Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zubsolv

Document Subject

Generated Narrative: MedicinalProductDefinition mpcfd694ab9fea1a901bb7d3272079545a

identifier: http://ema.europa.eu/identifier/EU/1/17/1233/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zubsolv 0.7 mg/0.18 mg sublingual tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-cfd694ab9fea1a901bb7d3272079545a

identifier: http://ema.europa.eu/identifier/EU/1/17/1233/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zubsolv

Attesters

What is in this leaflet

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

Zubsolv contains the active substances buprenorphine and naloxone. Zubsolv is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Zubsolv is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.

How Zubsolv works The tablet contains buprenorphine which is responsible for the treatment of opioid (narcotic) dependence. It also contains naloxone which is used to deter intravenous abuse of the product.

Do not take Zubsolv if you:

• are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6)
• have serious breathing problems
• have serious liver problems
• are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion, or hallucinations caused by alcohol
• are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence

Warnings and precautions

• Misuse, abuse and diversion Serious cases of infections with potential fatal outcome may occur if Zubsolv is misused, by taking it intravenously. 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 (see section 5). Do not give this medicine to anyone else. It can cause death or otherwise harm them.

• Breathing problems (see also Do not take Zubsolv above ) Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.

This medicine should be used with care in patients with pre-existing breathing problems

This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-opioid dependent people who accidentally or deliberately take it.

• Drowsiness This medicine can cause drowsiness, particularly when taken together with alcohol or other central nervous system depressants (such as tranquilisers, sedatives or hypnotics).

• Dependence This medicine can cause dependence.

• Liver damage Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is misused. This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines that can harm your liver (see section 4). Regular blood tests may be conducted by your doctor to monitor the condition of your liver. Tell your doctor if you have any liver problems before you start treatment with Zubsolv.

• Withdrawal symptoms This medicine can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.

Zubsolv can also cause withdrawal symptoms if you stop taking it abruptly.

• Blood pressure This medicine may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.

• Sleep-related breathing disorders
  Zubsolv can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

• Children and adolescents You may be more closely monitored by your doctor if you are below the age of 18. This medicine should not be taken by those under 15 years of age.

• Diagnosis of unrelated medical conditions This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. Do not forget to advise your doctor if you take this medicine.

Talk to your doctor before taking Zubsolv if you:

• have a depression or other conditions that are treated with antidepressants. The use of these medicines together with Zubsolv can lead to serotonin syndrome, a potentially life-threatening condition (see Other medicines and Zubsolv )
• have kidney problems
• have recently suffered a head injury or brain disease
• have low blood pressure, enlarged prostate gland or difficulties passing water because of narrowing of the urethra
• have under-active thyroid gland which can cause tiredness or weight gain
• have poor adrenal gland function (e.g. Addison s disease)
• have problems with the biliary tract (e.g. gall bladder, bile duct)
• are elderly
• are debilitated

Other medicines and Zubsolv Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines may increase the side effects of Zubsolv and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Zubsolv without first talking to your doctor, especially:

• anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Zubsolv 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.
• Naltrexone and nalmefene (drugs used to treat addictive disorders) as they may prevent the therapeutic effects of Zubsolv. They must not be taken at the same time as Zubsolv treatment because you may experience a sudden onset of prolonged and intense withdrawal.
• Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam. Concomitant use of Zubsolv 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 Zubsolv 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.
• Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain and other mental disorders. These types of medicines will reduce your alertness levels making it dangerous 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:

• other opioid containing medicines such as methadone, certain pain killers and cough suppressants
• some anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors (MAOIs) may increase the effects of this medicine
• sedative H receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine
• barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital
• tranquilisers (used to cause sleep or sedation) such as chloral hydrate
• clonidine (used to treat high blood pressure) and related medicines may extend the effects of this medicine

• anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine
• some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole and certain antibiotics, may extend the effects of this medicine
• some medicines may decrease the effect of Zubsolv. These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin)

Zubsolv with food, drink and alcohol Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Zubsolv. Do not take Zubsolv together with alcohol. Do not swallow or consume food or any drink until the tablet is completely dissolved.

Pregnancy and breast-feeding The risks of using Zubsolv in pregnant women are not known. Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will decide if your treatment should be continued with an alternative medicine. When taken during pregnancy, particularly late pregnancy, medicines like Zubsolv may cause drug withdrawal symptoms including problems with breathing in your newborn baby. This may appear several days after birth.

Do not breast-feed whilst taking this medicine, since Zubsolv passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines Zubsolv may cause drowsiness, dizziness or impair your thinking. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Zubsolv. Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.

Zubsolv contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

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

Your treatment is prescribed and monitored by doctors who are experienced in the treatment of drug dependence.

Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending upon your response.

Starting treatment The recommended starting dose for adults and adolescents over the age of 15 years is:

• one tablet of Zubsolv 1.4 mg/0.36 mg each day, or

• one tablet of Zubsolv 2.9 mg/0.71 mg each day

An additional tablet of the Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg may be administered on Day 1 depending on your needs.

There are other strengths that are available to be used by your doctor who will decide what is the best treatment for you. This may involve taking a combination of different strengths, but your daily dose should not exceed 17.2 mg of buprenorphine.

Clear signs of withdrawal should be evident before taking your first dose of Zubsolv. A doctor s assessment of your readiness for treatment will guide the timing of your first Zubsolv dose.

• Starting treatment of Zubsolv whilst dependent on heroin: If you are dependent upon heroin or a short acting opioid, your first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids

• Starting treatment of Zubsolv whilst dependent on methadone: If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Zubsolv therapy. The first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone

Taking Zubsolv

• Take the dose once a day or as advised by your doctor.

• Remove the tablet as described below. Only open the blister immediately before taking the dose. Never open in advance as the tablet is sensitive to moisture.

• Place the tablets under the tongue

• Keep the tablets in place under the tongue until they have completely dissolved

• Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms

• Do not consume any food or drink until the tablets have completely dissolved. Whilst you may notice that most of the table disintegrates within 40 seconds, it may take 5 to 10 minutes for the entire table to disappear from your mouth

How to remove the tablet from the blister

1. Do not push the tablet through the foil.

2. Remove just one section from the blister pack, tearing it along the perforated line.

3. Fold the packet along the dotted line.

4. Tear following the direction of the arrow. If the blister is damaged, discard the tablet.

Dose adjustment and maintenance therapy Your doctor may increase the dose of Zubsolv you take according to your needs. If you feel that the effect of Zubsolv is too strong or too weak, talk to your doctor or pharmacist. The maximum daily dose is 17.2 mg.

After a period of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.

Stopping treatment Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you.

Depending on your condition, the dose of Zubsolv may continue to be reduced under careful medical supervision, until eventually it may be stopped.

If you take more Zubsolv 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 for treatment as overdose with Zubsolv may cause serious and life-threatening breathing problems.

Symptoms of overdose may include breathing more slowly and weakly than normal, feeling more sleepy than normal, reduction in the size of the pupils, low blood pressure, feeling sick, vomit and/or slurred speech.

If you forget to take Zubsolv Tell your doctor as soon as possible if you miss a dose.

If you stop taking Zubsolv Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. Stopping treatment suddenly may cause withdrawal symptoms.

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

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

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

• swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash. These may be signs of a life-threatening allergic reaction
• feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you
• severe tiredness, itching with yellowing of skin or eyes. These may be symptoms of liver damage
• seeing or hearing things that are not there (hallucinations)

Other side effects Very common side effects (may affect more than one in 10 people):

• insomnia (inability to sleep)
• headache
• constipation, nausea
• excessive sweating
• drug withdrawal syndrome

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

• flu-like symptoms, infection, sore throat and painful swallowing, runny nose
• anxiety, depression, decreased sexual drive, nervousness, abnormal thinking
• migraines, dizziness, fainting, increase in muscle tension, tingling, drowsiness
• increased tearing (watering eyes) or other tearing disorder, blurred vision
• increased blood pressure, flushing
• increased cough
• abdominal pain, upset stomach or other stomach discomfort, diarrhoea, flatulence, vomiting
• rash, itching, hives
• back pain, joint pain, muscle pain, leg cramps (muscle spasm)
• urine abnormality
• difficulty in getting or keeping an erection
• weakness, chest pain, chills, fever, feeling of general discomfort, pain, swelling (hands and feet)
• abnormal liver function, weight loss
• accidental injury caused by loss of alertness or co-ordination

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

• abnormal blood tests, swollen glands (lymph nodes)
• abnormal dreams, agitation, loss of interest, depersonalisation (not feeling like yourself), medicine dependence, exaggerated feeling of well-being, feelings of hostility
• amnesia (memory disturbance), convulsion (fits), speech disorder, tremor
• eye inflammation or infection, small pupil size
• rapid or slow heartbeat, myocardial infarction (heart attack), palpitations, chest tightness
• low blood pressure
• asthma, shortness of breath, yawning
• pain and sores in mouth, tongue discolouration
• acne, hair loss, dry or scaling skin, skin nodule
• inflammation of joints
• protein in your urine, urinary tract infection, difficulty urinating, painful or difficult urination, blood in urine, kidney stone
• menstrual or vaginal problems, abnormal ejaculation
• sensitivity to heat or cold
• heat stroke
• excessive muscle activity
• loss of appetite

Not known (frequency cannot be estimated from the available data):

• slow or difficult breathing
• liver injury with or without jaundice
• hallucinations
• swelling of face and throat or life threatening allergic reactions
• drop in blood pressure on changing position from sitting or lying down to standing
• sudden withdrawal syndrome caused by taking product too soon after use of illicit opioids,
• drug withdrawal syndrome in newborn babies

Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see section 2, Warnings and precautions).

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store below 25 C. Store in the original package in order to protect from moisture.

Zubsolv can be a target for people who abuse prescription medicine. Keep this medicine in a safe place to protect it from theft.

Store the blister safely.

Never open the blister in advance.

Do not take this medicine in front of children.

An emergency unit should be contacted immediately in case of accidental ingestion or suspicion of ingestion.

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.

What Zubsolv contains The active substances are buprenorphine and naloxone.

Each 0.7 mg/0.18 mg sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).

Each 1.4 mg/0.36 mg sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).

Each 2.9 mg/0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).

Each 5.7 mg/1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).

Each 8.6 mg/2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).

Each 11.4 mg/2.9 mg sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).

The other ingredients are mannitol, citric acid, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica and sodium stearyl fumarate (see section 2 "Zubsolv contains sodium").

What Zubsolv looks like and contents of the pack

Zubsolv is available in six different strengths, differentiated by shape and debossing:

Zubsolv tablet strength (buprenorphine/naloxone) Zubsolv tablet description Zubsolv tablet debossing Appearance 0.7 mg/0.18 mg A white to off-white, oval tablet, length 6.8 mm and width 4.0 mm .7 on one side

1.4 mg/0.36 mg A white to off-white, triangular tablet, base 7.2 mm and height 6.9 mm 1.4 on one side

2.9 mg/0.71 mg A white to off-white, D- shaped tablet, height 7.3 mm and width 5.65 mm 2.9 on one side

5.7 mg/1.4 mg A white to off-white, round tablet, 7 mm in diameter 5.7 on one side

8.6 mg/2.1 mg A white to off-white, diamond shaped tablet, length 9.5 mm and width 8.2 mm 8.6 on one side

11.4 mg/2.9 mg A white to off-white, capsule shaped tablet, length 10.3 mm and width 8.2 mm 11.4 on one side

Zubsolv is available in blisters of 7, 28 or 30 sublingual tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n
Edifici Est 6 planta
08039 Barcelona
Spain

Manufacturer
Orexo AB
Virdings all 32 A
Uppsala 754 Sweden

This leaflet was last revised in MM/YYYY.

Detailed information on this medicine is available on the European Medicines Agency web site: