Prospecto: information for the user

Tramadol Basi 50 mg/ml injectable solution EFG

tramadol hydrochloride

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Tramadol Basi and for what it is used

2.What you need to know before starting to use Tramadol Basi

3.How to use Tramadol Basi

4.Possible adverse effects

1. Storage of Tramadol Basi
2. Contents of the package and additional information

Tramadol – the active ingredient of Tramadol Basi – is an analgesic belonging to the group of opioids that acts on the central nervous system. This medication relieves pain by acting on specific nerve cells in the spinal cord and the brain.

Tramadol Basi is indicated for the treatment of moderate to intense pain.

No use Tramadol Basi

- if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6);

- in case of acute alcohol intoxication, hypnotics (sleeping tablets), analgesics or other psychotropic drugs (medicines that affect mood and emotions);

- if you are also taking MAO inhibitors (some medicines used to treat depression) or if you have taken them in the last 14 days (see “Other medicines and Tramadol Basi”);

- if you have epilepsy and your seizures are not adequately controlled with treatment;

- as a substitute for drug withdrawal.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine

• if you think you are dependent on other analgesics (opioids);
• if you have consciousness disorders (if you think you are going to faint);
• if you are in a state of shock (a sign of this state may be cold sweat);
• if you have increased intracranial pressure (for example after a head injury or diseases that affect the brain);
• if you have difficulty breathing;
• if you have epilepsy or are prone to seizures, as the risk of seizures may increase;
• if you have any liver or kidney disease.

Respiratory disorders related to sleep

Tramadol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep or excessive daytime somnolence. If you or someone else observes these symptoms, inform your doctor. Your doctor may consider reducing the dose.

Consult your doctor, pharmacist or nurse if you experience any of the following symptoms while using this medicine:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. They may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Tolerance, dependence and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the drug less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Basi may also cause dependence, abuse and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you should use or the frequency with which you should use it. The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Tramadol Basi may be higher if:

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines or illegal drugs (“addiction”).

- You are a smoker.

- You have had any problems with mood (depression, anxiety or personality disorder) or have followed treatment by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using Tramadol Basi, it could be a sign of dependence or addiction:

– You need to use the medicine for longer than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep”.

– You have made repeated and unsuccessful attempts to stop using the medicine or control its use.

– You feel unwell when you stop using the medicine, and you feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to determine the best treatment option for you, when it is appropriate to stop the medicine and how to do it safely (see section 3, if you interrupt treatment with Tramadol Basi).

If you experience any of the problems mentioned during treatment with this medicine or if you have had them before, inform your doctor.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol Basi

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

If you are taking tramadol, do not take MAO inhibitors (certain medicines for depression).

The analgesic effect of tramadol may be reduced and the duration of exposure may be shorter if you also take medicines that contain:

- carbamazepine (used to treat epilepsy);

- ondansetron (prevention of nausea).

Your doctor will indicate if you should use this medicine and what dose to use.

The risk of adverse effects increases:

• if you are taking other analgesics such as morphine and codeine (also used in cough medicines) and alcohol at the same time as tramadol. You may feel drowsy or feel a sense of weakness. If this happens, inform your doctor.

The concomitant use of tramadol and sedatives such as benzodiazepines or other related medicines increases the risk of somnolence, difficulty breathing (respiratory depression), coma and may be potentially fatal. Due to this situation, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol along with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's dose recommendations carefully. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you have these symptoms.

• if you are taking medicines that may cause seizures (seizure disorders), such as certain antidepressants or antipsychotics. The risk of developing a seizure may increase if you take tramadol at the same time. Your doctor will tell you if tramadol is suitable for you.
• if you are taking certain antidepressants, tramadol may interact with these medicines and you may experience symptoms such as involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
• if you are taking anticoagulant coumarins (medicines to thin the blood), such as warfarin, along with tramadol. The effect of these medicines may be affected and bleeding may occur;
• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Use of Tramadol Basi with food and alcohol

Do not drink alcohol during treatment with tramadol as its effects may be potentiated. Food does not affect the effect of tramadol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very little information available on the safety of tramadol during pregnancy. Therefore, do not use this medicine if you are pregnant.

Chronic treatment during pregnancy may cause withdrawal symptoms in newborns.

Generally, tramadol is not recommended during breastfeeding. Tramadol is excreted in breast milk. Therefore, do not use this medicine more than once during breastfeeding, or if you use it more than once, stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and operating machinery

Tramadol may cause drowsiness, dizziness and blurred vision and may impair your reactions. If you feel that your reaction time is impaired, do not drive a car or other vehicle, do not use electrical tools or machines, or work without a secure grip.

Tramadol Basi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will also explain to you what you can expect from the use of Tramadol Basi, when and for how long you should use it, when you should contact your doctor and when you should discontinue use (see also section 2).

The dose should be adjusted according to the intensity of the pain and your individual sensitivity to pain. Generally, the most effective analgesic dose should be used.

Normally, daily doses of up to 8 ml of tramadol (equivalent to 400 mg of tramadol hydrochloride) are sufficient. In exceptional cases, if it is clinically necessary, your doctor may prescribe a higher daily dose.

Unless your doctor prescribes otherwise, the usual dose is:

Adults and adolescents over 12 years old

Depending on the pain, 1 to 2 ml of tramadol (equivalent to 50-100 mg of tramadol hydrochloride) will be administered.

Depending on the pain, the effect lasts for 4 to 8 hours.

You can find additional information for doctors and healthcare professionals at the end of this leaflet.

Use in children

Children over 1 year old

Normally, a single dose of tramadol is 1 to 2 mg/kg of body weight. The most effective analgesic dose should be chosen. The daily dose should not exceed the lower of the following doses: 8 mg/kg of body weight or 400 mg of active ingredient.

You can find additional information for doctors and healthcare professionals at the end of this leaflet.

Older patients

In elderly patients (over 75 years old), the elimination of tramadol may be delayed. If this applies to you, your doctor may prolong the dosing interval.

Severe kidney or liver disease / patients on dialysis

You should not use tramadol if you have severe liver and/or kidney disease. If your disease is mild or moderate, your doctor may recommend increasing the interval between doses.

How and when to use Tramadol Basi

Tramadol should be injected slowly, usually into a vein in the arm, muscle (usually the buttocks) or under the skin. Alternatively, tramadol can be diluted and administered intravenously by infusion.

For how long to use Tramadol Basi

Tramadol should not be administered for longer than strictly necessary. If prolonged analgesic treatment is considered necessary, your doctor will closely and regularly monitor you (if necessary, with interruptions in treatment) to decide whether to continue using tramadol and at what dose.

If you estimate that the effect of tramadol is too strong or too weak, inform your doctor or pharmacist.

Using more Tramadol Basi than you should

If you have accidentally taken an additional dose of tramadol, generally you will not have any negative effects. You should continue with the next dose of tramadol as prescribed.

In case of overdose, the following symptoms may appear: miosis (pupils constricted), vomiting, decreased blood pressure, rapid heartbeats, circulatory collapse, alterations in consciousness up to coma (deep unconsciousness), generalized severe seizures, as well as difficulty breathing up to respiratory arrest.

Immediately contact your doctor if these signs occur.

In case of overdose or accidental ingestion, consult your doctor, pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

Missing a dose of Tramadol Basi

If you forget to take tramadol, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses. Continue using Tramadol Basi as before.

Stopping treatment with Tramadol Basi

If you stop or discontinue treatment with tramadol too soon, it is likely that the pain will return. If you want to stop treatment due to side effects, consult your doctor. Do not stop using this medication suddenly unless your doctor tells you to.

If you want to stop using your medication, talk to your doctor first, especially if you have been using it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment with tramadol is stopped. However, some patients who have been using tramadol for a prolonged period and suddenly stop using it may experience undesirable effects. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and experience gastrointestinal discomfort. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness and tingling, and ringing in the ears (tinnitus). Very rarely, unusual symptoms of the central nervous system have been detected, such as confusion, illusion, change in perception of personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these side effects after stopping treatment with tramadol, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should consult your doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria along with difficulty breathing.

The most common side effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• dizziness
• nausea

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• effects on the heart and blood circulation (palpitations, increased heart rate, feeling of fainting or collapse). These side effects may occur particularly when the patient is standing or in physically stressed patients.
• desire to vomit (retching), gastrointestinal disorders (e.g., feeling of pressure in the stomach, abdominal distension), diarrhea
• skin reactions (e.g., itching, skin rash, urticaria)

Rare: may affect up to 1 in 1,000 people

• allergic reactions (e.g., difficulty breathing, wheezing, skin edema) and shock (sudden circulatory failure) occur very rarely
• slow heart rate
• increased blood pressure
• abnormal sensations (e.g., itching, tingling, numbness), tremor, seizures, involuntary muscle contractions, uncoordinated movements, transient loss of consciousness (syncope), speech disorders
• seizures mainly occur after the use of high doses of tramadol or when taken simultaneously with another medication that may induce them
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased) and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to judgment errors).
• after treatment, symptoms of withdrawal from the medication may appear (see "If you interrupt treatment with Tramadol Basi")
• blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis)
• slow breathing, shortness of breath (dyspnea).
• if the recommended doses are exceeded or if taken concomitantly with other medications that depress brain function, a decrease in respiratory frequency may occur. Cases of asthma worsening have been reported, however, it has not been established if they were caused by tramadol.
• muscle weakness.
• difficulty urinating, painful urination, decreased urine output (dysuria).

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

• increased liver enzymes.

Frequency not known: cannot be estimated from available data

• low blood sugar (hypoglycemia)
• hypotension.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store this medication in a safe and protected place, to which other people cannot access. This medication can cause serious harm or even be fatal to people who have not been prescribed it.

Store below 30°C.

For single use. This medication must be used immediately after opening the ampoule/dilution.

Do not use this medication after the expiration date that appears on the packaging and on the ampoules after “EXP”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Tramadol Base Composition

• The active ingredient is tramadol hydrochloride. Each milliliter of solution contains 50 mg of tramadol hydrochloride. Each 2 ml ampoule contains 100 mg of tramadol hydrochloride.
• The other components are: sodium acetate trihydrate and water for injectable preparations.

Product Appearance and Packaging Contents

Tramadol Base is a transparent and colorless solution.

The injectable solution is presented in type I colorless glass ampoules of 2 ml (packs of 10 and 50 ampoules).

Marketing Authorization Holder

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua

Portugal

Tel: + 351 231 920 250 | Fax: + 351 231 921 055

E-mail: [email protected]

Responsible for Manufacturing

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid)

Last Review Date of this Leaflet: July 2024

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Information on the Handling of Tramadol Base

Parenteral medications must be visually inspected before use. This medication should only be administered if the solution is transparent and free of visible particles, and if the packaging is not damaged.

This medication is for single use only. Any unused amount must be discarded.

Instructions for Opening Ampoules with One-Point-Cut (OPC)

1. Hold the ampoule body between the thumb and index finger, with the tip pointing upwards;

2. Place the index finger of the other hand on top of the ampoule, with the thumb on top of the tip;

3. Press the area of the tip with the index fingers together to open the ampoule.

Information on Administration

For moderate pain, 1 ml of this medication (equivalent to 50 mg of tramadol hydrochloride) is administered. If pain relief is not achieved after 30 to 60 minutes, an additional 1 ml of tramadol may be administered. If severe pain requires a higher dose, 2 ml of tramadol (equivalent to 100 mg of tramadol hydrochloride) is administered.

For the treatment of severe postoperative pain, in the first hours after surgery, a higher dose may be necessary (pain treatment as needed).

The needs for a 24-hour period are usually not greater than those for conventional administration.

Tramadol Base is administered intravenously (usually in a vein of the arm), intramuscularly (usually in the gluteal muscle), or subcutaneously (under the skin). Intravenous administration should be slow, for example, 1 ml of this medication (equivalent to 50 mg of tramadol hydrochloride) per minute.

Alternatively, this medication can be diluted with an appropriate infusion solution (e.g., sodium chloride 0.9%, glucose 5%, Ringer's solution, or Ringer's lactate solution) and used directly for intravenous infusion or patient-controlled analgesia.

Incompatibilities of Tramadol Base

It has been demonstrated that the injectable solution of tramadol is incompatible (immiscible) with diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam, and nitroglycerin solutions.

Using Tramadol Base for the Treatment of Children Over 1 Year Old(see section 3 “How and when to use Tramadol Base?”)

Calculating the Injection Volume

1) Calculate the total dose of tramadol hydrochloride required (mg): body weight (kg) x dose (mg/kg)

2) Calculate the volume (ml) of the diluted solution to be injected: divide the total dose (mg) by an appropriate concentration of the diluted solution (mg/ml, see the table below).

Table: Dilution of Tramadol Base (appropriate diluted solution concentration, see section 3 “How and when to use Tramadol Base?”)

According to your calculations, dilute the contents of the ampoule by adding the appropriate amount of solvent, mix, and administer the calculated volume of diluted solution. Discard the remaining injectable solution.

Example

For a child weighing 27 kg who is to receive a dose of 1.5 mg of tramadol hydrochloride per kg of body weight.

The total required dose is 27 kg x 1.5 mg/kg = 40.5 mg of tramadol hydrochloride.

An appropriate concentration of diluted injectable solution is 10.0 mg/ml, so the volume to be injected would be approximately 4 ml (40.5 mg/10.0 mg/ml = 4.05 ml).

According to the above, 1 ml of this medication is diluted by adding 4 ml of solvent (e.g., sodium chloride 0.9%, glucose 5%, Ringer's solution, or Ringer's lactate solution), resulting in a diluted solution of 10 mg of tramadol hydrochloride per milliliter.

From the diluted solution, 4 ml (40 mg of tramadol hydrochloride) are administered.