Coirgen

Package leaflet: Information for the user

Coirgen 500 mg film-coated tablets

famciclovir
equivalent medicine
Please read all of this leaflet carefully before you take 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Coirgen is and what it is used for

Coirgen is an antiviral medicine. It prevents the infecting virus from reproducing. Since the virus begins to replicate immediately at the onset of infection, you will achieve better treatment outcomes if you take Coirgen as soon as the first symptoms appear.
Coirgen is used in adults to treat two types of viral infections:

• Herpes zoster, which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Coirgen stops the virus from spreading in the body, allowing faster healing.
• Coirgen is also used to treat infections around or within the eye (ophthalmic zoster).
• Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is usually transmitted sexually. It causes blisters and burning or itching in the genital area, which may be painful. Coirgen is used for the treatment of genital herpes infections in adults. Individuals who experience frequent episodes of genital herpes may also take Coirgen to help prevent new episodes.

2. What you need to know before taking Coirgen

Do not take Coirgen

• If you are allergic to famciclovir, to any of the other ingredients of this medicine (listed in section 6), or to penciclovir (the active metabolite of famciclovir and an ingredient in some other medicines).

Consult your doctor if you think you may be allergic.
Warnings and precautions
Talk to your doctor before taking Coirgen

• If you have kidney problems (or have had them in the past). Your doctor may decide to prescribe a lower dose of Coirgen.
• If you have any disorders of the immune system.
• If you have liver problems. If any of these conditions apply to you, talk to your doctor before taking Coirgen.

Children and adolescents (under 18 years of age)
The use of Coirgen is not recommended in children and adolescents.
Preventing the transmission of genital herpes to other people
If you are taking Coirgen for the treatment or suppression of genital herpes, or if you have previously had genital herpes, you should continue to practice protected sex by using a condom.
This is important to prevent spreading the infection to others. You should not have sexual intercourse if you have genital blisters or sores.
Other medicines and Coirgen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
It is especially important that you inform your doctor or pharmacist if you are taking any of the following medicines:

• Raloxifene (used to prevent and treat osteoporosis).
• Probenecid (used to treat high blood levels of uric acid associated with gout, and to increase blood levels of antibiotics such as penicillin), or any other medicine that may damage the kidneys.

Coirgen with food and drink
Coirgen can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor for advice before taking this medicine. Coirgen must not be used during pregnancy unless absolutely necessary. Your doctor will discuss with you the potential risks of taking Coirgen during pregnancy.
Coirgen must not be used during breastfeeding unless absolutely necessary. Your doctor will discuss with you the potential risks of taking Coirgen while breastfeeding.
Driving and using machines
Coirgen may cause dizziness, drowsiness, or confusion. Do not drive or operate machinery if you experience any of these symptoms while taking Coirgen.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take Coirgen

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

• The daily dose and duration of treatment will depend on the type of viral infection you have – see below. Your doctor will prescribe the correct dose for you.
• To achieve the best results, start taking the medicine as soon as possible after the first signs and symptoms appear.
• Avoid sexual contact if you have symptoms of genital herpes—even if you have already started treatment with Coirgen. This is because you could transmit the infection to your partner.
• If you have or have had kidney problems, your doctor may decide to prescribe a lower dose of Coirgen.

Dose for Herpes zoster
If you have a normal immune system, the recommended dose is:

• 500 mg three times a day, for seven days.

If your immune defenses are reduced, the recommended dose is:

• 500 mg three times a day, for ten days.

Dose for genital herpes
The dose depends on the condition of your immune system and the stage of the infection.
If you have a normal immune system, the doses are as follows:
For the first outbreak, the recommended dose is:

• 250 mg three times a day, for five days.

For the treatment of subsequent outbreaks, the recommended dose is:

• 125 mg twice a day, for five days.

For the prevention of future outbreaks, the recommended dose is:

• 250 mg twice a day.

Your doctor will tell you how long you should continue taking the tablets.
If your immune defenses are reduced, the doses are as follows:
For the treatment of the current outbreak, the recommended dose is:

• 500 mg twice a day, for seven days.

For the prevention of future outbreaks, the dose is:

• 500 mg twice a day.

Your doctor will tell you how long you should continue taking the tablets.
If you take more Coirgen than you should
If you have taken more tablets than you were told to take, or if someone else has accidentally taken your medicine, contact your doctor or go to a hospital immediately. Show them your tablet pack.
Taking too much Coirgen can impair kidney function. In patients who already have kidney problems, failure to appropriately reduce the dose may rarely lead to kidney failure.
If you forget to take Coirgen
If you forget to take a dose of Coirgen, take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses within an interval of less than 1 hour; in this case, you should skip the missed dose. Also, do not take a double dose to make up for a missed dose.
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 everyone experiences them.
Serious side effects of Coirgen include:
Most of these side effects are rare or uncommon (occur in 1-100 patients in 10,000)

• Severe blistering rash on the skin or mucous membranes of the lips, eyes, mouth, nasal cavity, or genitals (these may be signs of a severe skin allergic reaction).
• Unexplained bruising, reddish or purplish spots on the skin, or nosebleeds (these may be signs of a reduced platelet count).
• Swelling beneath the skin surface (e.g., facial swelling, swelling around the eye, eyelid swelling, throat swelling).
• Yellowing of the skin and/or eyes (signs of jaundice).

The frequency of the following side effects is unknown (frequency cannot be estimated from the available data):

• Purple spots on the skin, itching, burning (signs of blood vessel inflammation).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Skin rash, itching, hives, breathing difficulties or cough, sensation of emptiness in the head, dizziness, altered consciousness. Hypotension, with or without generalized itching, skin redness, swelling of the face and throat, bluish discoloration of the lips, tongue, or skin (signs of a severe allergic reaction).

Contact a doctor or go to the nearest hospital emergency department if you experience any of
these side effects.
Very common side effects (these side effects affect more than 1 in 10 people)

• Headache

Common side effects (these side effects affect up to 1 in 10 people)

• Feeling unwell (nausea)
• Vomiting
• Abdominal pain
• Diarrhea
• Dizziness
• Skin rash
• Itching
• Abnormal liver function test results

Uncommon side effects (these side effects affect up to 1 in 100 people)

• Confusion
• Drowsiness (usually in elderly patients)
• Itchy skin rash (urticaria)

Rare side effects (these side effects affect up to 1 in 1,000 people)

• Hallucinations (seeing or hearing things that are not really present)
• Palpitations (signs of abnormal heartbeat)

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 via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Coirgen

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after Exp.. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Store this medicine at a temperature not exceeding 30°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 Coirgen contains
The active substance is Famciclovir.
Each tablet contains 500 mg of famciclovir.
The other components are: Hydroxypropylcellulose, Sodium starch glycolate, Magnesium stearate, Microcrystalline cellulose 101, Microcrystalline cellulose 102 (coating: Hypromellose, Titanium dioxide BP, Polyethylene glycol 400).

Description of the appearance of Coirgen and contents of the pack
Film-coated tablets.
Coirgen tablets are coated, round, biconvex, white in colour.
Coirgen is available in a pack containing 21 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)
Manufacturer:
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)