HIMAVAT 10 mg/10 mg Tabletka Powlekana

Treść ulotki

1. HIMAVAT 10 mg/10 mg tablets, 10 mg/20 mg tablets, 10 mg/40 mg tablets, 10 mg/80 mg tablets
   1. What HIMAVAT is and what it is used for
   2. What you need to know before taking HIMAVAT
2. HIMAVAT contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.
   1. How to take HIMAVAT
   2. Possible side effects
   3. How to store HIMAVAT
   4. Contents of the pack and other information

HIMAVAT 10 mg/10 mg tablets, 10 mg/20 mg tablets, 10 mg/40 mg tablets, 10 mg/80 mg tablets

ezetimibe and atorvastatin

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What HIMAVAT is and what it is used for

HIMAVAT is a medicine used to lower high cholesterol levels. HIMAVAT
contains ezetimibe and atorvastatin.
HIMAVAT is used in adults to lower total cholesterol levels, “bad” cholesterol (LDL cholesterol) and fats in the blood called triglycerides. In addition,
HIMAVAT increases levels of “good” cholesterol (HDL cholesterol).
HIMAVAT works in two ways to lower cholesterol. It reduces the cholesterol absorbed from the digestive tract, as well as the cholesterol produced naturally by the body.
Cholesterol is one of several fatty substances present in the bloodstream. Total cholesterol is
mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up on the walls
of the arteries forming plaques. Over time, this buildup in the form of plaque
can lead to narrowing of the arteries. This narrowing can slow down or block the
flow of blood to vital organs such as the heart and brain. This blockage of blood flow
can cause a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps prevent “bad” cholesterol from accumulating in the arteries and provides protection against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of
heart disease.
HIMAVAT is used to treat patients in whom diet alone is not sufficient to keep
cholesterol levels under control. While taking this medicine you should still
follow a diet to lower cholesterol.
The doctor may prescribe HIMAVAT if you are already taking atorvastatin and ezetimibe at the
same dosage.
HIMAVAT does not help with weight loss.

2. What you need to know before taking HIMAVAT

Do not take HIMAVAT if

• you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• you have or have ever had a liver disease
• you have had blood tests to check your liver function that have come back inexplicably abnormal
• you are a woman of childbearing potential and are not using a reliable contraceptive method
• you are pregnant, trying to become pregnant or are breastfeeding
• you are using the glecaprevir/pibrentasvir combination in the treatment of Hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking HIMAVAT if

• you have had a stroke with cerebral haemorrhage in the past or if there are small collections of fluid in the brain resulting from previous strokes
• you have kidney problems
• you have an underactive thyroid gland (hypothyroidism)
• you have had repeated or unexplained muscle discomfort or pain, a personal or family history of muscle problems
• you have had muscle problems in the past while taking other medicines to lower lipids (e.g. other medicines based on “statins” or “fibrates”)
• you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) by mouth or by injection. The combination of fusidic acid and Atorvastatin/Ezetimibe can lead to serious muscle problems (rhabdomyolysis)
• you regularly consume large amounts of alcohol
• you have a history of liver disease
• you are over 70 years of age,

Contact your doctor immediately if you experience unexplained pain, tenderness or weakness
in your muscles while taking HIMAVAT.This is because muscle problems can be serious in rare cases, including muscle breakdown leading to kidney damage.
Before taking HIMAVAT, check with your doctor or pharmacist:

• if you have severe breathing difficulties.

If any of these conditions apply to you (or if you are not sure), talk to your doctor or
pharmacist before taking HIMAVAT as your doctor may need to ask you to have a blood test before and possibly during treatment to predict the risk of muscle-related side effects. It is known that the risk of developing muscle-related side effects, e.g. rhabdomyolysis (breakdown of skeletal muscles), increases when certain medicines are taken at the same time (see section 2 “Other medicines and
HIMAVAT”).
During treatment with this medicine, your doctor will carefully monitor you if you suffer from
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high
levels of sugar and fats in your blood, if you are overweight and if you have high blood pressure.
Tell your doctor about all your medical conditions including allergies.

Children
HIMAVAT is not recommended in children and adolescents.

Other medicines and HIMAVAT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Fibrates (medicines that lower cholesterol levels) should be avoided while you are
taking HIMAVAT.
Some medicines may change the effect of HIMAVAT or their effect may be
changed by HIMAVAT (see section 3). This type of interaction could reduce
the effectiveness of one or both medicines. Alternatively it could increase the risk of
developing side effects or their severity, including the serious condition of muscle wasting known as “rhabdomyolysis” described in section 4:

• cyclosporine (a medicine often used in patients who have had an organ transplant)
• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (medicines used to treat bacterial infections)
• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections)
• gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, colestyramine (medicines used to regulate lipid levels)
• some calcium antagonists used for the treatment of angina or hypertension, e.g. amlodipine and diltiazem
• digoxin, verapamil, amiodarone (medicines used to regulate heart rhythm)
• Leteremovir, a medicine that prevents cytomegalovirus disease
• medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the tipranavir/ritonavir combination, etc. (medicines for AIDS)
• some medicines used to treat Hepatitis C, e.g. telaprevir, boceprevir and the elbasvir/grazoprevir combination
• if you need to take fusidic acid by mouth to treat a bacterial infection you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with HIMAVAT. Taking HIMAVAT with fusidic acid can rarely lead to weakness, tenderness or pain in your muscles (rhabdomyolysis). See more information about rhabdomyolysis in section 4.
• Other medicines known to interact if used in combination
• oral contraceptives (medicines to prevent pregnancy),
• stiripentol (an anticonvulsant medicine for the treatment of epilepsy),
• cimetidine (a medicine used to treat heartburn and peptic ulcers),
• phenazone (a painkiller),
• antacids (medicines for digestive problems containing aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots),
• colchicine (used to treat gout),
• St John's Wort (a medicine to treat depression).

HIMAVAT with food and alcohol
See section 3 for instructions on how to take HIMAVAT. Pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice a day as large amounts
of grapefruit juice can change the effects of the medicine.

Alcohol
Avoid drinking excessive amounts of alcohol while being treated with this medicine. For more
information see section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility
Do not take HIMAVAT if you are pregnant, if you are trying to become pregnant.
Do not take HIMAVAT if you are a woman of childbearing potential unless you are using effective contraceptive measures. If you become pregnant during therapy with HIMAVAT, stop
taking it immediately and consult your doctor.
Do not take HIMAVAT if you are breastfeeding.
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
HIMAVAT is not expected to interfere with the ability to drive or operate machinery.
However, it should be noted that some people may experience dizziness after taking
HIMAVAT. If you experience dizziness after taking this medicine, avoid driving or
operating machinery.

HIMAVAT contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

HIMAVAT contains sodium

HIMAVAT contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

sodio”.

3. How to take HIMAVAT

Always take this medicine exactly as your doctor has instructed. The doctor will determine the appropriate tablet dosage for you based on the ongoing treatment and your risk profile. If you have any doubts, consult your doctor or pharmacist.

• Before starting treatment with HIMAVAT, you must have already started a diet to reduce cholesterol levels.
• During treatment with HIMAVAT, you must continue to follow a diet to reduce cholesterol levels.

What dose to take
The recommended dose is one HIMAVAT tablet once a day, preferably always at the same time. The tablet must be swallowed whole with a sufficient amount of liquid (e.g. a glass of water).
When to take the medicine
You can take HIMAVAT at any time of the day. You can take it with or without food.
If your doctor has prescribed HIMAVAT in association with colestyramine or another bile acid sequestrant (medicines used to lower cholesterol levels), you must take HIMAVAT at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more HIMAVAT than you should
Contact your doctor or pharmacist.

If you forget to take HIMAVAT
Do not take a double dose to make up for a missed dose; just take your usual dose of HIMAVAT the next day at the usual time.
If you have any further doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, HIMAVAT can cause side effects, although not everybody gets them.
manifest.

If you notice any of the following serious side effects or symptoms, stop taking the tablets and tell your doctor immediately or go to the nearest hospital emergency room, bringing the medicine with you.

• severe allergic reaction that causes swelling of the face, tongue and throat which can cause great difficulty in breathing
• severe illness with severe exfoliation and swelling of the skin, blistering of the skin, mouth, eyes, genitals and fever; rash with pink-red pustules especially on the palm of the hands or the sole of the feet, which may become covered with blisters
• weakness, tenderness, pain or muscle breakdown or reddish-brown discoloration of the urine and especially, if at the same time you do not feel well and have a high fever, this may be caused by

an unusual muscle breakdown which can be life-threatening and can cause kidney problems

• lupus-like syndrome (including rash, joint problems and effects on blood cells) If you experience problems characterized by unexpected or unusual bleeding or bruising, consult your doctor as soon as possible as these may be signs of a liver disorder.

Other possible side effects with HIMAVAT:
Common (may affect up to 1 in 10 people):

• inflammation of the nasal passages, sore throat, nosebleeds,
• allergic reactions,
• increased glucose in the blood; diabetic patients should monitor their blood glucose levels,
• headache,
• nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain,
• sore throat and/or larynx,
• joint and/or hand or foot pain, back pain, muscle pain (myalgia), muscle spasm, joint swelling,
• increased creatine kinase in the blood,
• increased liver enzymes ALT and/or AST,
• fatigue,
• abnormal liver function test. Uncommon (may affect up to 1 in 100 people):
• swelling due to allergic reaction,
• decreased glucose in the blood; diabetic patients should monitor their blood glucose levels,
• loss of appetite, weight gain
• cough,
• muscle weakness, neck pain, chest pain,
• hot flushes, hypertension,
• vomiting, belching, inflammation of the pancreas and liver, heartburn, inflammation of the stomach membranes, dry mouth,
• skin redness, hives, rash, itching, hair loss,
• nightmares, difficulty falling asleep,
• drowsiness, numbness, altered taste, amnesia, abnormal local sensations,
• blurred vision,
• ringing in the ears,
• feeling unwell, discomfort or general pain,
• weakness,
• increased gamma-glutamyltransferase liver enzyme,
• positive urine test for white blood cells, Rare (may affect up to 1 in 1000 people):
• decreased platelets,
• swelling of the lower layer of skin tissue of the face, tongue, throat, abdomen, arms or legs (angioedema),
• widespread rash forming clearly demarcated red patches or rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals due to an allergic reaction,
• inflammation of skeletal muscle, inflammation of tendons sometimes complicated by deterioration and muscle weakness due to loss of skeletal muscle fibers,
• vision disorders,
• yellowing of the skin and whites of the eyes. Very rare (may affect up to 1 in 10,000 people):
• anaphylactic shock from allergic reaction,
• hearing loss,
• liver failure,
• breast enlargement in men. Frequency not known (which cannot be estimated based on available data):
• allergic reaction including rash and swelling of the lower layer of skin
• shortness of breath, inflammation of the gallbladder, gallstones,
• physical weakness and loss of strength, loss of muscle tissue from autoimmune antibodies,
• depression,
• dizziness. In addition, the following side effects have been reported during post-marketing use of some statins (medicines used to lower cholesterol levels):
• breathing problems including persistent cough and/or shortness of breath or fever,
• diabetes: the frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m², increased triglycerides, history of hypertension),
• depression,
• sexual difficulties. Reporting of side effectsIf you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through

adverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store HIMAVAT

Keep this medicine out of the sight and reach of children.
Do not use HIMAVAT after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What HIMAVAT contains

• The active ingredients are ezetimibe and atorvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other ingredients are: lactose monohydrate, calcium carbonate, microcrystalline cellulose, sodium lauryl sulfate [E487], sodium croscarmellose, povidone K30, hydroxypropylcellulose, magnesium stearate and polysorbate 80.

Description of the appearance of HIMAVAT and contents of the pack
HIMAVAT 10 mg/10 mg: capsule-shaped tablets (12.7 mm x 5.1 mm), from white to off-white in colour with “1” imprinted on one side.
HIMAVAT 10 mg/20 mg: capsule-shaped tablets (14.5 mm x 6.8 mm), from white to off-white in colour with “2” imprinted on one side.
HIMAVAT 10 mg/40 mg: capsule-shaped tablets (16.4 mm x 6.3 mm), from white to off-white in colour with “3” imprinted on one side.
HIMAVAT 10 mg/80 mg: capsule-shaped tablets (17.0 mm x 8.0 mm), from white to off-white in colour with “4” imprinted on one side.
Available in packs of 30 tablets in OPA/Aluminum/PVC blisters contained in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo n. 15
20143 Milan

Manufacturer
Hennig Arzneimittel GmbH & Co.KG
Liebistr. 1-2
D-65439 Flörsheim, Germany