Darunavir Sandoz

Package Leaflet: Information for the Patient

Darunavir Sandoz, 600 mg, Film-Coated Tablets

Darunavir

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Darunavir Sandoz and What is it Used For
• 2. Before You Take Darunavir Sandoz
• 3. How to Take Darunavir Sandoz
• 4. Possible Side Effects
• 5. How to Store Darunavir Sandoz
• 6. Contents of the Pack and Other Information

1. What is Darunavir Sandoz and What is it Used For

What is Darunavir Sandoz

Darunavir Sandoz contains the active substance darunavir. Darunavir Sandoz is an antiretroviral medicine used to treat HIV infection in adults and children from the age of 3 years and at least 15 kg body weight, who have already taken other antiretroviral medicines.

What is it Used For

Darunavir Sandoz is used to treat HIV infection in adults and children from the age of 3 years and at least 15 kg body weight, who have already taken other antiretroviral medicines. Darunavir Sandoz should be taken in combination with other HIV medicines and a small dose of ritonavir.

2. Before You Take Darunavir Sandoz

When Not to Take Darunavir Sandoz

Do not take Darunavir Sandoz:

• if you are allergic to darunavir or any of the other ingredients of this medicine
• if you have severe liver problems

Tell your doctor about all the medicines you take.

Do Not Take Darunavir Sandoz With Any of the Following Medicines

The following medicines should not be taken with Darunavir Sandoz:

Do not take Darunavir Sandoz with products containing St. John's Wort (Hypericum perforatum).

Warnings and Precautions

Before you start taking Darunavir Sandoz, talk to your doctor, pharmacist or nurse.

Tell Your Doctor if You Have Had Any of the Following

Tell your doctor if you have had any of the following:

• liver disease, including viral hepatitis B or C
• diabetes
• symptoms of infection (e.g. enlarged lymph nodes and fever)
• haemophilia
• allergy to sulphonamides
• musculoskeletal disorders

Older People

Darunavir Sandoz has only been used in a small number of patients aged 65 years or older.

Children

Darunavir Sandoz should not be used in children below 3 years of age or weighing less than 15 kg.

Darunavir Sandoz With Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking.

• some medicines should not be taken with Darunavir Sandoz
• some medicines may need to have their dose changed

Darunavir Sandoz may interact with other medicines. Your doctor will decide whether you can take Darunavir Sandoz with other medicines.

Darunavir Sandoz With Food and Drink

See section 3 "How to Take Darunavir Sandoz".

Pregnancy and Breast-Feeding

Do not take Darunavir Sandoz if you are pregnant or might become pregnant, unless your doctor has decided that it is essential for you.

Driving and Using Machines

Some patients taking Darunavir Sandoz may experience dizziness, or other side effects that could affect their ability to drive or operate machinery.

3. How to Take Darunavir Sandoz

Always take Darunavir Sandoz exactly as your doctor has told you.

Children (from 3 years of age and at least 15 kg body weight)

The doctor will calculate the dose of Darunavir Sandoz based on the child's weight.

Adults

The recommended dose is 600 mg or 800 mg of Darunavir Sandoz once daily or 600 mg twice daily.

How to Open the Child-Resistant Closure

Push the plastic screw cap down while turning it anti-clockwise.

If You Take More Darunavir Sandoz Than You Should

Contact your doctor or pharmacist immediately.

If You Forget to Take Darunavir Sandoz

If you notice that you have missed a dose within 6 hours of the scheduled dose, take the missed dose as soon as possible. If it has been more than 6 hours since the scheduled dose, skip the missed dose and take the next dose at the regularly scheduled time.

If You Vomit After Taking Darunavir Sandoz and Ritonavir

If you vomit within 4 hours after taking Darunavir Sandoz and ritonavir, you should take another dose as soon as possible.

4. Possible Side Effects

Like all medicines, Darunavir Sandoz can cause side effects, although not everybody gets them.

Very Common Side Effects (May Affect More Than 1 in 10 People)

• diarrhoea

Common Side Effects (May Affect Up to 1 in 10 People)

• vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence
• headache, fatigue, dizziness, somnolence, paraesthesia, peripheral neuropathy, muscle weakness

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• chest pain, electrocardiogram abnormal, tachycardia
• hypoaesthesia, tremor, attention disturbance, memory impairment, amnesia
• dyspnoea, cough, nasal congestion, oropharyngeal pain
• gastritis, oral ulceration, haematemesis, dry mouth, dysgeusia
• renal impairment, renal failure, kidney stones, pollakiuria, nocturia
• urticaria, angioedema, rash, hyperhidrosis, night sweats, alopecia, acne, skin exfoliation
• myalgia, muscle spasms or weakness, arthralgia, osteoporosis
• hypothyroidism (as measured by blood tests)
• hypertension, flushing
• eye redness, dry eye
• fever, oedema peripheral, malaise, irritability, pain
• infections, herpes simplex
• erectile dysfunction, gynaecomastia
• sleep disorders, somnolence, depression, anxiety, abnormal dreams

Rare Side Effects (May Affect Up to 1 in 1,000 People)

• DRESS syndrome (severe skin reaction with fever, fatigue, swelling of the face or lymph nodes, increased eosinophils, liver or kidney problems)
• myocardial infarction, bradycardia, palpitations
• visual disturbances
• chills, malaise
• disorientation, mood changes, anxiety (mainly agitation)
• syncope, seizures, taste disturbances or loss
• oral ulceration, haematemesis, stomatitis, dry mouth, dysgeusia
• rhinitis
• skin disorders, dry skin
• muscle stiffness or cramps, muscle weakness, arthralgia with or without arthritis
• changes in blood tests (e.g. increased eosinophils)
• kidney stones

5. How to Store Darunavir Sandoz

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, blister and bottle after EXP.

The expiry date refers to the last day of that month.

Store in the original package.

After first opening of the bottle: do not store above 25°C. Shelf-life after first opening: 6 months.

6. Contents of the Pack and Other Information

What Darunavir Sandoz Contains

The active substance is darunavir. Each film-coated tablet contains 600 mg of darunavir.

What Darunavir Sandoz Looks Like and Contents of the Pack

Orange, oval, film-coated tablets with "600" embossed on one side and plain on the other side.

Pack sizes: 60 film-coated tablets

Marketing Authorisation Holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

For Further Information on This Medicine, Contact

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warszawa, tel. 22 209 70 00

Date of Last Revision: 05/2023