Nervaxon

Patient Information Leaflet

NERVAXON 300 mg coated tablets

Hypericum perforatum L. dry extract
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NERVAXON is and what it is used for

NERVAXON contains the active substance dry extract of Hypericum perforatum L. and belongs to the group
of antidepressant medicines.
Nervaxon is indicated for the treatment of mild to moderate depressive syndromes.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking NERVAXON

Do not use NERVAXON

• if you are allergic to dry extract of Hypericum perforatum L. or to any of the other ingredients of this medicine (listed in section 6).
• if you have known photosensitivity (increased sensitivity to light).
• if you are taking any of the following medicines concurrently:
  • medicines used in the treatment of HIV ("AIDS"), e.g. indinavir and nevirapine;
  • medicines used to treat hepatitis C infection, e.g. telaprevir;
  • immunosuppressants, e.g. cyclosporine, tacrolimus;
  • anticancer drugs, e.g. irinotecan, imatinib, vinca alkaloids, taxanes, etoposide, cyclophosphamide;
  • coumarin-type anticoagulants, e.g. warfarin;
  • other antidepressants (see section “Other medicines and NERVAXON”);
• in case of severe depressive episodes;
• during pregnancy and breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking NERVAXON.
Do not exceed the recommended dose.
If symptoms worsen or do not improve after four weeks, consult a doctor.
This medicine is indicated for the symptomatic treatment of mild-to-moderate depressive syndrome; therefore, if you experience signs and symptoms of major depression, consult your doctor for appropriate treatment.
During treatment with NERVAXON, avoid excessive exposure to sunlight, sunlamps, and/or solariums.
Medicinal preparations containing St. John’s wort may affect the metabolism of other drugs taken concomitantly. Therefore, it may be necessary to adjust the dose of these medicines.
Although Hypericum perforatum extract has been used for many years, safety data in patients with renal or hepatic impairment are not available. Therefore, if you belong to this patient group, use NERVAXON with caution.
Women using hormonal contraceptives may experience breakthrough bleeding as a result of drug interactions and should use additional contraceptive measures, as contraceptive efficacy may be reduced.

Suicide/Suicidal ideation
Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide (suicide/related events). The risk of suicide may persist or even increase during the early stages of improvement.
Especially during the initial phases of treatment and after dose adjustments, you must immediately report to your treating physician any worsening of symptoms, emergence of suicidal thoughts or behaviors, or behavioral changes.

Children and adolescents
NERVAXON must not be used in children and adolescents under 18 years of age, as adequate data are not available.

NERVAXON contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Other medicines and NERVAXON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use with the following medicines is contraindicated (see section “Do not use NERVAXON”):

• indinavir and nevirapine, used for the treatment of HIV;
• telaprevir, used for the treatment of hepatitis C;
• cyclosporines and tacrolimus, used in organ transplantation or to treat immune system disorders;
• irinotecan, imatinib, vinca alkaloids, taxanes, etoposide, cyclophosphamide, used in cancer treatment;
• warfarin and other anticoagulants used to delay blood clotting;
• medicines used to treat depression.

Inform your doctor if you are being treated with:

• digoxin (used for heart conditions);
• fexofenadine, used for allergies;
• benzodiazepines, used for the treatment of anxiety and insomnia;
• methadone, used for heroin detoxification;
• simvastatin, used to reduce blood cholesterol;
• and finasteride, used for prostate disorders;
• citalopram, fluoxetine, sertraline, paroxetine, nefazodone, MAO inhibitors, buspirone, used to treat depression;
• triptans, medicines used for migraine headache.

NERVAXON and alcohol
It is recommended to avoid alcohol consumption during treatment.

Pregnancy
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
NERVAXON must not be used during pregnancy. Women of childbearing potential must use a reliable method of contraception during treatment and for at least two weeks after its completion.

Breastfeeding
Mothers who are breastfeeding must not take NERVAXON.

Driving and use of machines
No studies have been conducted on the ability to drive vehicles or operate machinery.

3. How to take NERVAXON

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults:
The recommended dose is 1 tablet 2 or 3 times daily.
Swallow the tablets with a little water.
The antidepressant effect of NERVAXON usually becomes evident 10–14 days after starting treatment.
Therapeutic effects are generally expected within 4 weeks from the start of treatment.
Consult a doctor if symptoms persist during use of the medicine.
Longer-term treatments are at the discretion of the doctor, depending on the response to treatment.
Elderly:
No dose adjustment is necessary.
Use in children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
If you take more NERVAXON than you should
In case of accidental ingestion/overdose of NERVAXON, contact your doctor immediately or go to the nearest hospital.
Seizures and confusion have been reported.
If you have taken an excessive dose of this medicine, you must avoid exposure to direct sunlight and
protect yourself from UV radiation for 1 or 2 weeks; adverse effects related to such exposure could be
severe.
If you forget to take NERVAXON
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Rarely (may affect up to 1 in 1,000 people), the following may occur:

• Suicidal ideation/behaviour, nausea, abdominal pain and diarrhoea;
• Itching and urticaria;
• Fatigue;
• Restlessness and dizziness;
• Photosensitisation

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the system:

www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NERVAXON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the product stored in its original intact packaging and kept under proper conditions.
Do not store above 25°C.
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 NERVAXON contains

• The active substance is dry extract of Hypericum perforatum L. One coated tablet contains 300 mg of dry extract of Hypericum perforatum L.
• The other ingredients are: Acido ascorbico, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, silicon dioxide, magnesium stearate, hypromellose, macrogol 4000, lactose, vanillin, sodium saccharin, talc, titanium dioxide (E171), iron oxides (E172), activated dimethicone with silica, methylcellulose, sorbic acid.

Description of the appearance of NERVAXON and package contents
15 coated tablets
20 coated tablets
30 coated tablets
45 coated tablets
60 coated tablets
90 coated tablets
100 coated tablets

Marketing Authorization Holder and Manufacturer
Dr. Willmar Schwabe GmbH & Co. KG - Willmar-Schwabe-Str. 4 - 76227 Karlsruhe - Germany

Distributor
Schwabe Pharma Italia S.r.l.
Via Silvio Menestrina 1
39044 Egna-Neumarkt (BZ) – Italy