Valsartan Hct Fair-med

Patient Information Leaflet: User Information

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

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 thereby 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 of the active substances 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, bile duct obstruction in the liver (cholestatic jaundice) leading to bile accumulation in the liver;
• 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 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 artery;
• 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 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 fat levels in the blood;
• if you have had allergic reactions after taking other blood pressure-lowering medicines from this group of medicines (angiotensin II receptor antagonists) or if you are allergic or have asthma;
• if you experience vision loss or eye pain. These may be symptoms of increased pressure in the eye, which may occur within a few hours to a week after starting treatment with 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 take Valsartan HCT Fair-Med during the first trimester of pregnancy. Do not take it after 3 months of pregnancy, as it may harm the fetus during this period (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.

The effect of the medicine may change if Valsartan HCT Fair-Med is taken with certain other medicines. This may require a change in dose, the use of other precautions, or in some cases, discontinuation of one of the medicines. This applies in particular to such medicines as:

• 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
• medicines that may cause "torsades de pointes" (irregular heartbeat), such as medicines used to treat arrhythmias and certain antipsychotic medicines
• medicines that may decrease sodium levels in the blood, 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 digitalis glycosides (medicines used to treat heart conditions)
• medicines that may increase blood sugar levels, such as diazoxide or beta-adrenergic blockers
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
• painkillers, such as non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid > 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (medicines used to treat various diseases such as stomach cramps, urinary disorders, asthma, motion sickness, muscle cramps, Parkinson's disease, and as an adjunct in anesthesia)
• amantadine (a medicine used to treat Parkinson's disease and to treat and prevent certain viral diseases)
• cholestyramine and colestipol (medicines used mainly to treat high fat levels in the blood)
• cyclosporine, a medicine used after organ transplants to prevent rejection
• alcohol, sleeping pills, and anesthetics (medicines with a sedative or analgesic effect used, for example, during surgery)
• iodine-containing contrast agents (substances used in imaging tests)

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 are planning to become pregnant, consult a doctor or pharmacist before taking this medicine.

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

The doctor will usually recommend stopping treatment with Valsartan HCT Fair-Med before becoming pregnant or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Valsartan HCT Fair-Med. Do not take Valsartan HCT Fair-Med during the first trimester of pregnancy. Do not take it after 3 months of pregnancy, as it may harm the fetus during this period.

You must inform your doctor about breastfeeding or intending to breastfeed

Do not take Valsartan HCT Fair-Med while breastfeeding. The 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, the patient should make sure what effect Valsartan HCT Fair-Med has on them. Like many other medicines used to treat high blood pressure, Valsartan HCT Fair-Med may rarely cause dizziness and affect concentration.

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 a doctor or pharmacist.

Patients with high blood pressure often do not notice any symptoms of this disease. Many of them feel perfectly well. Therefore, it is very important to attend doctor's appointments, even if you feel well.

The doctor will tell you the exact number of Valsartan HCT Fair-Med tablets to take. Depending on the patient's response to treatment, the doctor may recommend increasing or decreasing the dose of the medicine.

• 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 a 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.

Taking a higher dose of Valsartan HCT Fair-Med than recommended

In case of severe dizziness and (or) fainting, lie down and contact a doctor immediately.

In case of accidental ingestion of too many tablets, contact a 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 the 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 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.

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:

Contact a 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 a doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Uncommon side effects:

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

Very rare side effects:

• dizziness
• diarrhea
• joint pain

Side effects with unknown frequency:

• breathing difficulties
• very low urine output
• 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, throat pain, 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 any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

5. How to store Valsartan HCT Fair-Med

Keep the 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 specified month.

There are no special precautions for storing the 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, 80 mg + 12.5 mg, film-coated tablets, contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

Valsartan HCT Fair-Med, 160 mg + 12.5 mg, film-coated tablets, contains 160 mg of valsartan and 12.5 mg of 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.

Other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, crospovidone (type A), magnesium stearate, hypromellose 6 cP, macrogol 400, talc, titanium dioxide (E 171).

In addition, Valsartan HCT Fair-Med, 80 mg + 12.5 mg, film-coated tablets, contains:

iron oxide red (E 172) and iron oxide yellow (E 172).

In addition, Valsartan HCT Fair-Med, 160 mg + 12.5 mg, film-coated tablets, contains:

iron oxide red (E 172).

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

iron oxide yellow (E 172), iron oxide black (E 172), and iron oxide red (E 172).

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

iron oxide yellow (E 172), iron oxide black (E 172), and iron oxide red (E 172).

In addition, Valsartan HCT Fair-Med, 320 mg + 25 mg, film-coated tablets, contains:

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, film-coated tablets with the inscription "L235" on one side and smooth on the other. The tablets are packaged in blisters containing 28 tablets per pack.

Valsartan HCT Fair-Med, 160 mg + 12.5 mg, film-coated tablets, are dark red, oval, film-coated tablets with the inscription "L236" on one side and smooth on the other. The tablets are packaged in blisters containing 28 tablets per 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 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 inscription "L238" 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 the inscription "L239" 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 authorization 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 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: