Prospect: Information for the User

Flurpax 5 mg Hard Capsules

Flunarizine Hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Flurpax belongs to a group of medicines called calcium channel blockers.

It is indicated for the prevention of migraine. It helps to reduce the frequency of migraine attacks and the severity of the same.

Flurpax is also indicated to alleviate symptoms of vestibular vertigo (when due to alterations of the vestibular system of the ear).

Do not take Flurpax

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have depression or have had it in the past.
• if you have symptoms of Parkinson's disease or other extrapyramidal disorders (movement or coordination disorders).

Warnings and precautions

Consult your doctor or pharmacist,

• if you experience progressive fatigue during treatment. In this case, your doctor should suspend treatment.
• if you experience symptoms of depression and movement disorders such as tremors, slow movements, involuntary abnormal muscle movements, and/or muscle rigidity, especially in older patients. Treatment may increase these symptoms.
• if the medication's effect is reduced.

Use of Flurpax with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are taking Flurpax, hypnotics, and tranquilizers may cause drowsiness and drowsiness more quickly. You should only take hypnotics and tranquilizers if your doctor prescribes them.

Taking Flurpax with food, drinks, and alcohol

If you take Flurpax with alcohol, you may experience drowsiness and drowsiness more quickly.

You should limit the amount of alcohol you consume.

Pregnancy and breastfeeding

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

There are no data on the use of flunarizine in pregnant women. It is unknown whether flunarizine passes into breast milk, so it is not recommended to take Flurpax unless your doctor specifically indicates it.

Driving and operating machinery:

Flurpax may cause drowsiness that can impair your ability to drive. In this case, avoid driving vehicles or operating machinery.

Flurpax contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Starting treatment with Flurpax:

• If you are under 65 years old, take 2 tablets a day before going to sleep.
• If you are 65 years old or older, take 1 tablet a day before going to sleep.

You may experience some benefits during the first month, but you may need another month before feeling the full effect of the medication.

Continuation of treatment with Flurpax:

After two months, your doctor will indicate if you need to continue taking Flurpax. The recommended dose is as follows:

• Take the same number of capsules you were used to taking (1 or 2 capsules a day before going to sleep) for 5 consecutive days, and stop taking it for 2 consecutive days (such as Saturdays and Sundays). Repeat this treatment (5 days taking medication followed by 2 days without taking it) until the end of treatment.

You must take the capsules with a little water.

You must not exceed the recommended dose. Patients should be regularly monitored, especially during maintenance treatment, so that any extrapyramidal symptoms (movement or coordination alterations) and depressive symptoms can be detected promptly, and if they appear, the medication should be suspended. If during maintenance treatment the medication's effectiveness decreases, treatment will be suspended.

If you take more Flurpax than you should

If you have taken Flurpax more than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, bringing the remaining capsules with you to inform the doctor. You can also call the Toxicological Information Service. Phone: 91 562 04 20.

You may feel drowsiness, fatigue, or, with very high amounts, agitation and acceleration of heart rate. Meanwhile, you can start treating these alterations with activated charcoal, available at the pharmacy, which absorbs any medication found in the stomach.

If you forget to take Flurpax

Do not take a double dose to compensate for the missed doses. If you are sure you have forgotten to take a capsule, take it as soon as possible and continue taking the medication normally. In case of doubt, consult your doctor or pharmacist.

If you interrupt treatment with Flurpax

The duration of treatment will be determined by your doctor. Treatment with Flurpax lasts a maximum of 6 months. If you interrupt treatment and your symptoms return, you should consult your doctor about whether you can start treatment with Flurpax again.

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

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

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

• Weight gain.

Common side effects(may affect up to 1 in 10 people):

• Nasal congestion or runny nose.
• Increased appetite
• Depression, difficulty sleeping or staying asleep
• Drowsiness
• Constipation, stomach discomfort, nausea.
• Muscle pain
• Irregular menstrual periods, breast pain
• Fatigue

Uncommon side effects(may affect up to 1 in 100 people):

• Depression symptoms, difficulty falling asleep, feeling indifferent, anxiety
• Abnormal muscle movements, disorientation, unusual weakness or calmness, abnormal sensation of tingling in arms and legs, restlessness or concern, ringing in the ears, involuntary and prolonged muscle contractions of the neck (torticollis), weakness
• Perception of heartbeats (palpitations)
• Low blood pressure (hypotension)
• Intestinal obstruction, dry mouth, digestive system alterations
• Excessive sweating
• Muscle cramps, muscle contractions
• Heavy and prolonged menstrual flow, menstrual irregularities (irregular or absent periods), infrequent or light menstruation, breast enlargement, loss of sexual desire
• Swelling due to fluid accumulation in tissues, in legs and feet or in other parts of the body, complete weakness or lack of energy (asthenia)

Side effects of unknown frequency (cannot be estimated from available data):

• Inability to remain still, slow and delayed movements, rigid muscle movements like a cogwheel, difficulty moving, involuntary and abnormal muscle movements; a group of symptoms known as extrapyramidal symptoms (EPS) that typically include abnormal involuntary muscle movements; Parkinson's disease (a chronic and degenerative disease that affects the nerves and causes progressive inability to move), feeling of sleepiness, tremor
• Redness or pink discoloration of the skin
• Muscle stiffness
• Fluid secretion from the nipples

Reporting side effects

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

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

No special storage conditions are required.

Do not use this medication after the expiration date indicated on the packaging, after CAD.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Flurpax

• The active principle is flunarizine in the form of hydrochloride. Each capsule contains hydrochloride of flunarizine equivalent to 5 mg of flunarizine.
• The other components are:lactose, dihydrate calcium phosphate, sodium starch glycolate, calcium stearate and talc.

Appearance of the product and content of the container

Flurpax 5 mg hard capsules are available in containers of 30 and 60 capsules.

Holder of the marketing authorization and responsible for manufacturing

Teofarma Srl

Via F.lli cervi, 8

27010 VALLE SALIMBENE (Pavia)

Italy

Last review date of this leaflet: January 2014

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