245 mg film-coated tablets
tenofovir disoproxil
1. What Ictady is and what it is used for
Ictady contains the active substance tenofovir disoproxil succinate. This active substance is an antiretroviral or antiviral medicine used to treat HIV or HBV infection or both. Tenofovir is a nucleotide-type reverse transcriptase inhibitor, commonly called an NRTI, and acts by affecting the normal function of enzymes (in HIV reverse transcriptase; in HBV DNA polymerase ) as a virus needed for its reproduction (propagation). For HIV, Ictady should always be taken in combination with other anti- HIV medicines.
Ictady 245 mg tablets is a treatment for HIV – (human immunodeficiency virus) infection. The tablets are suitable for:
- adults
- young people aged 12 to younger than 18 who have already been treated with other HIV drugs that can no longer be as effective because of resistance development, or have caused side effects are .
Ictady 245 mg tablets are also used to treat chronic hepatitis B, infection with HBV ( hepatitis B virus ). The tablets are suitable for:
- adults
- young people aged 12 to younger than 18 years
You do not need to have HIV to be treated with Ictady for HBV.
This medicine does not cure HIV – infection. While taking Ictady you may still develop infections you or other illnesses associated with HIV – infection. You can also pass on HIV or HBV to others, and it is therefore important that you take precautions to avoid infecting other people.
Tenofovir disoproxil contained in Ictady may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before taking Ictady
Do not take Ictady
- If you are allergic to 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 and do not take Ictady.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ictady.
- Be careful not to infect other people. You can still transmit HIV infection while taking this medicine, although the risk of effective antiviral therapy is reduced . Discuss with your doctor the necessary steps to avoid infecting others. Ictady does not reduce the risk of transmitting HBV to others through sexual contact or blood transfusion. You still need to take precautions to avoid this.
- Talk to your doctor or pharmacist if you have a history of kidney disease or if tests have shown that you have kidney problems. Ictady should not be given to adolescents with kidney problems. Before starting treatment, your doctor may prescribe some blood tests to assess that your kidneys are functioning normally. Ictady may affect your kidneys during treatment. Your doctor may prescribe blood tests during treatment to check how your kidneys are working. If you are an adult, your doctor may advise you to take the tablets less often. Do not reduce the prescribed dose one unless your doctor tells you to.
Ictady is not usually taken with other medicines that can damage the kidneys (see Other medicines and Ictady ). If this can not be avoided, your doctor will check your kidney function once a week.
- Skeletal problem. Some adult HIV patients receiving combination antiretroviral therapy may develop a skeletal disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are: long-term antiretroviral combination therapy , use of corticosteroids , alcohol consumption, severe weakening of the immune system and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
Skeletal problems (which manifest as persistent or aggravated skeletal pain and sometimes lead to fractures ) may also occur due to damage to renal tubules (see section 4, Possible side effects ) . Tell your doctor if you have skeletal pain or a fracture .
Tenofovir disoproxil may also cause bone loss. The most pronounced loss of bone mass was seen in clinical trials when patients were treated with tenofovir disoproxil in combination with an enhanced protease inhibitor .
Overall, the effects of tenofovir disoproxil on long-term skeletal health and future fracture risk in adults and children are uncertain.
Tell your doctor if you know you have osteoporosis. Patients with osteoporosis are at higher risk for fractures .
- Tell your doctor if you have or have had liver disease, including hepatitis . Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully choose the best treatment for you. If you have or have had liver disease or chronic hepatitis B, your doctor may take blood samples to check your liver function.
- Be observant of infection is. If you have HIV – infection in the advanced stage ( AIDS ) and have an infection , you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Ictady begins. These symptoms may indicate that your body’s improved immune system is fighting infection . Be aware of signs of inflammation or infection during the first period after you start taking Ictady. If you notice signs of inflammation or infection, you should inform your doctor immediately.
In addition to opportunistic infection, you can autoimmune disorders (conditions in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, informs your doctor immediately for the necessary treatment.
- Talk to your doctor or pharmacist if you are over 65 years old. Ictady has not been studied in patients over 65 years of age. If you are older than that and have been prescribed Ictady, your doctor will monitor you closely.
Children and young people
Ictady 245 mg tablets are suitable for:
- HIV-1 -infected adolescents aged 12 to younger than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines that no longer have a satisfactory effect due to the development of resistance or have caused side effects .
- HBV-infected adolescents aged 12 years to younger than 18 years who weigh at least 35 kg .
Ictady 245 mg tablets are not suitable for the following groups:
- Not for HIV -1 infected children under 12 years of age.
- Not for HBV-infected children under 12 years.
For dosage, see section 3, How to take Ictady.
Other medicines and Ictady
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
- Do not stop taking any HIV medicine prescribed by your doctor when you start taking Ictady, if you have both HBV and HIV .
- Do not take Ictady if you are already taking other medicines containing tenofovir disoproxil. Do not take Ictady with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
- It is very important that you tell your doctor if you are taking other medicines that may damage your kidneys.
Such drugs are:- aminoglycosides , pentamidine or vancomycin (against bacterial infection ),
- amphotericin B (against fungal infection),
- foscarnet, ganciclovir or cidofovir (for virus infection),
- interleukin -2 (for the treatment of cancer),
- adefovir dipivoxil (for HBV),
- tacrolimus (for suppression of the immune system),
- non-steroidal anti-inflammatory drugs ( NSAIDs , to relieve skeletal or muscle pain).
- Other medicines containing didanosine (for HIV – infection ): If you take Ictady with other antiviral medicines that contain didanosine, blood levels of didanosine and increase 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.
- It is also important that you tell your doctor if you are taking ledipasvir / sofosbuvir to treat hepatitis C infection.
Ictady with food, drink and alcohol
Take Ictady with food (eg a meal or a snack).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- If you are pregnant, you should not take Ictady until you have specifically discussed this with your doctor. Although there are limited clinical data on the use of Ictady during pregnancy, it is not usually used unless absolutely necessary.
- If you are becoming or planning to become pregnant , you should contact your doctor to discuss the potential benefits and risks of your antiretroviral therapy for you and your baby.
- If you have taken Ictady 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 medicines such as Ictady (NRTIs) during pregnancy, the benefit of HIV protection outweighs the risk of side effects .
- If you are a mother and you have HBV, and your baby has been treated to prevent hepatitis B transmission at birth, you may be able to breast-feed your baby, but talk to your doctor first for more information.
- If you are an HIV -infected mother, do not breast-feed your baby to avoid transmitting the virus to your baby through breast milk.
Driving and using machines
Ictady may cause dizziness. Do not drive or cycle or use tools or machines if you feel dizzy while taking Ictady.
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.
Ictady contains lactose
Talk to your doctor before taking Ictady if you are lactose intolerant or if you do not tolerate any sugar.
Ictady contains sodium
This medicine contains less than 1 mmol (23 mg) per tablet, ie. is almost sodium-free.
3. How to take Ictady
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
- Adults: 1 tablet a day with food (eg a meal or a snack).
- Adolescents aged 12 to younger than 18 years weighing at least 35 kg: 1 tablet a day with food (eg a meal or a snack).
If you have particular 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 an adult and have kidney problems, your doctor may advise you to take Ictady less often.
- If you have HBV, your doctor may offer you an HIV test to see if you have both HBV and HIV .
Read the package leaflets of the other antiretroviral medicines for information on how to take these medicines.
If you take more Ictady than you should
If you accidentally take too many tablets Ictady, you risk getting any side effects of this medicine (see section 4, Possible side effects). If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact your doctor, the nearest emergency department, 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 take Ictady
It is important that you do not miss any dose of Ictady. If you miss a dose, calculate when you should have taken it.
- If less than 12 hours have passed since the time it is usually taken, take it as soon as possible, and then take the next dose at its usual time.
- If it has been more than 12 hours since you should have taken it, do not take the missed dose . Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten tablet.
If you vomit within less than 1 hour after a dose of Ictady, take a new tablet. You do not need to take a new tablet if you vomit more than 1 hour after taking Ictady.
If you stop taking Ictady
Do not stop taking Ictady without consulting a doctor. Discontinuation of Ictady treatment may result in a reduced effect of the treatment recommended by your doctor.
If you have hepatitis B or HIV – infection and hepatitis B infection at the same time, it is very important not to stop Ictady treatment without first talking to your doctor. Some patients’ blood tests or symptoms have shown that their hepatitis has worsened when treatment with Ictady is stopped. You may need to submit blood samples for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, discontinuation of treatment is not recommended as this may lead to a worsening of hepatitis infection in some patients.
- Talk to your doctor before stopping Ictady for any reason, especially if you experience any side effects or have any other illness.
- Inform 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 .
- Contact your doctor before taking Ictady again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects: inform your doctor immediately
- Lactic acidosis (excess lactic acid in the blood) is a rare ( may occur in up to 1 in 1,000 patients ) but serious side effect that can be fatal. The following side effects may be signs of lactic acidosis:
- deep, rapid breathing
- drowsiness
- nausea, vomiting and abdominal pain
If you think you may have lactic acidosis, contact your doctor immediately.
Other possible serious side effect s
The following side effects are uncommon ( they may affect up to 1 in 100 people ):
- pain in the stomach (abdomen) caused by inflammation of the pancreas
- damage to the kidney (renal tubules)
The following side effects are rare ( may affect up to 1 in 1,000 patients ):
- kidney inflammation, that you urinate a lot and that you feel thirsty
- changes in urine and back pain caused by kidney problems, including kidney failure
- impaired bone hardness (which causes bone pain and sometimes leads to fractures ), which can occur due to damage to kidney tubules
- fatty liver
If you think you may have any of these serious side effects, talk to your doctor.
The most common side effects are
The following side effects are very common ( side effects that occur in more than 10 in 100 patients ):
- diarrhea, vomiting, nausea, dizziness, rash, feeling weakSamples can also show:
- lowering of the phosphate content in the blood
Other possible side effects are
The following side effects are common ( side effects that occur in up to 10 in 100 patients ):
- headache, abdominal pain, feeling tired, feeling bloated, gasSamples can also show:
- liver problems
The following side effects are uncommon ( side effects that occur in up to 1 in 100 patients ):
- muscle breakdown, muscle pain or muscle weaknessSamples can also show:
- decreased potassium levels in the blood
- elevated creatinine content in the blood
- pancreatic problems
Muscle breakdown decreased bone hardness (which causes bone pain and sometimes leads to fractures ), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood can occur due to damage to kidney tubules.
The following side effects are rare ( side effects that occur in up to 1 in 1,000 patients ):
- pain in the stomach (abdomen) caused by inflammation of the liver
- swelling of the face, lips, tongue or throat
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.
Läkemedelsverket, Box 26, 751 03 Uppsala
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ictady
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 jar and carton after {EXP}. The expiration date is the last day of the specified month.
No special storage instructions.
Opened packaging must be used within 30 days and stored at a maximum of 25 o C.
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
Content declaration
- The active substance is tenofovirEach Ictady tablet contains 245 mg of tenofovir disoproxil (as succinate).
- Other ingredients are:lactose , microcrystalline cellulose (E460), pregelatinised starch , croscarmellose sodium and magnesium stearate (E470b) which form the tablet core and indigo carmine (E132), titanium dioxide (E171), polyvinyl alcohol (E1203), macrogol talc (E1521 . See section 2 “Ictady contains lactose”.
What the medicine looks like and contents of the pack
Ictady 245 mg film-coated tablets are light blue, almond-shaped, measuring approximately 17.0 mm x 10.5 mm.
Ictady 245 mg film-coated tablets are supplied in cans containing 30 tablets. Each jar contains desiccant (silica gel) which must remain in the jar to protect the tablets. The desiccant (silica gel) is in a separate container and should not be swallowed.
The following pack sizes are available:
30 (1 x 30) film-coated tablets
90 (3 x 30) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
Local representative
SanoSwiss UAB
Lvovo 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com