TRAMADOL BASI 50 mg/mL Injectable Solution

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

Do not 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 intoxication with alcohol, hypnotics (sleeping pills), analgesics or other psychotropic medicines (medicines that affect mood and emotions);
• if you are also taking MAO inhibitors (certain 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 disorders of consciousness (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 (e.g. after a head injury or diseases that affect the brain);
• if you have difficulty breathing;
• if you have epilepsy or are prone to seizures, because 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 level in the blood). The symptoms may include pauses in breathing during sleep, waking up during the night due to difficulty breathing, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else notices 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 hormonal supplements.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Tramadol Basi can also lead to dependence, abuse, and addiction, which could result in a potentially life-threatening overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it. The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tramadol Basi may be greater 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 problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice 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 a longer period 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, 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 stop 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are using tramadol, you should not take MAO inhibitors (certain medicines used to treat depression).

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

• carbamazepine (used to treat epilepsy);
• ondansetron (prevention of nausea).

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

The risk of side 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 using tramadol. You may feel drowsy or faint. If this happens, inform your doctor.

Concomitant use of tramadol and sedatives such as benzodiazepines or other related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially life-threatening. 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 sedative medicines, you should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor when you have these symptoms.

• if you are taking medicines that can cause seizures (seizure crises), such as certain antidepressants or antipsychotics. The risk of developing a seizure crisis 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, including muscles that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
• if you are taking anticoagulant coumarins (blood-thinning medicines), 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).

Using Tramadol Basi with food and alcohol

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Chronic treatment during pregnancy may cause withdrawal symptoms in newborns.

Tramadol is generally not recommended during breast-feeding. Tramadol is excreted in breast milk. For this reason, you should not use this medicine more than once during breast-feeding, or if you use it more than once, you should interrupt breast-feeding.

Based on human experience, tramadol is not expected to affect fertility in men and women.

Driving and using machines

Tramadol may cause drowsiness, dizziness, and blurred vision, and may affect your reactions. If you feel that your reactions are affected, do not drive a car or other vehicle, do not use electric tools or machines, and do not work without a secure grip.

Tramadol Basi contains sodium

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

3. How to use Tramadol Basi

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain 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 stop using it (see also section 2).

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

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

Unless your doctor has prescribed otherwise, the usual dose is:

Adults and adolescents over 12 years

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

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

At the end of this leaflet, you can find additional information for doctors and healthcare professionals.

Use in children

Children over 1 year

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

At the end of this leaflet, you can find additional information for doctors and healthcare professionals.

Elderly patients

In elderly patients (over 75 years), 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 or kidney failure. If your failure is mild or moderate, your doctor may recommend that you increase 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 carefully monitor you and decide if you should continue using tramadol and at what dose.

If you think the effect of tramadol is too strong or too weak, tell your doctor or pharmacist.

If you use more Tramadol Basi than you should

If you have used an additional dose of tramadol by mistake, it will generally not have negative effects. You should continue with the next dose of tramadol as prescribed.

In case of overdose, the following symptoms may occur: miosis (narrow pupils), vomiting, low blood pressure, rapid heartbeat, circulatory collapse, changes in consciousness up to coma (deep unconsciousness), generalized epileptic seizures (severe), as well as difficulty breathing up to respiratory arrest.

If these signs occur, contact your doctor immediately.

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

If you forget to use Tramadol Basi

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

If you stop treatment with Tramadol Basi

If you stop or finish treatment with tramadol too early, it is likely that the pain will return. If you want to stop treatment due to side effects, consult your doctor. You should not stop using this medicine suddenly unless your doctor tells you to.

If you want to stop using your medicine, 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 side effects are expected when stopping treatment with tramadol. However, unwanted effects may occur in some patients who have been using tramadol for a long time and suddenly stop using the medicine. They may feel agitated, anxious, nervous, or trembly. They may be overactive, have difficulty sleeping, and experience gastrointestinal discomfort. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, unusual symptoms of the central nervous system such as confusion, illusion, change in perception of personality (depersonalization), and change in perception of reality (derealization) and delusions of persecution (paranoia) have been detected. 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 hives along with difficulty breathing.

The most frequent adverse 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 adverse effects may occur particularly when the patient is standing or in physically stressed patients.
• nausea (retching), gastric disorders (e.g., feeling of pressure in the stomach, abdominal distension), diarrhea
• skin reactions (e.g., itching, rash, hives)

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), tremors, epileptic seizures, involuntary muscle contractions, uncoordinated movements, transient loss of consciousness (syncope), speech disorders
• epileptic seizures occur mainly after the use of high doses of tramadol or when another medicine that may induce them has been taken simultaneously
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• psychological disturbances may appear after treatment with tramadol. Their intensity and nature may vary (depending on 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 can lead to errors of judgment).
• after treatment, symptoms of drug withdrawal may appear (see "If you stop treatment with Tramadol Basi")
• blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis)
• slow breathing, shortness of breath (dyspnea).
• muscle weakness.
• difficulty urinating, painful urination, less urine than normal (dysuria).

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

• increase in liver enzymes.

Frequency not known: cannot be estimated from the available data

• low blood sugar levels (hypoglycemia)
• hypo.

Reporting of Adverse Effects

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

5. Conservation of Tramadol Basi

Keep this medicine out of sight and reach of children.

Keep this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Store below 30°C.

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

Do not use this medicine 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 medicine if you notice visible signs of deterioration.

Medicines should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol Basi

• The active ingredient is tramadol hydrochloride. Each ml 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.

Appearance of the Product and Package Contents

Tramadol Basi is a clear and colorless solution.

The injectable solution is presented in type I colorless glass ampoules of 2 ml (packaging 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]

Manufacturer

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 medicine 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)

Date of the Last Revision of this Prospectus: July 2024

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Information on the Handling of Tramadol Basi

Medicines intended for parenteral administration must be visually inspected before use. This medicine should only be administered if the solution is transparent and free of visible particles, and if the packaging is not damaged.

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

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

1. Hold the body of the ampoule between the thumb and index finger, with the tip facing up;
2. Place the index finger of the other hand supporting the top of the ampoule. Place the thumb on top of the tip;
3. With the index fingers together, press the tip area to open the ampoule.

Administration Information

For moderate pain, 1 ml of this medicine is administered (equivalent to 50 mg of tramadol hydrochloride). If pain relief is not achieved after 30 to 60 minutes, an additional 1 ml of tramadol can be administered. If the need is greater in severe pain, 2 ml of tramadol (equivalent to 100 mg of tramadol hydrochloride) are 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 during a 24-hour period are normally not greater than during conventional administration.

Tramadol Basi is injected 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 medicine (equivalent to 50 mg of tramadol hydrochloride) per minute.

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

Incompatibilities of Tramadol Basi

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

How to Use Tramadol Basi for the Treatment of Children Over 1 Year(see section 3 "How and When to Use Tramadol Basi?")

Calculation of 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 Basi (appropriate diluted solution, see section 3 "How and When to Use Tramadol Basi?")

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

Example

For a child who weighs 27 kg and is to be administered 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 the 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 medicine is diluted by adding 4 ml of solvent (e.g., 0.9% sodium chloride, 5% glucose solution, 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.