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Herpex 400 mg tablets Aciclovir

Herpex 400 mg tablets Aciclovir

- HERPEX is used for treatment of Herpes zoster;
- prevention of severe cases of Herpes simplex virus infections in adults with suppressed immune system, exposed to an increased risk of infections, for example after organ transplantation.

CONTENT
White to nearly white, round, flat, bevelled tablets. Each box contains 1, 3 or 5 blisters of 10 tablets and a leaflet in a cardboard box. Not all pack can be put on the market.

Method of use
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Package leaflet: Information for the patient
HERPEX 400 mg tablets
Aciclovir
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 further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What HERPEX is and what it is used for
2. What you need to know before you take HERPEX
3. How to take HERPEX
4. Possible side effects
5. How to store HERPEX
6. Contents of the pack and other information
1. What HERPEX is and what it is used for
HERPEX is a medicinal product for treatment of virus infections
HERPEX is used for:
- treatment of Herpes zoster;
- prevention of severe cases of Herpes simplex virus infections in adults with suppressed immune system, exposed to an increased risk of infections, for example after organ transplantation.
HERPEX is not recommended for treatment of Herpes simplex viral infections in newborns and severe Herpes simplex infections in immunocompromised children.
2. What you need to know before you take HERPEX
Do not take HERPEX
- if you are allergic to aciclovir or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking HERPEX.
- If you have abnormal renal funcion, dose adjusment is required.
Elderly individuals are more likely to have abnormal renal function. Your doctor should monitor your renal function regularly.
- If you have abnormal renal function or decreased urine output you should not use HERPEX for prophylaxis.
- If you are taking high doses of HERPEX you need to drink more fluids.
- If you have severe immunodeficiency and you have been treated for a long time or several times with aciclovir, then in this case there is a risk of developing aciclovir-resistant types of Herpes simplex virus. Your doctor should monitor your condition closely.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Other medicines and HERPEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The effect of HERPEX may be affected when co-administered with:
- probenecid (medicine to lower the level of uric acid in the blood);
- cimetidine (medicine used to reduce the gastric secretion);
- mycophenolate mofetil (medicine that suppresses the body’s normal immune functions in transplant patients)
- theophylline (medicine used to treat asthma). However, dose adjustment is not required.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
Caution should be exercised when taking the medicine by pregnant women.
Do not take HERPEX if you are pregnant, think you may be pregnant or are planning to have a baby before seeking advice from your doctor.
Breast-feeding:
It has been found that the active substance aciclovir passes into breast milk.Therefore, breast-feeding should be discontinued while taking HERPEX. If you are breast-feeding or intend to breast-feed, ask your doctor for advice.
Driving and using machines
HERPEX can cause side effects that may impair your ability to drive. You should not drive and use machines if you are not sure if you are not experiencing such side effects.
3. How to take HERPEX
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults
Treatment of Herpes zoster and chickenpox:
2 tablets of 400 mg HERPEX 5 times daily every four hours during the day (corresponding to 4000 mg aciclovir/day)
To prevent severe cases of Herpes simplex viral infections in adult patients with suppressed immune system:
Patients with suppressed immune system, for example after organ transplantation, take 1 tablet of 400 mg HERPEX 4 times daily every six hours (corresponding to 1600 mg/day).
Elderly patients:
Elderly patients are more likely to have abnormal kidney function. The doctor should adjust the dose and the patients shall take care to ensure a sufficient intake of fluids, especially when taking high doses of HERPEX.
Patients with renal impairment
Reduced dosage is required in patients with impaired renal function. In case of abnormal renal function, the treating physician will determine the appropriate dosage.
Treatment method
The tablets must be taken whole (not chewed), after a meal, with enough fluid (for example a glass of water).
An increased amount of fluids should be taken when using HERPEX, especially in patients with impaired renal function.
Start of treatment
To achieve good results, the treatment with HERPEX should begin immediately with the appearance of the first symptoms of infection.
Duration of treatment
Infections caused by varicella zoster virus
Your doctor will decide the duration of treatment.
The treatment duration with HERPEX usually is 7-10 days and it depends on wheter the patient has been successfully cured.
Prevention of herpex simplex virus infections in patients with suppressed immune system
The treatment duration depends on the degree of suppression of the immune system and the risk of disease, and should be determined individually by the doctor.
If you take more HERPEX than you should
Serious problems or poisoning should not be expected with a single overdose of HERPEX. In case of repeated overdose and worsening of side effects or in case of such suspicions, contact your doctor immediately.
If you forget to take HERPEX
Continue the treatment as prescribed (take the tablets as usual – neither more often nor in higher dose). Do not take a double dose to make up for a forgotten dose.
If you miss more than one dose or take less than the prescribed amount, talk to your doctor.
If you stop taking HERPEX
Even if the condition improves, the use of HERPEX should be continued as prescribed by your doctor to ensure the success of the treatment. If you experience side effects, please talk to your doctor before stopping the treatment prematurely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are classified according to system organ class and frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (≤1/10 000), not known (data cannot be estimated).

Common:
Skin reactions such as itching, rash and raised photosensitivity; gastrointestinal disorders such as nausea, vomiting, diarrhoea and stomach pain; dizziness, headache.
Uncommon:
Tiredness, fever, urticaria, increased diffuse hair loss.
Rare:
Increased blood test values (blood tests that show changes in the functions of the liver, kidneys, changes in the values of bile pigments and urea).
Very rare:
Inflammation of the liver (hepatitis), jaundice, reduced numbers of red blood cells, which leads to pale skin, tiredness or shortness of breath; reduced numbers of platelets, which increases the risk of bleeding or bruising; reduced numbers of white blood cells, which increases the risk of infections; acute renal failure.

If you get one or more of the following symptoms of a severe allergic reaction, you should stop taking HEPREX and contact your doctor immediately, or go to the nearest emergency room:
- sudden onset of difficulty breathing, speaking, swallowing or dyspnoea;
- fatigue, lowering blood pressure;
- swelling of the lips, tongue, face or throat.
Severe allergic reactions (anaphylaxis, angioedema, dyspnoea) are rare.

If any of the following symptoms (affecting the nervous system) occur, you should stop taking HERPEX and contact your doctor immediately, or go to the nearest emergency room:
- confusion, tremor, unsteadiness when walking and lack of coordination, difficulties in speaking, depersonalization, hallucinations, convulsions, encephalopathy (a certain disturbance of the brain), feeling sleepy, unconsciousness (coma).
These side effects are reversible and are reported more frequently in patients with impaired renal function or with other predisposing factor and are classified as very rare.
Reporting of side effects
If you experience any unwanted effects, let your doctor or pharmacist know. This includes all effects not listed in this leaflet. You can also report your unwanted side effects here:
Executive Pharmacies Agency
8 Damian Gruev str, 1303 Sofia, Bulgaria
+359 2 8903417,
www.bda.bg
By reporting side unwanted effects, you can contribute to receiving more information about the safety of this medicine.
5. How to store HERPEX
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 carton, after “Use before:”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What HERPEX contains
- The active substance is 400 mg Aciclovir.
- The other ingredients excipient are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, copovidone (VA 64), magnesium stearate, cornstarch.
What HERPEX looks like and contents of the pack
White to nearly white, round, flat, bevelled tablets.
Each box contains 1, 3 or 5 blisters of 10 tablets and a leaflet in a cardboard box.
Not all pack can be put on the market.
Marketing Authorisation Holder and Manufacturer
Fortex Nutraceuticals Ltd.
10 Prohladen kat str
Sofia 1362, Bulgaria

Date of last revision of the leaflet
December 2021
What HERPEX contains
- The active substance is 400 mg Aciclovir.