Darunavir Viatris

Italy

Brand name Darunavir Viatris

Form tablets, film-coated

Active substance / Dosage

DARUNAVIR

Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription

ATC code

J05AE10

Registration number 045250

Manufacturer VIATRIS LIMITED

Table of Contents

Package leaflet: Information for the user
Darunavir Viatris 75 mg film-coated tablets
1. What Darunavir Viatris is and what it is used for What Darunavir Viatris is
2. What you need to know before taking Darunavir Viatris
3. How to take Darunavir Viatris
4. Possible side effects
5. How to store Darunavir Viatris
6. Package contents and other information
Package leaflet: Information for the user
Darunavir Viatris 150 mg film-coated tablets
1. What Darunavir Viatris is and what it is used for
2. What you need to know before taking Darunavir Viatris
3. How to take Darunavir Viatris
4. Possible side effects
5. How to store Darunavir Viatris
6. Package contents and other information
Package leaflet: Information for the user
Darunavir Viatris 300 mg film-coated tablets
1. What Darunavir Viatris is and what it is used for
2. What you need to know before taking Darunavir Viatris
3. How to take Darunavir Viatris
4. Possible side effects
5. How to store Darunavir Viatris
6. Package contents and other information
Package leaflet: information for the user
Darunavir Viatris 400 mg film-coated tablets
1. What Darunavir Viatris is and what it is used for
2. What you need to know before taking Darunavir Viatris
3. How to take Darunavir Viatris
4. Possible side effects
5. How to store Darunavir Viatris
6. Package contents and other information
Package leaflet: Information for the user
Darunavir Viatris 600 mg film-coated tablets
1. What Darunavir Viatris is and what it is used for
2. What you need to know before taking Darunavir Viatris
3. How to take Darunavir Viatris
4. Possible side effects
5. How to store Darunavir Viatris
6. Package contents and other information
Package leaflet: Information for the user
Darunavir Viatris 800 mg film-coated tablets
1. What Darunavir Viatris is and what it is used for
2. What you should know before taking Darunavir Viatris
3. How to take Darunavir Viatris
4. Possible side effects
5. How to store Darunavir Viatris
6. Package contents and other information

Package leaflet: Information for the user

Darunavir Viatris 75 mg film-coated tablets

darunavir
Read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Darunavir Viatris is and what it is used for
What you need to know before taking Darunavir Viatris
How to take Darunavir Viatris
Possible side effects
How to store Darunavir Viatris
Contents of the pack and other information

1. What Darunavir Viatris is and what it is used for What Darunavir Viatris is

Darunavir Viatris contains the active substance darunavir.
Darunavir is an antiretroviral medicine used to treat human immunodeficiency virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. Darunavir works by reducing the amount of HIV in the body, improving the immune system, and reducing the risk of developing HIV-related illnesses.

What it is used for
Darunavir is used to treat adult and pediatric patients aged 3 years and older, weighing at least 15 kg (kilograms), who have HIV infection and who have previously used other antiretroviral medicines.
Darunavir must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your doctor will discuss with you the most appropriate combination of medicines for your treatment.

2. What you need to know before taking Darunavir Viatris

Do not take Darunavir Viatris

If you are allergic to darunavir, to any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
If you have severe liver problems. Ask your doctor for advice if you are unsure about the severity of your liver disease. You may need further tests.

Do not take Darunavir Viatris together with any of the following medicines
If you are taking any of these medicines, ask your doctor how to switch to another medicine.

Medicine	Purpose of the medicine
Avanafil	for the treatment of erectile dysfunction
Astemizole or terfenadine	for the treatment of allergic symptoms
Triazolam and oral midazolam (taken by mouth)	used to help sleep and/or reduce anxiety
Cisapride	for the treatment of certain stomach disorders
Medicine	Purpose of the medicine
Colchicine (if you have kidney and/or liver problems)	for the treatment of gout or familial Mediterranean fever
Lurasidone, pimozide, quetiapine or sertindole	for the treatment of psychiatric disorders
Ergot alkaloids such as ergotamine, dihydroergotamine, ergometrine and methylergonovine	for the treatment of migraine
Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine	for the treatment of certain heart problems, such as abnormal heart rhythms
Lovastatin, simvastatin and lomitapide	to lower cholesterol levels
Rifampicin	for the treatment of certain infections, such as tuberculosis
Lopinavir/ritonavir combination	this anti-HIV medicine belongs to the same class as darunavir
Elbasvir/grazoprevir	for the treatment of hepatitis C infection
Alfuzosin	for the treatment of benign prostatic hyperplasia
Sildenafil	for treating high blood pressure in the pulmonary circulation
Ticagrelor	to help prevent platelet aggregation in the treatment of patients with a history of heart attack
Naloxegol	for the treatment of opioid-induced constipation
Dapoxetine	for the treatment of premature ejaculation
Domperidone	for the treatment of nausea and vomiting

Do not associate darunavir with products containing St John’s wort (Hypericum perforatum).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may still develop infections or other illnesses related to HIV infection. You should maintain regular contact with your doctor.
Patients taking darunavir may develop a rash. Rarely, the rash may become severe or potentially life-threatening. Contact your doctor whenever you develop a rash.
Skin rashes (generally mild or moderate) may occur more frequently in patients taking both darunavir and raltegravir (for HIV infection) than in patients taking each medicine separately.
Inform your doctor about your condition BEFORE and DURING treatment
Make sure to check the following points and inform your doctor if any of them apply to you.

Inform your doctor if you have had liver problems, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether to prescribe darunavir to you.
Inform your doctor if you have diabetes. Darunavir may increase blood sugar levels.
Inform your doctor immediately if you notice any signs of infection (for example, swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, which enables the body to fight infections that may have been present without causing obvious symptoms.
In addition to opportunistic infections, autoimmune disorders (a condition occurring when the immune system attacks healthy body tissue) may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading towards the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.
Inform your doctor if you have haemophilia. Darunavir may increase the risk of bleeding.
Inform your doctor if you are allergic to sulphonamides (used to treat certain infections).
Inform your doctor if you notice any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Some of the many risk factors for developing this disease may include duration of combined antiretroviral use, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Signs of osteonecrosis include joint stiffness, pain, and aching (especially in the hip, knee, and shoulders) and difficulty moving. If you notice any of these symptoms, inform your doctor immediately.

Elderly
Darunavir has been administered to a limited number of patients aged 65 years or older. If you belong to this age group, consult your doctor before taking Darunavir Viatris.
Children
Darunavir is not indicated for use in children under 3 years of age or weighing less than 15 kg (kilograms).
Other medicines and Darunavir Viatris
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.
There are medicines that must not be combined with darunavir. These have been listed earlier under the heading “Do not combine Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines belonging to another class [for example, NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and FIs (fusion inhibitors)]. Darunavir in combination with ritonavir has not been studied with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always inform your doctor if you are taking other anti-HIV medicines and carefully follow your doctor’s instructions on which medicines you can take.
The effects of darunavir may be reduced if you take any of the following medicines. Inform your doctor if you are taking:

Phenobarbital, phenytoin (to prevent epileptic seizures)
Dexamethasone (a corticosteroid)
Efavirenz (to treat HIV infection)
Rifapentine, rifabutin (medicines to treat certain infections such as tuberculosis)
Saquinavir (to treat HIV infection).

The effects of other medicines may be affected by taking darunavir, and your doctor may require additional blood tests. Inform your doctor if you are taking:

Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart conditions), as the therapeutic effect or side effects of these medicines may be altered.
Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce blood clotting), because both the therapeutic effect and side effects may be altered.
Hormonal contraceptives containing oestrogen or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormonal therapy is used for contraception, use of alternative contraceptive methods other than hormonal therapy is recommended.
Ethinylestradiol/drospirenone. Darunavir may increase the risk of elevated potassium levels due to drospirenone.
Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle damage may increase. Your doctor will evaluate which cholesterol-lowering medicine is most suitable for you.
Clarithromycin (antibiotic).
Cyclosporine, everolimus, tacrolimus, sirolimus (to reduce immune system activity), as the therapeutic effect or side effects of these medicines may be increased.
Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory skin, eye, joint, and muscle disorders, and other inflammatory conditions. These medicines are generally taken orally, by inhalation, by injection, or applied to the skin. If alternative treatments cannot be used, these medicines may be taken only after evaluation by your doctor and under careful monitoring for corticosteroid-related side effects.
Buprenorphine/naloxone (to treat opioid dependence).
Salmeterol (for the treatment of asthma).
Artemether/lumefantrine (a combination of medicines for the treatment of malaria).
Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristina (to treat cancer).
Sildenafil, tadalafil, vardenafil (for erectile dysfunction or for treating a heart or lung condition called pulmonary arterial hypertension).
Glecaprevir/pibrentasvir (for the treatment of hepatitis C infection)
Fentanyl, oxycodone, tramadol (for pain treatment).
Fesoterodine, solifenacin (to treat urological disorders).

Your doctor may require additional blood tests and the dosage of other medicines may be adjusted, as the therapeutic effect and side effects of these medicines or of darunavir may be affected when combined.
Inform your doctor if you are taking:

Dabigatran etexilate, edoxaban, warfarin (to reduce blood clotting)
Alfentanil (a strong, short-acting injectable painkiller used during surgery)
Digoxin (for the treatment of certain heart conditions)
Clarithromycin (antibiotic)
Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole may be taken only after evaluation by your doctor.
Rifabutin (for bacterial infections)
Sildenafil, vardenafil, tadalafil (for erectile dysfunction or for high blood pressure in the pulmonary circulation)
Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (for the treatment of depression and anxiety)
Maraviroc (to treat HIV infection)
Methadone (to treat opioid dependence)
Carbamazepine, clonazepam (to prevent epileptic seizures or to treat certain types of neuropathic pain)
Colchicine (to treat gout or familial Mediterranean fever)
Bosentan (to treat high blood pressure in the pulmonary circulation).
Buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, midazolam when used as an injection, zolpidem (sedatives).
Perphenazine, risperidone, thioridazine (to treat psychiatric conditions).

This is not a complete list of medicines. Inform your doctor about all medicines you are taking.
Darunavir Viatris with food and drinks
See section 3 “How to take Darunavir Viatris”.
Pregnancy and breastfeeding
Inform your doctor immediately if you are pregnant or planning a pregnancy.
Pregnant women should not take darunavir with ritonavir unless specifically instructed by their doctor. Pregnant women should not take darunavir with cobicistat.
Due to the possibility of adverse effects in infants, women should not breastfeed while receiving Darunavir Viatris.
Breastfeeding is not recommended for women with HIV infection, as the infection can be transmitted to the infant through breast milk. If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.
Driving and using machines
Do not operate machinery or drive if you feel dizzy after taking darunavir.
Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore essentially “sodium-free”.

3. How to take Darunavir Viatris

Take this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Even if you feel better, do not stop taking Darunavir Viatris and ritonavir without talking to your doctor.
After starting treatment, do not change the dose, dosage form, or stop treatment without instructions from your doctor.
Dose for children aged 3 years and older and weighing at least 15 kilograms who have not
previously taken antiretroviral medicines (this condition will be determined by the child's
doctor)
Your doctor will calculate the correct daily dose based on the child's body weight (see table below). This dose must not exceed the recommended dose for adults, which is 800 milligrams of darunavir together with 100 milligrams of ritonavir once daily.
Your doctor will inform you how many darunavir tablets and how much ritonavir (capsules, tablets, or solution) the child should take.

Weight	Darunavir dose is	Ritonavir dose is
between 15 and 30 kilograms	600 milligrams	100 milligrams
between 30 and 40 kilograms	675 milligrams	100 milligrams
over 40 kilograms	800 milligrams	100 milligrams

Dose for children aged 3 years and older and weighing at least 15 kg
(kilograms) who have previously taken antiretroviral medicines (this condition will be determined by the
child's doctor)
The doctor will calculate the appropriate dose based on the child's weight (see table below). The doctor will decide whether a once-daily or twice-daily dosing regimen is appropriate for the child. The dose must not exceed the recommended adult dose, which is 600 milligrams of darunavir together with 100 milligrams of ritonavir twice daily or 800 milligrams of darunavir together with 100 milligrams of ritonavir once daily.
Your doctor will inform you how many darunavir tablets and how much ritonavir (capsules, tablets or solution) the child should take. Tablets are available in other strengths, and the doctor may prescribe a combination of tablets to achieve the appropriate dosage regimen.
Other formulations of this medicine might be more suitable for children; please consult your doctor or pharmacist.
Twice-daily dosing regimen

Body weight	One dose is
between 15 and 30 kilograms	375 milligrams darunavir + 50 milligrams ritonavir twice daily
between 30 and 40 kilograms	450 milligrams darunavir + 60 milligrams ritonavir twice daily
greater than 40 kilograms	600 milligrams darunavir + 100 milligrams ritonavir twice daily

Once daily dose

Weight	A dose of darunavir is	A dose of ritonavir is
between 15 and 30 kilograms	600 milligrams	100 milligrams
between 30 and 40 kilograms	675 milligrams	100 milligrams
over 40 kilograms	800 milligrams	100 milligrams

Instructions for children

Your child must always take darunavir together with ritonavir. Darunavir cannot work effectively without ritonavir.
Your child must take the appropriate doses of darunavir and ritonavir twice daily or once daily. If darunavir is prescribed twice daily, your child should take one dose in the morning and one dose in the evening. Your doctor will determine which regimen is most appropriate for your child.
Your child must take darunavir with food. Darunavir cannot work effectively without food. The type of food is not important.
Your child should swallow the tablets with a drink such as water or milk.

Dose for adults who have never taken antiretroviral medicines (to be determined by the doctor)
Different doses of darunavir may be required that cannot be administered with these 75 mg tablets. Other darunavir strengths from Viatris are available.
Dose for adults who have previously taken antiretroviral medicines (to be determined by the doctor)
The doses are:

600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir, or 1 tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir, twice daily. OR
800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir or 1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir, once daily. The 400 milligram and 800 milligram darunavir tablets from Viatris should only be used to achieve the once-daily 800 milligram regimen.

Discuss with your doctor which dose is most appropriate.
Instructions for adults

Always take darunavir with ritonavir. Darunavir does not work adequately without ritonavir.
In the morning, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
In the evening, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
Take darunavir with food. Darunavir does not work adequately without food. The type of food taken is not important.
Swallow the tablets with a drink such as water or milk.
Darunavir Viatris 75 milligram and 150 milligram tablets were developed for use in children, but may be used in certain cases in adults as well.

If you take more Darunavir Viatris than you should
Contact your doctor, pharmacist, or nurse immediately.
If you forget to take Darunavir Viatris
If you remember within 6 hours, take the tablets immediately. Always take the tablets together with ritonavir and food. If you remember after 6 hours, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for the missed dose.
If you vomit after taking Darunavir Viatris and ritonavir
If you vomit within 4 hours of taking the medicine, take another dose of Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours after taking the medicine, you do not need to take another dose of Darunavir Viatris and ritonavir until the next scheduled dose.
Contact your doctor if you have any doubts about what to do if you miss a dose or vomit.
Do not stop treatment with Darunavir Viatris without first talking to your doctor
HIV medicines can make you feel better. Do not stop taking darunavir, even if you feel well. Talk to your doctor first.
If you have any questions about how to use this medicine, talk to your doctor, pharmacist, or nurse.

4. Possible side effects

During HIV therapy, an increase in weight and in blood levels of lipids and glucose may occur.
This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Tell your doctor if you develop any of the following side effects
Liver problems have been reported, which rarely can be serious. Your doctor will carry out blood tests before starting darunavir. If you have chronic hepatitis B or C, your doctor must check your blood tests more frequently, as you have a higher risk of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems.
These may include yellowing of the skin or the whites of the eyes, dark urine (tea-colored), pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness, or discomfort on the right side under the ribs.
Skin rashes (more frequent when used in combination with raltegravir), itching. These skin rashes are usually mild or moderate in severity. A rash may also be a symptom of a rare but serious condition. It is therefore important that you consult your doctor if you develop a skin rash. Your doctor will advise you on how to manage the symptoms or whether darunavir should be discontinued.
Other serious side effects included diabetes (common) and inflammation of the pancreas (uncommon).
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 bloating, dyspepsia (digestive difficulties), flatulence
headache, fatigue, dizziness, drowsiness, numbness, tingling or pain in the hands or feet, loss of strength, difficulty falling asleep.

Uncommon side effects (may affect up to 1 in 100 people)

chest pain, changes in electrocardiogram, rapid heartbeat
decreased or abnormal skin sensation, tingling sensation, attention disorders, memory loss, difficulty with balance
shortness of breath, cough, nosebleeds, sore throat
inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
urticaria, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, nail pigmentation
muscle pain, muscle cramps or weakness, pain in extremities, osteoporosis
slowing of thyroid function. This can be detected by blood test.
high blood pressure, hot flushes
red or dry eyes
fever, swelling of legs due to fluid accumulation, malaise, irritability, pain
symptoms of infection, herpes simplex
erectile dysfunction (problems with erection), breast enlargement
sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sex drive

Rare side effects (may affect up to 1 in 1,000 people)

a reaction called DRESS [a severe rash which may be accompanied by fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cells in the blood), effects on liver, kidneys or lungs]
heart attack, slow heartbeat, palpitations
vision disorders
chills, feeling unwell
a feeling of confusion or disorientation, altered mood, restlessness
fainting, seizures, change or loss of taste
mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
runny nose
skin lesions, dry skin
stiffness of muscles or joints, joint pain with or without inflammation
changes in certain blood cell or chemical values. These may be seen in blood and/or urine tests. Your doctor will explain these results to you. Examples include: increase in certain white blood cells
deposition of darunavir crystals in the kidney leading to kidney disease.

Some side effects are typical of anti-HIV medicines in the same family as darunavir. These are:

muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For bottles: once opened, use within 100 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Darunavir Viatris contains

The active substance is darunavir. Each tablet contains 75 milligrams of darunavir.
The other components are anhydrous colloidal silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The film coating contains partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc.

Description of the appearance of Darunavir Viatris and package contents
Darunavir Viatris 75 mg film-coated tablets are white to off-white, oval-shaped with two curved sides, marked with "M" on one side and "DV1" on the other.
Darunavir Viatris 75 mg film-coated tablets are available in blisters containing 480 tablets and in plastic bottles containing 480 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturer
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1, Hungary
McDermott Laboratories Limited, trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ.s.r.o. Viatris Healthcare Kft.
Tel: 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l Viatris Oy
Tel: + 39 (0) 2 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: + 357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Package leaflet: Information for the user

Darunavir Viatris 150 mg film-coated tablets

darunavir
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Darunavir Viatris is and what it is used for
What you need to know before taking Darunavir Viatris
How to take Darunavir Viatris
Possible side effects
How to store Darunavir Viatris
Contents of the pack and other information

1. What Darunavir Viatris is and what it is used for

What Darunavir Viatris is
Darunavir Viatris contains the active substance darunavir. Darunavir is an antiretroviral medicine
used to treat human immunodeficiency virus (HIV) infection. It belongs to a group of medicines
called protease inhibitors. Darunavir works by reducing the amount of HIV in the body, improving
the immune system, and reducing the risk of developing HIV-related illnesses.
What it is used for
Darunavir is used to treat adult and pediatric patients aged 3 years and older who weigh at least 15 kg
(kilograms) and who have HIV infection and have previously used other antiretroviral medicines.
Darunavir must be taken in combination with a low dose of ritonavir and other anti-HIV medicines.
Your doctor will discuss with you the best combination of medicines for your treatment.

2. What you need to know before taking Darunavir Viatris

Do not take Darunavir Viatris:

if you are allergic to darunavir or to any of the other ingredients of this medicine (listed in section 6) or to ritonavir.
if you have severe liver problems. Ask your doctor for advice if you are unsure about the severity of your liver disease. You may need further tests.

Do not take Darunavir Viatris together with any of the following medicines.
If you are currently taking one of these medicines, ask your doctor how to switch to another medicine.

Medicine	Purpose of the medicine
Avanafil	for the treatment of erectile dysfunction
Astemizole or terfenadine	for the treatment of allergic symptoms
Triazolam and oral midazolam (taken by mouth)	used to promote sleep and/or reduce anxiety
Medicine	Purpose of the medicine
Cisapride	for the treatment of certain stomach disorders
Colchicine (if you have kidney and/or liver problems)	for the treatment of gout or familial Mediterranean fever
Lurasidone, pimozide, quetiapine or sertindole	for the treatment of psychiatric disorders
Ergot alkaloids such as ergotamine, dihydroergotamine, ergometrine and methylergonovine	for the treatment of migraine
Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine	for the treatment of certain heart problems, such as heart rhythm abnormalities
Lovastatin, simvastatin and lomitapide	to lower cholesterol levels
Rifampicin	for the treatment of certain infections, such as tuberculosis
Combination of lopinavir/ritonavir	this anti-HIV medicine belongs to the same class as darunavir
Elbasvir/grazoprevir	for the treatment of hepatitis C infection
Alfuzosin	to treat benign prostatic hyperplasia
Sildenafil	to treat high blood pressure in the pulmonary circulation
Ticagrelor	to help prevent platelet aggregation in the treatment of patients with a history of heart attack
Naloxegol	to treat opioid-induced constipation
Dapoxetine	to treat premature ejaculation
Domperidone	to treat nausea and vomiting

Do not combine darunavir with products containing St. John's wort (Hypericum perforatum).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Darunavir Viatris.
Darunavir is not a cure for HIV infection.
People taking darunavir may still develop infections or other diseases associated with HIV infection. Regular follow-up with your doctor is necessary.
Patients taking darunavir may develop a rash. Rarely, the rash may become severe or potentially life-threatening. Contact your doctor whenever you develop a rash.
Skin rashes (generally mild or moderate) may occur more frequently in patients taking darunavir and raltegravir (for HIV infection) than in patients taking each medicine separately.
Inform your doctor about your medical condition BEFORE and DURING treatment
Make sure to check the following points and inform your doctor if any of them apply to you.

Inform your doctor if you have had liver problems, including hepatitis B or C. Your doctor may assess the severity of your liver disease before deciding whether to prescribe darunavir.
Inform your doctor if you have diabetes. Darunavir may increase blood sugar levels.
Inform your doctor immediately if you notice any signs of infection (e.g., swollen lymph nodes and fever). In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation from prior infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from improved immune response, enabling the body to fight infections that may have been present without causing obvious symptoms.
In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medications for HIV infection. Autoimmune disorders may occur several months after treatment initiation. If you notice any symptoms of infection or other symptoms such as muscle weakness, initial weakness in hands and feet progressing toward the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.
Inform your doctor if you have haemophilia. Darunavir may increase the risk of bleeding.
Inform your doctor if you are allergic to sulfonamides (used to treat certain infections).
Inform your doctor if you experience any musculoskeletal problems. Some patients taking a combination of antiretroviral medicines may develop a bone disease called osteonecrosis (bone tissue death due to reduced blood supply to the bone). Several risk factors for developing this condition include long-term use of combination antiretrovirals, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Signs of osteonecrosis include joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulders) and difficulty moving. If you notice any of these symptoms, inform your doctor immediately.

Elderly
Darunavir has been administered to a limited number of patients aged 65 years and older. If you belong to this age group, consult your doctor before taking Darunavir Viatris.
Children
Darunavir is not indicated for use in children under 3 years of age or weighing less than 15 kg (kilograms).
Other medicines and Darunavir Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are certain medicines that must not be combined with darunavir. These have been listed previously under the heading “Do not combine Darunavir Viatris with any of the following medicines”.
In most cases, darunavir can be combined with anti-HIV medicines belonging to another class [e.g., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists, and FIs (fusion inhibitors)]. Darunavir in combination with ritonavir has not been studied with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases, the dose of other medicines may need to be adjusted. Therefore, always inform your doctor if you are taking other anti-HIV medicines and follow your doctor’s instructions carefully regarding which medicines you can take.
The effects of darunavir may be reduced if you take any of the following medicines. Inform your doctor if you are taking:

Phenobarbital, phenytoin (to prevent epileptic seizures)
Dexamethasone (a corticosteroid)
Efavirenz (to treat HIV infection)
Rifapentine, rifabutin (medicines to treat certain infections such as tuberculosis)
Saquinavir (to treat HIV infection)

The effects of other medicines may be affected by taking darunavir, and your doctor may require additional blood tests. Inform your doctor if you are taking:

Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart conditions), as the therapeutic effect or side effects of these medicines may be altered.
Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce blood clotting), as both therapeutic effect and side effects may be altered.
Hormonal contraceptives containing estrogen or hormone replacement therapy. Darunavir may reduce their effectiveness. When hormonal therapy is used for contraception, use of alternative contraceptive methods other than hormonal therapy is recommended.
Ethinylestradiol/drospirenone. Darunavir may increase the risk of elevated potassium levels due to drospirenone.
Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle damage may increase. Your doctor will evaluate which cholesterol-lowering medicine is most suitable for you.
Clarithromycin (an antibiotic).
Cyclosporine, everolimus, tacrolimus, sirolimus (to reduce immune system activity), as the therapeutic effect or side effects of these medicines may be increased.
Corticosteroids, including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory skin, eye, joint, and muscular conditions, and other types of inflammatory disorders. These medicines are generally taken orally, by inhalation, by injection, or applied to the skin. If alternative treatments cannot be used, these medicines may be taken only after evaluation by your doctor and under close monitoring for corticosteroid-related side effects.
Buprenorphine/naloxone (to treat opioid dependence).
Salmeterol (to treat asthma).
Artemether/lumefantrine (a combination of medicines to treat malaria).
Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer).
Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart or lung condition called pulmonary arterial hypertension).
Glecaprevir/pibrentasvir (to treat hepatitis C infection).
Fentanyl, oxycodone, tramadol (to treat pain).
Fesoterodine, solifenacin (to treat urological disorders).

Dabigatran etexilate, edoxaban, warfarin (to reduce blood clotting).
Alfentanil (a strong, short-acting injectable painkiller used during surgery).
Digoxin (to treat certain heart conditions).
Clarithromycin (an antibiotic).
Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole may be taken only after evaluation by your doctor.
Rifabutin (for bacterial infections).
Sildenafil, vardenafil, tadalafil (for erectile dysfunction or for high blood pressure in the pulmonary circulation).
Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety).
Maraviroc (to treat HIV infection).
Methadone (to treat opioid dependence).
Carbamazepine, clonazepam (to prevent epileptic seizures or to treat certain types of neuropathic pain).
Colchicine (to treat gout or familial Mediterranean fever).
Bosentan (to treat high blood pressure in the pulmonary circulation).
Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection, zolpidem (sedatives).
Perphenazine, risperidone, thioridazine (to treat psychiatric conditions).

This is not a complete list of medicines. Inform your doctor about all medicines you are taking.
Darunavir Viatris with food and drink
See section 3 “How to take Darunavir Viatris”.
Pregnancy and breastfeeding
Inform your doctor immediately if you are pregnant or planning to become pregnant.
Pregnant women should not take darunavir with ritonavir unless specifically instructed by their doctor. Pregnant women should not take darunavir with cobicistat.
Due to the possibility of adverse effects in infants, women should not breastfeed while receiving Darunavir Viatris.
Breastfeeding is not recommended for women with HIV infection, as the infection can be transmitted to the infant through breast milk. If you are breastfeeding or considering breastfeeding, discuss this with your doctor as soon as possible.
Driving and using machines
Do not operate machinery or drive if you feel dizzy after taking darunavir.
Darunavir Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, therefore essentially “sodium-free”.

3. How to take Darunavir Viatris

Take this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, please consult your doctor, pharmacist, or nurse.
Even if you feel better, do not stop taking Darunavir Viatris and ritonavir without talking to your doctor.
After starting treatment, do not change the dose, dosage form, or stop treatment without your doctor's instructions.
Dose for children aged 3 years and older and weighing at least 15 kilograms who have not previously taken antiretroviral medicines (your child’s doctor will determine this condition).
The doctor will calculate the correct daily dose based on the child’s body weight (see table below). This dose must not exceed the recommended adult dose of 800 milligrams of darunavir together with 100 milligrams of ritonavir once daily.
Your doctor will inform you how many Darunavir Viatris tablets and how much ritonavir (capsules, tablets, or solution) the child should take.

Weight	One dose of darunavir is	One dose of ritonavir is
between 15 and 30 kilograms	600 milligrams	100 milligrams
between 30 and 40 kilograms	675 milligrams	100 milligrams
more than 40 kilograms	800 milligrams	100 milligrams

Dose for children aged 3 years and older and weighing at least 15 kg
(kilograms) who have previously taken antiretroviral medicines (this condition will be
determined by the child's doctor)
The doctor will calculate the appropriate dose based on the child's weight (see table below). The doctor will decide whether a once-daily or twice-daily dosing regimen is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligrams of darunavir together with 100 milligrams of ritonavir twice daily or 800 milligrams of darunavir together with 100 milligrams of ritonavir once daily.
The doctor will inform you how many Darunavir Viatris tablets and how much ritonavir (capsules, tablets or solution) the child should take. Other tablet strengths are available, and the doctor may prescribe a combination of tablets to achieve the appropriate dosing regimen.
Other formulations of this medicine may be more suitable for children; please consult the doctor or pharmacist.
Twice-daily dosing regimen

Weight	One dose is
between 15 and 30 kilograms	375 milligrams darunavir + 50 milligrams ritonavir twice daily
between 30 and 40 kilograms	450 milligrams darunavir + 60 milligrams ritonavir twice daily
over 40 kilograms	450 milligrams darunavir + 60 milligrams ritonavir twice daily

Once-daily dose

Weight	One dose of darunavir is	One dose of ritonavir is
between 15 and 30 kilograms	600 milligrams	100 milligrams
between 30 and 40 kilograms	675 milligrams	100 milligrams
more than 40 kilograms	800 milligrams	100 milligrams

Instructions for children

The child must always take darunavir together with ritonavir. Darunavir cannot work effectively without ritonavir.
The child must take the appropriate doses of darunavir and ritonavir twice daily or once daily. If darunavir is prescribed twice daily, the child must take one dose in the morning and one dose in the evening. The doctor will determine which regimen is most appropriate for the child.
The child must take darunavir with food. Darunavir cannot work effectively without food. The type of food consumed is not important.
The child must swallow the tablets with a drink such as water or milk.

Dosage for adults who have never taken antiretroviral medicines (to be determined by the doctor)
Different dosages of darunavir may be required that cannot be administered with these 150 mg tablets. Other darunavir dosages from Viatris are available.
Dosage for adults who have previously taken antiretroviral medicines (to be determined by the doctor)
The doses are:

600 milligrams of darunavir (2 tablets containing 300 milligrams of darunavir, or 1 tablet containing 600 milligrams of darunavir) together with 100 milligrams of ritonavir, twice daily. OR
800 milligrams of darunavir (2 tablets containing 400 milligrams of darunavir, or 1 tablet containing 800 milligrams of darunavir) together with 100 milligrams of ritonavir, twice daily. The 400 milligram and 800 milligram darunavir Viatris tablets should only be used to construct the 800 milligram once-daily regimen.

Discuss with the doctor which dosage is most appropriate.
Instructions for adults

Always take darunavir with ritonavir. Darunavir cannot work effectively without ritonavir.
In the morning, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
In the evening, take 600 milligrams of darunavir together with 100 milligrams of ritonavir.
Take darunavir with food. Darunavir cannot work effectively without food. The type of food consumed is not important.
Swallow the tablets with a drink such as water or milk.
Darunavir Viatris 75 milligram and 150 milligram tablets were developed for use in children, but may be used in certain cases in adults as well.

If you take more Darunavir Viatris than you should
Contact your doctor, pharmacist, or nurse immediately.
If you forget to take Darunavir Viatris
If you remember within 6 hours, take the tablets immediately. Always take the tablets together with ritonavir and food. If you remember after 6 hours, skip the missed dose and take the next dose as scheduled. Do not take a double dose to make up for the missed dose.
If you vomit after taking Darunavir Viatris and ritonavir
If vomiting occurs within 4 hours of taking the medicine, take another dose of Darunavir Viatris and ritonavir with food as soon as possible. If vomiting occurs more than 4 hours after taking the medicine, you do not need to take another dose of Darunavir Viatris and ritonavir until the next scheduled dose.
Contact your doctor if you have any doubts about what to do if you miss a dose or vomit.
Do not stop treatment with Darunavir Viatris without first consulting your doctor
Anti-HIV medicines can help you feel better. Do not stop taking darunavir, even if you feel better. Consult your doctor first.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

During HIV treatment, an increase in weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you develop any of the following side effects

Liver problems have been reported, which occasionally can be serious. Your doctor will need to perform blood tests before starting darunavir. If you have chronic hepatitis B or C, your doctor must monitor your blood tests more frequently, as you have a higher risk of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of the skin or whites of the eyes, dark urine (tea-colored), pale stools (bowel movements), nausea, vomiting, loss of appetite, or pain, tenderness, or discomfort under the right side of the ribs.

Skin rash (more frequent when used in combination with raltegravir), itching. These rashes are usually mild to moderate in severity. A rash may also be a symptom of a rare but more serious condition. It is therefore important that you consult your doctor if you develop a skin rash. Your doctor will advise you on how to manage symptoms or whether darunavir should be discontinued.

Other serious side effects included diabetes (common) and inflammation of the pancreas (uncommon).

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 bloating, dyspepsia (indigestion), flatulence
headache, fatigue, dizziness, somnolence, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep

Uncommon side effects (may affect up to 1 in 100 people)

chest pain, changes in electrocardiogram, rapid heartbeat
decreased or abnormal skin sensation, tingling sensation, attention disorders, memory loss, difficulty with balance
difficulty breathing, cough, nosebleed, throat irritation
inflammation of the stomach or mouth, heartburn, retching, dry mouth, abdominal discomfort, constipation, belching
kidney failure, kidney stones, difficulty urinating, frequent or excessive urination, sometimes at night
urticaria, severe swelling of the skin and other tissues (especially lips and eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, nail pigmentation
muscle pain, muscle cramps or weakness, limb pain, osteoporosis
slowed thyroid function. This can be detected by blood test.
high blood pressure, hot flushes
red or dry eyes
fever, leg swelling due to fluid accumulation, malaise, chills, unusual sensations, irritability, pain
symptoms of infection, herpes simplex
erectile dysfunction (problems with erection), breast enlargement
sleep disorders, drowsiness, depression, anxiety, altered dreams, decreased sexual desire

Rare side effects (may affect up to 1 in 1,000 people)

a reaction called DRESS [a severe rash which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cell), effects on the liver, kidneys or lungs]
heart attack, slow heartbeat, palpitations
visual disturbances
chills, feeling unwell
a feeling of confusion or disorientation, altered mood, restlessness
fainting, seizures, change or loss of taste
mouth ulcers, vomiting blood, inflammation of the lips, dry lips, coated tongue
runny nose
skin lesions, dry skin
stiffness of muscles or joints, joint pain with or without inflammation
changes in certain blood or chemical values. These may be seen in blood and/or urine tests. Your doctor will explain these results to you. Examples include: increase in certain white blood cells
deposition of darunavir crystals in the kidney leading to kidney disease

Some side effects are typical of anti-HIV medicines belonging to the same class as darunavir. These are:

muscle pain, fragility or weakness. In rare cases, these muscle disorders have been severe.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Darunavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
For bottles: once opened, use within 100 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Darunavir Viatris contains

The active substance is darunavir. Each tablet contains 150 milligrams of darunavir.
The other components are: anhydrous colloidal silica, microcrystalline cellulose, crospovidone, sodium starch glycolate, hypromellose, magnesium stearate. The coating contains partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol, and talc.

Description of the appearance of Darunavir Viatris and contents of the pack
Darunavir Viatris 150 mg tablets are film-coated, white to off-white, capsule-shaped with two curved edges, marked with "M" on one side and "DV2" on the other.
Film-coated Darunavir Viatris 150 mg tablets are available in blisters containing 240 tablets and in plastic bottles containing 60 and 240 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN,
Ireland

Manufacturers
Mylan Hungary Kft
H-2900 Komárom, Mylan utca 1, Hungary
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: