Leaflet: information for the user

Clanderon 37.5 mg/325 mg effervescent tablets EFG

Tramadol hydrochloride/ Paracetamol

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

1. What Clanderon is and what it is used for

2. What you need to know before you start taking Clanderon

3. How to take Clanderon

4. Possible side 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 children over 12 years old.

Do not take Clanderon

- If you are allergic to tramadol, paracetamol or any of the other components of this medication (listed in section 6);

- If you have taken any medication for the treatment of insomnia, analgesics 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 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 suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Clanderon").

- If you have recently experienced head trauma, shock or intense headaches associated with vomiting;

- If you have dependence 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 anesthetized. Inform your doctor or dentist that you are using Clanderon.

If any of these problems occur while taking Clanderon, inform your doctor. He/she will decide if you should continue taking this medication.

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.

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 monotherapy.

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

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme and this may 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.

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 have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or a family member have 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 a 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 tried repeatedly and unsuccessfully to stop or control the use of 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 stop taking tramadol/paracetamol).

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.

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, who will decide if you should take a hormone supplement.

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 doctor if you are takingany other medication that contains paracetamol or tramadol,so as not to exceed the maximum daily dose.

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

Do not use Clanderon if you are being treated with:

• Carbamazepine (medication normally used to treat epilepsy or some types of pain, such as trigeminal neuralgia attacks).
• Buprenorphine, nalbuphine or pentazocine (opioid analgesics). 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 experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions or diarrhea, you should call your doctor.
• if you are taking other analgesics such as morphine and codeine (also 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.
• if you are taking gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).
• the concomitant use of tramadol/paracetamol 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 about 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 tramadol/paracetamol simultaneously with these medications. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• if you are taking medications for the treatment of depression. Tramadol/paracetamol 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 (medication used to prevent blood clots). The effectiveness of these medications may be altered, with 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 are also taking:

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

- cholestyramine (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 more drowsy, 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.

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 stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects fertility in men and women. There are no data available 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 tramadol/paracetamol. 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 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 concomitantly with other medications.

Clanderon contains sodium

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

Consult your doctor or pharmacist if you need 2 or more effervescent tablets daily for a prolonged period, especially if you have been recommended a low-sodium diet.

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 take Clanderon for the shortest time possible.

Use in children under 12 years is not recommended.

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 else, the recommended starting dose for adults and adolescents over 12 years 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 your doctor has indicated.

Older patients

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

Administration form

The effervescent tablets are administered orally.

The effervescent tablets are taken dissolved in a glass of water. Before ingesting the medication, the effervescence must cease.

If you estimate 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), inform 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 severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call 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 Clanderon, it is likely that the pain will recur. 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 adverse effects (withdrawal symptoms).

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.

Very common:can affect more than 1 in 10 people;

- nausea,

- dizziness, drowsiness.

Common:can 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 "high" all the time).

Uncommon:can 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,

- difficulty breathing,

- difficulty swallowing, blood in stool,

- skin reactions (e.g. rashes, urticarial hives),

- increased liver enzyme values,

- presence of albumin in urine, difficulty or pain urinating,

- chills, hot flashes, chest pain.

Rare:can affect 1 in 1,000 people;

- convulsions, difficulties with coordinated movements, transient loss of consciousness (syncope),

- dependence on the medication,

- delirium,

- blurred vision, pupil constriction (miosis),

- speech disorders,

- excessive pupil dilation (mydriasis).

Frequency not known:cannot be estimated from available data:

- decreased blood sugar levels (hypoglycemia),

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 those 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, mood changes, 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. Inform your doctor immediately about any prolonged or unexpected bleeding.

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

In rare cases, using a medication like tramadol, may make you dependent on it, making it difficult to stop taking it.

In rare instances, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Clanderon, please consult your doctor.

Frequency not known:

• hypoglycemia
• serotonin syndrome, which may 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 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 Clanderón").

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

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

Cases of rare 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.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 where other people cannot access it. They 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 blister pack, aluminum foil, or at the bottom of the container for tablets after CAD. The expiration date is the last day of the month indicated.

Blister pack of tablets inaluminum stripscoated:
Store below 25°C

Container of tablets intablet containers:
Store below 30°C

Shelf life once opened: 9 months, not exceeding the expiration date.

Store in the original container to protect it from moisture.

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

Composition of Clanderon effervescent tablets

- The active principles are hydrochloride of tramadol and paracetamol.

Cada comprimido efervescente contiene 37.5 mg of hidrocloruro de tramadol and 325 mg of paracetamol.

- The other components (excipients) are:

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

Appearance of the product and content of the packaging:

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

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

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

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

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 Nº 26

28850 Torrejón de Ardoz

Madrid SPAIN

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Last review date of this prospectus: June 2024

The detailed information of this medicine is available on the website of theSpanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/