Prospect: Information for the patient

Clanderon 37.5 mg / 325 mg film-coated tablets EFG

hydrochloride of tramadol/paracetamol

Read this prospect carefully before starting to take this medication, 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 medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Clanderon and for what it is used

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 package and additional information

Clanderon is a combination of two analgesics, tramadol and paracetamol, which act 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 components 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 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 uncontrolled epilepsy 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, 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 to relieve pain, for example morphine;
• if you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• if you are 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").

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, drowsiness, 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 he will decide whether you should take a hormone 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 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 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:

• You need to take the medication for a longer period than recommended by your doctor.
• You need to take more of the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep".
• You have repeatedly and unsuccessfully tried to stop or control the use of the medication.
• 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 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 interrupt treatment with Clanderon").

Children and adolescents

Treatment is not recommended for 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.

Clanderonshould not be takenwith monoamine oxidase inhibitors (MAOIs) (see section "Do not take Clanderon").

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

-Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
-Buprenorphine, nalbuphine, or pentazocine (opioid analgesics).The pain relief may 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 contractions ordiarrhea, you should call your doctor.

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

• ifyou 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 somnolence, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, 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.

Inform your doctor of all sedative medications you are taking and follow your doctor's dose and duration recommendations strictly. It may be helpful to inform your friends and family about the signs and symptoms indicated 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 may be 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 the treatment of 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 cause drowsiness. Alcohol may cause drowsiness, so it is recommended not to drink alcohol while taking Clanderon.

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. Therefore, do not take Clanderon more than once during breastfeeding, or if you take Clanderon more than once, stop breastfeeding.

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

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with Clanderon. It is essential to observe how this medication affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or double 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 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 lowest 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 2 tablets.

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 8 tablets of tramadol/paracetamol 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 a 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 whole with sufficient liquid. They should not be broken or chewed.

Ifyouestimatethat theeffect oftramadol/paracetamolis too strong (e.g. youfeel verysomnolent 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 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 the 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 interrupt 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 urinating,
• chills, hot flashes, chest pain.

Rare: may affect 1 in 1,000 people

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope),
• dependence on the medication,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive pupil dilation (mydriasis)

Unknown frequency: cannot be estimated from available data

• decreased blood sugar levels (hypoglycemia).
• hypothalamus.
• serotonin 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 symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting to take Clanderon").

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

• 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 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 eruptions, indicating allergic reactions thatmay manifest as sudden swellingof the faceand neck, shortness of breath, or drop in blood pressure and dizziness. If this happens to you,interrupt the treatment and consult your doctor immediately. Do not take this medication again.

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

In rare cases, peoplewho have been taking tramadol for some timemay feel unwell if the treatmentis stoppedabruptly.They may feelagitated, anxious,nervous, orshaky.

They may be hyperactive, havedifficulty sleeping andpresentgastrointestinal andintestinalproblems.

Very few people may also experience panic attacks,hallucinations, unusual perceptions such asitching, 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 example lowplatelet count, whichmay result innosebleedsorbleeding gums.

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

Cases of rare respiratory depression with tramadol have been reported.

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 prospectus.

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 medication.

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

Store this medication in a safe and protected place, where other people 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 that appears 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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

• The active principles are hydrochloride of tramadol and paracetamol.

• Each film-coated tablet contains 37.5 mg of hydrochloride of tramadol and 325 mg of paracetamol.

• The other components (excipients) are:cellulose powder, cornstarchpregelatinized,carboxymethylstarchsodium(typeA) (from potato), cornstarch, magnesium stearate, hypromellose, titanium dioxide, talc,trietilcitrato.

Appearance of the product and contents of the packaging

Clanderon 37.5 mg / 325 mg film-coated tablets EFG are white or almost white tablets.

Clanderon is presented in PVC/aluminum 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 37.5 mg / 325 mg film-coated tablet

DE: Tramadol/Paracetamol Aristo 37,5 mg / 325 mg Filmtabletten

ES: Clanderon 37.5 mg / 325 mg film-coated tablets EFG

IT: Tramadolo e Paracetamolo 37.5 mg / 325 mg film-coated tablets

Last review date of this leaflet: August 2024

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