TADOMON 25 mg Extended-Release Tablet

Зміст інструкції

1. TADOMON 25 mg prolonged-release tablets, 50 mg prolonged-release tablets, 100 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets
   1. What is TADOMON and what is it used for
   2. What you need to know before you take TADOMON
   3. How to take TADOMON
   4. Possible side effects
   5. How to store TADOMON
   6. Contents of the pack and other information
2. TADOMON 100 mg is a light yellow, oblong, prolonged-release tablet and
3. TADOMON 150 mg is a light pink, oblong, prolonged-release tablet and
4. TADOMON 200 mg is a light ochre, oblong, prolonged-release tablet and

TADOMON 25 mg prolonged-release tablets, 50 mg prolonged-release tablets, 100 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets

TADOMON 250 mg prolonged-release tablets
tapentadol
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TADOMON and what is it used for

Tapentadol, the active ingredient of TADOMON, is a strong pain reliever that belongs to the
opioid class. TADOMON is administered to adults for the treatment of severe, long-term pain
that can only be adequately managed with an opioid pain reliever.

2. What you need to know before you take TADOMON

Do not take TADOMON

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from asthma or if your breathing is dangerously slow or weak (respiratory depression, hypercapnia),
• if you have no bowel movement due to severe constipation and bloating that may be accompanied by pain or discomfort in the lower abdomen,
• if you have a severe alcohol intoxication, sleeping pills, pain relievers or other psychotropic drugs (drugs that affect mood and emotions) (see 'Other medicines and TADOMON').

Warnings and precautions
Talk to your doctor or pharmacist before taking TADOMON if:

• you have slow or weak breathing,
• you have increased pressure in the brain or an altered state of consciousness that may lead to coma,
• you have had a head injury or brain tumors,
• you have problems with your liver or kidneys (see 'How to take TADOMON')
• you have a pancreatic disease, including inflammation of the pancreas (pancreatitis) or a biliary tract disease (bile duct disease)
• you are taking medicines called mixed opioid agonists/antagonists (for example, pentazocine, nalbufine) or mu-opioid partial agonists (e.g., buprenorphine)
• you have a predisposition to epilepsy or seizures or are taking other medicines capable of increasing the risk of seizures because the risk of convulsions may increase.

TADOMON can cause physical and psychological dependence. If you tend to abuse drugs
or if you are addicted to drugs, you should only take these tablets for short periods of time and
under strict medical supervision.

Sleep-related breathing disorders
TADOMON contains an active ingredient that belongs to the group of opioids. Opioids
can cause sleep-related breathing disorders, including central sleep apnea
(weak/pauses in breathing during sleep) and sleep-related hypoxemia (low
levels of oxygen in the blood).
The risk of developing central sleep apnea depends on the dose of opioids. Your doctor
may consider reducing the total opioid dosage if you experience central sleep apnea.

Other medicines and TADOMON
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. The doctor will prescribe you the medicines to take safely with TADOMON.

• The risk of side effects increases if you are taking medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of seizures may increase if you take TADOMON at the same time. Your doctor will tell you if TADOMON is suitable for you.
• The concomitant use of TADOMON and sedatives such as benzodiazepines or similar medicines (some sleeping pills or tranquilizing drugs (e.g. barbiturates) or pain relievers such as opioids, morphine and codeine (also used as a cough medicine), antipsychotics, antihistamines anti-H1, alcohol) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes TADOMON together with sedatives, the dose and duration of concomitant treatment must be established by the doctor. Tell your doctor about all the sedatives you are taking and carefully follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family about the signs and symptoms above. See a doctor when you experience these symptoms.
• If you are taking a medicine that affects serotonin levels (e.g. some medicines for the treatment of depression), consult your doctor before taking TADOMON as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but life-threatening condition. Symptoms include involuntary and rhythmic muscle contractions, including muscles that control the

movement of the eyes, agitation, excessive sweating, tremor, exaggerated reflexes,
increased muscle tension and body temperature higher than 38°C. Your doctor can
advise you.

• Taking TADOMON together with other drugs that belong to the group of μ-opioid receptor agonists/antagonists (e.g. pentazocine, nalbufine) or μ-opioid receptor partial agonists (e.g. buprenorphine) has not been studied. TADOMON may not be as effective if taken with one of these drugs. Tell your doctor if you are currently being treated with one of these drugs.
• Taking TADOMON with products (e.g. rifampicin, phenobarbital or St. John's wort) that affect the enzymes needed to remove TADOMON from the body, can affect the effectiveness of TADOMON or can cause unwanted effects. Effects may occur especially when starting or stopping the other drug.
• TADOMON should not be taken with monoamine oxidase inhibitors (MAOIs - some medicines for the treatment of depression). Tell your doctor if you are taking MAOIs or if you have taken them in the last 14 days.

Keep your doctor informed about all the medicines you are taking.

TADOMON with food, drinks and alcohol
Do not drink alcohol while taking TADOMON as some side effects, such as
drowsiness, may increase. Food does not affect the effect of these tablets.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take these tablets:

• if you are pregnant, unless your doctor has prescribed it,
• during childbirth, as it may cause dangerously slow or weak breathing (respiratory depression) in the newborn,
• during breastfeeding, as it may be excreted in breast milk.

If you become pregnant during treatment with TADOMON, see your doctor.

Driving and using machines
TADOMON can significantly affect your ability to drive a vehicle or use
machinery as it can cause drowsiness, dizziness and blurred vision and can impair
your reactions. This can happen especially when you start taking TADOMON, if
you change the dosage or if you are taking alcohol or tranquilizers.

3. How to take TADOMON

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The doctor will adjust the dose and the interval between doses based on the intensity of the
pain and your needs. In general, you should take the lowest dose capable of relieving the
pain.

Adults
The recommended dose is 1 tablet every 12 hours (i.e. 2 tablets per day).
Total daily doses of TADOMON greater than 500 mg of tapentadol are not recommended.
.
Your doctor may prescribe a different or more appropriate dosage or an interval between doses, if
he/she deems it necessary. If you think the effect of these tablets is too strong or too
weak, consult your doctor or pharmacist.

Use in children and adolescents
TADOMON should not be administered to children and adolescents under 18 years of age.

How and when to take TADOMON?

• TADOMON must be swallowed.
• Always swallow the tablets whole, with sufficient liquid.
• Do not chew, break or crush the tablet: this could cause an overdose, because the drug will be released into your body too quickly.
• You can take the tablets on an empty stomach or during meals.
• The empty tablet coating may not be completely digested and may therefore appear in the stool. This should not worry you as the drug (active substance) of the tablet has already been absorbed into the body and what you see is only the empty coating.

How long should you take TADOMON?
Do not take the tablets for a period longer than indicated by your doctor.

If you take more TADOMON than you should
After taking very high doses, the following may occur:
pinpoint pupils, vomiting, low blood pressure, tachycardia, altered consciousness,
collapse or coma (deep unconsciousness), seizures, dangerously
slow or weak breathing or respiratory arrest.
If the above occurs, you must call a doctor immediately!

If you forget to take TADOMON
If you forget to take the tablets, it is likely that the pain will return. Do not take a
double dose to make up for a missed dose, simply continue taking the tablets
as before.

If you stop taking TADOMON
If you stop or discontinue treatment too early, it is likely that the pain will
return. If you wish to stop treatment, tell your doctor first.
Usually no withdrawal effects occur when treatment is stopped.
However, in rare cases, people who have taken the tablets for some time
may experience unwanted effects if they stop taking them abruptly.
Symptoms may include:

• restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea and increased blood pressure, breathing or heart rate.

If you experience any of these disorders after stopping treatment, contact your doctor.
You should not suddenly stop taking this medicine unless your doctor
tells you otherwise. If your doctor wants you to stop taking the tablets, he/she will
tell you how to do it, this may involve a gradual reduction of the dose.
If you have any questions about 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 everyone will experience them.
If you experience the following side effects, contact your doctor immediately or go to the
nearest hospital.

• Allergic reactions. Symptoms may include shortness of breath, difficulty breathing, swelling of the eyelids, face or lips, skin rashes or itching, especially if they affect the whole body. (Frequency: Uncommon)
• If you breathe more slowly or with more difficulty than expected. This is most common in elderly and debilitated patients. (Frequency: Common)

Other side effects that may occur:
Very common (may affect more than 1 in 10 people)

• Feeling of nausea
• constipation
• dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people)

• loss of appetite
• anxiety
• depression
• difficulty sleeping
• nervousness
• restlessness
• attention disorder
• tremor
• muscle contractions
• hot flashes
• shortness of breath
• vomiting
• diarrhea
• indigestion
• itching
• increased sweating
• skin rashes
• feeling of weakness
• fatigue
• feeling of change in body temperature
• dryness of the mucous membranes
• fluid accumulation in the tissues (edema).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions
• weight loss
• disorientation
• confusion
• excitability (agitation)
• perception disorders
• abnormal dreams
• euphoria (feeling very happy)
• reduced level of consciousness
• memory impairment
• mental disorders
• fainting
• sedation
• balance disorder
• difficulty speaking
• numbness
• abnormal skin sensations (e.g. tingling, prickling)
• vision disorders
• tachycardia (faster heartbeat)
• bradycardia (slower heartbeat)
• decreased blood pressure
• abdominal discomfort
• urticaria (skin reactions)
• difficulty urinating
• increased frequency of urination
• sexual dysfunction
• drug withdrawal syndrome (see "If you stop taking TADOMON ")
• feeling of abnormality, irritability.

Rare (may affect up to 1 in 1000 people)

• drug dependence
• thought disorders
• seizures
• being about to faint
• coordination disorders
• dangerously slow or weak breathing (respiratory failure)
• altered gastric emptying
• feeling of drunkenness
• feeling of relaxation.

Not known: frequency cannot be estimated based on current data

• delirium

In general, the likelihood of having suicidal thoughts and behaviors increases in patients who
suffer from chronic pain. Furthermore, some medications for the treatment of depression (which
have an impact on the neurotransmitter system in the brain) can increase this
risk, especially at the beginning of treatment. Although tapentadol also affects
neurotransmitters, clinical use data of tapentadol in humans do not provide evidence of an
increased risk.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store TADOMON

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 packaging and on the blister
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TADOMON contains
The active ingredient is tapentadol
Each prolonged-release tablet contains 25, 50, 100, 150, 200 or 250 mg of tapentadol
(as tartrate).
The other ingredients are:
Tablet core: povidone, microcrystalline cellulose, hypromellose, colloidal anhydrous
silica, magnesium stearate.
Tablet coating for 25 mg and 250 mg: hypromellose (E464), polydextrose (E1200),
titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide
(E172), black iron oxide (E172), red iron oxide (E172).
Tablet coating for 50 mg: hypromellose (E464), polydextrose (E1200), titanium dioxide (E171),
maltodextrin, medium-chain triglycerides.
Tablet coating for 100 mg: hypromellose (E464), polydextrose (E1200), titanium dioxide
(E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172).
Tablet coating for 150 mg and 200 mg: hypromellose (E464), polydextrose (E1200),
titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide
(E172), red iron oxide (E172).

Description of the appearance of TADOMON and contents of the pack
TADOMON 25 mg is a prolonged-release tablet of light beige colour, round and
biconvex, with a diameter of approximately 8 mm.
TADOMON 50 mg is a prolonged-release tablet of white to off-white colour,
round and biconvex, with a diameter of approximately 12 mm.

TADOMON 100 mg is a light yellow, oblong, prolonged-release tablet and

biconvex, with a length of approximately 16 mm and a thickness of approximately 7 mm.

TADOMON 150 mg is a light pink, oblong, prolonged-release tablet and

biconvex, with a length of approximately 18 mm and a thickness of approximately 7.5 mm.

TADOMON 200 mg is a light ochre, oblong, prolonged-release tablet and

biconvex, with a length of approximately 18 mm and a thickness of approximately 7.5 mm.
TADOMON 250 mg is a reddish-brown, oblong and
biconvex, prolonged-release tablet, with a length of approximately 21 mm and a thickness of approximately 7.5 mm.
TADOMON is available in blisters of 7, 28, 30, 60 or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
Lannach
8502, Steiermark
Austria
Laboratorios Liconsa S.A.
Avenida Miralcampo 7
Azuqueca De Henares
19200, Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Sweden: Tapentadol Depot Liconsa
Italy: TADOMON
Czech Republic: Tapentadol Liconsa
Slovak Republic: Tapentadol Liconsa 25/50/100/150/200/250 mg tablety s predĺženým
uvoľňovaním
Austria: Tapentadol Liconsa 25/50/100/150/200/250 mg Retardtabletten
Poland: Tapentadol Liconsa
Denmark: Tapentadol Liconsa 25/50/100/150/200/250 mg depottabletter
France: Tapentadol Liconsa LP 25/50/100/150/200/250 mg, comprimés à libération prolongée