Valsartan and hydrochlorothiazide Pensà

PACKAGE LEAFLET: INFORMATION FOR THE USER

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 80 mg/12.5 mg film-coated tablets, 160 mg/12.5 mg film-coated tablets, 160 mg/25 mg film-coated tablets, 320 mg/12.5 mg film-coated tablets, 320 mg/25 mg film-coated tablets

Active substance: Valsartan and Hydrochlorothiazide
Generic medicine
Read all of this leaflet carefully before taking this medicine.

• 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT IS VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA AND WHAT IS IT USED FOR

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “fluid tablets”). Hydrochlorothiazide increases the amount of urine produced and, in this way, reduces blood pressure.

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is used to treat high blood pressure when blood pressure is not sufficiently controlled by a single medicine.

When blood pressure is high, the workload on the heart and arteries increases. Over time, this can damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. BEFORE TAKING VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA

Do not take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA:

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), soy, peanuts, or any of the excipients of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA (listed in section 6)
• if you are more than 3 months pregnant (it is better to avoid taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA even in the early stages of pregnancy – see section Pregnancy)
• if you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis)
• if you have severe kidney disease
• if you are unable to urinate (anuria)
• if you are undergoing treatment with an artificial kidney
• if your blood levels of potassium or sodium are lower than normal, or if your blood calcium levels are higher than normal despite treatment
• if you have gout
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these situations apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Consult your doctor before taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA

• if you are taking potassium-sparing medications, potassium supplements, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may need to regularly monitor your blood potassium levels
• if your blood potassium levels are low
• if you have diarrhea or severe vomiting
• if you are taking high doses of medicines that increase fluid elimination (diuretics)
• if you have severe heart disease
• if you suffer from heart failure or have had a heart attack. Follow your doctor’s instructions carefully regarding the starting dose of treatment. Your doctor will also monitor your kidney function
• if you have narrowing of the renal artery
• if you have recently received a kidney transplant
• if you suffer from hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, use of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended
• if you have liver or kidney diseases
• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur when taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA, stop taking it immediately and never take it again. See section 4, “Possible side effects”
• if you have fever, skin rashes, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease)
• if you have diabetes, gout, high cholesterol, or high blood lipid levels
• if you have had allergic reactions when using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma
• if you experience vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur from a few hours to weeks after taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.
• 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
• may cause increased skin sensitivity to sunlight
• if you have previously had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of non-melanoma skin and lip cancers. Protect your skin from sun and UV exposure while taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA. Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

The use of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended in children and adolescents (under 18 years of age).
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
Taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.
The effect of treatment may be influenced if VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is taken together with certain other medicines.
Dosage adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• lithium, a medicine used in the treatment of certain psychiatric disorders
• medicines that may increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
• medicines that may decrease blood potassium levels, such as diuretics (medicines that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), and an antiretroviral drug used to treat HIV/AIDS infections (ritonavir). These medicines may enhance the effect of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
• medicines that may induce torsades de pointes, such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics
• medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone, therapeutic vitamin D and calcium supplements, and medicines used to treat diabetes (oral or insulin)
• other medicines that lower blood pressure, such as beta-blockers or methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also under “Do not take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA” and “Warnings and precautions”) or medicines that constrict blood vessels or stimulate the heart, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medicines used to treat heart problems)
• medicines that increase blood sugar levels, such as diazoxide
• cancer treatment medicines, such as methotrexate or cyclophosphamide
• painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines, such as atropine or biperiden (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and to facilitate anesthesia)
• amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral diseases)
• cholestyramine and colestipol (medicines used in the treatment of high blood lipid levels)
• cyclosporine, a medicine used in organ transplantation to prevent organ rejection
• alcohol, anesthetics, and sedatives (medicines with narcotic or pain-relieving effects used, for example, during surgical procedures)
• carbamazepine, a medicine used to treat seizures
• iodinated contrast agents (used in radiological examinations).

Taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA with food and drinks
VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA can be taken with or without food.
Avoid consuming alcohol unless you have discussed it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
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 VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA before becoming pregnant or as soon as you find out you are pregnant and will recommend another medicine instead. VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy. Breastfeeding
• Inform your doctor if you are breastfeeding or planning to breastfeed. VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Before driving a vehicle, operating machinery, or performing other activities requiring concentration, you should know how you react to VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA. Like many other medicines used to treat high blood pressure, VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA may rarely cause dizziness and affect concentration ability.
Important information on some excipients of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA contains soybean oil. If you are allergic to peanuts or soy, do not take this medicine.
VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 160 mg/12.5 mg also contains Sunset Yellow FCF (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. HOW TO TAKE VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA

Always take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA exactly as prescribed by your doctor. This will help you achieve the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not notice any symptoms and usually feel perfectly well. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.

• The usual dose of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA is one tablet daily.
• Do not change the dose and do not stop taking the tablets without first consulting your doctor.
• This medicine should be taken every day at the same time, usually in the morning.
• You may take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA with or without food.
• Swallow the tablet with a glass of water.

If you take more VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you have taken too many tablets by accident, contact your doctor, pharmacist, or hospital.
If you forget to take VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten one.
If you stop taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA
Stopping treatment with VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA may cause your blood pressure to worsen.
Do not stop using this medicine unless your doctor tells you to do so.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA can cause adverse reactions, although not everyone experiences them. These adverse reactions may occur with certain frequencies defined as follows:

• very common: affects more than 1 in 10 users
• common: affects 1 to 10 in 100 users
• uncommon: affects 1 to 10 in 1,000 users
• rare: affects 1 to 10 in 10,000 users
• very rare: affects fewer than 1 in 10,000 users
• not known: frequency cannot be estimated from the available data.

Some adverse reactions may be serious and require immediate medical attention:

• Consult your doctor immediately if you experience symptoms of angioedema (an allergic reaction), such as:
• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing
• Severe skin diseases causing rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high intraocular pressure (possible sign of acute angle-closure glaucoma)
• Fever, sore throat, more frequent infections (agranulocytosis)

If you experience any of these symptoms, stop taking VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA and contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other adverse reactions include:
Uncommon

• cough
• low blood pressure
• sensation of emptiness in the head
• dehydration (with symptoms such as thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises in the ears (e.g. ringing, buzzing)

Very rare

• dizziness
• diarrhea
• joint pain

Not known

• difficulty breathing
• marked decrease in urine output
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, abnormal heart rhythm)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which may, in severe cases, cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate kidney dysfunction)
• increased blood uric acid levels (which may, in severe cases, lead to gout)
• syncope (fainting)

Adverse reactions reported with valsartan or hydrochlorothiazide alone, but not observed with VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA:
Valsartan
Uncommon

• sensation of dizziness
• abdominal pain

Not known

• appearance of blisters on the skin (sign of bullous dermatitis)
• skin rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of blood vessel inflammation)
• low platelet count in the blood (sometimes with unusual bleeding or bruising)
• increased potassium levels in the blood (sometimes with muscle cramps, abnormal heart rhythm)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, especially of the face and throat, skin rash, itching
• increased liver function test values
• decreased hemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, may both cause anemia)
• kidney failure
• low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)
  Hydrochlorothiazide

Very common

• low potassium levels in the blood
• increased blood lipids

Common

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rashes or other types of skin rashes
• decreased appetite
• mild nausea and vomiting
• dizziness, fainting upon standing
• impotence

Rare

• swelling and blistering of the skin (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of the metabolic state in diabetes
• constipation, stomach or intestinal disturbances, liver disorders (yellowing of the skin or eyes)
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

Very rare

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (cutaneous lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty including pneumonia and pulmonary edema)
• pallor, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat or mouth ulcers due to infections (leukopenia), confusion, fatigue, tremor and muscle cramp, labored breathing (hypochloremic alkalosis)
  Not known
• fatigue, easy bruising and frequent infections (aplastic anemia)
• severe decrease in urine output (possible sign of kidney disorder or kidney failure)
• skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramp
• fever (pyrexia)
• weakness (asthenia)
• decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• skin and lip cancer (non-melanoma skin cancer)

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

5. HOW TO STORE VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA

• Keep out of the reach and sight of children.
• Do not use VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA after the expiry date stated on the cardboard box or on the blister. The expiry date refers to the last day of the month.
  VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg film-coated tablets:
  • PVC/PE/PVDC-Al blister: Do not store above 30 °C.
    VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 320 mg/12.5 mg and 320 mg/25 mg film-coated tablets:
  • PVC/PE/PVDC-Al blister: Do not store above 25 °C.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA contains

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
• The excipients are: Tablet core: Microcrystalline cellulose, Lactose monohydrate, Sodium croscarmellose, Povidone K29-K32, Talc, Magnesium stearate, Anhydrous colloidal silica. Film coating: [80 mg/12.5 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Lecithin (contains soybean oil) (E322), Red iron oxide (E172), Yellow iron oxide (E172), Black iron oxide (E172). [160 mg/12.5 mg tablets] Polyvinyl alcohol, Talc, Macrogol 3350, Titanium dioxide (E171), Red iron oxide (E172), Sunset Yellow FCF aluminium lake (E110), Lecithin (contains soybean oil) (E322). [160 mg/25 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Yellow iron oxide (E172), Lecithin (contains soybean oil) (E322), Red iron oxide (E172), Black iron oxide (E172). [320 mg/12.5 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Yellow iron oxide (E172), Lecithin (contains soybean oil) (E322), Red iron oxide (E172). [320 mg/25 mg tablets] Polyvinyl alcohol, Talc, Titanium dioxide (E171), Macrogol 3350, Yellow iron oxide (E172), Lecithin (contains soybean oil) (E322), Red iron oxide (E172).

Description of the appearance of VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA and contents of the pack

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 80 mg/12.5 mg film-coated tablets: pink, oval, biconvex, film-coated tablets, 11 x 5.8 mm in size, marked with “V” on one side and “H” on the other.

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 160 mg/12.5 mg film-coated tablets: red, oval, biconvex, film-coated tablets, 15 x 6 mm in size, marked with “V” on one side and “H” on the other.

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 160 mg/25 mg film-coated tablets: orange, oval, biconvex, film-coated tablets, 15 x 6 mm in size, marked with “V” on one side and “H” on the other.

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 320 mg/12.5 mg film-coated tablets: pink, oval, biconvex, film-coated tablets, 18.9 x 7.5 mm in size, marked with “V” on one side and “H” on the other.

VALSARTAN AND HYDROCHLOROTHIAZIDE PENSA 320 mg/25 mg film-coated tablets: yellow, oval, biconvex, film-coated tablets, 18.9 x 7.5 mm in size, with a breakline on one side and lateral markings, namely “V” on one side and “H” on the other. The tablet can be divided into two equal parts.

Pack sizes:
Blister packs: 28 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milan, Italy

Responsible manufacturer for batch release
Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun, ZTN3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

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