TRAMADOLO 100 mg /2 Ml Инъекционный Раствор

Содержание инструкции

1. TRAMADOLO S.A.L.F. 50 mg /ml injectable solution, 100 mg /2 ml injectable solution
   1. What is TRAMADOLO S.A.L.F. and what is it used for?
   2. What you need to know before you take TRAMADOLO S.A.L.F.
   3. How to use TRAMADOLO S.A.L.F.
   4. Possible side effects
   5. How to store TRAMADOLO S.A.L.F.
   6. Package contents and other information

TRAMADOLO S.A.L.F. 50 mg /ml injectable solution, 100 mg /2 ml injectable solution

Generic medicine
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 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

• 1. What TRAMADOLO S.A.L.F. is and what it is used for.
• 2. What you need to know before you use TRAMADOLO S.A.L.F.
• 3. How to use TRAMADOLO S.A.L.F.
• 4. Possible side effects
• 5. How to store TRAMADOLO S.A.L.F.
• 6. Contents of the pack and other information

1. What is TRAMADOLO S.A.L.F. and what is it used for?

Tramadol hydrochloride is an analgesic (against pain) derived from the opioid class, acting at the
level of the central nervous system. It reduces pain by acting on specific nerve cells in the spinal
cord and brain.
TRAMADOLO S.A.L.F. is used for the treatment of moderate to severe pain, of various types and causes,
as well as for pain caused by diagnostic and surgical procedures.

2. What you need to know before you take TRAMADOLO S.A.L.F.

Do not use TRAMADOLO S.A.L.F.

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6);
• in acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (drugs that affect mood and emotions);
• if you are also taking MAO inhibitors (some drugs used to treat depression) or if you have taken them within the last 14 days before treatment with TRAMADOLO S.A.L.F. (see “Other medicines and TRAMADOLO S.A.L.F.”);
• if you have epilepsy and your seizures are not adequately controlled by therapy;
• as a substitute in drug detoxification therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRAMADOLO S.A.L.F.:

• if you think you are using other pain medications (opioids) excessively;
• if you suffer from consciousness disorders (if you feel faint);
• if you are in a state of shock (cold sweats may be a sign of it);
• if you have increased pressure in the brain (possible after a head injury or brain disease);
• if you have difficulty breathing;
• if you are prone to epilepsy or seizures, as the risk of an attack may increase;
• if you suffer from liver or kidney disease;
• if you suffer from depression and are taking antidepressants, as some of them may interact with tramadol (see “Other medicines and TRAMADOLO S.A.L.F.”).

Seizures have been reported in patients taking tramadol at recommended dosages. The
risk may increase when tramadol dosages exceed those recommended, beyond the daily limit dose of 400 mg.
TRAMADOLO S.A.L.F. can lead to physical and psychological dependence. When TRAMADOLO S.A.L.F. is
administered for a long period, its effect may decrease, therefore higher doses must be administered (development of tolerance). In patients with a tendency to abuse medicines or who are
dependent on medicines, TRAMADOLO S.A.L.F. should be taken for short periods and under strict
medical control.
There is a slight risk that you may develop so-called serotonin syndrome, which may
occur after taking tramadol together with certain antidepressants or tramadol in
monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with
this serious syndrome (see section 4 “Possible side effects”).
Sleep-related breathing disorders:
Tramadol S.A.L.F. can cause sleep-related breathing disorders such as sleep apnea
(pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to labored breathing, difficulty staying asleep, or excessive daytime sleepiness. If you or another
person observes these symptoms, contact your doctor, who may consider reducing the dose.
Tell your doctor if any of these problems occur during treatment with TRAMADOLO S.A.L.F.
or have occurred previously:
extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
These symptoms may be indicative of adrenal insufficiency (low levels of cortisol). If you experience
these symptoms, contact your doctor, who will decide if you need hormone replacement therapy.
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
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, constricted pupils,
feeling unwell or ill, constipation, loss of appetite.

Other medicines and TRAMADOLO S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
TRAMADOLO S.A.L.F. should not be taken together with MAO inhibitors (some medicines used for
depression).
The intensity and duration of the analgesic effect of TRAMADOLO S.A.L.F. may be reduced if you are
taking medicines that contain:

• carbamazepine (for epilepsy);
• ondansetron (to prevent nausea). Your doctor will tell you if and what dosages of TRAMADOLO S.A.L.F. you should take.

The risk of side effects increases:

• if you are taking tranquilizers, sleeping pills, other painkillers such as morphine and codeine (even when taken for cough), and alcohol together with TRAMADOLO S.A.L.F.. You may feel drowsy or weak. In these cases, consult your doctor.
• if you are taking medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having an attack may increase if you take TRAMADOLO S.A.L.F. at the same time. Your doctor will tell you if TRAMADOLO S.A.L.F. is suitable for you.
• if you are taking certain antidepressants. TRAMADOLO S.A.L.F. may interact with these drugs and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with TRAMADOLO S.A.L.F.. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Concomitant use with sedative medicines such as benzodiazepines or related medicines
The concomitant use of TRAMADOLO S.A.L.F. .and sedative medicines such as benzodiazepines or related
medicines 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 treatments are not possible.
However, if your doctor prescribes TRAMADOLO HYDROCHLORIDE S.A.L.F. together with sedative medicines, the
dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and strictly follow the dose
recommended by the doctor. It may be helpful to inform friends or family members to pay attention to the signs
and symptoms reported above. See a doctor when these symptoms occur.

TRAMADOLO S.A.L.F. with food, drinks and alcohol
Do not drink alcohol during treatment with TRAMADOLO S.A.L.F., as its effect may be
increased.
Food intake does not affect the effect of TRAMADOLO S.A.L.F..

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.

Pregnancy, breastfeeding and fertility
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.
There is limited information regarding the safety of tramadol in pregnant women. Therefore, if
you are pregnant, you should not use TRAMADOLO S.A.L.F.. Chronic use during pregnancy may lead
to withdrawal symptoms in newborns.
Generally, the use of tramadol is not recommended during breastfeeding. Small amounts of
tramadol are secreted into breast milk. Usually, after a single dose, it is not necessary
to stop breastfeeding. Ask your doctor for advice.
There is limited data on the effects of TRAMADOLO S.A.L.F. on fertility.

Driving and using machines
TRAMADOLO S.A.L.F. can cause drowsiness, dizziness and vision problems (blurred vision). If you feel
that your ability to react is affected, do not drive machines or other vehicles or use power tools
that require a secure support.

TRAMADOLO S.A.L.F. contains sodium
TRAMADOLO S.A.L.F. contains less than 1 mmol of sodium (23 mg) per ml, therefore it is essentially “sodium
free”.

3. How to use TRAMADOLO S.A.L.F.

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to pain. In
general, the lowest dose that reduces the pain should be taken. Generally, a
daily dose of up to 8 ml of TRAMADOLO S.A.L.F. injectable solution (equivalent to 8 vials of 50
mg or 4 vials of 100 mg, equivalent to 400 mg of tramadol hydrochloride) is sufficient, unless your
doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the recommended dose is:

Adults and adolescents over 12 years of age
Inject 1 or 2 ml (equivalent to 50 or 100 mg of tramadol hydrochloride) according to the intensity of the pain, every
4-6 hours.

Children over 1 year of age
The usual single dose is 1-2 mg of tramadol hydrochloride per kg of body weight. The
lowest dose that reduces the pain should be taken. Daily doses of more than 8 mg of active
substance per kg of body weight or 400 mg of active substance should not be exceeded.

Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this is the
case, your doctor may advise you to extend the time interval between doses.

Patients with severe hepatic or renal insufficiency/dialysis
Patients with severe hepatic and/or renal insufficiency should not take TRAMADOLO S.A.L.F. In case
of mild or moderate insufficiency, your doctor may advise you to extend the time interval between
doses.

How and when to administer TRAMADOLO S.A.L.F.
TRAMADOLO S.A.L.F. injectable solution should be injected slowly, into a vein (usually in the arm) or
into the muscle (usually in the buttock) or subcutaneously. TRAMADOLO S.A.L.F. injectable solution can
be diluted in a suitable infusion solution and infused into a vein.

Incompatibilities of TRAMADOLO S.A.L.F.
TRAMADOLO S.A.L.F. injectable solution should not be diluted in injectable or infusion solutions that
contain: diclofenac, piroxicam, indometacin, phenylbutazone, diazepam, flunitrazepam, midazolam,
nitroglycerin.
The injectable solution is compatible with solutions of sodium chloride 0.9%, glucose 5% and Ringer lactate
for up to 24 hours if stored at temperatures of 2-8°C and 25°C.

For how long should you take TRAMADOLO S.A.L.F.
Do not administer TRAMADOLO S.A.L.F. for longer than necessary. If you need to continue the
treatment for a long period, your doctor will subject you to checks at short and regular intervals (if
necessary temporarily interrupting therapy) to establish whether you should continue the
treatment and with what dose.
If it seems to you that the analgesic effect of TRAMADOLO S.A.L.F. is too strong or too weak, consult your
doctor or pharmacist.

If you take more TRAMADOLO S.A.L.F. than you should
If you have been given an extra dose by mistake, it should not have any negative effects. You can
continue to administer the medicine as prescribed.
After very high doses, the following may occur: pinpoint pupils, vomiting, low blood pressure,
fast heartbeat, collapse, disturbances of consciousness up to coma (profound unconsciousness), seizures,
and difficulty breathing up to respiratory arrest. In these cases, call your doctor
immediately.

If you forget to take TRAMADOLO S.A.L.F.
If TRAMADOLO S.A.L.F. has not been administered, it is likely that the pain will return. Do not take a
double dose to compensate for the missed dose, but continue the treatment according to the
instructions.

If you stop the treatment with TRAMADOLO S.A.L.F.
If you stop or terminate the treatment too early, it is likely that the pain will return.
If you wish to interrupt the treatment due to undesirable effects, consult your doctor.
You should not suddenly stop taking this medicine unless prescribed
by your doctor. If you intend to stop taking the medicine, talk to your doctor first, especially
if you have been taking it for a long time. The doctor will advise you when and how to stop it. This can happen
by gradually decreasing the dose to reduce the likelihood of developing unnecessary side effects (withdrawal symptoms).
Generally, when the treatment with TRAMADOLO S.A.L.F. is terminated, no withdrawal effects occur.
However, in rare cases, some people who have taken TRAMADOLO S.A.L.F. for a certain period of
time, when they suddenly stop taking it, may not feel well.
In fact, they may:

• feel agitated, anxious, nervous or weak
• be hyperactive, have difficulty sleeping or have stomach or intestinal disorders
• have panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• have other unusual rare CNS symptoms such as confusion, delusion, change in perception of one's personality (depersonalization) and changes in perception of reality (derealization) and sense of persecution (paranoia).

If you experience any of these symptoms after stopping the use of TRAMADOLO S.A.L.F., see
your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Seek immediate medical attention if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• urticaria (hives)
• difficulty breathing.

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

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, fast heartbeat, feeling faint or collapse). These side effects can occur particularly in patients in an upright position or during physical exertion
• urge to vomit (nausea), stomach pain (feeling of pressure in the stomach, bloating), diarrhea
• skin reactions (itching, rash)

Rare (may affect up to 1 in 1000 people)

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure) have occurred in very rare cases
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders; seizures have occurred especially with high doses of tramadol or when tramadol was taken together with other medicines that can cause seizures
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety and nightmares. Psychological symptoms may occur after treatment with TRAMADOLO S.A.L.F., of varying nature and intensity depending on the patient's personality and the duration of therapy. These can manifest as a change in mood (especially good mood, in some cases irritated mood), changes in activity (usually decrease or repression, sometimes an increase) and decreased cognitive and sensory perception (changes in the senses and the ability to recognize emotions, which can lead to errors in judgment)
• drug dependence. If TRAMADOLO S.A.L.F. is taken for a long period, dependence may develop, although the risk is very low. When treatment is stopped abruptly, withdrawal symptoms may occur (see “If you stop taking TRAMADOLO S.A.L.F.”).
• vision problems, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnea). If the recommended doses are exceeded, or if medicines that reduce brain function are taken at the same time, breathing may be slower
• worsening of asthma, however, it has not been established whether this was caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

Very rare (may affect up to 1 in 10,000 people)

• increased liver enzyme values

Frequency not known (frequency cannot be estimated from the available data)

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which can manifest as a change in mental status (for example, agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of

coordination and/or gastrointestinal symptoms (for example, nausea, vomiting, diarrhea) (see
section 2 “What you need to know before you take TRAMADOLO S.A.L.F.”).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at: 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 TRAMADOLO S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use TRAMADOLO S.A.L.F. after the expiry date which is stated on the package and on the label. The
expiry date refers to the last day of the month. This medicine does not require particular
storage conditions.
The diluted product, if not used immediately, may be stored for a maximum of 24 hours at 2-8°C
(recommended) and in any case up to 25°C.
The storage times during use and the conditions before use are the responsibility of the user.
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. Package contents and other information

What TRAMADOLO S.A.L.F. contains
The active ingredient is tramadol hydrochloride.
TRAMADOLO S.A.L.F. 100 mg/2 ml injectable solution: each vial contains 100 mg of tramadol hydrochloride.
TRAMADOLO S.A.L.F. 50 mg/ml injectable solution: each vial contains 50 mg of tramadol hydrochloride.
The other ingredients are: sodium acetate, sodium hydroxide (pH adjuster) or hydrochloric acid (pH adjuster), water for injections.

Description of the appearance of TRAMADOLO S.A.L.F. and package contents
Colorless, clear solution.
TRAMADOLO S.A.L.F. injectable solution is contained in clear glass vials, in packs of 5 vials.

Marketing authorisation holder and manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) – Italy.

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