600 mg / 200 mg / 245 mg film-coated tablets
efavirenz / emtricitabine / tenofovir disoproxil
What Padviram is and what it is used for
- efavirenz is a nucleoside-type non-reverse transcriptase inhibitor (NNRTI)
- emtricitabine is a reverse nucleotide-type transcriptase inhibitor (NRTI)
- tenofovir is a nucleotide-type reverse transcriptase inhibitor (NtRTI)
Padviram contains three active substances that are used to treat human immunodeficiency virus ( HIV ) infection:
These three active substances are antiretroviral drugs that act by affecting the normal function of an enzyme (reverse transcriptase) that the virus needs for its reproduction.
Padviram is a treatment for human immunodeficiency virus ( HIV ) infection in adults aged 18 years and older who have previously been treated with other antiretroviral drugs and who have had their HIV -1 infection under control for at least three months. Patients must not have shown treatment failure with previous HIV treatment.
Efavirenz, emtricitabine, and tenofovir disoproxil contained in Padviram may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Padviram
Do not take Padviram
- If you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
- If you have severe liver disease.
- If you have heart problems, such as an arrhythmia called QT prolongation. This can lead to a high risk of developing severe heart rhythm problems ( torsade de pointes ).
- If someone in your family (parents, grandparents, brothers, or sisters) has died suddenly due to heart problems or was born with heart problems.
- If your doctor has told you that you have high or low levels of electrolytes, such as potassium or magnesium, in your blood.
- If you are taking any of the following medicines at the same time (see also “Other medicines and Padviram”):
- astemizole or terfenadine (used to treat hay fever or other allergies )
- bepridil (used to treat heart disease)
- cisapride (used to treat heartburn)
- elbasvir/grazoprevir (used to treat hepatitis C)
- ergot alkaloids (eg ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
- midazolam or triazolam (sleeping pills)
- pimozide, imipramine, amitriptyline, or clomipramine (used to treat certain mental illnesses)
- St. John’s wort ( Hypericum perforatum ) (an herbal medicine used for mild depression and mild anxiety)
- voriconazole (used to treat fungal infections)
- flecainide, metoprolol (for the treatment of irregular heartbeat)
- certain antibiotics ( macrolides , fluoroquinolones , imidazole)
- certain antifungal drugs (triazoles)
- certain anti-malarial drugs
- methadone (for the treatment of opioid dependence).
→ If you are taking any of these medicines, tell your doctor immediately. Taking these medicines together with Padviram may cause serious or life-threatening side effects or counteract the effects of these medicines.
Warnings and cautions
Talk to your doctor or pharmacist before taking this medicine.
- You can still transmit HIV infection while taking this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV infection. While you are taking this medicine, you may still develop infections or other diseases associated with HIV infection.
- You must continue to be under medical supervision while taking this medicine.
- Inform your doctor:
- if you are taking other medicines containing efavirenz, emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine or adefovir dipivoxi. This medicine should not be taken with any of these medicines.
- if you have or have had kidney disease or if tests have shown that you have kidney problems. This medicine is not recommended if you have moderate to severe kidney disease.
This medicine may affect your kidneys. Before starting treatment, your doctor may prescribe a blood test to check your kidney function. Your doctor may also prescribe blood tests during treatment to check your kidneys.
This medicine is not usually taken with other medicines that can damage the kidneys (see Other medicines and Padviram). If this is unavoidable, your doctor will check your kidney function once a week. - if you have a heart condition, such as an abnormal electrical signal called an extended QT interval.
- if you have had a mental illness including depression or drug or alcohol abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts, or have strange thoughts (see section 4, Possible side effects).
- if you have had seizures or if you are being treated with anticonvulsants such as carbamazepine, phenobarbital, and phenytoin. If you are taking any of these medicines, your doctor may need to check how much of the medicine is in your bloodstream to ensure that it is not affected when you take this medicine. Your doctor may give you another medicine for seizures.
- if you have had liver disease, including chronic active hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are being treated with combination antivirals are at increased risk for serious and potentially life-threatening liver problems. Your doctor may take blood samples to check your liver function or allow you to switch to another medicine. If you have severe liver disease, do not take Padviram (see section 2, Do not take Padviram).
If you have a hepatitis B infection, your doctor will carefully choose the best treatment for you. Tenofovir disoproxil and emtricitabine, two of the active substances in this medicine, have some activity against the hepatitis B virus even though emtricitabine is not approved for the treatment of hepatitis B infection. The symptoms of your hepatitis may worsen after you stop taking this medicine. Your doctor may then take blood samples regularly to check your liver function (see section 3, If you stop taking Padviram). - Whether or not you have had liver disease, your doctor will consider taking regular blood tests to check your liver function.
- if you are over 65 years old. The insufficient number of patients over 65 years has been studied. If you are over 65 years of age and have been prescribed this medicine, your doctor will monitor you closely.
- When you start taking Padviram you should be observant of:
- symptoms such as dizziness, difficulty sleeping, drowsiness, difficulty concentrating, or abnormal dreams. These side effects may occur in the first 1 to 2 days after treatment and usually disappear after 2 to 4 weeks.
- symptoms of rash. This medicine may cause a rash. If you get a severe rash with blistering or fever, stop taking Padviram and tell your doctor straight away. If you get a rash while taking another NNRTI, you may be at greater risk of getting a rash with this medicine.
- symptoms of inflammation or infection. In some patients with advanced HIV infection ( AIDS ) and who have previously had opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting treatment for HIV. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present but without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection.
In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissues) can also occur after you start taking medicines to treat your HIV infection. Autoimmune disorders can occur several months after starting treatment. If you get any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment. - skeletal problems. Some patients receiving combination antiretroviral therapy may develop a skeletal disease called osteonecrosis (skeletal tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and a higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially hip, knee, and shoulder) 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 bone beauty are at higher risk for fractures.
Children and young people
Padviram should not be given to children and adolescents under 18 years of age. This medicine has not yet been studied in children and adolescents.
Other medicines and Padviram
You must not take certain medicines with Padviram. These are listed under Do not take Padviram, at the beginning of section 2 and include some common medicines and some herbal medicines (including St. John’s wort) which may cause serious interactions.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In addition, this medicine should not be taken with other medicines containing efavirenz (unless your doctor recommends it), emtricitabine, tenofovir disoproxil, tenofoviralafenamide, lamivudine or adefovir dipivoxil.
Tell your doctor if you are taking other medicines that may damage your kidneys. Examples of such drugs are:
- aminoglycosides, vancomycin (medicine for bacterial infection)
- foskarnet, ganciclovir, cidofovir (medicines for viral infections)
- amphotericin B, pentamidine (medicine for fungal infections)
- interleukin -2 (for the treatment of cancer)
- non-steroidal anti-inflammatory drugs ( NSAIDs, to relieve skeletal or muscle pain).
Padviram may interact with other medicines, including herbal medicines such as Ginkgo biloba extract. As a result, the amount of Padviram or other medicines in the blood may be affected. This can lead to the medicines not working properly or the side effects getting worse. In some cases, your doctor may need to adjust your dose or check your blood levels. You must tell your doctor or pharmacist if you are taking any of the following:
- Drugs containing didanosine (for HIV infection ): If you take this medicine together with other antiviral medicines containing didanosine, your blood levels of didanosine may increase and your CD4 cell count may decrease. 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 medicines containing tenofovir and didanosine.
- Other medicines used to treat HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir with an increased dose of atazanavir or saquinavir. Your doctor may consider giving you alternative medicines or changing the dose of one of your protease inhibitors. Also, tell your doctor if you are taking maraviroc.
- Medicines used to treat hepatitis C virus infection: elbasvir / grazoprevir, glekaprevir / pibrentasvir, sofosbuvir / velpatasvir, sofosbuvir / velpatasvir / voxilaprevir.
- Drugs used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. This medicine may reduce the number of statins in your blood. Your doctor will check your cholesterol level and, if necessary, consider changing your statin dose.
- Drugs used in the treatment of seizures ( antiepileptic drugs ): Carbamazepine, phenytoin, phenobarbital. Padviram may reduce the number of antiepileptic drugs in the blood. Carbamazepine may reduce the amount of efavirenz, one of the ingredients in this medicine, in the blood. Your doctor may consider giving you another antiepileptic drug.
- Drugs for the treatment of bacterial infections, including tuberculosis and AIDS-related Mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin. Your doctor may consider changing your dose or giving you another antibiotic. Your doctor may also consider adding a dose of efavirenz to treat your HIV infection.
- Medicines used to treat fungal infections: Itraconazole or posaconazole. This medicine may reduce the amount of ketoconazole or posaconazole in the blood. Your doctor may consider giving you another medicine for a fungal infection.
- Medicines used to treat malaria: Atovaquone/proguanil or artemether / lumefantrine: this medicine may reduce the amount of atovaquone / proguanil or artemeter / lumefantrine in the blood.
- Hormonal contraceptives, such as birth control pills,an injected contraceptive (eg Depo-Provera) o,r a contraceptive implant (eg Implanon): You must always use a reliable barrier contraceptive method (see Pregnancy and breast-feeding). Padviram may have a worse effect on hormonal contraceptives. Pregnancy has occurred in women taking efavirenz, one of the ingredients of this medicine, while using a contraceptive implant, although it has not been established that efavirenz treatment was the reason for the lack of contraceptive effect.
- Sertraline, is a medicine used to treat depression, your doctor may change your dose of sertraline.
- Bupropion,a medicine used to treat depression or to help quit smoking, your doctor may change your dose of bupropion.
- Diltiazem or similar medicines (so-called calcium channel blockers): When you start taking this medicine, your doctor may need to adjust your dose of the calcium channel blockers.
- Drugs used to prevent the rejection of transplanted organs (and also called immunosuppressive drugs) such as ciclosporin, sirolimus o,r tacrolimus. When you start or stop taking this medicine, your doctor will make frequent checks on your plasma levels of the immunosuppressive medicine and may need to adjust its dose.Warfarin or acenocoumarol (medicines used to inhibit blood clotting ): Your doctor may need to adjust your dose of warfarin or acenocoumarol.
- Ginkgo biloba extract (an herbal medicine).
- Metamizole,a medicine used to treat pain and fever.
Pregnancy and breastfeeding
If you are pregnant or brbreastfeedingthink you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women should not become pregnant during treatment with Padviram or for 12 weeks thereafter.Your doctor may ask you to take a pregnancy test to make sure you are not pregnant before starting your treatment with this medicine.
If you could become pregnant during treatment with Padviram, you must use a reliable barrier contraceptive method (eg condoms) together with other contraceptive methods such as tablets ( birth control pills ) or other hormonal contraceptive methods (eg implants, injection ). Efavirenz, one of the ingredients of this medicine, may remain in the blood for some time after stopping treatment. You should therefore continue to use contraception, as described above, for 12 weeks after stopping taking this medicine.
Tell your doctor immediately if you are pregnant or planning to become pregnant. If you are pregnant, you should only take Padviram if you and your doctor decide that there is a clear need.
Serious malformations have been observed in fetal animals and neonates in women treated with efavirenz during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine.
If you have taken Padviram during your pregnancy, your doctor may ask you to have regular blood tests and other tests to check your baby’s development. For children whose momothersook NRTIs during pregnancy, the benefit of HIV protection outweighs the risk of side effects.
Do not breastfeed during treatment with Padviram. Both HIV and the ingredients in this medicine can be transferred to breast milk and can seriously harm your baby.
Driving and using machines
Padviram may cause dizziness, impaired concentration,nd drowsiness. If you get these symptoms, do not drive, use any tools or machines.
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 anand/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.
Padviram contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Padviram
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:
One tablet once a day by mouth. Padviram is recommended to be taken on an empty stomach (usually defined as 1 hour before or 2 hours after a meal), preferably at bedtime. This may help reduce certain side effects (eg dizziness, drowsiness). Swallow the tablet whole with water.
Padviram must be taken every day.
If your doctor decides to remove one of the ingredients of this medicine, you may receive efavirenz, emtricitabine, anand/tenofovir disoproxil separately or with other medicines to treat your HIV infection.
If you take more Virviram than you should
If you accidentally take too many tablets of Padviram, you may be at greater risk of side effects from this medicine (see section 4, Possible side effects ).
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Save the outer carton or jar so that you can easily describe what you have taken.
If you forget to take Padviram
you mustn’t a dose of Padviram.
If you miss a dose of Padviram within 12 hours of the time it is usually taken, take it as soon as possible, and then take the next dose at its usual time.
If it is almost time (less than 12 hours) for the next dose, do not take the missed dose. Wait and take the next dose at its usual time. Do not take a double dose to make up for a forgotten tablet.
If you vomit the tablet (within 1 hour of taking Padviram), take a new tablet. Do not wait until it is time for your next tablet. You do not need to take a new tablet if you vomit for more than
1 hour after taking Padviram.
If you stop taking Padviram
Do not stop taking Padviram without talking to your doctor. Discontinuation of treatment with this drug can seriously affect how you respond to treatment in the future. If you have stopped taking this medicine, talk to your doctor before taking tablets again. If you have problems or need to adjust the dose, your doctor may consider giving you the ingredients of this medicine separately.
When your Padviram tablets start to run out,be sure to get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase as soon as you stop taking the medicine, even if it is only for a short time. The virus can then be more difficult to treat.
If you have both HIV infection and hepatitis B, you mustn’t stop treatment without talking to your doctor first. Some patients’ blood tests or symptoms have shown that their hepatitis worsens when treatment is stopped with emtricitabine or tenofovir disoproxil (two of the three ingredients in this medicine). If you stop taking this medicine, your doctor may recommend that you resume hepatitis B treatment. You may need to submit blood samples for 4 months after stopping treatment to check your liver function. In some patients with advanced liver or cirrhosis of the liver, discontinuation of treatment is not recommended as this may lead to hepatitis one worsening, which can be life-threatening.
→ Tell your doctor immediately about new or unusual symptoms that occur after stopping treatment, especially symptoms associated with hepatitis B infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects,although not everybody gets them.
Important side effects or symptoms to be aware of and measures to take if you are affected:
This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching,especially those that cover your entire body.
Another serious side effect is a condition where you breathe slower or weaker than expected. This mainly affects elderly and weak patients.
If you are experiencing these important side effects, consult a doctor immediately.
Other side effects that may occur:
| Very common: (may affect more than 1 in 10 people) | nausea, vomiting, dizziness, drowsiness, headache. |
| Common: (may affect up to 1 in 10 people) | decreased appetiteconcernconfusionhallucinationssleeping problems abnormalreamsshakingredness isconstipationdiarrheaindigestiondry mouthitchingincreased sweatingrashmuscle cramp feeling of weaknessfatiguefeeling of changed body temperature |
| Uncommon:(may affect up to 1 in 100 people) | Depressionorientation difficultiesagitation _ _nervousnessrestlessnesselated mood disturbed attention memory impairmentfainting sensationdrowsiness ( sedation )difficulties in controlling movements difficulty speakingnumbnessabnormal sensations in the skin (eg tickling tingling)muscle twitchingabnormal sin increased heart ratepalpitationdecreased blood pressure dangerously slow or shallow breathing ( respiratory depression )decreased oxygen in the blood respiratory distress feeling of discomfort in the abdomenhivesfeeling of heavinessdelay in emptying the bladder, frequent urinationwithdrawal symptoms ( abstinence ) of drugs (see “If you stop taking Palexia”)accumulation of water in the tissues ( edema )feel abnormal feeling of intoxication, irritability feeling of relaxation |
| Rare:(affects 1-10 of10,000 users) | allergic reactions of the drug including swelling under the skin, hives, and in severe cases difficulty breathing, drop in blood pressure, collapse or shock )abnormal thought epileptic seizuresimpaired consciousnessabnormal coordination decreased heart rate impaired emptying of the stomach |
| Not known: | delirium |
In general, patients with chronic pain are more likely to have suicidal thoughts and behaviors. In addition, some medications used for depression (which affect neurotransmitters in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data from the use of tapentadol in humans do not provide any evidence of increased risk.
How to store Palexia
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 carton after “EXP”. and on the blister after “EXP”.
The expiration date is the last day of the specified month.
No special storage instructions.
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.
Contents of the pack and other information
Content declaration
The active substance is tapentadol.
Each tablet contains 50 mg tapentadol (as 58.24 mg tapentadol hydrochloride).
Each tablet contains 75 mg of tapentadol (as 87.36 mg of tapentadol hydrochloride).
Each tablet contains 100 mg of tapentadol (as 116.48 mg of tapentadol hydrochloride).
Other ingredients are:
Palexia 50 mg film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet cover: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.
Palexia 75 mg film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet cover: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide, yellow (E172), iron oxide, red (E172).
Palexia 100 mg film-coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet cover: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide, yellow (E172), iron oxide, red (E172), iron oxide, black (E172).
What the medicine looks like and the contents of the pack
Palexia 50 mg film-coated tablets:
white round film-coated tablets 7 mm in diameter marked with the Grünenthal logo on one side and “H6” on the other side.
Palexia 75 mg film-coated tablets:
pale yellow round 8-mm film-coated tablets marked with the Grünenthal logo on one side and “H7” on the other side.
Palexia 100 mg film-coated tablets
light pink round film-coated tablets 9 mm marked with the Grünenthal logo on one side and “H8” on the other side.
Palexia film-coated tablets are packaged in blisters and are supplied in cartons of 5, 10, 10×1, 14, 14×1, 20, 20×1, 24, 28, 28×1, 30, 30×1, 40, 50, 50×1, 54, 56, 56×1, 60, 60×1, 90, 90×1, 100 and 100×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
This medicinal product is authorized under the European Economic Area under the names:
Germany: Palexia Akutschmerz
Belgium, Cyprus, Denmark, Finland, France, Greece, Ireland, Italy, Croatia, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom, Sweden, Czech Republic, Austria: PALEXIA