Clanderón 75 mg/650 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clanderon 75 mg/650 mg effervescent tablets

Tramadol hydrochloride / Paracetamol

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Clanderon
6. Contents of the pack and other information

1. What Clanderon is and what it is used for

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

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

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

2. What you need to know before taking 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);
• if you have taken any medicines for insomnia, analgesics, or psychotropic medicines (medicines that may alter mood and emotions) in cases of acute alcohol intoxication;
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease), or if you have taken them within the last 14 days before starting 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 medicines containing 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 a sign of jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe breathing difficulties, for example asthma or serious lung conditions;
• if you have epilepsy or have had seizures or convulsions;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Clanderon");
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other medicine used for pain relief, for example morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anesthetized. Tell your doctor or dentist that you are using Clanderon.

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

You have serious medical conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

If you develop or have previously experienced any of these problems while taking tramadol/paracetamol, inform your doctor. Your doctor will decide whether you should continue taking this medicine.

Sleep-related breathing disorders

Tramadol/paracetamol may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These symptoms may include pauses in breathing during sleep, waking up at night 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.

There is a low risk that you may experience a serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you experience any symptoms associated with this serious condition (see section 4, "Possible side effects").

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse 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 may cause the medicine to become less effective (you may become accustomed to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may 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 a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have previously 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 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 prescribed, for example, "to stay calm" or "to sleep".
• You have repeatedly tried and failed to stop or control medicine use.
• When you stop taking the medicine, you feel unwell, and feel better when you take it again ("withdrawal effect").

If you notice any of these signs, speak with your doctor to determine the best treatment approach 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

Use in children with respiratory problems

The use of tramadol is not recommended in children with respiratory problems, as 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 adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

Other medicines and Clanderon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

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

The use of Clanderon is not recommended if you are undergoing treatment with:

• Carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as intense facial pain known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

The risk of adverse effects increases:

• if you are taking triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle contractions, or diarrhea, contact your doctor.
• if you are taking other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).
• the concomitant use of tramadol/paracetamol with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine with sedative medicines, your dose and duration of concomitant treatment should be limited. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendations. 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 medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these medicines. Your doctor will advise whether tramadol/paracetamol is suitable for you.
• if you are taking medicines for depression treatment. Tramadol/paracetamol may interact with these medicines and may cause serotonin syndrome (see section 4, "Possible side effects").
• If you are taking warfarin or fenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must 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 (medicines for nausea and vomiting treatment),
• colestyramine (a medicine that lowers blood cholesterol).

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 increase drowsiness; therefore, 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 plan to become pregnant, consult your doctor or pharmacist before using 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. Therefore, you should not take Clanderon more than once during breastfeeding, or if you take Clanderon more than once, you must stop breastfeeding.

Based on human experience, there is no suggestion that tramadol affects fertility in men and women. There are no data available on the combination of tramadol and paracetamol regarding fertility.

Driving and use of machines

Ask your doctor whether you can drive or operate machinery during treatment with tramadol/paracetamol. It is important that you observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a formulation change, and/or when taken together with other medicines.

Use in athletes

This medicine may result in a positive finding in doping control tests.

Clanderon contains sodium

This medicine contains 356.22 mg of sodium (main component of table/cooking salt) in each effervescent tablet. This is equivalent to 18.22% of the maximum recommended daily sodium intake for an adult.

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

3. How to take Clanderon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using 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 duration.

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

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

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents over 12 years of age is 2 effervescent tablets.

If necessary, your doctor may advise you to increase the dose. The shortest interval between doses must be at least 6 hours.

Do not take more than 4 Clanderon tablets per day.

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

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal 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 disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration

The effervescent tablets are taken orally.

The effervescent tablets should be dissolved in a glass of water before taking.

If you feel 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 get 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, contact 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 at telephone number 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 Clanderon, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as usual.

If you stop taking Clanderon

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “on a high” all the time).

Uncommon: may affect 1 in 100 people;

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling sensation, numbness or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms,
• difficulty breathing,
• difficulty swallowing, blood in stools,
• skin reactions (e.g. rashes, urticaria),
• increased levels of liver enzymes,
• presence of albumin in urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare: may affect 1 in 1,000 people;

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

Frequency not known: cannot be estimated from available data:

• decrease in blood sugar levels (hypoglycaemia).

The following adverse effects have been reported in people who have taken medicines containing tramadol only or paracetamol only. However, if you experience any of these symptoms while taking Clanderon, you must inform your doctor:

• Dizziness when standing up after lying down or sitting, slow 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 together with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes may occur, 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 to you, stop treatment and consult your doctor immediately. You must not take this medicine again.

• Frequency not known (frequency cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

In rare cases, taking a medicine such as tramadol may lead to dependence, making it difficult for you to stop taking it.

In rare cases, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience 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:

• hiccups

• serotonin syndrome, which may present with changes in mental status (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 taking Clanderon”).

In exceptional cases, blood tests may reveal certain abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

Very rarely, serious skin reactions have been reported with paracetamol.

Rare cases of depression have been reported with tramadol.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide 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 secure place, where others cannot access it. It may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton, aluminum strip, or at the bottom of the tablet container after EXP. The expiry date refers to the last day of the month indicated.

Tablets in coated aluminum strips: Store below 25°C

Tablets in tablet containers in cartons: Store below 30°C

Shelf life after first opening: 9 months, without exceeding the expiry date printed on the packaging.

Keep in the original container to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Clanderon effervescent tablets

• The active substances are tramadol hydrochloride and paracetamol.

Each effervescent tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.

• The other components (excipients) are:

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

Appearance of the product and contents of the pack:

Clanderon effervescent tablets EFG are white or almost white effervescent tablets.

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

Aluminum blister strips: packs containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 effervescent tablets.

Tablet containers: packs containing 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 most recent review of this leaflet: June 2025

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