Yurelax 10 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Yurelax 10 mg hard capsules

Cyclobenzaprine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.
• 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Yurelax is and what it is used for
2. What you need to know before taking Yurelax
3. How to take Yurelax
4. Possible adverse effects
5. Storage of Yurelax
6. Contents of the pack and other information

1. What Yurelax is and what it is used for

Yurelax contains the active substance cyclobenzaprine. It is a muscle relaxant that acts on the musculoskeletal system. It is indicated for the relief of pain caused by muscle spasms associated with acute and painful musculoskeletal conditions.

Cyclobenzaprine is not effective in muscle spasm resulting from central nervous system disorders.

2. What you need to know before starting to take Yurelax

Do not take Yurelax

• If you are allergic to cyclobenzaprine or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems such as arrhythmias, cardiac conduction disorders, congestive heart failure, or recent myocardial infarction.
• If you have a thyroid condition known as hyperthyroidism.
• If you are taking or have taken MAOIs (medicines for depression or Parkinson’s disease) within the last 14 days before starting treatment with Yurelax.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Yurelax:

• If you are taking other central nervous system depressants at the same time, as this may increase their adverse effects.
• If you have a history of urinary retention.
• If you have elevated intraocular pressure or closed-angle glaucoma (an eye condition characterized by sudden and severe eye pain, blurred vision, halos, and redness).
• If you have epilepsy.
• If you have liver problems.
• If you have high blood pressure.
• If you are elderly.
• If you have depression or other conditions treated with antidepressants.
• Taking these medicines together with Yurelax may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Yurelax with other medicines").

Taking Yurelax with other medicines

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

During treatment with cyclobenzaprine, you should avoid using the following medicines unless your doctor advises otherwise:

• Anti-Parkinson’s drugs (MAO inhibitors used for Parkinson’s disease: rasagiline, selegiline); antidepressants (MAO inhibitors: tranylcypromine, moclobemide); analgesics (tramadol); antibacterials (linezolid), as they may cause increased blood pressure or severe seizures when taken with cyclobenzaprine.

• The following medicines may cause tachycardia or arrhythmias when taken with cyclobenzaprine:

• Medicines used for heart conditions such as antiarrhythmics (dronedarone, amiodarone, disopyramide, flecainide, ranolazine), antianginals (ivabradine), and beta-blockers (sotalol).

• Antineoplastics (medicines used to treat cancer: arsenic trioxide, lapatinib, nilotinib, pazopanib, sunitinib, vemurafenib, and vinflunine).

• Antibiotics (clarithromycin, erythromycin, telithromycin, levofloxacin, moxifloxacin).

• Antifungals (medicines used to treat fungal infections: fluconazole, voriconazole).

• Antimalarials (lumefantrine).

• Antipsychotics (medicines used to treat schizophrenia: pimozide, asenapine, clozapine, droperidol, paliperidone, ziprasidone).

• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Yurelax and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

• Medicines acting on the nervous system (methadone, tetrabenazine, pasireotide).

• Medicines containing sodium phosphate.

• Anti-asthma medicines (formoterol).

• Other antineoplastics (medicines to treat cancer: procarbazine), antimigraine agents (medicines used for severe headaches: almotriptan), and antidepressants (duloxetine, 5-hydroxytryptophan, trazodone, desvenlafaxine, escitalopram) or buprenorphine; because they may increase the risk of serotonin syndrome (elevated blood pressure, fever, changes in mental status, muscle contractions, etc.) when taken with cyclobenzaprine.

• Guanethidine (a medicine used to treat high blood pressure), because cyclobenzaprine may reduce the effect of guanethidine.

• Alcohol and other medicines that slow down central nervous system activity, as cyclobenzaprine may enhance their effects.

Taking Yurelax with food, drinks, and alcohol

During treatment with cyclobenzaprine, you should avoid drinking alcoholic beverages. Cyclobenzaprine may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

The safety of cyclobenzaprine in pregnant women is unknown. If you are pregnant, your doctor will only prescribe this medicine if they consider that the benefits of treatment outweigh the potential risks to you and your baby.

Breastfeeding:

It is unknown whether cyclobenzaprine passes into breast milk. While taking this medicine during breastfeeding, your doctor will monitor and evaluate the benefit of treatment for the mother against the potential risk to the infant.

Driving and using machines

Yurelax may cause drowsiness, dizziness, vision problems, or clumsiness or instability in some people. If this occurs, do not drive or operate tools or machinery.

3. How to take Yurelax

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 capsule of 10 mg three times daily.

The dose may range between 20 and 40 mg daily, divided into divided doses (2 to 4 capsules per day), up to a maximum of 60 mg daily (6 capsules per day).

The treatment period should not exceed 3 weeks.

The capsules may be taken with a little water.

If you take more Yurelax than you should

The most common symptoms associated with acute overdose are: seizures, severe drowsiness, rapid or irregular heartbeat, difficulty breathing, hallucinations, increased or decreased body temperature, and vomiting.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Yurelax

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is approaching, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for missed doses.

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 will experience them.

The most common adverse effects of cyclobenzaprine are:

Drowsiness, dizziness, and dry mouth.

Other adverse effects reported with cyclobenzaprine include:

Immune system disorders: allergic reactions including skin rash, urticaria, and angioedema (facial and tongue swelling).

Psychiatric disorders: confusion, nervousness, depression, sleep disturbances, anxiety, agitation, abnormal thoughts, hallucinations, insomnia, disorientation, excitement, euphoria.

Nervous system disorders: tremors, ataxia (lack of coordination in muscle movements), dysarthria (speech impairment), paresthesia (tingling, numbness, or prickling sensations), seizures, hypertonia (increased muscle tone or rigidity), dizziness.

Eye disorders: blurred vision.

Ear and labyrinth disorders: tinnitus (ringing in the ears).

Cardiac and vascular disorders: tachycardia, syncope, arrhythmias, hypotension, palpitations, vasodilation.

Gastrointestinal disorders: bad taste, constipation, dyspepsia (indigestion), nausea, vomiting, diarrhea, gastritis, anorexia, taste alteration, flatulence, thirst, abdominal pain, gastrointestinal pain.

Hepatobiliary disorders: abnormal liver function, hepatitis, jaundice (yellowing of the skin and mucous membranes), and cholestasis (suppression of bile flow).

Musculoskeletal and connective tissue disorders: muscle contractions and local weakness.

Renal and urinary disorders: pollakiuria (increased frequency of urination) and/or urinary retention, decreased bladder tone.

General disorders and administration site conditions: weakness, headache, asthenia (lack of energy), malaise.

Endocrine disorders: hypoglycemia (low blood glucose levels).

Skin and subcutaneous tissue disorders: sweating.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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. Yurelax Storage

This medicine does not require special storage conditions.

Keep out of the sight and reach of children.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Yurelax

• The active substance is cyclobenzaprine hydrochloride. Each capsule contains 10 mg of cyclobenzaprine hydrochloride.
• The other components are: magnesium stearate, talc, microcrystalline cellulose. The hard gelatin capsule contains: titanium dioxide (E171), indigotine (E132), quinoline yellow (E104).

Appearance of the product and contents of the container

Hard gelatin capsules, green and white in colour, packed in blisters. Pack containing 30 hard gelatin capsules.

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Labiana Pharmaceuticals, S.L.
C/Casanova, 27-31
08757 Corbera de Llobregat (Barcelona) Spain

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: February 2021

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