250 mg, 500 mg film-coated tablets
valaciclovir
What Valaciclovir Sandoz is and what it is used for
Valaciclovir Sandoz belongs to a group of medicines called antiviral medicines. It works by killing or stopping the growth of viruses called herpes simplex ( HSV ), varicella zoster ( VZV ), and cytomegalovirus ( CMV ).
Valaciclovir Sandoz can be used for:
- treatment of shingles (in adults)
- treatment of HSV skin infections and genital herpes (in adults and adolescents over 12 years of age). It is also used to help prevent these infections from recurring
- treatment of mouth ulcers (in adults and adolescents over 12 years of age)
- to prevent infection with CMV after organ transplantation (in adults and adolescents over 12 years of age)
- to treat and prevent HSV eye infections that keep coming back (in adults and adolescents over 12 years of age).
Valaciclovir contained in Valaciclovir Sandoz may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Valaciclovir Sandoz
Do not take Valaciclovir Sandoz
- if you are allergic to valaciclovir, aciclovir, or any of the other ingredients of this medicine (listed in section 6)
- if you have previously developed widespread skin rash with associated fever, enlarged lymph nodes, elevated levels of liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
→ Do not take Valaciclovir Sandoz if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valaciclovir Sandoz if:
- Do you have any kidney disease
- Do you have any liver disease
- you are over 65 years old
- your immune system is weak.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Valaciclovir Sandoz.
Drug reaction with eosinophilia and systemic symptoms (drug hypersensitivity syndrome, DRESS) has been reported in association with the use of valaciclovir. DRESS initially occurs as flu-like symptoms with skin rashes on the face that then spread, with elevated body temperature, increased levels of liver enzymes detected in blood tests, and an increase in a certain type of white blood cells (eosinophilia ), and enlarged lymph nodes.
If you develop a skin rash along with fever and enlarged lymph nodes, stop taking valaciclovir and contact a doctor or seek medical attention immediately.
Avoid infecting others with genital herpes
If you are taking Valaciclovir Sandoz to treat or prevent genital herpes, or if you previously had genital herpes, you should still practice safe sex, including the use of condoms. This is important to prevent you from passing the infection on to others. You should not have sex if you have genital sores or blisters.
Other medicines and Valaciclovir Sandoz
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include aminoglycosides, organoplatinum compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.
Always tell your doctor or pharmacist if you are taking other medicines while being treated with Valaciclovir Sandoz for shingles or if you have had an organ transplant.
Pregnancy and breastfeeding
Valaciclovir Sandoz is not normally recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take Valaciclovir Sandoz without consulting your doctor. Your doctor will weigh the benefit to you against the risk to your baby of taking Valaciclovir Sandoz while you are pregnant or breastfeeding.
Driving ability and use of machinery
Valaciclovir Sandoz can cause side effects that affect your ability to drive.
→ Avoid driving or using machines unless you are sure that you are unaffected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to take Valaciclovir Sandoz
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your dosage depends on why you have been prescribed Valaciclovir Sandoz by your doctor. Your doctor should discuss this with you.
Treatment of shingles
- The usual dose is 1000 mg (two 500 mg tablets) three times daily.
- You should take Valaciclovir Sandoz for seven days.
Treatment of mouth ulcers
- The usual dose is 2000 mg (four 500 mg tablets) twice daily.
- The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
- You should only take Valaciclovir Sandoz for one day (two doses ).
Treatment of HSV skin infections and genital herpes
- The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice daily.
- At the first infection, you should take Valaciclovir Sandoz for five days or up to ten days if your doctor prescribes it. In case of recurrent infection, the treatment period is normally 3-5 days.
To help prevent HSV infection from coming back after you’ve had them
- The usual dose is one 500 mg tablet once daily.
- Some patients with frequent relapses may benefit from taking one 250 mg tablet twice daily.
- You should take Valaciclovir Sandoz until your doctor prescribes you stop.
To prevent you from becoming infected with CMV ( cytomegalovirus )
- The usual dose is 2000 mg (four 500 mg tablets) four times daily.
- You should take each dose about 6 hours apart.
- You will usually start taking Valaciclovir Sandoz as soon as possible after the doctor’s appointment.
- You should take Valaciclovir Sandoz for about 90 days after the doctor’s visit, as long as your doctor has prescribed it.
The dose of Valaciclovir Sandoz may be adjusted by your doctor if:
- you are over 65 years old
- you have a weak immune system
- Do you have any kidney disease?
→ Consult your doctor before taking Valaciclovir Sandoz if any of the above applies to you.
Ingestion of this medicine
- Take this medicine by mouth.
- Swallow the tablets whole with a glass of water.
- Take Valaciclovir Sandoz at the same time every day.
- Take Valaciclovir Sandoz as directed by your doctor or pharmacist.
People who are over 65 years of age or who have any kidney disease
It is very important that during treatment with Valaciclovir Sandoz you drink water regularly during the day. This will help reduce side effects that may affect the kidneys or nervous system. Your doctor will carefully monitor you for signs of this. Nervous system side effects may include feeling confused or anxious, unusually sleepy, or drowsy.
If you have taken too much Valaciclovir Sandoz
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
Valaciclovir Sandoz is normally not harmful unless you take too much for several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, become confused, and anxious, feel less aware, see things that are not there, or pass out. Talk to your doctor or pharmacist if you have taken too much Valaciclovir Sandoz. Take the medicine package with you.
If you forget to take Valaciclovir Sandoz
- If you forget to take Valaciclovir Sandoz, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a missed dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Conditions you need to pay attention to
- severe allergic reactions ( anaphylaxis ). These are rare in users of Valaciclovir Sandoz. The rapid development of symptoms such as:
- redness, itchy rash
- swelling of the lips, face, neck, and throat, causing difficulty breathing ( angioedema )
- drop in blood pressure leading to collapse.
→ Stop taking Valaciclovir Sandoz and see a doctor immediately if you have an allergic reaction.
Very common (may affect more than 1 in 10 users)
- headache
Common (may affect up to 1 in 10 users)
- nausea
- dizziness
- vomiting
- diarrhea
- skin reaction after exposure to sunlight ( photosensitivity ).
- rash
- itching ( pruritus )
Uncommon (may affect up to 1 in 100 users)
- feeling of confusion
- seeing and hearing things that are not there ( hallucinations )
- the feeling of extreme drowsiness
- tremors _ _
- feeling of worry
These side effects on the nervous system usually occur in users with any kidney disease, the elderly, or in organ transplant patients who take high doses of 8 grams or more of Valaciclovir Sandoz per day. They usually get better when Valaciclovir Sandoz is stopped or when the dose is reduced.
Other less common side effects:
- shortness of breath ( dyspnea )
- stomach upset
- skin rash, sometimes itchy, hives ( urticaria )
- low back pain (kidney pain)
- blood in the urine ( hematuria )
Less common side effects that can be detected with a blood test:
- decrease in the number of white blood cells ( leukopenia )
- reduction in the number of platelets, which are cells that help the blood clot ( thrombocytopenia )
- increase in substances produced in the liver
Rare (may affect up to 1 in 1,000 users)
- unsteady gait and lack of coordination ( ataxia )
- slow, slurred speech ( dysarthria )
- seizures (convulsions)
- altered brain function ( encephalopathy )
- unconsciousness ( coma )
- confused or distorted thoughts ( delirium )
These side effects from the nervous system usually occur in users with any kidney disease, elderly, or organ transplant patients who take high doses of 8 grams or more of Valaciclovir Sandoz per day. It usually gets better when Valaciclovir Sandoz is stopped or when the dose is reduced.
Other less common side effects:
- kidney problems where little or no urine passes
Has been reported ( occurring in an unknown number of users):
- drug reaction with eosinophilia and systemic symptoms, also called DRESS or drug hypersensitivity syndrome, characterized by widespread skin rash, high body temperature, elevated levels of liver enzymes, abnormal blood counts ( eosinophilia ), enlarged lymph nodes, and possibly other organ effects. See also section 2.
How to store Valaciclovir Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and printed packaging after Ex.date. or EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 ºC.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is valaciclovir. Valaciclovir Sandoz 250 mg: One film-coated tablet contains 278.1375 mg of valaciclovir hydrochloride equivalent to 250 mg of valaciclovir.Valaciclovir Sandoz 500 mg: One film-coated tablet contains 556.275 mg of valaciclovir hydrochloride equivalent to 500 mg of valaciclovir.
- Other ingredients in the tablet core are crospovidone, microcrystalline cellulose, povidone, and magnesium stearate; and in the tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, and polysorbate 80.
Appearance and package sizes of the medicine
250 mg: White to off-white capsule-shaped, film-coated tablets, plain on both sides.
500 mg: White to off-white, capsule-shaped, film-coated tablets marked “500” on one side and plain on the other side.
The tablets are packed in PVC/PE/PVDC//Aluminium pressure packs.
Package sizes:
250 mg: Carton with blister pack(s) containing: 10, 30, 42 or 60 film-coated tablets
500 mg: Carton with blister pack(s) containing: 8, 10, 30, 42 or 90 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia