CLANDERON 37.5 mg/325 mg EFFERVSCENT TABLETS

2. What you need to know before you take Clanderon

Do not take Clanderon

• If you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Consult your doctor before taking Clanderon

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

If you experience or have experienced any of these problems while taking tramadol/paracetamol, inform your doctor. He/she will decide if you should continue taking this medicine.

Sleep-related breathing disorders

Clanderon may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in blood). These symptoms may be pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive drowsiness during the day. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

There is a slight 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 related to this serious syndrome (see section 4 "Possible side effects").

Tramadol is transformed 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 suffer from serious side effects. If you notice any of the following side effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine 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 that you no longer control the amount of medicine 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 medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or 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 medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine 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 medicine without success.
• When you stop taking the medicine, 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 so that he/she can indicate 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

Use in children with respiratory problems.

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

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 if you should take a hormonal supplement.

Other medicines and Clanderon

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

Important: this medicine contains paracetamol and tramadol. Tell your doctor if you are taking any other medicine that contains paracetamol or tramadol, so that you do not exceed the maximum daily dose.

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

Clanderon is not recommended if you are being treated with:

• Carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as intense pain attacks in the face called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that must be treated urgently (see section 2).

The risk of side effects increases:

• the concomitant use of tramadol/paracetamol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing 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 medicine with sedative medicines, you should limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendation strictly. It may be useful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms.

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

• metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting),
• cholestyramine (a medicine that reduces cholesterol in the blood).

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

Taking Clanderon with food, drinks, and alcohol

Clanderon may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking Clanderon.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Because Clanderon contains tramadol, it is not recommended to take this medicine 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 expected to affect fertility in men and women. There are no data available on the combination of tramadol and paracetamol on fertility.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tramadol/paracetamol. It is important that before driving or using machines, you observe how this medicine 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 administered concomitantly with other medicines.

Clanderon contains sodium

This medicine contains 178.11 mg of sodium (a major component of cooking/table salt) in each effervescent tablet. This is equivalent to 9.11% of the maximum recommended daily intake of sodium for an adult.

Consult your doctor or pharmacist if you need to take 2 or more effervescent tablets daily for a prolonged period, especially if you have been advised to follow a low-salt diet (sodium).

3. How to take Clanderon

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, 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 taking it (see also section 2).

You should take Clanderon for the shortest possible time.

Clanderon is not recommended for use in children under 12 years of age.

The dose should be adjusted according to the intensity of the pain and 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 2 effervescent 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 Clanderon tablets per day.

Do not take Clanderon more frequently than prescribed by your doctor.

Elderly patients

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

Patients with liver or kidney impairment/patients on dialysis

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

Method of administration

The effervescent tablets are taken orally.

The effervescent tablets are taken dissolved in a glass of water. Before ingesting the medicine, it is necessary that the effervescence has stopped.

If you think that the effect of Clanderon 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 Clanderon 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, go immediately to a medical center or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Clanderon

If you forget to take a dose of Clanderon, it is likely that the pain will return. Do not take a double dose to make up for the missed doses; simply continue taking the tablets as usual.

If you stop taking Clanderon

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 taking it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Very frequent: may affect more than 1 in 10 people;

• nausea,
• dizziness, drowsiness.

Frequent: may affect 1 in 10 people;

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

Infrequent: may affect 1 in 100 people;

• increased pulse or increased blood pressure, cardiac rhythm and frequency disorders,
• tingling sensation, numbness or pinching sensation in the limbs, ringing in the ears, involuntary muscle spasms,
• difficulty breathing,
• difficulty swallowing, blood in stools,
• skin reactions (e.g., eruptions, urticarial habon),
• 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 contraction (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),

The following recognized adverse 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, you should tell your doctor:

• Feeling of dizziness when standing up after being 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., Fenprocumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

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

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

In rare cases, using a medication 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 suddenly stop the treatment. 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.

Frequency not known:

• hypoglycemia
• serotonin syndrome, which can manifest 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start taking Clanderón").

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

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

There have been reports of rare cases of 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 www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Clanderon

Keep this medication out of sight and reach of children.

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

Do not use this medication after the expiration date that appears on the packaging, aluminum strip, or on the bottom of the container for tablets after CAD. The expiration date is the last day of the month indicated.

Container of tablets in aluminum strips: Store below 25°C

Box of tablets in containers: Store below 30°C

Validity period once opened: 9 months, without exceeding the expiration date.

Store in the original container to protect it from moisture.

Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Clanderon Effervescent Tablets

• The active ingredients are tramadol hydrochloride and paracetamol.

Each effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are:

povidone (PVK-90), maltodextrin, sodium saccharin dihydrate, orange flavor, anhydrous citric acid, anhydrous sodium citrate, sodium bicarbonate, copovidone, potassium acesulfame, PEG 6000.

Appearance of the Product and Container Content:

Clanderon effervescent tablets EFG are presented in the form of white or almost white effervescent tablets.

The effervescent tablets are packaged in aluminum strips or in containers for tablets.

Aluminum strips: containers with 2, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 effervescent tablets.

Containers for tablets: containers with 10, 16, 20, 25, 30, 40, 50, 60, 70, 80, 90, and 100 effervescent tablets.

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 Nº 26

28850 Torrejón de Ardoz

Madrid, Spain

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Date of the Last Revision of this Prospectus:May 2025

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