Tramadol Combix 200 mg prolonged-release tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Tramadol Retard Combix 200 mg prolonged-release tablets EFG
Tramadol hydrochloride
Read the entire leaflet carefully before you start taking this medicine.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet Contents
- What Tramadol Retard Combix is and what it is used for
- Before you take Tramadol Retard Combix
- How to take Tramadol Retard Combix
- Possible side effects
- How to store Tramadol Retard Combix
- Further information
1. What Tramadol Retard Combix is and what it is used for
Tramadol is an analgesic belonging to the opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
Tramadol Retard is indicated for the treatment of moderate to severe pain.
2. Before taking Tramadol Retard Combix
Do not take Tramadol Retard Combix
- If you are allergic (hypersensitive) to tramadol or to any of the other components of Tramadol Retard Combix.
- In cases of acute intoxication caused by alcohol, hypnotic drugs, analgesics, or psychotropic medications (medicines that affect mood and emotions).
- If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression) or if you have taken them within the last 14 days before starting treatment with Tramadol Retard Combix (see “Use of other medicines”).
- If you have epilepsy and your seizures are not adequately controlled by treatment.
- As a treatment for withdrawal syndrome.
Take special care with Tramadol Retard Combix
- 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 head injury or brain disease).
- If you have difficulty breathing.
- If you are epileptic or suffer from seizures, as the risk of seizures may increase.
- If you have liver or kidney disease.
- If you suffer from depression and are taking antidepressants, as they may interact with tramadol (see “Use of other medicines”).
In such cases, please consult your doctor before taking the medicine.
Warnings and precautions
Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to 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, general malaise or vomiting, constipation, loss of appetite.
Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended daily limit (400 mg).
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may result in the medicine becoming less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol may also lead to dependence, abuse, and addiction, which could potentially result in a 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 may be higher if:
- You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”).
- You are a smoker.
- You have ever had problems with mood (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.
If you notice any of the following symptoms while using tramadol, 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 stay 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 interrupt treatment with Tramadol Retard Combix).
Sleep-related breathing disorders
Tramadol Retard Combix may cause sleep-related breathing disorders, 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, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol Retard Combix:
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 supplements.
Also inform your doctor if any of these problems occur during treatment with Tramadol Retard Combix or if you have ever experienced them.
There is a slight risk that you may develop serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Consult a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 “Possible adverse effects”).
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.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Concomitant treatment with Tramadol Retard Combix and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) should be avoided.
The analgesic effect of Tramadol Retard Combix, as well as its duration, may be reduced if you take medicines containing:
- Carbamazepine (for epileptic seizures)
- Pentazocine, nalbuphine, or buprenorphine (analgesics)
- Ondansetron (a medicine to prevent nausea)
Your doctor will advise you whether you should take Tramadol Retard Combix and at what dose.
The risk of adverse effects increases:
-
If you take tranquilizers, hypnotic drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol Retard Combix. This may cause increased drowsiness or a feeling of fainting. If this occurs, consult your doctor.
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If you are taking medicines that may cause seizures, such as certain antidepressants. The risk of seizures may increase if you take Tramadol Retard Combix at the same time. Your doctor will tell you whether Tramadol Retard Combix is suitable for you.
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If you are taking selective serotonin reuptake inhibitors (SSRIs) or monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression). Tramadol Retard Combix may interact with them and may lead to serotonin syndrome (see section 4 “Possible adverse effects”).
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If you take coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with Tramadol Retard Combix. The effect of these medicines on blood clotting may be affected and may lead to bleeding.
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If you take gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).
Taking Tramadol Retard Combix with food and drinks
Do not consume alcohol during treatment with Tramadol Retard Combix, as its effect may be intensified. Food does not affect the action of Tramadol Retard Combix.
Pregnancy and breastfeeding
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 regarding the safety of tramadol during human pregnancy. Therefore, you should not take Tramadol Retard Combix if you are pregnant.
Chronic use during pregnancy may lead to withdrawal syndrome in newborns.
Generally, the use of tramadol is not recommended during breastfeeding. Tramadol is excreted in breast milk. For this reason, you should not take Tramadol Retard Combix more than once during breastfeeding, or if you take Tramadol Retard Combix more than once, you should stop breastfeeding.
Driving and using machines
Ask your doctor if you can drive or operate machinery during treatment with Tramadol Retard Combix. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care if you are taking this medicine together with other medicines.
3. How to take Tramadol Retard Combix
Follow exactly the instructions for the administration of Tramadol Retard Combix as given by your doctor.
Consult your doctor or pharmacist if you have any doubts.
Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using Tramadol Retard Combix, 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 individual sensitivity to pain. In general, the lowest effective analgesic dose should be taken.
Unless your doctor has given you different instructions, the usual dose is:
Adults and adolescents over 12 years of age
One tablet of Tramadol Retard Combix 100 mg prolonged-release tablets twice daily (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning and at night.
If necessary, your doctor may prescribe a different and more appropriate dose of this medicine.
If needed, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).
Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has specifically instructed you to do so.
Children
Tramadol Retard Combix is not suitable for children under 12 years of age.
Elderly patients
In geriatric patients (over 75 years of age), tramadol elimination may be slower. If this occurs, your doctor may extend the dosing intervals.
Patients with hepatic or renal impairment / dialysis
Patients with severe hepatic or renal impairment must not take Tramadol Retard Combix. If you have mild or moderate impairment, your doctor may extend the dosing interval.
How and when to take Tramadol Retard Combix
Tramadol Retard prolonged-release tablets are taken orally.
The Tramadol Retard Combix tablets must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You may take the tablet on an empty stomach or with food.
How long should you take Tramadol Retard Combix?
Tramadol Retard Combix should not be administered for longer than strictly necessary.
If long-term treatment is required, your doctor will monitor you at short, regular intervals (and if necessary with treatment interruptions) to determine whether treatment with Tramadol Retard Combix should continue and at what dose.
If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Tramadol Retard Combix than you should
If you have accidentally taken more Tramadol Retard Combix than you should, you generally will not experience negative effects. You should take the next dose as prescribed.
After taking very high doses, symptoms such as pupillary constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest may occur. In such a case, seek immediate medical attention.
If you forget to take Tramadol Retard Combix
If you forget to take your tablets, your pain may return. Do not take a double dose to make up for the missed dose; simply continue your treatment as directed by your doctor.
If you stop taking Tramadol Retard Combix
You must not stop taking this medicine suddenly unless your doctor tells you to do so. If you wish to stop taking this medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).
Generally, no undesirable effects occur when stopping treatment with Tramadol Retard Combix. However, in rare cases, some people who have been taking Tramadol Retard Combix for some time may feel unwell when they stop suddenly. They may feel restless, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Rarely, other uncommon central nervous system (CNS) symptoms have been reported, such as confusion, delirium, distorted perception of self (depersonalization), altered perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping Tramadol Retard Combix, please consult your doctor. If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Tramadol Retard Combix can have adverse effects, although not everyone experiences them. The frequency of adverse effects is usually classified as follows:
- Very common (more than 1 in 10 people)
- Common (more than 1 in 100 and less than 1 in 10 people)
- Uncommon (more than 1 in 1,000 and less than 1 in 100 people)
- Rare (more than 1 in 10,000 and less than 1 in 1,000 people)
- Very rare (less than 1 in 10,000 people)
- Frequency not known (cannot be estimated from the available data)
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, rash, and difficulty breathing.
The most common adverse effects during treatment with Tramadol Retard are nausea and dizziness, which occur in more than 1 in 10 patients.
Cardiac and blood disorders: | |
Uncommon: | Effects on the heart and blood circulation (strong and rapid heartbeat, fainting or collapse). These adverse effects may occur especially in patients who are immobile or who engage in physical exertion. |
Rare: | Slow heartbeat, increased blood pressure. |
Nervous system disorders | |
Very common: | Dizziness. |
Common: | Headaches, drowsiness. |
Rare: | Changes in appetite, abnormal sensations (such as itching, tingling, and numbness), tremor, slow breathing, epileptic seizures, muscle twitching, uncoordinated movements, temporary loss of consciousness (syncope). Breathing may slow down if recommended doses are exceeded or if other medications that depress brain function are taken simultaneously. Epileptic seizures may occur mainly after taking high doses of tramadol or when taking medications that may provoke seizures. |
Frequency unknown: | Speech disorders. |
Psychiatric disorders | |
Rare: | Hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychological problems may appear after treatment with Tramadol Retard Combix. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually excessive euphoria, occasionally irritable mood), changes in activity (usually suppression, occasionally increased activity), and reduced cognitive and sensory perception (changes in senses and recognition, which may lead to impaired judgment). Dependence may occur. |
Eye disorders | |
Rare: | Blurred vision. |
Frequency unknown: | Excessive dilation of the pupils (mydriasis). |
Respiratory disorders | |
Rare: | Shortness of breath (dyspnea). Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. |
Frequency not known: | Hiccups. |
Digestive disorders | |
Very common: | Nausea. |
Common: | Vomiting, constipation, dry mouth. |
Uncommon: | Nausea (feeling sick), stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea. |
Skin disorders | |
Common: | Sweating. |
Uncommon: | Skin reactions (e.g., itching, rash). |
Musculoskeletal disorders | |
Rare: | Muscle weakness. |
Hepatic and biliary disorders | |
Very rare: | Increased liver enzyme values. |
Urinary disorders | |
Rare: | Difficulty or pain during urination, reduced urine output. |
General disorders | |
Common: | Fatigue. |
Rare: | In very rare cases, allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have been reported. Signs of withdrawal may occur when treatment is abruptly discontinued (see "If you stop treatment with Tramadol Retard Combix"). |
Metabolism and nutrition disorders | |
Frequency not known: | Decreased blood sugar levels. |
Frequency not known (cannot be estimated from the available data)
Serotonin syndrome, which may present with 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, diarrhea) (see section 2, "Before taking Tramadol Retard Combix").
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Tramadol Retard Combix
Keep out of the reach and sight 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.
This medicine does not require special storage conditions.
Do not use Tramadol Retard Combix after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Additional Information
Composition of Tramadol Retard Combix
The active substance is tramadol hydrochloride. Each tablet contains 200 mg of tramadol hydrochloride.
The other components are:
Tablet core: microcrystalline cellulose, polyethylene oxide, povidone, and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), and quinoline yellow lake (E104).
Appearance of the product and contents of the pack
Tramadol Retard Combix 200 mg prolonged-release tablets are light brown, round, biconvex, coated tablets with the mark “200” printed on one side and smooth on the other.
Tramadol Retard Combix 200 mg is packaged in blisters containing 20 or 60 prolonged-release tablets.
Tramadol Retard Combix is also available as 100 mg and 150 mg prolonged-release tablets in packs containing 20 or 60 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain
Manufacturer
Zydus France
25, parc d’activités des Peupliers
92000 Nanterre
France
or
Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint Amant Tallende
France
This patient information leaflet was approved in June 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/