Package Leaflet: Information for the User

Velyntra 44 mg/56 mg Film-Coated Tablets

tramadol hydrochloride / celecoxib

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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Velyntra is and what it is used for

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

3.How to take Velyntra

4.Possible side effects

5.Storage of Velyntra

6.Contents of the pack and additional information

This medication contains two active principles: tramadol hydrochloride and celecoxib.

Tramadol is a pain reliever belonging to the opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the brain and spinal cord.

Celecoxib is a pain relieving anti-inflammatory belonging to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Velyntra is used for the short-term symptomatic treatment of moderate to severe acute somatic pain in adults, such aspostoperative pain (e.g., orthopedic and traumatological surgery, or after dental surgical procedures) or musculoskeletal pain (muscle, ligament, tendon, and joint injuries).

Do not take Velyntra

• if you are allergic to tramadol hydrochloride, celecoxib, or any of the other ingredients of this medication (listed in section 6);
• if you have an acute intoxication caused by alcohol, sleeping pills, analgesics, or other psychotropic medications (medications that affect mood and emotions);
• if you are also taking monoamine oxidase inhibitors (medications used to treat depression) or if you have taken them in the last two weeks before starting treatment with this medication;
• if you have epilepsy and your seizures are not adequately controlled with your treatment;
• as a substitute medication in the treatment of withdrawal syndrome;
• if you have had any allergic reaction to a medication in the group called "sulfonamides" (e.g., some antibiotics used to treat infections);
• if you have a current stomach ulcer or intestine, or bleeding in your stomach or intestines;
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID): asthma, nasal polyps, severe nasal congestion, or allergic reactions such as skin rash with itching, facial swelling, lip, tongue, or throat swelling, difficulty breathing, or wheezing;
• if you are pregnant. If you can become pregnant during treatment, you should consult your doctor about using contraceptive methods;
• if you are breastfeeding;
• if you have severe liver disease;
• if you have severe kidney disease;
• if you have inflammatory bowel disease such as ulcerative colitis or Crohn's disease;
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, for example, if you have had a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as "mini-stroke"), angina pectoris, or obstruction of blood vessels to the heart or brain;
• if you have or have had circulatory problems (peripheral arterial disease) or if you have had surgery on the arteries of your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Velyntra:

• if you think you have addiction to other analgesics (opioids);
• if you experience loss of consciousness (if you feel like you are going to faint);
• if you experience cold sweats, paleness, rapid pulse, rapid breathing, dizziness... (possible symptoms and signs of shock, among others);
• if you have been informed by a healthcare professional that your intracranial pressure is higher than normal. This can occur after a head injury or due to diseases that affect the brain, such as a brain tumor;
• if you have difficulty breathing;
• if you are prone to epilepsy or seizures, as the risk of these seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Velyntra");
• if you have any liver or kidney disease;
• if you have or have had a stomach or intestinal ulcer or bleeding;
• if you are taking acetylsalicylic acid (even at low doses as a heart protector);
• if you are taking antiplatelet therapies (e.g., clopidogrel, dipyridamole);
• if you are receiving medications to reduce blood coagulation (e.g., acenocoumarol, anticoagulant analogs of acenocoumarol, or new oral anticoagulants, e.g., apixaban);
• if you are receiving corticosteroids (e.g., prednisone);
• if you are taking this medication at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. Avoid using these medications together;
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol;
• if your heart, liver, or kidneys are not functioning well, your doctor may want to monitor you regularly;
• if you have fluid retention (e.g., swollen feet or ankles);
• if you are dehydrated, for example, due to vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body);
• if you have had a severe allergic reaction or a severe skin reaction to any medication;
• if you feel unwell due to an infection or think you have an infection, as taking this medication can mask fever or other signs of infection and inflammation;
• if you are over 65 years old, your doctor will want to monitor you regularly.

Speak with your doctor or pharmacist if you experience any of the following symptoms while taking this medication:

• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate that you have adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Respiratory disorders related to sleep

This medication may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor.

There is a lower risk that you will 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 severe syndrome (see section 4 "Possible adverse effects").

Seizures have been reported mainly when high doses of tramadol are administered.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication.The repeated use of opioids can make the medication less effective (the body becomes accustomed to it, known as pharmacological tolerance). The repeated use of this medication can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication you should use or the frequency with which you should use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to this medication may be higher if:

- You or any family member have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction");

- You are a smoker.

- You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

If you observe any of the following symptoms while using this medication, it could be a sign of dependence or addiction:

– You need to use the medication for a longer period than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medication for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".

– You have made repeated and unsuccessful attempts to stop using the medication or control its use.

– You feel unwell when you stop using the medication, and you feel better once you take it again ("abstinence symptoms").

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop taking the medication, and how to do it safely (see section 3, if you interrupt treatment with Velyntra).

You may also experience abstinence symptoms when you stop taking this medication. Your doctor will inform you for how long you should take this medication, when you should stop taking it, and how to do it safely. Inform your doctor if you experience any of these problems during treatment with this medication or if they occurred in the past.

Tramadol is metabolized by an enzyme in the liver. 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 adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Like other NSAIDs (e.g., ibuprofen or diclofenac), celecoxib (component of this medication) may increase your blood pressure, so your doctor may perform regular checks on it.

Some cases of severe liver reactions with celecoxib have been reported, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant). Most severe liver reactions reported to have started at the time of onset occurred in the first month of treatment.

Children and adolescents

This medication has not been studied in children or adolescents. Therefore, its safety and efficacy have not been established, and the medication should not be used in children or adolescents.

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these patients.

Other medications and Velyntra

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. Some medications should not be taken together, and others may require a dose adjustment if taken together.

Do not take this medication with:

• monoamine oxidase inhibitors (MAOIs), or 2 weeks before and after taking these medications. MAOIs are medications used to treat depression.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Other analgesics such as morphine and codeine (also used as a cough medication), or alcohol.
• Tranquilizers or sleeping pills (e.g., benzodiazepines).
• Medications that may cause seizures (e.g., certain antidepressants or antipsychotics).
• Antidepressants. Velyntra may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible adverse effects").
• Anticoagulants (e.g., acenocoumarol, apixaban).
• Dextromethorphan (used to treat cough).
• Inhibitors of the ECA, angiotensin II antagonists, beta-blockers, and diuretics (used to control high blood pressure and heart conditions).
• Fluconazole, ketoconazole, rifampicin, isoniazid, and erythromycin (used to treat fungal and bacterial infections).
• Lithium (used to treat certain types of depression).
• Other medications used to treat depression, sleep disorders, high blood pressure, or irregular heartbeat (quinidine, paroxetine, fluoxetine, sertraline, amitriptyline).
• Neuroleptics (used to treat certain mental disorders).
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia).
• Barbiturates (used to treat epilepsy/seizures and certain sleep disorders).
• Ciclosporin and tacrolimus (used to suppress the immune system, e.g., after transplants).
• Ritonavir (treatment of patients infected with HIV-1 in combination with other medications).
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The effect and duration of pain relief from treatment may be reduced if you take medications that contain:

• Carbamazepine (for epilepsy seizures).
• Ondansetron (to prevent nausea).

This medication can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Consult your doctor before taking both medications together.

Administration of Velyntra with food and alcohol

This medication can be taken with or without food. Do not take alcohol during treatment with this medication, as it may increase the adverse effects, especially those affecting the nervous system and digestive system.For instructions on how to take this medication, see section 3.

Pregnancy,breastfeeding,and fertility

The use of this medication is contraindicated during pregnancy as well as during breastfeeding.

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Tramadol (component of this medication) is excreted in breast milk.

Celecoxib (component of this medication) may make it difficult to become pregnant. Inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant.

Driving and operating machinery

This medication may cause drowsiness, dizziness, and blurred vision and may affect your ability to drive and operate machinery. If you are affected, do not drive cars or any other type of vehicle, or use machines or electrical tools until the symptoms disappear.

Velyntra contains mannitol and sodium

It may produce a mild laxative effect.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Velyntra, when and for how long you should use it, when you should contact your doctor and when you should discontinue use (see also Section 2).

For short-term use only.

Adults

The recommended dose is 2 tablets (corresponding to 88 mg of hydrochloride tramadol and 112 mg of celecoxib) every 12 hours.

Do not take more than 4 tablets (176 mg hydrochloride tramadol/224 mg celecoxib) in 24 hours. Your doctor will indicate for how long you should continue treatment.

Some patients may experience insufficient pain relief as they approach the time of the next dose. Talk to your doctor if the treatment does not control your pain.

Use in children and adolescents

This medication is not recommended for use in children and adolescents.

Older patients

No dose adjustment is required in elderly patients.

Patients with severe liver or kidney disease (insufficiency)/patients on dialysis

If you have any severe liver or kidney disease, do not take this medication. If your insufficiency is mild or moderate, your doctor will decide if you can take this medication.

Method of administration

The tablets are administered orally.

Swallow the tablets whole with a sufficient amount of water. Do not divide, crush, or chew the tablets.

The tablets can be taken at any time of the day, with or without food. However, try to take each dose at the same time every day.

If you take more Velyntra than you should

If you have taken an additional dose by mistake,generally you will not have any negative effects. Take the next dose as prescribed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately,go to the emergency department of your nearest hospitalor call the Toxicological Information Service, phone: 91 562 04 20.Please bring the packaging of the medication or this leaflet with you.

The symptoms of overdose of this medication are:

• pupil constriction;
• vomiting;
• decreased blood pressure;
• increased heart rate;
• collapse;
• decreased level of consciousness to coma (deep unconsciousness);
• epileptic seizures;
• difficulty breathing that can lead to respiratory arrest. In this case, call a doctor or go to the nearest emergency department immediately!

Your doctor will treat the symptoms of overdose of this medication.

If you forget to take Velyntra

If you forget to take a dose of this medication, it is likely that the pain will recur. Take the dose as soon as you remember, and then take the next ones at the same time as you were supposed to, as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Velyntra

Generally, pain is self-limiting and requires a few days or weeks of treatment. If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will recur. If you want to discontinue treatment due to adverse effects, consult your doctor.

Brisk discontinuation of treatment with this medication may cause worsening of symptoms (see Section 3 "How to take Velyntra").

Generally, no post-treatment effects are expected after discontinuing treatment with this medication.

However, in rare cases, patients who have been taking tramadol for some time may feel unwell if they stop taking it suddenly. They may feel agitation, anxiety, nervousness, or tremors, confusion, hyperactivity, difficulty sleeping, and gastrointestinal or intestinal disorders. Rarely, people may experience panic attacks, hallucinations, delirium, paranoia, or feelings of loss of identity.

They may experience unusual perceptions such as itching, tingling, and numbness, buzzing in the ears (tinnitus). Very rarely, other unusual symptoms have been observed, such as confusion, delirium, feeling detached from oneself (derealization), change in perception of reality (depersonalization), and delusions of persecution (paranoia). Please consult your doctor if you experience any of these effects after stopping this medication.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are listed below, grouped by how likely they are to occur.

Stop using this medicine and tell your doctor right away if you experience:

• Signs of an allergic reaction such as swelling of the face, lips, tongue, or throat, and/or difficulty swallowing and hives with wheezing or difficulty breathing.
• Heart problems such as chest pain.
• Severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or stools that are black or tarry, or blood in the vomit.
• Any injury inside the mouth or on the mucous membranes, or skin reaction such as rash, blisters, or peeling of the skin.
• Liver failure [the symptoms may include nausea (feeling unwell), diarrhea, jaundice (your skin or the white of your eyes may appear yellow)].

The most common side effects during treatment with this medicine are drowsiness, dizziness, fatigue, nausea, and vomiting, which occur in more than 1 in 10 patients (very common). The side effects reported for tramadol and celecoxib as individual products taken alone, and either after short-term or long-term administration, are listed below:

Very common (may affect more than 1 in 10 people)

• Feeling unwell (nausea).
• Dizziness.
• Increased blood pressure, including worsening of existing high blood pressure (hypertension).

Common (may affect up to 1 in 10 people)

• Uncomfortable (vomiting).
• Constipation.
• Dry mouth.
• Headache.
• Sweating (hyperhidrosis).
• Drowsiness.
• Fatigue.
• Heart attack.
• Fluid retention with swelling of the ankles, legs, and/or hands.
• Urinary tract infections.
• Difficulty breathing, sinusitis (inflammation, infection, obstruction, or pain of the paranasal sinuses), stuffy nose or runny nose, sore throat, cough, cold, flu-like symptoms.
• Difficulty sleeping.
• Stomach pain, diarrhea, indigestion, gas.
• Rash, itching.
• Muscle stiffness.
• Difficulty swallowing.
• Joint pain.
• Allergic reactions (e.g. difficulty breathing, wheezing, or a ringing sound when breathing, swelling of the face), worsening of existing allergies.
• Accidental injury.

Uncommon (may affect up to 1 in 100 people)

• Desire to vomit (retching).
• Gastrointestinal irritation (feeling of pressure in the stomach, swelling).
• Effects on cardiovascular regulation, including the perception of heartbeats (palpitations), rapid heartbeats (tachycardia), feeling of dizziness or fainting when standing up (postural hypotension), when there is not enough blood circulation because the heart is not working properly (cardiovascular collapse). These side effects may occur particularly in patients who are bedridden or who engage in physical exertion.
• Skin reactions, including hives (urticaria).
• Stroke.
• Abnormalities in blood test results related to the liver.
• Abnormalities in blood test results related to the kidneys.
• Anemia (changes in red blood cells that may cause fatigue and shortness of breath).
• Anxiety, depression, fatigue, feeling of tingling.
• Elevated potassium levels in blood test results [may cause nausea (feeling unwell), fatigue, muscle weakness, or palpitations].
• Blurred or altered vision, ringing in the ears, pain and ulcers in the mouth, difficulty hearing.
• Belching, inflammation of the stomach or intestines (including worsening of stomach or intestinal inflammation).
• Leg cramps.
• Inflammation of the eye.
• Difficulty breathing.
• Coloration of the skin (cardenals).
• Chest pain (generalized pain not related to the heart).
• Swelling of the face.

Rare (may affect up to 1 in 1,000 people)

• Changes in appetite.
• Slow heart rate (bradycardia).
• Increased blood pressure.
• Seizures. These are more likely to occur:
• • after taking a high dose of tramadol (component of this medicine); or
  • after taking medications that cause seizures or increase the likelihood of seizures along with Velyntra. For example, antidepressants or antipsychotics (see “Other medicines and Velyntra”).
• Muscle spasms.
• Tremors.
• Psychological problems may occur after treatment with tramadol. Their intensity and nature may vary depending on:
• • your personality;
  • the duration of treatment with Velyntra.

These problems include:

• • mood changes - usually elevated mood (euphoria), occasionally irritability (dysphoria);
  • changes in activity (usually less active, occasionally more active);
  • changes in the ability to think and perceive things clearly (your cognitive and sensory abilities) such as:
  • • decision-making (behavior when making decisions);
    • lack of awareness or understanding (alteration of perception);
    • seeing or hearing things that are not real (hallucinations);
    • confusion;
    • alteration of sleep;
    • delirium;
    • nightmares.
• Muscle weakness.
• Excessive constriction of the pupils (miosis).
• Difficulty or pain when urinating, less than normal amount of urine (dysuria).
• Uncoordinated movements.
• Transient loss of consciousness (syncope).
• Severe allergic reactions (swelling of the face, lips, mouth, tongue, or throat, or difficulty swallowing, including potential anaphylactic shock that can be fatal).
• Ulcers (bleeding) in the stomach, throat, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the esophagus, inflammation of the intestine or colon.
• Low sodium levels in the blood (a condition known as hyponatremia).
• Decreased white blood cell count (which helps protect the body from infections) or platelet count (increases the risk of bleeding and petechiae).
• Difficulty in coordinating muscle movements.
• Feeling of confusion, alterations in taste.
• Increased sensitivity to light.
• Loss of hair.
• Hallucinations.
• Eye hemorrhage.
• Acute reaction that may lead to pulmonary inflammation.
• Irregular heart rhythm.
• Rubefaction.
• Clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain, or collapse.
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills.
• Acute failure of kidney function.
• Menstrual disorders.

Very rare (may affect up to 1 in 10,000 people)

• Severe skin changes such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or peeling of the skin) and acute generalized pustular psoriasis (symptoms include redness of the skin with swollen areas and numerous small pustules).
• A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen lymph nodes, and abnormalities in clinical test results [e.g. liver, blood cells (eosinophilia, a type of increase in blood cell count)].
• Brain hemorrhage that causes death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Liver failure, liver damage, and severe liver inflammation (hepatitis fulminant) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills.
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellow discoloration of the skin or eyes).
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue, and loss of appetite).
• Worsening of epilepsy (possibility of more frequent and/or severe seizures).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision.
• Inflammation of blood vessels (may cause fever, pain, and purple spots on the skin).
• Pain, inflammation, and muscle weakness.
• Alteration of the sense of smell.
• Loss of taste.
• Decreased white blood cell, red blood cell, and platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections).

Unknown (frequency cannot be estimated from available data)

• Excessive dilation of the pupils (mydriasis).
• Alterations in speech.
• Decreased blood sugar levels (hypoglycemia).
• Decreased fertility in women, which is usually reversible if the medication is discontinued.
• Dependence and addiction.
• Hiccups.
• 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 “What you need to know before starting Velyntra”).

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 theSpanish System for 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 medicine.

Keepthis medicationout of the sight and reach of children.

Store this medication in a safe and protected location, inaccessible to others. This medication may cause severe harm or even be fatal to individuals not prescribed it.

Do not usethis medicationafter the expiration date appearing onthe box or blister packafter 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 trash. Dispose of packaging and unused medications at the SIGREpoint at the pharmacy. If unsure, ask your pharmacist how to properly dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Velyntra

• The active principle is a co-crystal of hydrochloride of tramadol and celecoxib. Each tablet contains 44 mg of hydrochloride of tramadol and 56 mg of celecoxib.
• The other components are:
• • Core of the tablet : sodium lauryl sulfate, crospovidone, mannitol (E-421), sodium stearate fumarate, talc, microcrystalline cellulose and copovidone.
  • Coating with a film : Opadry white II 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), polyethylene glycol and talc).

Appearance of Velyntra and content of the packaging

White to off-white film-coated tablets, elongated, with the inscription “100” on one face and “CTC” on the other. Approximate size: 16.2 mm (length) x 5.4 mm (width).

Available in Alu/Alu blisters. Packaging size: 30 film-coated tablets.

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Responsible for manufacturing

Towa Pharmaceutical Europe S.L.

c/ de Sant Marti, 75-97

08107 Martorelles (Spain)

Recipharm Leganés S.L.U.

Calle Severo Ochoa 13

28914 Leganés, Madrid (Spain)

Last review date of this prospectus: April 2024

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