PIFELTRO 100 mg FILM-COATED TABLETS

2. What you need to know before you take Pifeltro

Do not takePifeltro

• if you are allergic to doravirine or any of the other ingredients of this medicine (listed in section 6).
• if you are taking the following medicines:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat seizures)
• rifampicin, rifapentine (medicines to treat tuberculosis)
• St. John's Wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it
• mitotane (a medicine to treat cancer)
• enzalutamide (a medicine to treat prostate cancer)
• lumacaftor (a medicine to treat cystic fibrosis)

Do not take Pifeltro if you are in any of the above situations. If you are unsure, consult your doctor, pharmacist, or nurse before taking Pifeltro. Also, read the section "Other medicines and Pifeltro".

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking Pifeltro.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, have been reported with Pifeltro treatment. Stop taking Pifeltro and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Immune Reconstitution Syndrome

This syndrome may occur when you start treatment with any HIV medicine, including this medicine. Your immune system may become stronger and start to fight infections that have been hidden in your body for a long time. Tell your doctor immediately if you start to have new symptoms after starting HIV medicine.

Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and rising to the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

Children and adolescents

Do not give this medicine to children under 12years of age or weighing less than 35kg.The use of Pifeltro in children under 12 years of age or weighing less than 35 kg has not been studied.

Other medicines andPifeltro

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because other medicines may affect the way Pifeltro works and Pifeltro may affect the way other medicines work.

There are some medicines that you should not take with Pifeltro. Read the list in the section "Do not take Pifeltro".

Talk to your doctor before taking the following medicines with Pifeltro, as your doctor may need to adjust the dose of your medicines:

• bosentan (a medicine to treat lung diseases)
• dabrafenib (a medicine to treat skin cancer)
• lesinurad (a medicine to treat gout)
• modafinil (a medicine to treat excessive sleepiness)
• nafcillin (a medicine to treat certain bacterial infections)
• rifabutin (a medicine to treat certain bacterial infections, such as tuberculosis)
• telotristat ethyl (a medicine to treat diarrhea in people with carcinoid syndrome)
• thioridazine (a medicine to treat psychiatric disorders such as schizophrenia)

If your doctor decides that you should take these medicines with Pifeltro, you should take one doravirine tablet twice a day (with approximately 12 hours between each dose).

Your doctor may check your blood levels or monitor side effects if you take the following medicines with Pifeltro:

• sirolimus (a medicine used to control the immune response of your body after a transplant)
• tacrolimus (a medicine used to control the immune response of your body after a transplant)

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. It is recommended to avoid the use of this medicine during pregnancy, as it has not been studied during pregnancy and it is not known whether it will harm your baby while you are pregnant.

It is not recommended that HIV-infected women breastfeed their babies because HIV infection can be passed to the baby through breast milk.

If you are breastfeeding or think you may want to breastfeed, talk to your doctor as soon as possible.

Driving and using machines

Be careful when driving, cycling, or using machines if you feel tired, dizzy, or drowsy after taking this medicine.

Pifeltro tablets contain lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Pifeltro

Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are unsure, talk to your doctor, pharmacist, or nurse. This medicine must be used in combination with other HIV medicines.

How much to take

The recommended dose is one tablet once a day. If you are taking certain medicines, your doctor may need to adjust the amount of doravirine you take. Read the section "Other medicines and Pifeltro" to see the list of medicines.

How to take this medicine

• Swallow the tablet whole (do not crush or chew it).
• This medicine can be taken with or without food.

If you take more Pifeltro than you should

Do not take a higher dose than recommended. If you accidentally take more than the recommended dose, contact your doctor.

If you forget to takePifeltro

• It is important that you do not miss or skip any dose of this medicine.
• If you forget to take a dose, take it as soon as you remember. However, if it is less than 12 hours until the time of your next dose, skip the missed dose and take the next dose at the usual time. Then continue with your treatment as usual.
• Do not take a double dose to make up for forgotten doses.
• If you are unsure what to do, talk to your doctor or pharmacist.

If you stop takingPifeltro

Do not stop taking this medicine without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Do not stop taking this medicine without talking to your doctor.

Stop taking Pifeltro and seek medical attention immediately if you notice any of the following symptoms: red patches, target-like marks or circular patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can start with fever and symptoms similar to flu (Stevens-Johnson syndrome/toxic epidermal necrolysis). The frequency of these reactions cannot be estimated from the available data.

Other side effects that may occur

Common:may affect up to 1 in 10 people:

• abnormal dreams, difficulty sleeping (insomnia)
• headache, dizziness, drowsiness
• nausea, diarrhea, stomach pain, vomiting, gas (flatulence)
• rash
• feeling tired

Blood tests may also show:

• increased levels of liver enzymes (ALT)

Uncommon:may affect up to 1 in 100 people:

• nightmares, depression, anxiety, irritability, confusion, suicidal thoughts
• concentration problems, memory problems, tingling in hands and feet, muscle stiffness, poor quality sleep
• high blood pressure
• constipation, stomach upset, bloating or swelling of the stomach (abdominal distension), indigestion, soft stools
• itching
• muscle pain, joint pain
• feeling weak, general feeling of being unwell

Blood tests may also show:

• decreased levels of phosphate
• increased levels of liver enzymes (AST)
• increased levels of lipase
• increased levels of amylase
• decreased levels of hemoglobin

Rare:may affect up to 1 in 1,000 people:

• aggression, hallucinations, difficulty adapting to changes, mood changes, sleepwalking
• difficulty breathing, swelling of the tonsils
• feeling of incomplete defecation
• skin inflammation due to an allergy, redness of the cheeks, nose, chin, or forehead, bumps or pimples on the face
• kidney damage, kidney problems, kidney stones
• chest pain, feeling cold, pain, thirst

Blood tests may also show:

• decreased levels of magnesium
• increased levels of creatine phosphokinase

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pifeltro

• 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 bottle after EXP. This medicine should be used within 35 days of first opening the bottle.
• The bottle contains a desiccant that protects the tablets from moisture. Keep the desiccant in the bottle and do not throw it away until you have finished taking all the medicine.
• Keep the bottle tightly closed to protect it from moisture.
• This medicine does not require any special storage conditions.
• 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 protect the environment.

6. Package Contents and Additional Information

Pifeltro Composition

• The active ingredient is doravirine 100 mg.
• The other components are sodium croscarmellose E468; hypromellose acetate succinate; lactose monohydrate; magnesium stearate E470b; microcrystalline cellulose E460 and anhydrous colloidal silica E551. The tablets are coated with a film that contains the following components: carnauba wax E903; hypromellose E464; lactose monohydrate; titanium dioxide E171 and triacetin E1518.

Product Appearance and Package Contents

Pifeltro is presented in film-coated tablets, white, oval, engraved with the corporate logo and 700 on one side and smooth on the other side.

The following package sizes are available:

• 1 bottle with 30 film-coated tablets
• 90 film-coated tablets (3 bottles of 30 film-coated tablets)

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/YYYY}.

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.