Prospect: Patient Information

Clanderon 75 mg / 650 mg Film-Coated Tablets

Tramadol Hydrochloride/Paracetamol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Clanderon and what it is used for

2.What you need to know before starting to take Clanderon

3.How to take Clanderon

4.Possible adverse effects

5.Storage of Clanderon

6. Contents of the pack and additional information

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

Clanderon is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

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

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 insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are also taking MAO inhibitors (certain medications used for the treatment of 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 uncontrolled epilepsy;

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 problems, for example asthma or severe lung problems;
• if you are epileptic or have had seizures or convulsions;
• if you have recently had a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other medication used for pain relief, for example morphine;
• if you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• if you are to be anaesthetized. 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");

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 your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Respiratory problems related to sleep

Clanderon may cause respiratory problems related to sleep such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. 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, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, somnolence, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Inform 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, and they 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 become tolerant of it, known as tolerance). Repeated use of tramadol/paracetamol can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer use.

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

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

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

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

• Necesita tomar el medicamento durante más tiempo del aconsejado por su médico.
• Necesita tomar más de la dosis recomendada.
• Utiliza el medicamento por motivos distintos a los prescritos, por ejemplo “para mantener la calma” o “para dormir”.
• Ha intentado repetidamente y sin éxito dejar o controlar el uso del medicamento.
• Cuando deja de tomar el medicamento se siente mal, y se siente mejor cuando vuelve a tomarlo (“efecto de abstinencia”).

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

Children and adolescents

It is not recommended to treat children under 12 years old.

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.

Other medications and Clanderon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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").

Clanderon should not be used if you are being treated with:

-Carbamazepine (a medication normally usedfor treating epilepsyorsome types of pain, such as severe facial pain calledtrigeminal neuralgia).
-Buprenorphine, nalbuphineor pentazocine(opioid analgesics).Thepain reliefmay be reduced.

- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

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 experienceconfusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractionsordiarrhea, you should call your doctor.

• if you are taking analgesics such as morphine or codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• ifyou are taking gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

• Theconcomitant useof Clanderon and sedatives such as benzodiazepines or related medications increases the risk of somnolence, respiratory difficulties (respiratory depression), coma, and may 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 sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's dose recommendation 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 facilitate or may 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 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. Inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Clanderon may be altered if you are also taking:

-metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),

-colestiramine (a medication that reduces 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 may 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the fact that 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.

Lactation

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

Based on human experience, it is not suggested that tramadol affects male and female fertility. There are no available data on the combination of tramadol and paracetamol in fertility.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Clanderon. 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, after changing the formulation, and/or when taking it with other medications.

Clanderon contains sodium

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

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

Before starting treatment and regularly during it, 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 interrupt it (see also section 2).

You should taketramadol/paracetamolfor the shortest time possible.

This medication is not recommended for use in childrenunder 12years old.

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

Unless your doctor prescribes something different, the recommended starting dose for adults and adolescents over 12 years old 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 your doctor has indicated.

Older patients

In older patients (over 75 years old), 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 disease/patients on dialysis

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

Administration form

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.

Ifyou estimate that theeffect oftramadol/paracetamolis too strong (e.g., youfeel verysleepy or havedifficulty breathing)or tooweak (e.g.,:you do not have adequatepain relief), inform 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 severe liver damage that will only become apparent later.

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

If you forgot to take Clanderon

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

Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Clanderon

You should 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 "high" all the time).

Rare: may affect 1 in 100 people

• increased heart rate or increased blood pressure, heart rhythm and frequency disorders,
• sensation of tingling, numbness or pinching in the extremities, ear noises, 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, urticarial hives),
• 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, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope),
• dependence on the medication,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known: cannot be estimated from available data

• decreased blood sugar levels (hypoglycemia).
• hyperserotonergic syndrome, which may 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 rigidity, lack of coordination and/or gastrointestinal and intestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Clanderon").

In addition, the following recognized side effects have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Clanderon, please tell your doctor:

• Feeling dizzy when getting up from 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 with anticoagulants (e.g. Fenprocumona, warfarin) may increase the risk of bleeding. Please inform your doctor immediately about any prolonged or unexpected bleeding.

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

In rare cases, using a medication like tramadol can make you dependent on it, 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 orshaky.

They may be hyperactive, have difficulty sleeping andpresentdigestive andintestinalproblems.

Very few people may also experience panic attacks,hallucinations, unusual perceptions such asitching,sensation of tingling andnumbness, andear noises(tinnitus).

If you experience any of thesesymptoms after stoppingthe treatment with Clanderon, please consult your doctor.

In exceptional casesblood tests may reveal certain abnormalities, for examplelow platelet count, whichmay result innosebleedsorin the gums.

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

Tramadol-induced respiratory depression has been reported in rare cases.

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 the 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 secure location, where others cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date listed on the packaging, 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 packaging and unused medication at the SIGRE drop-off point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medication. This will help protect the environment.

• The active principles are hydrochloride of tramadol and paracetamol.

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

• The other components (excipients) are: cellulose powder , cornstarch pregelatinized , carboxymethylstarch sodium (type A) (from potato) , cornstarch, magnesium stearate , hypromellose, titanium dioxide, talc, trietilcitrato

Appearance of the product and contents of the packaging

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

Clanderon is presented in PVC/aluminium blisters that contain 20, 30, 50, 60 and 90 film-coated tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

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 with 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 film-coated tablets

Last review date of this leaflet: August 2024

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