Package leaflet: Information for the patient

Co-Dipper, 160 mg+12.5 mg, film-coated tablets
Valsartanum + Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
This medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Leaflet contents:

What Co-Dipper is and what it is used for
Important information before taking Co-Dipper
How to take Co-Dipper
Possible side effects
How to store Co-Dipper
Contents of the pack and other information

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

Co-Dipper film-coated tablets contain two active substances: valsartan and hydrochlorothiazide. Both
substances help control high blood pressure (hypertension).
Valsartan belongs to a group of medicines called angiotensin II receptor antagonists, which help
control high blood pressure. Angiotensin II is a substance that constricts blood vessels in the body, thereby
increasing blood pressure. Valsartan blocks the action of angiotensin II, resulting in relaxation of blood
vessels and reduction of blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. Hydrochlorothiazide
increases the volume of urine produced, which also helps reduce blood pressure.
Co-Dipper is used to treat high blood pressure that cannot be adequately controlled by either of the
aforementioned substances when used alone.
High blood pressure puts strain on the heart and blood vessels. If left untreated, it may damage blood
vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood
pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of
developing these conditions.

2. Important information before using Co-Dipper

When not to use Co-Dipper
if the patient is allergic to valsartan, hydrochlorothiazide, sulphonamide-derived substances (compounds
chemically similar to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
if the patient is more than 3 months pregnant (during early pregnancy it is also better not to
take Co-Dipper – see section on pregnancy);
if the patient has severe liver disease, damage to the small bile ducts in the liver
(cirrhosis), leading to bile stasis;
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 despite treatment the potassium or sodium blood levels in the patient are lower than normal, or
if calcium blood levels are 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, do not take the medicine, but
contact a doctor immediately.
Warnings and precautions
Before starting to take Co-Dipper, discuss this with a doctor if:
the patient is taking potassium-sparing medicines, potassium supplements, potassium-containing
salt substitutes, or other medicines that increase blood potassium levels (such as heparin),
regular monitoring of blood potassium levels by a doctor may be necessary.
the patient has low blood potassium levels.
the patient has diarrhoea 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 myocardial infarction; the recommended initial dose should be strictly followed. The doctor may also monitor the patient's kidney function.
the patient has renal artery stenosis.
the patient has recently received a new kidney (undergone kidney transplantation).
the patient has been diagnosed with hyperaldosteronism – a condition in which the adrenal glands produce too much aldosterone hormone; in such a case, the use of valsartan with hydrochlorothiazide is not recommended.
the patient has liver or kidney disease.
the patient has previously experienced swelling of the tongue and face (so-called angioedema) due to an allergic reaction while taking other medicines (including ACE inhibitors). If such symptoms occur during treatment with Co-Dipper, the medicine should be stopped immediately and never used again. See also section 4 "Possible side effects".
the patient has fever, rash, and joint pain, which may be symptoms of systemic lupus erythematosus (a so-called autoimmune disease).
the patient has diabetes, gout, high blood cholesterol or triglyceride levels.
the patient has previously experienced allergic reactions after taking other blood pressure-lowering medicines belonging to the same group (angiotensin II receptor antagonists), or if the patient has allergies or bronchial asthma.
the patient has experienced visual disturbances or eye pain. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – they may occur within a few hours to weeks after taking Co-Dipper, and if untreated may lead to permanent vision loss. Patients with previous allergy to penicillin or sulphonamides are at higher risk of such disorders.
the patient has previously had skin cancer or if an unexpected skin lesion appears during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer). During treatment with Co-Dipper, the skin should be protected from sunlight and UV radiation.
the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur after taking Co-Dipper, seek immediate medical help.
the patient is taking any of the following blood pressure-lowering medicines:

ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disease due to diabetes
aliskiren.

If any of the above situations apply to the patient, contact a doctor.
The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels
(e.g. potassium) in blood.
See also information in the section "When not to use Co-Dipper".
The medicine may increase skin sensitivity to sunlight.
If the patient is pregnant (or may become pregnant), it is essential to inform the doctor.
Administration of Co-Dipper is not recommended during early pregnancy and is contraindicated after the third month
of pregnancy, as its use during this period may be highly harmful to the fetus (see section "Pregnancy and breastfeeding").
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Co-Dipper,
this should be discussed with a doctor. The doctor will decide on further treatment. Do not independently
decide to stop taking Co-Dipper.
Children and adolescents
Co-Dipper is not recommended for use in children and adolescents (under 18 years of age).
Co-Dipper and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
The effectiveness of treatment may be affected by concomitant use of Co-Dipper and certain other medicines. Dose adjustment and/or additional precautions may be necessary, and in some cases discontinuation of one of the medicines may be required.
This particularly applies to the following medicines:
lithium, a medicine used in the treatment of certain psychiatric disorders
medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
medicines that may decrease blood potassium levels, such as diuretics, corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G
certain antibiotics (rifamycin group), a medicine to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used in HIV infection and AIDS treatment (ritonavir). These medicines may enhance the effect of Co-Dipper
medicines that may cause cardiac arrhythmias of the type "torsade de pointes", such as antiarrhythmic medicines (used to treat heart rhythm disorders) and certain antipsychotic medicines
medicines that may decrease blood sodium levels, such as antidepressants, antipsychotics, anticonvulsants
medicines used to treat gout (such as allopurinol, probenecid, sulfinpyrazone)
therapeutic 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 information in sections "When not to use Co-Dipper" and "Warnings and precautions")
medicines used to increase blood pressure, such as noradrenaline or adrenaline
digoxin or other cardiac glycosides (medicines used to treat heart function disorders)
medicines that may increase blood glucose levels, such as diazoxide or beta-blockers
cytotoxic medicines (used in cancer treatment), such as methotrexate or cyclophosphamide
painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses exceeding 3 grams per day
muscle relaxants, such as tubocurarine
anticholinergic medicines (used to treat various conditions such as stomach and intestinal spasms, bladder spasms, bronchial asthma, motion sickness, muscle spasms, Parkinson's disease, and as part of general anaesthesia)
amantadine (a medicine used to treat Parkinson's disease and to treat and prevent certain viral diseases)
cholestyramine and colestipol (medicines used mainly to treat high blood lipid levels)
cyclosporine (a medicine used to prevent rejection of transplanted organs)
alcohol, sedatives, and anaesthetics (medicines with sedative or pain-relieving effects, used e.g. during surgery)
iodinated contrast agents (used in imaging procedures).
Co-Dipper with food, drink and alcohol
Co-Dipper may be taken independently of meals.
Do not consume alcohol without first consulting a doctor. Alcohol may intensify
the lowering of blood pressure and/or cause dizziness or fainting.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
It is essential to inform the doctor if the patient is pregnant (or may become pregnant).
The doctor will advise discontinuation of Co-Dipper before pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Co-Dipper is not recommended during early pregnancy; it must not be taken after
the third month of pregnancy, as it may seriously harm the unborn child.
Inform the doctor about breastfeeding or intention to breastfeed.
Use of Co-Dipper is not recommended during breastfeeding. For patients planning to breastfeed, especially a newborn or premature infant, the doctor may choose a different, more suitable medicine.
Driving and operating machinery
Before driving, using tools, operating machinery, or performing any activity requiring concentration, the patient should ensure how Co-Dipper affects their body. Like other medicines used to treat high blood pressure,
Co-Dipper may rarely cause dizziness, which may impair the ability to concentrate.

3. How to use Co-Dipper

To achieve the best possible treatment results and reduce the risk of adverse effects, this
medicinal product should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
People with high blood pressure often do not experience any symptoms of their condition.
Many such individuals feel perfectly well. Therefore, it is very important to attend regular
doctor's appointments, even when feeling well.
Your doctor will clearly specify the number of Co-Dipper tablets you should take. Your doctor may
recommend a higher or lower dose depending on your response to treatment.
The usual recommended dose of Co-Dipper is one tablet daily.
Do not change the dose or stop taking the tablets without consulting your doctor.
Take the medicine at the same time each day, usually in the morning.
Co-Dipper may be taken independently of meals.
Swallow the tablets with a glass of water.
Taking more Co-Dipper than recommended
If severe dizziness and/or fainting occur, lie down immediately and contact your doctor without delay.
If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital.
Missing a dose of Co-Dipper
If you miss a dose, take it as soon as you remember. However, if it is almost time for the next dose,
skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Co-Dipper
Discontinuing treatment with Co-Dipper may lead to worsening of arterial hypertension. Do not stop
taking the medicine without your doctor's advice.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require urgent medical attention:
You should contact a doctor immediately if symptoms of angioedema occur, such as:
swelling of the face, tongue or throat
difficulty swallowing
urticaria and breathing difficulties.
You should also contact a doctor immediately if the patient develops acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion). This adverse reaction is very rare (may occur in fewer than 1 in 10,000 patients).
If any of these symptoms occur, stop taking Co-Dipper immediately and seek medical advice without delay (see also section 2 "Warnings and precautions").
Other adverse reactions include:
Uncommon (occur in 1 to 10 out of 1,000 people)
cough
low blood pressure
dizziness
dehydration (with intense thirst, dryness of the mouth and tongue, infrequent urination, dark urine, dry skin)
muscle pain
feeling of fatigue
tingling or numbness
blurred vision
tinnitus (e.g. ringing, buzzing in the ears)
Very rare (occur in fewer than 1 in 10,000 people)
dizziness
diarrhea
joint pain
Frequency not known (based on available data)
difficulty breathing
markedly 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 (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infection, weakness)
increased bilirubin levels in the blood (which in severe cases may cause yellowing of the skin and eyes)
increased blood urea and creatinine levels (which may indicate kidney dysfunction)
increased blood uric acid levels (which in severe cases may cause gout)
fainting
The following adverse reactions have been reported during the use of medicinal products
containing valsartan alone or hydrochlorothiazide alone:
Valsartan
Uncommon (occur in 1 to 10 out of 1,000 people)
sensation of spinning
abdominal pain
Very rare (occur in fewer than 1 in 10,000 people)
intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhea
Frequency not known (based on available data)
formation of blisters on the skin (symptom of bullous dermatitis)
skin rash with or without itching, together with some of the following symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
rash, purplish-red spots, fever, itching (symptoms of vasculitis)
low platelet count (sometimes with abnormal bleeding or subcutaneous hemorrhages)
high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disturbances)
allergic reactions (with symptoms such as rash, itching, urticaria, difficulty breathing or swallowing, dizziness)
swelling, mainly of the face and throat; rash; itching
increased liver enzyme activity
reduced hemoglobin levels and red blood cell count (which in severe cases may cause anemia)
renal failure
low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)
Hydrochlorothiazide
Very common (occur in more than 1 out of 10 people)
low potassium levels in the blood
increased blood lipid levels
Common (occur in 1 to 10 out of 100 people)
low sodium levels in the blood
low magnesium levels in the blood
high uric acid levels in the blood
itchy rash and other types of skin rash
decreased appetite
mild nausea and vomiting
dizziness, fainting upon standing
inability to achieve or maintain erection
Rare (occur in 1 to 10 out of 10,000 people)
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 disturbances
depression
low platelet count (sometimes with bleeding or subcutaneous hemorrhages)
dizziness
tingling or numb游戏副本

5. How to store Co-Dipper

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the stated 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Co-Dipper contains
The active substances are valsartan and hydrochlorothiazide.
Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica.
Coating: hypromellose, polyethylene glycol 8000, talc, titanium dioxide (E171), iron oxide red (E172).

What Co-Dipper looks like and contents of the pack
Dark red, oval, slightly convex film-coated tablet, printed (embossed) with the symbol "HHH" on one side and "CG" on the other side.
Pack sizes: 14, 28, 30, 56, 60 or 98 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers/Importers
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 Warszawa, Poland
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
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

For further information about the medicinal product and its names in the European Economic Area member countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel: 22 209 70 00