Skip to Content

UK Edition. Click here for US version.

VALSARTAN/HYDROCHLOROTHIAZIDE 80/12.5 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / VALSARTAN

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Valsartan/Hydrochlorothiazide 80/12.5 mg film-coated tablets
Valsartan/Hydrochlorothiazide 160/25 mg film-coated tablets
Valsartan/hydrochlorothiazide
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Ÿ Keep this leaflet. You may need to read it again.
Ÿ If you have any further questions, ask your doctor or pharmacist.
Ÿ This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
Ÿ If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1. What Valsartan/Hydrochlorothiazide film-coated tablets are and what they are used for
2. WhatyouneedtoknowbeforeyoutakeValsartan/Hydrochlorothiazidefilm-coatedtablets
3. How to take Valsartan/Hydrochlorothiazide film-coated tablets
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide film-coated tablets
6. Contents of the pack and other information
1. What Valsartan/Hydrochlorothiazide film-coated tablets are and what they are
used for
Valsartan/Hydrochlorothiazide film-coated tablets contain two active substances called
valsartan and hydrochlorothiazide. Both of these substances help to control high blood
pressure (hypertension).
Ÿ Valsartan belongs to a class of medicines known as “angiotensin II receptor
antagonists”, which help to control high blood pressure. Angiotensin II is a substance
in the body that causes vessels to tighten, thus causing your blood pressure to increase.
Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax
and blood pressure is lowered.
Ÿ Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also
known as “water tablets”). Hydrochlorothiazide increases urine output, which also
lowers blood pressure.
This medicine is used to treat high blood pressure which is not adequately controlled by a
single substance alone.
High blood pressure increases the workload of the heart and arteries. If not treated, it can
damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart
failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering
your blood pressure to normal reduces the risk of developing these disorders.
2. What you need to know before you take Valsartan/Hydrochlorothiazide filmcoated tablets
Do not take Valsartan/Hydrochlorothiazide film-coated tablets:
Ÿ if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives
(substances chemically related to hydrochlorothiazide) or to any of the other
ingredients of this medicine (listed in section 6).
Ÿ if you are more than 3 months pregnant (it is also better to avoid this medicine in early
pregnancy – see pregnancy section).
Ÿ if you have severe liver disease, destruction of the small bile ducts within the liver
(biliary cirrhosis) leading to the build up of bile in the liver (cholestasis).
Ÿ if you have severe kidney disease.
Ÿ if you are unable to produce urine (anuria).
Ÿ if the level of potassium or sodium in your blood is lower than normal, or if the level of
calcium in your blood is higher than normal despite treatment.
Ÿ if you have gout.
Ÿ if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.
If any of the above applies to you, do not take this medicine and speak to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine
Ÿ if you are taking potassium-sparing medicines, potassium supplements, salt substitutes
containing potassium or other medicines that increase the amount of potassium in your
blood such as heparin. Your doctor may need to check the amount of potassium in your
blood regularly.
Ÿ if you have low levels of potassium in your blood.
Ÿ if you have diarrhoea or severe vomiting.
Ÿ if you are taking high doses of water tablets (diuretics).
Ÿ if you have severe heart disease.
Ÿ if you are suffering from heart failure or have experienced a heart attack. Follow your
doctor's instruction for the starting dose carefully. Your doctor may also check your
kidney function.
Ÿ if you suffer from a narrowing of the kidney artery.
Ÿ if you have recently received a new kidney.
Ÿ if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands
make too much of the hormone aldosterone. If this applies to you, the use of
Valsartan/Hydrochlorothiazide film-coated tablets is not recommended.
Ÿ if you have liver or kidney disease.
Ÿ if you have ever experienced swelling of the tongue and face caused by an allergic reaction
called angioedema when taking another drug (includingACE inhibitors), tell your doctor.
If these symptoms occur when you are taking Valsartan/ Hydrochlorothiazide film-coated
tablets, stop taking Valsartan/Hydrochlorothiazide film-coated tablets immediately and
never take it again. See also section 4, “Possible side effects”.
Ÿ if you have fever, rash and joint pain, which may be signs of systemic lupus
erythematosus (SLE, a so-called autoimmune disease).
Ÿ if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
Ÿ if you have had allergic reactions with the use of other blood pressure-lowering agents
of this class (angiotensin II receptor antagonists) or if you have allergy or asthma.
Ÿ if you experience a decrease in vision or eye pain. These could be symptoms of an
increase of pressure in your eye and can happen within hours to a week of taking
Valsartan/Hydrochlorothiazide film-coated tablets. This can lead to permanent vision
loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy you can
be at higher risk of developing this.
Ÿ it may cause increased sensitivity of the skin to sun.
Ÿ if you are taking any of the following medicines used to treat high blood pressure:
o an ACE inhibitor ( for example enalapril, lisinopril, ramipril), in particular if you
have diabetes-related kidney problems.
o Aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Valsartan/Hydrochlorothiazide
film-coated tablets”.

You must tell your doctor if you think you are (or might become) pregnant.
Valsartan/Hydrochlorothiazide film-coated tablets are not recommended in early
pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause
serious harm to your baby if used at that stage (see pregnancy section).
Children and adolescents
The use of this medicine in children and adolescents (below the age of 18 years) is not
recommended.
Other medicines and Valsartan/Hydrochlorothiazide film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effect of the treatment can be influenced if Valsartan/Hydrochlorothiazide film-coated
tablets are taken together with certain other medicines. Your doctor may need to change your
dose and/or to take other precautions. This especially applies to the following medicines:
Ÿ
Ÿ
Ÿ
Ÿ

Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

lithium, a medicine used to treat some types of psychiatric diseases.
medicines or substances that may increase the amount of potassium in your blood.
These include potassium supplements or salt substitutes containing potassium,
potassium-sparing medicines and heparin.
medicines that may reduce the amount of potassium in your blood, such as diuretics
(water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.
some antibiotics (rifamycin group), a drug used to protect against transplant rejection
(ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir).
These drugs may increase the effect of Valsartan/Hydrochlorothiazide film-coated
tablets.
medicines that may induce “torsades de pointes” (irregular heart beat), such as
antiarrhythmics (medicines used to treat heart problems) and some antipsychotics.
medicines that may reduce the amount of sodium in your blood, such as
antidepressants, antipsychotics, antiepileptics.
medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone,
therapeutic vitamin D and calcium supplements.
medicines for the treatment of diabetes (oral agents such as metformin or insulins).
other medicines to lower your blood pressure, including methyldopa, ACE inhibitors
(such as enalapril, lisinopril, etc.) or aliskiren.
medicines to increase blood pressure, such as noradrenaline or adrenaline.
digoxin or other digitalis glycosides (medicines used to treat heart problems).
medicines that may increase blood sugar levels, such as diazoxide or beta blockers.
cytotoxic medicines (used to treat cancer) such as methotrexate or
cyclophosphamide.
pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including
selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) and acetylsalicylic acid > 3 g.
muscle relaxing medicines, such as tubocurarine.
anti-cholinergic medicines (medicines used to treat a variety of disorders such as
gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular
spasms, Parkinson's disease and as an aid to anaesthesia).
amantadine (medicine used to treat Parkinson's disease and also used to treat or
prevent certain illnesses caused by viruses).
cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in
the blood).
ciclosporin, a medicine used for organ transplant to avoid organ rejection.
alcohol, sleeping pills and anaesthetics (medicines with sleeping or painkilling effect
used for example during surgery).
iodine contrast media (agents used for imaging examinations).

Valsartan/Hydrochlorothiazide film-coated tablets with drink and alcohol
Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood
pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Ÿ You must tell your doctor if you think that you are (or might become) pregnant
Your doctor will normally advise you to stop taking this medicine before you become pregnant
or as soon as you know you are pregnant, and will advise you to take another medicine instead
of Valsartan/Hydrochlorothiazide film-coated tablets. This medicine is not recommended in
early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause
serious harm to your baby if it is used after the third month of pregnancy.
Ÿ Tell your doctor if you are breast-feeding or about to start breast-feeding
Valsartan/Hydrochlorothiazide film-coated tablets are not recommended for mothers who
are breast-feeding, and your doctor may choose another treatment for you if you wish to
breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines
Before you drive a vehicle, use tools or operate machines or carry out other activities that
require concentration, make sure you know how this medicine affects you. Like many other
medicines used to treat high blood pressure, Valsartan/Hydrochlorothiazide film-coated
tablets may occasionally cause dizziness and affect the ability to concentrate.
Valsartan/Hydrochlorothiazide film-coated tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. How to take Valsartan/Hydrochlorothiazide film-coated tablets
Always take this medicine exactly as your doctor has told you. This will help you to get the
best results and lower the risk of side effects. Check with your doctor or pharmacist if you
are not sure.
People with high blood pressure often do not notice any signs of this problem. Many may
feel quite normal. This makes it all the more important for you to keep your appointments
with your doctor even if you are feeling well.
Your doctor will tell you exactly how many tablets of Valsartan/Hydrochlorothiazide to take.
Dependingonhowyourespondtothetreatment,yourdoctormaysuggestahigherorlowerdose.
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

The usual dose of Valsartan/Hydrochlorothiazide is one tablet per day.
Do not change the dose or stop taking the tablets without consulting your doctor.
The medicine should be taken at the same time each day, usually in the morning.
You can take Valsartan/Hydrochlorothiazide film-coated tablets with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide film-coated tablets 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/Hydrochlorothiazide film-coated tablets
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 dose you missed.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Valsartan/Hydrochlorothiazide film-coated tablets
Stopping your treatment with Valsartan/Hydrochlorothiazide film-coated tablets may
cause your high blood pressure to get worse. Do not stop taking your medicine unless your
doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
You should see your doctor immediately if you experience symptoms of angioedema, such as:
Ÿ swollen face, tongue or pharynx
Ÿ difficulty in swallowing
Ÿ hives and difficulties in breathing
If you get any of these symptoms, stop taking Valsasrtan/Hydrochlorothiazide
Jubilant and contact your doctor straight away (see also section 2 “Take special care
with Valsasrtan/Hydrochlorothiazide Jubilant”).
Other side effects of Valsartan/Hydrochlorothiazide film-coated tablets include:
Uncommon (may affect up to 1 in 100 people)
Ÿ cough
Ÿ low blood pressure
Ÿ light-headedness
Ÿ dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark
colored urine, dry skin)
Ÿ muscle pain
Ÿ tiredness
Ÿ tingling or numbness
Ÿ blurred vision
Ÿ noises (e.g. hissing, buzzing) in ears
Very rare (may affect up to 1 in 10000 people)
Ÿ dizziness
Ÿ diarrhoea
Ÿ joint pain
Not known (frequency cannot be estimated from the available data)
Ÿ breathing difficulty
Ÿ severely decreased urine output
Ÿ low level of sodium in the blood (which can trigger tiredness, confusion, muscle
twitching and/or convulsions in severe cases)
Ÿ low level of potassium in the blood (sometimes with muscle weakness, muscle spasms,
abnormal heart rhythm)
Ÿ low level of white cells in the blood (with symptoms such as fever, skin infections, sore
throat or mouth ulcers due to infections, weakness)
Ÿ the level of bilirubin increased in blood (which can, in severe cases, trigger yellow skin
and eyes)
Ÿ the level of blood urea nitrogen and creatinine increased in blood (which can indicate
abnormal kidney function)
Ÿ the level of uric acid in blood increased (which can, in severe cases, trigger gout)
Ÿ syncope (fainting)
Ÿ blistering skin (sign of dermatitis bullous)
Side effects reported with valsartan or hydrochlorothiazide alone:
Valsartan
Uncommon (may affect up to 1 in 100 people)
Ÿ spinning sensation
Ÿ abdominal pain
Not known (frequency cannot be estimated from the available data)
Ÿ skin rash with or without itching together with some of the following signs or symptoms:
fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
Ÿ rash, purplish-red spots, fever, itching (symptoms of inflammation of blood vessels)
Ÿ low level of blood platelets (sometimes with unusual bleeding or bruising)
Ÿ high level of potassium in the blood (sometimes with muscle spasms, abnormal heart
rhythm)
Ÿ allergic reactions (with symptoms such as rash, itching, hives, difficulty in breathing or
swallowing, dizziness)
Ÿ swelling mainly of the face and throat; rash; itching
Ÿ elevation of liver function values
Ÿ the level of haemoglobin decreased and the percentage of red cells decreased in the
blood (which both can, in severe cases, trigger an anaemia).
Ÿ kidney failure
Ÿ low level of sodium in the blood (which can trigger tiredness, confusion, muscle
twitching and/or convulsions in severe cases)
Hydrochlorothiazide
Very common (may affect more than 1 in 10 people)
Ÿ low level of potassium in the blood
Ÿ increase of lipids in the blood
Common (may affect up to 1 in 10 people)
Ÿ low level of sodium in the blood
Ÿ low level of magnesium in the blood
Ÿ high level of uric acid in the blood
Ÿ itchy rash and other types of rash
Ÿ reduced appetite
Ÿ mild nausea and vomiting
Ÿ dizziness, fainting on standing up
Ÿ inability to achieve or maintain erection
Rare (may affect up to 1 in 1000 people)
Ÿ swelling and blistering of the skin (due to increased sensitivity to sun)
Ÿ high level of calcium in the blood
Ÿ high level of sugar in the blood
Ÿ sugar in the urine
Ÿ worsening of diabetic metabolic state
Ÿ constipation, diarrhoea, discomfort of the stomach or bowels, liver disorders which can
occur together with yellow skin and eyes
Ÿ irregular heart beat
Ÿ headache
Ÿ sleep disturbances
Ÿ sad mood (depression)
Ÿ low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
Ÿ dizziness

Ÿ
Ÿ

tingling or numbness
vision disorder

Very rare (may affect up to 1 in 10000 people)
Ÿ inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever
(vasculitis)
Ÿ rash, itching, hives, difficulty in breathing or swallowing, dizziness (hypersensitivity
reactions)
Ÿ severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin
peeling, fever (toxic epidermal necrolysis)
Ÿ facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
Ÿ severe upper stomach pain (pancreatitis)
Ÿ difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory
distress including pneumonitis and pulmonary oedema)
Ÿ fever, sore throat, more frequent infections (agranulocytosis)
Ÿ pale skin, tiredness, breathlessness, dark urine (haemolytic anaemia)
Ÿ fever, sore throat or mouth ulcers due to infections (leucopenia)
Ÿ confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic
alkalosis)
Not known (frequency cannot be estimated from the available data)
Ÿ weakness, bruising and frequent infections (aplastic anemia)
Ÿ severely decreased urine output (possible signs of renal disorder or renal failure)
Ÿ decrease in vision or pain in your eyes due to high pressure (possible signs of acute
angle-closure glaucoma)
Ÿ rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of
erythema multiforme)
Ÿ muscle spasm
Ÿ fever (pyrexia)
Ÿ weakness (asthenia)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of this medicine.
5.
Ÿ
Ÿ
Ÿ
Ÿ
Ÿ

6.

How to store Valsartan/Hydrochlorothiazide film-coated tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The
expiry date refers to the last day of that month.
Store below 25 °C.
Do not use any Valsartan/Hydrochlorothiazide film-coated tablets pack if you notice
that it is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.
Contents of the pack and other information

What Valsartan/Hydrochlorothiazide film-coated tablets contain
Ÿ The active substances are valsartan and hydrochlorothiazide.
Valsartan/Hydrochlorothiazide 80/12.5 mg film-coated tablets:
Each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide
Valsartan/Hydrochlorothiazide 160/25 mg film-coated tablets:
Each tablet contains 160 mg valsartan and 25 mg hydrochlorothiazide
Ÿ

The other ingredients are:
tablet core
Cellulose, microcrystalline (E460), crospovidone (E1202), silica, magnesium stearate
(E470b) and anhydrous lactose.
tablet coating
Valsartan/Hydrochlorothiazide 80/12.5 mg film-coated tablets:
Hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide yellow (E172),
iron oxide red (E172) and talc.
Valsartan/Hydrochlorothiazide 160/25 mg film-coated tablets:
Hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide yellow (E172),
iron oxide black (E172), iron oxide red (E172) and talc.

WhatValsartan/Hydrochlorothiazide film-coated tabletslook like and contentsofthe pack
Valsartan/Hydrochlorothiazide 80/12.5 mg film-coated tablets are peach coloured, oval
shaped, biconvex, film-coated tablets debossed with '364' on one side and 'J' on the other side.
Valsartan/Hydrochlorothiazide 160/25 mg film-coated tablets are brown coloured, oval
shaped, biconvex, film-coated tablets debossed with '366' on one side and 'J' on the other side.
The tablets are available in blister packs of 14, 20, 28, 30, 56, 60, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
MarketingAuthorisation Holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium

Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium

This medicinal product is authorized in the Member States of the EEA under the
following names:
Valsartan/Hydrochlorothiazide Jubilant 80 mg/12.5 mg film-coated tablets
Denmark
Valsartan/HydroklortiazidJubilant80mg/12,5mgfilmovertruknetabletter
Germany
Valsartan/Hydrochlorothiazid Jubilant 80 mg/12,5 mg Filmtabletten
The Netherlands Valsartan/HCT Jubilant 80 mg/12,5 mg filmomhulde tabletten
Sweden
Valsartan/HydroklortiazidJubilant80mg/12,5mgfilmdrageradetabletter
United Kingdom Valsartan/Hydrochlorothiazide 80/12.5 mg film-coated tablets
Valsartan/Hydrochlorothiazide Jubilant 160 mg/25 mg film-coated tablets
Denmark
Valsartan/HydroklortiazidJubilant160mg/25mgfilmovertruknetabletter
Germany
Valsartan/Hydrochlorothiazid Jubilant 160 mg/25 mg Filmtabletten
The Netherlands Valsartan/HCT Jubilant 160 mg/25 mg filmomhulde tabletten
Sweden
Valsartan/HydroklortiazidJubilant160mg/25mgfilmdrageradetabletter
United Kingdom Valsartan/Hydrochlorothiazide 160/25 mg film-coated tablets
This leaflet was last revised in July 2015.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide