Raltegravir Dr. Reddy's

Package leaflet: Information for the user

Raltegravir Dr. Reddy’s 600 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
If you are the parent of a child taking Raltegravir Dr. Reddy’s, please read these instructions carefully together with your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Raltegravir Dr. Reddy’s is and what it is used for
2. What you need to know before taking Raltegravir Dr. Reddy’s
3. How to take Raltegravir Dr. Reddy’s
4. Possible side effects
5. How to store Raltegravir Dr. Reddy’s
6. Contents of the pack and other information

1. What Raltegravir Dr. Reddy’s is and what it is used for

What Raltegravir Dr. Reddy’s is
Raltegravir Dr. Reddy’s contains the active substance raltegravir. Raltegravir Dr. Reddy’s is an
antiviral medicine that acts against the Human Immunodeficiency Virus (HIV). This is the
virus that causes Acquired Immunodeficiency Syndrome (AIDS).
How Raltegravir Dr. Reddy’s works
The virus produces an enzyme called HIV integrase. This enzyme helps the virus to replicate within
the cells of your body. Raltegravir Dr. Reddy’s blocks the activity of this enzyme. When used in
combination with other medicines, Raltegravir Dr. Reddy’s can reduce the amount of HIV in your
blood (this is known as “viral load”) and increase the number of your CD4 cells (a type of white blood
cell that plays an important role in maintaining a healthy immune system to help fight infection).
Reducing the amount of HIV in the blood may improve the function of your immune system. This
means your body can fight the infection more effectively.
When Raltegravir Dr. Reddy’s should be used
Raltegravir Dr. Reddy’s 600 mg film-coated tablets are used for the treatment of adult and paediatric
patients weighing at least 40 kg who are infected with HIV. Your doctor has prescribed Raltegravir
Dr. Reddy’s to help you control your HIV infection.

2. What you need to know before taking Raltegravir Dr. Reddy’s

Do not take Raltegravir Dr. Reddy’s:

• if you are allergic to raltegravir or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Raltegravir Dr. Reddy’s.
Keep in mind that Raltegravir Dr. Reddy’s is not a cure for HIV infection. This means that you may
continue to develop infections or other HIV-related illnesses. Continue to see your doctor regularly
while taking this medicine.
Mental health problems
Tell your doctor if you have a history of depression or psychiatric illness. Depression, including
suicidal thoughts and behaviours, has been reported in some patients taking this medicine,
particularly in those who have previously suffered from depression or psychiatric illness.
Bone problems
Some patients taking combination antiretroviral therapy may develop a bone disease called
osteonecrosis (death of bone tissue due to lack of blood supply to the bone). Duration of combination
antiretroviral therapy, use of corticosteroids, alcohol consumption, severely weakened immune
system, and higher body mass index may be, among others, some of the many risk factors for
developing this condition. Signs of osteonecrosis include stiffness, discomfort, and pain in the joints
(particularly the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms,
contact your doctor.
Liver problems
Tell your doctor, pharmacist, or nurse if you have previously had liver problems, including hepatitis B
or C. Your doctor may assess the severity of liver disease before deciding whether you can take this
medicine.
Infections
Tell your doctor, pharmacist, or nurse immediately if you notice any symptoms of infection, such as
fever and/or feeling unwell. In some patients with advanced HIV infection who have experienced
opportunistic infections, inflammatory signs and symptoms of prior infections may arise soon after
starting anti-HIV treatment. These symptoms are believed to be due to an improved immune response,
which enables the body to fight infections that may have been present without clear symptoms.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system
attacks healthy body tissue) may also occur after starting medications for the treatment of HIV
infection. Autoimmune disorders may occur many months after starting treatment. If you notice any
symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and
feet spreading upwards towards the trunk, palpitations, tremor, or hyperactivity, inform your doctor
immediately to receive necessary treatment.
Muscle problems
Contact your doctor, pharmacist, or nurse immediately if you experience unexplained muscle pain,
tenderness, or weakness while being treated with this medicine.
Skin problems
Contact your doctor immediately if you develop a skin rash. In some patients treated with this
medicine, serious and potentially life-threatening skin reactions and allergic reactions have been
reported.
Other medicines and Raltegravir Dr. Reddy’s
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine,
with or without a prescription.
Raltegravir Dr. Reddy’s may interact with other medicines.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take:

• antacids (agents that counteract or neutralize stomach acid to relieve symptoms of indigestion and heartburn)
• iron salts (to treat and prevent iron deficiency or anaemia). You must wait at least two hours between taking iron salts and taking Raltegravir Dr. Reddy’s, as these medicines may reduce the effectiveness of Raltegravir Dr. Reddy’s
  • atazanavir (an antiretroviral medicine)
  • rifampicin (a medicine used to treat certain infections such as tuberculosis)
  • tipranavir/ritonavir (antiretroviral medicines)

Make a list of all the medicines you are using and show it to your doctor and pharmacist.

• You may ask your doctor or pharmacist for a list of medicines that interact with Raltegravir Dr. Reddy’s.
• Do not start taking a new medicine without first informing your doctor. Your doctor will tell you whether it is safe to take Raltegravir Dr. Reddy’s with other medicines.

Raltegravir Dr. Reddy’s with food and drink
See section 3.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

• Raltegravir Dr. Reddy’s 1200 mg (two 600 mg tablets taken once daily) is not recommended during pregnancy because it has not been studied in pregnant women.
• Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the baby through breast milk.
• If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible. Ask your doctor, pharmacist, or nurse for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines
Do not operate machinery, drive, or ride a bicycle if you feel dizzy after taking this medicine.
Raltegravir Dr. Reddy’s contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Raltegravir Dr. Reddy’s

Take this medicine exactly as instructed by your doctor, pharmacist, or
nurse. If you have any doubts, consult your doctor, pharmacist, or
nurse. Raltegravir Dr. Reddy’s
must be used in combination with other HIV medicines.
How much to take
Adults, children and adolescents weighing at least 40 kg
The recommended dose is 1200 mg, taken as two 600 mg tablets once daily by mouth.
Do not chew, crush, or split the tablets, as this may alter the levels of the medicine in your body. This medicine can be taken with or without food or drinks.
Raltegravir Dr. Reddy’s is available only as 600 mg tablets. Other formulations and strengths of raltegravir may be available; for further information, consult your doctor, pharmacist, or
nurse.
If you take more Raltegravir Dr. Reddy’s than you should
Do not take more tablets than prescribed by your doctor. If you happen to take too many tablets, contact your doctor immediately.
If you forget to take Raltegravir Dr. Reddy’s

• If you forget to take a dose, take it as soon as you remember.
• However, if it is nearly time for your next dose, skip the missed dose and return to your regular dosing schedule.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Raltegravir Dr. Reddy’s
It is important that you take Raltegravir Dr. Reddy’s exactly as prescribed by your doctor. Do not change the dose or stop treatment with this medicine without first discussing it with your doctor, pharmacist, or nurse. Do not stop treatment because:

• It is very important to take all HIV medicines exactly as prescribed and at the exact times of day. This will help your medicines work as effectively as possible. It will also reduce the chance that the medicines may no longer be able to fight HIV (also known as “drug resistance”).
• When your supply of Raltegravir Dr. Reddy’s starts to run low, obtain a new supply from your doctor or pharmacist. It is very important not to run out of medicine, even for a short period. During a brief interruption in treatment, the amount of virus in your blood may increase. This could mean that the HIV virus is developing resistance to Raltegravir Dr. Reddy’s and becoming harder to treat.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects – these are uncommon (may affect up to 1 in 100 people)
Seek immediate medical advice if you notice any of the following:

• herpes infections including herpes zoster
• anaemia, including iron deficiency anaemia
• signs and symptoms of infection or inflammation
• mental disorder
• suicidal thoughts or attempts
• inflammation of the stomach
• inflammation of the liver
• liver failure
• allergic skin rash
• certain types of kidney problems
• taking the medicine in amounts higher than recommended

Seek immediate medical advice if you notice any of the above-listed side effects.

Common: the following may affect up to 1 in 10 people

• decreased appetite
• sleep disturbances; altered dream content; nightmares; abnormal behaviour; feelings of deep sadness and worthlessness
• dizziness; headache
• sensation of loss of balance
• swelling; abdominal pain; diarrhoea; excessive gas in the stomach or intestines; feeling unwell; vomiting; indigestion; burping
• certain types of skin rash (more often when used in combination with darunavir)
• fatigue; unusual tiredness or weakness; fever
• increased liver enzymes in the blood; changes in white blood cells in the blood; increased levels of fats in the blood; increased levels of enzymes secreted by the salivary glands or pancreas

Uncommon: the following may affect up to 1 in 100 people

• infection of hair follicles; influenza; viral skin infection; vomiting or diarrhoea due to an infectious agent; upper respiratory tract infection; lymph node abscess
• wart
• pain in lymph nodes; low number of white blood cells in the blood that fight infections; swelling of glands in the neck, armpits, and groin
• allergic reaction
• increased appetite; diabetes; increased cholesterol and blood lipids; high blood sugar levels; excessive thirst; severe weight loss; high levels of fat (such as cholesterol and triglycerides) in the blood; body fat disturbance
• feeling anxious; feeling confused; depressed mood; mood changes; panic attack
• memory loss; hand pain due to nerve compression; attention disorder; dizziness upon rapid postural changes; altered taste; increased drowsiness; lack of energy; forgetfulness, migraine; loss of sensation; numbness or weakness in arms and/or legs; tingling; somnolence; tension headache; tremors; poor sleep quality
• visual disturbances
• ringing, buzzing, hissing, or other persistent noise in the ears
• palpitations; slowed heart rate; rapid or irregular heartbeat
• hot flushes; high blood pressure
• hoarse, harsh, or strained voice; nosebleeds; nasal congestion
• pain in the upper abdomen; rectal disorder; constipation; dry mouth; heartburn; painful swallowing; inflammation of the pancreas; ulcer or sore in the stomach or upper intestine; bleeding from the anus; stomach discomfort; gum inflammation; swollen, red, painful tongue
• fat accumulation in the liver
• acne; abnormal hair loss or thinning; skin redness; abnormal distribution of body fat, which may include loss of fat from legs, arms, and face, and increased fat in the abdomen; excessive sweating; night sweats; skin thickening and itching due to repeated scratching; skin lesion; dry skin
• joint pain, painful joint disease; back pain; bone/muscle pain; muscle tenderness or weakness; neck pain; pain in arms or legs; tendon inflammation; decreased bone mineral content
• kidney stones; night-time urination; renal cyst
• erectile dysfunction; breast enlargement in men; menopausal symptoms
• chest discomfort; chills; facial swelling; feeling nervous; general feeling of being unwell; neck mass; swelling of hands, ankles, or feet; pain
• decreased white blood cells in the blood; decreased platelets in the blood (a type of cell involved in clotting); blood tests showing reduced kidney function; high blood sugar levels; increased muscle enzymes in the blood; presence of sugar in urine; presence of red blood cells in urine; weight gain; increased waist circumference; decreased blood proteins (albumin); prolonged blood clotting time

Additional side effects in children and adolescents

• hyperactivity

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Raltegravir Dr. Reddy’s

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the bottle after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Raltegravir Dr. Reddy’s contains
The active substance is raltegravir. Each film-coated tablet contains 600 mg of raltegravir (as potassium).
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, carbomers, magnesium stearate. Additionally, the coating contains the following excipients: macrogol, talc, titanium dioxide (E171), glycerol monocaprylocaprate (type I), poly(vinyl alcohol), and yellow iron oxide (E172).

Description of the appearance of Raltegravir Dr. Reddy’s and package contents
The 600 mg film-coated tablet is oval-shaped, yellow, with "C30" engraved on one side and "600" on the other side.
Pack sizes: packages containing 1 bottle with 60 tablets and multiple pack sizes containing 3 bottles, each with 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade, 1
20123 Milan
Italy

Manufacturer
Coripharma ehf
Reykjavíkurvegur 78-80
220 Hafnarfjörður
Iceland

This medicinal product is authorized in the European Economic Area Member States under the following names: