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ABACAVIR/LAMIVUDINE PHAROS 600 MG/300 MG FILM-COATED TABLETS

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The final size is 314 X 400
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Package leaflet: Information for the user

Pregnancy
Abacavir/Lamivudine PharOS is not recommended for use during pregnancy. Abacavir/Lamivudine PharOS and
similar medicines may cause side effects in unborn babies. If you become pregnant while you are taking Abacavir/
Lamivudine PharOS, your baby may be given extra check-ups (including blood tests) to make sure it is developing
normally.

Abacavir/Lamivudine PharOS 600 mg/300 mg film-coated tablets
abacavir/lamivudine

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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

IMPORTANT — Hypersensitivity reactions

If you are pregnant, if you become pregnant, or if you are planning to become pregnant:
Talk to your doctor immediately about the risks and benefits of taking Abacavir/Lamivudine PharOS, or other medicines
for treating HIV infection, during your pregnancy.
Breast-feeding
Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
A small amount of the ingredients in Abacavir/Lamivudine PharOS can also pass into your breast milk.
If you are breast-feeding, or thinking about breast-feeding:
Talk to your doctor immediately.

Abacavir/Lamivudine PharOS contains abacavir (which is also an active substance in other related medicines).
Some people who take abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which can be lifethreatening if they continue to take abacavir containing products.
You must carefully read all the information under ‘Hypersensitivity reactions’ in the panel in Section 4.

Driving and using machines
Abacavir/Lamivudine PharOS may cause side effects which could affect your ability to drive or use machines.
Talk to your doctor about your ability to drive or operate machines while taking Abacavir/Lamivudine PharOS.
Important information about some of the other ingredients of Abacavir/Lamivudine PharOS tablets
Abacavir/Lamivudine PharOS contains a colouring called sunset yellow Aluminium Lake (E110), this may cause allergic
reactions in some people.

The Abacavir/Lamivudine PharOS pack includes an Alert Card, to remind you and medical staff about abacavir
hypersensitivity. Detach this card and keep it with you at all times.

What is in this leaflet
1. What Abacavir/Lamivudine PharOS is and what it is used for
2. What you need to know before you take Abacavir/Lamivudine PharOS
3. How to take Abacavir/Lamivudine PharOS
4. Possible side effects
5. How to store Abacavir/Lamivudine PharOS
6. Contents of the pack and other information

3. How to take Abacavir/Lamivudine PharOS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose of Abacavir/Lamivudine PharOS for adults, adolescents and children weighing 25 kg or
more is one tablet once a day.

1. What Abacavir/Lamivudine PharOS is and what it is used for

Swallow the tablets whole, with some water. Abacavir/Lamivudine PharOS can be taken with or without food.

Abacavir/Lamivudine PharOS is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents
and in children weighing at least 25 kg.

Stay in regular contact with your doctor
Abacavir/Lamivudine PharOS helps to control your condition. You need to keep taking it every day to stop your illness
getting worse. You may still develop other infections and illnesses linked to HIV infection.
Keep in touch with your doctor, and do not stop taking Abacavir/Lamivudine PharOS without your doctor’s advice.

Do not take Abacavir/Lamivudine PharOS:
• if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir), lamivudine or any of the
other ingredients of this medicine (listed in section 6).
Carefully read all the information about hypersensitivity reactions in Section 4.
• if you have severe liver disease
Check with your doctor if you think any of these apply to you. Do not take Abacavir/Lamivudine PharOS.
Take special care with Abacavir/Lamivudine PharOS
Some people taking Abacavir/Lamivudine PharOS or other combination treatments for HIV are more at risk of serious
side effects. You need to be aware of the extra risks:
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Abacavir/
Lamivudine PharOS without your doctor’s advice, as your hepatitis may come back)
• if you are seriously overweight (especially if you are a woman)
• if you are diabetic and using insulin
• if you have a kidney problem
Talk to your doctor if any of these apply to you before using Abacavir/Lamivudine PharOS. You may need extra
check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.

If you take more Abacavir/Lamivudine PharOS than you should
If you accidentally take too much Abacavir/Lamivudine PharOS, tell your doctor or your pharmacist, or contact your
nearest hospital emergency department for further advice.
If you forget to take Abacavir/Lamivudine PharOS
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double
dose to make up for a forgotten dose.
It is important to take Abacavir/Lamivudine PharOS regularly, because if you take it at irregular intervals, you may be
more likely to have a hypersensitivity reaction.
If you have stopped taking Abacavir/Lamivudine PharOS
If you have stopped taking Abacavir/Lamivudine PharOS for any reason — especially because you think you are having
side effects, or because you have other illness:
Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a
hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take Abacavir/
Lamivudine PharOS, or any other medicine containing abacavir. It is important that you follow this advice.
If your doctor advises that you can start taking Abacavir/Lamivudine PharOS again, you may be asked to take your first
doses in a place where you will have ready access to medical care if you need it.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Abacavir hypersensitivity reactions
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic
reaction).

When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Abacavir/Lamivudine
PharOS or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your
doctor about any changes in your health.

Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.

Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic
reaction), described in this leaflet in the panel headed ‘Hypersensitivity reactions’.

Risk of heart attack
It cannot be excluded that abacavir may increase the risk of having a heart attack.
Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart
disease such as high blood pressure, or diabetes. Do not stop taking Abacavir/Lamivudine PharOS unless your doctor
advises you to do so.
Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about
important signs and symptoms to look out for while you are taking Abacavir/Lamivudine PharOS.
Read the information ‘Other possible side effects of combination therapy for HIV’ in Section 4 of this leaflet.
Protect other people
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for
example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered
by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
Other medicines and Abacavir/Lamivudine PharOS
Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including
herbal medicines or other medicines you bought without a prescription.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Abacavir/Lamivudine
PharOS.
These medicines should not be used with Abacavir/Lamivudine PharOS:
• Emtricitabine, to treat HIV infection
• other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B infection
• high doses of trimethoprim/sulfamethoxazole, an antibiotic
• cladribine, used to treat hairy cell leukaemia
Tell your doctor if you are being treated with any of these.
Some medicines interact with Abacavir/Lamivudine PharOS
These include:
• phenytoin, for treating epilepsy.
Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir/
Lamivudine PharOS.
• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is removed from the body.
If you are taking methadone, you will be checked for any withdrawal symptoms. Your methadone dose may need to be
changed.
Tell your doctor if you are taking methadone.
• ribavirin, for treating hepatitis C. Abacavir may make the combination of ribavirin and pegylated interferon less
effective at reducing levels of hepatitis C virus in the body.
Tell your doctor if you are taking ribavirin.

It is very important that you read and understand the information about this serious reaction.
As well as the side effects listed below for Abacavir/Lamivudine PharOS, other conditions can develop during
combination therapy for HIV.
It is important to read the information later in this section under ‘Other possible side effects of combination therapy for
HIV’.
Hypersensitivity reactions
Abacavir/Lamivudine PharOS contains abacavir (which is also an active substance in other related medicines).
Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions
have been seen more frequently in people taking medicines that contain abacavir.
Who gets these reactions?
Anyone taking Abacavir/Lamivudine PharOS could develop a hypersensitivity reaction to abacavir, which could be
life threatening if they continue to take Abacavir/Lamivudine PharOS.
You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction
even if you do not have this gene). You should have been tested for this gene before Abacavir/Lamivudine PharOS
was prescribed for you. If you know you have this gene, tell your doctor before you take Abacavir/Lamivudine
PharOS.
About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLA-B*5701 gene
developed a hypersensitivity reaction.
What are the symptoms?
The most common symptoms are:
- fever (high temperature) and skin rash.
Other common symptoms are:
- nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Other symptoms include:
Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches,
inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.
If you continue to take Abacavir/Lamivudine PharOS, the symptoms will get worse, and may be lifethreatening.
When do these reactions happen?
Hypersensitivity reactions can start at any time during treatment with Abacavir/Lamivudine PharOS, but are more
likely during the first 6 weeks of treatment.

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2. What you need to know before you take Abacavir/Lamivudine PharOS

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Not everyone responds to treatment with Abacavir/Lamivudine PharOS in the same way. Your doctor will monitor the
effectiveness of your treatment.

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Abacavir/Lamivudine PharOS does not completely cure HIV infection; it reduces the amount of virus in your body, and
keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are
important in helping your body to fight infection.

Abacavir/Lamivudine

Abacavir/Lamivudine PharOS contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine.
These belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

If you have stopped taking Abacavir/Lamivudine PharOS
If you have stopped taking Abacavir/Lamivudine PharOS because of a hypersensitivity reaction, you must NEVER
AGAIN take Abacavir/Lamivudine PharOS, or any other medicine containing abacavir. If you do, within
hours, your blood pressure could fall dangerously low, which could result in death.
If you have stopped taking Abacavir/Lamivudine PharOS for any reason — especially because you think you are
having side effects, or because you have other illness:
Talk to your doctor before you start again. Your doctor will check whether your symptoms were related to a
hypersensitivity reaction. If the doctor thinks they may have been, you will then be told never again to take
Abacavir/Lamivudine PharOS, or any other medicine containing abacavir. It is important that you follow this
advice.
Occasionally hypersensitivity reactions have developed in people who start taking abacavir containing products
again, but who had only one symptom on the Alert Card before they stopped taking it.
Very rarely patients who have taken medicines containing abacavir in the past without any symptoms of
hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
If your doctor advises that you can start taking Abacavir/Lamivudine PharOS again, you may be asked to take your
first doses in a place where you will have ready access to medical care if you need it.
If you are hypersensitive to Abacavir/Lamivudine PharOS, return all your unused Abacavir/Lamivudine
PharOS tablets for safe disposal. Ask your doctor or pharmacist for advice.
The Abacavir/Lamivudine PharOS pack includes an Alert Card, to remind you and medical staff about
hypersensitivity reactions. Detach this card and keep it with you at all times.
Common side effects
These may affect up to 1 in 10 people:
• hypersensitivity reaction
• headache
• being sick (vomiting)
• feeling sick (nausea)
• diarrhoea
• stomach pains
• loss of appetite
• tiredness, lack of energy
• fever (high temperature)
• general feeling of being unwell
• difficulty in sleeping (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• irritated or runny nose
• skin rash
• hair loss.
Uncommon side effects
These may affect up to 1 in 100 people and may show up in blood tests:
• a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
• an increase in the level of liver enzymes
• a decrease in the number of cells involved in blood clotting (thrombocytopenia).
Rare side effects
These may affect up to 1 in 1000 people:
• liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
• lactic acidosis (see the next section, ‘Other possible side effects of combination therapy for HIV’)
• inflammation of the pancreas (pancreatitis)
• breakdown of muscle tissue.
Rare side effects that may show up in blood tests are:
• increase in an enzyme called amylase
Very rare side effects
These may affect up to 1 in 10,000 people:
• numbness, tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a
dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–
Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal
necrolysis).
If you notice any of these symptoms contact a doctor urgently.
Very rare side effects that may show up in blood tests are:
• a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
If you get side effects
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not
listed in this leaflet.
Other possible side effects of combination therapy for HIV
Combination therapy such as Abacavir/Lamivudine PharOS may cause other conditions to develop during HIV treatment.
Symptoms of infection and inflammation
Old infections may flare up
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections
(opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before
treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which
can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following:
• headache
• stomach ache
• difficulty breathing
In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The
symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Symptoms may include:
• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness beginning in the hands and feet and moving up towards the trunk of the body.
If you get any symptoms of infection and inflammation or if you notice any of the symptoms above:
Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.
Your body shape may change
People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

Lactic acidosis is a rare but serious side effect
Some people taking Abacavir/Lamivudine PharOS, or other medicines like it (NRTIs), develop a condition called lactic
acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few
months of treatment. It can be life-threatening, causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweight) people, especially
women.
Signs of lactic acidosis include:
• feeling sick (nausea), being sick (vomiting)
• stomach pain
• generally feeling unwell
• loss of appetite, weight loss
• deep, rapid, difficult breathing
• numbness or weakness in the limbs
During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed
above or any other symptoms that worry you:
See your doctor as soon as possible.
You may have problems with your bones
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of
the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight.
Signs of osteonecrosis include:
• stiffness in the joints
• aches and pains (especially in the hip, knee or shoulder)
• difficulty moving.
If you notice any of these symptoms:
Tell your doctor.
Other effects may show up in blood tests
Combination therapy for HIV can also cause:
• increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
• increased levels of sugar and fats (triglycerides and cholesterol) in the blood
• resistance to insulin (so if you are diabetic, you may have to change your insulin dose to control your blood sugar).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 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
5. How to store Abacavir/Lamivudine PharOS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after . The expiry date refers
to the last day of that month.
Do not use this medicine after the expiry date which is stated on the carton and bottle after . The expiry date
refers to the last day of that month.
This medicinal product does not require any special storage conditions.
For bottles:
After first opening:
Chemical, physical and microbiological in-use stability has been demonstrated for 30 days below 25°C.
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 Abacavir/Lamivudine PharOS contains
- The active substances in each Abacavir/Lamivudine PharOS film-coated tablet are 600 mg of abacavir and 300 mg of
lamivudine.
- The other ingredients are cellulose, microcrystalline PH 102 (E460), cellulose, microcrystalline PH 200 (E460), sodium
starch glycolate (Type A), povidone K 90 (E 1201), magnesium stearate (E470b), hypromellose 5 (E464), macrogol 400
(E1521), titanium dioxide (E171), sunset yellow FCF aluminium lake (E110)
What Abacavir/Lamivudine PharOS looks like and contents of the pack
Abacavir/Lamivudine PharOS film-coated tablets are orange, film-coated, modified capsule shaped tablets. The dimensions
of the tablets are 19.4 mm x 10.4 mm.
Abacavir/Lamivudine PharOS is available in Aluminium-PVC/PE/PVDC white opaque blisters containing 30
tablets and Aluminium- PVC/PE/PVDC white opaque multipack blister packs containing 90 (3 x 30) tablets.
Abacavir/Lamivudine PharOS is available in white, plastic HDPE bottles with a white, plastic (PP) cap containing
30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PharOS – Pharmaceutical Oriented Services Ltd
Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis
Greece
Remedica Ltd
Aharnon Street, Limassol Industrial Estate 3056 Limassol
Cyprus
This medicinal product is authorised in the Member States of the EEA under the following names:
France
Abacavir/Lamivudine PharOS 600 mg/300 mg, comprimés pelliculés
Germany
Abacavir/Lamivudin PharOS 600 mg/300 mg Filmtabletten
Italy
Abacavir e Lamivudina PharOS
Netherlands
Abacavir/Lamivudine PharOS, 600 mg/300 mg filmomhulde tabletten
Spain
Abacavir/Lamivudina PharOS 600 mg/300 mg comprimidos recubiertos con película EFG
United Kingdom Abacavir/Lamivudine PharOS 600 mg / 300 mg film-coated tablets
This leaflet was last revised in 10/2016.
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Your doctor may advise you to stop taking Abacavir/Lamivudine PharOS.

• Fat may be lost from the legs, arms or face.
• Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs.
• Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.
It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice
changes in your body shape:
Tell your doctor.

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Contact your doctor immediately:
1. if you get a skin rash, OR
2. if you get symptoms from at least 2 of the following groups:
- fever
- shortness of breath, sore throat or cough
- nausea or vomiting, diarrhoea or abdominal pain
- severe tiredness or achiness, or generally feeling ill.

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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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