Co-dipper

Package leaflet: Information for the patient

Co-Dipper, 160 mg+25 mg, film-coated tablets
Valsartanum+Hydrochlorothiazidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What Co-Dipper is and what it is 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. 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 reduced blood vessel constriction and lower blood pressure.
Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics. Hydrochlorothiazide increases the volume of urine produced, which also helps lower blood pressure.
Co-Dipper is used to treat high blood pressure that cannot be adequately controlled by either of the above-mentioned substances when used alone.
High blood pressure places 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 myocardial infarction. 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, sulfonamide derivatives (substances
chemically similar to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6);
if the patient is pregnant for more than 3 months (it is also better not to take Co-Dipper during early
pregnancy – 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 are below normal, or if calcium blood
levels are above 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.
Warnings and precautions
Before starting to take Co-Dipper, consult 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 initial dose recommended by
the doctor must 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 kidney transplant.
the patient has been diagnosed with hyperaldosteronism – a condition in which the adrenal glands
produce too much aldosterone hormone; in such a case, treatment with valsartan and
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 while taking Co-Dipper, the medicine must be stopped immediately and must never be
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 (so-called autoimmune disease).
the patient has diabetes, gout, high cholesterol or triglyceride levels in the blood.
the patient has previously had allergic reactions after taking other blood pressure-lowering
medicines from the same group (angiotensin II receptor antagonists), or if the patient has a history
of allergy or bronchial asthma.
the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation
in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and
sclera) or increased intraocular pressure – these may occur from several hours to weeks after
taking Co-Dipper, and if untreated, may lead to permanent vision loss.
Patients previously allergic to penicillin or sulfonamides 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 long period, may
increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking 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 the patient develops severe
shortness of breath or breathing difficulties after taking Co-Dipper, immediate medical help
should be sought.
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 the 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 necessary 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 child (see
section "Pregnancy and breastfeeding").
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Co-Dipper,
discuss this with the 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 currently taken or 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 preventing transplant rejection (cyclosporine), or
an antiretroviral medicine used in the treatment of HIV infection and AIDS (ritonavir). These
medicines may enhance the effect of Co-Dipper
medicines that may cause cardiac arrhythmias of the torsade de pointes type, such as
antiarrhythmic medicines (used to treat heart function disorders) and certain antipsychotic
medicines
medicines that may decrease blood sodium levels, such as antidepressants, antipsychotics,
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 information in the section "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 in doses exceeding 3 grams
per day
muscle relaxants, such as tubocurarine
anticholinergic medicines (used to treat various diseases such as stomach and intestinal spasms,
bladder spasms, bronchial asthma, motion sickness, muscle spasms, Parkinson's disease, and as
a component 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 fat levels)
cyclosporine (a medicine used to prevent rejection of a transplanted organ)
alcohol, sleeping pills, 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 can be taken independently of meals.
Do not consume alcohol without first consulting a doctor. Alcohol may intensify the reduction 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 plans to have a child,
she should consult a doctor or pharmacist before using this medicine.
It is necessary to inform the doctor if the patient is pregnant (or may become pregnant).
The doctor will recommend discontinuing Co-Dipper before pregnancy or as soon as pregnancy is
confirmed, and will suggest an alternative medicine. Co-Dipper is not recommended during early
pregnancy; it must not be taken after the third month of pregnancy, as use during this period 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 activities requiring concentration,
ensure how Co-Dipper affects the patient's body. Like other medicines used to treat high blood
pressure, Co-Dipper may rarely cause dizziness, which may impair concentration ability.

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 exactly as directed by the physician. 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 determine precisely how many Co-Dipper tablets you should take. Your doctor may
decide to increase or decrease the dose depending on your response to treatment.
The usual recommended dose of Co-Dipper is one tablet per day.
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 can 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 one.
Stopping treatment with Co-Dipper
Stopping treatment with Co-Dipper may lead to worsening of hypertension.
Do not stop taking this 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 your 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 your 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
• diarrhoea
• joint pain

Frequency not known (cannot be estimated from available data)

• breathing difficulties
• significantly reduced urine output
• low blood sodium levels (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)
• low blood potassium levels (sometimes with muscle weakness, cramps, irregular heartbeat)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or oral ulcers due to infection, weakness)
• increased blood bilirubin levels (which in severe cases may cause yellowing of the skin and eyes)
• increased blood urea and creatinine levels (which may indicate impaired kidney function)
• increased blood uric acid levels (which in severe cases may cause gout)
• fainting

The following adverse reactions have been reported during use of medicinal products containing either walsartan or hydrochlorothiazide alone:

Walsartan
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 diarrhoea

Frequency not known (cannot be estimated from available data)

• blistering of the skin (symptoms 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 bruising)
• high blood potassium levels (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
• decreased haemoglobin and red blood cell count (which in severe cases may lead to anaemia)
• kidney failure
• low blood sodium levels (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 blood potassium levels
• increased blood lipid levels

Common (occur in 1 to 10 out of 100 people)

• low blood sodium levels
• low blood magnesium levels
• high blood uric acid levels
• 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 blood calcium levels
• high blood sugar levels
• presence of sugar in urine
• worsening of diabetic metabolic disturbances
• constipation, diarrhoea, 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 bruising)
• dizziness
• tingling or numbness
• visual disturbances

Very rare (occur in fewer than 1 in 10,000 people)

• vasculitis with symptoms such as rash, purplish-red spots, fever
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• severe skin disease causing rash, redness of the skin, blistering around the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• breathing difficulties with fever, cough, wheezing, breathlessness (respiratory failure, including pneumonia and pulmonary oedema)
• fever, sore throat, frequent infections (agranulocytosis)
• pale skin, fatigue, breathlessness, dark urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infection (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloraemic alkalosis)

Frequency not known (cannot be estimated from available data)

• weakness, bruising and frequent infections (aplastic anaemia)
• marked reduction in urine output (possible sign of impaired kidney function or kidney failure)
• impaired vision or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the uvea—the membrane surrounding the eye—or 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, peeling of the skin, fever (possible symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness
• skin and lip cancers (non-melanoma skin cancers)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

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 and carton after EXP. The expiry date refers to the last day of the mentioned month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
Do not use Co-Dipper if the packaging is damaged or shows any 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. Such 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 25 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica.
Coating: hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

What Co-Dipper looks like and contents of the pack
Brown-orange, oval, slightly convex film-coated tablet, printed (embossed) with the symbol "HXH" on one side and "NVR" 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

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 Warszawa
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

For more detailed information about the medicine and its names in the countries of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00