Product Information for the User

Miten Plus Forte 160mg/25mg Film-Coated Tablets

Valsartan/Hydrochlorothiazide

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

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you,as it may harm them.
• Ifyou experienceany side effects,consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1.What Miten Plus Forte is and what it is used for

2.What you need to know before you start taking Miten Plus Forte

3.How to take Miten Plus Forte

4.Possible side effects

5.Storage of Miten Plus Forte

6.Contents of the pack and additional information

Miten Plus Forte film-coated tablets contain two active ingredients known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartanbelongs to a class of medications known as “angiotensin II receptor antagonists” that help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to constrict, resulting in increased blood pressure. Valsartan acts by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazidebelongs to a class of medications known as thiazide diuretics. Hydrochlorothiazide increases diuresis, which also decreases blood pressure.

Miten Plus Forte is used to treat high blood pressure that is not adequately controlled with the use of a single component.

Hypertension increases the workload of the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys and may cause a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Reducing blood pressure to normal values reduces the risk of developing these disorders.

Do not takeMiten Plus Forte

• if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemical substances related to hydrochlorothiazide) or any other component of this medication (listed in section 6).

• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have severe liver disease, small bile duct destruction in the liver (biliary cirrhosis) that leads to a buildup of bile 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 low levels of potassium or sodium in your blood, or if your calcium levels in your blood are higher than normal despite treatment.
• if you have gout.
• if you have diabetes or kidney insufficiency and are being treated with a medication to reduce blood pressure that contains aliskiren.

If any of these situations affect you, inform your doctor and do not take Miten Plus Forte.

Warnings and precautions

Consult your doctor

• if you are using potassium-sparing medications, potassium supplements, salt substitutes containing potassium or other medications that increase the amount of potassium in your blood, such as heparin. Your doctor may consider it necessary to regularly monitor your potassium levels.
• if you have low levels of potassium in your blood.
• if you experience severe diarrhea or vomiting.
• if you are taking high doses of a diuretic.
• if you have severe heart disease.
• if you have heart failure or have had a heart attack. Follow your doctor's instructions carefully to start treatment. Your doctor may also monitor your renal function.
• if you have a narrowing of the renal artery.
• if you have recently undergone a kidney transplant.
• if you have primary aldosteronism, a disease in which the adrenal glands produce too much aldosterone hormone. In this case, Miten Plus Forte is not recommended.
• if you have kidney or liver disease.
• if you have experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking other medications (including ACE inhibitors), inform your doctor. If you have these symptoms when taking Miten Plus Forte, stop taking it immediately and never take it again. See also section 4 “Possible side effects”
• if you have fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).
• if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.
• if you have previously experienced an allergic reaction with the use of another medication of this class to reduce blood pressure (angiotensin II receptor antagonists), or if you have any type of allergy or asthma.
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and may occur during a period of time ranging from several hours to weeks after taking Miten Plus Forte. If left untreated, this may lead to permanent vision loss. You may be at greater risk of developing it if you have previously been allergic to penicillin or sulfonamides.

• if you are taking any of the following medications used to treat 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 a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Miten Plus Forte.

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

See also the information under the heading “Do not take Miten Plus Forte”.

Miten Plus Forte may cause increased sensitivity to the sun.

Miten Plus Forte is not recommended for use in children and adolescents (under 18 years old).

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Miten Plus Forte is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy as it may cause serious harm to your baby, see Pregnancy section.

Use of Miten Plus Forte with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

The effect of treatment with Miten Plus Forte may be altered if taken with certain medications. Your doctor may need to modify your dose and/or take other precautions or, in some cases, discontinue treatment with one of the medications. This is especially applicable to the following medications:

• lithium, a medication used to treat certain types of psychiatric disorders.
• medications or substances that may increase the amount of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medications, and heparin.
• medications that may decrease the amount of potassium in the blood, such as diuretics (urine-producing medications), corticosteroids, laxatives, carbenoxolone, amphotericin B, or penicillin G.
• some antibiotics (of the rifampicin group), a medication used to protect against rejection in a transplant (ciclosporin), or an antiretroviral medication used to treat HIV/AIDS (ritonavir). These medications may increase the effect of Miten Plus Forte.
• medications that may induce “torsades de pointes” (irregular heartbeats), such as antiarrhythmics (medications used to treat heart problems) and some antipsychotics.
• medications that may reduce the amount of sodium in the blood, such as antidepressants, antipsychotics, antiepileptics.
• medications used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
• therapeutic vitamin D and calcium supplements.
• medications used to treat diabetes (insulin or oral antidiabetic medications such as metformin).
• other medications used to reduce blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Miten Plus Forte” and “Warnings and precautions”).
• medications that increase blood pressure, such as norepinephrine or adrenaline.
• digoxin or other digitalis glycosides (medications used to treat heart problems).
• medications that may increase blood sugar levels, such as diazoxide or beta-blockers.
• cytotoxic medications (used to treat cancer), such as methotrexate or cyclophosphamide.
• pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and aspirin in doses above 3 g.
• muscle relaxants, such as tubocurarine.
• anticholinergic medications (medications used to treat a wide range of disorders such as gastrointestinal cramps, urinary tract spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia).
• amantadine (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).
• colestiramine and colestipol (medications used primarily to treat high levels of lipids in the blood).
• ciclosporin, a medication used to prevent organ rejection after transplantation.
• alcohol, sleep medications, and anesthetics (medications with sedative or pain-relieving effects used, for example, in surgery).
• iodinated contrast media (used for diagnostic imaging tests).

Taking Miten Plus Forte 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 risk of dizziness and weakness.

Pregnancy and breastfeeding

• You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.Generally, your doctor will advise you to stop taking Miten Plus Forte before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Miten Plus Forte is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

• Inform your doctor if you are planning to start or are breastfeeding, as Miten Plus Forte is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

Before driving a vehicle, using tools, or operating machinery, or engaging in other activities that require concentration, make sure you know your reactions to the effects of Miten Plus Forte. Like many other medications used to treat high blood pressure, Miten Plus Forte may cause, in rare cases, dizziness and affect concentration.

Always take this medication exactly as your doctor tells you to.This will help you get the best results and reduce the risk of side effects.If you are unsure, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any symptoms of the disease; many feel normal.This makes it very important to attend your appointments with your doctor, even if you feel well.

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

• The recommended dose of Miten Plus Forte is one tablet per day.
• Do not change the dose or stop treatment without consulting your doctor.
• This medication should be taken at the same time every day, usually in the morning.
• You can take Miten Plus Forte with or without food.
• Swallow the tablet with a glass of water.

If you take more Miten Plus Forte than you should

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

If you have taken too many tablets by accident, contact your doctor, pharmacist, or hospital.You can also call the toxicology information service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Miten Plus Forte

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

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Miten Plus Forte

If you stop taking Miten Plus Forte, your high blood pressure may worsen.Do not stop taking the medication unless your doctor tells you to.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

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

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

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

• Severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma)
• Fever, sore throat, increased frequency of infections (agranulocytosis)

These side effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking Miten Plus Forte and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects include:

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

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

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

• dizziness
• diarrhea
• joint pain

Unknown frequency(cannot be estimated from available data):

• difficulty breathing
• severe reduction 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 spasms, abnormal heart rhythm)
• low white blood cell count in the blood (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 the skin and eyes to turn yellow)
• increased urea nitrogen and creatinine levels in the blood (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 side effects have been observed with valsartan or hydrochlorothiazide-containing medications separately:

Valsartan

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

• feeling of spinning
• abdominal pain

Unknown frequency(cannot be estimated from available data):

• blistering of the skin (sign of dermatitis bullosa)
• skin rash with or without itching, along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, lymph node inflammation, and/or flu-like symptoms
• skin rash, red-purple patches, fever, itching (signs of blood vessel inflammation)
• low platelet count (sometimes with bleeding or bruising more frequently than usual)
• high potassium levels in the blood (sometimes with muscle spasms, abnormal heart rhythm)
• 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
• increased liver function values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may cause anemia)
• renal insufficiency
• 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 lipid levels in the blood

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
• skin rash with itching and other types of rash
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness when standing up
• difficulty achieving or maintaining an erection

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

• swelling and blisters on the skin (due to increased sensitivity to the sun)
• high calcium levels in the blood
• high blood sugar levels
• glucose in the urine
• emergence of diabetic metabolic state
• constipation, diarrhea, stomach or intestinal discomfort, liver alterations that may appear with yellow skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• depression
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

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

• inflammation of the blood vessels with symptoms such as skin rash, red-purple patches, fever (vasculitis)
• skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• skin rash, joint pain, muscle pain, fever (lupus erythematosus)
• severe stomach pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (difficulty breathing that includes pneumonitis and pulmonary edema)
• paleness, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle cramps, and spasms, rapid breathing (hypochloremic alkalosis)

Unknown frequency(cannot be estimated from available data):

• weakness, bruises, and frequent infections (aplastic anemia)
• significant reduction in urine production (possible signs of renal dysfunction or renal failure)
• skin rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle spasms
• fever (pyrexia)
• weakness (asthenia)
• skin cancer and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep out of sight and reach of children.
• Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.
• Do not store at a temperature above30°C. Store in the original packaging to protect it from moisture.
• Do not usethis medicationif you observe that the packaging is damaged or shows signs of manipulation.
• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at theSIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofMiten Plus Forte

• The active ingredients are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other components are:microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.
• The coating of the tablet contains: hypromellose, macrogol 4000, talc, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), titanium dioxide (E171).

Appearance of the product and contents of the package

Miten Plus Forte 160 mg/25 mg coated tablets are oval-shaped, brown in color with the mark “HXH” on one face and “NVR” on the other.

The tablets are presented in blister packs with 14 tablets, 28 tablets in a calendar pack, 56 tablets, 98 tablets in a calendar pack, or 280 tablets. They are also available in pre-cut blister packs of 56x1, 98x1, or 280x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Responsible for manufacturing

Novartis Farma S.p.A.

Via Provinciale Schito, 131

80058 Torre Annunziata (NA)

Italy

Novartis Farmacéutica, S.A.

Ronda Santa Maria, 158

Barbera del Valles, 08210 (Barcelona).

Spain

Novartis Farma – Productos Farmacêuticos, S.A.

Avenida Professor Doutor Cavaco Silva, n.° 10E (Taguspark, Porto Salvo).

Oeiras Parish. 2740 255

Portugal

Novartis Sverige AB

Torshamnsgatan 48

164 40 Kista

Sweden

Novartis Pharmaceuticals UK Ltd

2nd Floor, The WestWorks Building

White City Place, 195 Wood Lane,

London, W12 7FQ

United Kingdom

Demetriades & Papaellinas Ltd.

179 Giannos Kranidiotis avenue

Latsia, Nicosia, 2235

Cyprus

Novartis Pharma B.V.

Haaksbergweg 16,

1101 BX Amsterdam

Netherlands

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05

1020 Vienna

Austria

This medicine is authorized in themember states of the European Economic Area withthe following names:

Last review date of this leaflet:08/2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) htpp://www.aemps.gob.es/