FLURPAX 5 mg Hard Capsules

2. What you need to know before you take Flurpax

Do not take Flurpax

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have suffered from depression in the past or if you are currently suffering from it.
• 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 discontinue treatment.
• if symptoms of depression and movement disorders appear, such as tremors, slow movements, and delayed movements, involuntary abnormal muscle movements, and/or muscle stiffness, especially in elderly patients. Treatment may increase these symptoms.
• if the effect of the medicine decreases.

Use of Flurpax with other medicines:

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

If you are taking Flurpax, hypnotics and sedatives may cause you to feel drowsy and sleepy more quickly. You should only take hypnotics and sedatives if your doctor prescribes them.

Taking Flurpax with food, drinks, and alcohol

If you take Flurpax with alcohol, you may feel drowsy and sleepy more quickly.

You should limit the amount of alcohol you drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines:

Flurpax may cause drowsiness that can affect your ability to drive. In this case, avoid driving vehicles or using machines.

Flurpax contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Flurpax

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, 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 bed.
• if you are 65 years old or over, take 1 tablet a day before going to bed.

You will probably experience some benefits during the first month, but you may need another month to feel the full effect of the medicine.

Continuing treatment with Flurpax:

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

• take the same number of capsules you used to take (1 or 2 capsules a day before bedtime) for 5 consecutive days, and stop taking it for 2 consecutive days (like Saturdays and Sundays). Repeat this treatment (5 days taking the medicine followed by 2 days without taking it) until the end of the treatment.

You should take the capsules with a little water.

Do not exceed the recommended dose. Patients should be regularly monitored, especially during maintenance treatment, so that extrapyramidal symptoms (movement or coordination disorders) and depressive symptoms can be detected early and the medicine can be discontinued if they appear. If the effectiveness of the medicine decreases during maintenance treatment, the treatment should be discontinued.

If you take more Flurpax than you should

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

You may feel drowsy, tired, or with very high amounts, you may feel agitated and have an accelerated heart rate. Meanwhile, you can start treating these alterations with activated charcoal, available at the pharmacy, which absorbs any medicine that is in the stomach.

If you forget to take Flurpax

Do not take a double dose to make up for forgotten doses. If you are sure you have forgotten to take a capsule, take it as soon as possible and continue taking the medicine normally. If you are unsure, consult your doctor or pharmacist.

If you stop taking Flurpax

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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):

• Symptoms of depression, difficulty falling asleep, feeling of indifference, anxiety
• Abnormal muscle movements, disorientation, weakness or unusual calmness, abnormal sensation of tingling in arms and legs, restlessness or concern, ringing in the ears, involuntary and prolonged contraction of the neck muscles (torticollis), weakness
• Perception of heartbeat (palpitations)
• Low blood pressure (hypotension)
• Intestinal obstruction, dry mouth, digestive disorders
• Excessive sweating
• Muscle cramps, muscle contractions
• Abundant and prolonged menstrual flow, menstrual disorders (irregular or absent menstrual periods), scarce or infrequent 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, feeling of complete weakness or lack of energy (asthenia)

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

• Inability to remain still, slow and delayed movements, stiff muscle movements like a cogwheel, difficulty moving, involuntary tremulous movement, a set of symptoms known as extrapyramidal symptoms (EPS) that generally include involuntary abnormal muscle movements; Parkinson's disease or syndrome (a chronic and degenerative disease that affects the nerves and causes progressive movement disability), feeling of sleep, tremor
• Redness or pinkish discoloration of the skin
• Muscle stiffness
• Secretion of fluid through the nipples

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flurpax

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the pack, after EXP.

The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Flurpax

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

Appearance of the product and pack contents

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

Marketing authorisation holder and manufacturer

Teofarma Srl

Via F.lli Cervi, 8

27010 VALLE SALIMBENE (Pavia)

Italy

Date of last revision of this leaflet: January 2014

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