LENIZAK 75 mg/25 mg Tabletki Powlekane

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1. Lenizak 75 mg/25 mg granules for oral solution in sachet
   1. What is Lenizak and what is it used for
   2. What you need to know before taking Lenizak
   3. How to take Lenizak
   4. Possible side effects
   5. How to store Lenizak
   6. Contents of the pack and other information

Lenizak 75 mg/25 mg granules for oral solution in sachet

Tramadol hydrochloride/dexketoprofen

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

Contents of this leaflet:

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

1. What is Lenizak and what is it used for

Lenizak tablets contain the active ingredients tramadol hydrochloride and dexketoprofen.
Tramadol hydrochloride is a pain reliever that belongs to a group of drugs called opioids,
which act on the central nervous system. It relieves pain by acting on specific
nerve cells in the brain and spinal cord.
Dexketoprofen is a pain reliever that belongs to the group of drugs called non-steroidal
anti-inflammatory drugs (NSAIDs).
Lenizak is used for the symptomatic short-term treatment of acute pain from moderate
to severe in adults.

2. What you need to know before taking Lenizak

Do not take Lenizak:
if you are allergic to dexketoprofen, tramadol hydrochloride or any of the other
ingredients of this medicine (listed in section 6);
if you are allergic to acetylsalicylic acid or other NSAIDs;
if you have asthma or have suffered from asthma attacks, acute allergic rhinitis (short-term
inflammation of the nasal mucosa), nasal polyps (nodules inside the nasal cavity caused by
an allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue or
difficulty breathing) or wheezing after taking acetylsalicylic acid or other non-steroidal
anti-inflammatory drugs;
if you have had photoallergic or phototoxic reactions (redness of the skin and/or formation of
blisters on the skin following exposure to sunlight) during therapy with
ketoprofen (an NSAID) or with fibrates (medicines used to lower lipid levels in the
blood);
if you suffer from peptic ulcer, gastric or intestinal bleeding, or if you have suffered in the past
from gastric or intestinal bleeding, including episodes associated with previous use of
NSAIDs.
if you have chronic digestive disorders (e.g. indigestion, heartburn);
if you suffer from an inflammatory bowel disease (Crohn's disease or ulcerative
colitis);
if you suffer from severe heart failure, moderate or severe kidney disease or severe liver
disease;
if you suffer from bleeding disorders, coagulation disorders or ongoing bleeding;
if you are severely dehydrated (i.e. you have lost a lot of fluids) due to vomiting, diarrhea or
insufficient fluid intake;
if you have had acute episodes of alcohol intoxication, sleeping pills, painkillers or medicines that
affect mood and emotionality;
if you are taking monoamine oxidase inhibitors (MAOIs) (medicines used for the
treatment of depression) or if you have taken them within the last 14 days before treatment with
this medicine (see “Other medicines and Lenizak”);
if you suffer from epilepsy or seizures, because the risk of seizures may increase;
if you have difficulty breathing;
if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor before taking Lenizak:
if you have an allergy or have had allergies in the past;
if you suffer from kidney, liver or heart disorders (hypertension and/or heart failure) or
fluid retention or if you have suffered from any of these problems in the past;
if you are taking diuretics (substances that increase urine production);
if you suffer from heart disease, if you have had a stroke or if you think you may be at risk for such
diseases (e.g. if you suffer from high blood pressure, diabetes or have high cholesterol levels or
if you are a smoker), you should talk to your doctor before starting this therapy as
medicines like this can be associated with a slight increase in the risk of heart attacks
(myocardial infarction) or stroke. These risks are more likely with high doses and in case of
prolonged treatment; do not exceed the recommended dose or the duration of treatment
recommended;
if you are elderly, as the risk of side effects may be greater (see section 4).
If any undesirable effect occurs, consult your doctor immediately;
if you are a woman with fertility problems, this medicine may affect fertility, so
do not take it if you are planning a pregnancy or if you are undergoing
fertility tests;
if you suffer from blood or blood cell formation disorders;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system
disorders that affect connective tissue);
if you have had a chronic inflammatory bowel disease in the past (ulcerative colitis,
Crohn's disease);
if you have or have had other gastric or intestinal diseases;
if you have chickenpox, because NSAIDs, although rarely, can worsen this infection;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as
oral steroids, some antidepressants (e.g. SSRIs, i.e. selective serotonin reuptake inhibitors),
antiplatelet agents such as acetylsalicylic acid or anticoagulants such as warfarin; in these cases
consult your doctor before taking this medicine because he/she may prescribe you an additional
medicine to protect your stomach;
if you are taking other medicines containing the same active substances as this medicine, do
not exceed the maximum daily doses of dexketoprofen or tramadol;
if you think you are addicted to other painkillers (opioids);
if you suffer from consciousness disorders (feel faint);
if you are in a state of shock (a condition that can manifest with cold sweats);
if you have increased intracranial pressure (after a possible head injury or brain
disease);
if you have difficulty breathing;
if you suffer from porphyria (a condition characterized by abnormal heme metabolism).

Tramadol can create physical and psychological dependence. When taken for a long period of
time, its effect may decrease and it may be necessary to increase the dose (development of
tolerance). In patients with a tendency to abuse medicines or who are already dependent on
medicines, Lenizak should only be administered for short periods of time and under strict
medical supervision.
Talk to your doctor if these problems occur during therapy with Lenizak or if you have
had them in the past.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation of
this enzyme, which can have different effects on them. Some people may not get
sufficient pain relief, but others may experience serious side effects. If
you notice any of the following side effects, you should stop taking this medicine and
consult your doctor immediately: slowed or shallow breathing, confusion, drowsiness,
pinpoint pupils, feeling unwell or sick, constipation, loss of appetite.

Children and adolescents
This medicine has not been studied in children and adolescents. Consequently, as neither the safety nor the
efficacy have been established, it should not be used in children and
adolescents.
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol
toxicity may be worse in these children.

Other medicines and Lenizak
Tell your doctor if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription. Some medicines do
not have to be taken together, while others may require an adjustment of the
dosage if used concurrently.
Always tell your doctor if you are using or have been prescribed any of the following
medicines in addition to Lenizak.

Not recommended use with Lenizak:
acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs;
warfarin, heparin or other anticoagulant medicines;
lithium, used to treat some types of mood disorders;
methotrexate, used for rheumatoid arthritis and cancer;
hydantoin and phenytoin, used for epilepsy;
sulfamethoxazole, used for bacterial infections and other sulfonamides;
monoamine oxidase inhibitors (MAOIs) (medicines used to treat
depression).

Use that requires some precautions with Lenizak:
ACE inhibitors, diuretics and angiotensin II antagonists, used for high blood pressure and
heart disease;
pentoxifylline, used to treat chronic venous ulcers;
zidovudine, used to treat viral infections;
Sulfonylureas such as chlorpropamide and glibenclamide, used for diabetes;
aminoglycoside antibiotics, used to treat bacterial infections.
The concomitant use of Lenizak and sedatives such as benzodiazepines or benzodiazepine-related
drugs increases the risk of drowsiness, respiratory depression, coma and can be life-threatening.
Due to these risks, the concomitant use of these drugs should only be considered when alternative
treatments are not possible. However, if your doctor prescribes Lenizak together with sedatives,
the dose and duration of concomitant treatment must be limited by your
doctor. Tell your doctor about any sedative medicines you are taking and strictly follow the dose
recommended by your doctor. It may be helpful to inform friends and
family about the signs and symptoms described above. Tell your doctor when these
symptoms occur.

Use that requires caution with Lenizak:
quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;
cyclosporine or tacrolimus, used to treat immune system diseases and in organ
transplants;
streptokinase and other thrombolytic or fibrinolytic medicines, such as medicines used to break
blood clots;
probenecid, used to treat gout;
digoxin, used to treat chronic heart failure;
mifepristone, used for medical abortion;
antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
antiplatelet agents used to reduce platelet aggregation and blood clot formation;
tenofovir, deferasirox, pemetrexed;
beta-blockers, used for high blood pressure and heart problems.
The analgesic effect of tramadol may be reduced and its duration of action may be shorter if you also take medicines containing:
carbamazepine (for seizures);
buprenorphine, nalbuphine or pentazocine (painkillers);
ondansetron (against nausea).
The risk of side effects increases
if you take tranquilizers, sleeping pills, other painkillers such as morphine and codeine (even for
cough) or alcohol during treatment with Lenizak. You may feel drowsy or faint; if this happens, tell your
doctor;
if you are taking medicines that can cause seizures (seizures), such as some
antidepressants or antipsychotics. The risk of having a seizure may increase if you take Lenizak in
conjunction with these medicines; your doctor will tell you whether Lenizak is suitable or not for you;
if you are taking certain antidepressants. Lenizak may interact with these medicines and you
may experience symptoms such as rhythmic involuntary muscle contractions (including muscles that
control eye movements), agitation, excessive sweating, tremors, exaggerated
reflexes, increased muscle tension, body temperature above 38°C;
if you are taking anticoagulants (blood thinners), e.g. warfarin, together with
this medicine; the effect of these medicines on blood coagulation may be altered and you may experience
bleeding.

Lenizak with alcohol
Do not drink alcohol during therapy with Lenizak as it may increase the effect of the medicine.
For instructions on how to take Lenizak see section 3.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
Tramadol is excreted in breast milk.
Lenizak should not be used during pregnancy and breastfeeding.

Driving and using machines
Lenizak may affect your ability to drive vehicles and use machines because it may cause side effects such as
dizziness, blurred vision, drowsiness. This is especially true if
Lenizak is taken together with medicines that affect mood or together with alcohol.
If you notice these effects, do not drive and do not use machinery until the symptoms disappear.

Lenizak contains sucrose
Lenizak contains 2.7 g of sucrose per dose. This must be taken into account in people
affected by diabetes mellitus. If you have been diagnosed with sugar intolerance, contact
your doctor before taking this medicine.

3. How to take Lenizak

Always use this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor. The dose of Lenizak you need depends on the type, severity and duration of your pain. Your doctor will tell you how many sachets to take each day and for how long.
Generally, the recommended dose is 1 sachet (which corresponds to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen) every 8 hours, for a maximum of 3 sachets per day (which corresponds to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen) without exceeding 5 days of treatment.

Use in children and adolescents
Lenizak is not indicated in children and adolescents.

Elderly patients
If you are 75 years of age or older, your doctor may advise you to prolong the time interval between doses because your body may eliminate the medicine more slowly.

Severe kidney or liver disease/patients on dialysis:
If you have severe liver failure and/or moderate to severe kidney failure, you must not take Lenizak.
If you have kidney failure, if it is mild, your doctor may advise you to prolong the interval between doses.
If you have liver failure, if it is mild-moderate, your doctor may advise you to prolong the interval between doses.
Dissolve the entire contents of each sachet in a glass of water; shake/stir well to help dissolution.
The resulting solution must be taken immediately after reconstitution.
Concomitant intake of food slows down the absorption of Lenizak, therefore, for a faster effect, take the oral solution granules in a sachet at least 30 minutes before meals.

If you take more Lenizak than you should
If you take an excessive amount of this medicine, inform your doctor immediately or go to the emergency room of the nearest hospital, remembering to bring the packaging of this medicine or this leaflet with you.
The symptoms of an overdose with this medicine are:
vomiting, loss of appetite, stomach pain, dizziness, drowsiness/feeling of loss of balance, disorientation, headache (for dexketoprofen);
pupil constriction, vomiting, heart failure, loss of consciousness, convulsions and breathing difficulties (for tramadol).

If you forget to take Lenizak
Do not take a double dose to make up for a missed dose. Take the next dose regularly at the usual time (see section 3 “How to take Lenizak”).

If you stop taking Lenizak
Generally, there are no subsequent effects after stopping therapy with Lenizak.
However, in rare cases, patients who have taken Lenizak oral solution granules in a sachet for some time may not feel well if they suddenly stop taking it.
They may feel agitated, anxious, nervous or weak, confused, hyperactive, have difficulty sleeping and have gastrointestinal disturbances. Rarely, some people may experience panic attacks, hallucinations, illusions, paranoia or a sense of loss of identity. They may experience unusual perceptions such as itching, tingling and numbness and tinnitus (ringing in the ears). Rarely, other unusual symptoms such as confusion, illusion, a sense of detachment from oneself (depersonalization) and a different perception of reality (derealization) and persecutory delusions (paranoia) have been observed. If you experience any of these symptoms after stopping therapy with Lenizak, consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The possible side effects are listed below according to their frequency of occurrence.
You should immediately consult a doctor if you experience symptoms of an allergic reaction such as
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives together with
difficulty breathing.
Stop taking Lenizak if you notice the appearance of skin rash or lesions inside the
mouth or on the mucous membranes or signs of allergy.

Very common(may affect more than 1 in 10 people):
nausea/malaise;
dizziness;

Common side effects(may affect up to 1 in 10 people) :
vomiting;
stomach pain;
diarrhea;
digestive problems;
headache;
drowsiness, fatigue;
constipation;
dry mouth;
increased sweating.

Uncommon side effects(may affect up to 1 in 100 people):
increased number of platelets;
effects on the heart and blood circulation (palpitations, tachycardia, feeling of
fainting or collapse), low blood pressure. These adverse effects may occur
especially when patients are in an upright position or under physical exertion;
high or very high blood pressure;
swelling (edema) of the larynx;
reduced levels of potassium in the blood;
psychotic disorders;
swelling in the eye area;
slow and/or shallow breathing;
discomfort, abnormal sensations;
blood in the urine;
feeling of dizziness;
insomnia or difficulty falling asleep;
nervousness/anxiety;
flushing;
flatulence;
tiredness;
pain;
feeling of fever and chills, general feeling of unwellness;
abnormal blood tests;
retching;
feeling of pressure in the stomach, abdominal bloating;
gastric inflammation;
skin reactions (e.g. itching, rash);
swelling of the face.

Rare side effects(may affect up to 1 in 1,000) :
swelling of the lips and throat;
peptic ulcer, perforation or bleeding from a peptic ulcer, which may be revealed by
the presence of blood in the vomit or black stools;
prostate disorders;
liver inflammation (hepatitis), liver damage;
acute renal failure;
slowed heartbeat (bradycardia);
seizures;
allergic/anaphylactic reactions (e.g. difficulty breathing, wheezing, swelling of the
skin) and anaphylactic shock (sudden circulatory failure);
transient loss of consciousness (syncope);
hallucinations;
fluid retention or swollen ankles;
loss of appetite, changes in appetite;
acne;
back pain;
frequent or less frequent urination than normal, with difficulty or pain;
menstrual disorders;
abnormal sensations (such as itching, tingling, numbness);
tremor, muscle spasms, uncoordinated movement, muscle weakness;
confusion;
sleep disorders and nightmares;
disturbances of perception;
blurred vision, pupillary constriction;
shortness of breath.
After treatment with Lenizak, you may experience psychological side effects. These can be
of varying intensity and nature (depending on the patient's personality and the duration of therapy):
changes in mood (mainly increased mood, occasionally
irritation);
changes in activity (slowing down, but sometimes an increase in activity);
reduced awareness;
reduced ability to make decisions, which can lead to errors in judgment.
Worsening of asthma has been reported.
When you suddenly stop treatment, withdrawal symptoms may appear
(see "If you stop taking Lenizak").
Seizures have been observed especially with high doses of tramadol or when tramadol
was taken together with other medicines that can induce such seizures.

Very rare(may affect up to 1 in 10,000) :
pancreatitis;
kidney problems;
reduced number of white blood cells (neutropenia);
reduced number of platelets in the blood (thrombocytopenia);
lesions on skin, mouth, eyes and genitals (Stevens Johnson syndrome and Lyell's syndrome);
shortness of breath due to narrowing of the airways;
ringing in the ears (tinnitus);
sensitive skin;
photosensitivity.

Not known(frequency cannot be estimated based on available data):
speech disorders;
extreme dilation of the pupil;
reduction in blood glucose levels.
Contact your doctor immediately if you experience gastrointestinal/intestinal side effects
at the beginning of therapy (such as stomach pain, heartburn or bleeding), if you have
previously suffered from these side effects due to prolonged use of
anti-inflammatory medicines and especially if you are elderly.
The most common side effects during therapy with Lenizak are nausea and drowsiness, which occur in
more than 1 in 10 patients.
During therapy with NSAIDs, fluid retention and swelling (especially
at the level of the ankles and legs), an increase in blood pressure and heart failure have been observed.
Medicines like Lenizak may be associated with a slightly increased risk of
heart attack or stroke.
In patients with autoimmune disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines can
rarely cause fever, headache and stiff neck.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor.
You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Lenizak

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 sachet
after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions or temperature.
Store in the original packaging to protect the medicine from light.
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 Lenizak contains

• The active ingredients are tramadol hydrochloride and dexketoprofen. Each sachet contains: 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen (as dexketoprofen trometamol).
• The other ingredients are Sucrose, Lemon flavour, Acesulfame potassium (E-950).

Description of the appearance of Lenizak and contents of the pack
Oral solution granules from white to almost white, supplied in heat-sealed sachets of
paper/aluminium/multi-layer polyethylene sheets (as a copolymer with vinyl acetate) in a
cardboard box.
Lenizak is available in packs of 2, 3, 10, 15, 20, 50, 100 and 500 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 – Luxembourg
Manufacturer

E-Pharma Trento S.p.A.
Frazione Ravina, Via Provina, 2
38123, Trento (TN)
Italy

This medicinal product is authorised in the Member States of the European Economic Area EEA
with the following denominations:
Austria Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary,
Ireland, Iceland, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, The Netherlands, Norway,
Poland, Portugal, Romania, Slovak Republic, Slovenia, Sweden, United Kingdom: Skudexa
France: Skudexum
Italy: Lenizak
Spain: Enanplus