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The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 50805/0078.
Darunavir 800 mg film-coated tablets (100120)
Darunavir 800 mg film-coated tablets
darunavir
1. What Darunavir is and what it is used for
2. What you need to know before you take Darunavir
3. How to take Darunavir
4. Possible side effects
5. How to store Darunavir
6. Contents of the pack and other information
This medicine contains the active substance darunavir. Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Darunavir is used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and
Darunavir must be taken in combination with a low dose of ritonavir and other anti-HIV medicines.
Your doctor will discuss with you which combination of medicines is best for you.
Tell your doctor about all medicines you take including medicines taken orally, inhaled, injected or applied to the skin.
If you are taking any of these, ask your doctor about switching to another medicine.
Medicine Purpose of the medicine
Avanafil to treat erectile dysfunction
Astemizole or terfenadine to treat allergy symptoms
Triazolam and oral (taken by mouth) midazolam to help you sleep and/or relieve anxiety
Cisapride to treat some stomach conditions
Colchicine (if you have kidney and/or liver problems) to treat gout or familial Mediterranean fever
Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions
Ergot alkaloids like ergotamine, dihydroergotamine,ergometrine and methylergonovine to treat migraine headaches
Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine to treat certain heart disorders e.g. abnormal heart beat
Lovastatin, simvastatin and lomitapide to lower cholesterol levels
Rifampicin to treat some infections such as tuberculosis
The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as darunavir
Elbasvir/grazoprevir to treat hepatitis C infection
Alfuzosin to treat enlarged prostate
Sildenafil to treat high blood pressure in the pulmonary circulation
Ticagrelor to help stop the clumping of platelets in the treatment of patients with a history of a heart attack
Naloxegol to treat opioid induced constipation
Dapoxetine to treat premature ejaculation
Domperidone to treat nausea and vomiting
Do not combine darunavir with products that contain St John’s Wort (Hypericum perforatum).
Talk to your doctor, pharmacist or nurse before taking darunavir.
Darunavir is not a cure for HIV infection.
People taking darunavir may still develop infections or other illnesses associated with HIV infection.
You must keep in regular contact with your doctor.
People taking darunavir may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.
In patients taking darunavir and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Make sure that you check the following points and tell your doctor if any of these apply to you.
Darunavir has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use darunavir.
Darunavir is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
There are some medicines that you must not combine with darunavir. These are mentioned above under the heading ‘Do not combine Darunavir with any of the following medicines:’
In most cases, darunavir can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. Darunavir with cobicistat or ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.
The effects of darunavir might be reduced if you take any of the following products. Tell your doctor if you take:
The effects of other medicines might be influenced if you take darunavir and your doctor might want to do some additional blood tests. Tell your doctor if you take:
Your doctor might want to do some additional blood tests and the dosage of other medicines might need to be changed since either their own or darunavir’s therapeutic effect or side effects may be influenced when combined. Tell your doctor if you take:
This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking.
See section 3 ‘How to take Darunavir’
Tell your doctor immediately if you are pregnant or planning to become pregnant. Pregnant women should not take darunavir with ritonavir unless specifically directed by the doctor. Pregnant women should not take darunavir with cobicistat.
Because of the potential for side effects in breast-fed infants, women should not breast-feed if they are receiving darunavir.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Do not operate machines or drive if you feel dizzy after taking darunavir.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Even if you feel better, do not stop taking darunavir and ritonavir without talking to your doctor.
After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.
Darunavir 800 milligram tablets are intended for once daily use only.
The usual dose of darunavir is 800 milligram (2 tablets containing 400 milligram of darunavir or tablet containing 800 milligram of darunavir) once daily.
You must take darunavir every day and always in combination with 100 milligram of ritonavir and with food. Darunavir cannot work properly without ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your darunavir and ritonavir. The type of food is not important. Even if you feel better, do not stop taking darunavir and ritonavir without talking to your doctor.
The dose is either:
Please discuss with your doctor which dose is right for you.
The dose is either:
Please discuss with your doctor which dose is right for you.
The plastic bottle comes with a child resistant cap and must be opened as follows:
Contact your doctor, pharmacist or nurse immediately.
If you notice within 12 hours, you must take the tablets immediately. Always take with ritonavir and food. If you notice after 12 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.
If you vomit within 4 hours of taking the medicine, another dose of darunavir and ritonavir should be taken with food as soon as possible. If you vomit more than 4 hours after taking the medicine, then you do not need to take another dose of darunavir and ritonavir until the next regularly scheduled time.
Contact your doctor if you are uncertain about what to do if you miss a dose or vomit.
Anti-HIV medicines may make you feel better. Even when you feel better, do not stop taking darunavir. Talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests before you start darunavir. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is therefore important to talk to your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether darunavir must be stopped.
Other severe side effects were diabetes (common) and inflammation of the pancreas (uncommon).
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Some side effects are typical for anti-HIV medicines in the same family as darunavir. These are:
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 and on the bottle after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
The active substance is darunavir. Each tablet contains 800 mg of darunavir.
The other ingredients are:
Tablet core
Silicified microcrystalline cellulose, crospovidone B, hydroxypropyl cellulose, sodium chloride, silica colloidal anhydrous, magnesium stearate, polacrilin potassium.
Tablet coating
Polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol/PEG 3350, talc, iron oxide red (E172).
Brown coloured, oval shaped (approximately 20 mm long and 10 mm wide), biconvex, film-coated tablets, debossed with “D” on one side and “800” on the other side.
Pack size:
30 film-coated tablets or 90 film-coated tablets (3 bottles containing 30 tablets each) in a HDPE bottle with child-resistant closure.
Darunavir is also available as 400 mg and 600 milligrams film-coated tablets.
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Manufacturer
This leaflet was last revised in March 2023.