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RITONAVIR 100 MG FILM-COATED TABLETS

Active substance(s): RITONAVIR / RITONAVIR

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Ritonavir

Market

UK-IE-MT

Language

English

Size

250 x 600 mm (PIL)

Min. Font Size

9

Version No.

2 (Page 1 of 2)

Date

01/12/16 (Ritonavir (ACC-UK-IE-MT)PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

Ritonavir 100 mg film-coated tablets
ritonavir

Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
- If you get any of the side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Ritonavir tablets is and what it is used for
2. What you need to know before you take Ritonavir tablets
3. How to take Ritonavir tablets
4. Possible side effects
5. How to store Ritonavir tablets
6. Contents of the pack and other information

1. What Ritonavir tablets is and what it is used for
Ritonavir tablets contains the active substance ritonavir. Ritonavir is a protease
inhibitor used to control HIV infection. Ritonavir is used in combination with other
anti-HIV medicines (antiretrovirals) to control your HIV infection.
Ritonavir tablets is used by children 2 years of age or older, adolescents and adults
who are infected with HIV, the virus which causes AIDS. Ritonavir tablets should
not be administered to children younger than 2 years of age unless specifically
directed by their doctor.
Ritonavir tablets can be used at full dose on its own, or at lower doses (called
booster doses) with other medicines. Your doctor will discuss with you the best
combination of medicines for you.

2. What you need to know before you take Ritonavir
tablets
Do not take Ritonavir tablets
- if you are allergic to ritonavir or any of the other ingredients of this medicine (listed
in 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 Other medicines and Ritonavir tablets);
- avanafil or vardenafil (used to treat erectile dysfunction);
- products containing St John’s wort (Hypericum perforatum) as this may stop
Ritonavir tablets 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 Ritonavir tablets but a full dose of Ritonavir tablets 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 Ritonavir tablets. Often, there are other
medicines you can take instead.
Also read the list of medicines in ‘Other medicines and Ritonavir tablets’ for use
with certain other medicines which require special care.
Warnings and precautions
Talk to your doctor before taking Ritonavir tablets.
Important information
- If Ritonavir tablets 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 Ritonavir tablets should be avoided. If you have any further
questions about Ritonavir tablets or the other medicines prescribed, please ask
your doctor or pharmacist.
- Ritonavir tablets is not a cure for HIV infection or AIDS.
- People taking Ritonavir tablets 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 Ritonavir tablets.
- You can still pass on HIV when taking this medicine, although the risk is lowered
by effective antiretroviral therapy. Discuss with your physician the precautions
needed to avoid infecting other people.
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
Ritonavir tablets 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
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, light-headedness, fainting spells or abnormal heartbeat. Some
patients taking Ritonavir tablets may experience 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.
Ritonavir tablets is not recommended in children below 2 years of age.
Other medicines and Ritonavir tablets
There are some medicines you cannot take at all with Ritonavir tablets. These are
listed earlier in section 2, under ‘Do not take Ritonavir tablets’. 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 Ritonavir tablets is taken as a full dose.
However, these warnings may also apply when Ritonavir tablets is used in lower
doses (a booster) with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any of the medicines listed below, as special care should be taken:
- Sildenafil or tadalafilfor 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 Ritonavir tablets
with sildenafil if you suffer from pulmonary arterial hypertension (see also ‘Before
you take Ritonavir tablets’). 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 Ritonavir tablets in order to avoid
heart problems.
- Hormonal contraceptives containing ethinyl oestradiol as Ritonavir tablets 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
Ritonavir tablets.
- Atorvastatin or rosuvastatin (for high cholesterol) as Ritonavir tablets may raise
the blood levels of these medicines. Talk to your doctor before you take any
cholesterol-reducing medicines with Ritonavir tablets (see also ‘Do not take
Ritonavir tablets’ above).
- Steroids (e.g. dexamethasone, fluticasone propionate, prednisolone) as Ritonavir
tablets 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 an increase of unwanted effects like
nausea, dizziness, low blood pressure and fainting can occur when taken with
Ritonavir tablets.
- Rifampicin and saquinavir (used for tuberculosis and HIV, respectively) as
serious liver damage can occur when taken with Ritonavir tablets.
- Bosentan (used for pulmonary arterial hypertension) as ritonavir may increase
the blood levels of this medicine.
There are medicines that may not mix with Ritonavir tablets 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 (e.g. erythromycin, clarithromycin);
- anticancer treatments (e.g. dasatinib, nilotinib, vincristine, vinblastine);
- anticoagulants (e.g. rivaroxaban, warfarin);
- antidepressants (e.g. amitriptyline, desipramine, fluoxetine, imipramine,
nortriptyline, paroxetine, sertraline, trazodone);
- antifungals (e.g. ketoconazole, itraconazole);
- antihistamines (e.g. loratadine, fexofenadine);
- antiretroviral medicines including HIV-protease inhibitors and Non-nucleoside
reverse transcriptase inhibitors (NNRTI);
- antiviral medicine used to treat chronic hepatitis C virus (HCV) infection in adults
(simeprevir);
- 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 (e.g. carbamazepine, divalproex, lamotrigine, phenytoin);
- heart medicines (e.g. digoxin, disopyramide, mexiletine and calcium channel
antagonists such as amlodipine, diltiazem and nifedipine);
- immune system (e.g. cyclosporine, tacrolimus, everolimus);
- morphine and morphine-like medicines used to treat severe pain (e.g. methadone,
fentanyl);
- sleeping pills (e.g. alprazolam, zolpidem) and also midazolam administered by
injection;
- tranquillisers (e.g. haloperidol, risperidone, thioridazine);
- colchicine, a treatment for gout
There are some medicines you cannot take at all with Ritonavir tablets. These are
listed earlier in section 2 under ‘Do not take Ritonavir tablets’.
Ritonavir tablets with food and drink
Ritonavir 100 mg film-coated tablets should be taken with food.
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
Ritonavir tablets) 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. Ritonavir tablets did not appear to increase the
chance of developing birth defects compared to the general population.
It is not known if Ritonavir tablets passes into breast milk. To avoid transmitting the
infection, mothers with HIV should not breast feed their babies.
Driving and using machines
Ritonavir tablets can cause sleepiness and dizziness. If you are affected do not
drive or use machinery.
Ritonavir tablets contains sodium
This medicine contains 0.362 mg sodium per tablet. To be taken into consideration
by patients on a controlled sodium diet.

600 mm

Package leaflet: Information for the patient




Dummy

250 mm

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Ritonavir

Market

UK-IE-MT

Language

English

Size

250 x 600 mm (PIL)

Min. Font Size

9

Version No.

2 (Page 2 of 2)

Date

01/12/16 (Ritonavir (ACC-UK-IE-MT)PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

Dummy

250 mm

Always take this medicine 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. Ritonavir tablets film-coated tablets should be taken with food as
this can affect the way in which Ritonavir tablets is absorbed into your body.
It is important that Ritonavir tablets tablets are swallowed whole and not chewed,
broken or crushed.

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).

Recommended doses of Ritonavir tablets are:

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.

• if Ritonavir tablets is used to boost the effects of certain other anti-HIV medicines
the typical dose for adults is 1 to 2 tablets once or twice daily. For more detailed
dose recommendations, including those for children, see the Package Leaflet of
the anti-HIV medicines Ritonavir tablets is given in combination with.

Cases of diabetes mellitus or increased blood sugars have been reported in
patients receiving ritonavir or other protease inhibitors.

• if your doctor prescribes a full dose, adults may be started on a dose of 3 tablets
in the morning and 3 tablets 12 hours later, gradually increasing over a period of
up to 14 days to the full dose of 6 tablets twice daily (totaling 1,200 mg per day).
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, Ritonavir tablets 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 Ritonavir tablets as directed, tell your doctor straight away. During
episodes of diarrhoea your doctor may decide that extra monitoring is needed.
Always keep enough Ritonavir tablets on hand so you don't run out. When you
travel or need to stay in the hospital, make sure you have enough Ritonavir tablets
to last until you can get a new supply.
If you take more Ritonavir tablets than you should
Numbness, tingling, or a “pins and needles” sensation may occur if you take too
much Ritonavir tablets. If you realise you have taken more Ritonavir tablets 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 Ritonavir tablets
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 Ritonavir tablets
Even if you feel better, do not stop taking Ritonavir tablets without talking to your
doctor. Taking Ritonavir tablets as recommended should give you the best chance
of delaying resistance to the medicines.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. Also, the side effects of ritonavir 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
common
uncommon
rare
very rare
not known

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data.

Very common side effects:
• upper and lower stomach ache
• vomiting
• diarrhoea (may be severe)
• feeling sick (nausea)
• flushing, feeling hot
• headache
• dizziness
• pain in the throat
• cough
• 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
• itching
• rash
• joint pain and back pain
Common side effects
• allergic reactions including skin rashes (may be red, raised, itchy), severe swelling
of the skin and other tissues
• changes in fat distribution (see Side effects associated with combination
antiretroviral therapy below)
• increase in cholesterol
• inability to sleep (insomnia)
• increase in triglycerides
• anxiety
• gout
• stomach bleeding
• inflammation of the liver and yellowing of the 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
• fever
• weight loss
• laboratory test results: changes in blood test results (such as blood chemistry and
blood count)
• confusion
• difficulty paying attention
• fainting
• 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
• acne
Uncommon side effects
• heart attack
• diabetes
• kidney failure
Rare side effects
• severe or life threatening skin reaction including blisters (Stevens Johnson
syndrome, toxic epidermal necrolysis)
• 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 Ritonavir tablets.

Abnormal liver function tests, hepatitis (inflammation of the liver), and rarely
jaundice, have been reported in patients taking ritonavir. 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 ritonavir 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. By reporting side effects you can help
provide more information on the safety of this medicine.
For United Kingdom- You can also report side effects
directly via Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard.
For Ireland- You can also report side effects directly
via
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie.
For Malta- You can also report side effects directly via
ADR Reporting, Website:
www.medicinesauthority.gov.mt/adrportal.

5. How to store Ritonavir tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton and bottle. The expiry
date refers to the last day of that month.
Once the bottle is opened, use within 4 months.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other information
What Ritonavir tablets contains
- The active substance is ritonavir. Each film-coated tablet contains 100 mg
ritonavir.
- The other tablet ingredients are: copovidone, sorbitan laurate (E493), silica
colloidal anhydrous (E551), Calcium Hydrogen Phosphate anhydrous, sodium
stearyl fumarate.
- The tablet coating is composed of: hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), hydroxypropyl cellulose (E463), talc (E553b), silica colloidal
anhydrous (E551), polysorbate 80 (E433).
What Ritonavir tablets looks like and contents of the pack
Ritonavir tablets 100 mg tablets are white to off white, capsule shaped, film-coated
tablets debossed with 'H' on one side and 'R9' on other side.
Ritonavir 100 mg film-coated tablets are available in white HDPE bottles with child
resistant polypropylene caps of 30 and 120 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
Manufacturer:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta
This leaflet was last revised in 12/2016

600 mm

3. How to take Ritonavir tablets

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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