2. BEFORE YOU TAKE NORVIR
Do not take Norvir
- if you are allergic (hypersensitive) to ritonavir or any of the other ingredients of Norvir (see
- if you have severe liver disease.
- if you are currently taking any of the following medicines:
- astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available
- amiodarone, bepridil, encainide, flecainide, propafenone, quinidine (used to correct irregular
- dihydroergotamine, ergotamine (used to treat migraine headache);
- ergonovine, methylergonovine (used to stop excessive bleeding that may occur following childbirth or an
- clorazepate, diazepam, estazolam, flurazepam, triazolam or oral (taken by mouth) midazolam (used to
help you sleep and/or relieve anxiety);
- clozapine, pimozide, (used to treat abnormal thoughts or feelings);
- pethidine, piroxicam, propoxyphene (used to relieve pain);
- cisapride (used to relieve certain stomach problems);
- rifabutin (used to prevent/treat certain infections)*;
- voriconazole (used to treat fungal infections)*;
- simvastatin, lovastatin (used to lower blood cholesterol);
- alfuzosin (used to treat enlarged prostate gland);
- fusidic acid (used to treat bacterial infections);
- sildenafil if you suffer from a lung disease called pulmonary arterial hypertension that makes
breathing difficult. Patients without this disease may
use sildenafil for impotence (erectile dysfunction) under their doctor’s supervision (see the section on
Taking other medicines);
- products containing St John’s wort (Hypericum perforatum) as this may stop Norvir from working
properly. St John’s wort is often used in herbal
medicines that you can buy yourself.
* Your doctor may decide that you can take rifabutin and/or voriconazole with a booster (lower dose) of Norvir
but a full dose of Norvir must not be taken
together with these two medicines.
If you are currently taking any of these medicines, ask your doctor about switching to a different medicine
while you are taking Norvir. Often, there are
other medicines you can take instead.
Also read the list of medicines under ‘Taking other medicines’ for use with certain other medicines which
require special care.
Take special care with Norvir
- If Norvir is taken in combination with other antiretroviral medicines, it is important that you also
carefully read the leaflets that are provided with
these other medicines. There may be additional information in those leaflets about situations when Norvir should
be avoided. If you have any further
questions about Norvir (ritonavir) or the other medicines prescribed, please ask your doctor or
- Norvir is not a cure for HIV infection or AIDS.
- People taking Norvir may still develop infections or other illnesses associated with HIV infection or
AIDS. It is therefore important that you remain
under the supervision of your doctor while taking Norvir.
- Norvir does not lower the risk of passing HIV to others. Appropriate precautions should be taken
to prevent passing the disease through sexual contact (e.g. use of a condom) or blood contamination (you should
not give blood or share needles).
Tell your doctor if you have/had:
- A history of liver disease.
Hepatitis B or C and are being treated with a combination of antiretroviral agents, as you are
at a greater risk of a severe and potentially life threatening reaction
because of the effect on the liver. Regular blood tests may be required to check your liver is working
Haemophilia, as there have been reports of increased bleeding in patients with haemophilia who
are taking this type of medicine (protease inhibitors). The reason
for this is not known. You may need additional medicine to help your blood clot (factor VIII), in order to
control any bleeding.
Erectile dysfunction, as the medicines used to treat erectile dysfunction can cause hypotension
and prolonged erection.
Diabetes, as there have been reports of worsening of or the development of diabetes (diabetes
mellitus) in some patients taking protease inhibitors.
Kidney (renal) disease, since your doctor may need to check the dose of your other medicines
(such as protease inhibitors).
Tell your doctor if you experience:
Changes in the distribution of the fat on your body, or a build up or loss of body fat (see
section 4. Possible side effects).
Diarrhoea or vomiting that is not improving (persistent), as this may reduce how well the
medicines you are taking work.
Feeling sick (nausea), vomiting or have stomach pain, because these may be signs
of inflammation of the pancreas (pancreatitis).
Some patients taking Norvir can develop serious problems with their pancreas. Tell your doctor as soon as
possible if this applies to you.
Symptoms of infection – inform your doctor immediately. Some patients with advanced HIV
infection (AIDS) who then start anti-HIV treatment may develop the symptoms of
infections they have had in the past even if they didn’t know they had them. It is believed that this happens
because the body’s immune response
improves and helps the body to fight these infections. In addition to the opportunistic infections, autoimmune
disorders (a condition that occurs when
the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment
of your HIV infection. Autoimmune
disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other
symptoms such as muscle weakness,
weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or
hyperactivity, please inform your doctor
immediately to seek necessary treatment.
Joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty
moving, tell your doctor, as this may be a sign of a problem that can destroy bone
(osteonecrosis). Some patients taking a number of antiretroviral medicines may develop this disease.
Muscle pain, tenderness or weakness, particularly in combination with antiretroviral therapy
including protease inhibitors and nucleoside analogues. On rare occasions these muscle
disorders have been serious. (See section 4 Possible side effects)
Dizziness, lightheadedness, fainting spells or abnormal heartbeat. Some patients taking Norvir
may experiences changes in the electrocardiogram (ECG) Tell your doctor if you have a heart defect or conduction
- if you have any other health concerns, discuss these with your doctor as soon as you can.
Norvir is not recommended in children below 2 years of age.
Taking other medicines
There are some medicines you cannot take at all with Norvir. These are listed earlier in Section 2, under ‘Do
not take Norvir’. There are some other
medicines that can only be used under certain circumstances as described below. Please tell your doctor or
pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription.
The following warnings apply when Norvir is taken as a full dose. However, these warnings may also apply when
Norvir is used in lower doses (a booster)
with other medicines.
Tell your doctor if you are taking any of the medicines listed below, as special care should be
Sildenafil, tadalafil, vardenafil for impotence (erectile dysfunction). The dose and/or
frequency of use of these medicines may need to be reduced to avoid hypotension and prolonged
erection. You must not take Norvir with sildenafil if you suffer from pulmonary arterial hypertension (see also
section 2. Before you take Norvir). Tell your doctor if you are taking tadalafil for pulmonary arterial
Digoxin (heart medicine). Your doctor may need to adjust the dose of digoxin and monitor you
while you are taking digoxin and Norvir in order to avoid heart
Hormonal contraceptives containing ethinyl oestradiol as Norvir may reduce the effectiveness of
these medicines. It is recommended that a condom or other non-hormonal method
of contraception is used instead. You may also notice irregular uterine bleeding if you are taking this type of
hormonal contraceptive with Norvir.
Atorvastatin or rosuvastatin (for high cholesterol) as Norvir may raise the blood levels of
these medicines. Talk to your doctor before you take any cholesterol-reducing medicines
with Norvir (see also ‘Do not take Norvir’ above).
Steroids (eg dexamethasone, fluticasone propionate, prednisolone) as Norvir may raise the blood
levels of these medicines which may lead to Cushing’s syndrome
(development of a rounded face) and reduce production of the hormone cortisol. Your doctor may wish to reduce the
steroid dose or monitor your side
effects more closely.
Trazodone (a medicine for depression) as, unwanted effects like nausea, dizziness, low blood
pressure and fainting can occur when taken with Norvir.
Rifampicin and saquinavir (used for tuberculosis and HIV, respectively) as serious liver damage
can occur when taken with Norvir.
Bosentan (used for pulmonary arterial hypertension) as Norvir may increase the blood levels of
There are medicines that may not mix with Norvir because their effects could increase or decrease when taken
together. In some cases your doctor may need
to perform certain tests, change the dose or monitor you regularly. This is why you should tell your doctor if
you are taking any medicines, including
those you have bought yourself or herbal products, but it is especially important to mention these:
- amphetamine or amphetamine derivatives;
- antibiotics (eg erythromycin, clarithromycin);
- anticancer treatments (eg dasatinib, nilotinib, vincristine, vinblastine);
- anticoagulants (eg rivaroxaban, warfarin);
- antidepressants (eg amitriptyline, desipramine, fluoxetine, imipramine, nortriptyline, paroxetine,
- antifungals (eg ketoconazole, itraconazole);
- antihistamines (eg loratidine, fexofenadine);
- antiretroviral medicines including HIV-protease inhibitors and Non-nucleoside reverse transcriptase
- anxiety medicine, buspirone;
- asthma medicine, theophylline, salmeterol;
- atovaquone, a medicine used to treat a certain type of pneumonia and malaria;
- buprenorphine, a medicine used for the treatment of chronic pain;
- bupropion, a medicine used to help you stop smoking;
- epilepsy medicines (eg carbamazepine, divalproex, lamotrigine, phenytoin);
- heart medicines (eg digoxin, disopyramide, mexiletine and calcium channel antagonists such as
amlodipine, diltiazem and nifedipine);
- immune system (eg cyclosporine, tacrolimus, everolimus);
- morphine and morphine-like medicines used to treat severe pain (eg methadone, fentanyl);
- sleeping pills (eg alprazolam, zolpidem) and also midazolam administered by injection;
- tranquillisers (eg haloperidol, risperidone, thioridazine);
- colchicine, a treatment for gout.
Norvir should not be used with disulfiram (a medicine used to treat alcoholism) and metronidazole (a medicine
used for certain bacterial infections) as
they can interact with the alcohol contained in the oral solution.
There are some medicines you cannot take at all with Norvir. These are listed earlier in section 2, under ‘Do
not take Norvir’.
Taking Norvir with food and drink
Norvir should preferably be taken with food. The bitter taste of Norvir oral solution may be better if it is
mixed with chocolate milk. Do not mix with
water. Eating salty food or drinking fluids before or after taking Norvir oral solution can help clear the
aftertaste from your mouth.
Pregnancy and breast-feeding
If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss
this with your doctor.
There is very little information on the use of ritonavir (the active ingredient in Norvir) during pregnancy.
In general, the pregnant mothers received
ritonavir after the first three months of pregnancy at a lower dose (booster) along with other protease
inhibitors. Norvir did not appear to increase the
chance of developing birth defects compared to the general population.
It is not known if Norvir passes into breast milk. To avoid transmitting the infection, mothers with HIV
should not breast feed their babies.
Driving and using machines
Norvir can cause sleepiness and dizziness. If you are affected do not drive or use machinery.
Important information about some of the ingredients of Norvir
Norvir contains 43% v/v alcohol and 26.0% v/v propylene glycol. Each 1 ml of Norvir oral solution contains
344.0 mg of alcohol and 265.7 mg of propylene
glycol. Alcohol and propylene glycol are potentially harmful for those suffering from liver disease, alcoholism,
epilepsy, brain injury or disease as well
as for pregnant women and children. they may modify or increase the effect of other medicines.
Norvir contains polyoxyl 35 castor oil which may cause stomach upset and diarrhoea.
Norvir contains the colouring agent sunset yellow (E110) which may cause allergic reactions.
3. HOW TO TAKE NORVIR
Always take Norvir exactly as your doctor has told you. You should check with your doctor or pharmacist if you
are not sure. It is taken by mouth usually
two times every day. Norvir should preferably be taken with food.
Shake the bottle well before each use. If, after shaking, particles or solids can be seen in the solution,
take the next dose and see your doctor or
pharmacist about a fresh supply.
Recommended doses of Norvir are:
- if Norvir is used to boost the effects of other anti-HIV medicines, the typical dose for adults is 1.25
to 2.5 ml once or twice daily. For more
detailed dose recommendations, including those for children, see the Package Leaflet of the anti-HIV medicines
Norvir is given in combination with.
- if your doctor prescribes a full dose, adults may be started on a dose of 3.75 ml in the morning and
3.75 ml 12 hours later, gradually increasing over
a period of up to 14 days to the full dose of 7.5 ml twice daily. Children (2 – 12 years of age) will start with
a dose smaller than this and continue
up to the maximum allowed for their size.
Your doctor will advise you on the dosage to be taken.
Like all anti-HIV medicines, Norvir should be taken every day to help control your HIV, no matter how much
better you feel. If a side effect is preventing
you from taking Norvir, tell your doctor straight away. During episodes of diarrhoea your doctor may decide that
extra monitoring is needed.
Always keep enough Norvir on hand so you don’t run out. When you travel or need to stay in the hospital, make
sure you have enough Norvir to last until you
can get a new supply.
Norvir oral solution has a lingering aftertaste. You can take it alone or mix it with chocolate milk to
improve the taste. Mix only one dose at a time, and
be sure to take the whole dose right away. Do not mix Norvir with anything else without talking to your
doctor or pharmacist. Do not mix with water. Eating salty foods or drinking fluids before or after taking
Norvir oral solution may help clear the aftertaste
from your mouth.
How do I measure the correct dose of the solution?
Open the childproof cap by pushing down on it with your palm and twisting it anti-clockwise, or in the
direction of the arrow. Talk to your pharmacist if
you have difficulty opening the bottle.
1 dosing syringe is included in the 1 bottle carton of Norvir oral solution and 5 dosing syringes are included
in the 5 bottle carton of Norvir oral
Ask your pharmacist for instructions on how to use the syringe correctly.
After each dose of Norvir, separate the plunger and the syringe. Wash the plunger and the syringe with dish
soap and warm water as soon as you can; you may
soak both in the soapy water for up to 15 minutes. Rinse the syringe and plunger with clean water. Put the
syringe back together and draw up and expel tap
water a few times to rinse. Let the syringe dry completely before you use that syringe for dosing.
If you take more Norvir than you should
Numbness, tingling, or a “pins and needles” sensation may occur if you take too much Norvir. If you realise
you have taken more Norvir than you were
supposed to, contact your doctor or the Accident and Emergency Department of your nearest hospital straight
If you forget to take Norvir
If you miss a dose, take the missed dose as soon as possible. If it is nearly time for the next dose, just
take that one. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Norvir
Even if you feel better, do not stop taking Norvir without talking to your doctor. Taking Norvir as
recommended should give you the best chance of delaying
resistance to the medicines.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Norvir can cause side effects, although not everybody gets them. Also, the side effects of
Norvir when used with other antiretroviral
medicines are dependent on the other medicines. So it is important that you carefully read the side effects
section of the leaflets that are provided with
these other medicines.
The frequency of possible side effects listed below is defined using the following convention:
very common affects more than 1 user in 10
common affects 1 to 10 users in 100
uncommon affects 1 to 10 users in 1,000
rare affects 1 to 10 users in 10,000
very rare affects less than 1 user in 10,000
not known frequency cannot be estimated from the available data
Very common side effects:
- upper and lower stomach ache
- diarrhoea (may be severe)
- feeling sick (nausea)
- flushing, feeling hot
- pain in the throat
- upset stomach or indigestion
- a tingling sensation or numbness in the hands, feet or around the lips and mouth
- feeling weak/tired
- bad taste in the mouth
- damage to the nerves that can cause weakness and pain
- joint pain and back pain
Common side effects :
- allergic reactions including skin rashes (may be red, raised, itchy), severe swelling of the skin and
- changes in fat distribution (see Side effects associated with combination antiretroviral therapy
- inability to sleep (insomnia)
- increase in cholesterol
- increase in triglycerides
- stomach bleeding
- inflammation of the liver and yellowing of skin or whites of the eyes
- increase in urination
- reduced kidney function
- seizures (fits)
- low levels of blood platelets
- thirst (dehydration)
- abnormally heavy periods
- wind (flatulence)
- loss of appetite
- mouth ulcer
- muscle aches (pain), tenderness or weakness
- weight loss
- laboratory test results: changes in blood test results (such as blood chemistry and blood
- difficulty paying attention
- blurred vision
- swelling of the hands and feet
- high blood pressure
- low blood pressure and feeling faint when getting up
- coldness in the hands and feet
Uncommon side effects:
- heart attack
- kidney failure
Rare side effects:
- severe or life threatening skin reaction including blisters (Stevens Johnson syndrome, toxic epidermal
- serious allergic reaction (anaphylaxis)
- high levels of sugar in the blood
Tell your doctor if you feel sick (nauseous), are vomiting, or have stomach pain, because these may be signs
of an inflamed pancreas. Also tell your doctor
if you experience joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty
moving, as this may be a sign of
osteonecrosis. See also section 2 Before you take Norvir.
Side effects associated with combination antiretroviral therapy may cause changes in body shape due to
changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen
(belly) and internal organs, breast enlargement and fatty lumps on the back of the neck (“buffalo hump”). The
cause and long term health effects of these
conditions are not known. Combination antiretroviral therapy may also cause raised lactic acid and sugar in the
blood, increased fats in the blood and
resistance to insulin (insulin will not work as effectively).
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this
treatment or another protease inhibitor. Should
this happen to you, seek immediate advice from your doctor.
Cases of diabetes mellitus or increased blood sugars have been reported in patients receiving Norvir or other
Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely jaundice, have been reported
in patients taking Norvir. Some people had
other illnesses or were taking other medicines. People with liver disease or hepatitis may have worsening of
There have been reports of muscle pain, tenderness or weakness, particularly when taking medicines to lower
cholesterol in combination with antiretroviral
therapy, including protease inhibitors and nucleoside analogues. On rare occasions these muscle disorders have
been serious (rhabdomyolysis). In the event
of unexplained or continual muscle pain, tenderness, weakness or cramps, stop taking the medicine, contact your
doctor as soon as possible or go to the
Accident and Emergency Department of your nearest hospital.
Inform your doctor as soon as possible if you experience any symptoms that suggest an allergic reaction after
taking Norvir such as rash, hives or
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
contact your doctor, pharmacist, Accident and
Emergency department or if it is urgent get immediate medical help.
5. HOW TO STORE NORVIR
Keep out of the reach and sight of children.
Do not use Norvir oral solution after the expiry date on the bottle. The expiry date refers to the last day of
Bottles of Norvir oral solution should be stored below 25°C. Do not store Norvir oral solution in the
refrigerator, or in extreme heat or cold (such as in
a car during hot or very cold weather, or in your freezer).
It is important to keep Norvir in the bottle it came in. Don’t transfer it to any other container.
This leaflet was last approved in 01/2013.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: