Package leaflet: Information for the patient

FLUNAGEN 10 mg scored tablets, 5 mg hard capsules

Flunarizine hydrochloride
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What FLUNAGEN is and what it is used for
2. What you need to know before taking FLUNAGEN
3. How to take FLUNAGEN
4. Possible side effects
5. How to store FLUNAGEN
6. Contents of the pack and other information

1. What FLUNAGEN is and what it is used for
FLUNAGEN is an anti-vertigo preparation; it contains one active substance: flunarizine hydrochloride.
It is used for the prophylactic treatment of migraine with frequent and severe attacks in patients who have not responded to other therapies and/or in whom such therapies have caused serious adverse effects.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after the prescribed duration of treatment.

2. What you need to know before using FLUNAGEN

Do not use FLUNAGEN

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you currently have or have had depressive disorders, or if you have pre-existing Parkinson's disease symptoms or other extrapyramidal disorders, such as stiffness, resting tremor, slow or clumsy movements (see "Possible Side Effects").

Warnings and precautions
Talk to your doctor or pharmacist before using FLUNAGEN.
If you experience a progressive increase in weakness (asthenia), your doctor will instruct you to stop treatment.
Do not exceed the recommended doses. Your doctor will perform regular check-ups, especially during maintenance therapy, to detect early extrapyramidal signs (such as stiffness, resting tremor, slow or clumsy movements) or depressive symptoms, so that treatment can be stopped promptly. These checks will be particularly careful if you are elderly. If your doctor notices that treatment is losing effectiveness during the maintenance phase, you will be advised to discontinue therapy (for treatment duration, see "How to use FLUNAGEN").

Children and adolescents
Safety and efficacy in children have not been established. Therefore, use of this product is not recommended in pediatric patients.

Other medicines and FLUNAGEN
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
If you are taking drugs that induce a sleep-like state (hypnotics), tranquilizers (anxiolytics), or other psychotropic medications, interaction with Flunagen may cause excessive sedation. For this reason, do not consume alcoholic beverages during treatment.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Since safety has not been established, the use of flunarizine during pregnancy is not recommended.
Due to lack of data on the excretion of flunarizine in breast milk, use of this product during breastfeeding is not recommended.

Use in patients with celiac disease: if you have celiac disease, you can take this product without risk.

Driving and operating machinery
FLUNAGEN may cause drowsiness, especially during the initial phase of treatment; therefore, exercise extreme caution when performing tasks requiring full alertness (such as driving vehicles or operating dangerous machinery).

Important information about certain excipients
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use FLUNAGEN

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults
Initial treatment:
if you are under 65 years of age, treatment should begin at a dose of 10 mg daily, taken at bedtime;
if you are over 65 years of age, the dose should be reduced to 5 mg.
If during this phase of treatment depression, extrapyramidal signs or other serious adverse effects occur, your doctor will instruct you to discontinue treatment. If no significant improvement is observed after two months, your doctor will instruct you to stop therapy.
Maintenance therapy:
if you respond satisfactorily and maintenance therapy is considered necessary, your doctor will reduce the daily dose and instruct you to take Flunagen on alternate days or for five consecutive days with a two-day break each week.
Even if prophylactic treatment proves effective and well tolerated, it should be discontinued after six months and may only be restarted in case of relapse.
If you take more FLUNAGEN than you should
In case of accidental ingestion/overdose of FLUNAGEN, contact your doctor immediately or go to the nearest hospital.
In case of overdose, drowsiness (sedation), weakness (asthenia), and rapid heartbeat (tachycardia) are likely to occur.
If you have taken an excessive dose of Flunagen, consult your doctor, who will assess the appropriate intervention.
If you forget to take FLUNAGEN
Do not take a double dose to make up for the missed dose.
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 will experience them.
The most common side effects are:
drowsiness and/or asthenia (20%), usually transient,
weight gain and/or increased appetite (11%).
During long-term treatment, the following serious side effects have been reported:

depression, for which women with a history of depressive illness are at higher risk (see section 2: "Do not use FLUNAGEN")
extrapyramidal symptoms, such as slowness in performing movements (bradykinesia), rigidity, inability to remain still (akathisia), involuntary facial movements (orofacial dyskinesia), tremors, for which elderly patients are particularly at risk.

Less frequently reported side effects include: nausea, stomach pain (gastralgia), insomnia, anxiety, milk-like discharge from the breasts (galactorrhea), dry mouth sensation, muscle pain, and skin rashes.

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website 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 FLUNAGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
The expiry date refers to the product in its original, unopened packaging, stored correctly.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package Contents and Other Information

What FLUNAGEN contains
FLUNAGEN 10 mg, 50 divisible tablets
Active substance: Flunarizine hydrochloride
Each 10 mg divisible tablet contains: Flunarizine hydrochloride 11.8 mg (equivalent to 10 mg of flunarizine base).
Other components: microcrystalline cellulose, lactose, magnesium stearate, talc.

FLUNAGEN 5 mg, 50 hard capsules
Active substance: Flunarizine hydrochloride
Each 5 mg capsule contains: Flunarizine hydrochloride 5.9 mg (equivalent to 5 mg of flunarizine base).
Other components: microcrystalline cellulose, lactose, magnesium stearate, talc.
Capsule shell constituents: gelatin, indigotine, titanium dioxide.

Description of the appearance of FLUNAGEN and contents of the pack
FLUNAGEN is available as 10 mg, 50 divisible tablets
FLUNAGEN is available as 5 mg, 50 hard capsules

Marketing Authorization Holder
VISUFARMA S.p.A.
Via Canino, 21
Rome
Italy

Responsible person for batch release
FLUNAGEN 10 mg, 50 divisible tablets
FLUNAGEN 5 mg, 50 hard capsules
IBN Savio Srl
Via del Mare, 36 - Pomezia (Rm) 00040