Tramadol Basi 50 mg/ml solution for injection EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tramadol Basi 50 mg/ml injection solution EFG
tramadol hydrochloride
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Tramadol Basi is and what it is used for
- What you need to know before using Tramadol Basi
- How to use Tramadol Basi
- Possible side effects
- How to store Tramadol Basi
- Contents of the pack and other information
1. What Tramadol Basi is and what it is used for
Tramadol – the active substance in Tramadol Basi – is an analgesic belonging to the opioid group that acts on the central nervous system. This medicine relieves pain by acting on specific nerve cells in the spinal cord and brain.
Tramadol Basi is indicated for the treatment of moderate to severe pain.
2. What you need to know before using 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 due to alcohol, hypnotics (sleeping tablets), analgesics, or other psychotropic medicines (medicines affecting mood and emotions);
- if you are also taking MAO inhibitors (some medicines used to treat depression) or have taken them within the last 14 days (see "Other medicines and Tramadol Basi");
- if you have epilepsy and your seizures are not adequately controlled by treatment;
- as a substitute for drug withdrawal.
Warnings and precautions
Talk to 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 feel you might faint);
- if you are in shock (a sign of this condition may be cold sweating);
- if you have increased intracranial pressure (for example, after a head injury or diseases affecting the brain);
- if you have difficulty breathing;
- if you have epilepsy or are prone to seizures, as your risk of seizures may increase;
- if you have liver or kidney disease.
Sleep-related breathing disorders
Tramadol 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, waking up at 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.
Contact 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. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Basi may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.
Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take 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 higher if:
- You or any member of your family have abused alcohol or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
- You are a smoker.
- You have ever had mood disorders (depression, anxiety, or a 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 longer than prescribed by your doctor.
- You need to take 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 taking the medicine, and feel better once you take it again ("withdrawal effects").
If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so 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 have had them before, inform your doctor.
Children and adolescents
Use in children with respiratory problems:
The use of tramadol is not recommended in children with respiratory problems, as 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 need to take any other medicines.
If you are using tramadol, you must not take MAO inhibitors (certain medicines used to treat depression).
The analgesic effect of tramadol may be reduced and the duration of exposure shortened if you also take medicines containing:
- carbamazepine (used to treat epilepsy);
- ondansetron (used to prevent nausea).
Your doctor will advise you whether you should use this medicine and what dose to take.
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 faint. If this happens, inform your doctor.
The concomitant use of tramadol and sedatives such as benzodiazepines or other related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes tramadol together with sedative medicines, they will limit the dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members so they can watch for the symptoms listed above. Contact your doctor if you experience these symptoms.
- if you are taking medicines that may cause seizures (convulsive seizures), 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 whether 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 rhythmic muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C.
- if you are taking coumarin anticoagulants (blood-thinning medicines), for example warfarin, together 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 nerve-related pain (neuropathic pain).
Use of Tramadol Basi with food and alcohol
You should not drink alcohol during treatment with tramadol, as its effects may be enhanced. Food does not affect the action of tramadol.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
There is very limited 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 breastfeeding. Tramadol is excreted in breast milk. For this reason, you should not use this medicine more than once during breastfeeding, or if you use it more than once, you should stop breastfeeding.
Based on human experience, there is no indication that tramadol affects fertility in men or women.
Driving and using machines
Tramadol may cause drowsiness, dizziness, and blurred vision and may therefore impair your reactions. If you feel your reaction ability is impaired, do not drive a car or other vehicle, do not use tools or electric machines, and do not work without secure footing.
Tramadol Basi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ml; hence, it is essentially "sodium-free".
3. How to use Tramadol Basi
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using 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 pain and your individual sensitivity to pain. Generally, the lowest effective analgesic dose should be used.
Usually, 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 prescribes otherwise, the usual dose is:
Adults and adolescents over 12 years of age
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.
Additional information for doctors and healthcare professionals can be found at the end of this leaflet.
Use in children
Children over 1 year of age
Normally, a single dose of tramadol is 1 to 2 mg/kg of body weight. The lowest effective analgesic dose should be chosen. The daily dose must not exceed the lower of the following: 8 mg/kg body weight or 400 mg of active substance.
Additional information for doctors and healthcare professionals can be found at the end of this leaflet.
Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may extend the dosing interval.
Severe kidney or liver disease / patients on dialysis
You must not use tramadol if you have severe hepatic and/or renal impairment. If your impairment is mild or moderate, your doctor may recommend increasing the interval between doses.
How and when to use Tramadol Basi
Tramadol should be administered slowly, usually into a vein in the arm, into muscle (typically the buttocks), or under the skin. Alternatively, tramadol may be diluted and administered intravenously by infusion.
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 carry out careful and regular monitoring (if necessary, with treatment interruptions) to determine whether you should continue using tramadol and at what dose.
If you feel that the effect of tramadol is too strong or too weak, inform your doctor or pharmacist.
If you use more Tramadol Basi than you should
If you have accidentally used an additional dose of tramadol, you will generally not experience negative effects. You should continue with the next dose of tramadol as prescribed.
In case of overdose, the following symptoms may occur: miosis (constricted pupils), vomiting, drop in blood pressure, rapid heartbeat, circulatory collapse, disturbances of consciousness up to coma (deep unconsciousness), generalized seizures (severe), and breathing difficulties up to respiratory arrest.
If these signs occur, contact your doctor immediately.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medication and the amount used.
If you forget to use Tramadol Basi
If you forget to use tramadol, your pain is likely to return. Do not take a double dose to make up for missed doses. Continue using Tramadol Basi as before.
If you stop using Tramadol Basi
If you stop or discontinue treatment with tramadol too early, your pain is likely to reappear. If you wish to discontinue treatment due to adverse effects, consult your doctor. You must not stop using this medicine suddenly unless instructed by your doctor.
If you wish to stop using your medicine, speak to your doctor first, especially if you have been using it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).
Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, undesirable effects may occur in some patients who have been using tramadol for a prolonged period and suddenly stop using the medicine. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal discomfort. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, unusual central nervous system symptoms such as confusion, illusions, changes in perception of personality (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia) have been reported. If you experience any of these adverse effects after stopping treatment with tramadol, consult your doctor.
If you have any further 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 everyone will experience them.
You must 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 together with difficulty breathing.
The most common adverse effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in every 10 people.
Very common: may affect more than 1 in every 10 people
- dizziness
- nausea
Common: may affect up to 1 in every 10 people
- headache, drowsiness
- fatigue
- constipation, dry mouth, vomiting
- excessive sweating (hyperhidrosis)
Uncommon: may affect up to 1 in every 100 people
- effects on the heart and blood circulation (palpitations, increased heart rate, feeling faint or collapse). These adverse effects may occur particularly when the patient is standing or in physically stressed patients.
- urge to vomit (nausea), 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 every 1,000 people
- allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) occur very rarely
- slow heart rate
- increased blood pressure
- abnormal sensations (e.g. itching, tingling, numbness), tremor, epileptic seizures, involuntary muscle contractions, uncoordinated movements, transient loss of consciousness (syncope), speech disorders
- epileptic seizures occur mainly after use of high doses of tramadol or when another medicine that may trigger them has been taken simultaneously
- changes in appetite
- hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares
- psychological disturbances may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment)
- after treatment, withdrawal symptoms may occur (see “If you stop treatment with Tramadol Basi”)
- blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis)
- slow breathing, shortness of breath (dyspnea)
- if recommended doses are exceeded or if taken concomitantly with other medicines that depress brain function, respiratory rate may decrease. Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol
- muscle weakness
- difficulty urinating, painful urination, less urine than normal (dysuria)
Very rare: may affect up to 1 in every 10,000 people
- increased liver enzymes
Frequency not known: cannot be estimated from available data
- low blood sugar levels (hypoglycemia)
- hiccups
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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tramadol Basi
Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.
Store below 30 °C.
For single use only. This medicine should be used immediately after opening the ampoule/dilution.
Do not use this medicine after the expiry date stated on the packaging and on the ampoules after “EXP”. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tramadol Basi
- The active substance 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 injections.
Presentation of the product and contents of the pack
Tramadol Basi is a clear, colourless solution.
The injectable solution is supplied in 2 ml Type I colourless glass ampoules (packs of 10 and 50 ampoules).
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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 most recent revision of this leaflet: July 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
This information is intended for healthcare professionals only:
Information on the handling of Tramadol Basi
Medicinal products intended for parenteral administration should be inspected visually before use. This medicine should only be administered if the solution is clear and free from visible particles, and if the container is undamaged.
This medicine is for single use only. Any unused portion must be discarded.
Instructions for opening OPC (One-Point-Cut) ampoules
- Hold the body of the ampoule between thumb and index finger, with the tip pointing upwards;
- Place the index finger of the other hand against the top of the ampoule. Position the thumb over the tip;
- With both index fingers together, press on the tip area to open the ampoule.
Administration information
For moderate pain, administer 1 ml of this medicine (equivalent to 50 mg of tramadol hydrochloride). If pain relief is not achieved within 30 to 60 minutes, an additional 1 ml of tramadol may be administered. In cases of severe pain requiring higher doses, administer 2 ml of tramadol (equivalent to 100 mg of tramadol hydrochloride).
For the treatment of severe postoperative pain, during the first hours after surgery, a higher dose may be necessary (pain treatment as needed).
Requirements over a 24-hour period are normally not greater than with conventional administration.
Tramadol Basi is administered by intravenous route (usually into a vein in the arm), intramuscular route (usually into the gluteal muscle), or subcutaneous route (under the skin). Intravenous administration must be slow, for example, 1 ml of this medicine (equivalent to 50 mg of tramadol hydrochloride) per minute.
Alternatively, this medicine may be diluted with an appropriate infusion solution (e.g., 0.9% sodium chloride, 5% glucose solution, Ringer's solution, or Ringer lactate solution) and used directly for intravenous infusion or patient-controlled analgesia.
Incompatibilities of Tramadol Basi
The injectable solution of tramadol has been shown to be 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 of age (see section 3 “How and when to use Tramadol Basi?”)
Calculation of injection volume
- Calculate the total required dose of tramadol hydrochloride (mg): body weight (kg) × dose (mg/kg)
- Calculate the volume (ml) of the diluted solution to be injected: divide the total dose (mg) by the appropriate concentration of the diluted solution (mg/ml; see table below).
Table: Dilution of Tramadol Basi (suitable diluted solution; see section 3 “How and when to use Tramadol Basi?”)
Concentration of diluted injectable solution (mg of tramadol hydrochloride/ml) | Tramadol Basi + added solvent |
25.0 mg/ml | 2 ml + 2 ml |
16.7 mg/ml | 2 ml + 4 ml |
12.5 mg/ml | 2 ml + 6 ml |
10.0 mg/ml | 2 ml + 8 ml |
8.3 mg/ml | 2 ml + 10 ml |
7.1 mg/ml | 2 ml + 12 ml |
6.3 mg/ml | 2 ml + 14 ml |
5.6 mg/ml | 2 ml + 16 ml |
5.0 mg/ml | 2 ml + 18 ml |
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 any 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 × 1.5 mg/kg = 40.5 mg of tramadol hydrochloride.
An appropriate concentration of diluted injectable solution is 10.0 mg/mL; therefore, 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 containing 10 mg of tramadol hydrochloride per milliliter.
Administer 4 mL of the diluted solution (40 mg of tramadol hydrochloride).