GRADIENT 5 mg Hard Capsules

Зміст інструкції

1. Gradient Polifarma 5 mg hard capsules
   1. What is Gradient Polifarma and what is it used for
   2. What you need to know before taking Gradient Polifarma
   3. How to take Gradient Polifarma
   4. Possible side effects
   5. How to store Gradient Polifarma
   6. Contents of the pack and other information

Gradient Polifarma 5 mg hard capsules

Gradient Polifarma 10 mg hard capsules
Flunarizine dihydrochloride
Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Gradient Polifarma is and what it is used for
• 2. What you need to know before you take Gradient Polifarma
• 3. How to take Gradient Polifarma
• 4. Possible side effects
• 5. How to store Gradient Polifarma
• 6. Contents of the pack and other information

1. What is Gradient Polifarma and what is it used for

Gradient Polifarma contains flunarizine dihydrochloride, belonging to a group of medicines that
relax blood vessels so that blood can flow more easily to the brain.
Gradient Polifarma is indicated in adultsfor the prevention of migraine (headache) that manifests
with frequent and severe attacks.
Gradient Polifarma is used when other therapies have not had an effect or have caused
serious side effects.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Gradient Polifarma

Do not take Gradient Polifarma

• if you are allergic to flunarizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from or have suffered from depression
• if you suffer from symptoms of Parkinson's disease (a condition that prevents control of movement, which manifests, for example, with tremor, muscle rigidity, slowing of movements)
• if you suffer from extrapyramidal disorders (disorders in the control of movements).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gradient Polifarma.
During treatment and especially during maintenance therapy:

• you may experience serious side effects such as excessive fatigue, movement disorders or depression. At the first signs of these disorders, inform your doctor immediately(see section “Possible side effects”);
• your doctor will regularly monitor you to check for serious side effects in order to stop treatment promptly, especially if you are elderly (see section “Possible side effects”);
• if your doctor does not notice any improvement or notices a loss of effect of this medicine, they will consider stopping treatment (see section “How to take Gradient Polifarma”).

Other medicines and Gradient Polifarma
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking the following medicines, as concomitant administration with Gradient Polifarma may cause excessive sedation (physical and
mental relaxation):

• hypnotics (sleeping pills, substances that help to sleep)
• tranquilizers (medicines to treat anxiety) Tell your doctor if you are taking the following medicines, as concomitant administration may have effects on Gradient Polifarma:
• topiramate, phenytoin, carbamazepine, valproate and phenobarbital (used to treat epilepsy)

Gradient Polifarma with alcohol
Avoiddrinking alcoholic beverages during therapy with Gradient Polifarma, as
concomitant administration of Gradient Polifarma with alcohol may cause excessive
sedation (physical and mental relaxation).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Do nottake this medicine during pregnancy and breastfeeding, as the safety of use
has not been established during pregnancy and breastfeeding.

Driving and operating machinery
Take particular care if you need to drive or operate machinery or perform operations that
require perfect lucidity, as Gradient Polifarma, especially in the initial phase of
therapy, may cause drowsiness.

Gradient Polifarma contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Gradient Polifarma

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults

Initial attack therapy
If you are under 65 years of age,the recommended initial dose is 10 mg per day (1 capsule of 10 mg
or 2 capsules of 5 mg, according to your doctor's prescription), to be taken in the evening at bedtime.
Do not exceed the doses prescribed by your doctor.

Maintenance therapy
If your doctor believes that you have responded positively to the initial attack therapy, they will prescribe
maintenance therapy.
During maintenance therapy, your doctor will reduce the dose and have you take this medicine
on alternate days for 5 consecutive days, with a two-day break each week, for example
Monday, Wednesday and Friday with a break on Saturday and Sunday.
Do not exceed the doses prescribed by your doctor.

Elderly
If you are over 65 years of agethe recommended initial dose is 5 mg per day (1 capsule of 5 mg). Do not
exceed the doses prescribed by your doctor.

Duration of treatment

• The duration of the initial attack therapy is 2 months.
• If, after 2 months from the start of treatment, your doctor believes that you have responded positively to the initial attack therapy, they will prescribe maintenance therapy for a duration of 6 months.
• After 6 months of maintenance therapy, your doctor will have you stop treatment with Gradient Polifarma, even if you have responded positively to the treatment.
• If, during the 6 months of maintenance therapy, your doctor notes a loss of effect of this medicine or the presence of undesirable effects, your doctor will evaluate whether to interrupt treatment with Gradient Polifarma.
• Your doctor may have you resume therapy with Gradient Polifarma only in case of relapse.

If you take more Gradient Polifarma than you should
If you should take an excessive dose of this medicine, inform your doctor immediately
or go to the nearest hospital where you will be provided with the most appropriate care.
If you should take an excessive dose of this medicine you may experience the following

symptoms:

• sedation (physical and mental relaxation)
• asthenia (weakness)
• agitation
• tachycardia (increased heart rate per minute).

Treatment
The doctor will adopt the appropriate supportive therapy with induction of vomiting, activated charcoal, gastric lavage,
as well as other supportive therapies to reduce symptoms.
No specific antidote is known

If you forget to take Gradient Polifarma
Donot take a double dose to make up for the forgotten capsule.

If you stop taking Gradient Polifarma
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following seriousside effects during treatment with Gradient Polifarma:

informyour doctor immediately who will STOPtreatment with Gradient Polifarma:

• progressive increase in asthenia(excessive weakness)
• depression, for which women who have suffered from depression in the past are at greater risk (see "Do not take Gradient Polifarma")
• extrapyramidal symptoms(movement control disorders; see "Do not take Gradient Polifarma") such as:
• difficulty initiating a new movement of your body, resulting in slowing down of the same
• rigidity
• inability to stand still and/or sit with a desire to move continuously
• uncontrolled movements of the mouth, tongue and facial muscles
• tremors. These effects occur especially after prolonged treatments, particularly if you are elderly.

The side effects listed below are reported according to the frequency with which they occur.

Very common (affects more than 1 in 10 people):

• weight gain

Common (affects 1 to 10 people in 100):

• rhinitis (inflammation of the nasal cavities)
• increased appetite
• depression
• insomnia
• drowsiness
• constipation
• stomach discomfort
• nausea
• muscle pain
• menstrual irregularities
• breast pain
• fatigue

Uncommon (affects 1 to 10 people in 1,000):

• depressive symptoms
• sleep disorders
• anxiety
• apathy
• abnormalities in movement coordination
• disorientation
• lethargy (deep sleep)
• tingling in legs and arms or other parts of the body, numbness, feeling of warmth or cold
• restlessness
• indolence (lack of motivation)
• tinnitus (ringing in the ears)
• torticolis (wryneck)
• palpitations (sensations of increased heartbeat)
• hypotension (low blood pressure)
• intestinal obstruction
• dry mouth
• gastrointestinal disorders (stomach ache or other digestive problems)
• excessive sweating
• spasms and/or muscle contractions
• menorrhagia (heavy and abnormal menstrual bleeding)
• menstrual disorders (excessive menstrual flow)
• oligomenorrhea (alteration and scarcity of menstrual flow)
• excessive development of the breasts (large breasts)
• decreased libido (sexual desire)
• swelling that can affect hands and feet (peripheral edema) or more parts of the body (generalized edema)
• asthenia (fatigue)

Frequency not known (cannot be estimated from the available data):

• inability to sit
• pathological slowness of movements
• cogwheel rigidity (if when moving an arm it seems that the elbow has a gear wheel for which it moves in jerks)
• abnormal and involuntary movement of body muscles
• extrapyramidal disorders (rigidity, tremor) and parkinsonism
• sedation
• tremor
• increased liver enzymes (transaminases) which can lead to changes in some clinical tests
• erythema (skin irritation)
• muscle rigidity
• galactorrhea (abnormal secretion of milk in women who are not breastfeeding)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http:// www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gradient Polifarma

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

5 mg capsule: store at a temperature below 25°C.

10 mg capsule:this medicine does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the pack after Exp. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice changes in the color of the capsule.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gradient Polifarma contains
5 mg capsule

• the active ingredient is :flunarizine dihydrochloride (1 capsule contains 5.9 mg of flunarizine dihydrochloride equivalent to 5 mg of flunarizine base)
• the other ingredients are: anhydrous lactose(see section “Gradient Polifarma contains lactose”), corn starch, magnesium stearate, titanium dioxide, gelatin. 10 mg capsule
• the active ingredient is :flunarizine dihydrochloride (1 capsule contains 11.8 mg of flunarizine dihydrochloride equivalent to 10 mg of flunarizine base)
• the other ingredients are: anhydrous lactose(see section “Gradient Polifarma contains lactose”), corn starch, magnesium stearate, titanium dioxide, gelatin.

Description of the appearance of Gradient Polifarma and contents of the pack
Hard capsules
Gradient Polifarma 5 mg: pack containing 50 hard capsules packaged in five blisters of
10 capsules of opaque white color
Gradient Polifarma 10 mg: pack containing 50 hard capsules packaged in five blisters of
10 capsules of opaque white color.

Marketing Authorisation Holder
POLIFARMA S.p.A.
Viale dell’Arte, 69
00144 Roma

Manufacturer
ISTITUTO DE ANGELI S.r.l.
Località Prulli n. 103/C
50066 Reggello (FI)