Valaciclovir Tecnigen 1000 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Valaciclovir TecniGen 1000 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine:
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
- If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Valaciclovir TecniGen is and what it is used for
- What you need to know before taking Valaciclovir TecniGen
- How to take Valaciclovir TecniGen
- Possible side effects
- How to store Valaciclovir TecniGen
- Further information
1. What VALACICLOVIR TECNIGEN is and what it is used for
Valaciclovir TecniGen belongs to a group of medicines called antivirals. It works by eliminating or stopping the growth of viruses known as herpes simplex virus (HSV), varicella zoster virus (VZV), and cytomegalovirus (CMV).
Valaciclovir can be used for:
- Treating shingles (in adults).
- Treating HSV skin infections and genital herpes (in adults and adolescents over 12 years of age). It is also used to prevent the recurrence of these infections.
- Treating cold sores (in adults and adolescents over 12 years of age).
- Preventing CMV infection after organ transplantation (in adults and adolescents over 12 years of age).
- Eye infections
2. WHAT YOU NEED TO KNOW BEFORE TAKING VALACYCLOVIR TECNIGEN
Do not take Valaciclovir
- If you are allergic (hypersensitive) to valaciclovir, aciclovir, or to any of the other ingredients of the medicine (see section 6).
- Do not take Valaciclovir TecniGen if the above applies to you. If you are unsure, speak with your doctor or pharmacist before taking Valaciclovir TecniGen.
- If you have ever developed a prolonged skin rash associated with fever, swollen lymph nodes, increased liver enzyme levels, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
Take special care with Valaciclovir
Consult your doctor or pharmacist before taking Valaciclovir TecniGen if:
- You have kidney problems
- You have liver problems
- You are over 65 years of age
- Your immune system is weakened
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS initially presents with flu-like symptoms and a rash on the face, followed by a prolonged rash, high body temperature, increased liver enzyme levels seen in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.
If you develop a rash associated with fever and enlarged lymph nodes, stop taking valaciclovir and contact your doctor or seek immediate medical attention.
If you have kidney disease or are elderly, your doctor may use a lower dose. Also, you should drink enough fluids during treatment to maintain adequate hydration.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Valaciclovir TecniGen.
Preventing the spread of genital herpes to others
If you are taking Valaciclovir TecniGen to treat or prevent genital herpes, or have previously had genital herpes, you should practice safe sex, including using condoms. This is important to avoid spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.
Use of other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might use other medicines, including those obtained without a prescription or herbal medicines.
Inform your doctor or pharmacist if you are taking any medicine that affects the kidneys. These include: aminoglycosides, platinum-containing compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid. Always inform your doctor or pharmacist about any other medicines you are taking if you are taking Valaciclovir TecniGen for the treatment of herpes zoster or after an organ transplant.
Taking Valaciclovir with food and drinks
Valaciclovir TecniGen can be taken with or without food.
Pregnancy and breastfeeding
Valaciclovir TecniGen is generally not recommended for use during pregnancy. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take Valaciclovir TecniGen without consulting your doctor. Your doctor will weigh the benefits to you against the risks to the baby if you take Valaciclovir TecniGen during pregnancy or while breastfeeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Valaciclovir TecniGen may cause adverse effects that could affect your ability to drive. Do not drive or operate machinery unless you are certain that it does not affect you.
3. HOW TO TAKE VALACICLOVIR
Always take Valaciclovir TecniGen exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.
The dose you should take depends on why your doctor has prescribed Valaciclovir TecniGen for you. Your doctor will indicate the appropriate dosage.
Treatment of herpes zoster
- The usual dose is 1,000 mg (one 1,000 mg tablet or two 500 mg tablets) three times daily.
- You should take Valaciclovir PharOS for seven days.
Treatment of cold sores
- The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) twice daily.
- The second dose should be taken 12 hours after the first dose (not sooner than 6 hours after the first dose).
You should take Valaciclovir TecniGen for only one day (two doses).
Treatment of skin VHS infections and genital herpes
- The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice daily.
- For the first infection, you should take Valaciclovir PharOS for 5 days or up to 10 days, if your doctor instructs you to do so. For recurrent infections, the treatment duration is usually 3–5 days.
Prevention of recurrent VHS infections once you have had them
- The usual dose is one 500 mg tablet once daily.
- Some people with frequent recurrences may benefit from taking one 250 mg tablet twice daily.
- You should continue taking Valaciclovir TecniGen until your doctor tells you to stop treatment.
To prevent CMV (cytomegalovirus) infection
- The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) four times daily.
- Doses should be spaced every 6 hours.
- You will usually start taking Valaciclovir TecniGen as soon as possible after surgery.
- You should take Valaciclovir TecniGen for approximately 90 days after surgery, or until your doctor tells you to stop treatment.
Your doctor may adjust the dose of Valaciclovir TecniGen if:
- you are over 65 years of age
- you have a weakened immune system
- you have kidney problems
Talk to your doctor before taking Valaciclovir TecniGen if any of the above apply to you.
Method of administration
- Take this medicine by mouth.
- Swallow the tablets whole with a glass of water.
- Take Valaciclovir TecniGen at the same time each day.
- Take Valaciclovir TecniGen according to the instructions given by your doctor or pharmacist.
Patients over 65 years of age or with kidney problems
It is very important that you drink water regularly throughout the day while taking Valaciclovir TecniGen. This will help reduce adverse effects that may affect the kidneys or nervous system. Your doctor will monitor you for signs of such effects. Nervous system side effects may include confusion, agitation, or feeling abnormally drowsy or sleepy.
If you take more Valaciclovir than you should
Valaciclovir TecniGen is generally not harmful unless taken in excess over several days. If you take too many tablets, you may experience nausea, vomiting, or feel confused, agitated, or abnormally drowsy. Speak to your doctor or pharmacist if you take too much Valaciclovir TecniGen. Bring the packaging with you.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Valaciclovir
- If you forget to take Valaciclovir TecniGen, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
- Do not take a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, valaciclovir may cause adverse effects, although not everyone experiences them.
Symptoms you should be aware of
-
Severe adverse reactions (anaphylaxis). These are rare in people taking Valaciclovir TecniGen and involve rapid development of symptoms, including:
-
Skin rash with redness, itching
-
Swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
-
Drop in blood pressure leading to collapse
-
If you experience an allergic reaction, stop taking Valaciclovir TecniGen and contact your doctor immediately.
Very common (may affect more than 1 in 10 people):
- Headache
Common (may affect between 1 and 10 in 100 people):
- Nausea
- Dizziness
- Vomiting
- Diarrhea
- Skin reactions after sun exposure (photosensitivity)
- Rash
Uncommon (may affect between 1 and 10 in 1,000 people):
- Difficulty breathing (dyspnea)
- Stomach pain
- Rash, sometimes with itching, hives (urticaria)
- Pain in the lower back (kidney pain)
Uncommon adverse effects may appear in blood tests:
- Reduction in the number of white blood cells (leukopenia)
- Reduction in the number of platelets, which are cells that help blood to clot (thrombocytopenia)
- Increase in substances produced by the liver
Rare (may affect between 1 and 10 in 10,000 people):
- Seizures
- Confused or disturbed thoughts
These nervous system adverse effects usually occur in people with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valaciclovir TecniGen per day. They usually improve when treatment with Valaciclovir TecniGen is stopped or the dose is reduced.
Other rare adverse effects:
- Kidney problems causing reduced or no urine output.
Very rare (may affect fewer than 1 in 10,000 people):
- Agitation
- Confusion
- Tremor
- Difficulty with movement
- Difficulty speaking
- Confusion or hallucinations (hallucinations)
- Convulsions
- Drowsiness
- Encephalopathy (brain dysfunction)
- Coma
Frequency not known (cannot be estimated from available data):
- Drug reaction with eosinophilia and systemic symptoms, also known as drug hypersensitivity syndrome or DRESS, characterized by widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possibly involvement of other organs in the body. See also section 2.
- Inflammation of the kidneys (tubulointerstitial nephritis)
These effects are generally reversible and usually occurred in patients with renal impairment or predisposing factors.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of VALACICLOVIR TECNIGEN
Do not store above 30°C. Keep in the original container.
Keep out of the reach and sight of children.
Do not use Valaciclovir TecniGen after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
Composition of Valaciclovir TecniGen
The active substance is valaciclovir. Each coated tablet contains 1112.40 mg of valaciclovir hydrochloride, equivalent to 1000 mg of valaciclovir.
The other components are:
Tablet core: Povidone K90, pregelatinized corn starch, crospovidone, colloidal anhydrous silica, magnesium stearate.
Coating: Titanium dioxide (E171), hypromellose 6cP, hypromellose 3cP, polyethylene glycol 400, polysorbate 80.
Appearance of the medicinal product and contents of the pack
White, oval-shaped tablets.
Valaciclovir TecniGen 1000 mg film-coated tablets EFG is available in blister packs containing 21 tablets.
Other pack sizes:
Valaciclovir TecniGen 250 mg film-coated tablets EFG: packs of 10 or 42 tablets.
Valaciclovir TecniGen 500 mg film-coated tablets EFG: packs of 10 or 42 tablets.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid), SPAIN
Manufacturer:
ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.
Rua da Tapada Grande, No 2
2710-089 Abrunheira, Sintra, Portugal
This patient information leaflet was last reviewed in October 2022.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Care Products (AEMPS): http://www.aemps.es/