tablet, you have 7-8 hours for uninterrupted sleep.
Treatment usually does not last longer than four weeks.
The effectiveness of Nomefren may decrease if you take it for more than four weeks.
If you think the medicine is no longer working or your insomnia is not improving, you should consult your doctor. Additionally, you may become dependent on the medicine if you take high doses and for a long time.
Therefore, Nomefren is not suitable for long-term use, and after a few weeks, it is worth trying to manage without the medicine. This will help you avoid getting used to nitrazepam and reduce the risk of dependence.
After stopping Nomefren, you may experience withdrawal symptoms (see below: Stopping Nomefren). You should not stop taking Nomefren without consulting your doctor.

Taking a higher dose of Nomefren than recommended

If you have taken too many tablets or someone else has taken the medicine by mistake, you should immediately contact your doctor, pharmacist or go to the nearest hospital.

Missing a dose of Nomefren

You should not take a double dose to make up for a missed dose. Instead, you should take the next dose as scheduled.

Stopping Nomefren

Your doctor will tell you when to stop taking the medicine.
You should not suddenly stop taking Nomefren. If the treatment is stopped abruptly, you may experience withdrawal symptoms. This is less likely to happen if the dose is gradually reduced at the end of treatment.
Withdrawal symptoms may include:

• recurring sleep problems
• depression
• anxiety
• extreme anxiety states
• tension
• restlessness
• confusion
• mood changes
• irritability
• sweating
• diarrhea
• headaches
• muscle weakness

In severe cases, the following symptoms may occur:

• behavioral changes
• numbness and tingling of limbs
• seizures
• increased sensitivity to light, noise and touch
• hallucinations

If you wake up soon after taking the medicine, you may experience temporary memory disturbances.
Elderly patients may be more prone to experiencing side effects.
If this happens, you should inform your doctor, who may decide to change the dose.

4. Possible side effects

Like all medicines, Nomefren can cause side effects, although not everybody gets them.
Rarely, behavioral changes may occur. These changes may include aggression, excitement, confusion, restlessness, agitation, irritability, outbursts of anger, hallucinations, nightmares and depression.

If you experience any of the above behavioral changes, you should inform your doctor.

Your doctor may decide to stop the treatment.

Common (may affect up to 1 in 10 people)

• drowsiness during the day
• feeling empty
• reduced alertness
• confusion
• fatigue
• headaches
• dizziness
• muscle weakness
• poor muscle coordination
• double vision

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

• absent-mindedness
• low blood pressure
• upset stomach
• skin rashes
• vision disturbances other than double vision
• changes in sexual desire
• difficulty urinating
• yellowing of the skin and eyes (jaundice)
• blood disorders (dyscrasia)

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nomefren

The medicine should be stored out of sight and reach of children.
The medicinal product does not require special storage conditions.
Do not use this medicine after the expiry date stated on the bottle or blister and carton after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nomefren contains

The active substance of the medicine is nitrazepam. One 5 mg tablet contains the following excipients:
lactose monohydrate, maize starch, sodium carboxymethylcellulose (type A), talc and magnesium stearate.

What Nomefren looks like and contents of the pack

Nomefren is a white or almost white, round, flat tablet with beveled edges, with the inscription "DM" on one side and smooth on the other.
The tablets are available in PVC/PVdC/Aluminum blisters in a cardboard box or in HDPE bottles.
One cardboard box with PVC/PVdC/Aluminum blisters contains 10, 20, 25, 28, 30, 50, 60 or 100 tablets.
One HDPE bottle contains 30, 500 or 1000 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: December 2023