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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: PLGB 41042/0031.
Norvir 100 mg Powder for Oral Suspension
Norvir 100 mg powder for oral suspension
ritonavir
1. What Norvir is and what it is used for
2. What you need to know before you or your child takes Norvir
3. How to take Norvir
4. Possible side effects
5. How to store Norvir
6. Contents of the pack and other information
Norvir contains the active substance ritonavir. Norvir is a protease inhibitor used to control HIV infection. Norvir is used in combination with other anti-HIV medicines (antiretrovirals) to control your HIV infection. Your doctor will discuss with you the best combination of medicines for you.
Norvir is used by children 2 years of age or older, adolescents and adults who are infected with HIV, the virus which causes AIDS.
* 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.
Also read the list of medicines under ‘Other medicines and Norvir’ for use with certain other medicines which require special care.
Talk to your doctor before taking Norvir.
Norvir is not recommended in children below 2 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. 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.
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 taken.
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:
There are some medicines you cannot take at all with Norvir. These are listed earlier in section 2, under ‘Do not take Norvir’.
See section 3.
If you are pregnant, think you may be pregnant or are planning to have a baby, it is very important that you ask your doctor for advice before taking this medicine.
There is a large amount of information on the use of ritonavir (the active ingredient in Norvir) during pregnancy. In general, 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.
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.
Norvir can cause dizziness. If you are affected do not drive or use machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take this medicine one or two times a day every day with food.
For doses of exactly 100 mg amounts (100, 200, 300, 400, 500, or 600 mg) pour the entire content of each sachet over soft food (apple sauce or vanilla pudding) or mix with a small amount of liquid (water, chocolate milk, or infant formula) and consume entire serving.
For doses less than 100 mg amounts or doses between 100 mg amounts, the content of the entire sachet is to be mixed with a liquid and then dosed by the appropriate ml volume as told to you by your doctor using the oral dosing syringe.
For administration using a feeding tube follow the instructions in section ‘How do I take the correct dose of Norvir powder for oral suspension mixed with liquid?’ Use water to mix the medicine and follow the feeding tube instructions to administer the medicine.
Recommended doses of Norvir are:
Your doctor will advise you on the dosage to be taken.
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 powder for oral suspension has a lingering aftertaste. Eating peanut butter, hazelnut chocolate spread, or black currant syrup immediately after taking the medication may help clear the aftertaste from your mouth.
Prepare only one dose at a time using the correct number of sachets. When mixing the powder with food or liquid, be sure to take the whole dose within 2 hours. Do not mix Norvir with anything else without talking to your doctor or pharmacist.
Follow the instructions below:
Step 1. Before mixing dose of Norvir, collect the following supplies: a cup, Norvir Sachet, Spoon and soft food like applesauce or vanilla pudding.
Step 2. Check prescription for number of sachets or call your doctor or pharmacist.
Step 3. Before first using the mixing cup, wash the cup in warm water and dish soap. Rinse and allow to air dry.
Step 4. Put a small serving of soft food (applesauce or vanilla pudding) in a cup.
Step 5. Tear open sachet.
Step 6. Pour ALL powder from sachet onto food.
Step 7. Mix thoroughly.
Step 8. Feed serving to patient.
Step 9. ENTIRE serving must be eaten. If powder residue is left, add more spoonfuls of food and serve to patient. Use within 2 hours.
Step 10. Place empty sachet in rubbish. Wash and dry preparation area. Immediately wash the spoon and cup in warm water and dish soap. Rinse and allow to air dry.
Follow the instructions below:
What you need
Before mixing a dose of Norvir, collect the following items: Drinking cup with drinking water, infant formula, or chocolate milk, 10 ml syringe, 100mg Norvir oral powder packets, mixing cup with lid.
You may need more than 1 sachet for each dose. Check the prescription label on the carton or call your doctor or pharmacist if you are not sure. If you do need more than 1 sachet, repeat all the steps with each sachet.
Using the syringe
Before first using the dosing syringe, wash the syringe in warm water and dish soap. Rinse and allow to air dry.
Reading the scale
a. Each millilitre (ml) is shown as a number with a big line.
b. Each 0.2 ml is shown as a smaller line between the numbers.
Check the syringe before each use
You will need to use a new syringe if:
Step 1. Fill the syringe
a. Push the plunger all the way into syringe.
b. Place the syringe tip into the liquid.
c. Slowly pull the plunger back to the 10 ml mark on the syringe.
Step 2. Move any bubbles to the tip of the syringe
a. Hold the syringe with the tip pointing up.
b. Tap the syringe with your other hand. This will move any bubbles to the tip.
c. Pull the plunger down. Be careful not to pull the plunger out.
d. Tap the syringe again. This will help to break up the bubbles and make sure they are all at the tip.
Step 3. Measure the liquid
a. Keep the syringe pointed up.
b. Slowly push the plunger up until the top of the plunger is at 9.4 ml - this will remove any bubbles from the syringe.
Step 4. Empty the syringe
a. Slowly push the plunger to empty the liquid from the syringe into the mixing cup.
Step 5. Pour the powder into the cup
a. Tear open the sachet.
b. Pour all of the powder into the mixing cup.
c. Check if the sachet is empty.
Be careful not to spill any powder outside of the mixing cup (see Figure 6).
Step 6. Mix the powder and liquid
a.Tightly screw on the lid and keep shaking the mixing cup hard for at least 90 seconds until all the lumps have gone.
b. Check for any lumps of powder. If there are still lumps, keep shaking until they have all gone.
c. The liquid may look cloudy - this is okay.
d. Let the liquid stand for 10 minutes and most of the bubbles will disappear.
e. You may see some small bubbles on top of the liquid - this is also okay.
Step 7. Fill the syringe
a. Push the plunger completely into the syringe.
b. Place the syringe tip at the bottom of the mixing cup.
c. Slowly pull the plunger back to the 10 ml mark - try not to pull any bubbles into the syringe.
Step 8. Remove any bubbles
a. Hold the syringe with the tip pointing up.
b. Tap the syringe with your other hand. This will move any bubbles to the tip.
c. Pull the plunger down. Be careful not to pull the plunger out.
d. Tap the syringe again to break up the bubbles, so they are all at the tip.
e. Slowly push the plunger until you see a small amount of liquid at the tip of the syringe.
f. If there are any large air bubbles, empty the liquid from the syringe into the mixing cup and start again from Step 7.
Step 9. Measure the dose
a. Check the prescription label on the carton for the dose in ml. If you are not sure, call your doctor or pharmacist.
b. Point the syringe into the mixing cup and slowly push the plunger to the correct ml for the dose.
c. If you push out too much liquid, start again from Step 7. Be careful not to spill the liquid outside of the mixing cup.
Step 10. Give the medicine to the patient
a. Place the syringe tip against the inside of the patient’s cheek.
b. Slowly push the plunger to give all of the dose.
c. Give the patient the full dose within 2 hours of opening the sachet.
Step 11. (If required)
If you need to use more than one sachet, repeat the process from the beginning.
Step 12. After you have finished
a. Place the empty sachet and any left over medicine from the mixing cup into a rubbish bag.
b. Remove the plunger from the syringe.
c. Hand wash the syringe, plunger, and mixing cup and lid in warm water and dish soap. Rinse with water and allow to air dry. Do not wash these in the dishwasher.
d. Wash and dry the area used to mix the medicine.
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 away.
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.
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.
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, 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.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
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. What you need to know before you or your child takes Norvir.
In patients with haemophilia types 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.
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 liver disease.
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 breathing difficulties.
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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children.
Do not use Norvir powder for oral suspension after the expiry date on the sachet and carton. The expiry date refers to the last day of the month.
Norvir powder for oral suspension should be stored below 30°C.
Do not use this medicine if you notice the powder is not beige/pale yellow to yellow.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Norvir powder for oral suspension comes in individual sachets containing 100 mg ritonavir. 30 sachets are packed in a carton together with 1 mixing cup and 2 oral dosing syringes.
Not all pack sizes may be marketed.
Norvir is also supplied as a film-coated tablet containing 100 mg ritonavir.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved in 11/2023