Tramadol Kern Pharma 50 mg, hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tramadol Kern Pharma 50 mg hard capsules EFG

tramadol hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because 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, pharmacist or nurse.
• 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tramadol Kern Pharma is and what it is used for

Tramadol, the active substance of this medicine, 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 is used to treat moderate to severe pain.

2. What you need to know before taking Tramadol Kern Pharma

Do not take Tramadol:

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6).
• in cases of acute intoxication due to alcohol, sleeping medications, psychotropic drugs (medications acting on mood and emotions), analgesics, or hypnotics.
• if you are currently being treated with monoamine oxidase inhibitors (MAOIs) (a certain type of medication used to treat depression) or have taken them within the last 14 days before starting treatment with this medicine (see "Taking tramadol with other medicines").
• if you have epilepsy and your seizures are not adequately controlled by treatment.
• for the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting to take 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 (e.g., after head trauma or brain diseases);
• if you have difficulty breathing;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Taking tramadol with other medicines");
• if you have liver or kidney disease.

Sleep-related breathing disorders

Tramadol may cause sleep-related breathing disorders, such as central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, 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.

There is a slight risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious syndrome (see section 4, "Possible side effects").

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the drug (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Kern Pharma 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

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 Kern Pharma, 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 prescribed, e.g., "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).

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 contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, vomiting, constipation, or loss of appetite.

Talk to your doctor or pharmacist or nurse 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. 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.

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.

Taking tramadol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

Tramadol must not be combined with monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression).

Concomitant administration of this medicine with centrally acting depressants may enhance the effects of tramadol on the central nervous system.

Prior or concomitant administration of carbamazepine or ondansetron may shorten the duration and reduce the analgesic effect of tramadol.

Combination of tramadol with opioids such as buprenorphine, nalbuphine, or pentazocine is not recommended, as their effect may be reduced.

Isolated cases of seizures have been reported in patients treated with tricyclic antidepressants or selective serotonin reuptake inhibitors, neuroleptics, or other drugs that lower the seizure threshold, in combination with tramadol.

The risk of adverse effects increases:

• if you are taking this medicine simultaneously with other analgesics such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.
• if you are taking medicines that facilitate or may provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will advise you whether this is suitable for you.
• if you are taking medicines for depression, tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible side effects").
• Concomitant use of tramadol and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

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 are aware of the symptoms mentioned above. Contact your doctor if you experience such symptoms.

Taking tramadol with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified. Food does not affect the action of tramadol.

Pregnancy, breastfeeding, and fertility

Pregnancy

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 in pregnant women. Therefore, you should not take this medicine if you are pregnant.

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

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.

Fertility

Based on human experience, tramadol is not expected to influence fertility in men or women.

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, and/or when taking it together with other medicines.

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; hence, it is essentially "sodium-free".

3. How to take Tramadol Kern Pharma

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using 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 dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has specifically instructed you otherwise.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents aged 12 years and older

The usual initial dose is 1 or 2 capsules (equivalent to 50–100 mg of tramadol hydrochloride).

Depending on the pain, the effect may last between 4–6 hours.

Children

This medicine is not recommended for children under 12 years of age.

Elderly patients

In elderly patients (over 75 years): tramadol elimination may be slower. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with Tramadol is not recommended. If you have moderate liver or kidney dysfunction, your doctor may extend the dosing intervals.

How and when to take Tramadol?

The capsules are taken orally.

Swallow the capsules whole without dividing or chewing them, with sufficient liquid.

You may take the capsules either on an empty stomach or with food.

How long should you take Tramadol?

This medicine should not be used for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at short, regular intervals (and if necessary with treatment interruptions) to determine whether continued treatment with this medicine and at what dose is still appropriate.

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 than you should

If you have taken an extra dose by mistake, you will generally not experience negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, reduced level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest can occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact the Toxicology Information Service immediately at telephone (91)562.04.20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to take tramadol

If you forget to take your medicine, your pain may return.

Do not take a double dose to make up for missed doses; simply continue taking the capsules as usual.

If you stop taking tramadol

If you stop or discontinue treatment with this medicine too early, your pain is likely to return. If you wish to stop treatment due to adverse effects, consult your doctor.

You should not stop taking this medicine suddenly unless your doctor tells you to do so. If you want 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, in rare cases, people who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive or intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, or numbness, and ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, 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 may cause adverse effects, although not everyone experiences 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 and rash together with difficulty breathing.

The most common 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 1 in 10 people

• Headache, numbness.
• Fatigue.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeats, feeling of dizziness or collapse). These adverse effects may particularly occur in patients who are standing up or performing physical exertion.
• Nausea (feeling of wanting to vomit), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
• Skin reactions (e.g. itching, rash).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after use of high doses of tramadol or when taken simultaneously with other medicines that may trigger them.
• 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 decreased cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• It may lead to drug dependence. If treatment is abruptly discontinued, withdrawal syndrome may occur (see "If you stop taking tramadol").
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: frequency cannot be estimated from the available data

• Decreased blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may present as 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, diarrhoea) (see section 2 “What you need to know before taking Tramadol Kern Pharma”).

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 Kern Pharma

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.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Tramadol Kern Pharma

• The active substance in this medicine is tramadol. Each hard capsule contains 50 mg of tramadol (as hydrochloride).
• The other components (excipients) are: corn starch, sodium carboxymethyl starch (Type A), microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, yellow iron oxide (E-172), titanium dioxide (E-171), and gelatin.

Appearance of the product and contents of the pack

Tramadol Kern Pharma is presented as hard capsules for oral administration, in packs containing 20 and 60 hard capsules.

Hard capsule with cream-colored body and cap, unprinted.

Marketing Authorization Holder and Manufacturing Responsible Person:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: May 2024

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