Flurpax 5 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Flurpax 5 mg hard capsules
Flunarizine hydrochloride
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 may 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.
Leaflet contents:
- What Flurpax is and what it is used for
- What you need to know before taking Flurpax
- How to take Flurpax
- Possible side effects
- How to store Flurpax
- Contents of the pack and other information
1. What Flurpax is and what it is used for
Flurpax belongs to a group of medicines called calcium channel blockers.
It is indicated for the prevention of migraine. It helps reduce the frequency of migraine attacks and their severity.
Flurpax is also indicated for the relief of vestibular vertigo symptoms (when due to disturbances of the vestibular system of the ear).
2. What you need to know before starting to take Flurpax
Do not take Flurpax
- if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
- if you have depression or have previously suffered from it.
- if you have symptoms of Parkinson's disease or other extrapyramidal disorders (movement or coordination disturbances).
Warnings and precautions
Consult your doctor or pharmacist,
- if you experience a progressive increase in fatigue during treatment. In this case, your doctor should discontinue the treatment.
- if symptoms of depression or movement disorders such as tremors, slow or delayed movements, abnormal involuntary muscle movements, and/or muscle rigidity appear, especially in elderly patients. Treatment may worsen these symptoms.
- if the effect of the medicine decreases.
Use of Flurpax with other medicines:
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
If you are taking Flurpax, hypnotics and tranquilizers may cause drowsiness and sedation more rapidly. You should only take hypnotics and tranquilizers if prescribed by your doctor.
Taking Flurpax with food, beverages, and alcohol
If you take Flurpax together with alcohol, drowsiness and sedation may occur more rapidly.
You should limit the amount of alcohol you consume.
Pregnancy and 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.
There are no data on the use of flunarizine in pregnant women. It is unknown whether flunarizine passes into breast milk; therefore, Flurpax is not recommended unless specifically instructed by your doctor.
Driving and using machines:
Flurpax may cause drowsiness, which can impair your ability to drive. In such a case, avoid driving vehicles or operating machinery.
Flurpax contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Flurpax
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
Starting treatment with Flurpax:
- if you are under 65 years of age, take 2 tablets daily before going to bed.
- if you are 65 years of age or older, take 1 tablet daily before going to bed.
You may experience some benefits during the first month, but it might take another month before you feel the full effect of the medicine.
Continuation of treatment with Flurpax:
After two months, your doctor will advise you whether you need to continue taking Flurpax. The recommended dose is as follows:
- take the same number of capsules as before (1 or 2 capsules daily before bedtime) for 5 consecutive days, then stop taking it for 2 consecutive days (such as Saturday and Sunday). Repeat this regimen (5 days taking the medicine followed by 2 days without taking it) until the end of treatment.
You should take the capsules with a little water.
Do not exceed the recommended dose. Patients should be monitored regularly, especially during maintenance treatment, so that extrapyramidal symptoms (movement or coordination disturbances) and depressive symptoms can be promptly detected, and if they occur, the medicine should be discontinued. If during maintenance treatment the effectiveness of the medicine decreases, treatment will be stopped.
If you take more Flurpax than you should
If you have taken more Flurpax than you should have, contact your doctor or pharmacist immediately or go to the nearest hospital, taking the remaining capsules with you to inform the doctor. You may also call the Toxicology Information Service. Telephone: 91 562 04 20.
You may feel drowsiness or fatigue, or, with very high doses, agitation and increased heart rate. In the meantime, treatment with activated charcoal—available from the pharmacy—may be started to absorb any medicine present in the stomach.
If you forget to take Flurpax
Do not take a double dose to make up for missed doses. If you are sure you have missed a dose, take it as soon as possible and continue taking your medication as normal. If in doubt, consult your doctor or pharmacist.
If you stop taking Flurpax
The duration of treatment will be determined by your doctor. Treatment with Flurpax lasts a maximum of 6 months. If you stop treatment and symptoms return, you should consult your doctor about whether you can start treatment with Flurpax again.
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 experiences them.
Very common adverse effects (may affect more than 1 in 10 people):
- Weight gain.
Common adverse effects (may affect up to 1 in 10 people):
- Nasal congestion or runny nose.
- Increased appetite
- Depression, difficulty falling asleep or staying asleep
- Drowsiness
- Constipation, stomach discomfort, nausea
- Muscle pain
- Irregular menstrual periods, breast pain
- Fatigue
Uncommon adverse 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 tingling sensation in arms and legs, restlessness or worry, ringing in the ears (tinnitus), involuntary and prolonged contraction of neck muscles (torticollis), weakness
- Awareness of heartbeat (palpitations)
- Low blood pressure (hypotension)
- Intestinal obstruction, dry mouth, gastrointestinal disturbances
- Excessive sweating
- Muscle cramps, muscle contractions
- Heavy and prolonged menstrual flow, menstrual disorders (irregular or absent periods), scanty or infrequent menstruation, breast enlargement, loss of sexual desire
- Swelling due to fluid accumulation in tissues, in legs and feet or other parts of the body, feeling of complete weakness or lack of energy (asthenia)
Adverse effects of unknown frequency (cannot be estimated from available data):
- Inability to stay still, slow and delayed movements, cogwheel rigidity, difficulty moving, involuntary tremulous movements, a set of symptoms known as extrapyramidal symptoms (EPS), which generally include abnormal involuntary muscle movements; Parkinson's syndrome or Parkinson's disease (a chronic and degenerative disorder affecting the nerves and causing progressive motor impairment "paralysis"), drowsiness, tremor
- Redness or pinkish skin discoloration
- Muscle rigidity
- Discharge of fluid from the nipples
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 packaging, following EXP.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE 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 Flurpax
- The active substance is flunarizine in the form of hydrochloride. Each capsule contains flunarizine hydrochloride equivalent to 5 mg of flunarizine.
- The other components are: lactose, dicalcium phosphate dihydrate, sodium starch glycolate from potato, calcium stearate and talc.
Appearance of the product and contents of the container
Flurpax 5 mg hard capsules are available in packs of 30 and 60 capsules.
Marketing Authorization Holder and Manufacturer
Teofarma Srl
Via F.lli Cervi, 8
27010 VALLE SALIMBENE (Pavia)
Italy
Date of the most recent review of this leaflet: January 2014
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.