Velyntra 44 mg/56 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Velyntra 44 mg/56 mg film-coated tablets

tramadol hydrochloride / celecoxib

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 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.

Contents of the leaflet

What Velyntra is and what it is used for
What you need to know before taking Velyntra
How to take Velyntra
Possible side effects
How to store Velyntra
Contents of the pack and other information

1. What Velyntra is and what it is used for

This medicinal product contains two active substances: tramadol hydrochloride and celecoxib.

Tramadol is an analgesic 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 an anti-inflammatory analgesic belonging to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

Velyntra is used for the short-term symptomatic treatment of moderate to severe somatic pain in adults, such as postoperative pain (e.g., orthopedic and trauma surgery, or after dental surgical procedures) or musculoskeletal pain (injuries to muscles, ligaments, tendons, and joints).

2. What you need to know before taking Velyntra

Do not take Velyntra

if you are allergic to tramadol hydrochloride, celecoxib, or any of the other ingredients of this medicine (listed in section 6);
if you have acute intoxication due to alcohol, sleeping pills, painkillers, or other psychotropic medicines (medicines affecting mood and emotions);
if you are also taking monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression), or if you have taken them within the last two weeks before starting treatment with this medicine;
if you have been diagnosed with epilepsy and your seizures are not adequately controlled by your treatment;
as a substitute medication in the treatment of withdrawal syndrome;
if you have previously had an allergic reaction to medicines in the group called "sulfonamides" (e.g., certain antibiotics used to treat infections);
if you currently have a stomach or intestinal ulcer, or bleeding in your stomach or intestines;
if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory and analgesic drug (NSAID): asthma, nasal polyps, severe nasal congestion, or allergic reactions such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing;
if you are pregnant. If you could 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, e.g., you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction 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 have undergone surgery on the arteries in your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Velyntra:

if you think you are addicted to other painkillers (opioids);
if you have disorders of consciousness (if you feel you might faint);
if you experience cold sweating, paleness, rapid pulse, rapid breathing, dizziness… (possible symptoms and signs of shock, among others);
if a healthcare professional has informed you that your intracranial pressure is higher than normal. This may occur after a head injury or due to diseases affecting 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 may increase;
if you have depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Velyntra");
if you have any liver or kidney disease;
if you have or have previously had a stomach or intestinal ulcer or bleeding;
if you are taking acetylsalicylic acid (even at low doses such as for cardioprotection);
if you are taking antiplatelet therapies (e.g., clopidogrel, dipyridamole);
if you are receiving medicines to reduce blood clotting (e.g., acenocoumarol, acenocoumarol analog anticoagulants, or new oral anticoagulants, e.g.: apixaban);
if you are receiving corticosteroid medicines (e.g.: prednisone);
if you are taking this medicine at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided;
if you are a smoker, have diabetes, high blood pressure, or high cholesterol;
if your heart, liver, or kidneys are not functioning properly, your doctor may want to monitor you regularly;
if you have fluid retention (such as swollen feet or ankles);
if you are dehydrated, for example due to vomiting, diarrhea, or use of diuretics (used to treat excess fluid in the body);
if you have previously experienced a severe allergic reaction or a serious skin reaction to any medicine;
if you feel unwell due to an infection or think you have an infection, as taking this medicine may mask fever or other signs of infection and inflammation;
if you are over 65 years old, your doctor will want to monitor you regularly.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking this medicine:

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

Sleep-related breathing disorders

This medicine may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathing difficulties, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor.

There is a low risk of developing serotonin syndrome after taking tramadol, especially when combined with certain antidepressants or with tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious condition (see section 4 "Possible side effects").

Seizures have been reported mainly with high doses of tramadol.

Tolerance, dependence, and addiction

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

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

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

You or any member of your family has abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction").
You are a smoker.
You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

You need to use the medicine for longer than prescribed by your doctor.
You need to use a higher dose than recommended.
You are using the medicine for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep."
You have made repeated unsuccessful attempts to stop using the medicine or control its use.
You feel unwell when you stop using the medicine, and feel better once you take it again ("withdrawal effects").

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

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

Tramadol is metabolized by an enzyme in the liver. 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.

Like other NSAIDs (e.g., ibuprofen or diclofenac), celecoxib (a component of this medicine) may increase your blood pressure, so your doctor may periodically monitor it.

Some cases of serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Most serious liver reactions with a reported onset occurred within the first month of treatment.

Children and adolescents

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

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

Other medicines and Velyntra

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Some medicines should not be taken together, and others may require dose adjustments if used together.

Do not take this medicine with:

Monoamine oxidase inhibitors (MAOIs), or within 2 weeks before or after taking these medicines. MAOIs are medicines used to treat depression.

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

Other painkillers such as morphine and codeine (also used as a cough medicine), or alcohol.
Tranquilizers or sleeping pills (e.g., benzodiazepines).
Medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics.
Antidepressants. Velyntra may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible side effects").
Anticoagulants (e.g., acenocoumarol, apixaban).
Dextromethorphan (used to treat cough).
ACE inhibitors, angiotensin II antagonists, beta-blockers, and diuretics (used to control high blood pressure and heart disorders).
Fluconazole, ketoconazole, rifampicin, isoniazid, and erythromycin (used to treat fungal and bacterial infections).
Lithium (used to treat certain types of depression).
Other medicines 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).
Cyclosporine and tacrolimus (used to suppress the immune system, e.g., after transplants).
Ritonavir (treatment of HIV-1 infected patients in combination with other medicines).
Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

The effect and duration of pain relief from treatment may be reduced if you take medicines containing:

Carbamazepine (for epileptic seizures).
Ondansetron (to prevent nausea).

This medicine may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Seek advice from your doctor before taking both medicines together.

Taking Velyntra with food and alcohol

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

Pregnancy, breastfeeding, and fertility

The use of this medicine is contraindicated during pregnancy and while breastfeeding.

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.

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

Celecoxib (a component of this medicine) may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are experiencing difficulties in becoming pregnant.

Driving and using machines

This medicine may cause drowsiness, dizziness, and blurred vision and therefore may affect your ability to drive and use machines. If affected, do not drive cars or any other vehicle, or operate machinery or electrical tools until symptoms resolve.

Velyntra contains mannitol and sodium

It may cause a mild laxative effect.

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

3. How to take Velyntra

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using Velyntra, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

For short-term use only.

Adults

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

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

Some patients may experience insufficient pain relief as the time for the next dose approaches. Speak with your doctor if treatment does not control your pain.

Use in children and adolescents

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

Elderly patients

No dose adjustment is required in elderly patients.

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

If you have severe liver or kidney disease, you must not take this medicine. If your condition involves mild or moderate insufficiency, your doctor will decide whether you can take this medicine.

Method of administration

The tablets are taken orally.

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

The tablets may be taken at any time of 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 extra dose by mistake, you will generally not experience negative effects. Take the next dose as prescribed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone: 91 562 04 20. Please bring the medicine packaging or this leaflet with you.

Symptoms of overdose with this medicine include:

pupil constriction;
vomiting;
decreased blood pressure;
increased pulse rate;
collapse;
decreased level of consciousness up to coma (deep unconsciousness);
seizures;
breathing difficulties that may progress 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 with this medicine.

If you forget to take Velyntra

If you forget to take a dose of this medicine, pain may return. Take the missed dose as soon as you remember, then continue taking the following doses at the originally scheduled times as prescribed. Do not take a double dose to make up for a missed dose.

If you stop taking Velyntra

Pain is generally self-limiting and requires treatment for only a few days or weeks. If you stop or end treatment with this medicine too early, pain may return. If you wish to stop treatment due to undesirable effects, consult your doctor.

Abruptly stopping treatment with this medicine may cause worsening of symptoms (see Section 3 “How to take Velyntra”).

Generally, no adverse effects are expected after stopping treatment with this medicine.

However, in rare cases, patients who have taken tramadol for some time may feel unwell if they stop taking it suddenly. They may experience restlessness, anxiety, nervousness, or tremors, confusion, hyperactivity, difficulty sleeping, and stomach or intestinal disturbances. Rarely, individuals may experience panic attacks, hallucinations, delusions, paranoia, or a feeling of loss of identity.

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

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 can cause adverse effects, although not everyone will experience them.

The possible adverse effects are listed below, categorized according to their likelihood of occurrence.

Stop using this medicine and inform your doctor immediately if you experience:

Symptoms of an allergic reaction such as swelling of the face, tongue and/or throat and/or difficulty swallowing, accompanied by rash, 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, blood-stained stools, or blood in vomit.
Any lesion inside the mouth or on mucous membranes, or skin reactions such as rash, blisters, or peeling skin.
Liver failure [symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or whites of the eyes)].

The most common adverse effects during treatment with this medicine are drowsiness, dizziness, fatigue, nausea, and vomiting, which occur in more than 1 in every 10 patients (very common). Adverse effects reported for tramadol and celecoxib as individual products taken alone, 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 pre-existing high blood pressure (hypertension).

Common (may affect up to 1 in 10 people)

Feeling unwell (vomiting).
Constipation.
Dry mouth.
Headache.
Sweating (hyperhidrosis).
Drowsiness.
Fatigue.
Heart attack.
Fluid retention with swelling of ankles, legs and/or hands.
Urinary tract infections.
Difficulty breathing, sinusitis (inflammation or infection of the sinuses, sinus blockage or pain), stuffy 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, swelling of the face), worsening of existing allergies.
Accidental injury.

Uncommon (may affect up to 1 in 100 people)

Feeling the need to vomit (nausea).
Gastrointestinal irritation (feeling of pressure in the stomach, bloating).
Effects on cardiovascular regulation including awareness of heartbeat (palpitations), rapid heartbeat (tachycardia), feeling dizzy or faint upon standing (postural hypotension), or cardiovascular collapse due to inadequate blood circulation when the heart does not function properly. These adverse effects may occur particularly in patients who are standing up or engaging in physical exertion.
Skin reactions including rash (urticaria).
Stroke.
Abnormal blood test results related to the liver.
Abnormal blood test results related to the kidneys.
Anemia (changes in red blood cells that may cause fatigue and shortness of breath).
Anxiety, depression, tiredness, tingling sensation.
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 mouth ulcers, hearing difficulty.
Burping, inflammation of the stomach or intestines (including worsening of stomach or intestinal inflammation).
Leg cramps.
Eye inflammation.
Difficulty breathing.
Skin discoloration (bruising).
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 heartbeat (bradycardia).
Increased blood pressure.
Seizures. These are more likely to occur:
- after taking a high dose of tramadol (a component of this medicine); or
- after taking medications that cause seizures or increase the likelihood of seizures together with Velyntra. For example, antidepressants or antipsychotics (see “Other medicines and Velyntra”).
Muscle twitches.
Tremors.
Psychological problems may occur after treatment with tramadol. Their severity and nature may vary depending on:
- your personality;
- the duration of treatment with Velyntra.

These problems include:

- mood changes – typically elevated mood (euphoria), occasionally irritability (dysphoria);
- changes in activity (typically less active, occasionally more active);
- changes in the ability to think and perceive things clearly (your cognitive and sensory capacity), such as:
  - decision-making (behaviour when making decisions);
  - lack of awareness or understanding (altered perception);
  - seeing or hearing things that are not real (hallucinations);
  - confusion;
  - sleep disturbances;
  - delusions;
  - nightmares.
Muscle weakness.
Excessive contraction of the pupils (miosis).
Difficulty or pain when urinating, reduced urine output (dysuria).
Uncoordinated movements.
Transient loss of consciousness (syncope).
Severe allergic reactions (swelling of the face, lips, mouth, tongue or throat, or difficulty swallowing, including potentially life-threatening anaphylactic shock).
Ulcers (bleeding) in the stomach, throat or intestines; or intestinal rupture (which may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (which may cause stomach pain), inflammation of the throat (esophagus), inflammation of the intestine or colon.
Low levels of sodium in the blood (a condition known as hyponatremia).
Decreased number of white blood cells (which help protect the body from infections) or platelets (increased risk of bleeding and bruising).
Difficulty with muscular coordination of movements.
Feeling confused, taste disturbances.
Increased sensitivity to light.
Hair loss.
Hallucinations.
Eye bleeding.
Acute reaction that may lead to lung inflammation.
Irregular heartbeat.
Flushing.
Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp chest pain when breathing, or collapse.
Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching, or chills.
Acute kidney function failure.
Menstrual disorders.

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

Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (which may cause rash, blistering, or peeling of the skin), and generalized exanthematous pustulosis (symptoms include redness of the skin with swollen areas and numerous small pustules).
A delayed allergic reaction with possible symptoms such as rashes, facial swelling, fever, swollen lymph nodes, and abnormalities in clinical test results [e.g. liver, blood cells (eosinophilia, a type of increased blood cell count)].
Bleeding in the brain leading to death.
Meningitis (inflammation of the membranes surrounding the brain and spinal cord).
Liver failure, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or bleeding, itching, or chills.
Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellowing 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 (increased frequency and/or severity of seizures).
Blockage of an artery or vein in the eye leading to partial or complete vision loss.
Inflammation of blood vessels (may cause fever, pain, purple spots on the skin).
Muscle pain, inflammation, and weakness.
Changes in the sense of smell.
Loss of taste.
Decreased number of red blood cells, white blood cells, and platelets (may cause tiredness, easy bruising, frequent nosebleeds, and increased risk of infections).

Not known (frequency cannot be estimated from available data)

Excessive dilation of the pupils (mydriasis).
Speech disturbances.
Decreased blood sugar levels (hypoglycemia).
Decreased fertility in women, which is usually reversible upon discontinuation of the medicine.
Dependence and addiction.
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 Velyntra”).

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 Velyntra

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine 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 or blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Velyntra

The active substance is a co-crystal of tramadol hydrochloride and celecoxib. Each tablet contains 44 mg of tramadol hydrochloride and 56 mg of celecoxib.
The other components are:
- Tablet core: sodium lauryl sulfate, crospovidone, mannitol (E-421), sodium stearyl fumarate, talc, microcrystalline cellulose, and copovidone.
- Film coating: Opadry II White 85F18422 (partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E-171), polyethylene glycol, and talc).

Appearance of Velyntra and contents of the pack

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

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

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Manufacturer

Towa Pharmaceutical Europe S.L.

Carrer de Sant Marti, 75-97

08107 Martorelles (Spain)

Recipharm Leganés S.L.U.

Calle Severo Ochoa 13

28914 Leganés, Madrid (Spain)

Date of the latest revision of this product information: April 2024.

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