Valsartan and hydrochlorothiazide Mylan: detailed information

Package leaflet: Information for the user

Valsartan and Hydrochlorothiazide Mylan 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

valsartan and hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before you start 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 or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan and Hydrochlorothiazide Mylan is and what it is used for

Valsartan and Hydrochlorothiazide Mylan 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 diuretics). Hydrochlorothiazide increases the amount of urine produced and, in this way, helps reduce blood pressure.

Valsartan and Hydrochlorothiazide Mylan is used to treat high blood pressure when blood pressure is not controlled by a single medicine alone.
When blood pressure is high, the workload on the heart and arteries increases. If left untreated, it can damage the blood vessels in the brain, heart, and kidneys, and may lead 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. What you need to know before taking Valsartan and Hydrochlorothiazide Mylan

Do not take Valsartan and Hydrochlorothiazide Mylan:

if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically related substances to hydrochlorothiazide), or any of the other ingredients of this medicine (listed in section 6)
if you are more than 3 months pregnant (it is better to avoid taking Valsartan and Hydrochlorothiazide Mylan even in the early stages of pregnancy – see Pregnancy section)
if you have severe liver problems
if you have severe kidney problems
if you are unable to urinate
if you are undergoing treatment with an artificial kidney
if your blood potassium or sodium levels 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
Talk to your doctor or pharmacist before taking Valsartan and Hydrochlorothiazide Mylan

if you have previously experienced breathing or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulties occur after taking Valsartan and Hydrochlorothiazide Mylan, consult a doctor immediately.
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 radiation during treatment with Valsartan and Hydrochlorothiazide Mylan
if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may need to regularly monitor your blood potassium levels
if you have a history of allergy to sulfonamides or penicillin
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 serious heart problems
if you have renal artery stenosis
if you have recently received a kidney transplant
if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, use of Valsartan and Hydrochlorothiazide Mylan is not recommended
if you have liver or kidney disease
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, or elevated cholesterol or blood fat 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
it may cause increased skin sensitivity to sunlight
you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Mylan 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 Pregnancy section).
If you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren.

Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.
See also the information in the section “Do not take Valsartan and Hydrochlorothiazide Mylan”.

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 a week after taking Valsartan and Hydrochlorothiazide Mylan. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Contact your doctor if, after taking Valsartan and Hydrochlorothiazide Mylan, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether treatment should continue. Do not stop taking Valsartan and Hydrochlorothiazide Mylan on your own.

Children and adolescents
The use of Valsartan and Hydrochlorothiazide Mylan is not recommended in children and adolescents under 18 years of age.

Other medicines and Valsartan and Hydrochlorothiazide Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of this medicine may be altered when taken with certain other medicines. It may be necessary to adjust the dosage, take additional precautions, or, in some cases, discontinue one of the medicines. This particularly applies to the following medicines:

lithium, a medicine used in the treatment of certain psychiatric disorders
medicines that affect or may be affected by blood potassium levels, such as digoxin (a medicine that regulates heart rhythm), certain antipsychotics, and antidepressants
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 corticosteroids and certain laxatives
diuretics (medicines that increase fluid elimination), gout treatments such as allopurinol, therapeutic vitamin D and calcium supplements, medicines used to treat diabetes (oral agents or insulin)
other medicines that lower blood pressure, such as beta-blockers or methyldopa, or medicines that constrict blood vessels or stimulate the heart, such as noradrenaline or adrenaline
medicines that increase blood sugar levels, such as diazoxide
cancer treatments such as methotrexate or cyclophosphamide
painkillers
medicines for arthritis
muscle relaxants such as tubocurarine
anticholinergic medicines such as atropine or biperiden
amantadine (a medicine used to prevent influenza)
cholestyramine and colestipol (medicines used to treat high blood fat levels)
cyclosporine, a medicine used in organ transplantation to prevent organ rejection
barbiturates and narcotics (medicines with sedative or analgesic effects, used, for example, during surgical procedures)
antiepileptics such as carbamazepine, a drug used to treat seizures
rifampicin, a drug used to treat tuberculosis
ritonavir, a drug used to treat HIV infections
medicines affecting gastric motility, such as cisapride
if you are taking an ACE inhibitor or aliskiren (see also information in the sections “Do not take Valsartan and Hydrochlorothiazide Mylan” and “Warnings and precautions”)

Valsartan and Hydrochlorothiazide Mylan with food, drinks, and alcohol
Valsartan and Hydrochlorothiazide Mylan 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
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to stop taking Valsartan and Hydrochlorothiazide Mylan before becoming pregnant or as soon as you learn you are pregnant and will recommend an alternative medicine. Valsartan and Hydrochlorothiazide Mylan is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan and Hydrochlorothiazide Mylan 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.

Driving and using machines
Before driving, operating machinery, or performing other activities requiring concentration, you should be aware of how you react to Valsartan and Hydrochlorothiazide Mylan. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Mylan may rarely cause dizziness and affect your ability to concentrate.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Valsartan and Hydrochlorothiazide Mylan contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially "sodium-free".

3. How to take Valsartan and Hydrochlorothiazide Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Valsartan and Hydrochlorothiazide Mylan is one tablet daily. This medicine should be taken every day at the same time, usually in the morning. Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Mylan you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.
You may find that this medicine has an unusual odour and/or taste. This is normal and characteristic of the active substance valsartan.
Use in children and adolescents
Valsartan and Hydrochlorothiazide Mylan is not recommended for children and adolescents under 18 years of age.
Route and method of administration
You may take this medicine with or without food. Swallow the tablet with a glass of water.
Duration of treatment
Do not change the dose or stop taking the tablets without first consulting your doctor. Patients with high blood pressure often do not notice any signs of this condition and may feel as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.
If you take more Valsartan and Hydrochlorothiazide Mylan than you should
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
If you forget to take Valsartan and Hydrochlorothiazide Mylan
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 a forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide Mylan
Stopping treatment with Valsartan and Hydrochlorothiazide Mylan may cause your high blood pressure to worsen. Do not discontinue use of this medicine unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects may be serious and require immediate medical attention. Contact your doctor immediately or go to the nearest emergency room if you experience symptoms of angioedema, such as:

swelling of the face, tongue or pharynx
difficulty swallowing
hives and difficulty breathing
skin rash, which may appear as a dark central spot surrounded by a lighter area, with a dark ring around the edge (erythema multiforme).

The following side effects have been observed during treatment with Valsartan and Hydrochlorothiazide Mylan, with the following frequency:
Uncommon side effects: occur in 1-100 patients

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

Very rare side effects: occur in 1-10,000 patients

dizziness
diarrhoea
joint pain

Not known: frequency cannot be estimated from the available data

difficulty breathing
markedly decreased 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, cause gout)
syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan and Hydrochlorothiazide Mylan:
Valsartan
Uncommon side effects: occur in 1-100 patients

sensation of dizziness
abdominal pain

Very rare side effects: occur in 1-10,000 patients

intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Not known: frequency cannot be estimated from the available data

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 influenza-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 haemoglobin levels and decreased percentage of red blood cells in the blood (which, in severe cases, can both lead to anaemia)
renal failure

Hydrochlorothiazide
Very common side effects: occur in more than 1 in 10 patients

low potassium levels in the blood, increased lipid levels (especially at high doses)

Common side effects: occur in 1-10 patients

skin rashes with itching or other types of skin rashes
low sodium levels in the blood, low magnesium levels in the blood
high uric acid levels
decreased appetite
mild nausea and vomiting
feeling of faintness, fainting upon standing
impotence

Rare side effects: occur in 1-1,000 patients

swelling and blister formation on the skin (due to increased sensitivity to sunlight)
constipation, stomach or intestinal disturbances, diarrhoea, liver disorders (yellowing of the skin or eyes)
irregular heartbeat
high calcium levels, high blood sugar levels, sugar excretion in urine, worsening of diabetic metabolic state
headache, dizziness, numbness of hands and feet
sleep disturbances
low mood (depression)
low platelet count in the blood (sometimes with bleeding or bruising under the skin)
visual disturbances

Very rare side effects: occur in 1-10,000 patients

inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever
itching or redness of the skin
blister formation on lips, eyes or mouth
skin peeling
fever
facial rashes associated with joint pain
muscle disorders
fever (cutaneous lupus erythematosus)
severe upper abdominal pain; absence or low levels of various blood cells
severe allergic reactions
difficulty breathing
lung infection, shortness of breath
metabolic disturbances resulting in loss of chloride from the body
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)

Not known: frequency cannot be established from the available data

severe reduction in blood cells which may cause weakness, bruising or make infections more likely
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)
impaired kidney function, acute renal failure
fever, weakness
muscle cramp
skin and lip cancer (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 can 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 Valsartan and Hydrochlorothiazide Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton or blister pack after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Valsartan and Hydrochlorothiazide Mylan if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine 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 Valsartan and Hydrochlorothiazide Mylan contains
The active substances are valsartan and hydrochlorothiazide.
Each 80/12.5 mg film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Each 160/12.5 mg film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Each 160/25 mg film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
Each 320/12.5 mg film-coated tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.
Each 320/25 mg film-coated tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other components are: anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose, pregelatinized maize starch, lactose monohydrate, crospovidone, povidone and magnesium stearate. See section 2 “Valsartan and Hydrochlorothiazide Mylan contains lactose and sodium”.
The tablet coating contains hypromellose, titanium dioxide (E 171), macrogol, talc, vanillin and iron oxide (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Mylan and contents of the pack
Valsartan and Hydrochlorothiazide Mylan 80/12.5 mg film-coated tablets are peach-coloured, oval-shaped tablets, printed with “VH1” on one side and “M” on the other.
Valsartan and Hydrochlorothiazide Mylan 160/12.5 mg film-coated tablets are reddish-coloured, oval-shaped tablets, printed with “VH2” on one side and “M” on the other.
Valsartan and Hydrochlorothiazide Mylan 160/25 mg film-coated tablets are brown-coloured, oval-shaped tablets, printed with “VH3” on one side and “M” on the other.
Valsartan and Hydrochlorothiazide Mylan 320/12.5 mg film-coated tablets are pink-coloured, oval-shaped tablets, printed with “VH4” on one side and “M” on the other.
Valsartan and Hydrochlorothiazide Mylan 320/25 mg film-coated tablets are yellow-coloured, oval-shaped tablets, printed with “VH5” on one side and “M” on the other.
Valsartan and Hydrochlorothiazide Mylan is available in packs containing 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan – Italy

Batch release responsible person:
Mylan Hungary kft
H-2900 Komarom, Mylan utca 1
Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Valsartan and Hydrochlorothiazide Mylan
Netherlands: Valsartan/Hydrochloorthiazide Viatris