Package Insert: Information for the User

Raltegravir Dr. Reddys 600 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

If you are the parent of a child taking Raltegravir Dr. Reddys, please read this information carefully with your child.

Keep this package insert, as you may need to refer to it again.

If you have any questions, consult your doctor, pharmacist, or nurse.

This medicine has been prescribed only for you or your child, and should not be given to others who have the same symptoms as you, as it may harm them.

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

What is Raltegravir Dr. Reddys

This medication contains the active ingredient raltegravir. Raltegravir is an antiviral medication that acts against the human immunodeficiency virus (HIV). This is the virus that causes acquired immunodeficiency syndrome (AIDS).

How Raltegravir Dr. Reddys works

The virus produces an enzyme called HIV integrase, which helps the virus to enter the body's cells and multiply. Raltegravir prevents this enzyme from functioning. When used with other medications, raltegravir can reduce the amount of HIV in the blood (this is called its “viral load”) and increase the count of CD4 cells (a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection). By reducing the amount of HIV in the blood, it can improve the functioning of the immune system. This means that the body can fight better against infection.

When to use Raltegravir

Raltegravir Dr. Reddys 600 mg film-coated tablets are used to treat adults and pediatric patients with a weight of at least 40 kg who are infected with HIV. Your doctor has prescribed raltegravir to help you control the HIV infection you have.

Do not take Raltegravir Dr. Reddys:

if you are allergic to raltegravir or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take raltegravir.

Remember that raltegravir does not cure HIV infection. This means that you may continue to experience infections or other HIV-related illnesses. You should continue to attend your doctor's appointments regularly while taking this medication.

Mental health problems

Inform your doctor if you have a history of depression or mental illness. Depression, including suicidal thoughts and behaviors, has been observed in some patients taking this medication, especially in patients with a previous history of depression or mental illness.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). Factors that may increase the risk of developing this disease include the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, significant weight gain, and others. Signs of osteonecrosis include joint stiffness, pain, and difficulty moving (especially in the hip, knee, and shoulder). If you experience any of these symptoms, see your doctor.

Liver problems

Inform your doctor, pharmacist, or nurse if you have had liver problems in the past, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether you can take this medication.

Infections

If you notice any symptoms of infection, such as fever and/or feeling unwell, inform your doctor, pharmacist, or nurse immediately. Some patients with advanced HIV infection and a history of opportunistic infections may experience signs and symptoms of inflammation due to previous infections shortly after starting HIV treatment. These symptoms are believed to be due to the improvement of the body's immune response, which allows the body to fight off infections that may have been present but not causing obvious symptoms.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after starting HIV treatment. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Muscle problems

Contact your doctor, pharmacist, or nurse immediately if you notice unexplained muscle pain, sensitivity to pressure, or muscle weakness during treatment with this medication.

Skin problems

Contact your doctor immediately if you experience a rash. Severe and potentially fatal skin reactions and allergic reactions have been reported in some patients taking this medication.

Other medications and Raltegravir Dr. Reddys

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Raltegravir Dr. Reddys may interact with other medications. Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take:

Carry a list of all your medications to show your doctor and pharmacist.

You can ask your doctor or pharmacist to give you a list of medications that interact with raltegravir.

Do not start taking a new medication without informing your doctor. Your doctor may tell you if it is safe to take raltegravir with other medications.

Taking Raltegravir Dr. Reddys with food and drinks

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Raltegravir 1,200 mg (two 600 mg tablets once a day) is not recommended during pregnancy, as it has not been studied in pregnant women.

It is not recommended that women with HIV infection breastfeed, as the infection can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed, consult your doctor as soon as possible.

If you are pregnant or breastfeeding, consult your doctor, pharmacist, or nurse before using any medication.

Driving and operating machinery

Do not operate machinery, drive, or ride a bike if you feel dizzy after taking this medication.

Raltegravir Dr. Reddys contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again. Raltegravir should be used in combination with other medications for HIV infection.

How much to take

Adults, children and adolescents weighing at least 40 kg

The recommended dose is 1,200 mg taken as two 600 mg tablets orally once a day.

Do not chew, crush or break the tablets as it may alter the amount of medication in your body. You can take this medication with or without food or drinks.

Raltegravir Dr. Reddys is only available in 600 mg tablets. There may be other formulations and concentrations of raltegravir available; consult your doctor, pharmacist or nurse for more information.

If you take more Raltegravir Dr. Reddys than you should

Do not take more tablets than recommended by your doctor. If you take more tablets than recommended, consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Raltegravir Dr. Reddys

If you forget to take a dose, take it as soon as you remember that you have not taken it.

However, if it is time to take the next dose, do not take the missed dose and follow your usual dosing schedule.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Raltegravir Dr. Reddys

It is essential that you take raltegravir exactly as your doctor has told you. Do not change the dose or stop taking this medication without consulting your doctor, pharmacist or nurse first. Do not stop taking it, because:

It is very important that you take all HIV medications as prescribed and at the correct times of the day. This makes the medications work better and also reduces the possibility that they will no longer be able to combat HIV (also known as "drug resistance").

• When you have few tablets of raltegravir left, go to your doctor or pharmacy to get more. The reason is that it is very important not to run out of medication, not even for a few days. If you stop taking the medication for a few days, the amount of virus in the blood may increase and, as a consequence, HIV may develop resistance to raltegravir and the disease may be more difficult to treat.

If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects– these are rare (may affect up to 1 in 100 people)

Seek medical attention immediately if you notice any of the following side effects:

• Herpes infections, including shingles
• Anemia, including iron deficiency anemia
• Signs and symptoms of infection or inflammation
• Mental disorders
• Attempt or intention of suicide
• Stomach inflammation
• Liver inflammation
• Liver failure
• Allergic rash
• Determined types of kidney problems
• Medication overdose

Seek medical attention immediately if you notice any of the side effects mentioned above.

Frequent:the following side effects may affect up to 1 in 10 people

• Loss of appetite
• Difficulty sleeping; strange dreams; nightmares; abnormal behavior; deep sadness and low self-esteem
• Dizziness; headaches
• Dizziness
• Flatulence or gas; abdominal pain; diarrhea; excessive gas in the stomach or intestines; nausea; vomiting; indigestion; belching
• Determined types of rashes (more frequently when used in combination with darunavir)
• Unusual fatigue, weakness, or tiredness; fever
• Elevated liver parameters; abnormal white blood cell counts; increased blood lipid levels; increased salivary gland or pancreatic enzyme levels

Rare:the following side effects may affect up to 1 in 100 people

• Root hair infection; flu; skin infection due to virus; vomiting or diarrhea due to an infectious agent; upper respiratory tract infection; lymph node abscess
• Warts
• Lymph node pain; low white blood cell count; swelling of the neck, axillary, and inguinal glands
• Allergic reaction
• Increased appetite; diabetes; elevated cholesterol and blood lipid levels; increased blood sugar levels; excessive thirst; severe weight loss; high blood lipid levels (such as cholesterol and triglycerides); body fat disorders
• Anxiety; confusion; depressed mood; mood changes; panic attack
• Memory loss; hand pain due to nerve compression; attention alteration; vertigo; abnormal taste; increased somnolence; lack of energy; forgetfulness; migraines; numbness, tingling, or weakness of the arms and/or legs; paresthesia; somnolence; tension headache; tremors; poor sleep
• Vision alteration
• Tinnitus, high-pitched sounds, whistling, buzzing, or other persistent sounds in the ears
• Palpitations; slow heart rate; irregular heartbeats
• Angina; increased blood pressure
• Hoarse voice, rough, harsh, or forced voice; nasal bleeding; nasal congestion
• Upper abdominal pain; rectal discomfort; constipation; dry mouth; stomach burning; difficulty swallowing; pancreatitis; stomach or intestinal ulcer; rectal bleeding; stomach discomfort; gum inflammation; swollen tongue and ulcers
• Fatty liver accumulation
• Acne; hair loss or thinning; skin redness; unusual body fat distribution, including loss of fat in legs, arms, and face, and increased fat in the abdomen; excessive sweating; night sweats; skin itching and thickening due to repeated scratching; skin lesions; dry skin
• Joint pain; painful joints; back pain; bone or muscle pain; muscle weakness or pain; neck pain; arm or leg pain; tendon inflammation; decreased mineral levels in the bones
• Kidney stones; nocturia; renal cyst
• Erectile dysfunction; breast enlargement in men; menopausal symptoms
• Chest discomfort; chills; facial swelling; feeling of nervousness; general feeling of discomfort; neck lump; hand, foot, or ankle swelling; pain
• Low white blood cell count; low platelet count in the blood (a type of cell involved in blood clotting); decreased renal function in blood tests; high blood sugar levels; elevated muscle enzymes in the blood; sugar in the urine; red blood cells in the urine; weight gain; increased waist circumference; decreased blood protein (albumin); prolonged blood clotting time

Other side effects in children and adolescents

• Hyperactivity

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the reach and sight of children.
• • Do not use this medication after the expiration date that appears in the bottle after CAD. The expiration date is the last day of the month indicated.
  • This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the containers and themedications that you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the containers and the medications that you no longer need. In this way, you will help protect the environment.

Composition of Raltegravir Dr. Reddys

The active ingredient is raltegravir. Each film-coated tablet contains 600 mg of raltegravir (potassium).

The other components are: microcrystalline cellulose, sodium croscarmellose, carbomers, magnesium stearate. Additionally, the film coating contains the following inactive components: macroglols, talc, titanium dioxide (E171), glycerol monocaprinate (type I), poly(vinyl alcohol) and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

The 600 mg film-coated oval-shaped tablet is yellow in color, with the inscription “C30” engraved on one face and “600” on the other face.

Packaging sizes: a pack containing 1 bottle of 60 tablets and multiple packs containing 3 bottles of 60 tablets each.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reddy Pharma Iberia, S.A.

Avenida Josep Tarradellas nº 38

08029 Barcelona

Spain

Responsible for manufacturing

Coripharma ehf.

Reykjavikurvegur 78

IS -220 Hafnarfjordur

Iceland

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:May 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.