Tramadol S.A.L.F.

Italy
Brand name Tramadol S.A.L.F.
Form solution for injection
Active substance / Dosage
TRAMADOL HYDROCHLORIDE
Prescription type Prescription only – special ministerial triplicate form required
ATC code
N02AX02
Registration number 044718
Manufacturer S.A.L.F. SPA LABORATORIO FARMACOLOGICO

Table of Contents

Package leaflet

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

Generic medicine
Read this leaflet carefully before using 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact 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 using 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

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

Tramadol hydrochloride is an analgesic (for pain) belonging to 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 taking TRAMADOLO S.A.L.F.

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

  • if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
  • in acute alcohol, hypnotics, analgesics or other psychotropic drugs poisoning (medicines acting on mood and emotions);
  • if you are currently taking MAO inhibitors (certain medicines used to treat depression) or have taken them within the last 14 days before starting 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 may excessively use other painkillers (opioids);
  • if you suffer from disturbances of consciousness (if you feel faint);
  • if you are in a state of shock (cold sweats may be a sign);
  • if you have increased intracranial pressure (possible after head trauma or brain diseases);
  • if you have breathing difficulties;
  • if you have a tendency 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, because 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 doses.
The risk may increase when tramadol doses exceed the recommended levels, beyond the daily maximum dose of 400 mg.
TRAMADOLO S.A.L.F. may lead to physical and psychological dependence. When TRAMADOLO S.A.L.F. is
administered for prolonged periods, its effect may decrease, thus higher doses may be required (development of tolerance). In patients with a tendency to misuse medicines or who are medicine-dependent, TRAMADOLO S.A.L.F. should be taken only for short durations and under strict medical supervision.
There is a small risk that you may develop the so-called serotonin syndrome, which may occur after taking tramadolo together with certain antidepressants or tramadol as 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. may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor, who may consider reducing the dose.
Inform your doctor if any of the following problems occur during treatment with TRAMADOLO S.A.L.F. or have occurred previously:
extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether hormonal replacement therapy is needed.
Tramadol is metabolized in the liver by an enzyme. Some individuals have variations in this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, 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. must not be taken together with MAO inhibitors (certain 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 containing:

  • carbamazepine (for epileptic seizures);
  • ondansetron (to prevent nausea). Your doctor will inform you whether and which doses of TRAMADOLO S.A.L.F. you should take.

The risk of adverse effects increases:

  • if you are taking tranquillizers, sleeping pills, other analgesics 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 such cases, consult your doctor.
  • if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take TRAMADOLO S.A.L.F. concurrently. Your doctor will advise whether TRAMADOLO S.A.L.F. is suitable for you.
  • if you are taking certain antidepressants. TRAMADOLO S.A.L.F. may interact with these medicines and you may develop 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 drugs
The concomitant use of TRAMADOLO S.A.L.F. and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no alternative treatments are 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.
Inform your doctor about all sedative medicines you are taking and strictly follow the recommended dose. It may be helpful to inform friends or relatives to watch for the signs and symptoms mentioned above. Contact your doctor if such 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 enhanced.
Food intake does not affect the action 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 tramadol toxicity symptoms may be worse in these children.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is limited information on 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 excreted in breast milk. Usually, after a single dose, it is not necessary to interrupt 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. may cause drowsiness, dizziness, and vision problems (blurred vision). If you feel your ability to react is impaired, do not drive or operate vehicles or use electrical tools requiring stable support.

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

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

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The dosage should be determined based on the intensity of pain and your individual sensitivity to pain. In
general, the lowest effective dose that relieves pain should be used. Typically, a daily dose 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, corresponding to 400 mg of tramadol hydrochloride) is sufficient, unless your doctor has given you different instructions.
Unless otherwise prescribed by your doctor, the recommended dosage 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 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 effective dose that relieves pain should be used. Daily doses exceeding 8 mg of active substance
per kg of body weight or 400 mg of active substance must not be exceeded.
Elderly patients
In elderly individuals (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may advise you to increase the interval between doses.
Patients with severe hepatic or renal insufficiency/dialysis
Patients with severe hepatic and/or renal insufficiency must not take TRAMADOLO S.A.L.F. In cases of mild or moderate insufficiency, your doctor may advise you to increase the interval between doses.
How and when to administer TRAMADOLO S.A.L.F.
TRAMADOLO S.A.L.F. injectable solution should be administered slowly, either intravenously (usually in the arm) or intramuscularly (typically in the buttock) or subcutaneously. TRAMADOLO S.A.L.F. injectable solution may be diluted in a suitable infusion solution and administered intravenously.
Incompatibilities of TRAMADOLO S.A.L.F.
TRAMADOLO S.A.L.F. injectable solution must not be diluted in injectable or infusion solutions containing: diclofenac, piroxicam, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam,
nitroglycerin.
The injectable solution is compatible with 0.9% sodium chloride solution, 5% glucose solution, and lactated Ringer's solution for up to 24 hours when stored at temperatures of 2-8°C and 25°C.
How long should you take TRAMADOLO S.A.L.F.
Do not administer TRAMADOLO S.A.L.F. for longer than necessary. If long-term treatment is required, your doctor will schedule regular, frequent check-ups (and may temporarily interrupt therapy if necessary) to determine whether treatment should continue and at what dosage.
If you feel 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 accidentally been given an extra dose, this should not cause adverse effects. You may continue administering the medicine as prescribed.
After very high doses, the following may occur: pinpoint pupils, vomiting, drop in blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties up to respiratory arrest. In such 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, pain is likely to return. Do not take a
double dose to make up for a missed dose; continue treatment as instructed.
If you stop treatment with TRAMADOLO S.A.L.F.
If you stop or discontinue treatment too early, pain is likely to return.
If you wish to discontinue treatment due to adverse effects, consult your doctor.
You must not abruptly stop taking this medicine unless instructed by your doctor. If you intend to stop taking the medicine, discuss it with your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to discontinue it. This may involve gradually reducing the dose to minimize the risk of developing unnecessary adverse effects (withdrawal symptoms).
Generally, discontinuation of treatment with TRAMADOLO S.A.L.F. does not cause withdrawal effects.
However, in rare cases, some individuals who have taken TRAMADOLO S.A.L.F. for a prolonged
period may feel unwell when stopping abruptly.
They may:

  • feel restless, anxious, nervous, or weak
  • be hyperactive, have difficulty sleeping, or experience stomach or intestinal disturbances
  • experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
  • experience other very rare central nervous system (CNS) symptoms such as confusion, delusions, altered perception of self (depersonalization), altered perception of reality (derealization), and feelings of persecution (paranoia).

If you experience any of these symptoms after stopping TRAMADOLO S.A.L.F., consult your doctor.
If you have any questions 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.
Consult a doctor immediately if you experience symptoms of an allergic reaction such as:

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

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

  • nausea
  • dizziness

Common (may affect less than 1 in 10 people)

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

Uncommon (may affect less than 1 in 100 people)

  • effects on the heart and blood circulation (palpitations, rapid heartbeat, feeling of fainting or collapse). These side effects may occur particularly in patients in an upright position or undergoing physical exertion
  • urge to vomit (nausea), stomach ache (feeling of pressure in the stomach, bloating), diarrhoea
  • skin reactions (itching, rashes)

Rare (may affect less than 1 in 1,000 people)

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

Very rare (may affect less than 1 in 10,000 people)

  • increase in liver enzyme values

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

  • decrease in blood sugar levels
  • hiccups
  • serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you should know before taking TRAMADOLO S.A.L.F.”).
    Reporting of side effects
    If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the carton and label. The expiry date refers to the last day of the month. This medicine does not require any special storage conditions.
The diluted product, if not used immediately, may be stored for up to 24 hours at 2-8°C (recommended) and in any case up to 25°C.
The storage times during use and the conditions prior to use are the responsibility of the user.
Do not dispose of any medicine via 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 substance is tramadol hydrochloride.
TRAMADOLO S.A.L.F. 100 mg/2 ml injectable solution: each ampoule contains 100 mg of tramadol hydrochloride.
TRAMADOLO S.A.L.F. 50 mg/ml injectable solution: each ampoule contains 50 mg of tramadol hydrochloride.
The other components are: sodium acetate, sodium hydroxide (pH regulator) or hydrochloric acid (pH regulator), water for injections.

Description of the appearance of TRAMADOLO S.A.L.F. and contents of the pack
Colourless, clear solution.
TRAMADOLO S.A.L.F. injectable solution is contained in clear glass ampoules, in packs of 5 ampoules.

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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