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.
• Ask your doctor or pharmacist if you have any questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those 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 section 6);
• in pregnancy over 3 months (you should also avoid taking Valsartan HCT Fair-Med in early pregnancy - see section "Pregnancy and breastfeeding");
• if you have severe liver disease, damage to small bile ducts in the liver (bile duct cirrhosis) leading to bile accumulation in the liver (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 increased 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 your doctor.

Warnings and precautions

Before starting treatment with Valsartan HCT Fair-Med, consult your 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; your doctor may need to regularly check your potassium levels;
• if you have low potassium levels in the blood;
• if you have diarrhea or severe vomiting;
• if you are taking high doses of diuretics (water pills);
• if you have severe heart disease;
• if you have heart failure or have had a heart attack. You should carefully follow your doctor's instructions regarding the initial dose of Valsartan HCT Fair-Med. Your doctor may also examine your kidney function;
• if you have narrowing of the renal artery;
• if you have recently had a kidney transplant;
• 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 take it again. See also section 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 after taking 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

Do not recommend Valsartan HCT Fair-Med for children and adolescents (under 18 years of age).

You must inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy.

Do not recommend Valsartan HCT Fair-Med in the first trimester of pregnancy and do not take it after 3 months of pregnancy, as it may seriously harm the fetus (see section "Pregnancy and breastfeeding").

Other medicines and Valsartan HCT Fair-Med

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, 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 (water pills), 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 drinking alcohol without consulting your doctor. Alcohol may enhance the blood pressure-lowering effect of Valsartan HCT Fair-Med and (or) increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

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

You must inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy

Usually, your 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. Do not recommend Valsartan HCT Fair-Med in the first trimester of pregnancy and do not take it after 3 months of pregnancy, as it may seriously harm the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed

Do not recommend Valsartan HCT Fair-Med during breastfeeding. Your doctor may choose a different medicine if you intend 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-lowering medicines, Valsartan HCT Fair-Med may rarely 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 your treatment and reduce the risk of side effects. If you are unsure, ask 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 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 a higher dose of 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.

Missing a dose of 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.

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 the medicine unless your doctor tells you to.

If you have any further questions about the use of 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.

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 seek medical attention immediately (see section 2 "Warnings and precautions").

Other side effects include:

Uncommon side effects:

• cough
• low blood pressure
• vertigo
• dehydration (with thirst, dry mouth and tongue, rare 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 with unknown frequency:

• breathing difficulties
• very little urine production
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, poor condition, 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 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)

If you experience any side effects, including those 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.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Valsartan HCT Fair-Med contains

The active substances 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, colloidal anhydrous 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 (E 172) and red iron oxide (E 172).

In addition, Valsartan HCT Fair-Med, 320 mg + 12.5 mg, film-coated tablets, contains black iron oxide (E 172) and red iron oxide (E 172).

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 "L237" embossed on one side and smooth on the other. The tablets are packaged in blisters containing 14, 28 tablets per pack.

Valsartan HCT Fair-Med, 320 mg + 12.5 mg, film-coated tablets, are pink, oval, film-coated tablets with "L238" embossed on one side and smooth on the other. The tablets are packaged 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 "L239" embossed on one side and smooth on the other. The tablets are packaged 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 Warsaw

This medicinal product is authorised in the Member States of 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

Date of last revision of the leaflet: