Valsartan hct fair-med

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

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

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, 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.

Leaflet contents:

1. What is Valsartan HCT Fair-Med and what is it 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 is Valsartan HCT Fair-Med and what is it 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 to treat 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 effects 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 is not adequately controlled with either active substance 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 causing 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 high blood calcium levels, despite treatment;
• if the patient has gout.

If any of the above situations apply, the patient must not take this medicine.
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. 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 lipid 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 worsening of vision 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. Patients who previously had an allergy to penicillin or sulfonamides 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 and must not be taken after 3 months of pregnancy, as it may seriously harm 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 change if Valsartan HCT Fair-Med is taken together with certain other medicines. Dose adjustments, additional precautions, or in some cases discontinuation of one of the medicines may be necessary. 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 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 (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 to treat 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 conditions);
• 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 to treat 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 to treat Parkinson's disease and to treat and prevent certain viral infections);
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels);
• cyclosporine, a medicine used after organ transplantation to prevent transplant rejection;
• alcohol, sleeping pills, and anaesthetics (medicines with sedative or pain-relieving effects, e.g. used during surgery);
• iodinated contrast agents (substances used in imaging procedures).

Valsartan HCT Fair-Med with food and drink
Valsartan HCT Fair-Med may be taken with or without food.
Avoid consuming alcohol without consulting a doctor. Alcohol may intensify the lowering of blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should 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 and must not be taken after 3 months of pregnancy, as it may seriously harm 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 nursing newborns or preterm infants.

Driving and operating machinery
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 use Valsartan HCT Fair-Med

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
Following these instructions ensures optimal treatment results and reduces the risk of
unwanted side effects. If in doubt, consult your doctor or pharmacist.
Patients with high blood pressure often do not experience any noticeable symptoms
of this condition. Many feel perfectly well. Therefore, it is very important to attend
regular medical check-ups, even when feeling well.
Your doctor will specify the exact number of Valsartan HCT Fair-Med tablets to take.
Depending on the patient's response to treatment, the 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 can be taken with or without food.
• Swallow the tablet with a glass of water.

Taking more than the recommended dose of Valsartan HCT Fair-Med
If severe dizziness and/or fainting occur, lie down and contact your doctor immediately.
In case of accidental overdose, contact your doctor, pharmacist, or hospital immediately.
Missing a dose of Valsartan HCT Fair-Med
If a dose is missed, take it as soon as you remember. However, if it is almost time for the
next dose, skip the missed dose and continue with the regular schedule.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Valsartan HCT Fair-Med
Stopping treatment with Valsartan HCT Fair-Med may cause blood pressure to rise.
Do not discontinue the medicine unless instructed by your doctor.
If you have any further questions about the use of this medicine,
consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects that may occur with the following frequency are defined as:

Very common – affects more than 1 in 10 people
Common – affects 1 to 10 in 100 people
Uncommon – affects 1 to 10 in 1,000 people
Rare – affects 1 to 10 in 10,000 people
Very rare – affects fewer than 1 in 10,000 people
Frequency not known – frequency cannot be estimated from available data

Some adverse effects may be serious 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, stop taking Valsartan HCT Fair-Med immediately and seek urgent medical advice
  (see section 2 “Warnings and precautions”).

Other adverse effects include:
Adverse effects occurring uncommonly:

• cough
• low blood pressure
• vertigo
• dehydration (with sensation of thirst, dryness of 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 effects occurring very rarely:

• dizziness
• diarrhoea
• joint pain

Adverse effects with unknown frequency:

• difficulty breathing
• very low urine output
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, heart rhythm disturbances)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or oral ulcers due to infections, weakness)
• increased bilirubin levels in the blood (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 uric acid levels in the blood (which in severe cases may trigger a gout attack)
• fainting (syncope)

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

• sensation of spinning
• abdominal pain

Adverse effects with unknown frequency:

• 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 unusual bleeding or skin purpura)
• high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disturbances)
• 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 levels and reduced number of red blood cells in the blood (both may lead to anaemia in severe cases)
• kidney failure
• low sodium levels in the blood (which may cause fatigue, confusion, muscle twitching and/or seizures in severe cases)

Hydrochlorothiazide
Adverse effects occurring very commonly:

• low potassium levels in the blood
• increased blood lipid levels

Adverse effects occurring commonly:

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rash and other types of skin rash
• reduced appetite
• mild nausea and vomiting
• feeling faint, fainting upon standing
• inability to achieve or maintain erection

Adverse effects occurring rarely:

• skin swelling and blisters (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• presence of glucose in the urine
• worsening of metabolic status in diabetes
• constipation, diarrhoea, gastric or intestinal discomfort, liver disorders (jaundice, 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 effects occurring very rarely:

• vasculitis with symptoms such as rash, purplish-red spots, fever
• 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)
• confusion, fatigue, rapid breathing, muscle twitching and cramps (hypochloraemic alkalosis)

Adverse effects with unknown frequency:

• weakness, bruising and frequent infections (aplastic anaemia)
• significantly reduced urine volume (may be symptoms of impaired kidney function 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 effects occur, including any possible adverse effects 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 conditions are required 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. Doing so helps 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 160 mg + 25 mg, film-coated tablets, contains 160 mg of
valsartan and 25 mg of hydrochlorothiazide.
Valsartan HCT Fair-Med 320 mg + 12.5 mg, film-coated tablets, contains 320 mg of
valsartan and 12.5 mg of hydrochlorothiazide.
Valsartan HCT Fair-Med 320 mg + 25 mg, film-coated tablets, contains 320 mg of
valsartan and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, colloidal anhydrous silica,
crospovidone (type A), magnesium stearate, hypromellose 6 cP, polyethylene glycol 400, talc,
titanium dioxide (E 171), iron oxide yellow (E 172).
Additionally, Valsartan HCT Fair-Med 160 mg + 25 mg, film-coated tablets contain:
iron oxide black (E172) and iron oxide red (E172).
Additionally, Valsartan HCT Fair-Med 320 mg + 12.5 mg, film-coated tablets contain:
iron oxide black (E172) and iron oxide red (E172).

What Valsartan HCT Fair-Med looks like and contents of the pack
Valsartan HCT Fair-Med 160 mg + 25 mg, film-coated tablets are orange-brown, oval,
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,
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,
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
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 countries 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