Clanderón 75 mg/650 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Clanderon 75 mg / 650 mg film-coated 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could 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 side 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 adolescents over 12 years of age.

2. What you need to know before taking Clanderon

Do not take Clanderon

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• if you have taken any medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may affect mood and emotions) in cases of acute alcohol intoxication;
• if you are currently taking or have taken monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease) 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

Talk to 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, such as asthma or serious lung conditions;
• if you have epilepsy or have had seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other pain-relief medicines, such as morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anaesthetised. Tell your doctor or dentist that you are taking tramadol/paracetamol;
• if you suffer from depression and are taking antidepressants, as some of them may interact with tramadol (see “Other medicines and Clanderon”);

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

You have serious medical conditions such as severe renal failure, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

There is a weak risk that you may experience a serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol used alone. Contact your doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 “Possible side effects”).

Sleep-related breathing disorders

Clanderon may cause sleep-related breathing disorders such as central sleep apnoea (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 staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tramadol is metabolised 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.

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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which may result in a 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 how much medicine you need to take or how often.

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 ever 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 your use of the medicine.
• You feel unwell when you stop taking the medicine, and feel better when you take it again (“withdrawal effect”).

If you notice any of these signs, talk to your doctor so they can advise you on the best treatment approach, including when and how to stop taking it safely (see section 3, “If you stop taking tramadol/paracetamol”).

Children and adolescents

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

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Other medicines and Clanderon

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

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 together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Clanderon”).

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

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain attacks known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that must be treated urgently (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 diarrhoea, contact your doctor immediately.

• if you are taking painkillers such as morphine or codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. 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).

• Concomitant use of Clanderon and 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 together with sedative medicines, they will limit the dose and duration of concomitant treatment.

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 lower the seizure threshold, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Clanderon simultaneously with these medicines. Your doctor will advise whether Clanderon is suitable for you.

• If you are taking antidepressants, Clanderon may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).

• If you are taking warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. Inform your doctor immediately if you experience any prolonged or unexpected bleeding.

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

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting),
• colestyramine (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 increase drowsiness, so it is recommended not to drink alcohol while taking Clanderon, as it may cause excessive drowsiness.

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 while being treated 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, tramadol is not thought to affect fertility in men and women. There are no data available on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with Clanderon. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Use in athletes

This medicine may result in a positive doping test.

Clanderon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Clanderon

Follow exactly the instructions for administration of this medicinal product as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to 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 tramadol/paracetamol for the shortest time possible. This medicinal product is not recommended for use in children under 12 years of age.

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 1 tablet.

If necessary, the dose may be increased as advised by your doctor.

The shortest interval between doses must be at least 6 hours.

Do not take more than 4 tablets of tramadol/paracetamol per day.

Do not take tramadol/paracetamol more frequently than instructed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower. 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 this medicinal product is not recommended. If you have moderate liver or kidney dysfunction, your doctor may extend the dosing intervals.

Method of administration

This medicinal product is supplied as tablets for oral administration.

The tablets should be swallowed with sufficient liquid. They must not be chewed.

Clanderon tablets may be divided into equal doses.

If you feel that the effect of tramadol/paracetamol 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 tramadol/paracetamol 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, contact the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicinal product and the amount taken.

If you forget to take Clanderon

If you forget to take a dose of this medicinal product, 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

Do not stop taking this medicinal product suddenly unless instructed by your doctor. If you wish to discontinue treatment, 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 likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 people

• nausea,
• dizziness, drowsiness.

Common: may affect up to 1 in 10 people

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “high” all the time).

Uncommon: may affect up to 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,
• depression, nightmares, hallucinations (hearing, seeing or sensing something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stools,
• skin reactions (e.g. rashes, urticaria),
• increased liver enzyme levels,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare: may affect up to 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),
• hiccups,
• serotonin syndrome, which may present with 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, diarrhoea) (see section 2 “What you need to know before taking Clanderon”).

Additionally, the following adverse effects have been reported in individuals taking medicines containing tramadol or paracetamol alone. However, if you experience any of these symptoms while taking Clanderon, you must inform your doctor:

• Dizziness when standing up from a lying or sitting position, slow 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 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 indicating allergic reactions, which may manifest as sudden swelling of the face and neck, shortness of breath, drop in blood pressure and dizziness. If this occurs, stop treatment and consult your doctor immediately. You must not take this medicine again.

• Frequency not known (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 use paracetamol (see section 2).

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

Occasionally, 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 digestive and intestinal disturbances.

Very few people may also experience panic attacks, hallucinations, unusual sensations 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.

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

Serious skin reactions have been reported rarely with paracetamol.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects

If you experience any 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 Medicines: https://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 and can be fatal to people for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substances are tramadol hydrochloride and paracetamol.

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

• The other components (excipients) are: microcrystalline cellulose powder, pregelatinized corn starch, sodium carboxymethyl starch (type A) (from potato), corn starch, magnesium stearate, hypromellose, titanium dioxide, talc, triethyl citrate.

Appearance of the product and contents of the pack

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

Clanderon is available in PVC/aluminum blisters containing 20, 30, 50, 60 and 90 film-coated tablets.

Only certain pack sizes may be commercially available.

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, 26
28850, Torrejón de Ardoz
Madrid, Spain

or

ARISTO PHARMA GMBH
Wallenroder Strasse 8-10 - Berlin - 13435 - Germany

This medicinal product is authorized in the European Economic Area member states under 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 compresse rivestite con film

Date of the most recent revision of this leaflet: June 2025

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