Co-dipper

Patient Information Leaflet

Co-Dipper, 320 mg+25 mg, film-coated tablets
Valsartanum+Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet for future reference.
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.
It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents:

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 known as 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 lower blood pressure.
Co-Dipper is used to treat high blood pressure that cannot be adequately controlled by either of the above-mentioned substances 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 also 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 ingredients of this medicine (listed
in section 6);
if the patient is more than 3 months pregnant (it is also better not to take Co-Dipper during early
pregnancy – see the 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 impairment and is taking an antihypertensive medicine
containing aliskiren.
If any of the above situations apply to the patient, the medicine must not be taken and the patient
should 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 doctor's recommended initial
dose must be strictly followed. The doctor may also monitor 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 cases, 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 while taking Co-Dipper, the medicine must be stopped immediately and never taken 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, or high blood cholesterol or triglyceride levels.
the patient has previously had allergic reactions after taking other antihypertensive medicines from
the same class (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 the choroid and
sclera) or increased intraocular pressure – these may occur from several hours to several weeks after
taking Co-Dipper, and if untreated, may lead to permanent vision loss. Patients with prior allergy
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 at high doses and 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 difficulty breathing after taking Co-Dipper, immediate medical help must be sought.
the patient is taking any of the following antihypertensive 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, the patient should contact a doctor.
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood
electrolyte levels (e.g. potassium).
See also the 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 unborn child
(see the section "Pregnancy and breastfeeding").
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Co-Dipper,
this should be discussed with the doctor. The doctor will decide on further treatment. The patient must
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
The patient should inform the doctor or pharmacist about all medicines currently taken, recently
taken, or planned for use.
The effectiveness of treatment may be affected by concomitant use of Co-Dipper and certain other
medicines. Dose adjustments 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, including 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 used to prevent 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 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,
antiepileptics
medicines used to treat gout (such as allopurinol, probenecid, sulfinpyrazone)
therapeutic vitamin D and calcium supplements
medicines used to treat diabetes (oral agents [e.g. metformin] or insulin)
other antihypertensive medicines, including methyldopa, ACE inhibitors (e.g. enalapril, lisinopril,
etc.) or aliskiren (see also information in the 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 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 mainly used to treat high blood lipid levels)
cyclosporine (a medicine used to prevent rejection of transplanted organs)
alcohol, sedatives, and anaesthetics (medicines with sedative or analgesic 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.
Alcohol should not be consumed without prior consultation with a doctor. Alcohol may intensify the
reduction in 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 discontinuing 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 use during this period may
seriously harm the unborn child.
The doctor should be informed about breastfeeding or the 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 exactly as directed by the physician. In case of doubt, consult
your physician 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
physician visits, even when feeling well.
Your physician will precisely determine the number of Co-Dipper tablets you should take. Your physician may
decide to increase or decrease the dose of the medicine, 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 physician.
The medicine should be taken at the same time each day, usually in the morning.
Co-Dipper may be taken with or without food.
Tablets should be swallowed with a glass of water.
Taking more Co-Dipper than prescribed
If severe dizziness and/or fainting occur, lie down immediately and contact your physician without delay.
If you accidentally take too many tablets, contact your physician, pharmacist, or hospital immediately.
Missed dose of Co-Dipper
If you miss 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 missed dose.
Stopping treatment with Co-Dipper
Discontinuing treatment with Co-Dipper may lead to worsening of hypertension.
Do not stop taking this medicine without your physician's advice.
If you have any further questions about the use of this medicine, consult your
physician 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, treatment with Co-Dipper must be discontinued immediately and medical advice sought without delay (see also section 2 "Warnings and precautions").

Other adverse reactions include:
Uncommon (occur in 1 to 10 of 1,000 people)

• cough
• low blood pressure
• dizziness
• dehydration (with intense thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• muscle pain
• feeling of fatigue
• tingling or numbness
• blurred vision
• tinnitus (e.g. ringing, buzzing)

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

• dizziness
• diarrhoea
• joint pain

Frequency not known (based on 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 mouth 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 kidney dysfunction)
• increased blood uric acid levels (which in severe cases may lead to gout)
• fainting

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

Valsartan
Uncommon (occur in 1 to 10 of 1,000 people)

• sensation of spinning (vertigo)
• abdominal pain

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

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

Frequency not known (based on 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 bruising)
• high blood potassium levels (sometimes with muscle cramps, irregular heartbeat)
• allergic reactions (with symptoms such as rash, itching, urticaria, breathing or swallowing difficulties, 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 in 10 people)

• low blood potassium levels
• increased blood lipid levels

Common (occur in 1 to 10 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 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 glucose in urine
• worsening of diabetic metabolic disorders
• 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, breathing or swallowing difficulties, dizziness (hypersensitivity reactions)
• severe skin disease causing rash, redness of the skin, blistering around the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe upper abdominal pain (pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary oedema)
• fever, sore throat, frequent infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• fever, sore throat or mouth ulcers due to infection (leucopenia)
• confusion, fatigue, muscle twitching and cramps, increased breathing rate (hypochloraemic alkalosis)

Frequency not known (cannot be determined from available data)

• weakness, bruising and frequent infections (aplastic anaemia)
• marked reduction in urine output (possible sign of kidney dysfunction or kidney failure)
• visual impairment or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the uvea—the layer surrounding the eye—or excessive fluid buildup 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
• 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 at 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.
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 following EXP. The expiry date refers to the last day of the stated month.
Do not store above 30ºC.
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. 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 320 mg of valsartan and 25 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silicon dioxide.
Coating: hypromellose, polyethylene glycol 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, printed (embossed) with the symbol "NVR" on one side and "CTI" 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 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, Poland
tel. 22 209 70 00