Norvir Oral Solution

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Norvir is and what it is used for
2. Before you take Norvir
3. How to take Norvir
4. Possible side effects
5. How to store Norvir
6. Further information

Do not take Norvir

• if you are allergic (hypersensitive) to ritonavir or any of the other ingredients of Norvir (see section 6).
• 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 without prescription);
  • amiodarone, bepridil, encainide, flecainide, propafenone, quinidine (used to correct irregular heartbeats);
  • dihydroergotamine, ergotamine (used to treat migraine headache);
  • ergonovine, methylergonovine (used to stop excessive bleeding that may occur following childbirth or an abortion);
  • 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

Important information

• 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 pharmacist.
• 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 properly.
• 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 defect.
• 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 taken.

• 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 hypertension.
• 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 problems.
• 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 this medicine.

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, sertraline, trazodone);
• antifungals (eg ketoconazole, itraconazole);
• antihistamines (eg loratidine, fexofenadine);
• antiretroviral medicines including HIV-protease inhibitors and Non-nucleoside reverse transcriptase inhibitors (NNRTI);
• 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.

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 solution

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 away.

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.

What Norvir contains

• The active substance is ritonavir. Each ml of Norvir contains 80 mg ritonavir.
• The other ingredients are alcohol, purified water, polyoxyl 35 castor oil, propylene glycol, saccharin sodium, anhydrous citric acid, peppermint oil, creamy caramel flavouring and sunset yellow E110.

What Norvir looks like and contents of the pack

Norvir oral solution comes in an amber bottle containing 90 ml of liquid.

Two pack sizes are available for Norvir oral solution:

• 1 bottle of 90 ml (90 ml) plus one 7.5 ml dosing syringe
• 5 bottles of 90 ml (450 ml) plus five 7.5ml dosing syringes.

Not all pack sizes may be marketed.

Norvir is also supplied as a film-coated tablet containing 100 mg of ritonavir.

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