FULCIN 125 mg Tablet

Зміст інструкції

1. FULCIN 125 mg tablets, 500 mg tablets
   1. What is FULCIN and what it is used for
   2. What you need to know before taking FULCIN
   3. How to take FULCIN
   4. Possible side effects
   5. How to store FULCIN
   6. Contents of the pack and other information

FULCIN 125 mg tablets, 500 mg tablets

griseofulvin

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

Contents of this leaflet:

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

1. What is FULCIN and what it is used for

FULCIN contains griseofulvin which belongs to the class of medicines called “antifungals” active against fungi that cause infections.
This medicine is used in skin, nail and scalp infections caused by fungi, when topical (local) therapy has not been effective.
This medicine helps the skin, hair and nails that have regrown to resist fungal infection.
While the new tissue forms, the old infected tissue is lost. It is important to continue the treatment until the complete elimination of the infected tissue.

2. What you need to know before taking FULCIN

Do not take FULCIN

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

Warnings and precautions
Consult your doctor or pharmacist before taking FULCIN.
The use of the medicine may lead to sensitivity to sunlight and UV rays (photosensitivity).
While taking this medicine, avoid prolonged exposure to sunlight or UV rays.
Be careful if you have a hypersensitivity to penicillin because you may also be hypersensitive to the
griseofulvin contained in this medicine.
If you have been treated for a long time, your doctor may prescribe you periodic tests (blood tests, liver or kidney tests).
Do not use this medicine to prevent an infection, but only to cure 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 medicine.
In particular, tell your doctor if you are taking:

• oral contraceptives (used to prevent pregnancy), because griseofulvin may reduce their effectiveness. During treatment with this medicine and up to 1 month after the end of treatment, you should therefore use additional contraceptive methods. Furthermore, episodes of bleeding between periods or disappearance of periods (amenorrhea) may occur;
• medicines used to thin the blood (anticoagulants) because they may become less effective;
• medicines to reduce anxiety or promote sleep (barbiturates), because they may reduce the effectiveness of this medicine.

If you are going to have a particular urine test (vanilmandelic acid dosage) used to monitor
certain types of tumors, tell your doctor firstthat you are taking FULCIN, because this medicine
can alter the test results.

FULCIN with alcohol
Do not drink alcohol while taking this medicine because it increases the effects of alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy DO NOT takethis
medicine because the effects in these situations are unknown.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and operating machinery
This medicine can cause dizziness, mental confusion and can alter coordination
of movements. If any of these effects occur, do not drive and do not use machinery that requires
concentration and coordination of movements.

3. How to take FULCIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
This medicine can be taken in a single dose or divided into multiple doses to be taken with a full
stomach.
The recommended dose in adultsis:

• 1 - 2 tablets of 125 mg 4 times a day, as prescribed by your doctor; or:
• 1 tablet of 500 mg 1 - 2 times a day, as prescribed by your doctor.

In more severe infections, your doctor may prescribe a higher dose (up to 8 tablets of 125 mg or 2
tablets of 500 mg per day) at the beginning of treatment, and then continue with a lower dose
after observing the first signs of improvement.

Use in children
The pediatrician will prescribe the most appropriate daily dose based on your child's body weight.
Duration of treatment
Skin infections: the usual treatment is approximately 3 – 6 weeks.
Scalp infections: the treatment may be approximately 3 – 6 weeks or 6-12 weeks
depending on the infection.
Nail infections: the usual treatment is approximately 4 – 6 months for fingernails and approximately 12
months for toenails.
For complete resolution of the infection, it is important that therapy is associated with appropriate
hygiene measures.

If you take more FULCIN than you should
If you take a dose of FULCIN, higher than that prescribed immediately inform your doctoror

go to the nearest hospital.
If you have any doubts about the use of this medicine, ask 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 treatmentand immediately inform your doctor:

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

Rarely have been reported:

• transient hearing loss;
• feeling of thirst;
• alteration of sensitivity in hands and feet (paresthesia);
• nausea, vomiting, diarrhea;
• weakness (asthenia), dizziness, insomnia, mental confusion, inability to make coordinated movements; nerve problems (conditions related to peripheral neuropathy);
• fungal infection of the mouth (oral candidiasis);
• worsening of lupuserythematosus systemic.

Occasionally have been reported:

• presence of protein in the urine, a sign of kidney inflammation (proteinuria);
• alteration of blood cells (leukopenia and granulocytopenia. The latter may require discontinuation of treatment);
• sensitivity to the sun and UV rays (photosensitivity).

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist.
You can also report side effects directly through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Expiry”. The
expiry date refers to the last day of that month.
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 FULCIN contains
FULCIN 125 mg tablets

• The active ingredient is griseofulvin. One tablet contains 125 mg of griseofulvin.
• The other ingredients are povidone, corn starch, calcium carmellose, magnesium stearate.

FULCIN 500 mg tablets:

• The active ingredient is griseofulvin. One tablet contains 500 mg of griseofulvin.
• The other ingredients are povidone, corn starch, calcium carmellose, magnesium stearate.

Description of the appearance of FULCIN and contents of the pack
FULCIN 125 mg tablets are presented in a box of 20 tablets in blisters.
FULCIN 500 mg tablets are presented in a box of 10 tablets in blisters.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)