Valsartan and hydrochlorothiazide Almus

Patient Information Leaflet

Valsartan and Hydrochlorothiazide Almus 80 mg/12.5 mg film-coated tablets, 160 mg/12.5 mg film-coated tablets, 160 mg/25 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valsartan and Hydrochlorothiazide Almus is and what it is used for

Valsartan and Hydrochlorothiazide Almus film-coated tablets contain two active substances called
valsartan and hydrochlorothiazide. Both of these substances 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, thereby increasing 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 group of medicines called thiazide diuretics. Hydrochlorothiazide increases the amount of urine produced and, in this way, reduces blood pressure.

Valsartan and Hydrochlorothiazide Almus is used to treat high blood pressure when it is not
sufficiently controlled by a single medicine.
When blood pressure is high, the workload on the heart and arteries increases. If left untreated,
it can damage the blood vessels in the brain, heart, and kidneys, and may lead to stroke, heart failure, or
kidney failure. High blood pressure increases the risk of heart attack. Lowering blood pressure to normal levels reduces the risk of developing these conditions.

2. What you should know before taking Valsartan and Hydrochlorothiazide Almus

Do not take Valsartan and Hydrochlorothiazide Almus:

• If you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulfonamide derivatives (chemicals related to hydrochlorothiazide), or any of the excipients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is best to avoid taking Valsartan and Hydrochlorothiazide Almus even in early pregnancy – see section Pregnancy).
• If you have severe liver disorders, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• If you have severe kidney disorders.
• If you are unable to urinate (anuria).
• If you are undergoing treatment with an artificial kidney.
• If your blood levels of potassium or sodium are lower than normal, or if your blood calcium levels are higher than normal despite treatment.
• If you have gout.
• If you suffer from diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Consult your doctor:

• If you are taking potassium-sparing medicines, potassium supplements, potassium-containing salt substitutes, or other medicines that increase blood potassium levels, such as heparin. Your doctor may need to regularly monitor your blood potassium levels.
• If your blood potassium levels are low.
• If you have diarrhoea or severe vomiting.
• If you are taking high doses of medicines that increase fluid elimination (diuretics).
• If you have serious heart problems.
• If you suffer from heart failure or have had a heart attack. Follow your doctor’s instructions carefully regarding the starting dose of treatment. Your doctor will also monitor your kidney function.
• If you have narrowing of the renal artery.
• If you have recently received a kidney transplant.
• If you suffer from hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. If this applies to you, the use of Valsartan and Hydrochlorothiazide Almus is not recommended.
• If you have liver or kidney diseases.
• If you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema when taking other medicines (including ACE inhibitors), inform your doctor. If these symptoms occur while taking Valsartan and Hydrochlorothiazide Almus, stop taking it immediately and never take it again. See section 4, "Possible side effects".
• If you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (SLE, an autoimmune disease).
• If you have diabetes, gout, or elevated cholesterol or triglyceride levels in the blood.
• If you have had allergic reactions when using other blood pressure-lowering medicines belonging to the same class (angiotensin II receptor antagonists) or if you suffer from allergies or asthma.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur from a few hours to weeks after taking Valsartan and Hydrochlorothiazide Almus. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition.
• If you are taking any of the following medicines for high blood pressure:
• an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• Aliskiren.
• If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).
• If you have previously had skin cancer or develop unexpected skin lesions 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 and UV exposure while taking Valsartan and Hydrochlorothiazide Almus.
• If you previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe difficulty breathing occurs after taking Valsartan and Hydrochlorothiazide Almus, consult a doctor immediately.

Contact your doctor if, after taking Valsartan and Hydrochlorothiazide Almus, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Valsartan and Hydrochlorothiazide Almus on your own.
Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the section “Do not take Valsartan and Hydrochlorothiazide Almus”.
Valsartan and Hydrochlorothiazide Almus may cause increased skin sensitivity to sunlight.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Valsartan and Hydrochlorothiazide Almus is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test. Any use differing from the prescribed dosage regimen or route of administration is prohibited.
Children and adolescents
The use of Valsartan and Hydrochlorothiazide Almus is not recommended in children and adolescents (under 18 years of age).
Other medicines and Valsartan and Hydrochlorothiazide Almus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
The treatment effect may be affected if Valsartan and Hydrochlorothiazide Almus is taken with certain other medicines. It may be necessary to adjust the dose, take additional precautions, or, in some cases, stop taking 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 that increase fluid elimination), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G.
• Certain antibiotics (rifampicin group), a medicine used to prevent transplant rejection (cyclosporine), and an antiretroviral medicine used to treat HIV/AIDS infections (ritonavir). These medicines may increase the effect of Valsartan and Hydrochlorothiazide Almus.
• Medicines that may cause torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and certain antipsychotics.
• Medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics.
• Medicines used to treat gout, such as allopurinol, probenecid, sulfinpyrazone.
• Therapeutic vitamin D and calcium supplements.
• Medicines used to treat diabetes (oral such as metformin or insulin).
• Other medicines that lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also section: “Do not take Valsartan and Hydrochlorothiazide Almus” 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.
• Painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (Cox-2) inhibitors and acetylsalicylic acid > 3 g.
• Muscle relaxants such as tubocurarine.
• Anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and to facilitate 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 in organ transplantation to prevent organ rejection.
• Alcohol, hypnotics, and anaesthetics (medicines with narcotic or pain-relieving effects used, for example, during surgical procedures).
• Iodinated contrast agents (used in radiological examinations).

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also section: "Do not take Valsartan and Hydrochlorothiazide Almus" and "Warnings and precautions"). If you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprololo).
Taking Valsartan and Hydrochlorothiazide Almus with food and drinks
Avoid consuming alcohol unless you have discussed it with your doctor. Alcohol may further lower blood pressure and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding

• You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Valsartan and Hydrochlorothiazide Almus before becoming pregnant or as soon as you know you are pregnant and will recommend another medicine instead of Valsartan and Hydrochlorothiazide Almus. Valsartan and Hydrochlorothiazide Almus is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
• Inform your doctor if you are breastfeeding or planning to breastfeed. Valsartan and Hydrochlorothiazide Almus is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Before driving, operating machinery, or performing other activities requiring concentration, you should be aware of how you react to Valsartan and Hydrochlorothiazide Almus. Like many other medicines used to treat high blood pressure, Valsartan and Hydrochlorothiazide Almus may rarely cause dizziness and affect your ability to concentrate.
Valsartan and Hydrochlorothiazide Almus contains lactose.
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Valsartan and Hydrochlorothiazide Almus contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially 'sodium-free'.
Valsartan and Hydrochlorothiazide Almus contains soybean oil.
This medicine contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
Valsartan and Hydrochlorothiazide Almus contains sunset yellow (E110)
Valsartan and Hydrochlorothiazide Almus 160/12.5 mg contains the colouring agent sunset yellow FCF (E110), which may cause allergic reactions.

3. How to take Valsartan and Hydrochlorothiazide Almus

Take this medicine exactly as prescribed by your doctor. This will help you achieve better results and reduce the risk of unwanted side effects. If you have any doubts, consult your doctor or pharmacist.
People with high blood pressure often do not experience any noticeable symptoms and may feel perfectly well. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.
Your doctor will tell you exactly how many tablets of Valsartan and Hydrochlorothiazide Almus you should take. Depending on your response to treatment, your doctor may recommend a higher or lower dose.

• The recommended dose of Valsartan and Hydrochlorothiazide Almus is one tablet per day.
• Do not change the dose and do not stop taking the tablets without first consulting your doctor.
• This medicine should be taken every day at the same time, usually in the morning.
• You may take Valsartan and Hydrochlorothiazide Almus with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide Almus 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.
If you forget to take Valsartan and Hydrochlorothiazide Almus
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 a forgotten dose.
If you stop taking Valsartan and Hydrochlorothiazide Almus
Stopping treatment with Valsartan and Hydrochlorothiazide Almus may cause your high blood pressure to worsen. Do not discontinue use of this medicine unless instructed to do so by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical attention

• 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
• Severe skin diseases causing rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Decreased vision or eye pain due to high intraocular pressure (possible sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Fever, sore throat, more frequent infections (agranulocytosis)
• Severe shortness of breath, fever, weakness and confusion (acute respiratory distress)

These side effects are very rare or of unknown frequency.
If you experience any of these symptoms, stop taking Valsartan and Hydrochlorothiazide Almus and
contact your doctor immediately (see also section 2 “Warnings and precautions”).
Other side effects include:
Uncommon (may affect up to 1 in 100 people)

• Cough
• Low blood pressure
• Feeling of emptiness in the head
• Dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin)
• Muscle pain
• Fatigue
• Tingling or numbness
• Blurred vision
• Noises in the ears (e.g. ringing, buzzing)

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

• Dizziness
• Diarrhea
• Joint pain

Not known (frequency cannot be estimated from available data)

• Difficulty breathing
• Marked reduction in urine output
• Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)
• Low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, abnormal heart rhythm)
• 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 kidney dysfunction)
• Increased uric acid levels in the blood (which in severe cases may lead to gout)
• Syncope (fainting)

The following side effects have been reported with medicines containing valsartan or
hydrochlorothiazide alone
Valsartan
Uncommon (may affect up to 1 in 100 people)

• Dizziness
• 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

Not known (frequency cannot be estimated from available data)

• Appearance of blisters on the skin (sign of bullous dermatitis)
• 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 blood vessel inflammation)
• Low platelet count in the blood (sometimes with unusual bleeding or bruising)
• Increased potassium levels in the blood (sometimes with muscle cramps, abnormal heart rhythm)
• Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
• Swelling, especially of the face and throat, rash, itching
• Increased liver function test values
• Decreased haemoglobin levels and percentage of red blood cells in the blood (which, in severe cases, may both cause anaemia)
• Renal failure
• Low sodium levels in the blood (which may cause fatigue, mental confusion, muscle cramps and/or seizures in severe cases)

Hydrochlorothiazide
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 rashes with itching or other types of skin rashes
• Decreased appetite
• Mild nausea and vomiting
• Dizziness, fainting when standing up
• Inability to achieve or maintain erection

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

• Swelling and blistering of the skin (due to increased sensitivity to sunlight)
• High calcium levels in the blood
• High blood sugar levels
• Sugar in the urine
• Worsening of the metabolic state in diabetes
• Constipation, diarrhea, stomach or intestinal disturbances, liver disorders which may present with yellowing of the skin and eyes
• Irregular heartbeat
• Headache
• Sleep disturbances
• Sadness (depression)
• Low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• Dizziness
• Tingling or numbness
• Vision disturbances

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

• Inflammation of blood vessels with symptoms such as skin rashes, red-purple spots, fever (vasculitis)
• Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• Facial rashes, joint pain, muscle disorders, fever (lupus erythematosus)
• Severe upper abdominal pain (pancreatitis)
• Difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty, including pneumonia and pulmonary oedema)
• Pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• Fever, sore throat or mouth ulcers due to infections (leucopenia)
• Confusion, fatigue, tremor and muscle cramp, shortness of breath (hypochloraemic alkalosis)

Not known (frequency cannot be estimated from available data)

• Fatigue, bruising and frequent infections (aplastic anaemia)
• Severe reduction in urine output (possible sign of kidney disorder or renal failure)
• Skin rash, redness of the skin, blistering on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
• Muscle cramp
• Fever (pyrexia)
• Weakness (asthenia)
• Skin and lip cancer (non-melanoma skin cancer)
• Sudden-onset difficulty seeing distant objects (acute myopia), 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)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at “https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse”. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valsartan and Hydrochlorothiazide Almus

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 "EXP.".
The expiry date refers to the last day of that month.
Blister:
Do not store above 30°C.
Tablet containers:
This medicine does not require any special storage conditions.
After first opening of the bottle: use within 100 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valsartan and Hydrochlorothiazide Almus contains
80/12.5 mg tablets

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Film coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (contains soybean oil) (E322), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

160/12.5 mg tablets

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Film coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (contains soybean oil) (E322), iron oxide red (E172), sunset yellow FCF, aluminium lake (E110).

160/25 mg tablets

• The active substances are valsartan and hydrochlorothiazide. Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.
• The other components are: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K29-K32, talc, magnesium stearate, anhydrous colloidal silicon dioxide. Film coating: polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (contains soybean oil) (E322), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

Description of the appearance of Valsartan and Hydrochlorothiazide Almus and contents of the pack
Valsartan and Hydrochlorothiazide Almus 80 mg/12.5 mg film-coated tablets, pink, oval-shaped, biconvex, film-coated tablets, 11 x 5.8 mm, marked with “V” on one side and “H” on the other.
Valsartan and Hydrochlorothiazide Almus 160 mg/12.5 mg film-coated tablets, red, oval-shaped, biconvex, film-coated tablets, 15 x 6 mm, marked with “V” on one side and “H” on the other.
Valsartan and Hydrochlorothiazide Almus 160 mg/25 mg film-coated tablets, orange, oval-shaped, biconvex, film-coated tablets, 15 x 6 mm, marked with “V” on one side and “H” on the other.
Blister packs: 7, 14, 28, 30, 56, 98 and 280 tablets.
Bottles: 7, 14, 28, 30, 56, 98 and 280 tablets.

Marketing Authorization Holder
Almus S.r.l. - Via Cesarea 11/10, 16121 Genoa, Italy

Manufacturer
Actavis Ltd. - BLB016 Bulebel Industrial Estate, Zejtun ZTN3000 (Malta)
Balkanpharma Dupnitsa AD - 3, Samokovsko Shosse Str., 2600 Dupnitsa (Bulgaria)