DEXTRADOL 75 mg/25 mg Фильм-Коатированные Таблетки

Содержание инструкции

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

Dextradol 75 mg/25 mg film-coated tablets

Tramadol hydrochloride/dexketoprofen

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
information on safety. You can contribute by reporting any adverse effects encountered during
taking this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before 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.
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 could be dangerous. .
If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is Dextradol and what is it used for

Dextradol 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).
Dextradol is used for the symptomatic short-term treatment of acute pain from moderate to
severe in adults.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms during treatment
with Dextradol.

2. What you need to know before taking Dextradol

Do not take Dextradol:
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 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 dyspnea 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 after 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 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 or coagulation disorders;
if you are severely dehydrated (i.e. if 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 emotions;
if you are taking monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) or if you
have taken them in the last 14 days before treatment with this medicine (see “Other medicines and
Dextradol”);
if you suffer from epilepsy or convulsions, 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 Dextradol:
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;
if you suffer from heart disease, if you have had a stroke or if you think you may be at risk for such
diseases (for example, if you suffer from high blood pressure, diabetes or if you have high cholesterol
levels or if you are a smoker), you should talk to your doctor before starting this therapy as medicines
like this may be associated with a slight increase in the risk of heart attack (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 side effect occurs, see
your doctor immediately;
if you are a woman with fertility problems: this medicine may affect fertility, so you should not take it if
you are planning a pregnancy or if you are undergoing fertility tests;
if you suffer from blood and 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 inflammatory bowel disease in the past (ulcerative colitis, Crohn's disease);
if you have or have had other gastric or intestinal diseases in the past;
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 loss of consciousness (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.
Tramadol can create physical and psychological dependence. When taken for a long 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, Dextradol 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 Dextradol 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 enough 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 a doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils,
feeling unwell or sick, constipation, loss of appetite.

Children and adolescents
This medicine has not been studied in children and adolescents. Therefore, as safety and efficacy have
not 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 Dextradol
Tell your doctor if you are taking, have recently taken or might take any other medicines, including over-the-
counter medicines. Some medicines must not be taken together, while others may require a dose
adjustment when used concomitantly.
Always tell your doctor if you are using or have been prescribed any of the following medicines in addition to
Dextradol.

Not recommended use with Dextradol:
acetylsalicylic acid (aspirin), 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;
monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression).

Use that requires some precautions with Dextradol:
ACE inhibitors, diuretics, beta-blockers 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;
chlorpropamide and glibenclamide, used for diabetes;
aminoglycoside antibiotics, used to treat bacterial infections.
The concomitant use of Dextradol and sedating drugs 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 Dextradol together with sedating drugs, the dose and
duration of concomitant treatment must be limited by your doctor. Tell your doctor about any sedating
medicine you are taking and strictly follow your doctor's recommended dose. 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 Dextradol:
quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;
cyclosporine or tacrolimus, used to treat immune system diseases and 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.
The analgesic effect of tramadol may be reduced and its duration of action may be shorter if you also take
medicines containing:
carbamazepine (for epileptic 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 coughs) or
alcohol during treatment with Dextradol, you may feel drowsy or faint; if this happens, tell your doctor;
if you are taking medicines that can cause seizures (epileptic seizures), such as some
antidepressants or antipsychotics, the risk of having a seizure may increase if you take Dextradol in
conjunction with these medicines; your doctor will tell you whether Dextradol is suitable for you or not;
if you are taking certain antidepressants. Dextradol can interact with these medicines and you may
experience symptoms such as rhythmic involuntary muscle contractions (including muscles that control eye
movements), agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body
temperature above 38°C;

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
Dextradol is contraindicated in pregnancy and during breastfeeding.

Driving and using machines
Dextradol can affect your ability to drive and operate machinery because it can cause side effects such as
dizziness, drowsiness and visual disturbances. This is especially true if Dextradol is taken together with
medicines that affect mood or with alcohol.
If you experience these effects, do not drive and do not use machinery until the symptoms have disappeared.
This medicine contains less than 1 mmol of sodium (23mg) per dose, therefore it is essentially “sodium-free”.

3. How to take Dextradol

Always use this medicine exactly as your doctor has told you.
If you have any doubts, ask your doctor. The dose of Dextradol you need depends on the type, severity and
duration of your pain. Your doctor will tell you how many tablets to take each day and for how long.
Generally, the recommended dose is 1 film-coated tablet (which corresponds to 75 mg of
tramadol hydrochloride and 25 mg of dexketoprofen) every 8 hours, for a maximum of 3 film-coated
tablets 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
Dextradol 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:
Patients with severe kidney or liver failure should not take Dextradol.
In case of kidney failure, if it is mild, your doctor may advise you to prolong
the interval between doses.
In case of liver failure, if it is mild-moderate, your doctor may advise you to
prolong the interval between doses.
Swallow the tablet with sufficient liquid (preferably with a glass of water).
Concomitant intake of food slows down the absorption of Dextradol, therefore, for a faster effect,
take the tablet at least 30 minutes before meals. The score line on the tablet is to
facilitate halving if you have difficulty swallowing it whole.

If you take more Dextradol 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 with you the packaging of this
medicine or this leaflet.
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 difficulty
breathing (for tramadol).

If you forget to take Dextradol
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 Dextradol”).

If you stop taking Dextradol
Generally there are no after-effects after stopping therapy with Dextradol.
However, in rare cases, patients who have taken Dextradol tablets 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
stomach or intestinal disorders. 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 have been observed
such as confusion, illusion, a sense of detachment from oneself (depersonalization) and a different perception
of reality (derealization) and persecutory delusions (paranoia). If you experience any of these
symptoms after stopping therapy with Dextradol, 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 everybody gets them.
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 Dextradol if you notice the appearance of skin rash or lesions inside the mouth or
on mucous membranes or signs of allergy.

Very common(may affect more than 1 in 10 people):
nausea/discomfort;
drowsiness.

Common side effects(may affect up to 1 in 10 people) :
vomiting;
stomach pain;
diarrhea;
digestive problems;
headache;
dizziness, 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, weakness or collapse),
low blood pressure. These adverse effects can 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 around the eyes;
slow and/or shallow breathing;
discomfort, abnormal sensations;
blood in the urine;
feeling of dizziness;
insomnia or difficulty falling asleep;
nervousness/anxiety;
hot flashes;
flatulence;
tiredness;
pain;
feeling of fever and chills, general feeling of discomfort;
abnormal blood tests;
retching;
feeling of pressure in the stomach, abdominal bloating;
gastric inflammation;
skin reactions (e.g. itching, rash).
facial swelling.

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;
bradycardia;
seizures;
allergic/anaphylactic reactions (e.g. difficulty breathing, wheezing, skin swelling) 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, numbness, tinnitus);
tremor, muscle spasms, uncoordinated movement, muscle weakness;
confusion;
sleep disorders and nightmares;
perception disorders;
visual disturbances, pupillary constriction;
shortness of breath.
After treatment with Dextradol, 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 irritability);
changes in activity (slowing down, but sometimes an increase in activity);
reduced awareness;
reduced ability to make decisions, which can lead to poor judgment.
Worsening of asthma has been reported.
When you suddenly stop treatment, withdrawal symptoms may appear (see "If you stop taking Dextradol").
If you take Dextradol for a long time, it is possible that you may become dependent on
the medicine, although the risk is very low. When you suddenly stop treatment, withdrawal symptoms may
appear (see "If you stop taking Dextradol").
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 syndromes and Lyell's syndrome);
shortness of breath due to narrowing of the airways;
facial swelling;
shortness of breath due to narrowing of the airways;
tinnitus;
sensitive skin;
photosensitivity.

Not known(frequency cannot be estimated based on available data):
speech disorders;
extreme pupillary dilation;
decreased blood glucose levels.
Contact your doctor immediately if you experience gastrointestinal/intestinal effects
at the beginning of therapy (such as stomach pain, burning or bleeding), if you have previously suffered from
these side effects due to prolonged use of anti-inflammatory drugs and especially if you are
elderly.
The most common side effects during therapy with Dextradol 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
ankles and legs), increased blood pressure and heart failure have been observed.
Medicines like Dextradol 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 drugs 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 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 Dextradol

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 Scad.
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 Dextradol contains

• The active ingredients are tramadol hydrochloride and dexketoprofen. Each tablet contains: 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen.
• Other ingredients are: Tablet content:microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, sodium stearyl fumarate, anhydrous colloidal silica. Film coating:polyvinyl alcohol, titanium dioxide, Macrogol/PEG 3350, talc. Description of the appearance of Dextradol and contents of the packFilm-coated tablets, oblong, from almost white to slightly yellow in colour with a score line on one side to divide the tablet and an “M” engraved on the other side in blister packs made of plastic/aluminium.

Dextradol is available in packs of 2, 4, 10, 20, or 50 film-coated tablets.
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:
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy: Dextradol
Spain: Takudex 75 mg/25 mg film-coated tablets

Dextradol 75 mg/25 mg granules for oral solution in sachets

Tramadol hydrochloride/dexketoprofen

This medicinal product is subject to additional monitoring. This will allow the rapid identification of new
information on safety. You can contribute by reporting any adverse effects you experience during
taking this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before 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.
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 experience any side effects, including those not listed in this leaflet,
consult your doctor. See section 4.

Contents of this leaflet:

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

1. What is Dextradol and what is it used for

Dextradol 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).
Dextradol 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 Dextradol

Do not take Dextradol:
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 decrease the level of lipids 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 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 current 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 emotions;
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 Dextradol”);
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 Dextradol:
if you have an allergy or if you 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 (for example, if you suffer from high blood pressure, diabetes or if you have high
cholesterol levels or if you are a smoker), you should talk to your doctor before starting this
therapy as medicines like this may 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, immediately consult your doctor;
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 and 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 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 they 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 loss of consciousness (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 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, Dextradol should be administered only for short periods of time and under strict
medical supervision.
Talk to your doctor if these problems occur during therapy with Dextradol 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 may have different effects on them. Some people may not get
enough 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. Therefore, as
safety and efficacy have not 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 Dextradol
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 concomitantly.
Always tell your doctor if you are using or have been prescribed any of the following
medicines in addition to Dextradol.

Not recommended use with Dextradol:
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 Dextradol:
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 Dextradol 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 be considered only when alternative
treatments are not possible. However, if your doctor prescribes Dextradol 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 follow
strictly 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 Dextradol:
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 for the treatment of 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 epileptic 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 Dextradol. You may feel drowsy or faint; if this happens, tell your
doctor;
if you are taking medicines that can cause seizures (epileptic seizures), such as some
antidepressants or antipsychotics. The risk of having a seizure may increase if you take Dextradol
in conjunction with these medicines; your doctor will tell you whether Dextradol is suitable or not
for you;
if you are taking certain antidepressants. Dextradol may interact with these medicines and you
may have symptoms such as involuntary rhythmic contractions of the muscles (including the muscles
that control eye movements), agitation, excessive sweating, tremors, exaggeration
of reflexes, increased muscle tension, body temperature above 38°C;
if you are taking anticoagulants (blood-thinning medicines), e.g. warfarin, together with
this medicine; the effect of these medicines on blood coagulation may be altered and you may
experience bleeding.

Dextradol with alcohol
Do not drink alcohol during therapy with Dextradol as it may increase the effect of the medicine.
For instructions on how to take Dextradol 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.
Dextradol should not be used during pregnancy and breastfeeding.

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

Dextradol contains sucrose
Dextradol 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 Dextradol

Always use this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor. The dose of Dextradol 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
Dextradol 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.

Kidney or severe liver disease/patients on dialysis:
If you suffer from severe liver failure and/or moderate to severe kidney failure, you should not
take Dextradol.
If you suffer from kidney failure, if it is mild, your doctor may advise you to
prolong the interval between doses.
If you suffer from liver failure, if it is mild to 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 dissolve.
The resulting solution should be taken immediately after reconstitution.
Concomitant intake of food slows the absorption of Dextradol, therefore, for a faster effect, take the oral solution granules in a sachet at least 30 minutes before meals.

If you take more Dextradol 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 with you
the packaging of this medicine or this leaflet.
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 contraction, vomiting, heart failure, loss of consciousness, convulsions and
difficulty breathing (for tramadol).

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

If you stop taking Dextradol
Generally there are no after-effects after stopping therapy with Dextradol.
However, in rare cases, patients who have taken Dextradol 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 Dextradol, 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 Dextradol if you notice the appearance of a skin rash or lesions inside the
mouth or on 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 malaise;
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, constriction of the pupil;
shortness of breath.
After treatment with Dextradol 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
irritability);
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.
A worsening of asthma has been reported.
When you suddenly stop treatment, withdrawal symptoms may appear
(see "If you stop taking Dextradol").
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 syndromes and Lyell);
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 side effects
at the beginning of therapy (such as stomach pain, burning 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 Dextradol 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), increased blood pressure and heart failure have been observed.
Medicines such as Dextradol 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 drugs 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 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 Dextradol

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 Dextradol 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 aroma, Acesulfame potassium (E-950).

Description of the appearance of Dextradol and contents of the pack
Oral solution granules from white to almost white, supplied in heat-sealed sachets of
paper/aluminium/multilayer polyethylene sheets (as a copolymer with vinyl acetate) in a
cardboard box.
Dextradol 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
Trento, 38123
Italy

This medicinal product is authorised in the Member States of the European Economic Area (EEA)
under the following denominations:
Italy: Dextradol
Spain: Takudex