Valaciclovir 1000mg Film-Coated Tablets
Out of date information, search another^ Talk to your doctor before taking Valaciclovir if any of the above apply.
Taking this medicine
• Take this medicine by mouth.
• Swallow the tablets whole with a drink of water.
• Take Valaciclovir at the same time each day.
• Take Valaciclovir according to instructions from your doctor or pharmacist.
People over 65 years of age or with kidney problems
It is very important while you are taking Valaciclovir 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. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.
If you take more Valaciclovir than you should
Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, or be confused, agitated or unusually sleepy. Talk to your doctor or pharmacist if you take too much Valaciclovir. Take the medicine pack with you.
If you forget to take Valaciclovir
• If you forget to take Valaciclovir, take it as soon as you remember. However, it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Valaciclovir can cause side effects in some people. The following side effects may happen with this medicine.
Conditions you need to look out for
• severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir. Rapid development of symptoms including:
- flushing, itchy skin rash
- swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema)
- fall in blood pressure leading to collapse.
^ If you have an allergic reaction, stop taking Valaciclovir and see a doctor straight away.
Very Common (affects more than 1 in 10 people):
• headache
Common (affects up to 1 in 10 people)
• feeling sick
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight (photosensitivity).
• rash
Uncommon (affects up to 1 in 100 people)
• feeling confused
• seeing or hearing things that aren’t there (hallucinations)
• feeling very drowsy
• tremors
• feeling agitated
These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valaciclovir a day. They usually get better when Valaciclovir is stopped or the dose reduced.
Other uncommon side effects:
• shortness of breath (dyspnoea)
• stomach discomfort
• rash, sometimes itchy, hive-like rash (urticaria)
• low back pain (kidney pain)
Uncommon side effects that may show up in blood tests:
• reduction in the number of white blood cells (leucopenia)
• reduction in the number of blood platelets which are cells that help blood to clot (thrombocytopenia)
• increase in substances produced by the liver.
Rare (affects up to 1 in 1,000 people)
• unsteadiness when walking and lack of coordination (ataxia)
• slow, slurred speech (dysarthria)
• fits (convulsions)
• altered brain function (encephalopathy)
• unconsciousness (coma)
• confused or disturbed thoughts
These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valaciclovir a day. They usually get better when Valaciclovir is stopped or the dose reduced.
Other rare side effects:
• kidney problems where you pass little or no urine.
5. How to store Valaciclovir
Keep out of the reach and sight of children.
Do not use Valaciclovir after the expiry date which is stated on the blister, bottle and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Valaciclovir contains
- The active substance is Valaciclovir.
Each 500 mg film-coated tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride).
Each 1000 mg film-coated tablet contains 1000 mg of valaciclovir (as valaciclovir hydrochloride).
- The other ingredients are microcrystalline cellulose, crospovidone (Type A), povidone K90, magnesium stearate, Opadry blue 13B5057 (hypromellose, indigo carmine aluminium lake (E132), titanium dioxide (E171), macrogol 400, polysorbate).
What Valaciclovir looks like and contents of the pack
Film-coated tablet.
Valaciclovir 500 mg film-coated tablets
Blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing ‘F’ on one side and ‘9’ and ‘3’ on the other side.
The tablet can be divided into equal halves.
Valaciclovir 1000 mg film-coated tablets
Blue, film coated, capsule shaped tablets with partial scorebar on both sides containing ‘F’ on one side and ‘8’ and ‘3’ on the other side.
The tablet can be divided into equal halves.
Valaciclovir film-coated tablets are available in clear PVC/PVdC Aluminium foil blister pack or in HDPE bottle pack.
Blister pack:
500 mg: 5, 10, 21, 24, 30, 42, 50, 90 and 112 tablets 1000 mg: 5, 10, 14, 21, 24, 30, 42, 50 and 90 tablets
Bottle pack:
500 mg & 1000 mg: 30 and 500 tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark Valaciclovir BMM Pharma
Sweden Valaciclovir BMM Pharma 500 mg filmdragerade tabletter
United Kingdom Valaciclovir 500 mg & 1000 mg film-coated tablets