Jubitrex 500 mg/000 mg Film-Coated Tablets

JUBITREX belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses and can be used to:

• treat herpes zoster (shingles);
• treat repeated genital herpes simplex infections (a common sexually transmitted virus infection);
• prevent repeated herpes simplex infections of the skin and mucous membranes (the inner surface) of the anus and genital areas;
• prevent cytomegalovirus infection or disease after an organ transplant.

Do not take JUBITREX if you:

• are hypersensitive (allergic) to valaciclovir or aciclovir or any of the other ingredients of JUBITREX listed in section 6.

Warnings and precautions:

Talk to your doctor or pharmacist before taking JUBITREX if:

• you have advanced HIV disease (AIDS);
• you had a bone marrow transplant;
• you have kidney problems, or you have had a kidney transplant;
• you are dehydrated;
• you are elderly (over 65 years of age);
• you have liver problems;
• your immune system is weak.

People over 65 years of age or with kidney problems: It is very important while you are taking JUBITREX that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these.

Take special care with JUBITREX – Important Information:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS appears initially as flu like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Prevent passing genital herpes on to others:

If you are taking JUBITREX to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters. JUBITREX does not cure genital herpes or completely eliminate the risk of transmission. Because genital herpes is a sexually transmitted disease, you should minimise having intercourse when you have an outbreak of herpes or show any symptoms. This will avoid the risk of spreading herpes to your partner.

Other medicines and JUBITREX:

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.) The following medicines may cause an interaction when used in combination with JUBITREX:

• aminoglycosides (antibiotic medicine),
• organoplatinum compounds (used to treat cancer),
• iodinated contrast media (radiographic dye used during radiographic procedures),
• methotrexate (used to treat certain cancers, psoriasis or rheumatoid arthritis),
• pentamidine (used to prevent a serious lung infection (Pneumocystis pneumonia (PCP)) in people with acquired immunodeficiency syndrome (AIDS)),
• foscarnet (an antiviral medicine used to treat herpes viruses and herpes simplex viruses),
• cimetidine (used to treat heartburn),
• probenecid (used to treat gout),
• mycophenolate mofetil, ciclosporin or tacrolimus (used after an organ transplant).

JUBITREX with food, drink and alcohol:

There are no known interactions between JUBITREX and food or alcohol.

Pregnancy and breastfeeding:

If you are pregnant, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking JUBITREX. Do not take JUBITREX if you are breastfeeding.

Driving and using machines:

It is not always possible to predict to what extent JUBITREX may interfere with your daily activities. JUBITREX may impair your ability to drive a vehicle and use machinery. Do not drive a vehicle, operate machinery, or do anything else that requires your attention until you know how JUBITREX affects you.

Do not share medicines prescribed for you with any other person. Always take JUBITREX exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will calculate your dosage and frequency, according to your condition. The usual dosage is 500 mg to 8 000 mg (four times 2 000 mg) daily. If you have a kidney disorder, your doctor will adjust your dose accordingly. If you have the impression that the effect of JUBITREX is too strong or too weak, tell your doctor or pharmacist.

If you take more JUBITREX than you should:

If you take too many tablets you may feel sick, vomit, may be confused, agitated, feel less aware, see things that aren’t there, or become unconscious. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take along any tablets that are left, including the carton, so that the hospital staff can easily tell what you have taken.

If you forget to take JUBITREX:

If you miss a dose, you should take it as soon as possible, but you should not take more than the total daily dose in any 24-hour period. Do not take a double dose to make up for a forgotten dose.

JUBITREX can have side effects. Not all side effects reported for JUBITREX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking JUBITREX, please consult your doctor, pharmacist or health care provider for advice.

Skin rashes or redness

The adverse reaction of the skin may appear as rashes with or without blisters. Skin irritation, oedema (DRESS syndrome) and fever and flu like symptoms may occur.

If any of the following happens to you, stop taking JUBITREX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• rash, hives or itching;
• fainting.

These are all very serious side effects. If you have them, it may be due to a serious reaction to JUBITREX. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• signs of recurrent infections such as fever or sore throat;
• unexplained bruising, pinpoint bleeds on your skin;
• fits (seizures);
• unconsciousness (coma);
• yellowing of your skin and eyes (jaundice);
• blood in your urine;
• kidney problems where you pass little or no urine, or dark coloured urine.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headaches or dizziness;
• nausea, vomiting (being sick), diarrhoea;
• skin reaction after exposure to sunlight;
• low back pain (kidney pain).

Less frequent side effects:

• abnormal thinking and perceptions including hallucinations (seeing, hearing or feeling things that are not real), feeling confused;
• feeling drowsy;
• involuntary shaking of your hands and feet (tremor);
• feeling agitated;
• unsteadiness when walking and lack of coordination (ataxia);
• slow, slurred speech (dysarthria);
• altered brain function (encephalopathy);
• shortness of breath (dyspnoea);
• discomfort in your stomach area;
• swelling of your face or body due to water retention.

Frequency Not Known (cannot be estimated from the available data)

Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug reaction hypersensitivity syndrome, which is characterised by widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects:

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of JUBITREX.

• Store at or below 25 °C.
• Protect from light.
• Keep in the outer carton until required for use.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the blister/carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).