Valsartan Hct Fair-med

Patient Information Leaflet: User Information

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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

Table of Contents of the Leaflet:

• 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).

• Valsartanbelongs 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 and thus increases blood pressure. Valsartan works by blocking angiotensin II. As a result, blood vessels dilate and blood pressure decreases.
• Hydrochlorothiazideis a diuretic belonging to the group of thiazide diuretics. Hydrochlorothiazide increases urine production, which also lowers blood pressure.

Valsartan HCT Fair-Med is used to treat high blood pressure that cannot be adequately controlled by taking each active substance separately.

2. Important information before taking Valsartan HCT Fair-Med

When not to take Valsartan HCT Fair-Med

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemically similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in point 6);
• in pregnancy over 3 months (you should also avoid taking Valsartan HCT Fair-Med in early pregnancy - see "Pregnancy and breastfeeding");
• if you have severe liver disease, bile duct obstruction (cholestasis);
• if you have severe kidney disease;
• if you are unable to urinate (anuria);
• if you are on dialysis;
• if you have low potassium or sodium levels in the blood or high calcium levels in the blood, despite treatment;
• if you have gout.

If any of the above situations apply to you, do not take this medicine. Consult a doctor.

Warnings and precautions

Before starting treatment with Valsartan HCT Fair-Med, consult a doctor or pharmacist.

• if you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, such as heparin; regular monitoring of potassium levels in the blood by a doctor may be necessary;
• if you have low potassium levels in the blood;
• if you have diarrhea or severe vomiting;
• if you are taking high doses of diuretics (diuretics);
• if you have severe heart disease;
• if you have heart failure or have had a heart attack. You should carefully follow the doctor's instructions regarding the initial dose of the medicine. The doctor may also examine your kidney function;
• if you have narrowing of the renal arteries;
• if you have had a kidney transplant recently;
• if you have hyperaldosteronism; this is a disease in which the adrenal glands produce too much of a hormone called aldosterone; if you have this disease, taking Valsartan HCT Fair-Med is not recommended;
• if you have liver or kidney disease;
• if you have ever had swelling of the tongue or face caused by an allergic reaction (called angioedema) when taking another medicine (including ACE inhibitors), tell your doctor. If such symptoms occur while taking Valsartan HCT Fair-Med, stop taking Valsartan HCT Fair-Med and never start taking it again. See also point 4 "Possible side effects";
• if you have had fever, rash, and joint pain, which may indicate systemic lupus erythematosus (SLE, an autoimmune disease);
• if you have diabetes, gout, high cholesterol, or high triglycerides in the blood;
• if you have had allergic reactions to other blood pressure-lowering medicines from this group (angiotensin II receptor antagonists) or if you have allergies or asthma;
• if you experience vision loss or eye pain. These may be symptoms of increased pressure in the eye, which can occur within a few hours to a week after starting Valsartan HCT Fair-Med. If left untreated, it can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at greater risk of such a reaction;
• the medicine may cause increased sensitivity of the skin to sunlight.

Children and adolescents

Valsartan HCT Fair-Med should not be used in children and adolescents (under 18 years of age).

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

Valsartan HCT Fair-Med should not be used in the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").

Other medicines and Valsartan HCT Fair-Med

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• lithium, a medicine used to treat certain mental illnesses
• medicines or substances that may increase potassium levels in the blood. Such medicines include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin
• medicines that may lower potassium levels in the blood, such as diuretics (diuretics), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (from the rifamycin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). Such medicines may increase the effect of Valsartan HCT Fair-Med

Valsartan HCT Fair-Med with food and drink

Valsartan HCT Fair-Med can be taken with or without food.

Avoid consuming alcohol without consulting a doctor. Alcohol may enhance the blood pressure-lowering effect and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult a doctor or pharmacist before taking this medicine.

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant

Usually, the doctor will advise you to stop taking Valsartan HCT Fair-Med before becoming pregnant or as soon as you find out you are pregnant, and will recommend taking a different medicine instead of Valsartan HCT Fair-Med. Valsartan HCT Fair-Med should not be used in the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby.

You must inform your doctor if you are breastfeeding or plan to breastfeed

Valsartan HCT Fair-Med should not be used during breastfeeding. The doctor may choose a different medicine if you plan to breastfeed, especially when breastfeeding newborns or premature babies.

Driving and using machines

Before driving, using tools, or operating machines, or performing other activities that require concentration, you should make sure what effect Valsartan HCT Fair-Med has on you. Like many other blood pressure medicines, Valsartan HCT Fair-Med may cause dizziness and affect your ability to concentrate.

3. How to take Valsartan HCT Fair-Med

Always take this medicine exactly as your doctor or pharmacist has told you. This will help you get the best results from the treatment and reduce the risk of side effects. If you are unsure, consult your doctor or pharmacist.

• The recommended dose of Valsartan HCT Fair-Med 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 every day, usually in the morning.
• Valsartan HCT Fair-Med can be taken with or without food.
• Swallow the tablet with a glass of water.

What to do if you take more Valsartan HCT Fair-Med than you should

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.

What to do 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 dose.

What to do if you want to stop taking Valsartan HCT Fair-Med

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

If you have any further questions about taking this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, Valsartan HCT Fair-Med can cause side effects, although not everybody gets them.

Side effects that may occur with a certain frequency are defined as follows:

Very common

occur in more than 1 in 10 patients

Common

occur in 1 to 10 patients in 100

Uncommon

occur in 1 to 10 patients in 1,000

Rare

occur in 1 to 10 patients in 10,000

Very rare

occur in less than 1 in 10,000 patients

Frequency not known

frequency cannot be estimated from the available data

Some side effects may be serious and require immediate medical attention:

You should contact your doctor immediately if you experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

If you experience any of these symptoms, stop taking Valsartan HCT Fair-Med and contact your doctor immediately (see point 2 "Warnings and precautions").

Other side effects include:

Uncommon side effects:

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

Rare side effects:

• dizziness
• diarrhea
• joint pain

Side effects of unknown frequency:

• breathing difficulties
• very low urine output
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, poor condition, convulsions)
• 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 mouth ulcers caused by infections, weakness)
• increased bilirubin levels in the blood (which in severe cases can cause yellowing of the skin and eyes)
• increased urea and creatinine levels in the blood (which may indicate impaired kidney function)
• increased uric acid levels in the blood (which in severe cases can cause a gout attack)
• fainting (syncope)

Side effects that have been observed with products containing valsartan or hydrochlorothiazide in monotherapy:

Valsartan

Uncommon side effects:

• dizziness
• abdominal pain

Side effects of unknown frequency:

• skin rash with or without itching, in combination with some of the following symptoms: fever, joint pain, muscle pain, swelling of lymph nodes, and (or) flu-like symptoms
• rash, purple-red spots, fever, itching (symptoms of vasculitis)
• low platelet count (sometimes with unusual bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, heart rhythm disturbances)
• allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling, mainly of the face and throat; rash; itching
• increased liver enzyme activity
• decreased hemoglobin and red blood cell count in the blood (both symptoms may cause anemia in severe cases)
• kidney failure
• low sodium levels in the blood (which may cause fatigue, confusion, tremors, and (or) convulsions in severe cases)

Hydrochlorothiazide

Very common side effects:

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

Common side effects:

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itching rash and other types of rash
• decreased appetite
• mild nausea and vomiting
• feeling of fainting, fainting when standing up
• erectile dysfunction

Rare side effects:

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• presence of sugar in the urine
• worsening of metabolic condition in diabetes
• constipation, diarrhea, discomfort in the stomach or intestines, liver disorders (yellowing of the skin or eyes)
• irregular heartbeat
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with subcutaneous bleeding or bruising)
• dizziness
• numbness or tingling
• vision disturbances

Very rare side effects:

• vasculitis with symptoms such as rash, purple-red spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (allergic reactions)
• severe skin disease causing rash, redness of the skin, blisters on the mouth, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• systemic lupus erythematosus (SLE, an autoimmune disease) with symptoms such as rash, joint pain, muscle pain, fever
• severe abdominal pain (which may be symptoms of pancreatitis)
• breathing difficulties with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonia and pulmonary edema)
• fever, sore throat, frequent infections (agranulocytosis)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers caused by infection (leukopenia)
• confusion, fatigue, tremors, and rapid breathing (hypochloremic alkalosis)

Side effects of unknown frequency:

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

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

5. How to store 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 month stated.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Valsartan HCT Fair-Med contains

The active substances of the 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 ingredients are: microcrystalline cellulose, anhydrous colloidal silica, crospovidone (type A), magnesium stearate, hypromellose 6 cP, macrogol 400, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

In addition, Valsartan HCT Fair-Med, 160 mg + 25 mg, film-coated tablets, contains:

black iron oxide (E172) and red iron oxide (E172).

In addition, Valsartan HCT Fair-Med, 320 mg + 12.5 mg, film-coated tablets, contains:

black iron oxide (E172) and red iron oxide (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 inscription "L237" on one side and smooth on the other. The tablets are packaged in blisters containing 14, 28 tablets in a pack.

Valsartan HCT Fair-Med, 320 mg + 12.5 mg, film-coated tablets, are pink, oval, film-coated tablets with the inscription "L238" on one side and smooth on the other. The tablets are packaged in blisters containing 28 tablets in a pack.

Valsartan HCT Fair-Med, 320 mg + 25 mg, film-coated tablets, are yellow, oval, film-coated tablets with the inscription "L239" on one side and smooth on the other. The tablets are packaged in blisters containing 28 tablets in a pack.

Not all pack sizes may be marketed.

Marketing Authorization 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 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Cyprus

Valsartan/HCTZ Fair-Med

Denmark

Valsartan/hydrochlorothiazide 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

Date of last revision of the leaflet: