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LOPINAVIR / RITONAVIR ACCORD 200 MG/50 MG FILM-COATED TABLETS

Active substance(s): LOPINAVIR / RITONAVIR

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Package leaflet: Information for the user

Lopinavir/ Ritonavir 200 mg/50 mg
film-coated tablets
lopinavir/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, please 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 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 Lopinavir/ Ritonavir tablets is and what it is used for
2. What you need to know before you take Lopinavir/ Ritonavir tablets
3. How Lopinavir/ Ritonavir tablets is used
4. Possible side effects
5. How to store Lopinavir/ Ritonavir tablets
6. Contents of the pack and other information

1. What Lopinavir/ Ritonavir tablets is and what it is
used for

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− Your doctor has prescribed Lopinavir/ Ritonavir tablets to help to
control your Human Immunodeficiency Virus (HIV) infection.
Lopinavir/ Ritonavir tablets does this by slowing down the spread
of the infection in your body.
− Lopinavir/ Ritonavir tablets is used by children 2 years of age or
older and adults who are infected with HIV, the virus which causes
AIDS. Lopinavir/ Ritonavir tablets should not be administered to
children younger than 2 years of age unless specifically directed by
their doctor.
− Lopinavir/ Ritonavir tablets is an antiretroviral medicine. It belongs
to a group of medicines called protease inhibitors.
− Lopinavir/ Ritonavir tablets is prescribed for use in combination
with other antiviral medicines. Your doctor will discuss with you and
determine which medicines are best for you.

− Nausea, vomiting, abdominal pain as large increases in the amount
of triglycerides (fats in the blood) have been considered a risk factor
for pancreatitis (inflammation of the pancreas) and these symptoms
may suggest this condition.
− 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 other 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 at
this time.
− In some patients with advanced HIV infection and a history of
opportunistic infection, signs and symptoms of inflammation from
previous infections may occur soon after anti-HIV treatment is
started. It is believed that these symptoms are due to an
improvement in the body’s immune response, enabling the body to
fight infections that may have been present with no obvious
symptoms.
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 in movement as some patients taking these
medicines may develop a bone disease called osteonecrosis (death
of bone tissue caused by loss of blood supply to the bone). The
length of combination antiretroviral therapy, corticosteroid use,
alcohol consumption, severe immunosuppression (reduction in the
activity of the immune system), higher body mass index, among
others, may be some of the many risk factors for developing this
disease.
− Muscle pain, tenderness or weakness, particularly in combination
with these medicines. On rare occasions these muscle disorders
have been serious.
− Symptoms of dizziness, lightheadedness, fainting or sensation of
abnormal heartbeats. Lopinavir/ Ritonavir tablets may cause
changes in your heart rhythm and the electrical activity of your
heart. These changes may be seen on an ECG
(electrocardiogram).

Other medicines and Lopinavir/ Ritonavir tablets
Tell your doctor if you are taking any of the medicines listed
below, as special care should then be taken:
− Antibiotics (e.g. rifabutin, rifampicin, clarithromycin);
2. What you need to know before you take Lopinavir/ − Anticancer medicines (e.g. most tyrosine kinases inhibitors such as
dasatinib and nilotinib, also vincristine and vinblastine);
Ritonavir tablets
− Anticoagulants (e.g. warfarin, rivaroxaban);
− Antidepressants (e.g. trazodone, bupropion);
Do not take Lopinavir/ Ritonavir tablets:
− if you are allergic (hypersensitive) to lopinavir, ritonavir or any of the − Anti-epilepsy medicines (e.g. carbamazepine, phenytoin,
phenobarbital, lamotrigine and valproate);
other ingredients of Lopinavir/ Ritonavir tablets.

Antifungals
(e.g. ketoconazole, itraconazole, voriconazole);
− if you have severe liver problems
− Anti-gout medicines (e.g. colchicine);
Do not take Lopinavir/ Ritonavir tablets with any of the following − Anti-HCV medicine used to treat chronic hepatitis C in adults (e.g.
boceprevir and telaprevir);
medicines:

Erectile
dysfunction medicines (e.g. sildenafil and tadalafil);
− Astemizole or terfenadine (commonly used to treat allergy
− Fusidic acid used to treat long-term infections of the bones and
symptoms – these medicines may be available without
joints (e.g. osteomyelitis);
prescription);

Heart
medicines including:
− Midazolam taken orally (taken by mouth), triazolam (used to relieve

Digoxin;
anxiety and/or trouble sleeping);
− Calcium channel antagonists (e.g. felodipine, nifedipine,
− Pimozide (used to treat schizophrenia);
nicardipine);
− Quetiapine (used to treat schizophrenia, bipolar disorder and major

Medicines
used to correct heart rhythm (e.g. bepridil, systemic
depressive disorder);
lidocaine, quinidine);
− Cisapride (used to relieve certain stomach problems);

HIV
CCR5-antagonist (e.g. maraviroc);
− Ergotamine, dihydroergotamine, ergonovine, methylergonovine

HIV-1
integrase inhibitor (e.g. raltegravir);
(used to treat headaches);
− Medicines used to lower blood cholesterol (e.g. atorvastatin,
− Amiodarone (used to treat abnormal heart beat);
lovastatin, rosuvastatin or simvastatin);
− Lovastatin, simvastatin (used to lower blood cholesterol);

Medicines
use to treat asthma and other lung-related problems
− Alfuzosin (used in men to treat symptoms of an enlarged prostate
such
as
chronic
obstructive pulmonary disease (COPD) (e.g.
(benign prostatic hyperplasia (BPH));
salmeterol);
− Fusidic acid (used to treat skin infections caused by

Medicines
used to treat pulmonary arterial hypertension (high blood
Staphylococcus bacteria such as impetigo and infected dermatitis.
pressure
in
the pulmonary artery) (e.g. bosentan, sildenafil,
Fusidic acid used to treat long-term infections of the bones and
tadalafil);
joints may be taken under doctor’s supervision (see Other

Medicines
affecting the immune system (e.g. cyclosporin, sirolimus
medicines and Lopinavir/ Ritonavir tablets section);
(rapamycin),
tacrolimus);
− Colchicine (anti-gout medicine) – patients with renal or hepatic
− Medicines used for smoking cessation (e.g. bupropion);
impairment;
− Pain-relieving medicines (e.g. fentanyl);
− Avanafil or vardenafil (used to treat erectile dysfunction);
− Sildenafil used to treat pulmonary arterial hypertension (high blood − Morphine-like medicines (e.g. methadone);
− Non-nucleoside reverse transcriptase inhibitors (NNRTIs) (e.g.
pressure in the pulmonary artery). Sildenafil used to treat erectile
efavirenz, nevirapine);
dysfunction may be taken under doctor’s supervision (see Take

Oral
contraceptive or using a patch contraceptive to prevent
special care with Lopinavir/ Ritonavir tablets section);
pregnancy
(see section below titled Contraceptives);
− Products that contain St John’s wort (Hypericum perforatum).
− Protease inhibitors (e.g. amprenavir, fosamprenavir, indinavir,
nelfinavir, ritonavir, saquinavir, tipranavir);
Read the list of medicines under ‘Other medicines and Lopinavir/

Sedatives
(e.g. midazolam administered by injection);
Ritonavir tablets’ for information on certain other medicines which
− Steroids (e.g. budesonide, dexamethasone, fluticasone propionate,
require special care.
ethinyl oestradiol).
If you are currently taking any of these medicines, ask your doctor
about making necessary changes either in the treatment for your
other condition(s) or in your antiretroviral treatment.
Take special care with Lopinavir/ Ritonavir tablets
Important information
− Lopinavir/ Ritonavir tablets is not a cure for HIV infection or AIDS.
− People taking Lopinavir/ Ritonavir tablets may still develop
infections or other illnesses associated with HIV disease and AIDS.
It is therefore important that you remain under the supervision of
your doctor while taking Lopinavir/ 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:
− Haemophilia type A and B as Lopinavir/ Ritonavir tablets might
increase the risk of bleeding.
− Diabetes as increased blood sugars has been reported in patients
receiving lopinavir/ritonavir.
− A history of liver problems as patients with a history of liver
disease, including chronic hepatitis B or C are at increased risk of
severe and potentially fatal liver side effects.
Tell your doctor if you experience:
− Nausea, vomiting, abdominal pain, difficulty breathing and severe
weakness of the muscles in the legs and arms as these symptoms
may indicate raised lactic acid levels.
− Thirst, frequent urination, blurred vision or weight loss as this may
indicate raised sugar levels in the blood.

Read the list of medicines under ‘Do not take Lopinavir/
Ritonavir tablets with any of the following medicines’ for
information on medicines that you must not take with Lopinavir/
Ritonavir tablets.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without prescription.
Erectile dysfunction medicines (avanafil, vardenafil, sildenafil,
tadalafil)
− Do not take Lopinavir/ Ritonavir tablets if you are currently
taking avanafil or vardenafil.
− You must not take Lopinavir/ Ritonavir tablets with sildenafil used to
treat pulmonary arterial hypertension (high blood pressure in the
pulmonary artery) (see also Do not take Lopinavir/ Ritonavir
tablets section).
− If you take sildenafil or tadalafil and Lopinavir/ Ritonavir tablets
together, you may be at risk of side effects such as low blood
pressure, passing out, visual changes and penile erection lasting
more than 4 hours.
If an erection lasts longer than 4 hours, you should get medical help
immediately to avoid permanent damage to your penis. Your doctor
can explain these symptoms to you.




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different type of contraception (e.g. condom) as Lopinavir/ Ritonavir
tablets may reduce the effectiveness of oral and patch
contraceptives.
− Lopinavir/ Ritonavir tablets does not eliminate the risk of passing
HIV to others. Appropriate precautions (e.g. use of a condom)
should be taken to prevent passing on the disease through sexual
contact.
Pregnancy and breast-feeding
− Tell you doctor immediately if you are planning to have a baby,
you are pregnant, think you may be pregnant or if you are
breast-feeding.
− Breast-feeding mothers should not take Lopinavir/ Ritonavir tablets
unless specifically directed by the doctor.
− It is recommended that HIV-infected women do not breast-feed
their infants because there is a possibility that the baby can be
infected with HIV through your breast milk.
Driving and using machines
Lopinavir/ Ritonavir tablets has not specifically been tested for its
possible effects on the ability to drive a car or operate machines. Do
not drive a car or operate machinery if you experience any side
effects (e.g. nausea) that impact your ability to do so safely. Instead,
contact your doctor.

3. How Lopinavir/ Ritonavir tablets is used
How should Lopinavir/ Ritonavir tablets be taken?
It is important that Lopinavir/ Ritonavir tablets are swallowed whole
and not chewed, broken or crushed.
− Always take Lopinavir/ Ritonavir tablets exactly as your doctor has
told you.
− You should check with your doctor or pharmacist if you are not sure
how you should take your medicine.
How much Lopinavir/ Ritonavir tablets should be taken and
when?
Use in adults
− The usual adult dose is 400 mg/100 mg twice a day i.e. every 12
hours, in combination with other anti-HIV medicines. Adult patients
who have not previously taken other antiviral medicines can also
take Lopinavir/ Ritonavir tablets once daily as an 800 mg/200 mg
dose.
Your doctor will advise on the number of tablets to be taken. Adult
patients who have previously taken other antiviral medicines can
take Lopinavir/ Ritonavir tablets once daily as an 800 mg/200 mg
dose if their doctor decides it is appropriate.
− Lopinavir/ Ritonavir tablets must not be taken once daily with
amprenavir, efavirenz, nevirapine, nelfinavir, carbamazepine,
phenobarbital and phenytoin.
− Lopinavir/ Ritonavir tablets can be taken with or without food.
Use in children
− For children, your doctor will decide the right dose (number of
tablets) based on the child’s height and weight.
− Lopinavir/ Ritonavir tablets can be taken with or without food.
If you take more Lopinavir/ Ritonavir tablets than you should
− If you realise you have taken more Lopinavir/ Ritonavir tablets than
you were supposed to, contact you doctor right away.
− If you cannot contact your doctor, go to the hospital.
If you forget to take Lopinavir/ Ritonavir tablets
− If you miss a dose, take the missed dose as soon as possible, and
then continue with your normal dose on the regular schedule as
prescribed by your doctor.
− Do not take a double dose to make up for a forgotten dose.
If you stop taking Lopinavir/ Ritonavir tablets
− Do not stop or change the daily dose of Lopinavir/ Ritonavir tablets
without first consulting with your doctor.
− Lopinavir/ Ritonavir tablets should always be taken every day to
help control your HIV infection, no matter how much better you feel.
− Using Lopinavir/ Ritonavir tablets as recommended should give
you the best chance of delaying the development of resistance to
the product.
− If a side effect is preventing you from taking Lopinavir/ Ritonavir
tablets as directed tell your doctor right away.
− Always keep enough Lopinavir/ Ritonavir tablets on hand so you
don’t run out. When you travel or need to stay in the hospital make
sure you will have enough Lopinavir/ Ritonavir tablets to last until
you can get a new supply.
− Continue to take this medicine until your doctor tells you otherwise.

4. Possible side effects
Like all medicines, Lopinavir/ Ritonavir tablets can cause side effects,
although not everybody gets them. It may be difficult to tell which side
effects have been caused by Lopinavir/ Ritonavir tablets and which
may occur due to other medicines you take at the same time or by the
complications of the HIV infection.
You should tell your doctor promptly about these or any other
symptoms. If the condition persists or worsens, seek medical
attention.
VERY COMMON side effects (affects more than 1 user in 10):
− Diarrhoea;
− Nausea;
− Upper respiratory tract infection.

COMMON side effects (affects 1 to 10 users in 100):
− Inflammation of the pancreas;
− Vomiting, enlarged abdomen, pain in the lower and upper stomach
area, passing wind, indigestion, decreased appetite, reflux from
your stomach to your oesophagus which may cause pain;
− Swelling or inflammation of the stomach, intestines and colon;
− Increased cholesterol levels in your blood, increased triglycerides (a
form of fat) levels in your blood, high blood pressure;
− Decreased ability of the body to handle sugar including diabetes
mellitus, weight loss;
− Low number of red blood cells, low number of white blood cells
which are usually used to fight infection;
Contraceptives
− Rash, eczema, accumulation of scales of greasy skin;
− Dizziness, anxiety, difficulty in sleeping;
− If you are currently using an oral contraceptive or using a patch
− Feeling tired, lack of strength and energy, headache including
contraceptive to prevent pregnancy, you should use an additional or
migraine;












Haemorrhoids;
Inflammation of the liver including increased liver enzymes;
Allergic reactions including hives and inflammation in the mouth;
Changes in body shape or face shape due to changes in fat
distribution;
Lower respiratory tract infection;
Enlargement of the lymph nodes;
Impotence, abnormally heavy or extended menstrual flow or a lack
of menstruation;
Muscle disorders such as weakness and spasms, pain in the joints,
muscles and back;
Damage to nerves of the peripheral nervous system;
Night sweats, itching, rash including raised bumps on the skin,
infection of the skin, inflammation of skin or hair pores,
accumulation of fluid in the cells or tissues.

Further information about nausea, vomiting or abdominal pain
Tell your doctor if you experience nausea, vomiting or abdominal pain
as these may be suggestive of pancreatitis (inflammation of the
pancreas).
Further information about increased cholesterol and
triglycerides
− The long-term risks for complications such as heart attacks or
stroke due to increased triglycerides and cholesterol are not known
at this time.
− Your doctor will monitor you and may prescribe other medicines if
needed.
− Large increases in the amount of triglycerides (fats in the blood)
have been considered a risk factor for pancreatitis (inflammation of
the pancreas).
Changes in body shape due to changes in fat distribution
Combination antiretroviral therapy, which may include Lopinavir/
Ritonavir tablets , 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 other 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 at this time.
Tell your doctor if you notice any changes in your body shape due to
changes in fat distribution.
UNCOMMON side effects (affects 1 to 10 users in 1,000):
− Abnormal dreams;
− Loss or changed sense of taste;
− Hair loss;
− An abnormality in your electrocardiogram called atrioventricular
block;
− Plaque building up inside your arteries which could lead to heart
attack and stroke;
− Inflammation of blood vessels and capillaries;
− Inflammation of the bile duct;
− Uncontrolled shaking of the body;
− Constipation;
− Deep vein inflammation related to a blood clot;
− Dry mouth;
− Inability to control your bowels;
− Inflammation of the first section of the small intestine just after the
stomach, wound or ulcer in the digestive tract, bleeding from the
intestinal tract or rectum;
− Red blood cells in the urine;
− Fatty deposits in the liver, enlarged liver;
− Lack of functioning of the testes;
− A flare-up of symptoms related to an inactive infection in your body
(immune reactivation);
− Increased appetite;
− Abnormally high level of bilirubin (a pigment produced from the
breakdown of red blood cells) in the blood
− Decreased sexual desire;
− Inflammation of the kidney;
− Bone death caused by poor blood supply to the area;
− Mouth sores or ulcerations, inflammation of the stomach and
intestine;
− Kidney failure;
− Breakdown of muscle fibers resulting in the release of muscle fiber
contents (myoglobin) into the bloodstream;
− A sound in one ear or both ears, such as buzzing, ringing or
whistling;
− Tremor;
− Abnormal closure of one of the valves (tricuspid valve in your
heart);
− Vertigo (spinning feeling);
− Eye disorder, abnormal vision;
− Weight gain.
Other side effects that have been reported with lopinavir/ritonavir :
yellowing of the skin or whites of eyes (jaundice), severe or life
threatening skin rashes and blisters (Stevens-Johnson syndrome and
erythema multiforme). It is not known how frequently these effects
may occur.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please inform your doctor or pharmacist.
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. You can
also report side effects directly via the national reporting system (see
contact details below). By reporting side effects you can help provide
more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt//adrportal

5. How to store Lopinavir/ Ritonavir tablets
− Keep this medicine out of the sight and reach of children.
− Do not use Lopinavir/ Ritonavir tablets after the expiry date which
is stated on the pack.
− This medicinal product does not require any special storage
conditions.
How should I dispose of any unused Lopinavir/ Ritonavir tablets ?

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− Medicines should not be disposed of via wastewater or household
waste.
− Ask your pharmacist how to dispose of medicines not longer
required.
These measures will help protect the environment.

6. Contents of the pack and other information
What Lopinavir/ Ritonavir tablets contains
The active substances are lopinavir and ritonavir.
Each tablet of Lopinavir/ Ritonavir tablets contains 200 mg of
lopinavir and 50 mg of ritonavir.
The other ingredients are:
Tablet: Copovidone, sorbitan laurate, colloidal anhydrous silica,
sodium stearyl fumarate.
Tablet coating: Hypromellose (E464), titanium dioxide (E171),
macrogol (polyethylene glycol 400), hydroxypropyl cellulose (E463),
talc (E553b), colloidal anhydrous silica (E551), macrogol
(polyethylene glycol 3350), yellow ferric oxide (E172), polysorbate 80
(E433).
What Lopinavir/ Ritonavir tablets looks like and contents of the
pack
Lopinavir/ Ritonavir tablets are yellow, oval, biconvex, film-coated
tablets, debossed with “H” on one side and “L3” on other side.
Lopinavir/ Ritonavir film-coated tablets are supplied in packs of 120
tablets (1 plastic bottle of 120 tablets) and 360 tablets (3 plastic
bottles of 120 tablets). Blister multipacks containing 60 and 120
tablets (1 pack of 120 tablets or 3 packs of 40 tablets) are also
available.
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

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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 01/2017

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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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