Tramadol Aurovitas 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Leaflet: Information for the patient

Tramadol Aurovitas 50 mg hard capsules EFG

tramadol hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• 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 only, and you should not give it to others, even if they have the same symptoms as you, because it could 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.

Leaflet contents

1. What Tramadol Aurovitas is and what it is used for
2. What you need to know before taking Tramadol Aurovitas
3. How to take Tramadol Aurovitas
4. Possible side effects
5. How to store Tramadol Aurovitas
6. Contents of the pack and other information

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

Tramadol hydrochloride, the active substance in Tramadol Aurovitas, is an opioid-type analgesic that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol is used to treat moderate to severe pain.

2. What you need to know before taking Tramadol Aurovitas

Do not take Tramadol Aurovitas

• if you are allergic to tramadol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are under the influence of alcohol, sleeping medicines, other analgesics, or sedatives.
• if you are taking, or have taken within the last two weeks, medicines called "monoamine oxidase inhibitors" or MAOIs (used, for example, to treat depression, or the antibiotic linezolid). The combination may cause serious, potentially fatal interactions.
• if you have epilepsy that is not controlled by treatment.
• for the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tramadol Aurovitas.

• if you have epilepsy or seizures, or have had them in the past, because tramadol may increase the risk of seizures.
• if you have liver or kidney disease.
  • if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Aurovitas”).
  • there is a weak risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Consult a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 “Possible side effects”).

As with all analgesics of this type (opioids), tramadol should be used with caution and only under medical supervision in severely ill patients, including those with breathing difficulties, excessively low blood pressure (shock), loss of consciousness, severe brain injury, or brain diseases that may cause increased intracranial pressure.

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 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 may be higher if:

• You or any member of your family have abused 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, 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 use 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 using 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 taking Tramadol Aurovitas”).

The dose needed to achieve the desired effect may increase over time. In patients addicted to other opioid analgesics, tramadol should be used with caution and only for short periods.

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.

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.

Sleep-related breathing disorders

Tramadol may cause sleep-related breathing disorders, such as central 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, consult your doctor. Your doctor may consider reducing the dose.

Inform your doctor or pharmacist if you experience any of the following symptoms while taking tramadol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

Other medicines and Tramadol Aurovitas

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

Do not take tramadol at the same time as medicines called monoamine oxidase inhibitors (MAOIs) (used, for example, to treat depression), or if you have taken them within the last two weeks.

The effect and duration of pain relief provided by tramadol may be reduced if you take medicines containing:

• carbamazepine (used to treat epilepsy).
• pentazocine, nalbuphine, or buprenorphine (analgesics).
• ondansetron (used to prevent nausea).

The risk of adverse effects increases if you take tramadol at the same time as:

• medicines that may cause seizures, such as certain types of antidepressants or antipsychotics. The risk of seizures 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 antidepressants, tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• sedative medicines such as tranquilizers, sleeping medicines, antidepressants, and other analgesics (morphine, codeine); you may feel excessively drowsy or dizzy.
• medicines that prevent blood clotting, such as warfarin; the dose of these medicines may need to be reduced, as otherwise the risk of serious bleeding may increase.
• gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

The simultaneous use of tramadol and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may result in death. For this reason, simultaneous use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol together with sedative medicines, they should limit the dose and duration of concurrent treatment.

Inform your doctor about all sedative medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to ask friends or family members to watch for the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking Tramadol Aurovitas with food, drinks, and alcohol

Do not consume alcohol during treatment with tramadol, as its effects may be intensified.

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.

Pregnancy

Very little information is available on the safety of tramadol during pregnancy. Therefore, tramadol should not be used during pregnancy. If you become pregnant, inform your doctor as soon as possible.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take tramadol more than once during breastfeeding, or if you take tramadol more than once, you must stop breastfeeding.

Driving and using machines

Ask your doctor if you can drive or operate machinery while being treated with tramadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Tramadol Aurovitas contains sodium

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

3. How to take Tramadol Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from the use of tramadol, 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 capsules should be swallowed whole with a glass of water.

The capsules may be taken with or without food and must not be chewed.

The following are the recommended doses. Your doctor may gradually increase or decrease your dose depending on your response to treatment.

The dose should be adjusted according to the intensity of pain and your individual sensitivity to pain. In general, the lowest effective dose that relieves pain should be used.

Adults and adolescents over 12 years of age

The recommended dose is 50 mg or 100 mg (1 or 2 capsules) every 6–8 hours, depending on the intensity of pain. Generally, you should not take more than 400 mg (8 capsules) per day.

Children under 12 years of age

Tramadol is not recommended for children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may recommend extending the dosing intervals.

Patients with severe hepatic or renal impairment/dialysis patients

Tramadol must not be used by patients with severe hepatic or renal impairment. If you have mild or moderate impairment, your doctor may recommend extending the dosing intervals.

If you take more Tramadol Aurovitas than you should

If you take more capsules than prescribed, inform your doctor immediately or go to the emergency department. Various symptoms may occur, which could include: vomiting, decreased blood pressure, increased pulse rate, collapse, fainting, and even coma, seizures, and breathing difficulties.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tramadol Aurovitas

If you miss a dose of tramadol, take it as soon as you remember, then continue as before.

Do not take a double dose to make up for missed doses.

If you stop taking Tramadol Aurovitas

If you stop taking tramadol, pain may return.

You must not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the 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 unnecessary adverse effects (withdrawal symptoms).

If you wish to discontinue treatment due to adverse effects, consult your doctor. If you have been taking this medicine for a long time, you may experience the following adverse effects upon abrupt discontinuation: restlessness, anxiety, nervousness, tremors, or stomach pain. Consult your doctor if you experience any of these effects after stopping tramadol treatment.

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 may cause adverse effects, although not everyone will experience them.

Tramadol may occasionally cause allergic reactions, although serious allergic reactions (including anaphylaxis and angioedema) are rare. Contact a doctor or emergency services immediately if you suddenly develop wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching (especially if affecting the whole body). Also seek immediate help if you have seizures.

The following effects may occur:

Very common (may affect more than 1 in 10 people):

Nausea, dizziness.

Common (may affect up to 1 in 10 people):

Headache, somnolence, fatigue, vomiting, constipation, dry mouth, sweating.

Uncommon (may affect up to 1 in 100 people):

Rapid or irregular heartbeat, increased heart rate, low blood pressure (especially when standing up), which may lead to collapse. Diarrhea, nausea, gastrointestinal irritation (feeling of pressure in the stomach, bloating), skin disorders (e.g., itching, rash, sudden reddening of the skin).

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

Slow heart rate, increased blood pressure, changes in appetite, speech disturbances, skin tingling sensation, tremor, breathing difficulties, epileptic-type seizures (fits), uncoordinated movements, muscle spasms, fainting, blurred vision, difficulty urinating and urinary retention. Muscle weakness. Generalized allergic reactions (e.g., anaphylaxis and angioedema, see below). Hallucinations, confusion, anxiety, sleep disorders and nightmares, mood changes, changes in activity (usually slowing down, sometimes increased activity), decreased consciousness and impaired decision-making ability, which may lead to poor judgment.

Frequency not known (cannot be estimated from available data):

Increased liver enzymes. Worsening of asthma has been reported, although it has not been established whether it was caused by tramadol. Decreased blood sugar levels, hiccups. 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 “What you need to know before taking Tramadol Aurovitas”).

With prolonged use of tramadol, dependence, abuse, or addiction may occur. When stopping treatment, withdrawal symptoms may occur, such as agitation, anxiety, restlessness, insomnia, uncontrolled muscle movements (hyperkinesia), tremor, and gastrointestinal symptoms. Other symptoms that have very rarely been observed upon discontinuation of tramadol treatment include panic attacks, severe anxiety, hallucinations, skin tingling sensation, hearing sounds such as ringing or buzzing without an external cause (tinnitus).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Aurovitas

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

Store this medicine in a safe and secure place, inaccessible to others. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol Aurovitas

• The active substance is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other components are:

Capsule contents: Microcrystalline cellulose (grade 112), colloidal anhydrous silica, sodium carboxymethylstarch (potato type A), magnesium stearate.

Capsule shell: Gelatin, sodium lauryl sulfate, indigo carmine (E132), yellow iron oxide (E172) and titanium dioxide (E171).

Printing ink: Shellac glaze, black iron oxide (E172).

Appearance of the product and contents of the pack

Green/yellow hard gelatin capsules of size “4”, filled with white to off-white powder, printed with “T” on the green cap and “02” on the yellow body in black ink.

Tramadol Aurovitas hard capsules are available in blister packs.

Pack sizes: 20, 30 and 60 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: June 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).