Patient leaflet - Clonazepam Dawa 0.5 mg tablets

1. What Clonazepam is and what it is used for

This medicine has been prescribed to treat epilepsy in infants, children and adults.

It lowers the number of ﬁts (seizures) that you have.
Any ﬁts that you do have will be less serious.

It contains the active ingredient clonazepam which belongs to a class of medicines called benzodiazepines.

This medicine has been prescribed to you and should not be given to anyone else.

Benzodiazepines can cause dependence, tolerance and addiction, and you may get withdrawal symptoms if you stop taking it or reduce the dose suddenly. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is speciﬁc to you and may occur over a period of weeks to months. As this medicine is being used for the treatment of epilepsy you must continue to take it as prescribed by your doctor.

2. What you need to know before you take Clonazepam

Do not take Clonazepam if you are allergic (hypersensitive) to:

clonazepam or to any of the other ingredients of this medicine (listed in
section 6)
other benzodiazepine medicines. These include diazepam, ﬂurazepam
and temazepam.

Do not take Clonazepam if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Do not take Clonazepam if you have:

breathing problems or lung disease
severe liver problems
a condition called myasthenia gravis (where your muscles become
weak and get tired easily)
a condition called 'sleep apnoea syndrome' (where your breathing stops
when you are asleep)
problems with alcohol or drug (prescription or recreational) use.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

A small number of people being treated with anti-epileptics such as clonazepam have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Talk to your prescriber before taking this medicine if you:

you have liver, kidney or lung problems
you have ever had depression
you have ever tried to harm or kill yourself
a close friend or relative has recently died
you regularly drink alcohol or use recreational drugs, or you have had
problems with alcohol or drug use in the past. This is because you should not drink alcohol or take recreational drugs while you are taking clonazepam
you have spinal or cerebellar ataxia (where you may become shaky and
unsteady, have slurred speech or rapid eye movements) • you have a rare, inherited blood condition called 'porphyria’ • you are elderly or debilitated (weak); your doctor may adjust your dose. • are or have ever been addicted to opioids, alcohol, prescription
medicines, or illegal drugs, or if you have ever had a history of struggling to control your alcohol or drug intake.
have previously suﬀered from withdrawal symptoms such as agitation,
anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
feel you need to take more of Clonazepam Tablets to get the same level
of symptom control, this may mean you are developing tolerance to the eﬀects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative medication.

Taking this medicine regularly, particularly for a long time, can lead to physical dependence and addiction. Your prescriber should have explained how long you will be taking it for and, when it is appropriate to stop, how to do this safely. When your treatment is stopped, it is usually done gradually over a period which is speciﬁc to you and may occur over a period of weeks to months.

Physical dependence and addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include: • headaches, muscle pain, anxiety, tension, depression, restlessness,

sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiﬀ and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Benzodiazepines should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of benzodiazepines may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Other medicines and Clonazepam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Clonazepam can aﬀect the way some other medicines work. Also some other medicines can aﬀect the way Clonazepam works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

other medicines to treat epilepsy, such as carbamazepine, hydantoins, phenobarbital, phenytoin, primidone or sodium valproate • cimetidine (used to treat stomach problems and heartburn) • rifampicin (an antibiotic used to treat infections)
medicines used to make you sleep (hypnotics), or that make you feel sleepy as a side-eﬀect
medicines that help with anxiety (tranquillisers)
pain-killers (analgesics) or medicines to relax your muscles (muscle relaxants)
medicines that reduce your blood pressure, such as ramipril, candesartan, amlodipine, doxazosin

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Clonazepam.

Concomitant use of Clonazepam and opioids (strong pain killers, medicines used for substitution therapy and some cough medicines) increase the risk of drowsiness, diﬃculties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Clonazepam together with opioids the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all opioid medicines you are taking and follow your doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Operations

If you are going to have an anaesthetic for an operation or for dental treatment, it is important to tell your doctor or dentist that you are taking Clonazepam.

Clonazepam and alcohol

Do not drink alcohol whilst taking Clonazepam. This is because it may cause side eﬀects or cause your ﬁts to return. Alcohol can also increase the eﬀects of Clonazepam, possibly leading to severe sedation that could result in coma or death.

Pregnancy and breast-feeding

Do not take Clonazepam if you are pregnant, might become pregnant or are breast-feeding, unless your doctor tells you to. Clonazepam is known to have harmful eﬀects on the unborn child.

Driving and using machinery

Talk to your doctor about driving or using machines or tools, whilst you are taking Clonazepam. This is because it can slow down your reactions, particularly when you start taking it. If you are in any doubt about whether you can do a particular activity, talk to your doctor.

The medicine can aﬀect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it aﬀects you. • It is an oﬀence to drive if this medicine aﬀects your ability to drive. • However, you would not be committing an oﬀence if:
The medicine has been prescribed to treat a medical or dental problem and
You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
It was not aﬀecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Dependence

When taking this medicine there is a risk of dependence. The risk increases with the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse.

Clonazepam 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 take Clonazepam

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets with water. The tablets can be broken in half to give a smaller dose.
Your doctor will start you on a low dose and may increase it gradually over 2 to 4 weeks until the right dose has been found for you. • Your doctor will usually tell you to split your daily dose into three or four equal amounts which you will take at evenly spaced times throughout the day.
If the daily dose cannot be split equally, take the largest dose at bedtime.
Once your doctor has found the right dose for you, they may tell you to take your medicine as a single dose in the evening.

Your prescriber should have discussed with you how long the course of Clonazepam Tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Adults and children over 12 years

The usual starting dose is 1 mg a day, or less.

This will be increased gradually, usually to between 4 mg and 8 mg a day, although your doctor may tell you to take more. The maximum dose is 20 mg a day.

Elderly

The usual starting dose is 0.5 mg a day, or less.

This will be increased gradually, usually to between 4 mg and 8 mg a day, although your doctor may tell you to take more. The maximum dose is 20 mg a day.

Infants (aged 0 to 1 year)

The usual starting dose is 0.25 mg a day, or less.

This will be increased gradually, usually to between 0.5 mg and 1 mg a day.

Small children (aged 1 to 5 years)

The usual starting dose is 0.25 mg a day, or less.

This will be increased gradually, usually to between 1 mg and 3 mg a day.

Older children (aged 5 to 12 years)

The usual starting dose is 0.5 mg a day, or less.

This will be increased gradually, usually to between 3 mg and 6 mg a day.

If you take more Clonazepam than you should

If you take too much Clonazepam talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you take too much Clonazepam you may feel drowsy, sleepy, light-headed, have a lack of coordination or be less responsive than normal. If someone else takes your Clonazepam tablets by mistake, they should talk to a doctor or go to a hospital straight away.

Product Name :

Date : 13.11.2025

Clonazepam 0.5/2mg tablets

0181-0182/L-4 If you forget to take Clonazepam

If you forget to take a dose, skip the missed dose. Then take the next dose when it is due.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Clonazepam

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber ﬁrst. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal eﬀects are kept to a minimum. This may occur over a period of weeks to months. Your prescriber will ensure that your plan for stopping treatment is tailored to you and can be adapted according to your needs and experience of any withdrawal symptoms.

Withdrawal symptoms such as:

headaches, muscle pain, anxiety, tension, depression, restlessness,
sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiﬀ and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).

If you have any further questions on 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.

Important side eﬀects to look out for:

Allergic reactions

If you get an allergic reaction, see a doctor straight away. The signs may include:

sudden swelling of the throat, face, lips and mouth. This may make it
diﬃcult to breathe or swallow
sudden swelling of the hands, feet and ankles
skin rash or itching

Eﬀects on the heart

If you notice any of the following eﬀects, see a doctor straight away. The signs may include:

breathlessness, swelling of the ankles, cough, tiredness and a racing
heart
chest pain which may spread to your neck and shoulders and down
your left arm

Eﬀects on behaviour

If you notice any of the following eﬀects, talk to your doctor as they may want you to stop taking Clonazepam. The signs may include: • being aggressive, hyperactive, irritable, nervous, agitated, hostile or

anxious

problems sleeping, nightmares and abnormal dreams • mental problems such as seeing or hearing things that are not really
there (hallucinations), delusions (believing in things that are not real) and problems with your speech
inappropriate behaviour, emotional and mood changes • types of ﬁts (seizures) that you have not had before

Infants and children

If an infant or small child is taking Clonazepam, watch them carefully.
This is because they could develop breathing problems, coughing or choking. This can be caused by too much saliva being made. • Early puberty in children. This is reversible after stopping treatment with
Clonazepam.

Other possible side eﬀects

When you start taking Clonazepam you may notice the following eﬀects: • feeling drowsy and tired

feeling dizzy and light-headed
weak or ﬂoppy muscles or jerky movements (poor coordination). • feeling unsteady when walking

If you notice any of these eﬀects, talk to your doctor. Your doctor may be able to help you by giving you a lower dose of Clonazepam and then increasing it slowly.

The following may occur at any time during your treatment:

Mind and nervous system

poor concentration, confusion and a feeling of being lost (disorientation) • feeling restless
diﬃculty remembering new things
headache
depression
slowing or slurring of speech
poor coordination, including feeling unsteady when walking • an increase in how often you have ﬁts

Liver, kidney and blood

changes in how well your liver is working (shown by blood tests) • loss of bladder control
blood problems. The signs include feeling tired, bruising easily, being
short of breath and nose bleeds. Your doctor may want you to have blood tests from time to time

Stomach and gut

feeling sick (nausea)
stomach upset

Eyes

double vision
jerky movements of the eyes (nystagmus)

Breathing

breathing problems (respiratory depression). Early signs include
suddenly noisy, diﬃcult and uneven breathing. Your skin may become blue.

Skin and hair

skin rashes, hives (lumpy rash) and itchy skin
changes to the colour of your skin
hair loss (the hair usually grows back)

Sexual

loss of sex drive
diﬃculty getting or keeping an erection (erectile dysfunction)

Dependence and addiction – Unknown frequency (see section “How do I know if I am tolerant or addicted?”)

Less common withdrawal symptoms include:

feeling sensitive to light, noise and physical contact
seeing or hearing things that are not really there (hallucinations) • tingling and feeling numb in your arms and legs
a feeling of losing contact with reality

Injury

Patients taking benzodiazepine medicines are at risk of falling and
breaking bones. The risk is increased in the elderly and those taking other sedatives (including alcohol).
Drug Withdrawal
When you stop taking Clonazepam Tablets, you may experience drug withdrawal symptoms, which include headaches, muscle pain, anxiety, tension, depression, restlessness, sweating, confusion or irritability. Do not stop taking your tablets suddenly. This could lead to more serious symptoms such as loss of the sense of reality, feeling unreal or detached from life, and unable to feel emotion. Some patients have also experienced numbness or tingling of the arms or legs, tinnitus (ringing sounds in the ears), oversensitivity to light, sound and touch, uncontrolled or overactive movements, twitching, shaking, feeling sick, being sick, stomach upsets or stomach pain, loss of appetite, agitation, abnormally fast heartbeats, panic attacks, dizziness or feeling that you are about to fall, memory loss, hallucinations, feeling stiﬀ and unable to move easily, feeling very warm, convulsions (sudden uncontrolled shaking or jerking of the body).
How do I know if I am tolerant or addicted?
If you notice any of the following signs whilst taking Clonazepam Tablets, it could be a sign that you have become addicted.
- You may feel the need to keep taking the medication for longer than your doctor recommended
- You feel you need to use more than the recommended dose • You are using the medicine for reasons other than prescribed • When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects you can help provide more information on the safety of this medicine.

5. How to store Clonazepam

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

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

Do not use this medicine after the expiry date that is printed on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. What Clonazepam contains

The active substance in Clonazepam Tablets is clonazepam.

Clonazepam Dawa 0.5 mg Tablets.

Each tablet contains 0.5 mg clonazepam.

The other ingredients are lactose anhydrous, pregelatinised starch, magnesium stearate and cellulose microcrystalline

Clonazepam Dawa 2 mg Tablets

Each tablet contains 2 mg clonazepam.

The other ingredients are lactose anhydrous, pregelatinised starch, magnesium stearate and cellulose microcrystalline.

What Clonazepam looks like and contents of the pack Clonazepam Dawa 0.5 mg Tablets are white coloured, round shaped bevelled uncoated tablets with a score line on one side and plain on the other side.

Clonazepam Dawa 2 mg Tablets are white coloured, round shaped bevelled uncoated tablets with a cross line on one side and plain on the other side. Clonazepam Dawa 2 mg Tablets can be broken into equal halves so that you can take low doses at the start of your treatment.

Clonazepam tablets are supplied in blister packs of 28, 30, 56, 60, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

DAWA Limited

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited