Co-dipper

Package leaflet: Information for the patient

Co-Dipper, 320 mg+12.5 mg, film-coated tablets
Valsartanum+Hydrochlorothiazidum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
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 share it with others.
This medicine may harm others, even if their symptoms are identical.
If you experience any adverse reactions, 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 a reduction in 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 in the treatment of 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. 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
components 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 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 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, discuss this with a doctor if:
the patient is taking potassium-sparing medicines, potassium supplements, salt substitutes
containing potassium, 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; strictly follow the
initial dose recommended by the doctor. The doctor may also monitor kidney function
in the patient.
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 excessive
amounts of the hormone aldosterone; 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 while taking Co-Dipper, discontinue the medicine immediately and never take it 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 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 a history of allergy or bronchial asthma.
the patient has experienced visual disturbances 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 – they may occur from several hours to weeks after taking Co-Dipper, and if untreated, may lead to permanent vision loss. The risk of such disorders is higher in patients with previous allergy to penicillin or sulphonamides.
the patient has previously had skin cancer or if any unexpected skin changes occur 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). While taking Co-Dipper, protect the skin from sunlight and UV radiation.
the patient has previously experienced breathing problems or lung issues (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, 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 blood electrolyte levels
(e.g. potassium).
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 time may be highly harmful to the foetus (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 about any medicines the patient plans to use.
The effectiveness of treatment may be affected by taking Co-Dipper together with certain
other medicines. A 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 to treat certain psychiatric disorders
medicines or substances that may increase blood potassium levels. These include potassium supplements
or salt substitutes containing potassium, 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 to treat 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 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)
medicinally used vitamin D and calcium supplements
medicines used to treat diabetes (oral [e.g. metformin] or insulin)
other medicines lowering blood pressure, including methyldopa, ACE inhibitors (e.g. enalapril,
lisinopril, etc.) or aliskiren (see also information in 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 disorders)
medicines that may increase blood glucose levels, such as diazoxide or beta-blockers
cytotoxic medicines (used to treat cancer), 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 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 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 plans 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 recommend discontinuing Co-Dipper before pregnancy or as soon as possible after pregnancy is confirmed, and will instead suggest another 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 foetus.
Inform the doctor about breastfeeding or plans 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 another, more suitable medicine.
Driving and operating machinery
Before driving, using tools, operating machinery, or performing tasks requiring concentration, ensure how Co-Dipper affects the patient. 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 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 precisely determine the number of Co-Dipper tablets to be taken. Your 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.
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 regardless 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 the patient accidentally takes too many tablets, contact a doctor, pharmacist, or hospital immediately.
Missing a dose of Co-Dipper
If a dose is missed, take it as soon as remembered.
However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed one.
Stopping treatment with Co-Dipper
Discontinuing treatment with Co-Dipper may lead to worsening of arterial hypertension. Do not stop
taking the medicine without medical 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, dry mouth and tongue, infrequent urination, dark-coloured 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, 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 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 lead to gout)
• fainting

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

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

• sensation of spinning (vertigo)
• 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, accompanied by one or more 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 haemorrhages)
• high blood potassium levels (sometimes with muscle cramps, heart rhythm disturbances)
• 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 levels and red blood cell count (which in severe cases may lead to anaemia)
• renal failure

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 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 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 haemorrhages)
• 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, 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, shortness of breath (respiratory failure, including pneumonia and pulmonary oedema)
• fever, sore throat, frequent infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark-coloured 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)
• markedly reduced urine output (possible sign of impaired kidney function or renal failure)
• visual impairment or eye pain due to increased intraocular pressure (possible signs of fluid accumulation in the uvea—the layer 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 signs 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 Drug Reactions, 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 which is stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30ºC.
Store in the original packaging to protect from moisture.
Do not use Co-Dipper medicine 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 12.5 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), black iron oxide (E172).

What Co-Dipper looks like and contents of the pack
Pink, oval, film-coated tablet with a bevelled edge, printed (embossed) with "NVR" on one side and "HIL" 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 Warsaw, 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 this medicinal product and its names in the Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00