Package Leaflet: Information for the user

Tramadol Kern Pharma 50 mg Hard Capsules EFG

tramadol, hydrochloride

Read this leaflet carefully before you start to take 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Tramadol, the active ingredient of this medication, is an analgesic belonging to the group of opioids 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 for the treatment of moderate to intense pain.

Do not take Tramadol:

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

Warnings and Precautions

Consult your doctor before starting to take this medication:

- if you think you have dependence on other analgesics (opioids);

- if you have consciousness disorders (if you think you are going to faint);

- if you are in shock (a sign of this state may be cold sweat);

- if you have increased intracranial pressure (for example, after a head trauma or brain disease);

- if you have difficulty breathing;

- if you are epileptic or have seizures, as the risk of seizures may increase;

- if you have depression and are taking antidepressants, as some may interact with tramadol (see "Taking tramadol with other medications");

- if you have any liver or kidney disease.

Sleep-related respiratory disorders

Tramadol maycause sleep-related respiratory disorders, such as central sleep apnea (shallow breathingorpauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Among the symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor mayconsider reducing the dose.

There is a weak risk that you may experience a serotonin syndrome that can appear after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any of the symptoms linked to this severe 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 recommended maximum daily dose (400 mg).

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Kern Pharma may also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction may cause a feeling of lack of control over the amount of medication you should use or the frequency with which you should use 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 alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using Tramadol Kern Pharma, it could be a sign of dependence or addiction:

• You need to use the medication for longer than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medication or control its use.
• You feel unwell when you stop using the medication, 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 discontinue the medication, and how to do it 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, and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Talk to your doctor, 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. 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 hormone supplements.

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Taking tramadol with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

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

The simultaneous administration of this medication with central depressants may potentiate the effects of tramadol on the nervous system.

The previous or simultaneous administration of carbamazepine or ondansetron may shorten the duration and reduce the analgesic effect of tramadol.

Combining tramadol with opioids such as buprenorphine, nalbuphine, or pentazocine is not recommended, as it may reduce its effect.

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

The risk of adverse effects increases,

• if you are taking this medication 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 medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take tramadol simultaneously with these medications. Your doctor will tell you if it is suitable for you.
• if you are taking medications for depression, tramadol may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• The concomitant use of tramadol and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members to be aware of the mentioned signs and symptoms. Contact your doctor when you experience such symptoms.

Taking tramadol with food and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is very little information available on the safety of tramadol in pregnant women. Therefore, do not take this medication if you are pregnant.

Long-term treatment during pregnancy may cause withdrawal syndrome in newborns.

Lactation

Tramadol is excreted in breast milk. Therefore, do not take tramadol more than once during breastfeeding or, if you take tramadol more than once, discontinue breastfeeding.

Fertility

Based on human experience, it is not suggested that tramadol affects the fertility of men and women.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with tramadol. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, and/or when taking it with other medications.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Before starting treatment and regularly during it, your doctor will also explain what you can 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 discontinue use (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible that produces pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you otherwise.

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

Adults and adolescents 12 years and older

Normally, the 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 medication is not recommended for children under 12 years.

Older patients

In older patients (over 75 years): the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney insufficiency/patients on dialysis

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

How and when to take Tramadol?

The capsules are administered orally.

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

You can take the capsules either with an empty stomach or with meals.

For how long should you take Tramadol?

This medication should not be administered for longer than strictly necessary. If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary with interruptions in treatment) to see if you should continue treatment with this medication and at what dose.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more tramadol than you should

If you have taken an additional dose by mistake, generally you will not have any negative effects. Take the next dose as prescribed.

After taking very high doses of tramadol, contraction of the pupil, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest may occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult the Toxicological Information Service immediately. Telephone (91)562.04.20, indicating the medication and the amount ingested. It is recommended to bring the medication leaflet to the healthcare professional.

If you forget to take tramadol

If you forget to take the medication, it is likely that the pain will return.

Do not take a double dose to compensate for the missed doses, simply continue taking the capsules in the usual way.

If you interrupt treatment with tramadol

If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will return. If you want to discontinue treatment due to side effects, consult your doctor.

Do not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment with tramadol is discontinued. However, in rare cases, people who have been taking this medication for some time may feel unwell if they discontinue treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ringing in the ears (tinnitus). Very rarely, more unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after discontinuing treatment with this medication, consult your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 and hives along with difficulty breathing.

The most common side 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 and rapid heartbeats, feeling of dizziness or collapse). These side effects may occur particularly in patients who are lying down or who are engaging in physical effort.

- Desire to vomit (retching), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, swelling), diarrhea.

- Dermatological reactions (e.g. itching, skin 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 heart rate.

- Increased blood pressure.

- Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.

- Seizures mainly occur after the use of high doses of tramadol or when another medicine that may induce them is taken simultaneously.

- Changes in appetite.

- Hallucinations, confusion, alterations in sleep, delirium, anxiety, and nightmares.

- Psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These may appear in the form of changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased and occasionally increased) and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to judgment errors).

- It may cause dependence on the medicine. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking tramadol") may occur.

- Blurred vision, constriction of the pupils (miosis), excessive dilation of the pupils (mydriasis).

- Slow breathing, shortness of breath (dyspnea).

- Cases of worsening asthma have been reported, however it has not been established if they were caused by tramadol. Exceeding the recommended doses or taking it concomitantly with other medicines that depress brain function may cause a decrease in respiratory frequency.

- Muscle weakness.

- Difficulty or pain urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

- Increased liver enzymes.

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

- Decreased blood sugar levels.

- Hiccups.

- Serotonin syndrome, which may manifest itself through changes in mental state (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 starting to take Tramadol Kern Pharma").

Reporting of side effects

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

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

Store this medication in a safe and protected place, to which other people cannot access. This medication can cause serious harm or even be fatal to people who have not been prescribed it.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD.The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol Kern Pharma

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

Appearance of the product and contents of the packaging

Tramadol Kern Pharma is presented in the form of hard capsules for oral administration in packaging with 20 and 60 hard capsules.

Hard capsule with a cream-colored body and head without printing.

Holder of the marketing authorization and responsible for manufacturing:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Date of the last review of this leaflet:May 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/