Valsartan hydrochlorothiazide fair-med

Valsartan HCT Fair-Med, 80 mg + 12.5 mg, film-coated tablets
Valsartan HCT Fair-Med, 160 mg + 12.5 mg, film-coated tablets
Valsartan HCT Fair-Med, 160 mg + 25 mg, film-coated tablets
Valsartan HCT Fair-Med, 320 mg + 12.5 mg, film-coated tablets
Valsartan HCT Fair-Med, 320 mg + 25 mg, film-coated tablets
Valsartan + hydrochlorothiazide

Please read the entire leaflet carefully before using this medicine, because
it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Table of contents of the leaflet:

1. What Valsartan HCT Fair-Med is and what it is used for
2. Important information before taking Valsartan HCT Fair-Med
3. How to take Valsartan HCT Fair-Med
4. Possible side effects
5. How to store Valsartan HCT Fair-Med
6. Contents of the pack and other information

1. What Valsartan HCT Fair-Med is and what it is used for

Valsartan HCT Fair-Med contains 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, used in the treatment of high blood pressure. Angiotensin II is a substance produced in the human body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan works by blocking the action of angiotensin II. As a result, blood vessels dilate and blood pressure decreases.
• Hydrochlorothiazide is a diuretic (water pill) belonging to a group of medicines called thiazide diuretics. Hydrochlorothiazide increases urine output, which also helps lower blood pressure.

Valsartan HCT Fair-Med is used to treat high blood pressure that cannot be adequately controlled with either active substance given alone.
High blood pressure increases the workload on the heart and blood vessels. If left untreated, it may lead to damage of blood vessels in the brain, heart, and kidneys, potentially resulting in stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. Important information before using Valsartan HCT Fair-Med

When not to take Valsartan HCT Fair-Med

• if the patient is allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically similar substances to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
• during pregnancy beyond 3 months (use of Valsartan HCT Fair-Med should also be avoided in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has severe liver disease, damage to the small bile ducts in the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis);
• if the patient has severe kidney disease;
• if the patient is unable to pass urine (anuria);
• if the patient is undergoing dialysis;
• if the patient has low blood potassium or sodium levels, or increased blood calcium levels, despite treatment;
• if the patient has gout.

If any of the above situations apply to the patient, this medicine should not be taken.
Consult a doctor.
Warnings and precautions
Before starting treatment with Valsartan HCT Fair-Med, consult a
doctor or pharmacist.

• 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;
• if the patient has low blood potassium levels;
• if the patient has diarrhoea or severe vomiting;
• if the patient is taking high doses of diuretics (water tablets);
• if the patient has severe heart disease;
• if the patient has heart failure or has had a heart attack. The patient should strictly follow the doctor's instructions regarding the initial dose of the medicine. The doctor may also check kidney function;
• if the patient has renal artery stenosis;
• if the patient has recently received a kidney transplant;
• if the patient has hyperaldosteronism; a condition in which the adrenal glands produce too much of a hormone called aldosterone; if the patient has this condition, use of Valsartan HCT Fair-Med is not recommended;
• if the patient has liver or kidney disease;
• if the patient has ever experienced swelling of the tongue or face due to an allergic reaction (called angioedema) while taking another medicine (including ACE inhibitors), inform the doctor. If such symptoms occur while taking Valsartan HCT Fair-Med, stop taking the medicine immediately and never restart it. See also section 4 "Possible side effects";
• if the patient develops fever, rash, and joint pain, which may indicate systemic lupus erythematosus (SLE, an autoimmune disease);
• if the patient has diabetes, gout, high cholesterol or high blood fat levels;
• if the patient has previously experienced allergic reactions after taking other antihypertensive medicines from this class (angiotensin II receptor antagonists), or if the patient has allergies or asthma;
• if the patient experiences visual disturbances or eye pain. These may be symptoms of increased intraocular pressure, which may occur from a few hours to a week after starting Valsartan HCT Fair-Med. If left untreated, this may lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at higher risk of such a reaction;
• the medicine may cause increased skin sensitivity to sunlight.

Children and adolescents
Use of Valsartan HCT Fair-Med is not recommended in children and adolescents (under 18 years of age).
It is essential to inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy.
Use of Valsartan HCT Fair-Med is not recommended during the first trimester of
pregnancy. Do not take it after 3 months of pregnancy, as it may cause significant harm to the unborn child (see section "Pregnancy and breastfeeding").

Other medicines and Valsartan HCT Fair-Med
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
The effect of the medicine may be altered if Valsartan HCT Fair-Med is taken simultaneously with certain other medicines. This may require dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines. This particularly applies to:

• lithium, a medicine used in the treatment of certain psychiatric disorders;
• medicines or substances that may increase blood potassium levels. Such medicines include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• medicines that may reduce blood potassium levels, such as diuretics (water tablets), 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/AIDS infection (ritonavir). These medicines may enhance the effect of Valsartan HCT Fair-Med;
• medicines that may cause "torsades de pointes" (irregular heartbeat), such as medicines used for heart rhythm disorders and certain antipsychotic medicines;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines used in the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone;
• therapeutic doses of vitamin D and calcium supplements;
• antidiabetic medicines (oral medicines such as metformin or insulin);
• other blood pressure-lowering medicines, including methyldopa;
• medicines that increase blood pressure, such as noradrenaline or adrenaline;
• digoxin or other cardiac glycosides (medicines used in heart diseases);
• 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 > 3 g;
• muscle relaxants, such as tubocurarine;
• anticholinergic medicines (used in the treatment of various conditions such as stomach cramps, bladder dysfunction, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an adjunct in anaesthesia);
• amantadine (a medicine used in the treatment of Parkinson's disease and in the treatment and prevention of certain viral diseases);
• cholestyramine and colestipol (medicines mainly used in the treatment of high blood fat levels);
• cyclosporine, a medicine used after organ transplantation to prevent transplant rejection;
• alcohol, sleeping pills, and anaesthetics (medicines with sedative or pain-relieving effects used, for example, during surgery);
• iodine-containing contrast agents (agents used in imaging procedures).

Valsartan HCT Fair-Med with food and drink
Valsartan HCT Fair-Med may be taken with or without food.
Alcohol should be avoided without prior consultation with a doctor. Alcohol may intensify the lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if there is suspicion of pregnancy or plans for pregnancy, consult a doctor or pharmacist before using this medicine.

• It is essential to inform the doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend discontinuing Valsartan HCT Fair-Med before becoming pregnant or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Use of Valsartan HCT Fair-Med is not recommended during the first trimester of pregnancy. Do not take it after 3 months of pregnancy, as it may cause significant harm to the unborn child.
• Inform the doctor about breastfeeding or plans to breastfeed. Use of Valsartan HCT Fair-Med is not recommended during breastfeeding. The doctor may choose an alternative medicine if the patient intends to breastfeed, especially when breastfeeding newborns or premature infants.

Driving and using machines
Before driving, using tools, operating machinery, or performing other tasks requiring concentration, the patient should ensure how Valsartan HCT Fair-Med affects them. Like many other medicines used to treat high blood pressure, Valsartan HCT Fair-Med may rarely cause dizziness and affect the ability to concentrate.

3. How to take Valsartan HCT Fair-Med

This medicine should always be taken exactly as recommended by your doctor or pharmacist.
Doing so will ensure the best treatment results and reduce the risk of adverse effects.
If in doubt, consult your doctor or pharmacist.
Patients with high blood pressure often do not notice any symptoms of the condition.
Many feel perfectly well. Therefore, it is very important to attend regular check-ups with your doctor, even when feeling well.
Your doctor will tell you exactly how many tablets of Valsartan HCT Fair-Med to take.
Depending on your response to treatment, your doctor may decide to increase or decrease the dose.

• The recommended dose of Valsartan HCT Fair-Med is one tablet daily.
• Do not change the dose or stop taking the tablets without consulting your doctor.
• The medicine should be taken at the same time each day, usually in the morning.
• Valsartan HCT Fair-Med may be taken with or without food.
• Swallow the tablet with a glass of water.

Taking more Valsartan HCT Fair-Med than recommended
If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.
If you accidentally take too many tablets, contact your doctor, pharmacist, or hospital at once.

If you forget to take Valsartan HCT Fair-Med
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
Do not take a double dose to make up for a missed one.

Stopping treatment with Valsartan HCT Fair-Med
Stopping treatment with Valsartan HCT Fair-Med may cause your blood pressure to rise.
Do not stop taking this medicine unless your doctor tells you to do so.

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.
Adverse reactions occurring with the following frequencies have been defined as follows:
Very common: occurs in more than 1 in 10 patients
Common: occurs in 1 to 10 in 100 patients
Uncommon: occurs in 1 to 10 in 1,000 patients
Rare: occurs in 1 to 10 in 10,000 patients
Very rare: occurs in less than 1 in 10,000 patients
Not known: frequency cannot be estimated from available data

Some adverse reactions may be severe and require immediate medical attention:
Seek immediate medical advice if symptoms of angioedema occur, such as:

• swelling of the face, tongue or throat,
• difficulty swallowing,
• urticaria and breathing difficulties.
  If any of these symptoms occur, treatment with Valsartan HCT Fair-Med must be discontinued immediately and medical advice sought immediately (see section 2 "Warnings and precautions").

Other adverse reactions include:
Adverse reactions occurring uncommonly:

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

Adverse reactions occurring very rarely:

• dizziness
• diarrhoea
• joint pain

Adverse reactions with unknown frequency:

• difficulty breathing
• very low urine output
• low blood sodium levels (sometimes with nausea, fatigue, confusion, malaise, seizures)
• 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 oral ulcers due to infections, 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 trigger a gout attack)
• collapse (fainting)

Adverse reactions observed with products containing valsartan or hydrochlorothiazide used as monotherapy:
Valsartan
Adverse reactions occurring uncommonly:

• sensation of spinning
• abdominal pain

Adverse reactions with unknown frequency:

• skin rash with or without skin itching, associated 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 unusual bleeding or skin purpura)
• high blood potassium levels (sometimes with muscle cramps, irregular heartbeat)
• 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 concentration and reduced number of red blood cells in blood (both may lead to anaemia in severe cases)
• kidney failure
• low blood sodium levels (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)

Hydrochlorothiazide
Adverse reactions occurring very commonly:

• low blood potassium levels
• increased blood lipid levels

Adverse reactions occurring commonly:

• 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
• feeling faint, fainting upon standing
• inability to achieve or maintain erection

Adverse reactions occurring rarely:

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high blood calcium levels
• high blood glucose levels
• presence of glucose in urine
• worsening of metabolic control in diabetes
• constipation, diarrhoea, gastric or intestinal discomfort, liver disorders (yellowing of skin or eyes)
• irregular heartbeat
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with subcutaneous bleeding or bruising)
• dizziness
• numbness or tingling
• visual disturbances

Adverse reactions occurring very rarely:

• vasculitis with symptoms such as rash, purplish-red spots, fever (inflammation of blood vessels)
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• severe skin disease causing rash, redness of the skin, blisters on lips, eyes or in the mouth, skin peeling, fever (toxic epidermal necrolysis)
• facial rash, joint pain, muscle disorders, fever (systemic lupus erythematosus)
• severe upper abdominal pain (may be symptoms of 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 oral ulcers due to infection (leukopenia)
• confusion, fatigue, tremor and muscle cramps, rapid breathing (hypochloraemic alkalosis)

Adverse reactions with unknown frequency:

• weakness, bruising and frequent infections (aplastic anaemia)
• significant reduction in urine volume (may be symptoms of kidney dysfunction or kidney failure)
• worsening of vision or eye pain associated with high pressure (may be symptoms of acute angle-closure glaucoma)
• rash, redness of the skin, blisters on lips, eyes or in the mouth, skin peeling, fever (may be symptoms of erythema multiforme)
• muscle cramps
• fever
• weakness (asthenia)

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

5. How to store the medicine Valsartan HCT Fair-Med

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "expiry date". The expiry date refers to the last day of the stated month.
No special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan HCT Fair-Med contains
The active substances in this medicine are valsartan and hydrochlorothiazide.
Valsartan HCT Fair-Med 80 mg + 12.5 mg, film-coated tablets contain 80 mg of
valsartan and 12.5 mg of hydrochlorothiazide.
Valsartan HCT Fair-Med 160 mg + 12.5 mg, film-coated tablets contain 160 mg of
valsartan and 12.5 mg of hydrochlorothiazide.
Valsartan HCT Fair-Med 160 mg + 25 mg, film-coated tablets contain 160 mg of
valsartan and 25 mg of hydrochlorothiazide.
Valsartan HCT Fair-Med 320 mg + 12.5 mg, film-coated tablets contain 320 mg of
valsartan and 12.5 mg of hydrochlorothiazide.
Valsartan HCT Fair-Med 320 mg + 25 mg, film-coated tablets contain 320 mg of
valsartan and 25 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, colloidal anhydrous silica,
crospovidone (type A), magnesium stearate, hypromellose 6 cP, macrogol 400, talc,
titanium dioxide (E 171).
Additionally, Valsartan HCT Fair-Med 80 mg + 12.5 mg, film-coated tablets contain:
iron oxide red (E 172) and iron oxide yellow (E 172).
Additionally, Valsartan HCT Fair-Med 160 mg + 12.5 mg, film-coated tablets contain:
iron oxide red (E 172).
Additionally, Valsartan HCT Fair-Med 160 mg + 25 mg, film-coated tablets contain:
iron oxide yellow (E 172), iron oxide black (E 172), and iron oxide red (E 172).
Additionally, Valsartan HCT Fair-Med 320 mg + 12.5 mg, film-coated tablets contain:
iron oxide yellow (E 172), iron oxide black (E 172), and iron oxide red (E 172).
Additionally, Valsartan HCT Fair-Med 320 mg + 25 mg, film-coated tablets contain:
iron oxide yellow (E 172).

What Valsartan HCT Fair-Med looks like and contents of the pack
Valsartan HCT Fair-Med 80 mg + 12.5 mg film-coated tablets are light orange,
oval-shaped, film-coated tablets with the imprint “L235” on one side and smooth on
the other side. The tablets are packed in blisters containing 28 tablets per pack.
Valsartan HCT Fair-Med 160 mg + 12.5 mg film-coated tablets are dark red,
oval-shaped, film-coated tablets with the imprint “L236” on one side and smooth on
the other side. The tablets are packed in blisters containing 28 tablets per pack.
Valsartan HCT Fair-Med 160 mg + 25 mg film-coated tablets are orange-brown,
oval-shaped, film-coated tablets with the imprint “L237” on one side and smooth on
the other side. The tablets are packed in blisters containing 14 or 28 tablets per pack.
Valsartan HCT Fair-Med 320 mg + 12.5 mg film-coated tablets are pink,
oval-shaped, film-coated tablets with the imprint “L238” on one side and smooth on
the other side. The tablets are packed in blisters containing 28 tablets per pack.
Valsartan HCT Fair-Med 320 mg + 25 mg film-coated tablets are yellow,
oval-shaped, film-coated tablets with the imprint “L239” on one side and smooth on
the other side. The tablets are packed in blisters containing 28 tablets per pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fair-Med Healthcare GmbH
Planckstrasse 13, 22765 Hamburg
Germany

Manufacturer/Importer
Pharmadox Healthcare Ltd
KW 20A - Corradino Park - Paola
Malta
MEDICOFARMA S.A.
ul. Żelazna 58
00-866 Warszawa
Poland

This medicinal product is authorised in the European Economic Area under the following names:
Cyprus Valsartan/HCTZ Fair-Med
Denmark Valsartan/hydrochlorthiazid Fair-Med
Netherlands Valsartan/HCTZ Fair-Med 80mg/12.5mg, 160mg/12.5mg,
160mg/25mg, 320mg/12.5mg, 320mg/25mg, filmomhulde tabletten
Ireland Valsartan/Hydrochlorothiazide Fair-Med 80mg/12.5mg,
160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg Film-
coated Tablets
Malta Valsartan/HCTZ Fair-Med 80mg/12.5mg, 160mg/12.5mg,
160mg/25mg, 320mg/12.5mg, 320mg/25mg film-coated Tablets
Germany Valsartan/HCTZ Fair-Med Healthcare 80mg/12.5mg,
160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg
Filmtabletten
Poland Valsartan HCT Fair-Med