200 mg / 245 mg film-coated tablets
emtricitabine / tenofovir disoproxil
What Emtricitabine / Tenofovir disoproxil Stada is and what it is used for
Emtricitabine / Tenofovir disoproxil Stada contains two active substances, emtricitabine and tenofovir disoproxil . Both of these active substances are antiretroviral drugs used to treat HIV – infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are commonly called NRTIs and act by affecting the normal function of an enzyme (reverse transcriptase) that the virus needs for its reproduction (propagation).
- Emtricitabine / Tenofovir disoproxil Stada is a treatment for human immunodeficiency virus 1 infection ( HIV- 1 ) in adults 18 years of age and older.
- Emtricitabine / Tenofovir disoproxil Stada should always be taken in combination with other anti- HIV medicines.
- Emtricitabine / Tenofovir disoproxil Stada can be used instead of separate administration of emtricitabine and tenofovir disoproxil at the same dose .
People who are HIV -positive can still transmit HIV -smitten when taking this medicine, even though the risk is reduced with effective antiretroviral treatment. Discuss the necessary steps to avoid infecting others with your doctor.
This medicine does not cure HIV – infection. While taking emtricitabine/tenofovir disoproxil Stada may still develop infections you or other illnesses associated with HIV – infection.
- Emtricitabine/tenofovir disoproxil STADA is also used to reduce the risk of becoming infected with HIV -1 when used daily with safe sex: See Section 2 for a list of precautions that can be taken against HIV – infection.
Emtricitabine and tenofovir disoproxil contained in Emtricitabine / Tenofovir disoproxil Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Emtricitabine / Tenofovir disoproxil Stada
Do not use Emtricitabine / Tenofovir disoproxil Stada
Do not take Emtricitabine / Tenofovir disoproxil Stop treatment for HIV or reduce the risk of HIV infection if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil succinate, or any of the other ingredients of this medicine (listed in section 6).
→ If this applies to you, tell your doctor immediately.
Before you take Emtricitabine / Tenofovir disoproxil Stada to reduce your risk of getting HIV:
Emtricitabine / Tenofovir disoproxil Stada can only help reduce the risk of getting HIV before you become infected.
- To reduce the risk of getting HIV you must be HIV negative before starting Emtricitabine / Tenofovir disoproxil Stada. You must be tested to ensure that you do not already have HIV – infection. Do not take Emtricitabine / Tenofovir disoproxil Stada to reduce your risk of infection unless you have been confirmed to be HIV- negative. People with HIV must take Emtricitabine / Tenofovir disoproxil Stada in combination with other medicines.
- Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean that you have recently been infected with HIV. These may be signs of HIV infection:
- fatigue
- fever
- joint or muscle pain
- headache
- vomiting or diarrhea
- rash
- night sweats
- enlarged lymph nodes in the throat or groin.
→ Tell your doctor about any flu-like symptoms – either during the month before starting treatment with Emtricitabine / Tenofovir disoproxil Stada or at any time while you are taking Emtricitabine / Tenofovir disoproxil Stada.
Warnings and cautions
While taking Emtricitabine / Tenofovir disoproxil Stada to reduce the risk of getting HIV:
- Take emtricitabine/tenofovir disoproxil STADA every day to reduce the risk, not just when you think you have been exposed to the risk of getting HIV – infection. Do not miss any dose of Emtricitabine / Tenofovir disoproxil Stada or stop taking it. If you miss the dose you may be more likely that you suffer from HIV – infection increase.
- Get tested regularly for HIV.
- If you think you have been infected with HIV, tell your doctor immediately. Your doctor may want to perform several tests to make sure you are still HIV- negative.
- Taking Emtricitabine / Tenofovir disoproxil Stada alone may not prevent you from getting HIV.
- Always exercise safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
- Do not share personal items where there may be blood or body fluids, e.g. toothbrushes and razor blades.
- Do not share or reuse needles or other injection or drug equipment.
- Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make it easier for you to get infected with HIV.
Ask your doctor if you have more questions about how to prevent getting HIV or transmitting HIV to other people.
While you are taking Emtricitabine / Tenofovir disoproxil Stada for HIV treatment or to reduce your risk of getting HIV:
- Emtricitabine / Tenofovir disoproxil Stada may affect your kidneys. Before and during treatment, your doctor may prescribe some blood tests to measure your kidney function. Tell your doctor if you have a history of kidney disease or if tests have shown that you have kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabine / Tenofovir disoproxil Stada or, if you already have HIV, to take the tablets less often. Emtricitabine / Tenofovir disoproxil Stada is not recommended if you have severe kidney disease or if you are on dialysis. Skeletal problems (sometimes leading to fractures ) can also occur due to damage to the renal tubules (see section 4, Possible side effects).
- Tell your doctor if you already have or have had liver disease, including hepatitis. HIV patients with liver disease (including chronic hepatitis B or C) treated with antiretroviral agents are at increased risk for severe and potentially fatal liver complications. If you have hepatitis B or C, your doctor will carefully choose the best treatment for you.
- Find out your hepatitis B virus status (HBV status) before you start taking Emtricitabine / Tenofovir disoproxil Stada. If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine / Tenofovir disoproxil Stada, whether you have HIV or not. It is important not to stop taking Emtricitabine / Tenofovir disoproxil Stada without talking to your doctor, see section 3, “ Do not stop taking Emtricitabine / Tenofovir disoproxil Stada ”.
- Talk to your doctor if you are over 65 years old. Emtricitabine / Tenofovir disoproxil Stada has not been studied in patients over 65 years of age.
- Talk to your doctor if you have lactose intolerance (see ‘Emtricitabine / Tenofovir disoproxil Stada contains lactose’ later in this section).
Children and young people
Emtricitabine / Tenofovir disoproxil Stada should not be used in children and adolescents under 18 years of age.
Other medicines and Emtricitabine / Tenofovir disoproxil Stada
Do not take Emtricitabine / Tenofovir disoproxil Stada if you are already taking other medicines that contain the components of Emtricitabine / Tenofovir disoproxil Stada, emtricitabine, and tenofovir disoproxil, or other antiviral medicines that contain tenofoviralafenamide, lamivudine, or adefovir dipivoxil.
Taking Emtricitabine / Tenofovir disoproxil Stop using other medicines that may damage your kidneys: it is especially important to tell your doctor if you are taking
- some such drugs, including
- aminoglycoside is (against a bacterial infection )
- amphotericin B (against fungal infection)
- foscarnet (against a viral infection)
- ganciclovir (for virus infection)
- pentamidine (against infection )
- vancomycin (against a bacterial infection )
- interleukin -2 (for the treatment of cancer)
- cidofovir (for virus infection)
- non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve skeletal or muscle pain).
If you are taking other antiviral medicines, called protease inhibitors, for the treatment of HIV, your doctor may prescribe blood tests to closely monitor your kidney function.
It is also important that you tell your doctor if you are taking ledipasvir/sofosbuvir to treat hepatitis C infection.
Taking emtricitabine/tenofovir disoproxil STADA with other medicines containing didanosine (for the treatment of HIV – infection ): If you take emtricitabine/tenofovir disoproxil STADA with other antiviral medicines that contain didanosine, blood levels of didanosine increase and CD4 cell counts. Rare cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), in some cases fatal, have been reported during concomitant treatment with drugs containing tenofovir disoproxil and didanosine. Your doctor will carefully consider whether you can be treated with a combination of tenofovir and didanosine.
→ Tell your doctor if you are taking any of these medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Emtricitabine / Tenofovir disoproxil Stada with food, drink, and alcohol
Whenever possible, Emtricitabine / Tenofovir disoproxil Stada should be taken with food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Although there are limited clinical data on the use of Emtricitabine / Tenofovir disoproxil Stada during pregnancy, it is not usually used unless clearly necessary.
- If you are a woman who may become pregnant during treatment with Emtricitabine / Tenofovir disoproxil Stada, you must use an effective method of contraception to avoid pregnancy.
- If you are becoming or planning to become pregnant, you must contact your doctor to discuss the benefits and risks of treatment with Emtricitabine / Tenofovir disoproxil Stada for you and your baby.
If you have taken Emtricitabine / Tenofovir disoproxil Stada during your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to check your baby’s development. For children with a mother who has taken NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.
Do not breast-feed during treatment with Emtricitabine / Tenofovir disoproxil Stada. This is because the active substances in this medicine are excreted in human breast milk.
If you are an HIV- infected woman, do not breast-feed your baby to avoid transmitting HIV to your baby through breast milk.
Driving and using machines
Emtricitabine / Tenofovir disoproxil Stada may cause dizziness. Do not drive or use any tools or machines if you feel dizzy while taking Emtricitabine / Tenofovir disoproxil Stada.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Emtricitabine / Tenofovir disoproxil Stada contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. essentially “sodium-free”.
How to use Emtricitabine / Tenofovir disoproxil Stada
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of emtricitabine/tenofovir disoproxil Stada for treatment for HIV or to reduce the risk of getting HIV are:
- Adults: one tablet a day. Whenever possible, Emtricitabine / Tenofovir disoproxil Stada should be taken with food.
If you have difficulty swallowing, you can crush the tablet with the tip of a spoon. Then mix the powder with about 100 ml (half a glass) of water, orange juice, or grape juice and drink immediately.
- Always take the dose prescribed by your doctor to ensure that the medicine is effective and to reduce the development of resistance to treatment. Do not change the dose unless your doctor tells you to.
- If you are being treated for HIV – infection, your doctor will write out the emtricitabine/tenofovir disoproxil STADA with other antiretroviral drugs. Read the package leaflets for these medicines for instructions on how to take them.
- If you are taking Emtricitabine / Tenofovir disoproxil Stada to reduce the risk of getting HIV, take Emtricitabine / Tenofovir disoproxil Stada every day, not just when you think you are at risk of being infected with HIV.
Ask your doctor if you have any questions about how to prevent getting HIV or transmitting HIV to other people.
If you use more Emtricitabine / Tenofovir disoproxil Stada then you should
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Save the jar so you can easily describe what you have taken.
If you forget to use Emtricitabine / Tenofovir disoproxil Stada
You mustn’t miss a dose of Emtricitabine / Tenofovir disoproxil Stada.
- If you notice it within 12 hours from the time you usually take Emtricitabine / Tenofovir disoproxil Stada, take the tablet, preferably with food, as soon as possible. Then take the next dose at the usual time.
- If you notice it 12 hours or more after the time you usually take Emtricitabine / Tenofovir disoproxil Stada, ignore the missed dose. Wait and take the next dose, preferably with food, at the usual time.
If you vomit within less than 1 hour after a dose of Emtricitabine / Tenofovir disoproxil Stada, take a new tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking Emtricitabine / Tenofovir disoproxil Stada.
If you stop using Emtricitabine / Tenofovir disoproxil Stada
Do not stop taking Emtricitabine / Tenofovir disoproxil Stada
- If you take emtricitabine/tenofovir disoproxil Stada for treatment of HIV – infection if you stop taking the tablets, the effect of the anti- HIV treatment the doctor has recommended is reduced.
- If you are taking Emtricitabine / Tenofovir disoproxil Stada to reduce the risk of getting HIV, do not stop taking Emtricitabine / Tenofovir disoproxil Stada or miss any dose. If you stop using emtricitabine/tenofovir disoproxil Stada or miss the dose you, the risk of you getting HIV – infection increase.
→ Do not stop taking Emtricitabine / Tenofovir disoproxil Stada without first talking to your doctor.
- If you have chronic hepatitis B, you mustn’t stop taking Emtricitabine / Tenofovir disoproxil Stada without talking to your doctor first. You may need to submit blood samples for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, discontinuation of treatment is not recommended as this may lead to worsening of hepatitis A, which may be life-threatening.
→ Tell your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects:
- Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect. Lactic acidosis occurs more frequently in women, especially if they are overweight, and in people with liver disease. The following may be signs of lactic acidosis:
- deep, rapid breathing
- drowsiness
- nausea, vomiting
- abdominal pain.
→ If you think you may have lactic acidosis, seek medical attention immediately.
- Any signs of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, ( the infection that occurs in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after the treatment against HIV begin. It is believed that these symptoms are due to an improvement in the body’s immune system and enable the body to fight infections that may have existed without any visible symptoms.
- Autoimmune disorders, where the immune system attacks healthy body tissue, can also occur after you start taking medicines for the treatment of HIV – infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms such as:
- muscle weakness
- weakness that begins in the hands and feet and moves upwards towards the torso
- palpitations, tremors or hyperactivity.
→ If you notice these or any symptoms of inflammation or infection, seek medical attention immediately.
Any side effects are
A very common side effect is (can occur in more than 1 in 10):
- diarrhea, vomiting, nausea
- dizziness, headache
- rash
- feeling weak.
Samples can also show:
- lowering of phosphate levels in the blood
- elevated creatine kinase.
Common side effects are (may affect up to 1 in 10):
- pain, abdominal pain
- difficulty sleeping, abnormal dreams
- indigestion which results in discomfort after meals, feeling of bloating, flatulence
- skin rash (including red spots or skin blemishes sometimes with blistering and swelling of the skin) which may be allergic reactions, itching, discoloration of the skin including dark spots on the skin
- other allergic reactions, such as wheezing/wheezing, swelling, or intoxication.
Samples can also show:
- low white blood cell count (a decrease in white blood cell count may make you more likely to get an infection )
- elevated levels of triglycerides (fatty acids) in the blood, increased amount of bile pigments in the blood, or elevated blood sugar
- liver and pancreatic disorders.
Less common side effects are (may affect up to 1 in 100):
- abdominal pain (stomach) caused by inflammation of the pancreas
- swelling of the face, lips, tongue, or throat
- anemia (low red blood cell count )
- muscle breakdown, muscle pain, or muscle weakness that can occur due to damage to kidney tubules.
Samples can also show:
- decreased potassium levels in the blood
- elevated creatinine content in the blood
- changes in the urine.
Rare side effects are (may affect up to 1 in 1000):
- lactic acidosis (see Possible serious side effects )
- fatty liver
- yellow skin or yellow eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver
- kidney inflammation, urinating a lot and feeling thirsty, kidney failure, damage to kidney tubules
- impaired bone hardness (which causes skeletal pain and sometimes leads to fractures )
- back pain caused by kidney problems.
- Damage to kidney tubules can be associated with muscle breakdown, decreased bone hardness (which causes skeletal pain and sometimes leads to fractures ), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood.
→ If you notice any of the above side effects or if any of the side effects gets serious, talk to your doctor or pharmacist.
The frequency of the following side effects is unknown.
- Skeletal problem. Some patients taking combination antiretroviral medicines such as Emtricitabine / Tenofovir disoproxil Stada may develop a bone disease called osteonecrosis (bone tissue death caused by the lost blood supply to the bone tissue). Some of the many risk factors for developing this disease are long-term use of this type of drug, use of corticosteroids, use of alcohol, very weak immune system, and obesity. Signs of osteonecrosis are:
- joint stiffness
- joint pain and pain (especially in the hip joint, knee joint, and shoulder joint)
- difficulty moving.
→ Tell your doctor if you notice any of these symptoms.
During treatment for HIV, there may be weight gain and an increase in blood fat and blood glucose levels. This is partly related to improved health and lifestyle and as far as blood fats are concerned, sometimes with the HIV drugs themselves. Your doctor will take samples for this.
5. How to store Emtricitabine / Tenofovir disoproxil Stada
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 can and carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive. Close the jar tightly.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substances are emtricitabine and tenofovir disoproxil.
One Emtricitabine / Tenofovir disoproxil Stada film-coated tablet contains 200 mg emtricitabine and 245 mg tenofovir disoproxil (equivalent to 300.6 mg tenofovir disoproxil succinate).
The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), pregelatinized maize starch, croscarmellose sodium, magnesium stearate (E470b), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521b), talc (E15igm) (ind2g).
What the medicine looks like and the contents of the pack
Emtricitabine / Tenofovir disoproxil Stada is a blue capsule-shaped, film-coated tablet that is smooth on both sides. The dimensions of the tablet are 19.3 mm x 8.8 mm ± 5%.
Emtricitabine / Tenofovir disoproxil Stada is supplied in HDPE bottles of 30 tablets. Each jar contains desiccant (silica gel) which must be present in the jar to protect the tablets. The desiccant (silica gel) is contained in a separate container and should not be swallowed.
Pack sizes: 1 x 30 film-coated tablets and 3 x 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Remedica Ltd
Aharnon Street, Limassol Industrial Estate, 3056 Limassol
Cyprus
STADA Arzneimittel GmbH
Muthgasse, 36/2, 1190 Vienna
Austria
STADA Nordic ApS
Marielundvej 46A, 2730 Herlev
Denmark
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC Etten-Leur
Netherlands
Clonmel Healthcare Ltd
Waterford Road, Clonmel, Co. Tipperary
Ireland
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark