Co-dipper

Package leaflet: Information for the patient

Co-Dipper, 80 mg+12.5 mg, film-coated tablets
Valsartanum+Hydrochlorothiazidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
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 give it to others.
This medicine may harm another person, 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 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 package 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 reduce blood pressure.
Co-Dipper is used for the treatment of high blood pressure that cannot be adequately controlled by either of the aforementioned 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 taking Co-Dipper

When not to take 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 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 produces no urine (anuria);
if the patient is undergoing dialysis ("artificial kidney");
if, despite treatment, the potassium or sodium level in the patient's blood is below normal, or if the calcium level in the blood is above normal;
if the patient has gout;
if the patient has diabetes or kidney function impairment 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 consult 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, potassium-containing salt substitutes, or other medicines that increase blood potassium levels (such as heparin),
as 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 patient must strictly follow the initial dose recommended by the doctor. 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 of the hormone aldosterone; 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 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 (a so-called autoimmune disease).
the patient has diabetes, gout, or high cholesterol or triglyceride levels in the blood.
the patient has previously had 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 experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between the 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.
Patients previously allergic to penicillin or sulfonamides are at higher risk of such disorders.
the patient has previously had skin cancer or if a skin change occurs during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged 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 problems or lung disorders (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, consult 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 take 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 unborn child (see the 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 make independent decisions 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 take.
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 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 to treat 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 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)
medicinal 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 take 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 disorders, 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 infections)
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, for example, during surgery)
iodinated contrast agents (used in imaging procedures).
Co-Dipper with food, drink, and alcohol
Co-Dipper can be taken regardless 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 taking 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 conception 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 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 a different, more suitable medicine.
Driving and using machines
Before driving, using tools, operating machinery, or performing activities requiring concentration, the patient should ensure how Co-Dipper affects them. 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. In case of 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 check-ups
with your doctor, even when feeling well.
Your doctor will precisely determine 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 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 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 your next dose,
skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Co-Dipper treatment
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 concerning 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 acute respiratory failure occurs (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)

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 sodium levels in blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)
• low potassium levels in blood (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 bilirubin levels in blood (which may cause yellowing of the skin and eyes in severe cases)
• increased blood urea and creatinine levels (which may indicate impaired kidney function)
• increased blood uric acid levels (which may cause gout in severe cases)
• fainting

The following adverse reactions have been reported during use of medicinal products containing either valsartan 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 (based on available data)

• blister formation on 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 potassium levels in blood (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 and red blood cell count (which may cause anaemia in severe cases)
• kidney failure
• low sodium levels in blood (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 potassium levels in blood
• increased blood lipid levels

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

• low sodium levels in blood
• low magnesium levels in blood
• high uric acid levels in 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 blister formation on the skin (due to increased sensitivity to sunlight)
• high calcium levels in blood
• high blood sugar levels
• presence of glucose 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, 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, rapid breathing (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 impaired kidney function or kidney failure)
• visual impairment or eye pain due to increased intraocular pressure (possible signs of fluid accumulation in the uvea surrounding the eye — excessive fluid accumulation between choroid and sclera — or acute angle-closure glaucoma)
• rash, redness of the skin, blistering around the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever
• weakness
• skin and lip malignancies (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 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Co-Dipper

Keep this medicine 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 stated month.
Do not store above 30ºC.
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. These measures will 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 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica.
Coating: hypromellose, polyethylene glycol 8000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

What Co-Dipper looks like and contents of the pack
Light orange, oval, slightly convex film-coated tablet, printed (embossed) with the symbol "HGH" 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

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, 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 Warsaw, Poland
Tel: 22 209 70 00