Valsartan/hydrochlorothiazide Normon 320 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valsartan/Hydrochlorothiazide Normon 320 mg/12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Valsartan/Hydrochlorothiazide Normon is and what it is used for
2. What you need to know before taking Valsartan/Hydrochlorothiazide Normon
3. How to take Valsartan/Hydrochlorothiazide Normon
4. Possible side effects
5. How to store Valsartan/Hydrochlorothiazide Normon
6. Contents of the pack and other information

1. What Valsartán/Hidroclorotiazida Normon is and what it is used for

Valsartán/Hidroclorotiazida Normon contains two active substances known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also helps lower blood pressure.

Valsartan/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with either single component alone.

Hypertension increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. What you need to know before taking Valsartan/Hydrochlorothiazide Normon

Do not take Valsartan/Hydrochlorothiazide Normon

• if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6),
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during early pregnancy (see section Pregnancy and breastfeeding),
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis),
• if you have severe kidney disease,
• if you are unable to produce urine (anuria),
• if you are undergoing dialysis,
• if you have abnormally low levels of potassium or sodium in the blood, or if your blood calcium levels are higher than normal despite treatment,
• if you have gout,
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• this medicine contains soya lecithin. It should not be used if you are allergic to peanuts or soya.

If any of these situations apply to you, inform your doctor and do not take valsartan/hydrochlorothiazide.

Warnings and precautions

Consult your doctor:

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, such as heparin. Your doctor may consider it necessary to monitor your potassium levels regularly,

• if you have low potassium levels in your blood,

• if you experience severe diarrhoea or vomiting,

• if you are taking high doses of a diuretic,

• if you have a severe heart condition,

• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function,

• if you have narrowing of the artery to the kidney (renal artery stenosis),

• if you have recently undergone a kidney transplant,

• if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, valsartan/hydrochlorothiazide is not recommended,

• if you have kidney or liver disease,

• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking Valsartan/Hydrochlorothiazide, stop treatment immediately and never take it again (see section 4 Possible side effects),

• if you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a well-known autoimmune disease),

• if you have diabetes, gout, or high cholesterol or triglyceride levels in your blood,

• if you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma,

• if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within a time frame ranging from several hours to one week after taking Valsartan/Hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulphonamides,

  • if you are taking any of the following medicines used to treat hypertension (high blood pressure):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,
  • aliskiren.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking hydrochlorothiazide.

• if you have previously had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnoea or severe difficulty breathing after taking Valsartan/Hydrochlorothiazide, seek medical attention immediately.

• if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking Valsartan/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Valsartan/Hydrochlorothiazide Normon as monotherapy without medical advice.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See information under the heading “Do not take Valsartan/Hydrochlorothiazide Normon”.

Valsartan/Hydrochlorothiazide may increase skin sensitivity to sunlight.

The use of valsartan/hydrochlorothiazide is not recommended in children and adolescents (under 18 years of age).

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of valsartan/hydrochlorothiazide is not recommended during early pregnancy (first 3 months), and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy and breastfeeding).

Anti-doping tests

This medicine, due to its content of hydrochlorothiazide, may produce a positive analytical result in anti-doping tests.

Other medicines and Valsartan/Hydrochlorothiazide Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment with valsartan/hydrochlorothiazide may be altered if taken together with certain medicines. Your doctor may need to adjust your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medicines. 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 decrease blood potassium levels, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G,
• certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Valsartan/Hydrochlorothiazide,
• medicines that may induce "torsades de pointes" (irregular heartbeats), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics,
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics,
• medicines for treating gout, such as allopurinol, probenecid, sulfinpyrazone,
• therapeutic vitamin D and calcium supplements,
• medicines for treating diabetes (oral antidiabetics such as metformin or insulin),
• other medicines to lower blood pressure, including methyldopa, ACE inhibitors (such as lisinopril, enalapril, etc.) or aliskiren (see information under the headings “Do not take Valsartan/Hydrochlorothiazide Normon” and “Warnings and precautions”),
• medicines that may increase blood pressure, such as noradrenaline or adrenaline,
• digoxin or other digitalis glycosides (medicines used to treat heart problems),
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers,
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide,
• pain medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid at doses exceeding 3 g,
• muscle relaxants, such as tubocurarine,
• anticholinergic medicines (medicines used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, travel sickness, muscle spasms, Parkinson's disease, and as an aid in anaesthesia),
• amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases),
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels),
• cyclosporine, a medicine used to prevent rejection of transplanted organs,
• alcohol, sleeping medicines, and anaesthetics (medicines with sedative or pain-relieving effects, used for example during surgery),
• iodinated contrast agents (used in diagnostic imaging procedures).

Taking Valsartan/Hydrochlorothiazide Normon with food, drinks, and alcohol

Avoid drinking alcohol until you have consulted your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

• You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Valsartan/hydrochlorothiazide is not recommended during early pregnancy, and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that point.
• Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Valsartan/Hydrochlorothiazide Normon is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and using machines

Before driving a vehicle, operating tools, handling machinery, or engaging in other activities requiring concentration, ensure you are aware of your response to the effects of valsartan/hydrochlorothiazide. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may rarely cause dizziness and affect concentration ability.

Valsartan/Hydrochlorothiazide Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Valsartan/Hydrochlorothiazide Normon

Always take this medicine exactly as your doctor has instructed you. This will help you achieve the best results and reduce the risk of adverse effects. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not experience any noticeable symptoms; many feel perfectly normal. This makes it very important to keep your medical appointments, even if you feel well.

Your doctor will tell you exactly how many tablets of valsartan/hydrochlorothiazide you should take. Depending on how you respond to treatment, your doctor may suggest increasing or decreasing the dose.

• The recommended dose of valsartan/hydrochlorothiazide is one tablet daily.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time every day, usually in the morning.
• You may take valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan/Hydrochlorothiazide Normon than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valsartan/Hydrochlorothiazide Normon

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Valsartan/Hydrochlorothiazide Normon

If you stop treatment with valsartan/hydrochlorothiazide, your hypertension may worsen. 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 adverse effects

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

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

• You should see your doctor immediately if you notice symptoms of angioedema, such as:

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

• Serious skin disease causing skin rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis).

• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

• Fever, sore throat, increased frequency of infections (agranulocytosis).

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Valsartan/Hydrochlorothiazide and contact your doctor immediately (see section 2 Warnings and precautions).

Other adverse effects include:

Uncommon (may affect up to 1 in 100 people):

• cough
• low blood pressure,
• dizziness,
• dehydration (with symptoms of thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, dry skin),
• muscle pain,
• fatigue,
• tingling or numbness,
• blurred vision,
• noises (e.g. ringing or buzzing) in the ears,

Very rare (may affect less than 1 in 10,000 people):

• dizziness,
• diarrhea,
• joint pain,

Frequency not known (cannot be estimated from available data):

• difficulty breathing,
• severe decrease in urine output,
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures),
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat),
• low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth 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 nitrogen and creatinine levels (which may indicate abnormal kidney function),
• increased uric acid levels in the blood (which, in severe cases, may trigger a gout attack),
• syncope (fainting).

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately:

Valsartan:

Uncommon (may affect up to 1 in 100 people):

• sensation of spinning,
• abdominal pain.

Very rare (may affect up to 1 in 10,000 people):

• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from available data):

• blisters on the skin (sign of bullous dermatitis),

• skin rash, with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms,

• skin rash, red-purple spots, fever, itching (symptoms of inflammation of blood vessels),

• low platelet count (sometimes with bleeding or bruising more frequently than usual),

• elevated potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat),

• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness),

• swelling mainly of the face and throat; skin rash; itching,

• elevated liver function test values,

• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia),

• renal failure,

• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations and/or seizures).

Hydrochlorothiazide:

Very common (may affect more than 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• 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,
  • decreased appetite,
  • mild vomiting and nausea,
  • dizziness, dizziness upon standing,
  • inability to achieve or maintain an erection.

Rare (may affect up to 1 in 1,000 people):

• • swelling and blisters on the skin (due to increased sensitivity to sunlight),
• high calcium levels in the blood,
• high blood sugar levels,
• sugar in the urine,
• worsening of diabetic metabolic status,
  • constipation, diarrhea, and stomach or intestinal discomfort, liver disorders that may occur together with yellowing of the skin and eyes,
  • irregular heartbeat,
  • headache,
  • sleep disturbances,
  • sadness (depression),
  • low platelet count (sometimes with bleeding or bruising under the skin),
• dizziness,
• tingling or numbness,
  • vision disturbances.

Very rare (may affect less than 1 in 10,000 people):

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis),

• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions),

• facial rash, joint pain, muscle disorders, fever (lupus erythematosus),

• severe pain in the upper abdomen (pancreatitis),

• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including pneumonitis and pulmonary edema),

• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia),

• fever, sore throat or mouth ulcers due to infections (leukopenia),

• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis).

• acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data):

• weakness, bruising, and frequent infections (aplastic anemia),
• marked decrease in urine production (possible signs of kidney impairment or kidney failure),
• skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme),
• muscle cramps,
• fever (pyrexia),
  • weakness (asthenia),
  • skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan/Hydrochlorothiazide Normon

• Keep this medicine out of the sight and reach of children.
• Do not store above 30 °C.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartán/Hidroclorotiazida Normon

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

• The other components are: microcrystalline cellulose (E460i), lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc (E553b), magnesium stearate (E470b), colloidal anhydrous silica (E551), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, soy lecithin (E322), iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the medicine and contents of the pack

Valsartán/Hidroclorotiazida Normon 320 mg/12.5 mg is presented as pink, oval-shaped, biconvex film-coated tablets, with the imprint “V” on one side and “H” on the other.

It is available in blisters containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Manufacturer

ACTAVIS LIMITED
BLB16 Bulebel Industrial Estate (Zejtun) – ZTN08 – Malta

BALKANPHARMA DUPNITSA AD
3, Samokovsko Shosse Str. (Dupnitsa) – 2600 – Bulgaria

Date of the most recent review of this leaflet: February 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/