Patient Information Leaflet: Information for the User

Snoverid 20 mg/12.5 mg film-coated tablets, 20 mg/25 mg film-coated tablets, 40 mg/12.5 mg film-coated tablets, 40 mg/25 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide
“Generic medicine”
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Snoverid is and what it is used for
What you need to know before taking Snoverid
How to take Snoverid
Possible side effects
How to store Snoverid
Contents of the pack and other information

1. What Snoverid is and what it is used for

Snoverid contains two substances called olmesartan medoxomil and hydrochlorothiazide. Both are used
to control high blood pressure (hypertension).

Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. It lowers blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics” (“water tablets”). It reduces blood pressure by helping the body get rid of excess fluid, causing the kidneys to produce more urine.

You will be prescribed Snoverid if olmesartan medoxomil alone has not adequately controlled your
blood pressure. When given together, the two active substances in Snoverid help reduce blood pressure more than when used individually.
If you are already taking medicines to treat high blood pressure, your doctor may prescribe Snoverid to achieve a further reduction.
High blood pressure can be controlled with medicines such as Snoverid tablets. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow these recommendations from your doctor.

2. What you should know before taking Snoverid

Do not take Snoverid:

if you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides)
if you are more than three months pregnant (it is advisable to avoid using Snoverid even during the first months of pregnancy – see the section “Pregnancy and breastfeeding”)
if you have low levels of potassium or sodium, or high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve with treatment
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

[Applies only to 20 mg/12.5 mg and 20 mg/25 mg]

if you have severe kidney problems
if you have severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile flow from the gallbladder (biliary obstruction, for example due to gallstones) [Applies only to 40 mg/12.5 mg and 40 mg/25 mg]
if you have severe kidney problems
if you have moderate or severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile flow from the gallbladder (biliary obstruction, for example due to gallstones)

If you think any of these conditions apply to you, or are unsure, do not take this medicine. Contact your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before using Snoverid.

Before taking this medicine, consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
Aliskiren

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Snoverid”.

Before taking the tablets, consult your doctor if you have any of the following health problems:

Liver disease
Heart failure or problems with heart valves or heart muscle
Severe vomiting or diarrhea lasting several days
Treatment with high doses of diuretics or if you are on a low-salt diet
Adrenal gland disorders (for example primary aldosteronism)
Diabetes
Lupus erythematosus (an autoimmune disease)
Allergy or asthma
If you have had skin cancer or develop a suspicious 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 cancer and lip cancer. While taking Snoverid, protect your skin from sun exposure and UV rays.
If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Snoverid, consult a doctor immediately.

[Applies only to 20 mg/12.5 mg and 20 mg/25 mg]

Mild or moderate kidney problems or if you have recently undergone a kidney transplant [Applies only to 40 mg/12.5 mg and 40 mg/25 mg]
Kidney transplant

Inform your doctor if you experience any of the following symptoms:

Severe and prolonged diarrhea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
Vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur within hours or weeks of taking Snoverid. If untreated, this increase in pressure may lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

Contact your doctor if, after taking Snoverid, you experience abdominal pain, nausea, vomiting, or diarrhea. Your doctor will decide whether to continue treatment. Do not stop taking Snoverid on your own.

Your doctor may want to examine you more frequently and order blood tests if you have any of the conditions listed above.

Snoverid may increase blood lipid and uric acid levels (which can cause gout – painful joint swelling). Your doctor may want to perform periodic blood tests to monitor these conditions.

Levels of certain substances called electrolytes in the blood may change. Your doctor may want to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), general weakness, lethargy, fatigue, drowsiness or lack of rest, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you experience these symptoms.

As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.

If you need to have tests for parathyroid function, you must stop taking Snoverid before undergoing such tests.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

You must inform your doctor if you think you are pregnant or are planning to become pregnant.

Snoverid is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents

Snoverid is not recommended for children and adolescents under 18 years of age.

Other medicines and Snoverid

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

In particular, inform your doctor or pharmacist about the following medicines:

Other medicines that lower blood pressure (antihypertensives) may increase the effect of Snoverid.
Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Snoverid” and “Warnings and precautions”).
Medicines that may alter potassium levels in the blood when used together with Snoverid. These include:
potassium supplements (such as potassium-containing salt substitutes)
diuretics
heparin (to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as sodium benzylpenicillin, an antibiotic)
certain painkillers such as aspirin or salicylates.
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Snoverid may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) used together with Snoverid may increase the risk of kidney failure. The effectiveness of Snoverid may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, used together with Snoverid, may cause a sudden drop in blood pressure when standing up.
Certain medicines such as baclofen and tubocurarine, used to relax muscles.
Amifostine and certain other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
Cholestyramine and colestipol, medicines used to reduce blood fat levels.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Snoverid. Your doctor may advise you to take Snoverid at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines, such as atropine and biperiden.
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric conditions.
Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart conditions.
Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin, which may alter heart rhythm.
Oral antidiabetic medicines, such as metformin, or insulin, used to reduce blood glucose levels.
Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood glucose levels, respectively, as Snoverid may enhance their hyperglycemic effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Difemethiazine, used to treat slow heartbeat or reduce sweating.
Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
Calcium supplements.
Amantadine, an antiviral medicine.
Cyclosporine, a medicine used to prevent rejection of transplanted organs.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Some antacids used for stomach acidity, such as aluminum and magnesium hydroxide, because they may slightly reduce the effectiveness of Snoverid.
Cisapride, used to increase movement of food through the stomach and intestines.
Halofantrine, used for malaria.

Olmesartan medoxomil Snoverid with food and drink

Snoverid can be taken with or without food.

Be cautious about consuming alcohol during treatment with Snoverid, as some people may feel weak or dizzy. If this happens to you, do not drink any more alcohol, including wine, beer, or flavored alcoholic beverages.

Patients of Black ethnicity

As with other similar medicines, the blood pressure-lowering effect of Snoverid may be somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you think you are pregnant or if you are planning a pregnancy. Your doctor will usually advise you to stop taking Snoverid before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Snoverid is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken after this time.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Snoverid is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Driving and using machines

You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

[Applies only to 20 mg/12.5 mg and 40 mg/12.5 mg]

Snoverid contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Snoverid contains sunset yellow, which may cause allergic reactions.

[Applies only to 20 mg/12.5 mg and 40 mg/12.5 mg]

Snoverid contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Snoverid

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

[Applies only to 20 mg/12.5 mg and 20 mg/25 mg]
The recommended dose is one tablet of Snoverid 20 mg/12.5 mg daily. However, if your blood pressure is not controlled, your doctor may decide to change your prescription to one tablet of Snoverid 20 mg/25 mg daily.

[Applies only to 40 mg/12.5 mg and 40 mg/25 mg]
The recommended dose is one tablet of Snoverid 40 mg/12.5 mg daily. However, if your blood pressure is not controlled, your doctor may decide to change your prescription to one tablet of Snoverid 40 mg/25 mg daily.

Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for example with breakfast. It is important to continue taking Snoverid until your doctor tells you to stop.

If you take more Snoverid than you should
If you take more tablets than prescribed, or if a child accidentally swallows any, go immediately to your doctor or nearest emergency department, and bring the medicine pack with you.

If you forget to take Snoverid
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Snoverid
It is important to continue taking Snoverid unless your doctor tells you to stop.

If you have any questions about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
However, the following side effects can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (the area containing the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Snoverid and contact your doctor immediately.
Snoverid may cause excessive lowering of blood pressure in predisposed individuals as a result of an allergic reaction. Dizziness or fainting are not very common. If this happens, stop taking Snoverid, contact your doctor immediately, and lie down.
Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Snoverid for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment for high blood pressure.

Snoverid is a combination of two active substances, and the information below first lists other side effects reported so far with the combination of olmesartan medoxomil and hydrochlorothiazide (in addition to those already mentioned above), followed by those known for the individual active substances.

Other possible side effects of Snoverid reported so far:
If these side effects occur, they are often mild, and you do not need to stop treatment.

Common side effects (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands, or arms.

Uncommon side effects (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle pain and muscle cramps, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following laboratory test abnormalities have also been observed:
Increased levels of lipids in the blood, increased levels of urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood glucose, increased liver function tests.

Your doctor will become aware of these through blood tests and will advise you if any action is needed.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (wheals), acute kidney failure.

Rarely, the following laboratory test abnormalities have also been observed:
Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will become aware of these through blood tests and will advise you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Snoverid or with higher frequency:

Olmesartan medoxomil:
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, nasal hypersecretion, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.

Commonly observed laboratory test abnormalities include:
Increased levels of lipids in the blood, increased levels of urea or uric acid in the blood, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a sudden drop in blood pressure leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), skin allergic reactions, itching, rash, skin blisters (wheals).

Uncommonly observed laboratory test abnormalities include:
Reduced number of blood platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.

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

Rarely, the following laboratory test abnormalities have also been observed:
Increased potassium levels in the blood.

Hydrochlorothiazide
Very common side effects (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of fats and uric acid in the blood.

Common side effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Laboratory test abnormalities observed include:
Increased levels of creatinine, urea, calcium, and glucose in the blood; decreased levels of chloride, potassium, magnesium, and sodium in the blood. Increased serum amylase (hyperamylasemia).

Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purpura (small hemorrhages appearing as spots or patches on the skin), skin blisters (wheals).

Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow damage, restlessness, feeling of depression, sleep disturbances, lack of interest (apathy), tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, lupus-like symptoms (such as skin rash, joint pain, cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement limitations).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte imbalances causing abnormally low chloride levels in the blood (hypochloremic alkalosis). Intestinal obstruction (paralytic ileus).
Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Side effects with unknown frequency (frequency cannot be estimated from the available data):
Skin and lip cancer (non-melanoma skin cancer).
Vision loss or eye pain due to 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 may also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Snoverid

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after
"Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Snoverid contains

The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The other components (excipients) are:
Tablet core: Monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose type 102, magnesium stearate.
Coating:
[Applies only to 20 mg/12.5 mg and 40 mg/12.5 mg]
Opadray II Orange 33G23991 containing hypromellose 6 cP, titanium dioxide (E171), monohydrate lactose, polyethylene glycol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), aluminium lake of sunset yellow FCF (E110).
[Applies only to 20 mg/25 mg and 40 mg/12.5 mg]
Opadry II Pink 33G34149 containing: hypromellose 6 cP, titanium dioxide (E171), monohydrate lactose, polyethylene glycol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172).

What Snoverid looks like and contents of the pack
Snoverid 20 mg/12.5 mg film-coated tablets are orange, round, biconvex, with a diameter of 8.5 mm, marked on one side with the code OH 21.
Snoverid 20 mg/25 mg film-coated tablets are pink, round, biconvex, with a diameter of 8.5 mm, marked on one side with the code OH 22.
Snoverid 40 mg/12.5 mg film-coated tablets are orange, oval, biconvex, 15 x 7 mm, marked on one side with the code OH 41.
Snoverid 40 mg/25 mg film-coated tablets are pink, oval, biconvex, 15 x 7 mm, marked on one side with the code OH 42.

Packaging
Blister (Al-Al): 28 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. Group Srl
Via Tiburtina, 1143
00156 – Rome, Italy

Manufacturer
Actavis Ltd.,
BLB 015-016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Snoverid