Raltegravir Mylan

Package leaflet: Information for the user

Raltegravir Mylan 600 mg film-coated tablets

raltegravir
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
If you are the parent of a child taking Raltegravir Mylan, 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 pass it on to others, even if they have the same symptoms as you do, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Raltegravir Mylan is and what it is used for

What Raltegravir Mylan is
Raltegravir Mylan contains the active substance raltegravir. Raltegravir Mylan is an antiviral medicine that
acts against the Human Immunodeficiency Virus (HIV). This is the virus that causes Acquired Immunodeficiency Syndrome (AIDS).
How Raltegravir Mylan works
The virus produces an enzyme called HIV integrase. This enzyme helps the virus to multiply within the cells
of your body. Raltegravir Mylan blocks the activity of this enzyme. When used in combination with other medicines,
Raltegravir Mylan 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 better fight the infection.
When Raltegravir Mylan should be used
Raltegravir Mylan 600 mg film-coated tablets are used to treat adults and paediatric patients weighing at least 40 kg who have HIV infection. Your doctor has prescribed Raltegravir Mylan to help you control your HIV infection.

2. What you should know before taking Raltegravir Mylan

Do not take Raltegravir Mylan:

• 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 Mylan.
Keep in mind that Raltegravir Mylan is not a cure for HIV infection. This means you may still develop HIV-related infections or other 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 behaviour, has been reported in some patients taking this medicine, particularly in those who have previously suffered from depression or psychiatric disorders.

Bone problems
Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone). The duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune deficiency, and higher body mass index may be among the many risk factors for developing this condition. Signs of osteonecrosis include stiffness, discomfort, and pain in the joints (especially 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 previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling 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 the body's healthy tissues) may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur several 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, tremors, or hyperactivity, contact 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 taking 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 Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, with or without a prescription.

Raltegravir Mylan 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 indigestion and heartburn symptoms)
• iron salts (to treat or prevent iron deficiency or anaemia). You must wait at least two hours between taking iron salts and Raltegravir Mylan, as these medicines may reduce the effectiveness of Raltegravir Mylan.
• atazanavir (an antiretroviral drug), rifampicin (a medicine used to treat certain infections such as tuberculosis)
• tipranavir/ritonavir (antiretroviral drugs)

Write down a list of all medicines you are using and show it to your doctor or pharmacist.

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

Raltegravir Mylan with food and drinks
Raltegravir can be taken with or without food or drinks.
See section 3.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Raltegravir Mylan 1 200 mg (two 600 mg tablets 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 infant through breast milk.
• If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Consult your doctor, pharmacist, or nurse before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines
Do not use machinery, drive, or ride a bicycle if you feel dizzy after taking this medicine.

Raltegravir Mylan 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 Mylan

Take this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse. Raltegravir Mylan 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 1 200 mg, two 600 mg tablets, taken orally once daily.
Do not chew, crush, or split the tablets, as this may alter the levels of the medicine in the body. This medicine can be taken with or without food or drink.
Raltegravir Mylan is available only as 600 mg tablets. Other formulations of raltegravir are available. For further information, please consult your doctor, pharmacist, or nurse.
If you take more Raltegravir Mylan than you should
Do not take more tablets than prescribed by your doctor. If you take too many tablets, contact your doctor.
If you forget to take Raltegravir Mylan

• If you forget to take a dose, take it as soon as you remember.
• However, if it is almost 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 Mylan
It is important that you take Raltegravir Mylan 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 Mylan 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 short interruption in treatment, the amount of virus in the blood may increase. This could mean that the HIV virus is developing resistance to Raltegravir Mylan, making it more difficult to treat.

If you have any questions about the use of 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 attention if you experience 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
• liver inflammation
• liver failure
• allergic skin rash
• certain types of kidney problems
• taking the medicine in quantities higher than recommended

Seek immediate medical attention if you experience any of the above-listed side effects.

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

• reduced 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; belching
• 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 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 disorder
• 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 of arms and/or legs; tingling; somnolence; tension headache; tremors; poor quality of sleep
• visual disturbances
• ringing, buzzing, whistling, or other persistent noise in the ears
• palpitations; slowed heartbeat; fast or irregular heartbeat
• hot flushes; high blood pressure
• hoarse, harsh, or strained voice; nosebleed; 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, sore 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; thickened and itchy skin 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; nocturnal 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 blood clotting); blood tests showing reduced kidney function; high blood sugar levels; increased muscle enzymes in the blood; presence of sugar in the urine; presence of red blood cells in the urine; weight gain; increased waist circumference; decreased protein levels in the blood (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 the following website:
. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Raltegravir Mylan

• Do not store above 30 °C.
• Blister: Keep in the original packaging to protect the active substance from moisture.
• Bottle: Keep the bottle tightly closed, with the desiccant (drying agent) inside, to protect the medicine from moisture.
• 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.

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

6. Package contents and other information

What Raltegravir Mylan contains
The active substance is raltegravir. Each 600 mg film-coated tablet contains 600 mg of raltegravir (as potassium).
The other components are: calcium sulfate (E516), microcrystalline cellulose (E460), anhydrous colloidal silica,
sodium croscarmellose (see section 2 “Raltegravir Mylan contains sodium”) and magnesium stearate. In addition,
the tablet coating contains the following inactive ingredients: polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Raltegravir Mylan and pack contents
The 600 mg film-coated tablet is yellow, capsule-shaped, with a bevelled convex edge, and marked with “RLT” on one side and “M” on the other.
Raltegravir Mylan 600 mg film-coated tablets are available as:
Aluminum blisters in packs of 60 or 60 x 1 film-coated tablets.
Opaque white bottles with desiccant in packs of 60 or 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturers
Mylan Hungary Kft
Mylan Utca 1
Komárom, 2900
Hungary
Mylan Germany GmbH
Benzstrasse 1
Bad Homburg v. d. H.
Bad Homburg, 61352
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria Ралтегравир Виатрис 600 mg филмирани таблетки
Croatia Raltegravir Viatris 600 mg filmom obložene tablete
Cyprus Raltegravir/Viatris
Denmark Raltegravir Viatris
Estonia Raltegravir Viatris
Finland Raltegravir Viatris 600 mg kalvopäällysteiset tabletit
France Raltegravir Viatris 600 mg, comprimé pelliculé
Germany Raltegravir Viatris 600 mg Filmtabletten
Greece Raltegravir/Viatris
Italy Raltegravir Mylan
Latvia Raltegravir Viatris 600 mg apvalkotās tabletes
Malta Raltegravir/Viatris
Netherlands Raltegravir Viatris 600 mg, filmomhulde tabletten
Norway Raltegravir Viatris
Poland Raltegravir Viatris
Portugal Raltegravir Mylan
Romania Raltegravir Viatris 600 mg comprimate filmate
Spain Raltegravir Viatris 600 mg comprimidos recubiertos con película EFG