DAPROHIN contains active substances called darunavir and ritonavir. DAPROHIN is an antiretroviral medicine. It belongs to a group called protease inhibitors. DAPROHIN 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. DAPROHIN 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.
1. What DAPROHIN is and what it is used for
2. What you need to know before you take DAPROHIN
Do not take DAPROHIN:
- if you are hypersensitive (allergic) to darunavir, ritonavir or any of the other ingredients of DAPROHIN (listed in section 6).
- if you have severe liver disease.
Do not take DAPROHIN 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 DAPROHIN:
- DAPROHIN must be taken together with food.
- DAPROHIN is not a cure for HIV infection.
- DAPROHIN 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 DAPROHIN 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.
3. How to take DAPROHIN
Do not share medicines prescribed for you with any other person. Always take DAPROHIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of DAPROHIN is two tablets once daily. You must take DAPROHIN every day and always in combination with food at approximately the same time of day. DAPROHIN cannot work properly without food. You must eat a meal or snack 30 minutes before you take your DAPROHIN. 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 DAPROHIN without talking to your doctor. Make sure that you always have enough DAPROHIN 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.
If you take more DAPROHIN 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 DAPROHIN
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.
4. Possible side effects
DAPROHIN can have side effects. Not all side effects reported for DAPROHIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DAPROHIN, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happens, stop taking DAPROHIN 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 DAPROHIN. 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
5. How to store DAPROHIN
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).