Dipperam HCT

Patient Information Leaflet: Information for the User

Dipperam HCT 5 mg/160 mg/12.5 mg film-coated tablets, 10 mg/160 mg/12.5 mg film-coated tablets, 5 mg/160 mg/25 mg film-coated tablets, 10 mg/160 mg/25 mg film-coated tablets, 10 mg/320 mg/25 mg film-coated tablets

amlodipine/valsartan/hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Dipperam HCT is and what it is used for
2. What you need to know before taking Dipperam HCT
3. How to take Dipperam HCT
4. Possible side effects
5. How to store Dipperam HCT
6. Contents of the pack and other information

1. What Dipperam HCT is and what it is used for

Dipperam HCT tablets contain three substances called amlodipine, valsartan, and hydrochlorothiazide. All of these substances help control high blood pressure.

• Amlodipine belongs to a group of substances known as “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels and thereby prevents the narrowing of blood vessels.
• Valsartan belongs to a group of substances known as “angiotensin II receptor antagonists”. Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances known as “thiazide diuretics”. Hydrochlorothiazide increases the elimination of urine, thus reducing blood pressure. As a result of these three mechanisms, blood vessels relax and blood pressure decreases.

Dipperam HCT is used to treat high blood pressure in adult patients whose blood pressure is already controlled with a combination of amlodipine, valsartan, and hydrochlorothiazide, and who may benefit from taking a single tablet containing all three substances.

2. What you need to know before taking Dipperam HCT

Do not take Dipperam HCT

• if you are more than 3 months pregnant. (It is recommended to avoid taking Dipperam HCT even during early pregnancy - see section on Pregnancy.)
• if you are allergic to amlodipine or any other calcium antagonist, valsartan, hydrochlorothiazide, sulfonamide derivatives (medicines used to treat chest and urinary tract infections), or to any of the other ingredients of this medicine (see section 6). If you think you may be allergic, do not take Dipperam HCT and consult your doctor.
• if you have liver problems, destruction of the small bile ducts in the liver (biliary cirrhosis), or bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or are on dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase them.
• if your blood calcium level is too high despite treatment to reduce it.
• if you have gout (uric acid crystals in the joints).
• if you have very low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these conditions apply to you, do not take Dipperam HCT and inform your
doctor
Warnings and precautions
Talk to your doctor or pharmacist before taking Dipperam HCT

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).
• if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures).
• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and twitching).
• if you have kidney problems, if you have had a kidney transplant, or if you have been told you have narrowing of the renal arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, especially if you have been prescribed the maximum dose of Dipperam HCT (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor's instructions carefully regarding initial dosing. Your doctor may also monitor your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or abnormal thickening of the heart muscle (a condition called “obstructive hypertrophic cardiomyopathy”).
• if you suffer from hyperaldosteronism. This is a condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Dipperam HCT is not recommended.
• if you suffer from a disease called systemic lupus erythematosus (also known as “lupus” or “SLE”).
• if you have diabetes (high blood sugar levels).
• if you have high cholesterol or triglyceride levels in your blood.
• if you experience skin reactions after sun exposure (e.g., skin rash).
• if you have had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as “water pills”), especially if you suffer from asthma and allergies.
• if you have felt unwell (vomiting or diarrhea).
• if you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you experience these symptoms, stop taking Dipperam HCT immediately and contact your doctor. You must never take Dipperam HCT again.
• if you experience dizziness and/or fainting while being treated with Dipperam HCT, inform your doctor as soon as possible.
• if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from hours up to a week after taking Dipperam HCT. If left untreated, these may lead to permanent vision damage. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.
• if you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
• aliskiren.
• if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Dipperam HCT.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such
as potassium) in your blood at regular intervals.
See also information under “Do not take Dipperam HCT”.
If any of these conditions apply to you, inform your doctor
For athletes: using this medicine without a therapeutic need constitutes doping and
may result in a positive anti-doping test.
Children and adolescents
Dipperam HCT is not recommended for use in children and adolescents under 18 years of age.
Elderly (65 years and over)
Dipperam HCT may be used by individuals aged 65 years and over at the same dosage and in the same manner as the individual components amlodipine, valsartan, and hydrochlorothiazide. Elderly patients, especially those taking the maximum dose of Dipperam HCT (10 mg/320 mg/25 mg), should monitor their blood pressure regularly.
Other medicines and Dipperam HCT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to adjust your dose and/or take other precautions. In some cases, it may be necessary to discontinue one of the medicines. This is particularly important if you are taking any of the following medicines:
Do not take with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• ACE inhibitors or aliskiren (see also information under “Do not take Dipperam HCT” and “Warnings and precautions”).

Use with caution:

• alcohol, sedatives, and anesthetics (medicines enabling patients to undergo surgery and other procedures);
• amantadine (used for anti-Parkinson therapy, also used to treat or prevent certain viral diseases);
• anticholinergic agents (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an adjunct to anesthesia);
• anticonvulsant medicines and mood stabilizers used to treat epilepsy and bipolar disorder (such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in transplantation to prevent organ rejection or for other conditions such as rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• verapamil, diltiazem (heart medicines);
• iodinated contrast agents (used in imaging procedures);
• medicines used to treat diabetes (oral agents such as metformin or insulin);
• medicines used to treat gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause “torsade de pointes” (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce potassium levels in the blood, such as diuretics (water tablets), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines used to increase blood pressure such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used for ulcers and esophageal inflammation (carbenoxolone);
• medicines used to relieve pain or inflammation, particularly non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors);
• muscle relaxants (medicines used to relax muscles during surgical procedures);
• nitroglycerin and other nitrates or other substances called “vasodilators”;
• other medicines for treating high blood pressure including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (infusion for severe body temperature abnormalities);
• vitamin D and calcium salts

Dipperam HCT with food, drinks, and alcohol
Grapefruit and grapefruit juice must not be consumed by people who have been prescribed Dipperam HCT. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Dipperam HCT. Consult your doctor before drinking alcohol. Alcohol may lower your blood pressure too much and/or increase the risk of dizziness and fainting.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Dipperam HCT before becoming pregnant or as soon as you know you are pregnant and will recommend another medicine instead of Dipperam HCT. Dipperam HCT is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Dipperam HCT is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may cause dizziness, drowsiness, nausea, or headache. If you experience any of these symptoms, do not drive or operate tools or machinery.

3. How to take Dipperam HCT

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor. This will help you achieve the best results and reduce the risk of side effects.
The usual dose of Dipperam HCT is one tablet per day.

• It is best to take the tablet at the same time each day. Morning is the best time.
• Swallow the tablet whole with a glass of water.
• Dipperam HCT can be taken with or without food. Do not take Dipperam HCT with grapefruit or grapefruit juice. Depending on your response to treatment, your doctor may recommend a lower or higher dose.

Do not take more than the prescribed dose.
If you take more Dipperam HCT than you should
If you accidentally take too many Dipperam HCT tablets, contact a doctor immediately. You may require medical treatment.
If you forget to take Dipperam HCT
If you forget to take a dose of this medicine, take it as soon as you remember, then take your next dose at the usual time. If it is almost time for your next dose, you should simply take the next tablet at the usual time. Do not take a double dose (two tablets together) to make up for a forgotten tablet.
If you stop taking Dipperam HCT
Stopping treatment with Dipperam HCT may cause your condition to worsen. Do not stop taking the medicine unless your doctor tells you to.
Keep taking the medicine even if you feel well
People with high blood pressure often do not notice any symptoms. Many feel perfectly normal. To achieve the best results and reduce the risk of side effects, it is very important that you take this medicine exactly as prescribed by your doctor. Keep your appointments with your doctor even if you feel well.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with any combination containing three active substances, side effects associated with each individual component cannot be ruled out. The side effects reported with Dipperam HCT or any of the three active ingredients (amlodipine, valsartan and hydrochlorothiazide) are listed below and may occur during treatment with Dipperam HCT.
Some side effects may be serious and require immediate medical attention.
Contact your doctor immediately if, after taking this medicine, you experience any of the following serious side effects:

Common (may affect up to 1 in 10 people):

• dizziness
• low blood pressure (feeling faint, lightheadedness, sudden loss of consciousness)

Uncommon (may affect up to 1 in 100 people):

• severe decrease in urine output (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorders

Very rare (may affect up to 1 in 10,000 people):

• sudden onset of shortness of breath, chest pain, breathlessness or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat which may cause severe breathing difficulties
• severe skin reactions including intense skin rash, hives, widespread skin redness, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• inflammation of the pancreas, which may cause severe abdominal and back pain, together with a strong feeling of illness
• weakness, bruising, fever and frequent infections
• stiffness

Other side effects may include:
Very common (may affect more than 1 in 10 people)

• low potassium levels in the blood
• increased blood lipids

Common (may affect up to 1 in 10 people)

• drowsiness
• palpitations (awareness of your heartbeat)
• flushing
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after meals
• fatigue
• headache
• frequent need to urinate
• high levels of uric acid in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, fainting when standing up
• reduced appetite
• nausea and vomiting
• itchy rash and other types of skin rashes
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 people)

• fast heartbeat
• sensation of dizziness
• vision disturbances
• stomach discomfort
• chest pain
• increased blood urea, creatinine and uric acid levels
• high levels of calcium, fats or sodium in the blood
• decreased potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered taste
• back pain
• joint swelling
• cramps / weakness / muscle pain
• pain in the extremities
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after physical exercise
• lack of energy
• sleep disorders
• tingling or numbness
• neuropathy
• sudden and temporary loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• insomnia
• altered taste
• fainting
• loss of sensitivity to pain
• visual disturbances
• impaired vision
• ringing in the ears
• sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
• altered bowel habits
• indigestion
• hair loss
• skin itching
• change in skin color
• urinary disorders
• increased need to urinate at night
• frequent need to urinate
• discomfort or breast enlargement in men
• pain
• malaise
• weight decrease

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

• low platelet count (sometimes with bleeding or bruising under the skin)
• glucose in urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders which may occur together with yellowing of the skin and eyes or dark urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purplish skin spots
• kidney disorders
• confusion

Very rare (may affect up to 1 in 10,000 people)

• decrease in the number of white blood cells in the blood
• low platelet count in the blood, which may lead to unusual bruising or tendency to bleed (damage to red blood cells)
• gum swelling
• abdominal swelling (gastritis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• increase in liver enzymes which may lead to abnormalities in certain clinical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rash
• light sensitivity
• disorders related to stiffness, tremor and/or movement disorders
• fever, sore throat or mouth ulcers, more frequent infections (lack of or low levels of white blood cells)
• paleness, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal destruction of red blood cells in blood vessels or elsewhere in the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonia)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• severe skin disease causing rash, skin redness, blistering on lips, eyes and mouth, skin peeling, fever (toxic epidermal necrolysis)

Not known (frequency cannot be estimated from the available data)

• changes in blood tests for kidney function, increased potassium in the blood, low levels of red blood cells in the blood
• abnormal red blood cell values in the blood
• low levels of certain types of white blood cells and platelets
• increased creatinine in the blood
• abnormal liver function tests
• severe decrease in the amount of urine produced
• inflammation of blood vessels
• weakness, bruising and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine output (possible signs of kidney disorders or kidney failure)
• severe skin disease causing rash, skin redness, blistering on lips, eyes and mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blister formation on the skin (sign of a disorder called bullous dermatitis)
• cancer of the skin and lips (non-melanoma skin cancer)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dipperam HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original packaging to protect the medicine from moisture.
Do not use Dipperam HCT if you notice any visible signs of damage or signs of tampering.
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 Dipperam HCT Contains
Dipperam HCT 5 mg/160 mg/12.5 mg film-coated tablets
The active substances in Dipperam HCT are amlodipine (as amlodipine besylate), valsartan, and
hydrochlorothiazide. Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica,
magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E171).

Dipperam HCT 10 mg/160 mg/12.5 mg film-coated tablets
The active substances in Dipperam HCT are amlodipine (as amlodipine besylate), valsartan, and
hydrochlorothiazide. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica,
magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Dipperam HCT 5 mg/160 mg/25 mg film-coated tablets
The active substances in Dipperam HCT are amlodipine (as amlodipine besylate), valsartan, and
hydrochlorothiazide. Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica,
magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

Dipperam HCT 10 mg/160 mg/25 mg film-coated tablets
The active substances in Dipperam HCT are amlodipine (as amlodipine besylate), valsartan, and
hydrochlorothiazide. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica,
magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, yellow iron oxide (E 172).

Dipperam HCT 10 mg/320 mg/25 mg film-coated tablets
The active substances in Dipperam HCT are amlodipine (as amlodipine besylate), valsartan, and
hydrochlorothiazide. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan, and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica,
magnesium stearate, hypromellose (type 2910), macrogol 4000, talc, yellow iron oxide (E172).

Description of the Appearance of Dipperam HCT and Contents of the Pack
Dipperam HCT 5 mg/160 mg/12.5 mg film-coated tablets
White, oval-shaped tablets, engraved with “NVR” on one side and “VCL” on the other. Approximate dimensions: 15 mm (length) x 5.9 mm (width).

Dipperam HCT 10 mg/160 mg/12.5 mg film-coated tablets
Light yellow, oval-shaped tablets, engraved with “NVR” on one side and “VDL” on the other. Approximate dimensions: 15 mm (length) x 5.9 mm (width).

Dipperam HCT 5 mg/160 mg/25 mg film-coated tablets
Yellow, oval-shaped tablets, engraved with “NVR” on one side and “VEL” on the other. Approximate dimensions: 15 mm (length) x 5.9 mm (width).

Dipperam HCT 10 mg/160 mg/25 mg film-coated tablets
Yellow-brown, oval-shaped tablets, engraved with “NVR” on one side and “VHL” on the other. Approximate dimensions: 15 mm (length) x 5.9 mm (width).

Dipperam HCT 10 mg/320 mg/25 mg film-coated tablets
Yellow-brown, oval-shaped tablets, engraved with “NVR” on one side and “VFL” on the other. Approximate dimensions: 19 mm (length) x 7.5 mm (width).

Dipperam HCT is available in PVC/PVDC-Alu blisters or divisible PVC/PVDC-Alu blisters for unit dose.
Dipperam HCT is available in pack sizes of 14, 28, 28x1, 30, 56, 56x1, 60, 90, 98, 98x1, 100,
280 or 280 x 1 film-coated tablets, and in multiple packs containing 280 tablets (comprising 4 packs each containing 70x1 tablets, or 20 packs each containing 14 tablets).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg,
Germany
Novartis Farmaceutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata (NA)
Italy
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany