Patient Information Leaflet

Yurelax 10 mg Hard Capsules

Ciclobenzaprine Hydrochloride

Read this 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 are unsure about anything, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4

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 side effects

5Storage of Yurelax

6.Contents of the pack and additional information

Yurelax contains cyclobenzaprine as its active ingredient. It is a muscle relaxant that acts on the locomotor system. It is indicated for the relief of pain caused by muscle spasms, associated with acute and painful musculoskeletal processes.

Cyclobenzaprine is not effective in muscle spasms due to central nervous system injuries.

Do not take Yurelax

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

Warnings and precautions

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

• If you are taking other central nervous system depressants at the same time, as it may increase their adverse effects.
• If you have a history ofurinary retention.
• If you have high intraocular pressure or closed-angle glaucoma (eye disease that presents sudden and intense pain in one eye, blurred vision, halos, and redness).
• If you haveepilepsy.
• If you haveliver problems.
• If you havehigh blood pressure.
• If you are an elderly person.
• If you have depression or other diseases treated with antidepressants.
• The use of these medications with Yurelax may cause serotonin syndrome, a potentially fatal disease (see "Yurelax use with other medications").

Yurelax use with other medications

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

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

• Antiparkinsonian medications (medications used for Parkinson's disease inhibitors of MAO: rasagilina, selegilina); antidepressants (inhibitors of MAO:tranilcipromina, moclobemida); analgesics (tramadol); antibacterials (linezolid), because they may produce increased blood pressure or severe convulsions if taken with cyclobenzaprine.

• These medications mayproduce tachycardia or arrhythmias if taken with cyclobenzaprine:

• Other antineoplastics (cancer medications: procarbacina), antimigraine medications (medications used for severe headaches: amilotriptán) and antidepressants (duloxetina,hidroxitriptófano, trazodona, desvenlafaxina, escitalopram) or buprenorfina; becausethey may increase the risk of serotonin syndrome (high blood pressure, fever, changes in mental state, muscle contractions …) when taken with cyclobenzaprine.

• Guanetidina (medication for high blood pressure) because cyclobenzaprine may reduce the effect of guanetidina.

• Alcohol and other medications that slow down the activity of the nervous system, as cyclobenzaprine may increase their effect.

Yurelax use with food, drinks, and alcohol

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

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 medication.

Pregnancy:

The safety of cyclobenzaprine in pregnant women is unknown. If you are pregnant, your doctor will only prescribe this medication if they consider that the benefits of treatment outweigh the possible risks for you and your child.

Breastfeeding:

The safety of cyclobenzaprine in breastfeeding women is unknown. While taking this medication during breastfeeding, your doctor will monitor and evaluate the benefits of treatment for the mother against the possible risk for the child.

Driving and using machines

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

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

The recommended dose is 1 capsule of 10 mg, taken three times a day.

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

The treatment period should not exceed 3 weeks.

The capsules can be taken with a little water.

If you take more Yurelax than you should

The most common symptoms that accompany acute overdose cases are: convulsions, severe drowsiness, rapid or irregular heartbeats, or difficult breathing, hallucinations, increased or decreased body temperature, and vomiting.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Yurelax

In case of forgotten dose, take the medication as soon as possible, continuing treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to compensate for the missed doses.

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

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

The most common side effects of cyclobenzaprine are:

Drowsiness, dizziness, and dry mouth.

Other side effects described for cyclobenzaprine are::

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

Mental health disorders: confusion, nervousness, depression, sleep disorders, anxiety, agitation, abnormal thoughts, hallucinations, insomnia, disorientation, excitement, and euphoria.

Nervous system disorders: tremors, ataxia (lack of coordination in muscle movements), dysarthria (language alteration), paresthesias (tingling, numbness, or prickling sensations),seizures, hypertonia (increased muscle tone or rigidity),vertigo.

Eye disorders: blurred vision.

Ear and labyrinth disorders: tinnitus.

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

Gastrointestinal disorders: bad taste, constipation, dyspepsia (difficult digestion), nausea, vomiting, diarrhea, gastritis, anorexia, altered taste, flatulence, abdominal pain, thirst, and gastrointestinal pain.

Hepatobiliary disorders: abnormal liver function, hepatitis, jaundice(yellow discoloration 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: polyuria(increased frequency of urination)and/or urinary retention, decreased bladder tone.

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

Endocrine disorders: hypoglycemia(low blood glucose level).

Skin and subcutaneous tissue disorders: sweating.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. Reporting side effects can help provide more information about the safety of this medicine.

This medication does not require special storage conditions.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Yurelax

• The active principle 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), indigotin (E132), quinoline (E104).

Appearance of the product and contents of the packaging

Hard gelatin capsules, green and white in color, packaged in a blister. Packaging with 30 hard gelatin capsules.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for Manufacturing

Labiana Pharmaceuticals, S.L.

C/Casanova, 27-31

08757 Corbera de Llobregat (Barcelona) Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: February 2021

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