SUVARTAR H 160 mg / 12.5 mg. 28 tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:
Suvartar H 160 mg / 12.5 mg film-coated tablets
One film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide

Suvartar H 160 mg / 25 mg film-coated tablets
One film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide

THERAPEUTIC INDICATIONS:
Treatment of essential hypertension.

Sulvarta H fixed dose combination is indicated in patients whose blood pressure is not adequately controlled by valsartan or hydrochlorothiazide monotherapy.

DOSAGE AND ROUTE OF ADMINISTRATION:
Dosage
The recommended dose of Suvartar H 80 mg / 12.5 mg is one film-coated tablet daily. Individual titration of the individual components is recommended.
When clinically relevant, a switch from monotherapy to a fixed-dose combination regimen may be directly considered in patients whose blood pressure is not adequately controlled by valsartan or hydrochlorothiazide monotherapy.
After initiation of treatment, the clinical response to Svalvarar H should be assessed and, if blood pressure control can not be achieved, the dose may be increased by increasing the individual components to a maximum dose of Suvartar H 320 mg / 25 mg.
The antihypertensive effect is markedly available after 2 weeks, and maximum effects are achieved within 4 weeks.

Application:
Suvartar H can be taken with or without food and should be taken with water.

Additional information about special patient groups:
Renal impairment
No dosage adjustment is required in patients with mild to moderate renal impairment. Because of the hydrochlorothiazide component, Svalvar H is contraindicated in patients with severe renal impairment.
Hepatic impairment:
In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg. Sulvarar H is contraindicated in patients with severe hepatic impairment.

Elderly:
No dosage adjustment is necessary in elderly patients.

Pediatric patients:
The use of  Suvartar H is not recommended in children below 18 years due to a lack of data on safety and efficacy.

CONTRAINDICATIONS:
- hypersensitivity to valsartan, hydrochlorothiazide, other sulphonamide derivatives or to any of the excipients.
- second and third trimesters of pregnancy
- severe hepatic impairment, biliary cirrhosis and cholestasis
- refractory hypokalaemia, hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia.
PREGNANCY AND BREAST
Pregnancy
Valsartan
The use of angiotensin II receptor blockers is not recommended during the first trimester of pregnancy. The use of ARB is contraindicated during the second and third trimesters of pregnancy.

Epidemiological data on the risk of teratogenicity following ACE inhibitor exposure during the first trimester of pregnancy are not conclusive; However, a slight increase in risk can not be ruled out. Although there are no controlled epidemiological data on the risk of ARB, such a risk may exist with this class of drugs. Except when treatment with ARA is considered to be very important, patients planning a pregnancy should undergo alternative antihypertensive treatments with a proven safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ARB should be discontinued immediately and, if necessary, alternative therapy initiated.

It is known that exposure to ARA during the second and third trimesters of pregnancy causes human fetotoxicity and neonatal toxicity
In case of exposure to ARB after the second trimester of pregnancy, an ultrasound check of the renal function of the skull is recommended.
Newborns whose mothers have taken ARB should be carefully monitored for hypotension.

Hydrochlorothiazide
There is limited experience with the use of hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are inadequate. Hydrochlorothiazide passes through the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use in the second and third trimesters may disrupt fetal bowel perfusion and lead to fetal and neonatal complications such as jaundice, electrolyte imbalance and thrombocytopenia.

Hydrochlorothiazide should not be used in gestational edema, gestational hypertension or preeclampsia because of the risk of lowering plasma volume and placental hypoperfusion without having a beneficial effect on the course of the disease.
Hydrochlorothiazide should not be used for the treatment of essential hypertension in pregnant women, except in rare cases when no other treatment can be given.

Breastfeeding
There are no data on the use of valsartan during breast-feeding.
Hydrochlorothiazide is excreted in human milk. Therefore, Suvartar H is not recommended during breast-feeding. Prefer alternate treatment with a better established safety profile
UNWANTED REACTIONS:
Valsartan / hydrochlorothiazide

Metabolism and nutrition disorders
Uncommon - dehydration

Nervous system disorders
Very rare - dizziness
Uncommon - paraesthesia, syncope

Eye disorders
Uncommon - blurred vision

Ear and labyrinth disorders
Uncommon - tinnitus

Vascular disorders
Uncommon - hypotension

Respiratory, thoracic and mediastinal disorders
Uncommon - cough
Not known - non-cardiogenic pulmonary edema

Gastrointestinal disorders
Very rare - diarrhea

Musculoskeletal and connective tissue disorders
Uncommon - myalgia
Very rare - arthralgia

Renal and urinary disorders
Not known - impaired kidney function

General disorders and administration site conditions
Uncommon - fatigue

Research
With a known frequency - elevated serum uric acid levels, elevated serum bilirubin and creatinine, hypokalaemia,

Valsartan
Blood and lymphatic system disorders
Not known - decreased hemoglobin, decreased hematocrit, neutropenia, thrombocytopenia.

Immune system disorders
Not known - other hypersensitivity reactions, including serum sickness

Metabolism and nutrition disorders
Not known - increased serum potassium

Ear and labyrinth disorders
Uncommon - dizziness

Vascular disorders
Not known - vasculitis

Respiratory, thoracic and mediastinal disorders
Uncommon - cough

Gastrointestinal disorders
Uncommon - abdominal pain

Skin and subcutaneous tissue disorders
Not known - angioedema, rash, itching.

Hydrochlorothiazide
Disorders of the blood and lymphatic system
Rare - thrombocytopenia, sometimes with purpura
Very rare - agranulocytosis, leucopenia, bone marrow suppression

Disorders of the immune system
Very rare - hypersensitivity reactions

Psychic reactions
Rare - depression, sleep disturbances

Nervous system disorders
Rare - headache

Cardiac disorders
Rare - cardiac arrhythmia

Vascular disorders
Common - orthostatic hypotension

Respiratory, thoracic and mediastinal disorders
Very rare - cough

Gastrointestinal disorders
Common - lack of appetite, mild nausea and vomiting
Rare - constipation, gastrointestinal discomfort
Very rare - pancreatitis

Skin and subcutaneous tissue disorders
Common - urticaria and other forms of rash
Rare - photosensitivity
Very rare - necrotizing vasculitis and toxic epidermal necrolysis, skin reactions

Reproductive system and breast disorders
Common - Impotence

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