Ronivid Film-Coated Tablets

RONIVID contains active substances called darunavir and ritonavir. RONIVID is an antiretroviral medicine. It belongs to a group called protease inhibitors. RONIVID works by reducing the amount of Human Immunodeficiency Virus (HIV) in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. RONIVID is used in combination with other antiretroviral medicines to treat adults who are infected by HIV and who have developed resistance to other antiretroviral medicines.

Do not take RONIVID:

• if you are hypersensitive (allergic) to darunavir, ritonavir or any of the other ingredients of RONIVID (listed in section 6).
• if you have severe liver disease.

Do not take RONIVID with any of the following medicines:

• medicines to treat tuberculosis (rifampicin, rifabutin)
• medicines to treat high blood pressure as a result of problems with your lungs (sildenafil, bosentan)
• medicines to treat migraine and headaches (dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• herbal products containing St John’s wort (e.g. for depression)
• medicines to treat high cholesterol (lovastatin and simvastatin)
• medicines to treat psychiatric conditions such as schizophrenia (pimozide)
• medicines to treat trouble with sleeping and/or anxiety (midazolam or triazolam)
• medicines to treat fungal infections (ketoconazole, itraconazole, voriconazole)
• medicines to treat convulsions (epilepsy) (phenobarbitone or phenytoin)
• medicines to treat allergy symptoms (astemizole)
• medicines to treat gout if you have liver or kidney problems (colchicine)
• medicines to treat prostate problems (alfuzosin)
• medicines to treat some stomach conditions (cisapride)
• medicines to treat hepatitis C virus (boceprevir, telaprevir)
• medicines to treat narcotic dependence (buprenorphine/naloxone)
• medicines used to correct irregular heartbeat (amiodarone, bepridil, encainide, flecainide, propafenone, quinidine, digoxin)
• medicines used to treat asthma (salmeterol)

If you are taking any of these, discuss it with your doctor.

Warnings and precautions

Take special care with RONIVID:

• RONIVID must be taken together with food.
• RONIVID is not a cure for HIV infection.
• RONIVID does not reduce the risk of passing HIV to others through sexual contact or blood contaminations. Therefore, you must continue to use appropriate precautions, such as condoms.
• People taking RONIVID may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.
• Contact your doctor immediately if the following is experienced:
• severe rash
• sulphonamide (antimicrobial used to treat certain infections) allergy.

Do not share medicines prescribed for you with any other person. Always take RONIVID exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of RONIVID is two tablets once daily. You must take RONIVID every day and always in combination with food at approximately the same time of day. RONIVID cannot work properly without food. You must eat a meal or snack 30 minutes before you take your RONIVID. The type of food is not important. Swallow the tablet with a drink such as water, milk, or any other nutritional drink. Even if you feel better, do not stop taking RONIVID without talking to your doctor. Make sure that you always have enough RONIVID tablets available so that you don’t run out. For example, in case you cannot return home, need to travel or stay in a hospital.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and should be opened as follows:

• Push the plastic screw cap down while turning it counter clockwise.
• Remove the unscrewed cap.

If you take more RONIVID than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take RONIVID

If you notice within 12 hours, you must take your tablet immediately. Always take with food. If you notice after 12 hours, then take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

RONIVID can have side effects. Not all side effects reported for RONIVID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking RONIVID, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happens, stop taking RONIVID and tell your doctor immediately or go to the casualty department of the nearest hospital:

• severe rash with blisters
• rash or itching with swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious effects. If you have them, you may have had a serious allergic reaction to RONIVID. You may need urgent medical attention.

Speak to your doctor immediately or go to the casualty department of your nearest hospital if you experience any of the following side effects:

• symptoms of infection or inflammation after the start of treatment (immune reconstitution inflammatory syndrome)
• inflammation of the liver or pancreas (symptoms may include abdominal pain, nausea and vomiting)
• diabetes

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:

• headache
• vomiting, nausea
• diarrhoea, stomach pain
• rash
• high cholesterol and other fats in the blood
• high blood sugar
• Weight loss
• Dehydration, increase in cholesterol, gout, swelling of hands and feet
• Agitation, confusion, mood alteration, nervousness
• Tingling sensation or numbness in the hands, feet or around the lips and mouth.
• Bad taste in the mouth; dizziness
• Blurred vision, painful eye, sensitivity to light
• Low blood pressure and feeling faint, when getting up
• increase in heart beat/rate
• Cough
• Stomach ache, vomiting, diarrhoea, nausea, dry mouth
• wind, indigestion, mouth ulcer
• Muscular pain
• Joint pain and back pain
• Increase/decrease in urination, reduced kidney function
• Feeling weak/tired, fever
• Changes in liver function tests
• Flushing, feeling hot

Less frequent:

• Changes in body fats (fat redistribution)
• Loss of appetite
• Abdominal swelling, indigestion, flatulence
• Itching
• Muscle pain
• Loss of strength and energy, tiredness
• Increase in pancreatic enzymes
• Changes in blood test results, Low levels of blood platelets
• High levels of sugar in the blood
• Buzzing/roaring sound in the ear, Pain in the ear
• Imbalance
• Abnormal dream, difficulty in paying attention, convulsions (fits)
• Change in the heart rate, fainting
• Shortness of breath, nose bleeding
• Decreased sexual drive

RONIVID may change some values of your blood chemistry. These can be seen in the results of blood tests. Your doctor will explain these to you. In some patients, RONIVID has been reported to cause a severe or life-threatening rash. In patients taking RONIVID and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately. Contact your doctor if you develop a rash. Your doctor will advise you whether your symptoms can be managed on therapy or whether RONIVID should be stopped. RONIVID should not be taken if you suffer from liver problems.

Store all medicines out of reach of children

Store at or below 25 °C

Store in the original package

Protect from light/ moisture

Do not use after the expiry date stated on the label

Return all unused medicine to your pharmacist

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).