Patient information leaflet

FULCIN 125 mg tablets, 500 mg tablets

griseofulvin
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, because it may be dangerous.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What FULCIN is and what it is used for
What you need to know before taking FULCIN
How to take FULCIN
Possible side effects
How to store FULCIN
Contents of the pack and other information

1. What FULCIN is and what it is used for

FULCIN contains griseofulvin, which belongs to a class of medicines known as "antifungal agents" active against fungi causing infections.
This medicine is used in fungal infections of the skin, nails, and scalp when topical (local) therapy has not been effective.
This medicine helps newly grown skin, hair, and nails to resist fungal infection.
As new tissue forms, the old infected tissue is shed. It is important to continue treatment until all infected tissue has been completely replaced.

2. What you need to know before taking FULCIN

Do not take FULCIN

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant;
if you have porphyria (a condition encompassing a group of metabolic disorders) or have liver disease (hepatic insufficiency);
if you have a disease in which the immune system reacts against the body (systemic lupus erythematosus).

Warnings and precautions
Talk to your doctor or pharmacist before taking FULCIN.
Use of this medicine may cause sensitivity to sunlight and UV rays (photosensitivity).
While taking this medicine, avoid prolonged exposure to sunlight or UV rays.
Be cautious if you have hypersensitivity to penicillin, as you may also be hypersensitive to griseofulvin contained in this medicine.
If you are undergoing long-term treatment, your doctor may periodically prescribe certain tests (blood tests, liver or kidney function tests).
Do not use this medicine to prevent an infection, but only to treat it, and use the lowest possible doses.

Other medicines and FULCIN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

oral contraceptives (used to prevent pregnancy), because griseofulvin may reduce their effectiveness. Therefore, during treatment with this medicine and for up to 1 month after treatment ends, you must use additional contraceptive methods. Moreover, episodes of breakthrough bleeding or absence of menstruation (amenorrhea) may occur;
medicines used to thin the blood (anticoagulants), as they may become less effective;
medicines used to reduce anxiety or promote sleep (barbiturates), as they may reduce the effectiveness of this medicine.

If you need to undergo a specific urine test (vanillylmandelic acid assay) used to monitor certain types of tumors, inform your doctor beforehand that you are taking FULCIN, as this medicine may alter test results.

FULCIN and alcohol
Do not drink alcoholic beverages while taking this medicine, as it increases the effects of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, DO NOT take this medicine, as the effects in these situations are unknown.
If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine may cause dizziness, mental confusion, and may impair motor coordination. If any of these effects occur, do not drive or operate machinery requiring concentration and coordination.

3. How to take FULCIN

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
This medicine may be taken in a single dose or divided into several doses to be taken with food.
The recommended dose in adults is:

1 - 2 tablets of 125 mg four times daily, according to the doctor's prescription; or
1 tablet of 500 mg 1 - 2 times daily, according to the doctor's prescription.

In more severe infections, the doctor may prescribe a higher dose (up to 8 tablets of 125 mg or 2
tablets of 500 mg daily) at the beginning of treatment, then continue with a lower dose
after the first signs of improvement have been observed.
Use in children
The paediatrician will prescribe the most appropriate daily dose based on your child's body weight.
Duration of treatment
Skin infections: the usual treatment duration is about 3 – 6 weeks.
Scalp infections: the treatment may last about 3 – 6 weeks or 6–12 weeks, depending on the infection.
Nail infections: the usual treatment duration is about 4 – 6 months for fingernails and about 12
months for toenails.
For complete resolution of the infection, it is important that treatment is accompanied by appropriate hygiene measures.
If you take more FULCIN than you should
If you take a dose of FULCIN higher than prescribed, inform your doctor immediately or
contact the nearest hospital.
If you have any doubts about how to use 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 any of the following side effects occur, stop treatment and contact your doctor immediately:

hypersensitivity reactions presenting as skin rashes, appearance of small spots on the skin (urticaria), severe allergic reaction causing swelling of the face or throat (angioedema);
rare, severe skin rash with blisters on the skin, particularly on the legs, arms, hands and feet, which may spread to the face and lips (erythema multiforme, toxic epidermal necrolysis);
a metabolic disorder causing abdominal pain and mental disturbances (porphyria);
headache (cephalaea) at the beginning of treatment, which tends to disappear spontaneously without requiring treatment interruption.

Rarely reported:

transient hearing loss;
sensation of thirst;
altered sensation in hands and feet (paraesthesia);
nausea, vomiting, diarrhoea;
weakness (asthenia), dizziness, insomnia, confusion, inability to perform coordinated movements; nerve problems (conditions related to peripheral neuropathy);
fungal infection of the mouth (oral candidiasis);
worsening of systemic lupus erythematosus.

Occasionally reported:

presence of protein in the urine, a sign of kidney inflammation (proteinuria);
changes in blood cells (leucopenia and granulocytopenia; the latter may require treatment discontinuation);
sensitivity to sunlight and UV rays (photosensitivity).

Additional side effects in children
In children, symptoms similar to those caused by oestrogen hormones may occur (breast swelling and development of sexual hair).

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 national reporting system at 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 FULCIN

This medicine does not require any special storage conditions.
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 "Expiry".
The expiry date refers to the last day of that month.
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 FULCIN contains
FULCIN 125 mg tablets

The active substance is griseofulvin. One tablet contains 125 mg of griseofulvin.
The other components are povidone, maize starch, calcium carmellose, magnesium stearate.

FULCIN 500 mg tablets:

The active substance is griseofulvin. One tablet contains 500 mg of griseofulvin.
The other components are povidone, maize starch, calcium carmellose, magnesium stearate.

Description of the appearance of FULCIN and contents of the pack
FULCIN 125 mg tablets are supplied in a box containing 20 tablets in blister packs.
FULCIN 500 mg tablets are supplied in a box containing 10 tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)