Co-dipper

Leaflet accompanying the packaging: patient information

Co-Dipper, 320 mg+25 mg, film-coated tablets

Valsartan+Hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you personally. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Co-Dipper and what is it used for
• 2. Important information before taking Co-Dipper
• 3. How to take Co-Dipper
• 4. Possible side effects
• 5. How to store Co-Dipper
• 6. Package contents and other information

1. What is Co-Dipper and what is it used for

Co-Dipper film-coated tablets contain two active substances: valsartan and hydrochlorothiazide. Both
substances help control high blood pressure (hypertension).
Valsartanbelongs to a group of medicines called angiotensin II receptor antagonists, which help
control high blood pressure. Angiotensin II is a substance that narrows blood vessels in the body and
increases blood pressure. Valsartan blocks the action of angiotensin II, resulting in decreased blood vessel
tension and lower blood pressure.
Hydrochlorothiazidebelongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide
increases the amount of urine excreted, which also lowers blood pressure.
Co-Dipper is used to treat high blood pressure that cannot be adequately controlled by either of the above
substances when used alone.
High blood pressure puts a strain on the heart and blood vessels. If left untreated, it can lead to damage to
blood vessels in the brain, heart, and kidneys, resulting in stroke, heart failure, or kidney failure. High blood
pressure increases the risk of heart attack. Lowering blood pressure to normal values reduces the risk of
these diseases.

2. Important information before taking Co-Dipper

When not to take Co-Dipper

if the patient is allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances with a
chemical structure similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed
in section 6);
if the patient is pregnant for more than 3 months (it is also recommended not to take Co-Dipper in early
pregnancy - see the section on pregnancy);
if the patient has severe liver disease, bile duct obstruction (cirrhosis) leading to bile stagnation;
if the patient has severe kidney disease;
if the patient's body does not produce urine (anuria);
if the patient is undergoing dialysis ("artificial kidney");
if the patient's blood potassium or sodium levels are lower than normal or if the blood calcium level is
higher than normal;
if the patient has gout;
if the patient has diabetes or kidney function disorders and is taking a blood pressure-lowering medicine
containing aliskiren.

If any of the above situations apply to the patient, they should not take the medicine, but should contact their doctor.

Warnings and precautions

Before starting to take Co-Dipper, the patient should discuss it with their doctor if:

the patient is taking potassium-sparing medicines, potassium supplements, salt substitutes containing
potassium, or other medicines that increase the amount of potassium in the blood (such as heparin),
regular monitoring of blood potassium levels by the doctor may be necessary.
the patient has low potassium levels in the blood.
the patient has diarrhea or severe vomiting.
the patient is taking high doses of diuretics.
the patient has severe heart disease.
the patient has heart failure or has had a heart attack; the doctor should be followed strictly
the recommended initial dose. The doctor may also monitor the patient's kidney function.
the patient has renal artery stenosis.
the patient has recently received a new kidney (has undergone a kidney transplant).
the patient has hyperaldosteronism - a disease in which the adrenal glands produce too much aldosterone;
in such cases, the use of valsartan with hydrochlorothiazide is not recommended.
the patient has liver or kidney disease.
the patient has ever experienced swelling of the tongue and face (angioedema) due to an allergic reaction
when taking other medicines (including ACE inhibitors). If such symptoms occur when taking Co-Dipper,
the patient should stop taking it immediately and never take it again. See also section 4 "Possible side effects".
the patient has a fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (an
autoimmune disease).
the patient has diabetes, gout, high cholesterol, or high triglycerides in the blood.
the patient has experienced allergic reactions when taking other blood pressure-lowering medicines
belonging to the same group (angiotensin II receptor antagonists) or if the patient has been diagnosed with
allergy or asthma.
the patient has experienced vision loss or eye pain. These may be symptoms of fluid accumulation in the
vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased
intraocular pressure - they can occur within a few hours to weeks after taking Co-Dipper and, if left untreated,
can cause permanent vision loss.
A higher risk of such disorders applies to patients with a history of penicillin or sulfonamide allergy.
the patient has a history of malignant skin tumor or if an unexpected skin change occurs during treatment.
Hydrochlorothiazide treatment, especially with high doses over a long period, may increase the risk of certain
types of skin cancer and lip cancer (non-melanoma skin cancer). When taking Co-Dipper, the patient should
protect their skin from sunlight and UV radiation.
if the patient has experienced breathing or lung problems (including pneumonia or fluid accumulation in the
lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty
breathing after taking Co-Dipper, they should seek medical attention immediately.
the patient is taking any of the following blood pressure-lowering medicines:

• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease
• aliskiren.

If any of the above situations apply to the patient, they should contact their doctor.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g.,
potassium) in the blood.
See also the information in the section "When not to take Co-Dipper".
The medicine may increase the sensitivity of the skin to sunlight.
If the patient is pregnant (or may become pregnant), they should inform their doctor.
Co-Dipper is not recommended in early pregnancy and is contraindicated after the third month of pregnancy,
as its use at this time may be very harmful to the fetus (see the section on "Pregnancy and breastfeeding").
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Co-Dipper, they should discuss
it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Co-Dipper
on their own.

Children and adolescents

Co-Dipper is not recommended for children and adolescents (under 18 years of age).

Co-Dipper and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently
taken, as well as any medicines they plan to take.

The effectiveness of the treatment may be affected by the simultaneous use of Co-Dipper and certain other
medicines. It may be necessary to change the dose and/or take other precautions, and in some cases, stop
taking one of the medicines.
This applies in particular to the following medicines:
lithium, a medicine used to treat certain mental illnesses
medicines or substances that may increase the amount of potassium in the blood. These include potassium
supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin
medicines that may decrease the amount of potassium in the blood, such as diuretics, corticosteroids, laxatives,
carbenoxolone, amphotericin, or penicillin G
certain antibiotics (from the rifamycin group), a medicine to prevent transplant rejection (cyclosporine), or
a antiretroviral medicine used to treat HIV infection and AIDS (ritonavir). These medicines may enhance the
effect of Co-Dipper
medicines that may cause arrhythmias of the "torsades de pointes" type, such as anti-arrhythmic medicines (used
to treat heart rhythm disorders) and certain antipsychotic medicines
medicines that may decrease the amount of sodium in the blood, such as antidepressants, antipsychotics, or
antiepileptics
medicines used to treat gout (such as allopurinol, probenecid, sulfinpyrazone)
therapeutically used vitamin D and calcium supplements
medicines used to treat diabetes (oral, e.g., metformin, or insulin)
other blood pressure-lowering medicines, including methyldopa, ACE inhibitors (i.e., enalapril, lisinopril, etc.) or
aliskiren (see also the information in the section "When not to take Co-Dipper" and "Warnings and precautions")
medicines used to increase blood pressure, such as noradrenaline or adrenaline
digoxin or other digitalis glycosides (medicines used to treat heart rhythm disorders)
medicines that may increase blood sugar levels, such as diazoxide or beta-adrenolytics
cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2
(COX-2) inhibitors and acetylsalicylic acid in doses greater than 3 grams per day
muscle relaxants, such as tubocurarine
anticholinergic medicines (used to treat various diseases, such as stomach and intestinal cramps, urinary
bladder cramps, asthma, motion sickness, muscle cramps, Parkinson's disease, and as part of general anesthesia)
amantadine (a medicine used to treat Parkinson's disease and to treat and prevent certain viral infections)
cholestyramine and colestipol (medicines used mainly to treat high fat levels in the blood)
cyclosporine (a medicine used to prevent transplant rejection)
alcohol, sleeping pills, and anesthetics (medicines with a sedative or analgesic effect, used, for example, during
operations)
iodinated contrast agents (used in imaging tests).

Co-Dipper with food, drink, and alcohol

Co-Dipper can be taken with or without food.
The patient should not drink alcohol without first consulting their doctor. Alcohol may enhance the blood
pressure-lowering effect of Co-Dipper and/or cause dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should
consult their doctor or pharmacist before taking this medicine.
The patient must inform their doctor if they are pregnant (or may become pregnant).
The doctor will recommend stopping Co-Dipper before the patient becomes pregnant or as soon as possible
after pregnancy is confirmed, and will offer an alternative medicine instead. Co-Dipper is not recommended in
early pregnancy; it must not be taken after the third month of pregnancy, as it may seriously harm the fetus.
The patient must inform their doctor if they are breastfeeding or plan to breastfeed.
Co-Dipper is not recommended during breastfeeding. For patients who plan to breastfeed, especially newborns or
premature infants, the doctor may choose a different, more suitable medicine.

Driving and using machines

Before driving, using tools, operating machines, or performing tasks that require concentration, the patient
should make sure how Co-Dipper affects their body. Like other medicines used to treat high blood pressure, Co-
Dipper may rarely cause dizziness, which can affect concentration.

3. How to take Co-Dipper

To achieve the best treatment results and minimize the risk of side effects, this medicine should always be
taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
People with high blood pressure often do not experience any symptoms of their disease. Many of them feel
completely well. Therefore, it is very important to attend doctor's appointments, even if the patient feels well.
The doctor will determine the exact number of Co-Dipper tablets the patient should take. The doctor may
recommend a higher or lower dose of the medicine, depending on the patient's response to treatment.
The usual recommended dose of Co-Dipper is one tablet per day.
The patient should not change the dose of the medicine or stop taking the tablets without consulting their doctor.
The medicine should be taken at the same time every day, usually in the morning.
Co-Dipper can be taken with or without food.
The tablets should be swallowed with a glass of water.

Taking a higher dose of Co-Dipper than recommended

If the patient experiences severe dizziness and/or fainting, they should lie down and contact their doctor
immediately.
If the patient accidentally takes too many tablets, they should contact their doctor, pharmacist, or hospital.

Missing a dose of Co-Dipper

If the patient misses a dose, they should take it as soon as possible after remembering.
However, if it is almost time for the next dose, the patient should skip the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping Co-Dipper treatment

Stopping Co-Dipper treatment may cause a worsening of high blood pressure. The patient should not stop taking
the medicine without their doctor's advice.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Dipper can cause side effects, although not everybody gets them.

Some side effects may be serious and require immediate medical attention:

The patient should contact their doctor immediately if they experience symptoms of angioedema, such as:
swelling of the face, tongue, or throat
difficulty swallowing
hives and difficulty breathing.
The patient should also contact their doctor immediately if they experience acute respiratory failure (symptoms
include severe shortness of breath, fever, weakness, and confusion). This side effect is very rare (may occur
less often than in 1 in 10,000 patients).

If the patient experiences any of these symptoms, they should stop taking Co-Dipper and seek medical attention
immediately (see also section 2 "Warnings and precautions").

Other side effects include:

Uncommon (occurring in 1 to 10 patients in 1000)
cough
low blood pressure
dizziness
dehydration (with increased thirst, dry mouth and tongue, rare urination, dark urine, dry skin)
muscle pain
fatigue
tingling or numbness
blurred vision
ringing in the ears (e.g., hissing, buzzing)
Rare (occurring in less than 1 in 10,000 patients)
dizziness
diarrhea
joint pain
Frequency not known (cannot be estimated from available data)
breathing difficulties
significantly reduced urine output
low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching, and/or seizures in
severe cases)
low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
low white blood cell count (sometimes with fever, skin infections, sore throat, or mouth ulcers due to infection,
weakness)
increased bilirubin levels in the blood (which may cause yellowing of the skin and eyes in severe cases)
increased urea and creatinine levels in the blood (which may indicate kidney function disorders)
increased uric acid levels in the blood (which may cause gout in severe cases)
fainting

The following side effects have been reported with the use of valsartan or hydrochlorothiazide alone:

Valsartan
Uncommon (occurring in 1 to 10 patients in 1000)
vertigo
abdominal pain
Rare (occurring in less than 1 in 10,000 patients)
angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting,
and diarrhea
Frequency not known (cannot be estimated from available data)
blistering of the skin (symptom of bullous pemphigoid)
skin rash with itching or without itching, along with some of the following symptoms: fever, joint pain, muscle
pain, lymph node swelling, and/or flu-like symptoms
skin rash, purpura, fever, itching (symptoms of vasculitis)
low platelet count (sometimes with abnormal bleeding or bruising)
high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
swelling, mainly of the face and throat; rash; itching
increased liver enzyme activity
decreased hemoglobin and red blood cell count (which may cause anemia in severe cases)
kidney failure
low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching, and/or seizures in
severe cases)
Hydrochlorothiazide
Very common (occurring in more than 1 in 10 patients)
low potassium levels in the blood
increased fat levels in the blood
Common (occurring in 1 to 10 patients in 100)
low sodium levels in the blood
low magnesium levels in the blood
high uric acid levels in the blood
itching rash and other types of rash
decreased appetite
mild nausea and vomiting
dizziness, fainting when standing up
Rare (occurring in 1 to 10 patients in 10,000)
swelling and blistering of the skin (due to increased sensitivity to sunlight)
high calcium levels in the blood
high blood sugar levels
presence of sugar in the urine
worsening of diabetic metabolic disorders
constipation, diarrhea, discomfort in the stomach or intestines, liver function disorders (which may occur
with yellowing of the skin and eyes)
irregular heartbeat
headache
sleep disorders
depression
low platelet count (sometimes with bleeding or bruising)
dizziness
tingling or numbness
vision disturbances
Very rare (occurring in less than 1 in 10,000 patients)
vasculitis with symptoms such as rash, purpura, fever, itching (allergic reactions)
severe skin disease causing rash, redness of the skin, blistering around the lips, eyes, or mouth, skin peeling,
fever (toxic epidermal necrolysis)
rash, redness of the skin, joint pain, muscle disorders, fever (lupus erythematosus)
severe abdominal pain (pancreatitis)
breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including
pneumonia and pulmonary edema)
fever, sore throat, frequent infections (agranulocytosis)
pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
fever, sore throat, or mouth ulcers due to infection (leukopenia)
confusion, fatigue, twitching, and muscle cramps, rapid breathing (hypochloremic alkalosis)
Frequency not known (cannot be estimated from available data)
weakness, bruising, and frequent infections (aplastic anemia)
significant reduction in urine output (possible sign of kidney function disorders or kidney failure)
vision loss or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the
vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute
angle-closure glaucoma)
rash, redness of the skin, blistering around the lips, eyes, or mouth, skin peeling, fever (possible symptoms
of erythema multiforme)
muscle cramps
fever
weakness
malignant skin tumors and lip cancer (non-melanoma skin cancer)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor,
pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C,
02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Co-Dipper

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers
to the last day of the month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use Co-Dipper if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist
how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Co-Dipper contains

The active substances are valsartan and hydrochlorothiazide.
Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous
silica.
Coating:hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).

What Co-Dipper looks like and contents of the pack

Yellow, oval, film-coated tablet with a beveled edge, with the symbol "NVR" embossed on one side and "CTI"
on the other side.
Pack sizes: 14, 28, 30, 56, 60, or 98 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Novartis Farma S.p.A
Via Provinciale Schito 131
I-800058 Torre Annunziata / NA, Italy
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Sandoz, S.R.L.
Livezeni Street no 7A
540472 Targu Mures, Romania