CLANDERON 75 MG/650 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Clanderon 75 mg / 650 mg film-coated tablets

tramadol hydrochloride/paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Clanderon is and what it is used for
2. What you need to know before taking Clanderon
3. How to take Clanderon
4. Possible side effects
5. Storage of Clanderon
6. Package contents and additional information

1. What Clanderon is and what it is used for

Clanderon is a combination of two pain relievers, tramadol and paracetamol, which work together to relieve pain.

Clanderon is indicated for the symptomatic treatment of moderate to severe pain, provided that your doctor considers the combination of tramadol and paracetamol necessary.

Clanderon should only be used by adults and adolescents over 12 years of age.

2. What you need to know before taking Clanderon

Do not take Clanderon

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medication (listed in section 6);
• if you have taken any medication for the treatment of insomnia, potent pain relievers (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with Clanderon.
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Consult your doctor before starting to take Clanderon:

• if you are taking other medications that contain paracetamol or tramadol;
• if you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe respiratory difficulties, such as asthma or severe lung problems;
• if you are epileptic or have had seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other medication used for pain relief, such as morphine;
• if you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anesthetized. Tell your doctor or dentist that you are taking tramadol/paracetamol;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Clanderon");

During treatment with tramadol/paracetamol, inform your doctor immediately if:

If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Sleep-related respiratory disorders

Clanderon may cause sleep-related respiratory disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

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, sufficient pain relief may not be achieved, while others are more likely to experience severe side effects. If you notice any of the following side effects, you should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Tell your doctor or pharmacist if you experience any of the following symptoms while taking Clanderon:

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

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you get used to it, which is known as tolerance). Repeated use of tramadol/paracetamol can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer control the amount of medication you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or someone in your family has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking tramadol/paracetamol, it could be a sign that you have become dependent or addicted:

• You need to take the medication for a longer period than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to calm down" or "to sleep".
• You have repeatedly tried to stop or control the use of the medication without success.
• When you stop taking the medication, you feel unwell, and you feel better when you take it again ("withdrawal effect").

If you observe any of these signs, talk to your doctor, who will indicate the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, If you stop taking tramadol/paracetamol).

Children and adolescents

Treatment is not recommended in children under 12 years of age.

Use in children with respiratory problems

Tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Other medications and Clanderon

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Important:This medication contains paracetamol and tramadol. Inform your doctorif you are taking any other medication that contains paracetamol or tramadol,so that you do not exceed the maximum daily dose.

Clanderon should not be taken with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Clanderon").

It is not recommended to use Clanderon if you are being treated with:

• Carbamazepine (a medication normally used to treat epilepsy or certain types of pain, such as severe facial pain called trigeminal neuralgia). - Buprenorphine, nalbuphine, or pentazocine (opioid pain relievers). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that require urgent treatment (see section 2).

The risk of side effects increases:

• if you are taking triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, muscle contractions, or diarrhea, you should call your doctor.

• if you are taking pain relievers such as morphine or codeine (also when used to treat cough), baclofen (a muscle relaxant), certain medications to lower blood pressure, or medications for the treatment of allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

• The concomitant use of Clanderon and sedative medications such as benzodiazepines or related medications increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medication with sedative medications, you should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medications you are taking and follow your doctor's dosage recommendations strictly. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• if you are taking medications that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Clanderon simultaneously with these medications. Your doctor will tell you if Clanderon is suitable for you.

• If you are taking antidepressants, Clanderon may interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

• If you are taking warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Clanderon may be altered if you also take:

• metoclopramide, domperidone, or ondansetron (medications for the treatment of nausea and vomiting),
• cholestyramine (a medication that lowers cholesterol in the blood).

Your doctor will know which medications are safe to use with Clanderon.

Taking Clanderon with food, drinks, and alcohol

Clanderon may make you feel drowsy. Alcohol can make you feel drowsy, so it is recommended not to drink alcohol while taking Clanderon, as it may cause drowsiness.

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 medication.

Because Clanderon contains tramadol, it is not recommended to take this medication during pregnancy or breastfeeding. If you become pregnant during treatment with Clanderon, consult your doctor before taking the next tablet.

Breastfeeding

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

Based on human experience, tramadol is not suggested to influence fertility in men and women. There are no data available on the combination of tramadol and paracetamol in fertility.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Clanderon. It is important that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it concomitantly with other medications.

Clanderon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Clanderon

Follow the instructions for administration of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from the use of tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor, and when you should stop it (see also section 2).

You should take tramadol/paracetamol for the shortest possible time. It is not recommended to use this medication in children under 12 years of age.

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age is 1 tablet.

If necessary, you can increase the dose, as recommended by your doctor.

The shortest interval between doses should be at least 6 hours.

Do not take more than 4 tramadol/paracetamol tablets per day.

Do not take tramadol/paracetamol more frequently than indicated by your doctor.

Elderly patients

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

Patient with liver or kidney impairment/patients on dialysis

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

Method of administration

This medication is presented in the form of tablets for oral administration.

The tablets should be swallowed with sufficient liquid. They should not be chewed.

Clanderon tablets can be divided into equal doses.

If you think the effect of tramadol/paracetamol is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., you do not have adequate pain relief), tell your doctor.

If you take more Clanderon than you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Clanderon

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

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

If you stop taking Clanderon

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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common: may affect more than 1 in 10 people

• nausea,
• dizziness, drowsiness.

Common: may affect 1 in 10 people

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth
• itching, increased sweating (hyperhidrosis),
• headache, agitation,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling of being "high" all the time).

Uncommon: may affect 1 in 100 people

• increased pulse or increased blood pressure, heart rhythm and frequency disorders,
• tingling sensation, numbness or pinching sensation in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or perceiving something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g. rashes, urticaria),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flashes, chest pain.

Rare: may affect 1 in 1,000 people

• seizures, difficulty carrying out coordinated movements, transient loss of consciousness (syncope),
• dependence on the medicine,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency Not Known: cannot be estimated from the available data

• decrease in blood sugar levels (hypoglycemia).
• hiccups
• serotonin syndrome, which can manifest as 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 stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Clanderon").

Additionally, the following recognized adverse effects have been reported by people who have taken medicines containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Clanderon, you should tell your doctor:

• Feeling of dizziness when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.

• The use of tramadol/paracetamol along with anticoagulants (e.g. Fenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes, indicating allergic reactions that can manifest as sudden swelling of the face and neck, shortness of breath or drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.

• Frequency not known (cannot be estimated from the available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

In rare cases, using a medicine like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or trembly.

They may be hyperactive, have difficulty sleeping and have digestive and intestinal disorders.

Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus).

If you experience any of these symptoms after stopping treatment with Clanderon, please consult your doctor.

In exceptional cases, blood tests may reveal certain anomalies, such as low platelet count, which can result in nosebleeds or bleeding gums.

In rare cases, serious skin reactions have been reported with paracetamol.

There have been reports of rare cases of respiratory depression with tramadol.

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 that does not appear in this prospectus.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Clanderon

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

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

• The active ingredients are tramadol hydrochloride and paracetamol.

• Each film-coated tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.

• The other components (excipients) are: cellulose powder, pregelatinized corn starch, sodium carboxymethyl starch (type A) (potato), corn starch, magnesium stearate, hypromellose, titanium dioxide, talc, triethyl citrate.

Appearance of the Product and Package Contents

Clanderon 75 mg / 650 mg film-coated tablets are white or almost white tablets with a break mark.

Clanderon is presented in PVC/aluminum blisters containing 20, 30, 50, 60 and 90 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Manufacturer

Laboratorios Medicamentos Internacionales S.A. (Medinsa)

C/Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

or

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10 - Berlin - 13435 - Germany

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

PT: Tramadol / Paracetamol Aristo 75 mg / 650 mg film-coated tablet

DE: Tramadol/Paracetamol Aristo 75 mg / 650 mg Filmtabletten

ES: Clanderon 75 mg / 650 mg film-coated tablets

IT: Tramadolo e Paracetamolo 75 mg / 650 mg compresse rivestite con film

Date of the Last Revision of this Prospectus:May 2025

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