Raltegravir Dr. Reddy's 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Raltegravir Dr. Reddys 600 mg film-coated tablets EFG

Read the entire 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. Reddys, please read this information carefully with your child.

Keep this leaflet as you may need to read it again.

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

This medicine has been prescribed for you or your child only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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

1. What Rategravir Dr. Reddys is and what it is used for

What Rategravir Dr. Reddys is

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

How Rategravir Dr. Reddys works

The virus produces an enzyme called HIV integrase, which helps the virus enter the body's cells and multiply. Raltegravir prevents this enzyme from working. When used with other medicines, raltegravir can reduce the amount of HIV in the blood (this is called your “viral load”) and increase the CD4 cell count (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 may improve the functioning of your immune system. This means your body can fight the infection more effectively.

When Rategravir should be used

Rategravir Dr. Reddys 600 mg film-coated tablets are used to treat adults and paediatric patients weighing at least 40 kg who are infected with HIV. Your doctor has prescribed raltegravir to help you control your HIV infection.

2. What you need to know before taking Raltegravir Dr. Reddys

Do not take Raltegravir Dr. Reddys:

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 starting raltegravir.

Remember that raltegravir does not cure HIV infection. This means you may still develop HIV-related infections or other illnesses. You must continue to visit your doctor regularly while taking this medicine.

Mental health problems

Tell 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 medicine, particularly in those with a previous history of depression or mental illness.

Bone problems

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severely weakened immune system, increased body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hip, knee, and shoulder) and difficulty moving. If you experience any of these symptoms, see your doctor.

Liver problems

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

Infections

If you notice any symptoms of infection, such as fever and/or feel unwell, inform your doctor, pharmacist, or nurse immediately. Some patients with advanced HIV infection who have previously had opportunistic infections may develop signs and symptoms of inflammation soon after starting HIV treatment. These symptoms are believed to result from improvement in immune response, enabling the body to fight infections that may have been present but not causing obvious symptoms.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medicines for your HIV infection. Autoimmune disorders may appear 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 moving up toward 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 to pressure, or muscle weakness during treatment with this medicine.

Skin problems

Contact your doctor immediately if you develop a rash. Serious and potentially life-threatening skin reactions and allergic reactions have been reported in some patients taking this medicine.

Other medicines and Raltegravir Dr. Reddys

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

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

• antacids (a medicine that counteracts or neutralizes stomach acid and relieves indigestion and heartburn)
• iron salts (to treat and prevent iron deficiency or anemia). You should wait at least two hours between taking iron salts and taking raltegravir, as these medicines may reduce the effectiveness of raltegravir
• atazanavir (an antiretroviral medicine)
• rifampicin (a medicine used to treat certain infections such as tuberculosis)
• tipranavir/ritonavir (antiretroviral medicines)

Keep a list of all your medicines to show your doctor and pharmacist.

You may ask your doctor or pharmacist for a list of medicines that interact with raltegravir.

Do not start taking a new medicine without informing your doctor. Your doctor can tell you whether it is safe to take raltegravir with other medicines.

Taking Raltegravir Dr. Reddys with food and drink

See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or considering breastfeeding, you should consult your doctor as soon as possible.

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

Driving and using machines

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

Raltegravir Dr. Reddys contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Raltegravir Dr. Reddy's

Follow exactly the instructions for using this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again. Raltegravir must be used in combination with other medicines for HIV infection.

What dose 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 daily.

Do not chew, crush, or split the tablets, as this may alter the amount of medicine in your body. You may take this medicine 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; speak with your doctor, pharmacist, or nurse for further information.

If you take more Raltegravir Dr. Reddy's than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

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 almost time for your next dose, do not take the missed dose and continue with your regular dosing schedule.

Do not take a double dose to make up for a missed dose.

If you stop taking Raltegravir Dr. Reddy's

It is important that you take raltegravir exactly as prescribed by your doctor. Do not change the dose or stop taking this medicine without first consulting your doctor, pharmacist, or nurse. Do not stop taking it because:

It is very important that you take all HIV medicines exactly as prescribed and at the correct times of day. This helps the medicines work better and also reduces the chance that the virus becomes resistant to them (also known as “drug resistance”).

• When you have only a few tablets of raltegravir left, go to your doctor or pharmacy to get more. This is because it is very important not to run out of medicine, even for a few days. If you stop taking the medicine for a few days, the amount of virus in your blood may increase, and as a result, HIV may develop resistance to raltegravir, making the disease harder to treat.

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

4. Possible adverse effects

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

Serious adverse effects – these are uncommon (may affect up to 1 in 100 people)

Seek medical advice immediately if you experience any of the following adverse effects:

• Herpes infections including herpes zoster
• Anaemia including iron deficiency anaemia
• Signs and symptoms of infection or inflammation
• Mental disorder
• Suicide attempt or suicidal ideation
• Inflammation of the stomach
• Inflammation of the liver
• Liver failure
• Allergic-type rash
• Certain types of kidney problems
• Ingestion of the medicine in amounts higher than recommended

Seek medical advice immediately if you experience any of the adverse effects listed above.

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

• Decreased appetite
• Sleep problems; strange dreams; nightmares; abnormal behaviour; feeling of deep sadness and low self-esteem
• Dizziness; headache
• Vertigo
• Flatulence or gas; abdominal pain; diarrhoea; excessive gas in the stomach or intestine; nausea; vomiting; indigestion; belching
• Certain types of rash (more frequently when used in combination with darunavir)
• Tiredness, unusual fatigue or weakness; fever
• Elevated liver parameters; abnormal white blood cell counts; increased blood fat levels; increased levels of enzymes from salivary glands or pancreas

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

• Infection of hair roots; flu; viral skin infection; vomiting or diarrhoea due to an infectious agent; upper respiratory tract infection; pus accumulation in lymph node
• Warts
• Lymph node pain; low count of white blood cells responsible for fighting infections; swelling of glands in neck, armpits, and groin
• Allergic reaction
• Increased appetite; diabetes; elevated cholesterol and blood lipids; increased blood sugar levels; excessive thirst; severe weight loss; high blood fat levels (such as cholesterol and triglycerides); body fat disorders
• Feeling of distress; feeling confused; depressed mood; mood changes; panic attack
• Memory loss; hand pain due to nerve compression; attention disturbance; dizziness upon rapid change in posture; abnormal taste; increased drowsiness; lack of energy; forgetfulness; migraine headache; loss of sensation, numbness or weakness in arms and/or legs; tingling; drowsiness; tension headache; tremors; poor sleep
• Vision disturbance
• Tinnitus, high-pitched sounds, ringing, buzzing, or other persistent noises in the ears
• Palpitations; slow pulse; rapid or irregular heartbeat
• Hot flushes; increased blood pressure
• Hoarse, rough, or strained voice; nosebleeds; nasal congestion
• Upper abdominal pain; rectal discomfort; constipation; dry mouth; heartburn; pain on swallowing; inflammation of the pancreas; ulcer or sore in the stomach or upper intestine; bleeding from the anus; stomach upset; gum inflammation; swelling, red and ulcerated tongue
• Fat accumulation in the liver
• Acne; hair loss or thinning; skin redness; unusual body fat distribution, which may include loss of fat in legs, arms, and face and increased fat in the abdomen; excessive sweating; night sweats; thickening and itching of the skin due to repeated scratching; skin lesion; dry skin
• Joint pain; painful joint disease; back pain; bone/muscle pain; muscle aching or weakness; neck pain; arm or leg pain; tendon inflammation; decreased bone mineral content
• Kidney stones; nocturnal urination; renal cyst
• Erectile dysfunction; breast enlargement in men; menopausal symptoms
• Chest discomfort; chills; facial swelling; feeling of nervousness; feeling of general malaise; lump in the neck; swelling of hands, ankles, or feet; pain
• Low white blood cell count; low platelet count in blood (a type of cell involved in blood clotting); decreased kidney function in blood tests; high blood sugar levels; elevated muscle enzymes in blood; sugar in urine; red blood cells in urine; weight gain; increased waist circumference; decreased blood proteins (albumin); prolonged blood clotting time

Other adverse effects in children and adolescents

• Hyperactivity

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Raltegravir Dr. Reddys

• 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 the month indicated.
  • This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Raltegravir Dr. Reddys

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

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

Appearance of the product and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

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

Date of the last revision of this leaflet: May 2024

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