PACKAGE LEAFLET

Package leaflet: information for the patient

Vasoretic 20 mg + 12.5 mg tablets

enalapril maleate + hydrochlorothiazide
Please read this entire leaflet carefully before 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, consult 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vasoretic is and what it is used for

Vasoretic contains two active substances: enalapril maleate and hydrochlorothiazide.
Enalapril maleate belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE-inhibitors). ACE-inhibitors work by causing relaxation of the blood vessels, thereby facilitating blood flow through them. ACE-inhibitors are used to treat high blood pressure (hypertension).
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works by stimulating the kidneys to produce a greater amount of urine (diuretic effect), thus reducing blood pressure (antihypertensive effect).
Vasoretic is used to treat high blood pressure and is indicated in patients whose blood pressure is not adequately controlled with enalapril maleate or hydrochlorothiazide given alone.

2. What you need to know before taking Vasoretic

Do not take Vasoretic:

if you are allergic to the active substances (enalapril maleate and hydrochlorothiazide) or to other medicines derived from sulfonamides (chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
if you have had an allergic reaction causing swelling of the hands, feet, ankles, or even face, lips, tongue and/or throat, leading to difficulty swallowing or breathing (angioedema) after taking ACE inhibitors;
if you suffer from hereditary angioedema (due to a familial predisposition);
if you suffer from idiopathic angioedema, i.e. angioedema of unknown cause;
if you have severe kidney problems (severe renal failure);
if you are unable to urinate (anuria);
if you are in the second or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
if you have severe liver problems (severe hepatic insufficiency);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see section “Other medicines and Vasoretic”);
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vasoretic.
In particular, talk to your doctor or pharmacist before taking Vasoretic if:

you are taking medicines that increase urine production (diuretics), are on a low-salt diet, or have experienced vomiting or diarrhoea. In these cases, you are at risk of excessive drop in blood pressure (hypotension), which may manifest as weakness or dizziness. Your doctor will prescribe regular monitoring of electrolyte levels in your blood.
you have disorders of blood flow to the heart (ischaemic heart disease) or brain (ischaemic cerebrovascular disease), or other heart problems, with or without kidney problems. In such cases, excessive lowering of blood pressure may be particularly dangerous. If you experience symptoms of hypotension during treatment with Vasoretic, lie down and contact your doctor immediately;
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 sun exposure and UV radiation while taking Vasoretic;
you are taking any of the following medicines, as the risk of angioedema may be increased:
- Racecadotril, a medicine used to treat diarrhoea.
- Medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus).
- Vildagliptin, a medicine used to treat diabetes.
inform your doctor if you are taking any of the following medicines used to treat high blood pressure:
an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
aliskiren.
you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Vasoretic, consult a doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes
(e.g. potassium) in your blood at regular intervals. See also information in the section
“Do not take Vasoretic”;

you are at risk of increased potassium levels in the blood (hyperkalaemia) due to:
kidney failure, worsening kidney function, diabetes, dehydration, acute heart failure (where the heart does not pump blood adequately throughout the body), increased blood acidity (metabolic acidosis);
concomitant use of medicines that promote urine elimination while retaining potassium (potassium-sparing diuretics, e.g. spironolactone, eplerenone, triamterene or amiloride), potassium supplements, potassium-containing salt substitutes, or if you are taking other medicines that may increase potassium in the
blood (e.g., heparin [a medicine used to prevent blood clots],
trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections]) (see section “Other medicines and Vasoretic”).
In such cases, your doctor will frequently monitor your blood potassium levels;
you have narrowing (stenosis) of the aortic valve or thickening of the heart walls (hypertrophic cardiomyopathy);
you have severe heart problems (severe heart failure);
you have kidney problems, e.g. narrowing (stenosis) of one or both renal arteries, as there is an increased risk of hypotension and renal failure. In this case, your doctor will closely monitor your kidney function;
you have recently undergone a kidney transplant. In this case, use of this medicine is not recommended;
you are undergoing dialysis (blood purification therapy) due to kidney failure. In this case, your doctor will consider an alternative treatment (see section “Do not take Vasoretic”);
you have liver problems or suffer from a disease that could lead to destruction of liver cells (progressive liver disease) (see sections “Do not take Vasoretic” and “Stop taking Vasoretic and inform your doctor if”);
you have chronic degenerative liver disease (hepatic cirrhosis), marked urine production, inadequate oral electrolyte intake, or are being treated with corticosteroids or adrenocorticotropic hormone (hormonal medicines). In such cases, the risk of low blood potassium levels (hypokalaemia) is highest;
you suffer from a connective tissue disease affecting blood vessels, are taking immunosuppressive medicines, suffer from gout or are taking allopurinol (used to treat gout) or procainamide (used to treat heart rhythm disorders), or have a combination of these risk factors, especially if you also have kidney problems. In this case, severe infections may occur that may not respond to antibiotic therapy. If you need to take Vasoretic under these conditions, your doctor will prescribe specific blood tests. Report any signs or symptoms of infection to your doctor;
you have diabetes and are taking oral antidiabetic medicines or insulin. In this case, your doctor will advise blood tests to monitor glucose levels, especially during the first month of treatment with Vasoretic, and will assess whether the dose of antidiabetic medicines needs adjustment;
you are taking lithium (a medicine for the treatment of mood disorders) (see section “Other medicines and Vasoretic”);
you are of black race. Vasoretic may be less effective in lowering blood pressure in black patients compared to non-black patients. In addition, you may have a higher risk of developing angioedema;
you have developed a persistent dry cough for a prolonged period after starting treatment with an ACE inhibitor;
if you have a history of allergies or bronchial asthma, as hypersensitivity reactions may occur with the use of Vasoretic;
if you suffer from a disorder called systemic lupus erythematosus (an autoimmune disease), which may develop or worsen with the use of Vasoretic;
if you experience decreased vision 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 Vasoretic. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing these symptoms.

If you are about to undergo any of the following procedures, inform your doctor that you are
taking Vasoretic:

any surgical procedure or if you are to receive anaesthetic therapy;
a treatment called dextran-sulfate LDL (low-density lipoprotein) apheresis, to remove cholesterol from the blood using machines. Your doctor may temporarily discontinue Vasoretic to prevent a possible allergic reaction;
a treatment to reduce the effects of an allergy, e.g. following an insect sting (desensitisation therapy). If you take Vasoretic during this treatment, you may experience a severe allergic reaction, so temporary interruption of therapy is advisable;
you need to undergo tests to assess parathyroid gland function. Consult your doctor, who will advise you to stop taking Vasoretic before this test.

Stop taking Vasoretic and inform your doctor if you experience:

swelling of the hands, feet, ankles, or face, lips, tongue and/or throat, causing difficulty swallowing or breathing (angioedema);
yellowing of the skin and whites of the eyes (jaundice), indicating liver problems or increased levels of transaminases (liver enzymes) in the blood;
increased levels of nitrogen and creatinine in the blood, which may suggest possible renal artery stenosis;
increased calcium levels in the blood (hypercalcaemia).

During treatment with Vasoretic, electrolyte imbalance may occur, manifesting with
signs and symptoms that may include:

dry mouth, thirst, weakness, pathological state of deep sleep (lethargy), drowsiness, restlessness, muscle pain or cramps, muscle fatigue, low blood pressure, reduced urine output, increased heart rate (tachycardia), and gastrointestinal disturbances such as nausea and vomiting. In such cases, inform your doctor promptly. This medicine must be used under regular medical supervision. Therefore, strictly follow all laboratory tests and check-ups prescribed by your doctor.

Children and adolescents
The use of Vasoretic is not recommended in children due to lack of data on safety and
efficacy.
Other medicines and Vasoretic
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
In particular, consult your doctor or pharmacist if you are taking:

an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information in sections “Do not take Vasoretic” and “Warnings and precautions”). Your doctor may need to adjust the dose and/or take other precautions;
other medicines that lower blood pressure (antihypertensives), including vasodilators, nitroglycerin and other nitrates, as excessive lowering of blood pressure may occur;
lithium, used to treat certain mood disorders, as excessive lithium concentration in the blood and lithium toxicity may occur;
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; heparin, a medicine used to thin the blood to prevent clot formation). See also information in section “Warnings and precautions”;
medicines that promote diuresis (diuretics), such as thiazides or loop diuretics, as they may cause a reduction in blood pressure;
anaesthetics, antipsychotics, and tricyclic antidepressants (used to treat mental disorders), as further reduction in blood pressure may occur;
medicines acting on the autonomic nervous system (sympathomimetics) such as ephedrine, pseudoephedrine, salbutamol, found in some nasal decongestants, cough and cold medicines, asthma treatments, treatments for low blood pressure, and cardiac conditions. These medicines may reduce the antihypertensive effects of Vasoretic;
insulin or other oral antidiabetic medicines. Blood glucose levels must be carefully monitored, especially during the first weeks of treatment with Vasoretic and in patients with kidney problems;
medicines used to treat stiffness and inflammation associated with painful conditions, particularly those affecting muscles, bones and joints, including:
gold-containing medicines administered by injection, e.g. sodium aurothiomalate, as they may cause facial flushing, nausea, vomiting and low blood pressure when taken with Vasoretic;
non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, as they may reduce the effectiveness of Vasoretic, increase blood potassium levels, and worsen kidney function;
carbenoxolone (a medicine used to treat stomach problems such as ulcers), kaliuretic diuretics (e.g. furosemide), or excessive use of laxatives. Using Vasoretic with these medicines may further reduce potassium and/or magnesium levels in the blood;
tubocurarine, used to relax muscles during surgery (muscle relaxant), as Vasoretic may enhance its effects;
barbiturates, which have a sedative effect on the central nervous system, used e.g. to treat epilepsy, or opioid analgesics, medicines used to relieve pain. These medicines may worsen dizziness upon standing due to low blood pressure (orthostatic hypotension);
medicines used to lower blood fat levels, such as cholestyramine or colestipol resins, as they may reduce the absorption of Vasoretic;
medicines used to treat irregular heartbeat (antiarrhythmics such as quinidine, procainamide, amiodarone, sotalol), as they may cause heart rhythm problems (torsades de pointes);
medicines used to treat heart failure (digitalis preparations);
corticosteroids (which modulate anti-inflammatory responses) and adrenocorticotropic hormone (ACTH) (used to check adrenal gland function), as they may further reduce blood electrolyte levels, particularly potassium (hypokalaemia);
pressor amines (e.g. noradrenaline), as Vasoretic may reduce their effects;
cancer medicines such as cyclophosphamide or methotrexate, as Vasoretic may increase their toxicity;
medicines used to treat gout, such as allopurinol (see section “Warnings and precautions”);
immunosuppressive medicines;
mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus), as concomitant administration may increase the risk of an allergic reaction called angioedema (see section “Stop taking Vasoretic and inform your doctor if”);
a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), racecadotril or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) may be increased. See also information in sections “Do not take Vasoretic” and “Warnings and precautions”.

Vasoretic and alcohol
Vasoretic should not be taken with alcohol, as this may cause excessive
lowering of blood pressure.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Vasoretic is not recommended during pregnancy and must not be taken if you are more than
3 months pregnant, as it may cause severe harm to the baby if taken after the third month
of pregnancy (see section “Do not take Vasoretic”).
You must inform your doctor if you think you are pregnant (or if you are planning a
pregnancy). Your doctor will tell you to stop taking Vasoretic immediately before
becoming pregnant or as soon as you learn you are pregnant and will advise you to take
another medicine instead of Vasoretic.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Vasoretic is not recommended for breastfeeding women, especially if your baby was born prematurely and during the first weeks after delivery.
Driving and using machines
Vasoretic may cause side effects that may affect your ability to drive or
use machinery, such as dizziness or tiredness, which may occur occasionally.
Therefore, exercise caution when driving or operating machinery.
Vasoretic contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
Vasoretic contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. 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 Vasoretic

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

The recommended dose is 1 tablet per day. If necessary, your doctor may increase the dose up to a maximum of 2 tablets taken once daily.

At the beginning of treatment, it is advisable to start with half the dose (10 mg of enalapril and 6.25 mg of hydrochlorothiazide).

Since the tablet cannot be divided into equal parts, your doctor may consider using the individual components at the doses indicated above or other medicines (with the same active substances and dosage) available in tablets that can be split.

Your doctor will determine the appropriate dose based on your condition and until adequate blood pressure control is achieved.

Prior diuretic therapy
If you are already taking another medicine that increases diuresis (a diuretic), taking enalapril contained in Vasoretic may cause an excessive reduction in blood pressure. In such cases, if your doctor still considers Vasoretic necessary, they may instruct you to stop taking the diuretic a few days before starting Vasoretic. If this is not possible, your doctor may decide to start treatment with lower doses of enalapril, using separate tablets containing the same active substances as Vasoretic (enalapril and hydrochlorothiazide). Vasoretic may be used later, once your doctor has determined that you need the dose of enalapril and hydrochlorothiazide contained in the Vasoretic tablet.

Patients with kidney problems (renal impairment)
You must not use Vasoretic if you have severe kidney problems (see section “Do not take Vasoretic”).

If you have kidney problems, your doctor will monitor your kidney function and decide the appropriate dose of Vasoretic.

Use in children and adolescents
The use of Vasoretic is not recommended in children.

Use in the elderly
Dosage adjustment is not required in elderly patients.

If you take more Vasoretic than you should
If you accidentally take an excessive dose of Vasoretic, contact your doctor immediately or go to the nearest hospital and stop the treatment.

Symptoms of overdose may include: feeling of light-headedness or dizziness due to excessive lowering of blood pressure, severe circulatory problems (circulatory shock), renal failure, hyperventilation, increased heart rate (tachycardia), palpitations, decreased heart rate (bradycardia), anxiety, cough, electrolyte disturbances such as low levels of potassium (hypokalaemia), chloride (hypochloraemia), and sodium (hyponatraemia) in the blood, and dehydration due to excessive diuresis.

If you forget to take Vasoretic
Do not take a double dose to make up for the missed tablet. If in doubt, contact your doctor.

If you stop taking Vasoretic
Do not stop treatment with Vasoretic unless instructed by your doctor.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vasoretic and contact your doctor immediately if you experience symptoms of angioedema
during treatment, such as:

allergic reaction accompanied by swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat, leading to difficulty swallowing or breathing (angioedema).

The side effects observed with the use of Vasoretic are listed below:
Very common (may affect more than 1 in 10 people)

blurred vision;
dizziness;
cough;
nausea;
loss of strength (asthenia).

Common (may affect up to 1 in 10 people)

low blood potassium levels (hypokalaemia) or high blood potassium levels (hyperkalaemia), increased blood cholesterol, triglycerides, uric acid levels (hyperuricaemia), and creatinine levels;
headache (cephalalgia), depression, temporary loss of consciousness (syncope), altered taste;
low blood pressure (hypotension), drop in blood pressure upon sudden change from sitting or lying position to standing (orthostatic hypotension), irregular heart rhythm, chest pain with a sensation of tightness and pressure (angina pectoris), increased heart rate (tachycardia);
difficulty breathing (dyspnoea);
diarrhoea, abdominal pain;
skin rash (exanthema);
involuntary muscle contractions (muscle cramps);
chest pain, fatigue.

Uncommon (may affect up to 1 in 100 people)

decreased number of red blood cells (anaemia, including aplastic and haemolytic anaemia);
low blood sugar levels (hypoglycaemia), low blood magnesium levels (hypomagnesaemia), joint pain and swelling (gout);
confusion, drowsiness, insomnia, nervousness, tingling sensation in legs, arms or other body parts (paraesthesia), sensation of dizziness (vertigo);
reduced sexual desire, impotence;
unpleasant sensation of ringing or buzzing in the ears (tinnitus);
flushing and sensation of warmth, mainly in the face (hot flushes), awareness of irregular or forceful heartbeat (palpitations), heart attack (myocardial infarction), or stroke (cerebrovascular accident), possibly secondary to a sudden drop in blood pressure in high-risk patients (see section “Warnings and precautions”);
runny nose (rhinorrhoea), sore throat (laryngodynia) and hoarseness, chest tightness causing difficult and noisy breathing (bronchospasm/asthma);
reduced intestinal movement (ileus), inflammation of the pancreas (pancreatitis), vomiting, difficulty in digestion (dyspepsia), constipation, loss of appetite (anorexia), stomach irritation, dry mouth, stomach lesions (peptic ulcer), increased production of intestinal gas (flatulence);
increased sweating (diaphoresis), itching (pruritus), hives (urticaria), hair loss (alopecia);
joint pain (arthralgia);
impaired kidney function, kidney failure, presence of protein in the urine (proteinuria);
malaise, fever;
increased blood urea levels (uraemia), low sodium concentration in the blood (hyponatraemia).

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

decreased number of certain white blood cells (neutropenia, leucopenia, and agranulocytosis), reduced haemoglobin levels, low total volume of red blood cells (low haematocrit), low platelet count (thrombocytopenia), or reduced levels of all types of blood cells (pancytopenia), bone marrow suppression (when the bone marrow fails to produce sufficient blood cells), swelling of glands called lymph nodes (lymphadenopathy), immune system disorders (autoimmune diseases);
increased blood sugar levels;
abnormal dreams, sleep disturbances, partial reduction in mobility (paresis due to hypokalaemia);
reduced blood flow to fingers of hands and feet causing redness and pain (Raynaud’s phenomenon);
lung problems including pulmonary infiltrates, severe respiratory failure (respiratory distress syndrome), lung inflammation (pneumonitis), fluid accumulation in the lungs (pulmonary oedema), allergic (hypersensitivity) reaction in the lungs (allergic alveolitis), lung disease (eosinophilic pneumonia);
irritation or inflammation of the nose (rhinitis);
inflammation of the mouth lining (stomatitis) with ulceration or aphthae, inflammation of the tongue (glossitis);
liver problems such as liver failure, liver damage (hepatic necrosis, potentially fatal), inflammation of the liver or bile ducts (hepatitis hepatocellular or cholestatic), yellowing of the skin and whites of the eyes (jaundice), inflammation of the gallbladder (cholecystitis, particularly in patients with pre-existing gallstones);
severe skin diseases with blistering, redness and peeling, including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease causing skin inflammation), pemphigus, and erythroderma (redness of the skin);
reduced urine output (oliguria), kidney disease (interstitial nephritis);
breast enlargement in men (gynaecomastia);
increased liver enzymes, elevated blood bilirubin levels (bilirubinaemia).

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

increased blood calcium levels (hypercalcaemia);
swelling of the intestinal mucosa (intestinal angioedema);
acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

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

syndrome of inappropriate antidiuretic hormone secretion (SIADH);
sudden-onset difficulty seeing distant objects (acute myopia), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
cancer of the skin and lips (non-melanoma skin cancer).

Other side effects
A complex disorder including one or more of the following symptoms has been reported, with frequency not known:

fever, serositis (inflammation of the membranes lining body cavities such as chest and abdomen), vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation (myalgia/myositis), joint pain or joint inflammation (arthralgia/arthritis), positive test for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased number of white blood cells (eosinophilia, leucocytosis), skin rash, skin sensitivity to light (photosensitivity), and other skin problems.

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

5. How to store Vasoretic

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.
This medicine does not require any special storage conditions.
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 Vasoretic contains

The active substances are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
The other excipients are: sodium bicarbonate, monohydrate lactose, yellow iron oxide, maize starch, pregelatinized starch, magnesium stearate.

Description of the appearance of Vasoretic and the contents of the pack
Vasoretic is presented as tablets contained in an aluminum blister.
Each pack contains 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN – Haarlem, The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands