NATZON 0.4 MG SUBLINGUAL TABLETS, BUPRENORPHINE 0.4 MG SUBLINGUAL TABLETS - patient leaflet, side effects, dosage

Natzon 0.4mg Sublingual Tablets

(Buprenorphine)

This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

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.

What is in this leaflet

• 1. What Natzon Sublingual Tablets are and what they are used for

• 2. What you need to know before you take Natzon Sublingual Tablets

• 3. How to take Natzon Sublingual Tablets

• 4. Possible side effects

• 5. How to store Natzon Sublingual Tablets

• 6. Contents of the pack and other information

1. What Natzon Sublingual Tablets are and what they are used for

This medicine has been prescribed for you for substitution (replacement) treatment in patients who are addicted to opioid drugs such as heroin and morphine.

It contains the Buprenorphine which belongs to a class of medicines called opioids.

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

Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it 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.

Natzon Sublingual Tablets are used in adults and adolescents over 16 years of age who are also receiving medical, social and psychological support.

2. what you need to know before you take natzon sublingual tablets if you are a child under the age of 16 years

• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
• if you have severe breathing problems.
• if you have serious problem with your liver
• if you are intoxicated due to alcohol or have trembling, sweating, anxiety confusion or hallucinations caused by alcohol

if you are breast-feeding a baby

Warnings and precautions

Talk to your doctor before taking Natzon Sublingual Tablets:

• if you have asthma or other breathing problems.
• if you have any kidney problems.
• if you have any liver disease such as hepatitis
• low blood pressure
• recently suffered head injury or brain disease
• a urinary disorder (especially linked to enlarged prostate in men)
• any kidney disease
• thyroid problems
• adrenocortical disorder (e.g. Addison’s disease)
• depression or other conditions that are treated with antidepressants. The use of these medicines together with Natzon Sublingual Tablets can lead to serotonin syndrome, a potentially lifethreatening condition (see “Other medicines and Natzon Sublingual Tablets”).
• if you have seizures, fits or convulsions

Taking this medicine regularly, particularly for a long time, can lead to addiction.

Important Things to be Aware of:

This medicine can be a target for people who abuse prescription medicines and should be kept in a safe place to protect it from theft. Opioids should only be used by those they are prescribed for. Do not give this medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Other medicines and Natzon Sublingual Tablets

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

Some medicines may increase the side effects of Natzon Sublingual Tablets and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Natzon Sublingual Tablets without first talking to your doctor, especially:

• Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam. Concomitant use of buprenorphine and sedative medicines such as benzodiazepines or related drugs increases 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 Natzon Sublingual Tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative 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.
• anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine,

fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with buprenorphine and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

• Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions / seizures, pain. These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines. They may also cause central nervous system depression, which is very serious. Below is a list of examples of these types of medicines: o other opioid containing medicines such as methadone, certain pain killers and cough suppressants

o antidepressants (used to treat depression) such as isocarboxazide, phenelzine, selegeline,

tranylcypromine, and valproate may increase the effects of this medicine

o sedative H1 receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine

o barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital

o tranquilisers (used to cause sleep or sedation) such as chloral hydrate.

• Naltrexone may prevent buprenorphine from working. If you take naltrexone whilst you are taking buprenorphine you may experience a sudden onset of prolonged and intense withdrawal symptoms.
• Clonidine (used to treat high blood pressure) may extend the effects of this medicine.
• Anti-retrovirals (used to treat AIDS) such as ritonavir, nelfinavir, indinavir may increase the

effects of this medicine.

• Some antifungal agents (used to treat fungal infections) such as ketoconazole and itraconazole and certain antibiotics (macrolide) may extend the effects of this medicine.
• Some medicines may decrease the effect of buprenorphine. These include medicines used to treat epilepsy (such as carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).

To get the greatest benefit from taking buprenorphine, you must tell your doctor about all the medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicine you are taking that has not been prescribed for you by your doctor.

Natzon Sublingual Tablets with food and drink

Alcohol may increase drowsiness and may increase the risk of respiratory failure (inability to breathe) if taken with Natzon sublingual tablets. Do not take Natzon sublingual tablets together with alcohol. Do not swallow or consume food or drink until the tablet is completely dissolved.

Pregnancy and breast-feeding

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

Do not take Natzon Sublingual Tablets if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Natzon Sublingual Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms including problems with breathing after the birth which may need to be treated. These symptoms may occur several days after birth.

Do not take Natzon Sublingual Tablets while you are breastfeeding as Buprenorphine passes into breast milk and will affect your baby.

Driving and using machines

If you feel drowsy or dizzy while taking these tablets do not use machinery.

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:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

o 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.

Natzon Sublingual Tablets contain lactose

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

Important information about Natzon Sublingual Tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’

3. how to take natzon sublingual tablets

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

You must place the tablet under your tongue (sublingual) and allow it to dissolve, which will take 5–10 minutes. This is the only way to take the tablets. Do not chew or swallow them m whole, as they will not work.

Your doctor will tell you how many tablets to take and you should always follow this advice.

To avoid sudden withdrawal symptoms, treatment with buprenorphine should be given when there are already clear signs of withdrawal symptoms.

Your prescriber should discuss your treatment and whether you need to continue taking tablets at regular intervals. If you and your prescriber decide to stop treatment, a plan will be put in place to gradually reduce the dose and stop taking the medicine to minimise the risk of withdrawal effects.

Adults and children over the age 16 years: when beginning treatment the dose is between 0.8 mg to 4 mg, taken once a day.

For drug addicts who have not had any withdrawal treatment: dose of buprenorphine should be taken at least 6 hours after the last use of the opioid (narcotic such as morphine or heroin), or when the first signs of craving appear. If you take it less than six hours after you use a narcotic you may get withdrawal symptoms.

For patient taking methadone: before beginning treatment, your doctor should reduce your dose of methadone to not more than 30 mg a day. Buprenorphine may cause withdrawal symptoms in patients who are dependent on methadone, if used within 24 hours of the last dose methadone.

During your treatment, your doctor may increase your dose of buprenorphine to a maximum single daily dose of 32 mg, depending upon your response. Once you have been stable for a while, your doctor will gradually reduce your dose and it may be possible to stop it altogether. Do not suddenly stop taking the tablets, as this may cause withdrawal symptoms.

If you take more Natzon Sublingual Tablets than you should

If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital as overdose with buprenorphine may cause serious and life-threatening breathing problems.

If you forget to take Natzon Sublingual Tablets

Tell your doctor as soon as possible if you miss a dose and follow his or her instructions. Do not take a double dose to make up for the forgotten dose.

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

If you stop taking Natzon Sublingual Tablets

Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. 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. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

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

4. possible side effects

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

Tell your doctor immediately or seek urgent medical attention if you experience side effects such as:

• sudden wheeziness, difficulty breathing, swelling of the eyelids, face, tongue, lips, throat or hands.

rash or itching especially those covering your whole body. These may be signs of a life-threatening

allergic reaction.

• if you start to breathe more slowly or weakly than expected (respiratory depression).
• if you start to feel faint, as this may be a sign of low blood pressure.

Also tell your doctor immediately if you experience side effects such as:

• severe fatigue (tiredness), have no appetite or if your skin or eyes look yellow. These may be symptoms of liver damage.

The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)
• common (affects 1 to 10 users in 100)
• not known (frequency cannot be estimated from the available data).

Side effects reported with Buprenorphine

Very common side effects:

Drug withdrawal syndrome, headache, hyperhidrosis (sweating), insomnia (inability to sleep), nausea (feeling sick), pain _____________­________________________­________________________­__________

Common side effects:_________­________________________­________________________­____________

Abdominal pain, agitation, anxiety, joint pain, weakness, back pain, bone pain, bronchitis, chest pain, chills, constipation, cough, decreased appetite, depression, diarrhoea, dizziness, dry mouth, painful period, indigestion, shortness of breath, flatulence, gastrointestinal disorder, hostility, increase in muscle tension, infection, influenza, nervousness, tearing (watery eyes) disorder, swollen glands (lymph nodes), malaise, migraine, muscle spasms, muscle pain, dilation of the pupil, neck pain, palpitations, paranoia, burning or tingling in hands and feet, swelling (hands and feet), sore throat and painful swallowing, fever, rash, somnolence, syncope (fainting), thinking abnormal, tooth disorder, tremor; flushing, vomiting (being sick), yawning Frequency not known: _____________­________________________­________________________­____

Drug dependence and addiction (see section ‘How do I know if I am addicted’, seizures, drug withdrawal syndrome in newborn, hallucinations (sensing things that are not real), drop in blood pressure on changing position from sitting or lying down to standing, difficulty in urinating, vertigo

Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems.

Drug Withdrawal

When you stop taking Natzon Sublingual Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

ow do I know if I am addicted?

If you notice any of the following signs whilst taking Natzon Sublingual Tablets, it could be a sign that you have become addicted.

• – You need to take the medicine for longer than advised by your prescriber

• – 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: 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 natzon sublingual tablets

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

Store your medicine in the original packaging to protect from moisture.

Do not store above 30°C.

Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. 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 to protect the environment.

6. contents of the pack and other information- the active substance is buprenorphine (as buprenorphine hydrochloride). each tablet contains 0.4mg of buprenorphine.

• – The other ingredients are lactose monohydrate, mannitol (E421), maize starch, citric acid (anhydrous), sodium citrate, povidone (plasdone K29/32), magnesium stearate, ascorbic acid and edetic acid (EDTA).

What Natzon Sublingual Tablets look like and the contents of the pack

Natzon 0.4mg Sublingual Tablets are off-white to brownish, round, biplane tablets.

Your medicine is available in blisters containing 7, 14, or 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Limited

Unit C, Harcourt Way

Leicester

LE19 1WP

United Kingdom.

Manufacturer

SMB TECHNOLOGY S.A.

39 rue du Parc Industriel

6900 Marche en Famenne

Belgium

This leaflet was last revised in November 2020.

7