Nomefren

Package leaflet: Information for the patient

Nomefren, 5 mg, tablets
Nitrazepamum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any side effects occur, including any not listed in this leaflet, please consult your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Nomefren is and what it is used for

Nomefren belongs to a group of medicines called benzodiazepines, which are sedatives.
Nomefren shortens the time needed 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 does not treat the underlying cause of insomnia, which should be discussed with your doctor.

2. Information before using Nomefren

When not to use Nomefren:

• if the patient is allergic (hypersensitive) to nitrazepam or any of the other ingredients of this medicine (listed in section 6 "Contents of the pack and other information"),
• if the patient is allergic (hypersensitive) to any medicine belonging to the benzodiazepine group (e.g. flurazepam, diazepam, chlordiazepoxide or temazepam),
• if the patient suffers from lung disease,
• if the patient has breathing difficulties upon waking or during sleep,
• if the patient has myasthenia (a disease characterised by muscle weakness and easy fatigability),
• if the patient suffers from mental illness or personality disorders (serious psychological problems),
• if the patient has severe liver disease.

Nomefren is not intended for use in individuals under 18 years of age.
Warnings and precautions
Before taking this medicine, inform your doctor:

• if the patient suffers from chronic lung, liver or kidney disease,
• if the patient suffers from depression or has recently experienced the death of someone close or a relative,
• if the patient suffers or has suffered from a mental illness,
• if the patient has abused alcohol or drugs. Do not drink alcohol or take drugs while taking Nomefren.
• if the patient is pregnant or breastfeeding.

Because Nomefren causes muscle relaxation, elderly patients should exercise particular caution when getting up at night, as there is a risk of falls and consequent injuries, including hip fractures.
Nomefren and other medicines
Tell your doctor about all medicines you are currently taking, including those obtained without a prescription. This is extremely important because concomitant medicines may either enhance or reduce each other's effects. In particular, inform your doctor if the patient is taking any of the following medicines:

• antidepressants, other sedatives and hypnotics, or other medicines that act on the brain and nerves,
• medicines used to relieve pain or for anaesthesia,
• antihistamines (used in the treatment of allergies) that cause drowsiness (e.g. chlorpheniramine),
• medicines used in the treatment of epilepsy (e.g. phenytoin and phenobarbital),
• medicines that affect the liver (e.g. the antibiotic rifampicin).

Concomitant use of Nomefren and opioid medicines (strong painkillers, medicines used in substitution treatment, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.
If your doctor prescribes Nomefren together with opioid medicines, the dose and duration of concomitant treatment should be limited.
Inform your doctor about all opioid medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. If such symptoms occur, contact your doctor immediately.
Nomefren with food and drink
Do not drink alcohol while taking Nomefren. Alcohol enhances the calming effect of the medicine, which may be dangerous.
Pregnancy, breastfeeding and fertility
Before taking Nomefren, inform your doctor if the patient is pregnant, suspects she may be pregnant, or is planning to have a child. The doctor will decide whether or not to take this medicine.
Before taking Nomefren, inform your doctor if the patient is breastfeeding.
If the patient is breastfeeding, avoid using Nomefren, as this medicine passes into breast milk.
If your doctor decides that the patient should take this medicine during late pregnancy or during delivery, the baby may have low body temperature, muscle weakness, and breathing and feeding difficulties. The unborn child is at risk of developing dependence on this medicine, and after birth there may be a risk of withdrawal symptoms in the newborn.
Driving and operating machinery
Nomefren may cause adverse effects such as reduced alertness, confusion, fatigue, dizziness, poor muscle coordination, and double vision. These may affect the ability to drive and operate machinery. Do not drive or operate machinery if any of these adverse effects occur.
This medicine may affect the ability to drive. Do not drive while taking this medicine until you know how the medicine affects you.
If your ability to drive safely is impaired, driving may constitute an offence.
However, you will not commit an offence if:

• this medicine was prescribed to treat a medical or dental condition, and
• you took the medicine as directed by your doctor or as stated in the medicine information, and
• the medicine did not affect your ability to drive safely.

Talk to your doctor or pharmacist if you are unsure whether driving is safe while taking this medicine.
Important information about certain ingredients of Nomefren
Nomefren contains lactose. Therefore, if you have been advised by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Sodium
Nomefren contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. the medicine is considered "sodium-free".

3. How to use Nomefren

Your doctor will determine the lowest effective dose needed to control symptoms.
The prescribed dose depends on the nature of the illness, the patient's response to the medicine, age, and body weight.
This medicine should always be taken exactly as prescribed by your doctor. Do not change the prescribed dose on your own.
Contact your doctor or pharmacist if you are unsure how to take this medicine.
If you feel the medicine's effect is too strong or too weak, 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 suffer from lung, liver, or kidney disease, or are generally unwell, the starting dose is usually no more than 2.5 mg (half a tablet).
You may not need to take the medicine every night.

Swallow the tablet whole with water or another non-alcoholic drink.
Take the medicine just before going to bed. You should ensure you have 7–8 hours of uninterrupted sleep after taking the tablet.
Treatment usually does not last longer than four weeks.

The effectiveness of Nomefren may decrease if used for longer than four weeks.
If you feel the medicine is no longer working or insomnia persists, consult your doctor.
Additionally, you may become dependent on the medicine if you take high doses over a prolonged period.
Therefore, Nomefren is not suitable for long-term use, and after a few weeks, it is advisable to try to manage without the medicine.
This helps prevent dependence on nitrazepam and reduces the risk of addiction.

After stopping Nomefren, withdrawal symptoms may occur (see section below: Stopping Nomefren).
Do not stop taking Nomefren without consulting your doctor.

Taking more Nomefren than prescribed
If you or someone else has taken too many tablets, contact a doctor, pharmacist, or go to the nearest hospital immediately.

If you miss a dose of Nomefren
Do not take a double dose to make up for a missed dose. Instead, take the next dose as prescribed.

Stopping Nomefren
Your doctor will advise you when to stop taking the medicine.
Do not stop taking Nomefren abruptly. If treatment is stopped suddenly, withdrawal symptoms may occur.
This is less likely if the dose is gradually reduced towards the end of treatment.

Withdrawal symptoms may include:

• return of sleep problems
• depression
• nervousness
• severe anxiety
• tension
• restlessness
• confusion
• mood changes
• irritability
• sweating
• diarrhoea
• headache
• muscle weakness

In severe cases, the following symptoms may occur:

• behavioural changes
• numbness and tingling in the limbs
• seizures
• increased sensitivity to light, noise, and touch
• hallucinations

If you have taken benzodiazepines for a prolonged period, reducing the dose will take longer than usual when stopping this medicine.
You may require additional support. Your doctor will discuss this with you.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Changes in behaviour may rarely occur. These changes may include aggression, agitation, confusion,
restlessness, excitement, irritability, anger outbursts, hallucinations, nightmares, and depression.
If any of the above behavioural changes occur, inform your doctor.
Your doctor may decide to discontinue treatment with this medicine.
Common (may affect up to 1 in 10 people)

• daytime drowsiness
• feeling of emptiness
• reduced alertness
• confusion
• fatigue
• headache
• dizziness
• muscle weakness
• poor coordination
• double vision

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

• inattention
• low blood pressure
• stomach discomfort
• skin rashes
• visual disturbances other than double vision
• changes in sexual desire
• inability to pass urine
• yellowing of the skin and eyes (jaundice)
• blood disorders (dyscrasia)

If the patient wakes up shortly after taking the medicine, transient memory disturbances may occur.
Elderly patients may be more susceptible to adverse effects.
If this occurs, inform the doctor, who may decide to adjust the dose.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Nomefren

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicinal product.
Do not use this medicine after the expiry date stated on the bottle or blister pack and on the carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Nomefren contains
The active substance is nitrazepam. One 5 mg tablet contains the following excipients:
monohydrate lactose, corn starch, sodium carboxymethyl starch (type A), talc and magnesium
stearate.
What Nomefren looks like and contents of the pack
Nomefren medicinal product is white or almost white, round, flat tablets with bevelled edges,
imprinted with the letters "DM" on one side and smooth on the other.
Tablets are available in PVC/PVdC/Aluminium blisters in cardboard boxes or in HDPE bottles.
One cardboard box with PVC/PVdC/Aluminium 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 Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice
This medicinal product is authorised in the European Economic Area countries under the following names: